[Federal Register Volume 65, Number 243 (Monday, December 18, 2000)]
[Rules and Regulations]
[Pages 79162-79190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31873]
[[Page 79161]]
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Part II
Nuclear Regulatory Commission
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10 CFR Parts 30, 31, and 32
Requirements for Certain Generally Licensed Industrial Devices
Containing Byproduct Material; Final Rule
Federal Register / Vol. 65, No. 243 / Monday, December 18, 2000 /
Rules and Regulations
[[Page 79162]]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30, 31, and 32
RIN 3150--AG03
Requirements for Certain Generally Licensed Industrial Devices
Containing Byproduct Material
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its
regulations governing the use of byproduct material in certain
detecting, measuring, gauging, or controlling devices, and devices to
produce light or an ionized atmosphere. The amendments include explicit
provisions for a registration process authorized under a provision of
the existing regulations. A registration fee will be required for each
registration. Although the amendments apply to all users of these
devices (general licensees), the registration and associated fee apply
to a limited fraction of these general licensees, not including, for
example, users of exit signs. The final rule also modifies the
reporting, recordkeeping, and labeling requirements for specific
licensees who distribute these generally licensed devices. The final
rule is intended to allow the NRC to better track certain general
licensees and the devices they possess, and to better ensure that
general licensees are aware of and understand the requirements for the
possession of devices containing byproduct material.
EFFECTIVE DATES: February 16, 2001.
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 nrc.gov">CRM@nrc.gov.
SUPPLEMENTARY INFORMATION:
Background
On February 12, 1959 (24 FR 1089), the Atomic Energy Commission
(AEC) amended its regulations to provide a general license (10 CFR
30.21(c)) for the use of byproduct material contained in certain
measuring, gauging, or controlling devices, and devices for producing
light or an ionized atmosphere. Under the regulations currently in 10
CFR 31.5, certain persons may receive and use a device containing
byproduct material under this general license that has been
manufactured and distributed according to a specific license issued by
the NRC or by an Agreement State. (An Agreement State is a State that
has entered into an agreement with the NRC that gives it the authority
to license and inspect persons using or possessing certain radioactive
materials, called byproduct, source, and special nuclear materials,
within their borders.) A specific license authorizing distribution of
generally licensed devices is issued if a regulatory authority (the
NRC, or where provided by a memorandum of agreement, an Agreement
State) determines that the safety features of the device and the
instructions for its safe operation are adequate and meet regulatory
requirements.
The person or organization 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 40,000 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. 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 (i.e. the slag and the baghouse dust).
Although known exposures have generally not exceeded the public dose
limits, there is a potential for significant exposures.
In July 1995, the NRC, with assistance from the Organization of
Agreement States, formed a working group to evaluate the issues related
to the loss of control of both generally and specifically licensed
devices. 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 initiate rulemaking to
establish an annual registration of some of the devices generally
licensed under Sec. 31.5.
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 to
explicitly require general licensees who possess certain measuring,
gauging, or controlling devices to provide the NRC with information
about the devices. The final rule was published on August 4, 1999 (64
FR 42269), and became effective October 4, 1999. The NRC intends to use
that general provision primarily to conduct a registration program. The
NRC is using the criteria developed by the working group for
determining which sources should be subject to the registration
program. Registration is being required only for those devices
considered to present a higher risk (compared to other generally
licensed devices) of potential exposure of the public or property
damage in the case of loss of control. This does not include self-
luminous exit signs.
[[Page 79163]]
These criteria were based on considerations of risk and are limited
to radionuclides currently used in devices covered under this general
license. 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 the additional radionuclides.
That rulemaking was not made a matter of compatibility for
Agreement States. The final rule was estimated to impact 5100 general
licensees. However, in the interim, Ohio and Oklahoma have become
Agreement States. Using the same criteria, and eliminating the general
licensees in Ohio and in Oklahoma, approximately 4300 NRC general
licensees will be subject to the registration requirement.
On July 26, 1999 (64 FR 40295), the Commission published another
proposed rule to add specific requirements concerning the registration
of devices and additional provisions for an enhanced regulatory
oversight program for all Sec. 31.5 general licensees. The rule also
proposed to require 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. Also, a few States have
exercised a higher level of control over these devices by requiring
specific licenses. The proposed category of compatibility for Sec. 31.5
would have required the essential objectives of the regulation to be
adopted by the States to avoid regulatory conflicts, duplications, or
gaps. However, the manner of addressing the essential objectives of the
regulation would not have been required to be the same as used by the
NRC. Strict compatibility was proposed only for revisions to the
requirements applicable to distributors. The Compatibility Categories
assigned to some provisions have been reconsidered by the Commission.
Changes to the proposed designations are discussed below.
General Discussion
The August 4, 1999, final rule provides one of the key elements in
improving the accountability and control over devices of particular
concern through the institution of a registration process. However,
regulatory provisions were still inadequate to allow the NRC to track
general licensees and the specific devices they possess. The NRC needs
to keep track of these general licensees so that they can be contacted
or inspected, when appropriate. The NRC also wishes to keep track of
each generally licensed device, so that the responsible party can be
identified when a device is found in an inappropriate situation.
Tracking devices will also allow the NRC to contact the appropriate
general licensees if a generic defect in a group of devices is
identified. As previously noted, that rule did not require Agreement
State regulations to be compatible.
There are other means for reducing the likelihood of incidents of
lost sources. The Commission 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 the proposed rule published on July 26, 1999, for
public comment. The Commission has considered the public comments
received on that rule, comments made on the December 2, 1998, proposed
rule that related to the issues in this rule, and the comments made at
two public meetings held on July 27-28, 1999, and October 1, 1999, in
completing this final rule.
Summary and Discussion of New Requirements
Revisions to the Requirements for General Licensees Under Sec. 31.5
Registration. This rule adds explicit provisions delineating the
annual registration requirements, including the requirement for a
registration fee. The registration fee will be established as a part of
the FY 2001 fee rulemaking. The registration process is being initiated
under the more general provision in Sec. 31.5(c)(11), which became
effective October 4, 1999. Paragraph 31.5(c)(11) requires licensees to
respond to requests for information from NRC within 30 days or as
otherwise specified. The provisions in this rule (new Sec. 31.5(c)(13))
are consistent with the Commission's plans for the registration process
discussed in the August 4, 1999, final rule. This final rule
specifically requires that licensees verify information about devices
through a physical inventory and by checking label information. The
advantage of including more specific requirements in the regulation is
that information about the registration process will be more clearly
defined and more readily 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 will 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 that 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 must complete more than one registration if it possesses
devices subject to registration at multiple distinct locations.
The final rule adds a provision to specifically exclude Agreement
State general licensees using a device in NRC jurisdiction for less
than 180 days in any calendar year from the registration requirement.
This is discussed further under section C.
A fee will be required for each annual registration. Based on the
current budgeted costs, FTE rate, and the estimated number of general
licensees subject to registration, the fee is expected to be
approximately $440-$450. The FTE rate is the rate established in part
170 to recover the costs for a professional employee. The fee is not
being finalized at this time because it is anticipated that the first
registration subject to the registration fee would not be filed until
FY 2002. Therefore, the final fee will be established as part of the FY
2001 notice and comment fee rulemaking based on that year's budgeted
costs, FTE rate, and number of registrants. The registration fee will
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
address at which devices are used (or stored), and will be assessed a
registration fee for each location of use. The first round of
registration will be completed without assessing fees.
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 registration fee will 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 use devices subject
to registration under the general license will now bear the operational
cost of the program instead of those who hold specific licenses.
[[Page 79164]]
The costs to be recovered through the registration fee will 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, may be exempt
from the fee under Sec. 170.11. Costs not recovered from this small
segment of the general licensees registering devices will continue to
be recovered from annual fees paid by holders of specific licenses.
This registration process is somewhat different from that used in
the Commission's other registration programs, in which blank forms are
filled out by registrants. Instead, registration requests containing
the information recorded in the Commission's database are being sent,
that ask the general licensee to verify, correct, and/or add to the
information provided. This process is similar to the approach typically
used by many States for the renewal of automobile registrations and is
intended to be more efficient for the general licensees and the
Commission.
The time of year for registration varies for licensees. However,
NRC's requests for renewal of registration will be made approximately 1
year after the previous registration request for that licensee.
Although registration is not 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 material transfer reports submitted under Sec. 32.52 shortly
after the NRC receives and records this information. If a general
licensee has previously registered devices and receives additional
devices requiring registration, the new devices will be registered when
the annual reregistration is carried out.
Other revisions for Sec. 31.5 general licensees. The rule
establishes additional requirements for all general licensees under
Sec. 31.5.
(1) An explicit requirement for the general licensee to appoint an
individual: to be responsible for knowing what regulatory requirements
are applicable to the general licensee; to have authority to take
required actions to comply with the applicable regulations; and through
whom the general licensee carries out its regulatory responsibilities
(new Sec. 31.5(c)(12)).
Rationale: The ``person'' who holds a general license is usually a
corporation, or public or private institution, rather than an
individual. In practice, 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. 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 a specific
individual to be responsible for knowing, and to have authority to take
required actions for complying with, the regulations should improve the
probability that the general licensees will comply with the
regulations. This individual does not have to be physically present
where and when the device is used and does not have to conduct all
required actions, but should be responsible to ensure that the general
licensee is aware of required actions to be taken. This assignment does
not, however, relieve the general licensee of its regulatory
responsibilities.
(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 (if required under Sec. 31.5(c)(2) and (3)) during the period
of storage; the final version includes an exception for devices in
standby for future use (new Sec. 31.5(c)(15)). These provisions do not
relieve the general licensee from the requirement to register devices
annually and pay a registration fee, if applicable.
Rationale: The rule limits to 2 years the time a licensee can keep
a device and not use it. 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. Experience shows that often
a device being held in storage indefinitely is being held to avoid the
costs of proper disposal.
Some devices are subject to leak testing or testing of on-off
mechanisms under Sec. 31.5(c)(2) and (3). Normal time intervals for
this testing are set for the particular device. If a period of storage
exceeds the normal interval for testing, this testing will not be
required until the device is to be put back into use again. This will
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. The final rule makes an exception to the 2-
year limit for devices held in standby for future use if the licensee
conducts quarterly inventories. Other options if a general licensee
intends to use a device after a period of more than 2 years of nonuse,
are, as noted in the proposed rule: 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. Licensees should have appropriate reasons for holding a device
in standby, such as when a gauge is kept on site as an essential spare
part for a production process, or when a university or other research
facility has intermittent needs for certain types of devices and a
clear expectation of continued use at some point.
(3) A provision to allow transfers to specific licensees authorized
under part 30, or equivalent Agreement State regulations, as waste
collectors, in addition to 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;
the final version removes the exception to reporting in the case of
device replacement (revision of Sec. 31.5(c)(8)).
Rationale: This proposed revision provides some flexibility to the
general licensee in transferring a device while ensuring that it is
transferred appropriately. It allows a general licensee to transfer a
device directly to a waste collector for disposal, rather than going
through a distributor. It also allows the transfer of a device to other
specific licensees, but requires NRC approval in these cases so that
NRC can ensure that the recipient is authorized to receive the device.
The final rule removes the exception to the transfer report requirement
in the case of a device replacement. This change is
[[Page 79165]]
discussed below under ``Public Comments on the Proposed Rule.''
The inclusion of a recipient's license number in the report of
transfer will 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 the device. It also provides 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) A provision to notify NRC of address changes, including name
changes (new Sec. 31.5(c)(14)).
Rationale: 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 names of general licensees in their
jurisdictions and the addresses where these general licensees can be
contacted (under this rule, 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 requirement to report address changes applies to the
mailing address for the location of use and, for portable devices, the
mailing address for the primary place of storage, although the devices
may be used at multiple field sites. Registration information may
include more than one address. For those registering devices, changes
in addresses other than the mailing address for the location of use
will be provided at the time of the next registration. 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 keep
track of licensee moves and to maintain current mailing address
information.
(5) A revision of the information required to be sent to NRC in the
case of device damage or failure, which adds a plan for ensuring that
premises and environs are suitable for unrestricted access in the case
of device damage or failures that are likely to, or are known to, have
resulted in contamination; a change to the addressee for reporting
information concerning a failure; 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); the final version adds a clarification
that byproduct material no longer in the device may only be transferred
to a licensee authorized to receive it or as otherwise approved by the
Commission. (revision to Sec. 31.5(c)(5)).
Rationale: 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 respond to the notification of an incident made under
Sec. 31.5(c)(5) to ensure that a facility is properly decontaminated.
Following this type of 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). The NRC can take action under
Sec. 30.61, ``Modification and revocation of licenses,'' as this
section is applicable to general licensees. The revision in this action
requires 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 preexisting requirements) along with any confirmatory
surveys may be sufficient.
The addressee for submitting information under Sec. 31.5(c)(5) is
being changed from Regional Administrator to Director, Office of
Nuclear Material Safety and Safeguards so there will be a single
addressee specified in Sec. 31.5 for reports by these licensees 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 are specified in the NRC registration request. Adding a
note concerning the possible applicability of Sec. 20.1402 is a
clarification.
(6) A revision of the reporting requirement, in the case of a
transfer to a general licensee taking possession of a device at the
same location, to provide the serial number of the device and the name,
title, and phone number for the person designated as the responsible
individual, rather than simply a contact name, and specifying the
required address as the mailing address for the location of use; the
final version also adds to the information to be provided by the
transferor to the transferee, copies of additional applicable
regulatory provisions. (revision to Sec. 31.5(c)(9)(i)).
Rationale: Consistent with the provision for appointing an
individual through whom the general licensee will ensure compliance
with the applicable regulations and requirements, and other new
reporting requirements, 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. The additional change in the final rule is to ensure that new
general licensees receive appropriate regulatory information, even in
the case of a transfer from another general licensee.
An additional amendment to Sec. 31.5 is intended to clarify the
status of a person who receives a device through an unauthorized
transfer and also removes a restriction on devices. Paragraph (b) is
revised to (1) limit the applicability of the general license to those
who receive a device through an authorized transfer, and (2) remove the
restriction to the applicability of the general license to devices
authorized for distribution by an Agreement State that have a general
license covering these devices within that State.
Concerning the first of these issues, the NRC has generally
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 new language clearly provides 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.
Paragraph 31.5(b) previously restricted applicability of the
general license in the case of devices from distributors in Agreement
States, to those devices from Agreement States
[[Page 79166]]
that authorize the devices to be used under a general license within
their respective States. However, the NRC practice has been 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 did 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 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, under the change of the compatibility requirement to category
B, these Agreement States should be establishing a comparable general
license provision in the future.
In addition to the changes to Sec. 31.5, other amendments are being
made that clarify which sections of the regulations in part 30 apply to
all of the part 31 general licensees. Section 31.1, ``Purpose and
scope,'' is 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,'' is
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 clarification makes 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 specifies sections of part 30
generally applicable to general licenses, it does 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 needed clarification. Under the previous
regulations, this requirement appeared to apply to all licensees.
However, because it was not referenced in Sec. 31.2 or Sec. 31.5, its
application to general licensees was not clear. This rule makes 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
This rule modifies the requirements for specific licensees who
distribute these generally licensed devices, specifically, the
quarterly transfer reporting, recordkeeping, and labeling requirements
and the requirement for providing information to users. These
requirements are a matter of strict compatibility for Agreement State
regulations, that is, the State regulations were required to be
essentially identical to NRC regulations. The amendments are also a
matter of strict compatibility so that revisions to Agreement State
regulations will be necessary and distributors in Agreement States will
be affected. The basis for this compatibility requirement is
significant direct transboundary implications because 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. There are now 21 NRC licensed
distributors and approximately 83 licensed distributors in Agreement
States.
Reporting. Paragraphs 32.52(a) and (b) are revised to require the
following additional information in the quarterly transfer reports: (1)
The serial number and model number of the device; (2) the date of
transfer; (3) for devices received from a general licensee, the
identity of the general licensee by name and address, the type, model
number, and serial number of the device received, the date of receipt,
and, in the case of devices not initially transferred by the reporting
licensee, the name of the manufacturer or initial transferor; (4)
information on changes to required label information; (5) name and
license number of reporting company; and (6) the specific reporting
period. The model number of the device was already required in reports
to Agreement States. The general licensee address is specified as the
mailing address for the location of use of the generally licensed
device.
The name, title, 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 replaces 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 is not required as long as the report is clear and
legible and includes all of the required information. The new
information must be included beginning in the report which covers the
first full reporting period occurring after the effective date of the
rule.
The previous reporting requirement was 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 could be contacted (which were 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 will allow the NRC and Agreement States to keep track of
individual devices distributed in the future.
The previous reporting requirement in Sec. 31.5(c)(8) did not
require the general licensee to report a transfer if it were for the
purpose of obtaining a replacement. This was consistent with the
original intent of this regulation in that the status of the general
licensee is unchanged, only the specific device is changed. For
individual devices to be tracked, the NRC or Agreement State needs to
be informed of such a transfer. The proposed rule would have required
that the distributor provide this information either to NRC or the
appropriate Agreement State specifically in the case of devices
replaced. Under preexisting requirements, quarterly reports are
required to include specifics on any new device transferred but not on
the devices returned. The final rule requires information for all
devices received from a general licensee. The NRC believes that the
distributor can include this additional information in the quarterly
reports without a significant burden and that it will be simpler than
the proposed provision involving identification of replacements.
Experience shows that the distributor is likely to be more reliable
than the general licensee in providing this information. Including this
information will also verify receipt of the devices.
The name and license number of the reporting company and the
specific reporting period are typically included in the reports to show
compliance with the reporting requirement. However,
[[Page 79167]]
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
was the intent of the previous requirement. However, in practice, the
name given to the distributor and reported to the NRC (or the Agreement
State) frequently was not an individual with this type of knowledge.
The rule specifies 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 final rule revises the content of recordkeeping
requirements in Sec. 32.52(c) by requiring maintenance of supporting
information for the revised reports. The period of retention for
recordkeeping requirements concerning transfers is reduced from 5 years
from the date of the recorded event, to 3 years from the date of
reported event.
All of the information needed to generate the transfer reports must
be kept long enough for NRC to receive and process the information,
identify and resolve any discrepancies or require any needed
clarifications. It is very important that this information is reported
and recorded correctly as it takes the place of the application and
approval process in obtaining, amending, and terminating specific
licenses.
In addition, distributors are required to make records of final
disposition of devices available to the various regulatory agencies in
the case of bankruptcy or termination of license (new paragraph
Sec. 32.51a(e)). When a distributor goes out of business and terminates
its license, the distributor can no longer be required to retain these
records. This requirement will give NRC, as well as State regulatory
agencies, the opportunity to obtain records of this type kept by the
distributor. These records could be helpful in verifying information
used to track devices relative to the final disposition of devices.
This provision does 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 final rule amends 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
paragraphs Sec. 32.51(a)(4) and (5) and Sec. 32.51a(d)). The NRC will
consider a label ``permanent,'' if, for example, it were embossed,
etched, stamped, or engraved in metal. Under these requirements, new
distributors will have labels approved as part of obtaining a license;
distributors, including existing licensees, have the new labeling
requirements as conditions of license in Sec. 32.51a(d). Approval of
the new labels by NRC for existing distributors is not 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. The new labeling requirements
supercede anything contradictory in individual license conditions. The
individual license conditions will 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
previous 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 permanent label for devices requiring registration will
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. Distributors 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 final rule
amends the requirements pertaining to the information distributors must
provide to the general licensee (Sec. 32.51a(a) and (b)). Distributors
have been required to provide general licensees with a copy of
Sec. 31.5 when the device was transferred. The rule requires that a
copy of Sec. 31.5 be provided before transfer. The final rule allows
omission of paragraphs that are not applicable to the particular
device. The distributor will also be required to provide: (1) Copies of
additional applicable sections of the regulations; (2) a listing of the
services that can only be performed by a specific licensee; (3)
information regarding disposal options for the devices being
transferred; and (4) a statement indicating that NRC's policy is to
issue high civil penalties for improper disposal. This last item was
added in the final rule and is applicable only for transfers to NRC
general licensees. The disposal options are to include the estimated
cost for disposal 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 will furnish the name or title, address, and phone
number of the contact at the Agreement State regulatory agency from
which additional information may be obtained. The final rule provides
that the distributor may propose for Commission approval some
alternative to that prescribed for adequately disclosing information to
their customers (new Sec. 32.51a(c)).
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'' will be before a final decision to purchase so
that the information can be considered in making that decision.
While Sec. 31.5 contains the primary requirements related to the
general license, it does not reference the applicable sections of part
30; thus, Sec. 31.2 should also be provided. The general licensee
should also have copies of at least those regulations that may require
an action on his part, so Secs. 20.2201, 20.2202, and 30.51 are added.
The sections of the regulation that are 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 will 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
[[Page 79168]]
disposal could exceed the purchase price of the device.
Additional clarifying amendments are being made in Secs. 30.31,
30.34(h), and 31.5(c)(9)(ii). The amendment to Sec. 30.34(h) is
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 for later use by an end-user.
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) or equivalent Agreement State
regulations. 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) or equivalent Agreement State regulations.
Public Meetings
An Agreement State Workshop, open to the public, was held on July
27-28, 1999, just after publication of the proposed rule. The purposes
of the workshop were to answer questions to clarify the proposed
provisions, to solicit input of the Agreement States on a number of
particular issues related to the rulemaking, and also to discuss an
application from Seaman Nuclear to allow certain moisture density
gauges to be distributed for use under Sec. 31.5. Specific topics
included: compatibility and timing of compatible requirements, moves
between different jurisdictions, temporary work locations in a
different jurisdiction, increasing civil penalties for lost or
improperly disposed devices, and lessons learned from Agreement State
programs for increased accountability. There were a wide range of
opinions concerning such issues as compatibility requirements and
portable devices. Although not included in the detailed discussion of
written public comments below, the opinions expressed were considered
in developing this final rule and implementation procedures.
Another public meeting was held on October 1, 1999, to discuss
implementation issues related to this rulemaking and related aspects of
the program being developed to improve accountability of generally
licensed devices. The focus of the meeting was to obtain input from the
distributors of these devices concerning the practical aspects of
implementation and how the program could be most efficient and
effective. Most of the issues discussed at the meeting were reflected
in written comments submitted by the distributors and others. A few
issues were discussed more explicitly at that meeting than in the
written comments discussed below. The following takes note of the few
points made specifically at the meeting and not included in written
comments. A transcript of the meeting is available on the NRC website
at: http://www.nrc.gov/NRC/PUBLIC/GLTS/index.html.
Public Comments on the Proposed Rule
The NRC reviewed the public comments received on the July 26, 1999
(64 FR 40295), proposed rule. Thirty-nine comment letters were
received, including one which provided supplemental input from the same
commenter. The commenters included: The Steel Manufacturers Association
(SMA), the Nuclear Energy Institute (NEI), the National Automobile
Dealers Association (NADA), three Agreement States, one non-Agreement
State, twelve distributors of generally licensed devices, a couple of
utilities, several other specific licensees who are also general
licensees, and several general licensees. One source material licensee
also wrote in about a loss of control problem related to an exempt
source material product.
Most commenters were supportive of the rule with respect to the
goals and primary provisions. Most negative comments came from users
and sellers of tritium exit signs, some of whom had not realized that
the registration and fee provisions were not proposed to apply to users
of tritium exit signs. A few others thought the impact on general
licensees was too great. These included one distributor of a thickness
gauge using Am-241 who voiced strong opposition to the proposal.
A few commenters, including the State of New Jersey and the SMA,
thought that the rule did not go far enough to solve the problems of
accountability of radioactive sources. For example, a few noted that
the rule did not address improvement of accountability for specifically
licensed devices.
Most of the distributors of generally licensed devices generally
supported the proposed rule, but all raised some concerns about
implementation problems related to specific provisions of the rule.
Some of these concern the variations among the numerous industries
using devices falling under this general license. Both the distributors
and their customers vary widely in size and type of organization and
how they do business.
A. Broad Comment About Applicability of the Requirements
Comment: One commenter thought that tritium exit signs should be
exempt from general license requirements. A few general licensees were
concerned with the possible applicability of registration and fees to
tritium exit signs. A few commenters did not support applying any of
the new provisions to any of the general licensees other than those
included in the registration requirement. Three distributors of exit
signs recommended that exit signs be removed from the Sec. 31.5 general
license and covered by a separate section of the regulations. This was
in part related to their contention that fewer requirements should be
applied. Another reason given was the confusion created by the fact
that Sec. 31.5 includes some provisions that do not apply to exit
signs. These commenters discussed the low hazard presented by exit
signs, the fact that they are an important safety device, and the
difficulties of applying some of the provisions of the rule to such a
large number of devices and diverse categories of users. One commenter,
however, suggested that exit signs be handled differently because they
are more likely to be disposed of improperly than an expensive gauge.
Response: Because exit signs do not require any testing, there are
no routine actions to be taken by the user. As a result of this, the
types of users involved, and, in some cases, misleading information
provided by at least one distributor of exit signs, users of exit signs
generally have the lowest level of awareness of the regulations.
Although they do represent a relatively low potential for public
exposure, it would not be appropriate to exempt them from all
requirements, such that all would be disposed of in normal trash. The
Commission believes that the requirements added for all Sec. 31.5
general licensees are not burdensome and are justified to improve
general licensee awareness of responsibilities and accountability for
the devices. These general licensees are not subject to the
registration and fee requirements.
There is difficulty with presenting adequate information to the
users of devices, particularly exit signs, without causing confusion
due to the amount and complexity of the information. The final rule
provides some flexibility in the requirement for providing information
to prospective customers.
[[Page 79169]]
This is discussed further below under Sec. 32.51a in section B.
Comment: Three of the commenters were concerned that some of the
requirements were inappropriate and unnecessary for power reactors
using such devices. They suggested that power reactors should be exempt
from all general license requirements. Two of these commenters
suggested that all specific licensees should be excluded. One commenter
suggested that the requirement to obtain written NRC approval before
transferring an item to a licensee's specific license will be
unnecessarily costly, time consuming, and cumbersome. The commenter
stated that when the specific license already authorizes possession of
the type of material in question, a notification to the NRC of the
transfer, in lieu of obtaining permission, will still enable NRC to
track the devices. This commenter believed that a notification in this
case would be more cost effective and efficient for industry.
Response: Although this might be true to some extent, the reporting
system that allows the Commission to keep track of generally licensed
devices presents some difficulties with exempting some specific
licensees from the general license requirements. For example, inputting
the data from the material transfer reports would involve the
additional step of identifying and eliminating those exempt. Also,
devices sold as generally licensed devices are labeled to indicate that
they are generally licensed. As mentioned in the Statement of
Considerations for the proposed rule, specific licensees have the
option of obtaining devices under their specific license initially or
transferring a generally licensed device to a specifically licensed
status. This latter option is not particularly difficult, especially
for reactor licensees and broad scope licensees, who already have broad
authority to possess radioactive materials. The communication with the
NRC allows NRC to update its information on licensee status and ensure
that the appropriate authority is in the particular license. Specific
licensee users and distributors should communicate about whether a new
device is to be held under a general or specific license. It should be
labeled appropriately. If it is to be specifically licensed, it should
not be included in distributors' material transfer reports.
Comment: One commenter asked whether the Commission intends to
reclassify any devices from general license status to specific license
status or vice versa.
Response: The Commission does not plan on making any regulatory
changes at this time that would affect whether a device may be
distributed for use under the general license in Sec. 31.5. The
criteria on which a decision to allow a device to be used under the
general license in Sec. 31.5 are contained in Sec. 32.51. A
specifically licensed device could be reclassified as generally
licensed using these criteria through a licensing action.
Comment: One commenter recommended that the proposed rule be
modified to require annual registration by specific licensees of
devices and sources containing the radionuclides and activities
specified by Sec. 31.5(c)(13)(i).
This commenter provided the following reasons for taking the
position that there is no basis for requiring special registration,
labeling, etc. for generally licensed devices when there are no
comparable regulations for sources and devices with the same
radionuclides that happen to be held under specific licenses. The
commenter noted that naturally occurring radioactive material (NORM) is
the largest single contributor to the problem of radioactive
contamination in metal scrap, that NRC has not been given authority to
regulate the use of naturally occurring or accelerator-produced
radioactive material, and that this limitation on NRC's jurisdiction is
a serious problem in itself and an issue that should be reviewed. The
proposed rule also ignores a large fraction of sources and devices that
are major contributors to the metal scrap problem and that NRC does
have clear authority to regulate. The commenter stated that
specifically licensed devices generally contain larger quantities of
the same radionuclides (e.g. cobalt-60 (Co-60) and cesium-137 (Cs-137))
that have been identified for special requirements in the proposed rule
for general licensees and that loss of source/device control is not
limited to general licensees. The commenter believes that whenever the
justification for ignoring specific licensees in the proposed rule has
been addressed, much has been made of the ongoing contact between the
licensee and NRC and believes that this ongoing contact is greatly
overstated. In fact, many specific licensees go years between
inspections and license renewals--ample time for organizational changes
that compromise source/device accountability.
Another commenter stated that the proposed rule has become so
extreme that some sections require more information of general
licensees than from existing specific licensees. The commenter
contended that the NRC must establish some sense of consistency in
order to meet the goals and objectives outlined in SECY-97-273 dated
November 26, 1997. Some examples of inconsistency noted were reporting
of specifics on devices and individual transfers and the suggestion of
a backup responsible person.
Response: As noted by the commenter, NRC does not have jurisdiction
to control sources of NORM or accelerator-produced radioactive
material. Although it is true that some specific licensees are not
inspected very often, the regulations in place provide an adequate
basis for requiring accountability for specifically licensed devices.
In any case, the scope of this rulemaking is limited to devices
generally licensed under Sec. 31.5.
Comment: One commenter requested that because the intent of these
proposed regulations is to increase the oversight of 5,100 licensees
with 20,000 sources deemed higher risk, paragraphs 31.5(c)(12),
(c)(14), and (c)(15) should only be applicable to general licensees who
must register under Sec. 31.5(c)(13), and not to all general licensees.
Otherwise, the burden is imposed upon 40,000 general licensees with
580,000 devices. The commenter suggested grouping these paragraphs with
the registration requirements or reference the applicability to
Sec. 31.5(c)(13).
Response: Although the registration process is being limited to
higher risk devices, it is desirable to improve licensee awareness of
regulatory responsibilities and accountability for all devices
generally licensed under Sec. 31.5. The provisions being applied to all
Sec. 31.5 general licensees are considered to be an appropriate means
of doing so with minimal burden on licensees and NRC staff. As
discussed below, some revisions have been made to Sec. 31.5(c)(15) to
minimize burden, and to Sec. 31.5(c)(14) for clarity.
Comment: One distributor who currently sells very few generally
licensed devices asserts that the cost of changing systems and
procedures and of training personnel to implement the proposed
requirements would be very significant relative to the income derived
from sales of these devices. Further, he contends that the registration
program fees would adversely affect existing customers and discourage
potential new customers from buying these products.
Response: For most devices subject to registration, the
registration fee is considered to be small compared to the cost of the
device. The NRC does not believe that the fees represent a significant
burden to industry for the benefits gained. The registration fee will
be established in 10 CFR part 170 under the Independent Offices
Appropriation
[[Page 79170]]
Act (IOAA), which authorizes agencies to charge fees for special
benefits rendered to identifiable persons. The NRC is required by the
Omnibus Budget Reconciliation Act of 1990 to recover approximately 100
percent of its budget authority, less amounts appropriated from the
Nuclear Waste Fund, by assessing IOAA and annual fees. The registration
fee will be established as part of the FY 2001 fee rulemaking and will
be based on the budgeted costs and FTE rates for that FY, as well as
the number of general licensees subject to registration. Based on the
current estimated budgeted costs, FTE rate, and, estimated number of
general licensees in this group, we expect the registration fee to be
approximately $440 to $450.
B. Comments Relating to Specific Provisions of the Proposed Amendments
Requirements for General Licensees
Section 30.31--Revision to reconcile the apparent conflict between
the description of a general license and a registration requirement.
Comment: One commenter noted that the registration of particular
general licensees is mentioned in Sec. 30.31(b), stating that the
registration requirements, however, are buried in Sec. 31.5(c)(13). The
commenter thought that the provision would not easily be located by
general licensees, many of whom do not regularly read the regulations.
Response: Section 30.31 is a general description of the two types
of licenses provided by the Commission for the use of byproduct
material (general and specific). Section 31.5 contains the primary
requirements applicable to these general licensees and would be the
requirements the general licensees are most likely to be aware of.
Section 30.34(h)(1)--Revision to make the bankruptcy notification
requirement applicable only to those general licensees subject to the
registration requirement.
Comment: Two commenters believed that the bankruptcy reporting
requirement should apply to all general licensees. One stated that the
requirement imposes little additional burden on licensees, and the
possibility that a licensee could lose sources is heightened following
bankruptcy.
Response: The Commission does not believe it is justified to apply
this requirement to all general licensees. There would be limited
additional benefit with requiring bankruptcy reporting for users of
relatively low risk devices. The costs to be considered include, in
addition to the minimal effort required for licensees to report
bankruptcy, the efforts involved in making and keeping the general
licensees aware of such a requirement, enforcing it, and following up
on reports of bankruptcy.
Section 31.1--Revision 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--Revision to clarify references to the sections of
part 30 that are applicable to all of the part 31 general licensees.
Comment: One commenter stated that, in order to clarify which parts
apply to general licensees, all the items that apply to a general
licensee should be put in one place in the regulations so that a
booklet can be given to a general licensee by the NRC or the
manufacturer and the general licensee will have all the necessary
information in one place.
Response: This would create a great deal of duplication in the
regulations. The information that this rule will require distributors
to provide to their customers will include copies of the primary
applicable requirements. The Commission is also developing a pamphlet
summarizing basic information the general licensee needs to know. It
appears as Appendix K in the draft of NUREG-1556, Vol. 16,
``Consolidated Guidance about Material Licenses: Program-Specific
Guidance about Licenses Authorizing Distribution to General
Licensees.'' This document will be published in final in the near
future. The pamphlet may be used by NRC, the Agreement States, or the
distributors of generally licensed devices as information for general
licensees.
Section 31.5(c)(2) through (4)--No revision.
Comment: One commenter suggested that even though a six-month
physical inventory is implied by the testing requirements, it should be
clearly stated and the licensee must be required to verify, as a
minimum, the name plate information (i.e., manufacturer, model and
serial number, assay date, isotope, activity, location of device).
Response: The Commission does not believe at this time that adding
an inventory requirement for all generally licensed devices is
appropriate. Those persons subject to registration will be required to
conduct an annual inventory as part of the registration process. Those
subject to testing must test and make records of testing at various
intervals applicable to the particular device; this involves an
inventory process to ensure compliance with the testing and
recordkeeping requirements. For at least some of the devices that are
not subject to either testing or registration, such as exit signs, a
requirement to check all the name plate information every six months
would not be justified.
Section 31.5(c)(8)--Proposed revision to allow transfers to
specific licensees authorized under part 30, or equivalent Agreement
State regulations, as waste collectors, in addition to previously
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.
Comment: Most comments on Sec. 31.5(c)(8) concerned possible
confusion over the concept of ``replacement.'' There was considerable
concern for this problem also with respect to the use of
``replacement'' as a determinant in the reports of receipts made by
distributors under Sec. 32.52.
Response: The concept of ``replacement'' was previously in
Sec. 31.5(c)(8). Reports of transfer were not required if the device
transferred was being replaced. The original intent of the reporting
requirement was only to maintain up-to-date information on the basic
status of the general licensee, such as whether a licensee possesses a
particular type of device. Given this purpose, potential problems with
the general licensee reporting under Sec. 31.5(c)(8) were limited. The
proposed rule would have extended the use of ``replacement'' as a
determinant on whether a particular type of transfer needed to be
reported by the distributor under Sec. 32.52(a) or (b). This was
proposed in order to minimize changes being made to the requirements
for general licensees. However, this would have created greater
practical problems for the distributors with respect to Sec. 32.52(a)
or (b), as discussed below. The use of the replacement process as a
determinant as to who must report a particular transfer has been
removed from the final rule. Paragraph 31.5(c)(8) has been revised to
require the general licensees to report all device transfers to NRC
even if they are obtaining a replacement.
Section 31.5(c)(9)(i)--Proposed revision to 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, 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
[[Page 79171]]
requirements, rather than simply a contact name.
Section 31.5(c)(9)(ii)--Revision to add the term, ``intermediate
person,'' to clarify that a report of transfer is not required only in
the situation where the information on both an intermediate person and
an intended user would have been provided through the distributor in a
quarterly material transfer report.
Comment: One comment on Sec. 31.5(c)(9) concerned the words
describing the responsible individual. This commenter thought this
person should be in management as in EPA permits or OSHA standards, and
that a certified statement be required by the president/ owner, etc.
Another commenter stated that a general licensee taking over a facility
should provide the name of a responsible individual (and backup) and
that these individuals should have knowledge of the device, general
license, and relevant regulations.
Response: The Commission believes that it is adequate for there to
be an individual assigned the 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. These requirements will apply to the new general licensee
as well. However, it is the general licensee transferring the property
who is required to provide the information on the new general licensee,
including the name of the new responsible individual, to NRC.
Section 31.5(c)(12)--New provision to 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.
Comment: A number of commenters specifically supported the concept
of assigning a responsible individual. No one specifically objected to
the requirement, although one suggested that the requirement be limited
to those subject to the registration requirement. Most who commented on
this subject were concerned about the following issues:
1. Further clarification that the ultimate responsibility resides
with the general licensee;
2. Whether the responsible individual must be present on site at
the location of use; and
3. Whether the responsible individual must be an employee of the
general licensee.
One commenter wanted the rule to specifically require documentation
that the individual has been informed of their assigned
responsibilities. Some commenters gave support for allowing the
responsible individual to be a non-employee, stating that a consultant
may be more likely to be well informed and make sure management is also
informed. Some commenters also supported flexibility in assigning
someone who is not on site, one stating that centralized radiation
safety programs may be best. One specifically wanted to know if the RSO
(Radiation Safety Officer) for a specific licensee would have to fill
the role of responsible individual. One commenter thought that these
clarifications needed to be made in the regulation itself.
Response: On the first of these issues, the rule specifically notes
that the general licensee is not relieved from responsibility. Beyond
this, it should be understood that responsible individuals will be
answerable to their management as they would regarding any assigned
duties, but the general licensees are answerable to the Commission for
meeting regulatory requirements. It should also be understood that a
person who is assigned duties must be made aware of those duties in
order to perform them. The Commission should not need to require
documentation of these internal procedures of the general licensees.
The proposed rule text did not include restrictions on who can be
appointed as the responsible individual, only that he or she have ``the
authority for taking required actions to comply with appropriate
regulations and requirements.'' The Commission agrees that the person
assigned does not need to be on site, nor necessarily an employee of
the general licensee, nor, in the case of a specific licensee, the RSO.
However, the Commission does not believe that the rule should address
non-existent restrictions. The regulations should be concise and allow
focus on the words that are most important to understanding the
requirement. Further, the distributor in obtaining information about
responsible individuals from their customers should be cognizant of the
Commission's interpretations and be able to answer questions in this
regard. Guidance will also be available to assist with informing
general licensees.
Section 31.5(c)(13)--New provision to 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.
Comment: One commenter stated that once a registration policy and
annual fees are implemented for certain general licensees, these
licensees should be changed to a new category of specific licensees for
these devices. The commenter believed that this would be consistent
with other license types that present a potential higher risk and are
assessed an annual fee.
Response: The revisions made in this rule are designed to improve
control and accountability of generally licensed devices especially for
certain devices that are being registered. The devices are designed to
be inherently safe to use so that an application process to evaluate
the prospective licensee is not necessary. Making these licensees
specifically licensed would be a major change in the approach for these
licensees and is not considered necessary.
Comment: This commenter also requested clarification as to who is
responsible for doing the certifying in Sec. 31.5(c)(13)(iii)(E) and
(F) which require ``certification by the responsible representative of
the general licensee.'' Specifically, do these paragraphs require this
``certification'' by the licensee's management or the ``responsible
individual''? The NRC requires specific licensee's management to review
and sign all licensing actions.
Response: In Sec. 31.5(c)(13)(iii)(E) and (F), ``the responsible
representative of the general licensee'' is intended to mean the
responsible individual as appointed under Sec. 31.5(c)(12). As noted
earlier, the Commission believes that it is adequate for there to be an
individual assigned the 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. This person is the appropriate person to handle the
registration. A second signature, that of a manager, is not required.
The general licensee is nonetheless responsible for providing complete
and accurate information and not engaging in deliberate misconduct.
Comment: Another commenter brought up the problem of distributors
or ``intermediates.'' This commenter stated that beyond the
technicality that anyone possessing or storing the device before its
final installation is also a general licensee, the focus needs to be on
the end user. The use of a ``registration card'' similar to the common
warranty card that comes with nearly every appliance should be
instituted. The registration card should have the appropriate device,
source holder, and source model and serial
[[Page 79172]]
numbers pre-printed. The end user need only fill in the facility
information and address it to the appropriate agency. The manufacturer
continues to report ``distributions,'' the agency cross checks the
distributions against end user cards, and follows up with the
manufacturer or distributor if all devices leaving the manufacturer are
not reported to be installed after some appropriate time.
Response: There is a problem with secondary distributors believing
they fall within the intent of the ``intermediate person.'' This is
discussed further under Sec. 32.52(a) and (b). The Commission agrees
that the focus should be on the end user. The Commission does not
currently plan to register general licensees who are intermediate
persons, holding devices temporarily at the intended place of use,
although the Commission may do so if considerable time passes before
the property is taken over by the intended user. Because the
registration process is initiated by NRC, there is no need to exempt
intermediate persons in the rule to carry out this policy.
The Commission has given consideration to the use of a registration
card and decided against requiring this additional documentation at
this time. This is discussed further under Sec. 32.51a(a) and (b).
Comment: One commenter, who was against the proposed rule,
suggested that if implemented, it could be made less burdensome by
adopting a four-year registration requirement instead of an annual
registration requirement. He believed that this change would
substantially reduce financial and other impacts on stakeholders while,
combined with the other reporting requirements contained in the rule
(i.e., report of transfer and disposal), meeting NRC accountability
needs. This commenter stated that only after experience with this type
of rule should the NRC consider a more burdensome requirement.
Another commenter stated that charging fees every four years to
lessen the cost of collection sounds good except that the issue is
``contact'' with the general licensee. That commenter noted that the
annual registration and fee collection is also the opportunity to ``jog
the general licensee'' on ``responsible individual,'' leak testing,
inventory, storage limitation, etc., and that it would be easier on the
budget to keep the fee relatively constant and ``low''.
Response: The Commission believes that annual contact is important
to improving compliance with all of the general licensee requirements
and that registration at significantly longer intervals such as four
years would not save as much as might be assumed. The fee will be
established to recover the cost of the registration program. The
general licensees will be able to plan for the fee because it will be
required with each annual registration.
Comment: Another commenter was concerned about the requirement in
the new Sec. 31.5(c)(13)(ii) that the user will be required to respond
to the notification within 30 days. It was suggested that in the first
round of notifications, this requirement could cause substantial burden
for the manufacturers and distributors. Because there are many general
licensees who do not realize the requirement(s) imposed by a general
license, these users will likely contact the manufacturers and/or
distributor of the device and look for assistance in providing the
required information. This commenter also suggested that mailing all of
the notifications simultaneously may cause an undue burden on the
supplier. This commenter would like NRC to take this into account and
provide the extra time required for the first round of registrations.
Response: The existing Sec. 31.5(c)(11) is being used as a basis
for requesting the first round of registrations. Both this provision
and the specific registration provision give the staff flexibility to
adjust the amount of time allowed for licensee response. The Commission
is beginning the registration allowing 45 days for response. Once a
registration program has been implemented along with the new provisions
for improving the upfront disclosure to general licensees, 30 days is
considered adequate for response. Too much time can lead to requests
being put aside and forgotten. Also, the requests for registration are
being spread out over the year for efficiency.
Comment: One commenter believed that the NRC currently has the
necessary authority and resources in place to effectively run the
program. The effect of the registration is to improve accountability.
The commenter noted that all manufacturers currently provide transfer
and sales information to the NRC for generally licensed devices within
the NRC's authority, and that regulations do not require the reporting
of gauges that are sold to specific license holders. The only method
the NRC has in place for the tracking of material for specific
licensees is through inventories, and reliance on the integrity of the
licensee. This commenter believed that the proposed regulations would
create a third class of license holders, who would be subject to more
restrictive regulations, with less reliance placed on the integrity of
the licensee.
Response: The difference between these types of licensees relates
to the level of knowledge and training rather than integrity. Generally
licensed devices must be designed to be used safely by persons with no
radiation protection training. The important aspect of these devices is
that they be disposed of properly. Because control and accountability
are of primary importance, a different approach to licensing is
appropriate. The general licensees are required to do certain things
that specific licensees are not; however, the requirements are not more
restrictive overall. The general license, even with registration, is
simpler than obtaining a specific license.
Comment: Another commenter, although not supporting the creation of
a registration program for general licensees at this time, thought that
Sec. 31.5(c)(13)(ii) was particularly unnecessary and inappropriate.
This commenter believed that the rule should be changed to require the
general licensee to register within a specific time period after
receipt of the device, regardless of whether contacted by the
Commission. See also the comments in response to the first and second
of the Commission's specific questions, discussed under section D.
below.
Response: The Commission believes that it will be more efficient to
contact the general licensees to begin the registration process and
provide the information currently in its records for verification and
supplementation. Many general licensees would not know about the
registration requirement if they were not contacted, others would have
difficulty understanding what is required. Also, there would be
increased burden on distributors handling requests for assistance from
general licensees. If the Commission is unable to contact the general
licensees to request registration because of missing information on
their identities and addresses, it would also be unable to contact them
to inform them of the requirement.
Section 31.5(c)(13)(i)--Criteria for registration.
Comment: One commenter believed that all general licensees should
be registered. Another wanted nickel-63 (Ni-63) added to the list of
those radioactive elements targeted for registration and tracking
because of the expected improvement in the NRC's ability to track their
devices once they leave their control. This commenter has been
contacted by many customers who have inherited their devices without
receiving necessary regulatory information from the previous owners and
learn of those requirements only by
[[Page 79173]]
chance or when a state regulatory agency representative shows up at the
door. This commenter believed that a $420 annual fee is cheap compared
to the panic these customers experience. One commenter believed that
the physical design of devices to contain the byproduct material should
be considered. Another commenter opposed the idea of exempting
``robust'' sources stating that this rule is based on a history of
smelted sources, among other concerns and that so-called ``robust''
sources are not smelter-proof. This commenter also stated that if
radioactivity is present, the risk is present and some enterprising
soul will someday find a way, probably inadvertently, to defeat
whatever safety barriers have been put in place.
One commenter thought that it was unclear whether any of the
devices (e.g., exit signs, static eliminators, or thickness gauges)
potentially used at auto dealerships would be subject to the proposal's
registration requirements and that such requirements would be excessive
given the nature of these devices and their use.
One commenter wanted to know what criteria will be used to amend
Sec. 31.5(c)(13)(i) to add additional devices to the list of devices
that require registration and stated that these criteria should be
specified so that knee jerk reactions by the NRC to improper
management, use or disposal of certain generally licensed devices does
not occur.
Response: The Commission does not believe there is adequate
justification to make any changes to the criteria for registration at
this time. If the Commission considers any changes in the future,
consideration will be given to the risks of inappropriate exposure to
the public and possible costs for cleanup of incidents involving lost
sources. Another factor will be the efficiency and effectiveness of the
registration program, based on experience in implementing it.
Comment: At the public meeting of October 1, 1999, one distributor
suggested that registration would create a competitive disadvantage
where radionuclides included in and those not included in registration
are used in competing products (portable gas and aerosol detectors, and
X-ray fluorescence analyzers).
Response: The rule is based on the risk of the device not the
economic advantage of the types or activities of the radionuclides.
Section 31.5(c)(14)--New requirement for general licensees to
notify NRC of address changes.
Comment: One commenter noted that the requirement for reporting
changes of addresses does not provide for the exemption from reporting
if the device is transferred to the specific licensee to obtain a
replacement device from the same specific licensee as previously
described in Sec. 31.5(c)(8)(ii). The commenter raised the question
that if a replacement is purchased from the specific licensee,
shouldn't the same provision be made in Sec. 31.5(c)(14).
Response: This provision is for address changes and is separate
from any reporting of device transfers. The replacement process as a
designator of when to report has been removed. A change of address can
occur either from the movement of a general licensee's business to
another location or the changing of a company name or building
identification such that only the mailing address itself changes.
Section 31.5(c)(15)--Proposed revision to 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.
Comment: Many commenters did not agree with the 2-year storage
limit. This seemed to be the issue of most concern for the general
licensees who commented. One commenter asked the Commission to extend
the storage of devices to 3 years, stating that this would allow
customers to maintain a spare probe. The spare probe would be on the
same schedule for leak testing and would ensure that the probe was
accounted for. Another recommended that the permitted storage time
period be changed to 5 years. This commenter did not agree that
``general licensees are unlikely to keep a device unused for more than
2 years.'' The commenter believed that the imposition of a 2-year limit
on storage would be a hardship for the university research community.
The commenter pointed out that it is often the nature of scientific
research in a university setting for radioactive devices to be used
intermittently. For instance, funding of grants to conduct research
utilizing generally licensed devices is sometimes not forthcoming and a
device may need to be stored until the project is again funded. The
commenter gave as an example of a common laboratory device, the liquid
scintillation counter, and suggested that the proposed rule might
require disposal of this expensive piece of lab equipment, which would
almost certainly be used at a future time.
Another commenter stated that it is not uncommon for these devices
to be stored for periods exceeding 2 years and then be put back into
use for special projects and noted that the Safe Drinking Water Act
specifies testing for contaminants on 3- and 9-year intervals. The
commenter also stated that while some devices may be in use during this
timeframe, other devices may be in storage for use during the peak
demand time. In addition, a device needing foil replacement may be kept
on hand to minimize down time. The device is eventually shipped out for
foil replacement while another device is kept in service. In addition,
other devices currently unaccounted for may have found their way to
other general licensees capable of caring properly for them. The
commenter thought that owners of these devices, when faced with a 2-
year maximum storage time, may be reluctant to admit the presence of
all of the devices on the premises, in particular, any devices they may
have acquired without authorization. In such cases, the 2-year maximum
holding time may actually run contrary to the purpose of the proposed
rule and encourage some to withhold disclosing the presence of these
devices or improperly dispose of the devices. The commenter stated that
accounting for all of the devices is far more important than time
restrictions on device storage and suggested NRC consider eliminating
the time restrictions on storage of devices or alternately, consider
exempting devices with replaceable isotopes from the time-based storage
rule.
Another commenter urged the Commission to limit the 2-year storage
provision to nuclear sources that have been removed from service and
are either awaiting transfer back to a specific licensee for disposal
or have been temporarily removed from service. The commenter provided
these two reasons: (1) Because NRC's proposal would provide for
procedures to assure that sources (including those kept in storage)
would be properly managed, there is no compelling reason to limit
storage time for unused sources to 2 years; and (2) Some sealed nuclear
gauges are essential spare parts for production processes. The
commenter gave the example of a gauge to control the level of material
inside a chemical reactor, saying that in several instances, there is
no feasible alternative to a nuclear gauge measuring device. If the
level gauge fails, the equipment must be shut down until the gauge is
replaced. In this case, it is essential to have an onsite spare. It
would be excessively restrictive if the 2-year storage requirement were
to apply to this situation. A facility would be forced to recycle a
new, unused gauge and
[[Page 79174]]
purchase a new one merely because an arbitrary time limit had passed.
One commenter also stated that the requirement that a general
licensee not hold devices that are not in use for longer than 2 years
would prove burdensome. Generally licensed devices may be placed in
storage and not be used for a period of more than 2 years. The owner
may intend to use the device at a later date. This proposed rule would
preclude this activity and would require the general licensee to
dispose and repurchase the generally licensed device.
Another commenter questioned the short time period of 2 years as
the life expectancy of their devices is in the decades, and different
product life expectancies vary depending on equipment type and half-
life of the radioactive materials in them.
Another commenter noted that a general licensee who receives a copy
of these regulations after the final rule will not have the comments as
outlined on 64 FR 40299 to guide him as to what must be done with a
device after 2 years of storage. This commenter suggested that, for
clarity, the regulation should state possible actions such as: (a)
Disposal of device via an authorized licensee; (b) Send the device back
to the supplier (or authorized licensee) for interim storage (The
supplier may not want to provide this service and/or almost certainly
will impose a storage charge); or (c) Request an exemption from this
paragraph from the NRC (will a ``timely request'' prevent enforcement
action until the request is acted upon?). This commenter pointed out
that it possesses several gas chromatographs with generally licensed
Ni-63 electron capture sources which have not been used for more than 2
years. However, research interests change and the units may be used
again.
One commenter suggested that any rule provision that does not
directly affect the accountability issue be deleted. This commenter
stated that additional requirements on labeling, length of storage, or
the information supplied to the customer will have little or no effect
on the accountability of the radioactive material. This commenter
believed that these rules place an arbitrary limit on the storage of
devices not in service. They requested that NRC provide clarification
for devices that may be out of service but are planned to be reused at
a future date that could be several years. They stated that, in
addition, for some critical applications, a spare device might be kept
in storage for years. It is also possible for a general licensee to
possess a device that is kept in secure storage because there is no
path for disposal or transfer. Americium-241 (Am-241) is an example of
what would be orphaned waste. This commenter also stated that the
portions of this rule that require a responsible individual and
reporting will be sufficient to ensure accountability of sources in
storage.
Another commenter suggested that a note be added that devices
containing only krypton need not be tested for leakage.
One commenter stated that devices in storage should still be
required to be subject to six month physical inventory requirements.
Another commenter supported the proposed requirement to limit the
period during which a device may be stored and unused to 2 years and
agreed that when a device is not used for a prolonged period of time,
it is susceptible to neglect and improper disposal. This commenter
believed that the provision would compel licensees to decide whether to
use, return, or properly dispose of their sources, and would hold
licensees accountable for their decisions.
Response: The Commission had not anticipated the level of
difficulty this provision might cause and the number of instances that
devices are currently held in storage purposefully for future use
rather than simply being taken off line and put aside rather than being
properly disposed. In the proposed rule notice, it was noted that there
are options if one did want to keep a device which is likely to be used
again. It noted specifically that the device could be returned 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. However, if this is as common a practice as indicated in the
comments, use of these options alone would be burdensome. The final
rule has been revised to allow for standby for future use. To address
the fact that devices not in use can quickly be forgotten and lost
track of, this provision requires quarterly inventory of devices in
standby. This provision does not relieve these general licensees from
the registration requirement or the requirement to pay a registration
fee.
Comment: A commenter indicated that they would prefer to see
customers required to maintain the current wipe test frequency during
storage as this keeps the customer knowledgeable of the device's
ownership and location. This commenter suggested that, if the
Commission does allow a 2-year exemption of testing during storage, the
NRC should build upon the proposal and require that a wipe test be
performed at the time of removal from storage by an authorized
organization, forbidding installation or use of the device until
acceptable results are obtained.
Response: The provision does require testing for leakage (wipe
test) before use or transfer, if the normal schedule for testing has
been exceeded. Paragraph 31.5(c)(5) indicates that a device may not be
used if contamination is detected (0.005 microcuries (185 bequerels) or
more removable contamination). These two provisions together do what
was suggested.
Comment: Another commenter noted that persons holding generally
licensed devices that have been in storage for more than 2 years will
be in immediate noncompliance if this rule is implemented in its
present form. This commenter stated that public safety will be better
served if general licensees are given a reasonable amount of time after
implementation of this rule to properly dispose of devices. If the
storage provisions become effective 2 years after the passage of the
rule, general licensees with material currently in storage will have
the same amount of time as general licensees with newly acquired
devices to arrange for proper disposition of the devices.
Response: The Commission interprets this provision such that the
time before the effective date does not count towards the 2-year limit.
However, if the general licensee considers a device in standby for
future use, he is to begin conducting quarterly inventories as of the
effective date of the rule.
Comment: One commenter noted that some devices, specifically static
eliminators, are distributed without serial numbers, and that makes
them difficult to inventory, and thus it would be very difficult for
the responsible individual to determine when such a device has been
held in storage for longer than 2 years. This commenter believes that
the additional regulatory burden required by the proposed rule is not
warranted in light of the following: Typically, the devices employed by
the pharmaceutical industries, as with many other industries, are those
which present a lower risk. These devices are sealed sources which are
designed to be inherently safe with regard to radiation safety.
Therefore, to require a general licensee to inventory and assure that
devices are not stored for more than 2 years poses an undue regulatory
burden.
Response: The labeling requirements of Sec. 32.51(a)(3) require
inclusion of a serial number. This requirement is a
[[Page 79175]]
Compatibility Category B (i.e., Agreement State regulations must be
essentially identical). Thus, all distributors should be labeling
devices distributed for use under Sec. 31.5 or comparable Agreement
State regulations with a serial number. If this is not the case, there
is noncompliance on the part of the distributor, or possibly
inconsistency in some Agreement State regulations. The Commission will
address this through inspection and enforcement of the labeling
requirement. Note also, most static eliminators contain polonium-210
(Po-210), which is relatively short-lived and would not be kept in
storage for long except when awaiting disposal.
Section 170.31--Proposed revision would have added a $420
registration fee for general licensees subject to Sec. 31.5(c)(13). The
fee is not being finalized at this time because it is anticipated that
the first registrations subject to the fee will not be filed until FY
2002. The final fee will be established as part of the FY 2001 notice
and comment fee rulemaking based on that year's budgeted costs, FTE
rate, and the number of registrants. Based on current budgeted costs,
FTE rate, and the estimated number of registrants, the fee is expected
to be approximately $440-$450.
Comment: Two commenters objected to registration of exit signs,
stating that most people would replace them with nonradioactive
alternatives rather than pay a fee. One of these commenters also
suggested that there are alternatives for thickness gauges, gas
chromatographs, level detectors, etc., and that a fee charged over a
ten-year life could significantly affect life cycle cost analysis. This
commenter believed that significant numbers of people will go to
nonradioactive alternatives, reducing the number of people to collect
fees from, leading to higher fees, and further reduction in use of
products, and suggested that fees for smoke detectors would increase
the numbers to divide costs among.
Response: Exit signs are not included in the registration
requirement. Neither are some of the devices of the other types
mentioned. The fee will be established in the FY 2001 notice and
comment fee rulemaking to recover the costs for the registration
program for the devices covered by the registration requirement. It
would not be appropriate to extend the registration requirement to
other devices for the sole purpose of potentially reducing the fee for
each registrant. For at least most of the devices subject to
registration, the Commission believes that the amount of the
registration fee will not create a significant effect on the market for
these devices.
Comment: One commenter noted that NRC has always had in the rule
the requirement and ability to maintain accountability of general
license devices via the manufacturer's required general license
distribution reports. This commenter stated that it is unclear as to
the rationale of an annual $420 fee and suggested that this be an
initial start up fee and that further evaluation for maintenance/
inspection fees be conducted after the program has been in place for a
few years.
Another commenter believes the proposed $420 annual fee to be a
modest and reasonable fee for all licensees, including small
businesses. This commenter asserted that the current regulatory regime
has shifted the costs of lax accountability and control onto steel
makers, insurers, and the taxpayers and noted that general licensees do
not pay directly for their licenses. The cost has instead fallen on
steel producers to detect the sources, on the steel producers and
taxpayers to arrange for proper disposal, and on steel producers and
their insurers to pay the cost when a source is inadvertently melted.
The cost has also fallen on the general public, in the form of
increased risk to health and safety from unanticipated exposure to
dangerous levels of radioactivity. This commenter believes that general
licensees, who benefit economically from the manufacture, sale and/or
use of radioactive devices, should be required to shoulder their fair
share of this burden to protect the public and that an annual fee in
the neighborhood of $420 is not only equitable, but entirely
reasonable.
Response: The Commission believes that it is appropriate to
increase its efforts to improve compliance of general licensees
specifically in the area of accountability, that this can be done
through more regular contact with licensees, and that an annual
registration process is an efficient way to do this. Charging the
general licensees a registration fee to cover the cost of this process,
including needed followup, is a matter of equity. 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. The
registration fees will 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. In accordance with the Chief
Financial Offices Act of 1990, the NRC conducts a biennial review of
part 170 fees and revises those fees as necessary to reflect costs in
providing the services. Thus, the fees will be revised to reflect any
changes that occur in the program.
There were no comments other than minor editorial suggestions on
Secs. 31.5(b) and 31.5(c)(5).
There was no comment on Secs. 170.2, 170.3, 171.5, and 171.16.
Requirements for Distributors
Section 32.51(a)(4) and (5)--Adds requirement for an additional
label on any separable source housing and a permanent label on devices
meeting the criteria for registration.
Section 32.51a(c)--Proposed revision to make labeling requirements
a condition of license 1 year after effective date of rule.
Redesignated Sec. 32.51a(d) in the final rule.
Comment: Two commenters recommended that the wording in proposed
Sec. 32.51(a)(4) be changed to replace the word ``permanent'' with the
word ``durable.'' These commenters stated that distributors of these
devices must be able to remove the labeling as required by
Sec. 20.1904(b). If ``permanent'' markings are truly added, this will
not be possible. Similarly, another commenter noted that all containers
or devices are required to be labeled now by Sec. 20.1904(a). This
commenter believed that the wording that refers to ``permanent'',
``embossed'' or ``engraved'' will result in confusion. This commenter
stated that many components that would be shipped as part of the
manufacturing process would be labeled and contain no radioactive
material and that any label must be removable to meet the requirements
of Sec. 20.1904(b). This commenter also stated that additional
requirements on labeling, length of storage, or the information
supplied to the customer will have little or no effect on the
accountability of the radioactive material and suggested that any
rulemaking that does not directly affect the accountability issue be
deleted. Also, these commenters believed that additional rulemaking on
labeling is unnecessary and should be considered part of the device
registration.
One commenter supported the requirement of additional labeling on
any separable source housing. This commenter stated that steel
companies have received, on several occasions, improperly discarded
sources and source housings on which the label has been removed. A
marking of the serial number on the source housing would
[[Page 79176]]
alert NRC and the public to the existence of the missing source. This
commenter also supported the requirement that labels be embossed,
etched, stamped, or engraved on the devices for the reasons NRC listed
in its proposal. This commenter believed that permanent labeling would
help alleviate the problem of removed labels and that it would also
help to prove criminally improper disposal, as the effort and
deliberation required to remove such labeling would indicate the
willfulness of the offense.
Response: The rule requires that the label itself be ``permanent''
and that it be affixed to the device. Labels on all devices must be
durable. The intent of this provision is to apply a higher standard of
durability for these ``higher risk'' devices. The Commission recognizes
that labels on devices must be removable. Labels should be securely
affixed to the device, tamper resistant, but able to be removed,
defaced, or otherwise marked to indicate no radioactive material to
meet requirements in Sec. 20.1904(b). In many cases, the current
designs will satisfy the new labeling requirements. The Commission
believes that is appropriate to include these additional details
concerning labeling in the regulation to ensure consistency and that
proper labeling does contribute to accountability. No change has been
made to the proposed rule changes to the labeling requirements.
Section 32.51a(a) and (b)--Revision to 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 before transfer rather than at the time of
transfer. The distributor is also required to provide copies of
additional applicable sections of the regulations, and other
information.
Comment: The majority of those commenting on this issue were in
favor of ensuring that general licensees are better informed of
regulatory requirements, etc. Three of the distributors, however,
claimed that the requirement to provide information to their customers
was unnecessary or would not affect accountability. A few thought that
having the information provided in the package is more effective as it
would likely get to the person actually using the device. However,
another thought that when information is included with other
documentation accompanying the device, that often the ``responsible
individual'' does not receive it. One of the general licensees who
commented claimed that no information had been provided when the
company had purchased exit signs. An Agreement State noted the
importance of the general licensees being informed specifically about
any regulatory fees that will be required and that doing so would lead
to better cooperation and reduce the potential for unauthorized
transfer of devices.
One commenter argued that making a requirement for the distributor
of the generally licensed device to provide applicable regulations to
the general licensee is insufficient. If the regulations are part of a
large packet of information they are too easily overlooked. Also, if
the individual is unfamiliar with regulations, the significance of the
information may not be understood.
Response: Although the new provision cannot completely resolve the
difficulties of ensuring that the general licensees, and the
appropriate persons within the general licensees' organization, are
fully aware of all regulatory requirements, the Commission believes
that the requirement for providing the primary applicable regulations
and additional information to customers prior to sale, together with
the requirement for general licensees to appoint a ``responsible
individual'' should significantly improve general licensee awareness of
and ultimately compliance with regulatory requirements.
Comment: A State commented that the information provided to
recipients of the generally licensed devices should also include a
Safety Analysis Summary (SAS) for each generally licensed device
transferred. The SAS should provide information that would be useful to
regulating agencies and end users during normal use and accident
conditions. The commenter noted that the NRC recognizes the fact that
general licensees have no radiation background and, therefore, the NRC
should recognize that general licensees would not be able to answer any
questions raised by the employees about the hazards associated with
routine use of the device or working in the area of such a device.
Additionally, the general licensee would not know how to deal with
incidents involving their device. This State believed that a well
thought-out SAS should provide general recommendations that should be
taken to reduce contamination and unnecessary radiation exposure in
dealing with incidents, and that this information could be used by the
general licensee in a manner similar to Material Safety Data Sheets,
used routinely by many industrial facilities.
Response: The general license is based on the standard that the
device can be used safely by someone without radiation protection
training. Distributors are required to provide instructions and
precautions necessary to assure safe installation, operation, and
servicing of a device on the label or in operating and service manuals
referenced on the label. Paragraph 31.5(c)(5), which is included in the
information that the distributor must also provide to general
licensees, requires the general licensee, in the event of a failure or
damage to a device, to suspend operation of the device until it has
been repaired by or disposed of by transfer to a specific licensee
authorized to do so. This paragraph requires the general licensee to
report the event to the Commission. If the event is likely to have
resulted in contamination of the premises or environs, the revised
Sec. 31.5(c)(5) also requires the general licensee to submit a plan for
ensuring that the premises and environs are acceptable for unrestricted
use. In the unusual event of damage to a device involving significant
contamination of the premises and/or environs, the general licensee
should consult with the distributor or other person with the
appropriate training in radiation protection. Therefore, beyond the
requirements discussed here, the Commission does not believe additional
instructions are needed.
Comment: One commenter was concerned that companies selling devices
sell to the individual researcher or department within the institution
and the institution is oftentimes unaware that the device is in its
possession. The commenter claimed that only one of its six vendors
routinely notifies the institution when a new source is transferred.
Response: It is the responsibility of the licensed organization to
communicate appropriately within house. Information provided before
purchase on the requirement for a ``responsible individual'' should
lead to some improvement in this area. It is not the distributor's
responsibility to ensure that all appropriate persons within the
general licensee's organization are informed.
Comment: There was particular concern about the proposed
requirement to provide information on options for disposal and
estimated costs of disposal. The primary reason stated was that
disposal availability and costs for disposal change continually and any
estimated costs are likely to be meaningless at the actual time of
disposal. This is considered particularly problematic for devices with
useful lifetimes of 30 or more years, and for devices containing Am-241
because
[[Page 79177]]
there is no viable disposal option. One commenter stated that the
information would likely be wrong and misleading. It was also pointed
out that disposal costs are not required to be given to a specific
licensee.
Response: The commenters are correct in that the costs of disposal
may change dramatically between purchase and ultimate disposal,
particularly for devices with long lifetimes. The distributor can only
provide current information and indicate that it could change
considerably by the time of disposal. The Commission believes that this
amount of information should be made available to the purchaser in
spite of the uncertainties in the ultimate cost of disposal. Some
information about the situation needs to be provided even in the case
of Am-241. In some cases, the distributor can agree to take back
devices. Customers should be able to assume that there is always some
uncertainty whether they will be around to fulfill that promise.
Comment: There were questions concerning how compliance with the
requirement can be shown and specifically whether there would have to
be written proof to demonstrate that each customer has been informed.
One of the distributors recommended that a validation form be sent
along with Sec. 31.5 to end users purchasing devices, requiring the
user to sign the form indicating they had received, read, understood,
and would comply with the regulation(s) provided, because people have a
much greater tendency to read and comply with something if they must
put their signature to it. Another option suggested was for the
distributor to provide a registration type card, similar to warranty
registration cards, that would be sent to the regulator rather than the
distributor.
Response: Although some distributors may find a system using a
validation card effective in communicating with their customers, the
Commission believes requiring this extra documentation for all
distributors may not be justified and that some would find this
burdensome. Which method of providing disclosure information is most
efficient and effective is likely to vary amongst different businesses.
If a particular distributor finds that it is appropriate for their
organization to get a signed card back from its customers to ensure
compliance, they may chose to do this. The Commission will not require
written proof to verify that each customer has received the required
information before deciding to purchase a device. NRC inspectors have a
variety of means at their disposal for determining compliance,
including reviews of the written material that the distributor provides
to the general licensee, conducting interviews with the distributor's
staff, and sampling the distributor's customers if necessary.
On the option of a registration type card provided by the
distributor and sent by the general licensee to the regulator, the
Commission believes at this time that this will not be cost effective.
There could be considerable cost resulting from reconciliation of
quarterly transfer report information with the cards received from
general licensees and followup when general licensees fail to send in
the card.
Comment: A few commenters were concerned over the amount of
paperwork ``thrown at a proposed customer.'' One suggested that
Sec. 31.5 is critical for review before the sale, but that additional
information could be provided with the product at time of delivery. It
was suggested that the distributor may be better able to accomplish the
communication of necessary information, if they could indicate that
further regulatory requirements are specified with the delivery of the
product. The exit sign distributors, although suggesting that exit
signs be removed from Sec. 31.5 and put into a separate provision, were
concerned that their customers found it particularly difficult to
understand the regulations. At the public meeting on October 1, 1999,
they pointed out specifically that some of the provisions in Sec. 31.5
do not apply, and even the title of the section doesn't include
reference to that type of device.
Response: A few changes have been made in the final rule to help
reduce confusion on the part of exit sign users, as well as address
others' concerns about the amount of information to be provided prior
to sale. The title of Sec. 31.5 has been changed to be more inclusive
of all the devices covered. It may have been an added cause of
confusion that exit signs did not fall into the shorter title. The
provisions to provide copies of Sec. 31.5 or, in the case of Agreement
State customers, comparable Agreement State regulations, have been
changed to allow specific paragraphs not applicable to a particular
device to be omitted. Also, a provision (Sec. 32.51a(c)) has been added
that would provide some flexibility to distributors for properly
informing their customers. Distributors would have to receive
Commission approval before using a substitute to the prescribed
information. One might, as suggested, provide a more simply stated
summary of regulatory requirements in sales information and provide
actual copies of regulations at transfer.
In addition, the Commission staff has added another pamphlet
designed as guidance specifically for self-luminous exit sign users as
Appendix L to the final version of NUREG-1556, Vol. 16, ``Consolidated
Guidance about Material Licenses: Program-Specific Guidance about
Licenses Authorizing Distribution to General Licensees,'' to be
published shortly. It may be used by NRC, the Agreement States, or the
distributors of exit signs as information for users.
Comment: One commenter questioned the value of indicating a
person's name instead of the title ``Director'' for a contact at an
Agreement State regulatory agency. The commenter indicated that at
least one of the Agreement States had asked that the state director's
name not be used in quarterly reports and suggested that the same
information be provided to customers.
Response: In Sec. 32.51a(b), the title has been added as an
alternate to the name of an individual as a contact at an Agreement
State regulatory agency. A particular agency may prefer the use of a
title in lieu of an individual's name whose position may change.
Comment: There were three issues that commenters wanted clarified:
(1) The fact that the specific sections of the regulations included in
the information to be provided does not match the applicable
requirements mentioned in Sec. 31.2; (2) how the services that can only
be performed by a specific licensee are determined; and (3) the
alternative of providing NRC's regulations to customers in Agreement
States is not as clear in the proposed text as in the existing rule.
Response: On the first of these issues, the portions of the
regulations which must be provided to customers are those considered
most important for the general licensees to be aware of. The required
sections are not all inclusive of sections of the regulations that may
apply. However, Secs. 31.2 and 31.5(c)(10) make reference to the other
applicable regulations.
On the second issue, Sec. 32.51 requires an applicant for a license
to distribute devices for use under Sec. 31.5 to provide information
about labeling, including instructions and precautions to assure safe
use and installation, operation and servicing of the device. It also
requires the applicant to propose whether the general licensee can
perform certain testing procedures. This application process is where
the details of which activities can be performed by the general
licensee or must be performed by a specific licensee are determined for
a particular device. The Commission believes it is easier to specify
what services only the specific licensee can
[[Page 79178]]
perform, rather than what the general licensee is allowed to do.
On the third issue, the Commission believes these options are clear
but further clarifying language has been added.
Section 32.52(a) and (b)--Proposed revision to 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 is 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
replaces the name and/or position of a simple contact between the
Commission and the general licensee. Also, a form (NRC Form 653) will
be provided for use in making these reports. However, the use of the
form is not required as long as the report is clear and legible and
includes all of the required information.
Comment: The distributors who commented were concerned about the
difficulty of identifying a replacement device. They noted that the
replaced device may be returned long after obtaining another. If the
distributors were required to include the information pertaining to the
replaced device in the transfer report, in anticipation of its return,
the replaced device would be deleted from NRC's database, although it
may never be returned. They claimed that adding the tracking of which
device replaces another device to their recordkeeping would be
burdensome. One of the Agreement States had a similar comment and
suggested that the report include information on the device returned
regardless of whether or not it was replaced.
Response: The Commission agrees that identifying when a device
replaces another and reporting the receipt and transfer of both devices
in the same quarterly report is impractical. The final rule has been
changed to remove the replacement process as a determinant for which
transfers (by general licensees) or receipts (by distributors) must be
reported. The final rule requires the distributors to include
information on all devices received from general licensees.
``Indication if device is a replacement, and if so, the type, model
number, and serial number of the one returned,'' is replaced by, ``For
devices received from a general licensee, * * * the identity of the
general licensee by name and address, the type, model number, and
serial number of the device received, the date of receipt, and, in the
case of devices not initially transferred by the reporting licensee,
the name of the manufacturer or initial transferor.''
Comment: One commenter was concerned that there was no definition
of the term ``intermediate person'' defined in any of the regulations.
He understood that intermediate persons referred to general licensees
who receive a radioactive device but are not the ultimate user and that
it does not refer to holders of materials licenses to receive and
redistribute general license devices.
Response: The commenter is correct in this interpretation. Some
distributors and redistributors apparently have misinterpreted this
requirement in the past. The Commission believes that the new wording
of Secs. 31.5(c)(9), 32.51a and 32.52 should help to clarify this
issue; therefore, a definition is not needed. Redistribution is not
allowed under the general license, except that an intermediate person
may possess the devices at their intended place of use. However, a
warehouseman may be exempt from licensing under Sec. 30.13 to the
extent that they temporarily store a device being transferred to a
general licensee known to the initial distributor. This exemption would
not allow a warehouseman to stock devices for future sale.
Comment: One commenter said that the distributors should be told
that the institution is the general licensee and not the individual
researcher or department within the institution.
Response: In the case of universities, the general license is
provided to the educational institution, an individual working for a
university is not a general licensee. Thus, the distributor should not
list an individual researcher as the general licensee.
Comment: An Agreement State said that the report should specify the
type, model, and serial numbers of the device, source holder, and
source, as appropriate, noting that many devices have multiple
(different) serial numbers used to identify the various components. The
concern was that any of these numbers could be reported by themselves
at different times leading to mis-identification of transfers, returns,
and deliveries. They concluded that all numbers associated with a
device should be reported.
Response: Each device should have a device serial number. As noted,
devices may have multiple sources and some have their sources changed
routinely. This rule is intended to allow the Commission to keep track
of individual devices distributed in the future, and those already in
use that are subject to registration. Although a separate source
housing will be required to have a source serial number, the Commission
believes that the extra reporting necessary to keep track of all source
serial numbers is not cost effective at this time. There would be many
source replacements to report. In the unusual event of finding an
intact source outside of the device, the source could usually be traced
back to the general licensee through the distributor. Also, sources
that are readily separable from the device for replacement purposes,
often contain short-lived nuclides which present relatively low risks.
Comment: One commenter made the following statements concerning
reporting the specific location of use rather than the mailing address
of location of use, or identifying the precise physical location:
``This is `nice to have' information if the agency intends to routinely
inspect the facility. We believe the burden of locating the device
should fall on the general license. If the general licensee cannot
locate a device in a timely manner, it should be presumed `lost' and
the appropriate fine would be in order.''
Response: The Commission agrees. The distributor may have
difficulty obtaining this information. The device could later be moved,
in which case, the information the NRC has would become incorrect.
Having to report moves within building(s) at the same address would not
be justified. The mailing address for location of use continues to be
the only required information on the location of use. An exception to
that, however, has been added only if the address reported is not
directly associated with the location of use, because there is no
mailing address for the location of use, such as on a pipeline.
Comment: One of the distributors at the public meeting pointed out
that sometimes labels are changed on a device making information the
Commission has incorrect. This can happen in a source changeout if the
radionuclide or activity is different (not just because of decay) and
in the case where the distributor uses the same serial number for the
device and source. The question was raised as to whether the
distributor should report these changes. It was also noted that, on
occasion, the change of a source could even change whether registration
is required.
[[Page 79179]]
Response: The Commission agrees that the distributors should report
any changes to the device to accurately maintain accountability of the
device. Only service providers, who are specifically licensed to change
the information on the label which is required under Sec. 32.51, are
allowed to do so. The service providers should report these changes to
the NRC or Agreement State. The final rule has been changed to require
this of Sec. 32.51 licensees. This information will include the old and
new information regarding the device. However, many service providers
are not distributors licensed under Sec. 32.51, and licensing action
will be necessary to get all changes reported.
Comment: One of the distributors urged the NRC to move quickly
toward allowing electronic submission of quarterly reports.
Response: The Commission is exploring a means for the quarterly
report data to be submitted electronically.
Section 32.52(c)--Proposed revision was to add to the recordkeeping
requirements, information on final disposition of devices and
significantly extend the retention period for recordkeeping concerning
transfers.
Comment: One of the distributors thought that extension of
recordkeeping was unnecessary, because the same information would be
submitted in quarterly transfer reports. This commenter also asserted
that maintaining the records would not be as simple as assumed by the
Commission, stating that long term retention of records to meet a
regulatory requirement requires more rigorous systems, procedures, and
training than are necessary to meet normal business needs and involves
commensurately greater time and costs.
Response: Under the proposed rule, long term retention would have
been required of all the information required in the reports and
additional information on final disposition of returned devices. As the
final rule requires information to be reported on all devices received,
there is no need for long term retention of records or for specifying
information on final disposition of returned devices. Instead, the
retention period is reduced from 5 years after the reported event to 3
years after the reported event. Three years should be adequate to cover
the time from the transfer through the time reported, time for NRC to
record the information, and time for NRC to verify and correct any
inconsistencies or obtain clarification from the distributors. The rule
also revises the content of recordkeeping requirements by specifying
that information supporting the revised reports needs to be retained.
There were no comments on Sec. 32.51a(d), which was redesignated
Sec. 32.51a(e) in the final rule.
C. Comments on Compatibility Category for Agreement States
Comment: Most of the distributors who commented presented
considerable argument that Compatibility Category C was not appropriate
because of significant direct transboundary implications. They strongly
urged that Secs. 31.5 and 31.6, be made Compatibility Category B. One
commenter suggested that Category A might be appropriate saying that
the loss or non-accountability of radioactive material is a serious
matter that is contrary to the basic principles of radiation safety.
Two of the commenters stated that the time radiation safety personnel
spend attempting to comply with any Agreement States' unique versions
of Secs. 31.5 and 31.6 is directly at the expense of efforts that are
meaningful to product safety, training, following up with customers who
have not returned devices, etc. One commenter concluded that
consistency in the regulations significantly improves the chance of
compliance by both the end user and the distributor, thereby increasing
safety.
These distributors presented a number of arguments for consistent
regulations, noting that a few States have required specific licensing
for these devices. One commenter stated that Agreement States are in
essence voiding other Agreement States sealed source and device
registry reviews and technical positions. Many complained about the
difficulty of staying current on all jurisdictions' regulations. There
is no mechanism in place for someone who is not a licensee in a
particular state to be made aware of any changes of staff and rules.
The case of a recent rulemaking by the State of New York was
discussed. Under the regulations that are New York's current version of
Sec. 31.5, certain devices (gamma gauges, Sr-90, transuranics) may no
longer be possessed under a general license within the State of New
York. This change affects customers in New York who have been required
to apply for and obtain specific licenses for these gauges.
Distributors are affected in terms of providing additional customer
support for licensing, assuring shipments don't occur before specific
license verification, and added recordkeeping. In addition, there is
another seemingly unintended, but real consequence of permitting
different Agreement State versions of Sec. 31.5. In non-Agreement
States, distributors and other servicers provide gauge service to end
users under Sec. 31.6. This permits work under the detailed terms of
their specific license for gauge service, issued by an Agreement State,
without needing to apply for a specific license from NRC and without
being required to work under the reciprocity provision in 10 CFR
150.20. Like most other Agreement States, New York regulations contain
a provision similar to Sec. 31.6; however, with New York's new version
of Sec. 31.5, their regulation comparable to Sec. 31.6 no longer
authorizes distributors or servicers licensed by NRC or other Agreement
States to provide installation or on-going service to New York end
users of some gauges. New York's version of reciprocity requires filing
for permission a minimum of 7 days in advance of the activity and is
limited to 30 days of work per calendar year. Because there are
distributors' employees who live and report to work on a daily basis at
end-user sites in New York State, these reciprocity provisions are too
restrictive to be useful on an ongoing basis. As a result, some of the
distributors and other servicers will be required, in order to continue
to offer service to all customers, to apply for a specific license from
the State of New York, even though they already have specific licenses
issued by NRC or Agreement States that were designed to regulate their
installation and service activities throughout the country. If
Sec. 31.5 is designated Category C compatibility and other Agreement
States eliminate the general license for certain gauges, those states
and the out-of-state service providers working within those states will
be involved in the time-consuming process of negotiating new specific
licenses (in duplication of existing licenses).
Response: The Commission agrees that there are significant
transboundary implications of these regulations. The compatibility
requirements for Secs. 31.5 and 31.6 are being made a Category B. After
the Agreement States make the required changes to their regulations (in
about three years), the distributors' and other servicers' problems
with reciprocity for servicing will be eliminated. There will be
limited possible changes in various regulations for distributors to
keep up with, such as fee amounts. Although Part 170 provisions are not
amongst the regulations which must be provided to customers, it is
expected that distributors will be asked and will inform customers on
the amount of fees.
In implementing the Agreement State Program through the regulations
in 10
[[Page 79180]]
CFR part 150 in 1962, the Commission (then AEC) stated: ``The
Commission's decision not to exercise its authority to license the
transfer of products containing atomic energy materials (other than
products designed for distribution to the general public) is based on
the assumption that agreement States will maintain continuing
compatibility between their programs and Commission programs; and that
procedures will be devised assuring reasonable, reciprocal recognition
of licenses and licensing requirements among such States and the
Commission.'' This will unfortunately require a number of Agreement
States to revise existing registration programs; however, the
Commission believes consistency of regulations in this area is very
important to improve the effectiveness of the general license program.
Comment: One Agreement State thought that the supplementary
information was unclear on how general licensees in Agreement States
must demonstrate that they can account for devices and are
knowledgeable of the applicable requirements; specifically, that it did
not say if NRC intends to request that Agreement States keep track of
general licensees and individual devices. Because establishing a
tracking system is a significant undertaking, they recommended that NRC
clarify its expectations of the Agreement States.
Response: For there to be complete accountability for devices and
the ability to trace orphaned devices to responsible parties, tracking
by all jurisdictions will be necessary. If NRC were to develop a
National Database in the future, Agreement States would have to provide
detailed data for general licensees and devices in their jurisdictions.
In addition, with all reporting requirements necessary for keeping
track of individual devices being Compatibility Category B, the
necessary information will be required to be provided by all licensees
in the future. It is expected that if a jurisdiction requires
information to be reported, it would keep and make use of that
information.
Other Comments Concerning Transboundary Activities
Comment: One commenter recommended that supplementary information
for the final rulemaking explicitly describe the conditions under which
an Agreement State licensee would be allowed to use a portable
generally licensed device in an area of NRC jurisdiction.
Response: Although there is no reciprocity for general licenses,
the general license in Sec. 31.5 applies automatically without
application for license or other permission as long as the device has
been manufactured or distributed by an appropriate specific licensee
and obtained in an authorized manner. The user of a portable device in
NRC jurisdiction would be using the authority of Sec. 31.5 and would be
subject to NRC regulation. However, the NRC would not require
registration of a device used in NRC jurisdiction by a company located
in another jurisdiction, as the registration is based on the address of
the primary place of storage. The NRC would be relying on the Agreement
State to have appropriate controls in place under equivalent
regulations to ensure accountability for the device. An additional
provision has been added to Sec. 31.5(c)(13) to specifically exclude
from the registration requirement Agreement State general licensees
using a device temporarily in NRC jurisdiction. This provision limits
the time this exclusion is applicable to less than 180 days in any
calendar year. This is consistent with the reciprocity provision for
specific licensees in Sec. 150.20 and is intended to avoid, for
example, the situation of a general licensee purposefully storing a
device normally used in NRC jurisdiction in another jurisdiction to
avoid NRC registration.
Comment: There was comment on whether portable and ``mobile fixed''
gauges should be allowed under a general license. An Agreement State
commenter stated that there are obvious transboundary implication to
this practice and reciprocal recognition of the general license is not
provided (and should not be). Another Agreement State supported
limiting portable and ``mobile fixed'' gauges to specific license only.
Response: The Commission believes that it is reasonable for each
jurisdiction to allow the use of portable or ``mobile fixed'' devices
under a general license within its jurisdiction that are being
regulated by another jurisdiction. This should be particularly true
with the regulations in Sec. 31.5 a Compatibility Category B. Each
jurisdiction relies on the others in approving devices for use under a
general license.
Timing of Adoption of Requirement for Augmented Material Transfer
Reports
Comment: The three Agreement States that commented all opposed an
accelerated implementation by the Agreement States, favoring the normal
three years. However, one referred only to the difficulty of having all
of the States revise their regulations. Another discussed the
difficulty of developing an infrastructure (a state registration
program) which may not already exist. This commenter did indicate that,
if necessary, they could apply appropriate license conditions for their
several distributors.
Response: The proposal for accelerated adoption of the Agreement
States was only for updating distributors' material transfer reporting
requirements. It is assumed that this would likely be done by applying
license conditions, if required to do so quickly. The States would
still have the normal three years to implement a registration program
and to make changes to their regulations. The Commission would like to
start getting the additional information from all jurisdictions as soon
as possible. Because the new reporting requirements include all the
necessary information that was required previously, it will not be a
problem for States to start receiving the augmented material transfer
reports before revising their rules or implementing a registration
program. The Commission is requiring that the Agreement States require
their distributors to make their material transfer reports consistent
with this rule 6 months after the effective date of this rule.
D. Comments on Specific Questions Posed
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.
Comment: There were about equal responses for and against such a
provision. A non-Agreement State wanted registration to be completed in
30 days after receipt. One commenter noted that general licensees will
have difficulty knowing whether the registration requirement applies to
them. They stated that it would be inappropriate to cause general
licensees to attempt to register unnecessarily and that registration
should be a response to an NRC or Agreement State directive based on
agency assessment of the devices received. Another argument against was
that if an entity is unaware that a device should be registered because
they have not been notified by a manufacturer, distributor, NRC or
Agreement State, it would be unfair to impose a penalty on them. One of
those presenting this view stated that the burden for the initial
implementation should not be placed on the general licensee, but should
be on the NRC, associated Agreement State, or the specific licensee
distributor.
[[Page 79181]]
Response: Although there may be some general licensees for which
the NRC does not have current name and address information and who may
not get registered, the Commission has decided not to add a requirement
that the general licensee complete registration by a certain time,
whether or not the NRC requests registration. The NRC will rely instead
on its process of specifically requesting the general licensee to
register those sources and devices to which the registration
requirement applies. No change has been made to the proposed rule.
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).
Comment: There was a mix of responses to this question. Three
commenters, including two States, would like to see earlier
acknowledgement. The other two States that commented, as well as a
couple of general licensees, thought it was logical, efficient, and
effective to add new devices at the time of reregistration.
Response: The Commission believes that updating at time of
reregistration is adequate, and that the additional paperwork of
reporting receipts in the interim is not justified. No change has been
made from the proposed rule.
3. The Commission solicits comment on whether general licensees
should be required to assign a backup responsible individual (BRI).
Comment: Two commenters supported the addition of a requirement for
a backup responsible individual. Many others were against it. The main
concern of those supporting a BRI was that if the person in that role
leaves the company, no one else may know about the general license and
associated requirements. Those opposed thought it was unnecessary and
impractical especially in the case of very small businesses.
Response: The Commission continues to believe that a requirement to
appoint a BRI is not appropriate. It should be noted that the process
of appointing an RI involves management; someone other than the RI
would know that there is a general license and associated requirements.
As this is a management appointment, management would know to reassign
these duties if the individual leaves the organization. An employee
should not be obtaining a device and assuming that he can act as the RI
without his management being aware of these responsibilities.
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?
Comment: Some commenters objected to the possible use of the words
``prior to purchase.'' Some expressed the concern that ``prior to
transfer'' would not be adequate to achieve the objective. Most
commenters talked about the importance of achieving the objective of
disclosure before decision, without commenting on the best approach. A
couple of the commenters wanted written acknowledgment that the
information had been received and read before transfer. However, a
couple of the distributors thought it was unreasonable and less
effective to require information to be provided prior to transfer
instead of at transfer.
Response: The Commission believes the words, ``prior to purchase,''
is unnecessarily restrictive and presents more problems than ``prior to
transfer.'' Therefore, the final rule requires that the required
information regarding the device be provided to the purchaser ``before
the device may be transferred.'' Although providing information with
the device at the time of transfer may, in a few cases, not always get
it to the person actually using the device, the Commission believes
that overall, upfront disclosure prior to transfer of the device is
preferable. The general licensee personnel considering the purchase
should see the requirement for appointing a ``responsible individual,''
and, if they purchase the device, will have to provide the distributor
the name of the person appointed. The final rule also allows
flexibility to the distributor to use another approach to disclose the
information, if approved by the Commission. For example, if the
distributor believes that providing some of the detailed regulatory
text at the time of transfer would be more effective for his customers,
he may propose this to the Commission; the Commission would have to
determine whether the upfront disclosure under the proposal is
adequate.
5. The Commission seeks comment on the advantages and disadvantages
of implementing a national database of general licensees and their
devices.
Comment: There was considerable support for establishing a national
database but also some concerns about integrity and security. Those
supporting a national database pointed to the ease of tracking the
responsible parties when abandoned devices are found. Some commenters
thought it would make discrepancies easier to reconcile. Cost was
mentioned as a possible concern for both a national database and
separate databases in each jurisdiction. Potential disadvantages
included potential misuse by outsiders. There were questions about who
would have the authority to make changes, how changes and additions
would be made, what mechanism would be used to ensure accuracy and
completeness, and who would pay the cost of establishing a national
database. One Agreement State suggested that a new database may or may
not be effective during the first 5 years of operation, based on their
experience, which revealed difficulties that were overcome only with
time and experience. They stated that, they would be reluctant to
exchange their existing database for one introduced by NRC until the
new national database had been proven effective over several years at
no additional cost to the regulated community. Another Agreement State
indicated that it would likely maintain its own database to support its
registration program. That State thought that even though a national
database would be quicker in tracking a device, there was no urgency
with identifying a responsible party, once a source is secured. It also
noted that once a source is smelted there is no serial number or
similar information to trace.
Response: The Commission believes that it is best to implement the
new database for NRC general licensees, use it for implementing a
registration program, gain experience with it, and give consideration
to expanding the database at a later date.
E. Additional Comment on Implementation Issues
Comment: One commenter asked whether there is a way for general
licensees to request a list of devices that should be in their
possession, stating that this would be a great benefit to the
``responsible individual'' once these proposed rules are implemented.
Response: General licensees can and have contacted NRC to obtain
this type of information. They can write to Director, Office of Nuclear
Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001.
[[Page 79182]]
Comment: One commenter recommended that the NRC develop a list of
Sec. 31.5 licensed devices and make the list readily available to the
public, possibly via the NRC web site. The list should contain the
manufacturer, model number, and brief description of the device and
should also state whether the device meets the registration criteria.
This would assist current general licensees in identifying Sec. 31.5
devices already in their possession.
Response: Information is available on the Internet on manufacturers
of devices, model numbers, etc. in the Sealed Source and Device
Registry (SSDR) at http://www.hsrd.ornl.gov/nrc/ssdr/ssdrindx.htm. The
electronic version is not currently complete, but is expected to be
complete relatively soon. The SSDR includes devices that are generally
licensed, specifically licensed, and exempt. Creating a separate set of
information on the Internet of devices allowed under a general license
would be a significant effort, and would still not allow the general
licensee to identify which devices have been received. The current
information is organized by name of manufacturer and can provide
additional information about a device if one knows the manufacturer and
model number. However, the SSDR provides a maximum activity that is
allowed in a device and the individual device may have a lesser amount
of activity. Thus the SSDR information would not and can not allow one
to determine whether a device is subject to registration. However, the
general licensee does not need to determine this in advance, as the NRC
will contact the licensee requesting verification of registration
information. The NRC is not assessing a fee the first time this request
is being made for devices held before the registration requirement.
F. Comment on Enforcement and Civil Penalties
Comment: One commenter asked whether past inspection and
enforcement history of a specific license may be used to escalate the
enforcement actions against the general license and vice versa. He also
asked if that were the case, is there precedence set for these actions?
Response: The NRC's enforcement actions are guided by its written
Enforcement Policy (General Statement of Policy and Procedure for NRC
Enforcement Actions, NUREG-1600). The Enforcement Policy encourages
licensees to achieve a high standard of compliance in all regulated
activities. The NRC's civil penalty assessment process considers, as
one of its decisional points, whether there has been any previous
escalated enforcement action, regardless of the activity area
(Enforcement Policy, Section VI.B.2.). Thus, in a situation where an
entity holds both a specific and a general license, escalated
enforcement action for activities conducted under one of those licenses
may be considered in determining the appropriate enforcement action for
activities conducted under the other license. Precedence is not the
controlling factor. Each enforcement action is dependent on the
circumstances of the case.
Comment: One commenter believed that the civil penalties proposed
for the loss or unauthorized disposal do not reflect real safety
implications, stating that, in the case of polonium-210 (Po-210), the
safety hazard involved is minimal.
Response: As explained in the statement of considerations for the
proposed rule, the change to the base civil penalty amounts for loss or
unauthorized disposal of a sealed source or device will better relate
the size of the civil penalty to the costs avoided by the failure to
dispose of the source in an authorized manner. While safety
implications are an important consideration, a licensee should not
receive an economic benefit by committing a violation. A separate
notice, published elsewhere in today's Federal Register, establishes
the new civil penalty amounts and gives a more complete explanation.
The base civil penalties range from $6,000 to $45,000.
Comment: One commenter suggested that the NRC was creating a new
class of license. The commenter stated that although a license is not
required, there are still several requirements the user has to meet
before getting the device, that in essence there are additional
prerequisites that must be accomplished by the vendor (distributor) and
end user before receiving the device. The commenter also stated that
many of these prerequisites are going to be difficult to demonstrate
compliance.
Response: General licenses are established in various Parts of
Title 10, Code of Federal Regulations. Some convey only after certain
requirements, such as registration, are fulfilled; others convey
automatically. In some cases, general licensees must obtain NRC-
licensed materials only from distributors who are specifically licensed
to supply them. The practical effect of this restriction is that
distributors who wish to supply materials to general licensees must
obtain a specific license to do so, and must meet certain NRC
requirements. Thus, the Commission does not see this rule as creating a
new class of license. Where licensees are required to ``demonstrate
compliance,'' such as by maintaining records, that requirement is
specifically noted in the regulation or the license. In the absence of
a specific requirement, such as recordkeeping, NRC inspectors have a
variety of means at their disposal for determining compliance,
including interviews, sampling, etc.
Comment: A question raised at the public meeting was: In order for
high civil penalties to be a deterrent to improper disposal, how do we
keep the general licensee aware of the penalties?
Response: A copy of the Federal Register Notice stating the policy
of establishing separate civil penalties for loss, abandonment, or
improper transfer or disposal is being sent to current Sec. 31.5
general licensees along with this notice. The rule has been revised to
require the distributors to also provide a general statement concerning
the Enforcement Policy of the NRC with respect to the improper disposal
of generally licensed devices.
G. Comments Outside the Scope of the Rulemaking
Comment: One source material licensee presented detailed concerns
about the exemption in Sec. 40.13(c)(5) for depleted uranium in
aircraft counterweights, calling it a parallel problem, with a more
immediate and much larger potential for public exposure.
Response: The commenter has since submitted a petition for
rulemaking (PRM-40-28) to address his concern related to aircraft
counterweights. This issue is outside the scope of this rulemaking but
will be considered in resolving the petition.
Comment: One commenter stated that because the purpose of these
regulation changes is to increase the accountability of devices, the
limit for Cs-137 that requires registration should be lowered.
Currently, some manufacturers are attempting to circumvent the rules
and the interest of public health and safety by packaging or directing
other people to repackage exempt quantities of radioactive material. If
the proposed rule were to state that any quantity of Cs-137, Co-60,
strontium-90, Am-241 or any other transuranic distributed under
Sec. 31.5 would require registration, the loophole that allows
significant quantities to be unaccounted for and improperly disposed of
could be closed. This would still allow for the use of individual
exempt quantities of material to be used as calibration or check
sources.
[[Page 79183]]
Response: The issue concerns the improper use of exempt sources in
devices to avoid licensing under Sec. 31.5, so adjusting registration
criteria in Sec. 31.5 would not address the problem. Thus, this issue
is outside the scope of this rulemaking. The Commission is considering
action regarding this issue separate from this rulemaking.
Comment: One commenter was concerned about the use of the provision
in the recently issued final rule (64 FR 42269; August 4, 1999),
providing for the occasional solicitation of information from general
licensees stating that with respect to small business general
licensees, these solicitations should be conducted only when absolutely
necessary.
Response: With the exception of the first round of registration to
be conducted under Sec. 31.5(c)(11), the Commission is not expecting to
make numerous requests for information from general licensees under
this provision and will give appropriate consideration to the
justification of any burden placed on these licensees when making such
requests.
In addition, editorial changes have been made in the revisions to
improve the organization and readability of the regulations being
revised. These types of changes are not discussed further in this
notice. A few comments were received concerning possible clarifications
of the rule language. These have been considered in writing the final
rule.
Availability of Detailed Summary of Comments
A more detailed document that presents all of the comments sorted
by subject is available. This document is available for inspection in
the NRC Public Document Room, 11555 Rockville Pike, Rockville,
Maryland. Single copies 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 CRM@nrc.gov.
Additional Revisions in Final Rule
During the development of plans for implementing the revised
regulations, some issues were identified related to the efficiency of
the program. Some minor changes have been made in the final rule to
improve the clarity of the regulation and the efficiency of
implementing it.
Section 31.5(c)(5)--It has been clarified that, in addition to the
device itself, any radioactive material no longer within the device,
can only be transferred to a specific licensee authorized to receive it
or as otherwise approved by the Commission. Section 30.41 would limit
such transfers; however, it is preferable for this point to be clear in
Sec. 31.5.
Section 31.5(c)(8)--Paragraph 31.5(c)(7) allows export of a device
in accordance with part 110. This would seem in conflict with the
limited set of options for transfer in Sec. 31.5(c)(8). An exception
such as already exists for transfers under Sec. 31.5(c)(9) has been
added. Also, a requirement to report in the case of export has also
been added to allow the NRC to update its records in the case of
disposition of the device by export. This is estimated to occur rarely
and add few additional transfer reports.
Before 1978, Sec. 31.5(c)(7) indicated that a specific license was
required to export devices. When part 110 was added to incorporate all
the requirements for import and export of nuclear equipment and
material, Sec. 31.5(c)(7) was revised to indicate that devices can only
be exported in accordance with part 110. Section 110.23 provides a
general license to export byproduct material. There are restrictions on
types and quantities of materials and export to certain countries is
not permitted. This section has been revised over time. Currently,
most, if not all devices under Sec. 31.5 would be allowed to be
exported under this general license without any reporting requirement.
Because a specific license is no longer required, the Commission would
not know when a general licensee has exported devices. Thus, the need
to add this circumstance to the reporting requirement.
Section 31.5(c)(9)(i)--The address of the transferee is specified
as the mailing address of the transferee for location of use. This is a
clarification and consistent with the specification of the address to
be provided by the distributors under Sec. 32.52(a) and (b). It also
tends to remove any implication that the location of use may change.
The title of the responsible person is added to the information
provided about the transferee. It should help to reduce the incidence
of mail being returned because the individual named no longer works for
the general licensee.
In addition, it adds to the information to be provided to the
transferee, copies of additional applicable sections of the
regulations. This is consistent with the changes to Sec. 32.51a with
respect to providing regulatory information to new general licensees.
Section 31.5(c)(13)--For clarification, a statement concerning the
practice of considering each addressee at a different location of use
as a separate general licensee has been added. This had been included
in the discussion, but not the regulatory text of the proposed rule.
Section 31.5(c)(8), (9), and (13)--In each place where the name of
the manufacturer of a device is to be provided to the NRC, the words,
``(or initial distributor)'' has been added in case the manufacturer's
name is not known to the general licensee. In the case of a U.S.
distributor of a device manufactured elsewhere, the name of the initial
transferor (distributor) may appear on the label in accordance with the
labeling requirements in Sec. 32.51(a)(3) (or comparable Agreement
State regulations). The label is a likely source of information for the
general licensee in reporting under each of these requirements.
Section 31.5(c)(14)--The address change requirement has been
changed to specify that changes are to be reported specifically for the
mailing address of the location of use. This is a clarification and
consistent with the specification of the address to be provided by the
distributors under Sec. 32.52(a) and (b).
Some clarification concerning this requirement needs to be made. In
the Statement of Considerations of the proposed rule, it was stated
that this would only apply to previously supplied mailing addresses.
The reference to previously provided addresses was meant to limit the
requirement to the primary address used by NRC for tracking the general
licensee (as obtained from the distributor), and not for alternate
addresses such as the mailing address of the responsible individual if
different from the mailing address for the location of use. The
specification of the mailing address for the location of use also
limits the requirement to the primary address to be used by NRC, and
relieves the general licensee of trying to determine what was
previously supplied.
The Statement of Considerations also stated that it was intended to
track moves into and within NRC jurisdiction. However, the Commission
interprets this provision such that general licensees moving out of NRC
jurisdiction are also required to report. Although the period allowed
to make a report of an address change extends to a time after leaving
NRC jurisdiction, a general licensee is not relieved of the requirement
to report the address change because he leaves the Commission's
jurisdiction before the time allowed for reporting runs out. If a
general licensee intends to move from one jurisdiction to another, he
should contact the applicable regulatory authority, NRC or the
particular
[[Page 79184]]
Agreement State, before doing so to determine the applicable, current
regulations in that jurisdiction, even though the requirement allows
after-the-fact reporting. Currently, all jurisdictions do not have a
comparable general license and certain provisions of the general
license may vary among jurisdictions.
Section 31.5(c)(5), (8), (9), and (14)--``ATTN: GLTS'' has been
added to the address for all submittals under Sec. 31.5 to improve the
efficiency of mail routing within NRC.
Section 32.52(a) and (b)--The title of the responsible individual
has been added to the information to be provided about the general
licensees' responsible individual in the distributors' material
transfer reports. This one additional item should not change the effort
involved in obtaining and reporting this information. It should help to
reduce the incidence of mail being returned because the individual
named no longer works for the general licensee. Although a general
licensee, in complying with Sec. 31.5(c)(12), would have to appoint a
replacement to a responsible individual when that person leaves or
changes assignments, he would only be reporting these changes through
the registration process, if subject to registration. Followup for
returned mail involves additional effort for NRC, general licensees,
and distributors.
Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' published on September 3, 1997 (62 FR
46517), the final rule is 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 and Sec. 31.5 are
classified as Category B. Through this action, existing provisions of
Sec. 31.5 are also being reclassified from Category D to Category B and
Sec. 31.6 is being reclassified from Category C to Category B. Although
changes are being made to Secs. 30.31, 30.34(h)(1), 31.1, and 31.2 as
part of this rulemaking, the existing compatibility designations for
these regulations are not 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 the Office of State
and Tribal 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, the name and license number of the
reporting company, and the specific reporting period. The revisions
also require the name, title, and phone number of a general licensee's
``responsible individual'' rather than simply a contact and 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 the distributors' quarterly transfer reports
as soon as possible. The Commission requests Agreement States to
require distributors to provide all the information consistent with
this rule (Sec. 32.52(a) and (b)) within 6 months following the
effective date of this final action. Agreement States have the
flexibility to adopt this provision through rulemaking, license
conditions, or other legally binding requirements.
Summary of Final Amendments by Paragraph With Compatibility
Categories
Section 30.31--Revision reconciles the apparent conflict between
the description of a general license and a registration requirement.
(Category C)
Section 30.34(h)(1)--Revision makes the bankruptcy notification
requirement applicable to those general licensees subject to the
registration requirement. (Category D/H & S)
Section 31.1--Revision clarifies that only those paragraphs in part
30 specified in Sec. 31.2 or the particular general license apply to
part 31 general licensees. (Category D)
Section 31.2--Revision clarifies references to the sections of part
30 that are applicable to all of the part 31 general licensees.
(Category D)
Section 31.5(b)--Revision clarifies 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 removes the restriction on devices
distributed by Agreement State licensees in Agreement States without a
general license. (Category B)
Section 31.5(c)(5)--Revision adds 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;
changes the addressee for reporting information concerning a failure;
and clarifies that the criteria in Sec. 20.1402 may be applied and that
byproduct material no longer in the device may only be transferred to a
licensee authorized to receive it or as otherwise approved by the
Commission. (Category B)
Section 31.5(c)(8)--Revision allows transfers to specific licensees
authorized under part 30, or equivalent Agreement State regulations, as
waste collectors, in addition to previously allowed transfers to part
32 (and Agreement State) licensees; allows transfers to other specific
licensees, but only with prior written NRC approval; and adds 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 also requires a report in the case of
export under Sec. 31.5(c)(7) and removes the exception to reporting
when a device is being replaced. (Category B)
31.5(c)(9)(i)--Revision adds 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, title, 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. It also specifies that the address of the
transferee be the mailing address at the location of use. In addition,
it adds to the information to be provided to the
[[Page 79185]]
transferee, copies of additional applicable sections of the
regulations. (Category B)
Section 31.5(c)(9)(ii)--Revision adds the term, ``intermediate
person,'' to clarify that the only time a report of transfer is not
required, is when the information on both an intermediate person and an
intended user was provided through the distributor in a quarterly
material transfer report. (Category B)
Section 31.5(c)(12)--Adds 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. (Category B)
Section 31.5(c)(13)--Adds an explicit requirement for the general
licensee to register devices meeting certain criteria, specifying the
information to be provided and referencing the fee requirement in
Section 170.31. (Actual fee to be added to Sec. 170.31 in next overall
fee rulemaking.) (Category B)
Section 31.5(c)(14)--Adds a requirement for the general licensee to
notify NRC of changes to the mailing address for the location of use.
(Category B)
Section 31.5(c)(15)--Limits to 2 years 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. It allows a device to be held
longer in standby for future use, if the general licensee conducts
quarterly inventory for these devices. (Category B)
Section 32.51(a)(4) and (5)--Adds a requirement for an additional
label on any separable source housing and a permanent label on devices
meeting the criteria for registration. (Category B)
Section 32.51a(a) and (b)--Revision amends the requirements
pertaining to the information distributors must provide to the general
licensee. Distributors were previously required to provide general
licensees with a copy of Sec. 31.5 when the device is transferred. This
rule requires that Sec. 31.5 be provided before transfer. The
distributor is also 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, information regarding disposal
options for the devices being transferred, including estimated costs of
disposal, and a statement concerning the policy of assessing high civil
penalties for improper 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 shall furnish the name or title, address, and phone
number of the contact at the Agreement State regulatory agency from
which additional information may be obtained. (Category B)
Section 32.51a(c)--Allows distributor to propose alternative
approach to informing his customers for Commission approval. (Category
B)
Section 32.51a(d)--Makes labeling requirements a condition of
license 1 year after effective date of rule. (Category B)
Section 32.51a(e)--Adds a 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. (Category B)
Section 32.52(a) and (b)--Revision adds the following information
to the existing quarterly transfer reporting requirement: the serial
number and model number of the device; the date of transfer; for
devices received from a general licensee, the type, model number, and
serial number of the devices received, the identity of the general
licensee by name and address, the date of receipt, and, in the case of
devices not initially transferred by the reporting licensee, the name
of the manufacturer or initial transferor; information that has been
changed on device labels; the name and license number of the reporting
company; and the specific reporting period. Also, the general licensee
address is specified as the mailing address for the location of use of
the generally licensed device.
The name, title, 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, replaces the name and/or position of a simple contact
between the Commission and the general licensee. Also, a form (NRC Form
653) will be provided for use in making these reports. However, the use
of the form is not required as long as the report is clear and legible
and includes all of the required information. (Category B)
Section 32.52(c)--Revises the content of the recordkeeping
requirement through specifying that information supporting the revised
reports is to be maintained. The period of retention for recordkeeping
concerning transfers is reduced from 5 years to 3 years from the date
of the recorded event. (Category B)
Early State Input
These final amendments were provided to the Agreement States during
their development via the use of the NRC Technical Conference Website
and notification to the States of its availability. Input was received
following posting from the State of Nebraska. Their comments concerned
two areas. The primary issue was the difficulty of keeping track of
devices possessed by general licensees, when distributors report all
devices transferred to general licensees, but information is not
received on those returned. They were in favor of the distributors
reporting serial numbers of those devices returned for replacement.
They were also concerned about the clarity of which proposed regulatory
provisions would apply to all Sec. 31.5 general licensees and which
would apply only to those who will register and pay fees.
National Database
The Commission has developed a new computer database to handle
information about general licensees and generally licensed devices.
Among other improvements from the previous system, it has been designed
to handle the registration process efficiently with automated features.
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 will give further consideration to establishing such
a database at a later date after experience is gained with the new
database and the registration program. Establishing a national database
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 the various jurisdictions into which devices
are transferred.
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
[[Page 79186]]
source until the responsible general licensee is identified and the
device 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 will 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 have to search its own files. In addition, a
national general license database would contain the most complete
information about general licensees and generally licensed devices and
would make that information immediately available.
The primary disadvantage of 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.
Enforcement Policy
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 (63 FR 66492) proposed rule, the
Commission also planned 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
establishing three levels of base civil penalty for loss or improper
disposal. The higher tiers are for sources that are relatively costly
to dispose of and is based on approximately three times the average
cost of proper transfer or disposal of the source or device.
A separate notice, published elsewhere in today's Federal Register,
establishes the new civil penalty amounts and gives a more complete
explanation.
Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995,
Public Law 104-113, requires that agencies use technical standards that
are developed or adopted by voluntary consensus standards bodies unless
the use of such a standard is inconsistent with applicable law or
otherwise impractical. In this final rule, the NRC is amending its
regulations governing the use of byproduct material in certain
measuring, gauging, or controlling devices. There are no voluntary
consensus standards available concerning accountability of such
devices.
The amendments are primarily administrative in nature and include
explicit requirements for a registration process and a clarification on
which provisions of the regulations apply to all general licenses for
byproduct material. This rule also modifies the reporting,
recordkeeping, and labeling requirements for specific licensees who
distribute these generally licensed devices. Therefore, this action
does not constitute the establishment of a standard that establishes
generally applicable requirements.
Environmental Impact: Categorical Exclusion
The NRC has determined that the revisions made in this final 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 final rule amends information collection requirements that are
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.). The information collection requirements in this rule have been
approved by the Office of Management and Budget, approval numbers 3150-
0017, 3150-0016, and 3150-0001.
The public reporting burden for this information collection is
estimated to average 19 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 many of the
amendments are minor revisions to existing information collection
requirements. Send comments on any aspect of this information
collection, including suggestions for reducing the burden, to the
Records Management Branch (T-6 E6), U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, or by Internet electronic mail at
BJS1@NRC.GOV; and to the Desk Officer, Office of Information
and Regulatory Affairs, NEOB-10202, (3150-0017, 3150-0016, and 3150-
0001), Office of Management and Budget, Washington, DC 20503.
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 regulatory analysis for this final
regulation. The analysis examines the cost and benefits of the
alternatives considered by the NRC. The regulatory analysis is
available for inspection in the NRC Public Document Room, 11555
Rockville Pike, Rockville, Maryland.
[[Page 79187]]
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 CRM@nrc.gov.
Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)),
the Commission certifies that this final rule does not have a
significant economic impact on a substantial number of small entities.
The most significant cost of this final rule is the fee to be assessed
for each registration. The fee will be established as part of the FY
2001 notice and comment fee rulemaking based on that year's budgeted
costs, FTE rate, and number of registrants. Based on current
information, the fee is expected to be approximately $440-$450.
Portions of the final rule apply to the approximately 40,000 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 apply to about 4300 of these general
licensees. Based on input received previously from small entities who
hold specific materials licenses, the NRC believes that the part 170
registration fee will not have a significant economic impact on a
substantial number of small entities. The NRC believes that the
economic impact of the other requirements on any general licensee would
be a negligible increase in administrative burden.
The final rule also revises requirements for specifically licensed
distributors of certain generally licensed devices. Currently, there
are 21 NRC licensed distributors and approximately 83 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.
Backfit Analysis
The NRC has determined that the backfit rule, Sec. 50.109, does not
apply to this final rule and, therefore, a backfit analysis is not
required because these amendments do not involve any provisions that
impose backfits as defined in Sec. 50.109(a)(1).
Small Business Regulatory Enforcement Fairness Act
In accordance with the Small Business Regulatory Enforcement
Fairness Act of 1996, the NRC has determined that this action is not a
major rule and has verified this determination with the Office of
Information and Regulatory Affairs, Office of Management and Budget.
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.
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. 552 and 553, the NRC is adopting the following
amendments to 10 CFR Parts 30, 31, and 32.
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 through 36, and 39.
(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,
[[Page 79188]]
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, the title and 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 detecting, measuring, gauging, or controlling
devices and certain devices for producing light or an ionized
atmosphere.\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) 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 185 bequerel (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 and any radioactive material from the device may only be
disposed of by transfer to a person authorized by a specific license to
receive the byproduct material in the device or as otherwise approved
by the Commission. 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, ATTN: GLTS, 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 export as provided by paragraph (c)(7) of this
section, 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, or part 30 of this chapter that authorizes waste collection,
or equivalent regulations of an Agreement State, or as otherwise
approved under paragraph (c)(8)(iii) of this section.
(ii) Shall furnish a report to the Director of Nuclear Material
Safety and Safeguards, ATTN: GLTS, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001 within 30 days after the transfer of a device
to a specific licensee or export. The report must contain--
(A) The identification of the device by manufacturer's (or initial
transferor's) name, model number, and serial number;
(B) The name, address, and license number of the person receiving
the device (license number not applicable if exported); and
(C) The date of the transfer.
(iii) Shall obtain written NRC approval before transferring the
device to any other specific licensee not specifically identified in
paragraph (c)(8)(i) of this section.
(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,
a copy of Secs. 31.2, 30.51, 20.2201, and 20.2202 of this chapter, and
any safety documents identified in the label of the device. Within 30
days of the transfer, the transferor shall report to the Director of
Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001--
(A) The manufacturer's (or initial transferor's) name;
(B) The model number and the serial number of the device
transferred;
(C) The transferee's name and mailing address for the location of
use; and
(D) The name, title, 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; 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
any of its 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. Each address for a location of
use, as described under paragraph (c)(13)(iii)(D) of this section,
represents a separate general licensee and requires a separate
registration and fee.
(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--
[[Page 79189]]
(A) Name and mailing address of the general licensee.
(B) Information about each device: the manufacturer (or initial
transferor), model number, serial number, the radioisotope and activity
(as indicated on the label).
(C) Name, title, and telephone number of the responsible person
designated as a representative of the general licensee under paragraph
(c)(12) of this section.
(D) Address or location 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.
(iv) Persons generally licensed by an Agreement State with respect
to devices meeting the criteria in paragraph (c)(13)(i) of this section
are not subject to registration requirements if the devices are used in
areas subject to NRC jurisdiction for a period less than 180 days in
any calendar year. The Commission will not request registration
information from such licensees.
(14) Shall report changes to the mailing address for the location
of use (including change in name of general licensee) to the Director
of Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001 within 30 days of the
effective date of the change. For 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 use or transfer and
the shutter tested before use. Devices kept in standby for future use
are excluded from the two-year time limit if the general licensee
performs quarterly physical inventories of these devices while they are
in standby.
* * * * *
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; if paragraphs (c)(2) through (4) or (c)(13) of Sec. 31.5 do
not apply to the particular device, those paragraphs may be omitted.
(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;
(4) Information on acceptable disposal options including estimated
costs of disposal; and
(5) An indication that NRC's policy is to issue high civil
penalties for improper 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 in lieu of the Agreement State's regulations, it shall be
accompanied by a note explaining that use of the device is regulated by
the Agreement State; if certain paragraphs of the regulations do not
apply to the particular device, those paragraphs may be omitted.
(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 or title, address, and phone number of the contact at
the Agreement State regulatory agency from which additional information
may be obtained.
(c) An alternative approach to informing customers may be proposed
by the licensee for approval by the Commission.
(d) 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).
(e) 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:
[[Page 79190]]
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 and all
receipts of devices from persons licensed under Sec. 31.5 to the
Director of the Office of Nuclear Material Safety and Safeguards, ATTN:
GLTS, 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 for transfers to general licensees
includes--
(i) The identity of each general licensee by name and mailing
address for the location of use; if there is no mailing address for the
location of use, an alternate address for the general licensee shall be
submitted along with information on the actual location of use.
(ii) The name, title, 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) For devices received from a Sec. 31.5 general licensee, the
report must include the identity of the general licensee by name and
address, the type, model number, and serial number of the device
received, the date of receipt, and, in the case of devices not
initially transferred by the reporting licensee, the name of the
manufacturer or initial transferor.
(4) If the licensee makes changes to a device possessed by a
Sec. 31.5 general licensee, such that the label must be changed to
update required information, the report must identify the general
licensee, the device, and the changes to information on the device
label.
(5) 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.
(6) The report must clearly identify the specific licensee
submitting the report and include the license number of the specific
licensee.
(7) If no transfers have been made to or from 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 and all receipts of devices
from general licensees in the Agreement State's jurisdiction 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 for transfers to general licensees
includes--
(i) The identity of each general licensee by name and mailing
address for the location of use; if there is no mailing address for the
location of use, an alternate address for the general licensee shall be
submitted along with information on the actual location of use.
(ii) The name, title, 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) For devices received from a general licensee, the report must
include the identity of the general licensee by name and address, the
type, model number, and serial number of the device received, the date
of receipt, and, in the case of devices not initially transferred by
the reporting licensee, the name of the manufacturer or initial
transferor.
(4) If the licensee makes changes to a device possessed by a
general licensee, such that the label must be changed to update
required information, the report must identify the general licensee,
the device, and the changes to information on the device label.
(5) 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.
(6) The report must clearly identify the specific licensee
submitting the report and must include the license number of the
specific licensee.
(7) If no transfers have been made to or from 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 maintain all information concerning transfers
and receipts of devices that supports the reports required by this
section. Records required by this paragraph must be maintained for a
period of 3 years following the date of the recorded event.
Dated at Rockville, Maryland, this 8th day of December 2000.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 00-31873 Filed 12-15-00; 8:45 am]
BILLING CODE 7590-01-P