[Federal Register Volume 64, Number 142 (Monday, July 26, 1999)]
[Proposed Rules]
[Pages 40295-40310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18981]


      
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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 64, No. 142 / Monday, July 26, 1999 / 
Proposed Rules  

[[Page 40295]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 30, 31, 32, 170, and 171

RIN 3150-AG03


Requirements for Certain Generally Licensed Industrial Devices 
Containing Byproduct Material

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend 
its regulations governing the use of byproduct material in certain 
measuring, gauging, or controlling devices. The proposed amendments 
would include adding explicit requirements for a registration process 
that the NRC plans to initiate through a related rulemaking, would add 
a registration fee, and would clarify which provisions of the 
regulations apply to all general licenses for byproduct material. The 
proposed rule would also modify the reporting, recordkeeping, and 
labeling requirements for specific licensees who distribute these 
generally licensed devices. The proposed rule is intended to allow the 
NRC to better track certain general licensees and the devices they 
possess and to further ensure that general licensees are aware of and 
understand the requirements for the possession of devices containing 
byproduct material.

DATES: Submit comments by October 12, 1999. Comments received after 
this date will be considered if it is practical to do so, but the 
Commission is able to ensure consideration only for comments received 
on or before this date.

ADDRESSES: Send comments by mail to the Secretary, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001. Attention: 
Rulemakings and Adjudications Staff.
    Hand deliver comments to: 11555 Rockville Pike, Rockville, 
Maryland, between 7:30 am and 4:15 pm on Federal workdays.
    You may also provide comments via the NRC's interactive rulemaking 
web site through the NRC home page 
(http://www.nrc.gov). This site provides the availability to upload 
comments as files (any format), if your web browser supports that 
function. For information about the interactive rulemaking site, 
contact Ms. Carol Gallagher (301) 415-5905; e-mail [email protected].
    Certain documents related to this rulemaking, including comments 
received and the regulatory analysis, may be examined at the NRC Public 
Document Room, 2120 L Street NW. (Lower Level), Washington, DC. These 
same documents also may be viewed and downloaded electronically via the 
interactive rulemaking website established by NRC for this rulemaking.

FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of 
Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, telephone (301) 415-6264, or e-
mail at [email protected].

SUPPLEMENTARY INFORMATION:

Background

    On February 12, 1959 (24 FR 1089), the Atomic Energy Commission 
(AEC) amended its regulations to provide a general license (10 CFR 
30.21(c)) for the use of byproduct material contained in certain 
measuring, gauging, or controlling devices. Under current regulations 
in 10 CFR 31.5, certain persons may receive and use a device containing 
byproduct material under this general license if the device has been 
manufactured and distributed according to a specific license issued by 
the NRC or by an Agreement State. A specific license authorizing 
distribution of generally licensed devices is issued if a regulatory 
authority determines that the safety features of the device and the 
instructions for its safe operation are adequate and meet regulatory 
requirements.
    The person or firm who receives such a device is a general 
licensee. These general licensees are subject to requirements for 
maintaining labels, following instructions for safe use, storing or 
disposing of the device properly, and reporting transfers and failure 
of or damage to the device. For some devices, the general licensee must 
also comply with testing requirements for leakage and for proper 
operation of on-off mechanisms. General licensees are also subject to 
the terms and conditions in Sec. 31.2 concerning general license 
requirements, transfer of byproduct material, reporting and 
recordkeeping, and inspection. General licensees must comply with the 
safety instructions contained in or referenced on the label of the 
device and must have the testing or servicing of the device performed 
by an individual who is authorized to manufacture, install, or service 
these devices except as indicated on the label.
    A generally licensed device usually consists of radioactive 
material, contained in a sealed source, within a shielded housing. The 
device is designed with inherent radiation safety features so that it 
can be used by persons with no radiation training or experience. The 
general license simplifies the licensing process so that a case-by-case 
determination of the adequacy of the radiation training or experience 
of each user is not necessary.
    There are about 45,000 general licensees authorized by Sec. 31.5 to 
possess about 600,000 devices that contain byproduct material. The NRC 
has not contacted or inspected these general licensees on a regular 
basis because of the relatively small radiation risk posed by these 
devices.
    Individuals who possess devices under this general license are not 
always aware of applicable requirements and thus are not necessarily 
complying with all of these requirements. The NRC is most concerned 
about occurrences where generally licensed devices have not been 
handled or disposed of properly. In some cases, this has resulted in 
radiation exposure to the public and contamination of property. Some 
generally licensed devices have been accidentally melted in steel mills 
causing considerable contamination of the mill, the steel product, and 
the wastes from the process, the slag and the baghouse dust. Although 
known exposures have generally not exceeded the public dose limits, 
there is a potential for significant exposures.
    The NRC conducted a 3-year sampling (1984 through 1986) of general 
licensees to assess the effectiveness of the general license program. 
The sampling revealed several areas of concern regarding the

[[Page 40296]]

use of generally licensed devices. In particular, the NRC concluded 
that--
    (1) Many general licensees are unaware of the regulations that 
apply to the possession of a generally licensed device; and
    (2) Many general licensees are unable to account for their devices.
    Approximately 15 percent of the general licensees sampled could not 
account for all of their generally licensed devices. The NRC concluded 
that these problems could be resolved by more frequent and timely 
contact between general licensees and the NRC.
    On December 27, 1991 (56 FR 67011), the NRC published a notice of 
proposed rulemaking concerning the accountability of generally licensed 
devices. The proposed rule contained a number of provisions, including 
a requirement under Sec. 31.5 for general licensees to provide 
information to the NRC upon request, through which a device registry 
could be developed. The proposed rule also included requirements in 
Secs. 32.51a and 32.52 for specific licensees who manufacture or 
initially transfer generally licensed devices. Although the public 
comments received were reviewed and a final rule developed, a final 
rule was not issued because the resources to fully implement the rule 
were not available.
    The NRC has continued to consider the issues related to the loss of 
control of generally licensed, as well as specifically licensed, 
devices. In July 1995, the NRC, with assistance from the Organization 
of Agreement States, formed a working group to evaluate these issues. 
The working group consisted of both NRC and Agreement State regulatory 
personnel and encouraged the involvement of all persons having a stake 
in the process and its final recommendations. All working group 
meetings were open to the public. A final report was published in 
October 1996 as NUREG-1551, ``Final Report of the NRC-Agreement State 
Working Group to Evaluate Control and Accountability of Licensed 
Devices.''
    In considering the recommendations of this working group, the NRC 
decided, among other things, to again initiate rulemaking to establish 
an annual registration of devices generally licensed under Sec. 31.5. 
This registration program would be similar to the program originally 
proposed in the 1991 proposed rule. However, it would apply only to 
those devices considered to present a higher risk of potential exposure 
of the public or property loss in the case of loss of control (compared 
to other generally licensed devices). Initially, the NRC has been using 
the criteria developed by the working group for determining which 
sources should be subject to the registration program. Using these 
criteria, it is now estimated that the registration requirement would 
apply to about 5100 general licensees possessing about 20,000 devices. 
These criteria were based on considerations of relative risk and are 
limited to radionuclides currently in use in these types of devices. If 
quantities of other radionuclides that would present a similar risk are 
used in these devices in the future, the criteria may be revised to 
include additional radionuclides. The Commission may also consider 
revising the criteria to include a larger number of devices in the 
registration requirement for other reasons in future rulemaking.
    The Atomic Energy Act of 1954 (AEA), as amended, provides the NRC 
with the authority to request information from its licensees concerning 
licensed activities. However, the Commission had not included an 
explicit provision in its regulations that would require Sec. 31.5 
general licensees to provide information on request. On December 2, 
1998 (63 FR 66492), the Commission published a proposed rule that would 
explicitly require general licensees who possess certain measuring, 
gauging, or controlling devices to provide the NRC with information 
about the devices. Assuming it becomes a final rule, the NRC intends to 
use that provision primarily to institute a registration and accounting 
system for the devices containing certain quantities of specific 
radionuclides that present a higher risk of exposure to the public or 
property damage if a device were lost. That rulemaking was not proposed 
as a matter of compatibility for Agreement States. That proposed rule 
presented an estimate of 6000 general licensees, based on the estimates 
made in the working group report. However, this had not accounted for 
the fact that, in the interim, Massachusetts had become an Agreement 
State. Using the same criteria, and removing the previously NRC general 
licensees in Massachusetts, results in an estimate of 5100 NRC general 
licensees that would be subject to the registration requirement.
    This proposed rule would add specific requirements concerning the 
registration of devices and additional provisions of an enhanced 
regulatory oversight program for all general licensees to be 
registered. The proposed rule would also establish levels of 
compatibility for Agreement State regulations so that an increased 
level of oversight for general licensees in Agreement States would also 
be required. Some States have already instituted some form of enhanced 
oversight for these general licensees. In a few cases, States have 
instituted a registration program. A few States have a higher level of 
control on these devices through requiring specific licenses. Under the 
proposed level of compatibility for Sec. 31.5, the essential objectives 
of the regulation should be adopted by the State to avoid conflicts, 
duplications, or gaps. However, the manner in which the essential 
objectives of the regulation are addressed need not be the same as NRC. 
Strict compatibility would only be required for revisions to the 
requirements applicable to distributors because of interjurisdictional 
distribution.

Discussion

    The December 2, 1998, proposed rule would provide one of the key 
elements in improving the accountability and control over devices of 
particular concern through the institution of a registration process. 
However, current regulatory provisions are inadequate to allow for the 
NRC to track general licensees and the specific devices they possess. 
The NRC needs to track these general licensees in order that they can 
be contacted or inspected when appropriate. The NRC also needs to track 
individual generally licensed devices, so that the responsible party 
can be identified when a device is found in an inappropriate situation.
    Tracking devices would also allow the NRC to contact the 
appropriate general licensees if a generic defect in a group of devices 
is identified. As noted, that proposed rule would not require Agreement 
State regulations to be compatible.
    There are other means for reducing the likelihood of incidents of 
lost sources. The Commission has reconsidered the provisions in its 
1991 proposed rule, evaluated the recommendations of the NRC-Agreement 
State Working Group, and identified additional issues concerning these 
devices in developing this proposed rule.

Summary and Discussion of Proposed Requirements

Revisions to the Requirements for General Licensees Under Sec. 31.5

Registration
    This proposed rule would add explicit provisions delineating an 
annual registration requirement, as well as a registration fee. The 
registration process would be initiated under Sec. 31.5(c)(11), 
proposed on December 2,

[[Page 40297]]

1998, if that requirement is adopted in a final rule. Proposed 
Sec. 31.5(c)(11) would require licensees to respond to requests for 
information from NRC within 30 days or as otherwise specified. The 
provisions proposed in this document (new Sec. 31.5(c)(13)) are 
essentially consistent with the Commission's plans for the registration 
process discussed in the December 2, 1998, proposed rule. This proposed 
rule would specifically require that the information about devices be 
verified by the licensee through a physical inventory and by checking 
label information. The advantage of including more explicit 
requirements in the regulation is that information about the 
registration process will be more clearly defined and more available. 
When the distributor of a device supplies copies of Sec. 31.5 to its 
customers (under Sec. 32.51a(a)), the potential general licensees would 
be made aware of the registration requirement, the devices to which it 
applies, the nature of the registration information, and the 
registration fee.
    An organization which uses generally licensed devices at numerous 
locations is considered a separate general licensee at each location. 
Different facilities at the same complex or campus are not, however, 
considered separate locations. In the case of portable devices that are 
routinely used at multiple field sites, there is one general licensee 
for each primary place of storage, not for each place of use. Thus, an 
organization would be required to complete more than one registration, 
if it possess devices subject to registration at multiple distinct 
locations.
    The proposed rule would add a fee to Sec. 170.31 to be assessed in 
conjunction with the annual registration process. This registration fee 
would be for each general licensee filing a registration under 
Sec. 31.5(c)(13) regardless of the number of devices. As noted above, 
an organization is considered to be a separate general licensee at each 
separate address at which devices are used, and would be assessed a 
registration fee for each location of use.
    The NRC is required by the Omnibus Budget Reconciliation Act of 
1990, as amended (OBRA-90), to recover approximately 100 percent of its 
budget through fees. Since OBRA-90 was enacted, all costs of the 
general license program have been recovered through annual fees paid by 
specific licensees. The proposed registration fees would recover the 
cost of the general license program associated with this group of 
general licensees in an equitable way, as required by law. Those who 
are allowed to use devices under the general license would now bear the 
operational cost of the program instead of those who hold specific 
licenses. However, it should be noted that the initial program startup 
costs would be recovered from the annual fee paid by current holders of 
specific licenses.
    The costs to be recovered through the registration fee include the 
costs for obtaining and maintaining information associated with the 
devices subject to the registration requirement, the costs of 
processing and reviewing the registrations, and the costs for 
inspections and follow-up efforts expected to be made as a result of 
the registration process identifying noncompliance with existing 
regulations. The fee would be based on the average cost of the program 
for each of the licensees registering devices. Some of the general 
licensees, such as non-profit educational institutions, will be exempt 
from the fee under Sec. 170.11. Costs not recovered from this small 
segment of the general licensees registering devices would continue to 
be recovered from annual fees paid by current holders of specific 
licenses.
    It is expected that the overall cost will decline after the initial 
years of implementation of the registration process, due to increased 
compliance leading to reduced inspection and follow-up. However, the 
number of generally licensed devices in NRC jurisdiction is reduced 
when a State becomes an Agreement State and takes over responsibility 
for the general licensees in that State. Although a large part of the 
cost of the program is proportional to the number of general licensees, 
a portion of the cost is fixed. Thus, the cost per general licensee 
could increase if the number of general licensees subject to 
registration decreases. The proposed registration fee is $420 based on 
the current estimated cost of the program and the current number of 
general licensees with devices that would be subject to registration. 
If additional States become Agreement States before this rule is made 
final, the fee could be somewhat higher in the final rule.
    The Commission considered other approaches to the proposed fee 
structure, such as a fee per device or a sliding scale, i. e., fees set 
for a few ranges of numbers of devices. However, basing fees on the 
number of devices or a sliding scale would not necessarily meet the 
intent of the Independent Offices Appropriation Act of 1952 (IOAA), 
which is the authority under which 10 CFR part 170 fees are 
established. The IOAA provides that fees recover the agency's cost in 
providing the service. The agency's costs to register generally 
licensed devices at each location is projected to be nearly the same 
regardless of the number of sources/devices possessed by the licensee. 
Costs of follow-up and inspection do not go up substantially with 
increased numbers of devices. In addition, these alternative methods 
would complicate the determination of the proper fee and the fee 
recovery process, not only for NRC but for the registrants as well. 
With the uncertainty of the licensees' status from one year to the 
next, the additional administrative effort related to the 
reconciliation of the fee based on the number of devices possessed from 
year to year, would not be cost effective, considering the total amount 
projected to be recovered for the registration program. Additionally, 
under these alternative methods a large diversified firm that owns one 
device would pay a reduced fee, while a small entity whose business may 
depend solely on the use of the devices might pay a disproportionate 
fee because it has more than one device. The NRC believes that basing 
the fee on a per device basis or a sliding scale would not result in a 
fair and equitable allocation of its regulatory costs, and would not 
achieve the goal of the Regulatory Flexibility Act to reduce the impact 
of fees on small entities. The NRC believes that the proposed approach 
of assessing a fee for each licensee subject to registration--
    (1) Better reflects the costs to administer the program,
    (2) Is most consistent with existing NRC fee assessment practices,
    (3) Would simplify fee collection,
    (4) Would be fair and equitable, and
    (5) Would minimize impacts to small entities.
    The planned registration process will be somewhat different from 
that used in the Commission's other registration programs, in which 
blank forms are filled out by registrants. Instead, it is planned to 
send a registration request containing the information recorded in the 
Commission's database, which would ask the general licensee to verify, 
correct, and/or add to the information provided. This would be similar 
to the approach typically used by States for the renewal of automobile 
registrations. This is intended to be more efficient for the general 
licensees and the Commission.
    The first registration that would be carried out under 
Sec. 31.5(c)(11) would depend on the NRC's ability to contact general 
licensees because the NRC must request the information. This proposed 
rule also specifies that the general licensee would complete 
registration by verifying, correcting, and/or adding to the information 
in a request for

[[Page 40298]]

registration received from the Commission. It is silent on when or how 
general licensees should register if the Commission fails to contact 
the general licensee. Thus, it might be interpreted that, if the 
Commission fails to contact a general licensee, the registration 
requirement would not apply. The Commission seeks comment on whether 
the registration requirement should include a provision that would 
require the general licensee to complete registration by a certain 
time, such as 15 months after--
    (1) The date of the previous registration certificate;
    (2) The receipt of a device subject to registration; or
    (3) The effective date of this rule for an unregistered device 
possessed at the time of the effective date of a final rule enacted in 
response to this proposed rule.
    This would put the burden of registering on general licensees who 
have not been notified by the NRC of the requirement. The intent would 
be for general licensees who find out about the new requirements, for 
example, from a distributor, to contact the NRC to begin the 
registration process. If this approach were taken, the Commission would 
likely exercise enforcement discretion in cases where the Commission 
locates a general licensee who has not previously registered devices, 
if the general licensee was unaware of the requirement. It is 
recognized that some general licensees who have received devices in the 
past may never be located.
    The time of year for registration would vary for licensees. 
However, requests for renewal of registration would be made 
approximately 1 year after the previous registration request for that 
licensee. Although registration would not be required before the 
receipt of a device, the Commission plans to send requests for 
registration to new general licensees subject to registration that are 
identified in distributors' quarterly transfer reports submitted under 
Sec. 32.52 shortly after this information is received and recorded. If 
a general licensee has previously registered devices and receives 
additional devices requiring registration, the new devices would be 
registered when the annual reregistration is carried out. The 
Commission requests comment on whether the NRC should have earlier 
contact with previous registrants who receive additional devices, 
either by an acknowledgment by NRC to the user or by a required 
response from the general licensee that accounts for the additional 
device(s). The effective date of the registration fee will be set to 
apply after the initial registration requests have been sent for 
response under Sec. 31.5(c)(11) so that the first round of annual 
registration will be complete prior to this effective date and the fee 
will be imposed with the first reregistration for all devices currently 
in use.
Other Revisions for Sec. 31.5 General Licensees.
    The proposed rule would establish additional requirements for all 
general licensees under Sec. 31.5. These proposed requirements 
include--
    (1) An explicit requirement for the general licensee to appoint an 
individual assigned responsibility for knowing what regulatory 
requirements are applicable and having authority to take required 
actions to comply with the applicable regulations and through whom the 
general licensee carries out its responsibilities to comply with the 
applicable regulations (new Sec. 31.5(c)(12));
    (2) A provision that limits the amount of time a general licensee 
can keep an unused device in storage and allows the deferment of 
testing during the period of storage (new Sec. 31.5(c)(15));
    (3) A provision to allow transfers to specific licensees authorized 
under part 30, or equivalent Agreement State regulations, as waste 
collectors, in addition to currently allowed transfers to part 32 (and 
Agreement State) licensees; to allow transfers to other specific 
licensees but only with prior written NRC approval; and to add the 
recipient's license number, the serial number of the device, and the 
date of transfer to the information required to be provided to NRC upon 
transfer of a device (revision of Sec. 31.5(c)(8));
    (4) A provision to notify NRC of address changes, including name 
changes (new Sec. 31.5(c)(14));
    (5) For device damage or failures that are likely to or are known 
to have resulted in contamination, the addition of a plan for ensuring 
that premises and environs are suitable for unrestricted access, to the 
information that must be sent to NRC in the case of a failure; a change 
to the addressee for reporting information concerning a failure; and a 
note that the criteria in Sec. 20.1402, ``Radiological criteria for 
unrestricted use,'' may be applied by the Commission in the case of 
contamination in spite of the exemption in Sec. 31.5(c)(10) (revision 
to Sec. 31.5(c)(5)); and
    (6) A revision of the reporting requirement, in the case of a 
transfer to a general licensee taking over possession of a device at 
the same location, to provide the serial number of the device and the 
name and phone number for the person designated as the responsible 
individual, rather than simply a contact name (revision to 
Sec. 31.5(c)(9)(i)).
    The rationale for each of these proposed amendments is:
    (1) New Sec. 31.5(c)(12)--Responsible person. The ``person'' who 
holds a general license is usually a corporation, or public or private 
institution, rather than an individual. In practice, in order for the 
general licensee to comply with existing regulations, an individual in 
the corporation or institution must be aware of the requirements and be 
authorized to take the required actions. Appointing a specific 
individual to be responsible for knowing about and taking actions to 
comply with regulations is an appropriate operational practice, which, 
unfortunately, is not always followed. If a device is not subject to 
testing under Sec. 31.5(c)(2), there are no routine actions required to 
be taken, because the requirements are generally restrictions on 
actions, such as not abandoning the device, or actions to be taken only 
in the case of particular, non-routine events, such as notification of 
NRC of the transfer or failure of the device. It is this type of 
situation, where knowledge of the nature of the device, the general 
license, and the associated regulations is unlikely to be maintained 
and passed on to individuals using the device. Requiring the assignment 
of the responsibility for knowing and having authority to take required 
actions for complying with regulations to a specific individual would 
improve the probability that the general licensees will do what they 
are already required to do. The impact of this should be minimal, 
somewhat limiting operational flexibility with regard to the assignment 
of duties. This individual does not have to work on site at the place 
of use of the device and does not have to conduct all required actions, 
but would be responsible to ensure that the general licensee is aware 
of required actions to be taken. This assignment does not relieve the 
general licensee of responsibility.
    The NRC/Agreement State Working Group recommended that general 
licensees assign a backup responsible individual (BRI) as well. The 
proposed rule does not include this requirement, but the Commission 
solicits comment on this issue and will consider adding it to the final 
rule. A BRI would add some assurance that there is a continuation of 
knowledge of the requirements in the event of the person assigned to be 
the responsible individual leaves his assigned duties.

[[Page 40299]]

However, even without a BRI, the general licensee would have the 
responsibility under the proposed rule to replace the responsible 
individual to maintain compliance with proposed Sec. 31.5(c)(12).
    (2) New Sec. 31.5(c)(15)--Timeliness of disposition and deferral of 
testing while in storage. When a device is not in use for a prolonged 
time, it is particularly susceptible to being forgotten and ultimately 
disposed of or transferred inappropriately. General licensees are 
unlikely to keep a device unused for more than 2 years and subsequently 
use it. If a device is being held in storage indefinitely, it is likely 
that it is being stored to avoid the costs of proper disposal. If a 
general licensee intends to use a device after a period of more than 2 
years of nonuse, the device could be sent back to the supplier to be 
held under the distributor's specific license until later use, or the 
general licensee could request an exemption from Sec. 31.5(c)(15) 
indicating the reason(s) why the licensee intends to use the device 
after 2 years and prefers to keep it on site in the interim.
    If a period of storage exceeds the normal interval for testing, 
testing would not need to be done until the device is to be put back 
into use again. This would relieve the burden of unnecessary testing 
during the period of storage as well as eliminate any unnecessary 
exposure that could occur during testing for that period.
    (3) Revision to Sec. 31.5(c)(8)--Provisions for transfers to 
specific licensees. This proposed revision would provide some 
flexibility to the general licensee in transferring a device while 
ensuring that it is transferred appropriately. It would allow a general 
licensee to transfer a device directly to a waste collector for 
disposal, rather than going through a distributor. It would also allow 
the transfer of a device to other specific licensees, but would require 
NRC approval in these cases so that NRC can ensure that the recipient 
is authorized to receive the device.
    The inclusion of a recipient's license number in the report of 
transfer would better ensure that the general licensee has verified 
that the recipient is a part 32 licensee, a part 30 waste collection 
licensee, or a specific licensee under equivalent Agreement State 
regulations authorized to receive it. It would also supply an 
additional means for NRC to identify the recipient, because company 
names and addresses sometimes change. The addition of the date of 
transfer will make the transfer easier to track and help to ensure that 
the general licensee makes the report in a timely manner (required 
within 30 days of transfer).
    (4) New Sec. 31.5(c)(14)--Change of address notification (including 
change in name of general licensee). The quarterly reports required of 
distributors under Sec. 32.52(a) and (b) are intended to provide NRC 
and the Agreement State regulatory agencies with the identity of 
general licensees in their jurisdictions and addresses at which these 
general licensees can be contacted (proposed to now be specifically the 
mailing address for the location of use of the generally licensed 
device). These general licensees can then be contacted or inspected. If 
general licensees move their operations without notifying the NRC, or 
appropriate Agreement State agency, they may be difficult to locate. 
Even a change of name can cause mail to be returned. This proposed 
requirement to report address changes would only apply to previously 
supplied mailing addresses and, for portable devices, the mailing 
address for the primary place of storage, although the devices may be 
used at multiple field sites. For those registering devices, other 
changes in addresses, if different from the mailing address for the 
location of use, will be provided at the time of the next registration.

    Note: Changes to the general licensee, other than a simple name 
change, such as in the case of a sale of a company, require 
reporting of additional information under Sec. 31.5(c)(9)(i).

    This simple change of address notification is intended to track 
moves into and within NRC jurisdiction and to maintain current mailing 
address information. The general license in Sec. 31.5 only applies to 
persons within NRC jurisdiction. If a general licensee intends to move 
from one jurisdiction to another, it should contact the applicable 
regulatory authority, NRC or the particular Agreement State, before 
doing so to determine the applicable, current regulations in that 
jurisdiction. All jurisdictions do not have a comparable general 
license and specific provisions of the general license may vary among 
jurisdictions. If a general licensee has obtained a portable device in 
an Agreement State and wishes to use the device within NRC 
jurisdiction, it must do so under Sec. 31.5, because there is no 
reciprocity provision applicable to general licenses. In this case, 
they would be subject to the provisions of Sec. 31.5.
    (5) Revision to Sec. 31.5(c)(5)--Reports of device failures. 
General licensees are not subject to decommissioning requirements. A 
general license is granted by regulation and, under normal 
circumstances, does not involve any termination of license process. If 
a generally licensed device fails or is seriously damaged so as to 
cause significant contamination of the premises or environs, the NRC 
may need to respond to the notification of an incident made under 
Sec. 31.5(c)(5) to ensure that a facility is properly decontaminated. 
Following such an incident, the NRC would determine what actions are 
necessary on a case-by-case basis and, if necessary, would apply the 
criteria set out in Sec. 20.1402, ``Radiological criteria for 
unrestricted use.'' The general licensee is exempt from this section of 
part 20 when in possession of an intact generally licensed device. 
However, when a device has been damaged, the material in the device may 
no longer be fully contained within the device, i.e., it may also be 
unsealed radioactive material. Action can be taken by the NRC under 
Sec. 30.61, ``Modification and revocation of licenses,'' which is 
applicable to general licensees. The provision proposed in this action 
would require that the general licensee propose to the Commission how 
it will be shown that the premises are or will be adequately cleaned 
up. Depending on the nature of the event, the remedial action taken 
(and reported under existing requirements) along with any confirmatory 
surveys may be sufficient to complete action on the event.
    The addressee for submitting information under Sec. 31.5(c)(5) 
would be changed from Regional Administrator to Director of Nuclear 
Material Safety and Safeguards so that all NRC addressees specified in 
Sec. 31.5 for reports by these licensees are the same and to eliminate 
the need for the general licensee to refer to part 20 to determine the 
appropriate addressee. The addressee and address for registration will 
be specified in the registration request. Adding a note concerning the 
possible applicability of Sec. 20.1402 is a clarification.
    (6) Revision to Sec. 31.5(c)(9)(i)--Reporting new general 
licensee's responsible individual. Consistent with the provision for 
appointing an individual through whom the general licensee will ensure 
compliance with the applicable regulations and requirements, and other 
reporting requirements being proposed, it is more effective for the 
general licensee to provide the name of the new responsible individual 
when another general licensee takes over the facility and 
responsibility for the device.
    An additional proposed amendment to Sec. 31.5 would clarify the 
status of a person who receives a device through an unauthorized 
transfer and would remove a restriction on devices. Paragraph (b) would 
be revised to (1)

[[Page 40300]]

limit the applicability of the general license to those who receive a 
device through an authorized transfer and (2) expand the applicability 
of the general license to devices authorized for distribution by an 
Agreement State that has no general license covering the use of such 
devices within that State.
    Concerning the first of these issues, the NRC has generally, 
although not consistently, interpreted the general license to apply to 
any recipient within the group identified in Sec. 31.5(a), i.e., ``* * 
* commercial and industrial firms and research, educational and medical 
institutions, individuals in the conduct of their business, and 
Federal, State or local government agencies * * *'', even if the device 
is received through an unauthorized transfer. The proposed language 
would clearly provide that the general license does not apply if the 
device is obtained through an unauthorized transfer. In the case of an 
unauthorized transfer, the recipient would possess the device without a 
license.
    Section 31.5(b) currently restricts applicability of the general 
license in the case of devices from distributors in Agreement States, 
to those devices from Agreement States that authorize the devices to be 
used under a general license within their respective States. However, 
the NRC practice is to allow a device to be used under the general 
license in Sec. 31.5, that is distributed in accordance with a license 
issued under equivalent regulations to Sec. 32.51 by an Agreement State 
that does not authorize devices to be used under a general license 
within their State. This approach reserved for NRC the right to require 
distributors in this situation to obtain an NRC distribution license in 
order to transfer devices into NRC jurisdiction, but did not require 
them to do so as long as the State issued acceptably equivalent 
licenses. Through NRC's oversight of Agreement State programs, NRC 
ensures the safety of these devices. Given this fact and the experience 
to date with these few States, the Commission believes that this 
restriction is no longer necessary.
    In addition to the proposed changes to Sec. 31.5, other amendments 
are proposed that would clarify which sections of the regulations in 
part 30 apply to all of the general licensees under part 31. Section 
31.1, ``Purpose and scope,'' would be amended to clarify that only 
those paragraphs in part 30 specified in Sec. 31.2 or the particular 
general license apply to part 31 general licensees. Section 31.2, 
``Terms and conditions,'' would be amended to reference the sections of 
part 30 that are applicable to all of the part 31 general licensees, 
including Sec. 30.7, ``Employee protection,'' Sec. 30.9, ``Completeness 
and accuracy of information,'' and Sec. 30.10, ``Deliberate 
misconduct.'' The proposed clarification would make it easier for 
general licensees to be aware of applicable regulations. In addition, 
future amendments to part 30 that would apply to part 31 general 
licensees would include a conforming amendment to part 31. Note, 
however, that while Sec. 31.2 would specify sections of part 30 
generally applicable to general licenses, it would not eliminate the 
applicability of other parts of the Commission's regulations that may 
apply.
    The applicability of Sec. 30.34(h) on bankruptcy notification to 
general licensees also needs to be clarified. Under the existing 
regulations, this requirement appears to apply to all licensees. 
However, its application to general licensees is not clear because it 
is not referenced in Sec. 31.2 or Sec. 31.5. This proposed rule would 
make the bankruptcy notification requirement applicable only to those 
general licensees subject to the registration requirement. These 
licensees possess devices for which the Commission believes a higher 
level of oversight is appropriate. Thus, notification that such a 
general licensee is filing for bankruptcy may be important to allow the 
Commission to intervene to ensure that the financial status of the 
licensee does not lead to the improper disposal or abandonment of a 
device.

Requirements for Manufacturers and Initial Distributors of Devices

    The proposed rule would modify the quarterly transfer reporting, 
recordkeeping, and labeling requirements for specific licensees who 
distribute these generally licensed devices, and the requirement for 
providing information to users. The existing requirements in these 
areas are a matter of strict compatibility of Agreement State 
regulation, that is, the State regulations are essentially identical. 
The proposed amendments would also be a matter of strict compatibility 
so that revisions to Agreement State regulations would be necessary and 
distributors in Agreement States would be affected. The basis of this 
compatibility requirement is significant direct transboundary 
implications. This results from the fact that devices are distributed 
under various Agreement State and NRC authorities into other 
jurisdictions where different regulatory agencies regulate the 
possession and use of the devices. Currently, there are 28 NRC licensed 
distributors and approximately 61 licensed distributors in Agreement 
States.
Reporting
    The following information would be added to the existing quarterly 
transfer reporting requirement: The serial number and model number of 
the device; the date of transfer; indication if the device is a 
replacement, and if so, the type, model number, and serial number of 
the one returned; name and license number of reporting company; and the 
specific reporting period. The model number of the device is already 
required in reports to Agreement States. The general licensee address 
would be specified as the mailing address for the location of use of 
the generally licensed device.
    The name and phone number of the person identified by the general 
licensee as having knowledge of and authority to take required actions 
to ensure compliance with the appropriate regulations and requirements 
would replace the name and/or position of a simple contact between the 
Commission and the general licensee.
    A form will be provided for use in making these reports. However, 
the use of the form would not be required as long as the report is 
clear and legible and includes all of the required information. 
Proposed amendments would be made to Sec. 32.52(a) and (b).
    The existing reporting requirement is intended to provide NRC and 
the Agreement State regulatory agencies with the identity of general 
licensees in their jurisdictions, addresses at which the general 
licensees can be contacted (which are usually the location of use of 
the devices), the particulars of the type of device possessed, and the 
name (or position) of an individual who constitutes a point of contact 
between the NRC or the Agreement State and the general licensee. These 
general licensees can then be contacted or inspected. Including the 
serial number would allow the NRC and Agreement States to track 
individual devices. The existing reporting requirement in 
Sec. 31.5(c)(8) does not require the general licensee to report a 
transfer if it is for the purpose of obtaining a replacement. This is 
consistent with the original intent of this regulation in that the 
status of the general licensee is unchanged, only the specific device 
is changed. In order for individual devices to be tracked, the NRC or 
Agreement State needs to be informed of such a transfer. The proposed 
rule would require that the distributor provide this information either 
to NRC or the appropriate Agreement State. Under existing requirements, 
quarterly reports are

[[Page 40301]]

required to include specifics on any new device transferred but not on 
the devices returned. The NRC believes that the distributor could 
include this additional information in the quarterly reports without a 
significant burden and that the distributor is likely to be more 
reliable than the general licensee in providing this information. The 
name and license number of the reporting company and the specific 
reporting period are typically included in the reports in order to show 
compliance with the reporting requirement. However, this information is 
not always readily identifiable.
    The individual who acts as contact with the NRC or the Agreement 
State concerning the general license should have knowledge of the 
device, the general license, and the regulations pertaining to the 
general license, or at least know who in the organization does. This is 
the intent of the existing requirement. However, in practice, the name 
given to the distributor and reported to the NRC (or the Agreement 
State) frequently is not an individual with this type of knowledge. The 
proposed rule would specify that the contact designated be the person 
(1) assigned responsibility for ensuring that the general licensee is 
aware of its regulatory responsibilities and (2) who has authority to 
take required actions for complying with the applicable regulations.
Recordkeeping
    The proposed rule would add to the recordkeeping requirements 
information on final disposition of devices. The recordkeeping 
requirements concerning transfers would have the period of retention 
extended from 5 years from the date of the recorded event, to 3 years 
after the expected useful life of the device or the final disposition, 
if known. Proposed amendments would be made to Sec. 32.52(c).
    It is important that information about the general licensees and 
the specific devices in their possession be available until the device 
is disposed of permanently. Requiring the distributor to keep these 
records for an extended time provides a backup to the recordkeeping of 
NRC and State regulatory agencies. The records include information on 
final disposition that may not have been included in reports to NRC and 
the Agreement States. It is NRC's understanding that these distributors 
generally keep these records indefinitely. Thus, this regulatory 
requirement should have little, if any, impact.
    In addition, distributors would be required to make available 
records of final disposition of devices to the various regulatory 
agencies in the case of bankruptcy or termination of license (new 
Sec. 32.51a(d)). When a distributor goes out of business and terminates 
its license, the distributor can no longer be required to retain these 
records. This requirement would give NRC, as well as State regulatory 
agencies, the opportunity to obtain and retain records of this type 
previously kept by the distributor. These records could be helpful in 
verifying information used to keep track of devices relative to the 
final disposition of devices. This provision would not require 
distributors to automatically provide these records unless the NRC or 
the Agreement State in which the device was distributed makes a request 
for these records. In the case of bankruptcy, NRC or the Agreement 
State may want to secure these records early in the process, in case 
financial difficulties interfere with the licensee fulfilling its 
responsibilities.
Labeling
    The proposed rule would amend the existing labeling requirements to 
require an additional label on any separable source housing and a 
permanent label on devices meeting the criteria for registration (new 
Sec. 32.51(a)(4) and (5) and Sec. 32.51a(c)). The NRC would consider a 
label ``permanent,'' if, for example, it were embossed, etched, 
stamped, or engraved in metal. Under these requirements, new 
distributors would have labels approved as part of obtaining a license; 
distributors, including existing licensees, would have the new labeling 
requirements as conditions of license in Sec. 32.51(a)(4) and (5). 
Approval of the new labels by NRC for existing distributors would not 
be required. However, distributors may voluntarily submit information 
for NRC review on how they plan to comply with the new labeling 
requirements. In any case, labeling is subject to inspection. To the 
extent necessary, the new labeling requirements would supercede 
anything contradictory in individual license conditions. The individual 
license conditions would be updated to include specifics related to the 
new requirements during the first license renewal or amendment 
following the effective date of those paragraphs of the rule.
    The first change simply carries out the initial intent of the 
existing requirement for devices where the source may be separable in a 
housing that does not include the label. It is important that this 
housing, if separated from the remainder of the device, can also be 
identified. The impact of this requirement should be minimal. The 
permanent label for devices requiring registration would provide better 
assurance that even when a device has been exposed to other than normal 
use conditions, for example, when a building has been refurbished or 
demolished with the device in place, the label will be intact and the 
device may be identified and proper actions can be taken. This may 
result in a more significant change to the production of devices. 
Distributors would have 1 year after the effective date of the rule to 
implement these changes to minimize any impact to the manufacturing and 
distributing process.
Information To Be Provided to General Licensees
    The proposed rule would amend the requirements pertaining to the 
information distributors must provide to the general licensee 
(Sec. 32.51a(a) and (b)). Distributors are now required to provide 
general licensees with a copy of Sec. 31.5 when the device is 
transferred. The proposed rule would require that a copy of Sec. 31.5 
be provided before transfer. The distributor would also be required to 
provide copies of additional applicable sections of the regulations, a 
listing of the services that can only be performed by a specific 
licensee, and information regarding disposal options for the devices 
being transferred. The disposal options would include the estimated 
cost for disposal of the device at the end of its useful life to the 
extent that the cost information is available to the distributor at the 
time of the sale of the device. For transfers to general licensees in 
Agreement States, the distributor may furnish either the applicable NRC 
regulations or the comparable ones of the Agreement State. In addition, 
the distributor would furnish the name, address, and phone number of 
the contact at the Agreement State regulatory agency from which 
additional information may be obtained.
    The general licensee should be aware of the specific requirements 
before purchasing a generally licensed device, rather than afterward. 
While the Commission does not want to get involved with details of 
licensees' business practices, it is the Commission's intent that 
``prior to transfer'' would be before a final decision to purchase so 
that the information can be considered in making that decision. The 
Commission seeks comment on how best to achieve and enforce this 
intent. For example: What are the advantages/disadvantages of using the 
words, ``prior to purchase'' in the regulatory text?

[[Page 40302]]

    While Sec. 31.5 contains the primary requirements related to the 
general license, it does not reference the applicable sections of part 
30. The general licensee should have copies of at least those 
regulations that may require an action on his part. The sections of the 
regulation that would be included in this requirement are believed to 
be the most important for the general licensee to be aware of. The 
inclusion of a listing of services that can only be performed by a 
specific licensee would clarify the services that can and cannot be 
performed by the general licensee. These services vary depending on the 
nature and design of the particular device and so are not specified in 
the regulations. Information on the estimated cost for disposal of the 
device at the end of its useful life may be a significant factor in a 
decision to purchase a device because of the high costs of disposing of 
radioactive materials. In some cases, the cost of disposal could exceed 
the purchase price of the device.
    Additional clarifying amendments would be made in Secs. 30.31, 
30.34(h), and 31.5(c)(9)(ii). The wording of Sec. 30.31 would provide a 
similar clarification as that in the Suggested State Regulations with 
respect to general licenses. The amendment to Sec. 30.34(h) would be 
consistent with the previously discussed change concerning reporting 
bankruptcy.
    The revision of Sec. 31.5(c)(9)(ii) to include the term, 
``intermediate person,'' is intended to provide clarification about 
intermediate persons holding devices. Specifically, intermediate 
persons holding devices in their original shipping containers at their 
intended location of use are general licensees. Distributors licensed 
under Sec. 32.51, or equivalent Agreement State regulations, must 
provide information about both intermediate persons and intended users 
in their quarterly reports submitted under Sec. 32.52(a). Transfers 
from intermediate persons to intended users under Sec. 31.5(c)(9)(ii) 
do not need to be reported to NRC because information about the 
intended user must be reported by the distributor under Sec. 32.52(a).
    Minor conforming amendments would also be made to Secs. 170.2, 
170.3, 171.5, and 171.16.

Public Comments on the Original Proposed Rule

    The NRC reviewed the comments received on the December 27, 1991, 
proposed rule in developing both the proposed rule published on 
December 2, 1998 (63 FR 66492), and this proposed rule. There were 26 
comment letters received from a variety of sources including private 
and publicly held corporations, private citizens, citizens groups, the 
Armed Forces, and State governments. These comments have been 
considered to the extent applicable to each rule. A detailed analysis 
of the comments received on the December 27, 1991, proposed rule, which 
was withdrawn by the notice of proposed rulemaking on December 2, 1998, 
is not presented in either of the subsequent proposed rules because 
many of the specific comments pertain to specific provisions that have 
been withdrawn, a great deal of time has passed since these comments 
were made, and additional opportunity for comment is being provided.

Early State and Public Input

    These proposed amendments were provided to the Agreement States 
twice during its development via the use of the NRC Technical 
Conference Website and notification to the States of its availability. 
Input was received following the first posting through discussions at 
an All Agreement State meeting in October of 1998. The second posting 
was also available to the public. A notice of availability was 
published December 31, 1998 (63 FR 72216). The States and the 
distributors were notified of its availability directly, as well. Two 
comments were received. One from a State and one from industry. They 
were generally supportive and indicated points needing clarification.

Summary of Proposed Provisions by Paragraph

    Section 30.31--Revision would reconcile the apparent conflict 
between the description of a general license and a registration 
requirement.
    Section 30.34, paragraph (h)(1)--Revision would make the bankruptcy 
notification requirement applicable only to those general licensees 
subject to the registration requirement.
    Section 31.1--Revision would clarify that only those paragraphs in 
part 30 specified in Sec. 31.2 or the particular general license apply 
to part 31 general licensees.
    Section 31.2--Revision would clarify references to the sections of 
part 30 that are applicable to all of the part 31 general licensees.
    Section 31.5, paragraph (b)--Revision would clarify the status of a 
person who receives a device through an unauthorized transfer by 
limiting the applicability of the general license to those who receive 
a device through an authorized transfer; and would remove the 
restriction on devices distributed by Agreement State licensees in 
Agreement States without a general license.
    Section 31.5, paragraph (c)(5)--Revision would add a plan for 
ensuring that premises and environs are suitable for unrestricted 
access, to the information that must be sent to NRC in the case of a 
failure, when device damage or failure is likely to or known to have 
resulted in contamination; would change the addressee for reporting 
information concerning a failure; and would clarify that the criteria 
in Sec. 20.1402 may be applied in spite of the exemption in 
Sec. 31.5(c)(10).
    Section 31.5, paragraph (c)(8)--Revision would allow transfers to 
specific licensees authorized under part 30, or equivalent Agreement 
State regulations, as waste collectors, in addition to currently 
allowed transfers to part 32 (and Agreement State) licensees; would 
allow transfers to other specific licensees but only with prior written 
NRC approval; and would add the recipient's license number, the serial 
number of the device, and the date of transfer to the information 
required to be provided to NRC upon transfer of a device.
    Section 31.5, paragraph (c)(9)(i)--Revision would add to the 
reporting requirement, in the case of a transfer to a general licensee 
taking over possession of a device at the same location, to provide the 
serial number of the device and the name and phone number of the person 
identified as having knowledge of and authority to take required 
actions to ensure compliance with the appropriate regulations and 
requirements, rather than simply a contact name.
    Section 31.5, paragraph (c)(9)(ii)--Revision would add the term, 
``intermediate person,'' to clarify that a report of transfer is not 
required only when the information on both an intermediate person and 
an intended user was provided through the distributor in a quarterly 
material transfer report.
    Section 31.5, paragraph (c)(12)--Would add an explicit requirement 
for the general licensee to appoint an individual assigned 
responsibility for knowing what regulatory requirements are applicable 
to the general licensee and having authority to take required actions 
to comply with the applicable regulations.
    Section 31.5, paragraph (c)(13)--Would add an explicit requirement 
for the general licensee to register devices meeting certain criteria, 
which specifies the information to be provided and references the fee 
requirement in Sec. 170.31.

[[Page 40303]]

    Section 31.5, paragraph (c)(14)--Would add requirement for general 
licensees to notify NRC of address changes.
    Section 31.5, paragraph (c)(15)--Would limit to 2 years the amount 
of time a general licensee can keep an unused device in storage and 
allow the deferment of testing during the period of storage.
    Section 32.51, paragraphs (a)(4) and (5)--Would add requirement for 
an additional label on any separable source housing and a permanent 
label on devices meeting the criteria for registration.
    Section 32.51a, paragraphs (a) and (b)--Revision would amend the 
requirements pertaining to the information distributors must provide to 
the general licensee. Distributors are now required to provide general 
licensees with a copy of Sec. 31.5 when the device is transferred. The 
proposed rule would require that Sec. 31.5 be provided before transfer. 
The distributor would also be required to provide copies of additional 
applicable sections of the regulations, a listing of the services that 
can only be performed by a specific licensee, and information regarding 
disposal options for the devices being transferred, including estimated 
costs of disposal. For transfers to general licensees in Agreement 
States, the distributor may furnish either the applicable NRC 
regulations or the comparable ones of the Agreement State. In addition, 
the distributor would furnish the name, address, and phone number of 
the contact at the Agreement State regulatory agency from which 
additional information may be obtained.
    Section 32.51a, paragraph (c)--Would make labeling requirements a 
condition of license 1 year after effective date of rule.
    Section 32.51a, paragraph (d)--Would add requirement for 
distributors to make available records of final disposition of devices 
to the various regulatory agencies in the case of bankruptcy or 
termination of the distributor's license.
    Section 32.52, paragraphs (a) and (b)--Revision would add the 
following information to the existing quarterly transfer reporting 
requirement: the serial number and model number of the device; the date 
of transfer; indication if device is a replacement, and if so, the 
type, model number, and serial number of the one returned; name and 
license number of reporting company; and the specific reporting period. 
Also, the general licensee address would be specified as the mailing 
address for the location of use of the generally licensed device.
    The name and phone number of the person identified by the general 
licensee as having knowledge of and authority to take required actions 
to ensure compliance with the appropriate regulations and requirements 
would replace the name and/or position of a simple contact between the 
Commission and the general licensee. Also, a form will be provided for 
use in making these reports. However, the use of the form would not be 
required as long as the report is clear and legible and includes all of 
the required information.
    Section 32.52, paragraph (c)--Revision would add to the 
recordkeeping requirements information on final disposition of devices. 
The recordkeeping requirements concerning transfers would have the 
period of retention extended from 5 years from the date of the recorded 
event to 3 years after the expected useful life of the device or the 
final disposition, if known.
    Section 170.2--Would conform the scope of part 170 to include a 
general licensee registrant.
    Section 170.3--Would revise definition of ``Materials License'' to 
include part 31 and the words, ``or granted'' as general licenses are 
granted by regulation rather than individually issued to licensees.
    Section 170.31--Revision would add $420 registration fee for 
general licensees subject to Sec. 31.5(c)(13).
    Section 171.5--Would revise definition of ``Materials License'' to 
include part 31 and the words, ``or granted'' as general licenses are 
granted by regulation rather than individually issued to licensees.
    Section 171.16--Would add category for part 31 general license 
registration for consistency with the Table in Sec. 170.31.

National Database

    The Commission is in the process of developing a new computer 
database to handle information about general licensees and generally 
licensed devices. Among other improvements from the currently used 
system, it will be designed to handle the registration process 
efficiently with automated features. In doing so, the Commission has 
given some consideration to whether a national database should be 
established in which information on the identity of general licensees 
and device information for all jurisdictions would be maintained, 
making this information accessible to all Agreement States and the NRC. 
There are variations on the exact approach that might be taken 
particularly with respect to access and update authority. At this time, 
the Commission has not yet found it practical to resolve all the issues 
related to having broad access to the database.
    The Commission would like to give further consideration to 
establishing such a database. It would not require rulemaking. However, 
if it were to be established, one option would be to change the 
material transfer reporting requirements so that distributors would 
report all transfers to the NRC rather than reporting to all 
jurisdictions into which transfers of devices are made.
    A primary advantage of a national database would be the ease of 
tracing a ``found'' device back to the general licensee owner 
responsible for the device. A ``found'' generally licensed device would 
be considered an orphan source until such time as the responsible 
general licensee is identified and it is returned to the licensee. The 
Commission is in the process of modifying the Nuclear Materials Events 
Database (NMED) to accept and track information on orphan sources 
nationally (i.e. all States). Access to the NMED will be available to 
the NRC and all the States. The Commission will encourage the States to 
use NMED for this purpose so that this category of information will be 
shared nationally. However, NMED would rely on reporting of events for 
its data. In order for a device to be traced back to the responsible 
general licensee, each jurisdiction would need to search its own files. 
In addition, information in a national general license database would 
be immediately available, and would contain the most complete 
information about general licensees and generally licensed devices.
    The primary disadvantage to a national database would be the 
difficulty of maintaining the security of the data, which is primarily 
made up of proprietary information. A national database would also 
present more risk to the integrity of the data, because there would be 
a higher potential for illicit corruption of data.
    In considering whether or not to implement a national database and, 
if so, what the particular approach would be used, there are a number 
of aspects to be considered including--
    (1) Who will maintain the database (the NRC, an independent third 
party, or each agency maintaining its own data)?
    (2) How access to the data would be controlled.
    (3) Potential changes to the reporting requirements for transfers.
    (4) The ability for the NRC and the Agreement States to protect 
information of other agencies.

[[Page 40304]]

    (5) Costs to implement and maintain the system or systems 
(including training).
    The Commission seeks comment on the advantages and disadvantages of 
implementing a national database and on these related issues.

Specific Questions for Public Comment

    The Commission welcomes comments on all aspects of this proposed 
rule, and is especially interested in receiving comments on the 
specific questions summarized here:
    1. The Commission seeks comment on whether the registration 
requirement should include a provision that would require the general 
licensee to complete registration by a certain time, whether or not the 
NRC requests registration.
    2. The Commission requests comment on whether it is appropriate for 
new devices obtained by registrants to be registered when the annual 
reregistration is carried out without the NRC having earlier contact 
after additional devices are received. Earlier contact could be made 
either by an acknowledgment by NRC to the user or by a required 
response from the general licensee to account for the additional 
device(s).
    3. The Commission solicits comment on whether general licensees 
should be required to assign a backup responsible individual (BRI).
    4. The Commission seeks comment on how best to achieve and enforce 
the intent that full disclosure of information required to be provided 
to general licensee customers by distributors be made early enough to 
be considered in a decision to purchase. For example: Would it be 
better to use the words, ``prior to purchase'' in the regulatory text?
    5. The Commission seeks comment on the advantages and disadvantages 
of implementing a national database of general licensees and their 
devices.

Enforcement

    On March 9, 1999 (64 FR 11508), the Commission established an 
interim enforcement policy for violations of Sec. 31.5 that licensees 
discover and report during the initial cycle of the registration 
program. This policy supplements the normal NRC Enforcement Policy in 
NUREG-1600, Rev. 1. It will remain in effect through one complete cycle 
of the registration program.
    Under this interim enforcement policy, enforcement action normally 
will not be taken for violations of Sec. 31.5 that are identified by 
the general licensee, and reported to the NRC if reporting is required, 
provided that the general licensee takes appropriate corrective action 
to address the specific violations and prevent recurrence of similar 
problems and otherwise has undertaken good faith efforts to respond to 
NRC notices and provide requested information. This change from the 
Commission's normal enforcement policy is to remove the potential for 
the threat of enforcement action to be a disincentive for the licensee 
to identify deficiencies. This approach is warranted given the limited 
NRC inspections of general licensees. This approach is intended to 
encourage general licensees to determine if applicable requirements 
have been met, to search their facilities to ensure sources are 
located, and to develop appropriate corrective action when deficiencies 
are found. Under the interim enforcement policy, enforcement action, 
including issuance of civil penalties and Orders, may be taken where 
there is--
    (a) Failure to take appropriate corrective action to prevent 
recurrence of similar violations;
    (b) Failure to respond and provide the information required by 
regulation;
    (c) Willful failure to provide complete and accurate information to 
the NRC; or
    (d) Other willful violations, such as willfully disposing of 
generally licensed material in an unauthorized manner.
    As noted in the December 2, 1998, proposed rule, the Commission 
also plans to increase the civil penalty amounts specified in its 
Enforcement Policy in NUREG-1600, Rev. 1, for violations involving lost 
or improperly disposed sources or devices. This increase will better 
relate the civil penalty amount to the costs avoided by the failure to 
properly dispose of the source or device. Due to the diversity of the 
types of sources and devices, the Commission is considering the 
establishment of three levels of base civil penalty for loss or 
improper disposal. The three levels of base civil penalty would be 
$5500, $15,000, and $45,000. The higher tiers would be for sources that 
are relatively costly to dispose of and would be based on approximately 
three times the average cost of proper transfer or disposal of the 
source or device.

Agreement State Compatibility

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' published on September 3, 1997 (62 FR 
46517), the proposed rule would be a matter of compatibility between 
the NRC and the Agreement States, thereby providing consistency among 
Agreement State and NRC requirements. The revisions to part 32 would be 
classified as Category B and the revisions to Sec. 31.5 would be 
classified as Category C. Through this action, existing provisions of 
Sec. 31.5 would also be reclassified from Category D to Category C. 
Although changes are being made to Secs. 30.31, 30.34(h)(1), 31.1, and 
31.2, and parts 170 and 171 as part of this rulemaking, the existing 
compatibility designations for these regulations will not be affected.
    Category B means the provisions affect a program element with 
significant direct transboundary implications. The State program 
element should be essentially identical to that of NRC. Category C 
means the provisions affect a program element, the essential objectives 
of which should be adopted by the State to avoid conflicts, 
duplications, or gaps in the national program. The manner in which the 
essential objectives are addressed need not be the same as NRC provided 
the essential objectives are met.
    Specific information about the compatibility or health and safety 
components assigned to this rule may be found at Office of State 
Programs website, http://www.hsrd.ornl.gov/nrc/home.html.
    As discussed above, revised Sec. 32.52(a) and (b) would add the 
following information to the existing distributors' quarterly transfer 
reporting requirements: the serial number and model number of the 
device, the date of transfer, indication if the device is a replacement 
(and if so, the type, model number, and serial number of the device 
returned), the name and license number of the reporting company, and 
the specific reporting period. The proposed revisions would also 
require the name and phone number of a general licensee's ``responsible 
individual'' rather than simply a contact and would specify that the 
address of the general licensee be the mailing address for the location 
of use. According to NRC Management Directive (MD) 5.9, ``Adequacy and 
Compatibility of Agreement State Programs,'' NRC regulations that 
should be adopted by an Agreement State for purposes of compatibility 
should be adopted in a time frame such that the effective date of the 
State requirement is no later than 3 years after the effective date of 
NRC's final rule. MD 5.9 also provides that some circumstances may 
warrant that the States adopt certain regulations in less than the 
recommended 3-year time frame or that the effective dates for both NRC 
licensees and Agreement State licensees be the same. The Commission 
believes it is important to the implementation of this program, and to 
Agreement State programs, to begin receiving the additional information 
in

[[Page 40305]]

the distributors' quarterly transfer reports as soon as possible. The 
Commission requests comments on whether NRC and the Agreement States 
should establish a single implementation date for this provision which 
would be earlier than is usually allowed for revision of Agreement 
State rules for compatibility. One approach would be to request 
Agreement States to require distributors to provide all the information 
consistent with this rule (proposed Sec. 32.52(a) and (b)) either 
coincident with the effective date of the Commission's final action on 
this rulemaking or within 1 year of that effective date. Agreement 
States would have the flexibility to adopt this provision through 
rulemaking, license conditions, or other legally binding requirements.

Plain Language

    The Presidential Memorandum dated June 1, 1998, entitled, ``Plain 
Language in Government Writing,'' directed that the government's 
writing be in plain language. This memorandum was published June 10, 
1998 (63 FR 31883). In complying with this directive, editorial changes 
have been made in the proposed revisions to improve the organization 
and readability of the existing language of paragraphs being revised. 
These types of changes are not discussed further in this notice. The 
NRC requests comments on this proposed rule specifically with respect 
to the clarity and effectiveness of the language used. Comments should 
be sent to the address listed under the heading: ADDRESSES above.

Environmental Impact: Categorical Exclusion

    The NRC has determined that the revisions proposed in this rule are 
the types of actions described in the categorical exclusions in 
Sec. 51.22(c)(1) through (3). Therefore, neither an environmental 
impact statement nor an environmental assessment has been prepared for 
this regulation.

Paperwork Reduction Act Statement

    This proposed rule amends information collection requirements that 
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq). This rule has been submitted to the Office of Management and 
Budget for review and approval of the information collection 
requirements.
    The public reporting burden for this information collection is 
estimated to average 2 minutes per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
information collection. The time involved is small because most of the 
proposals are minor revisions to existing information collection 
requirements. The U.S. Nuclear Regulatory Commission is seeking public 
comment on the potential impact of the information collections 
contained in the proposed rule and on the following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the NRC, including whether the 
information will have practical utility?
    2. Is the estimate of burden accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques?
    Send comments on any aspect of this proposed information 
collection, including suggestions for reducing the burden, to the 
Records Management Branch (T-6F33), U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, or by Internet electronic mail at 
[email protected]; and to the Desk Officer, Office of Information and 
Regulatory Affairs, NEOB-10202 (3150-0016), Office of Management and 
Budget, Washington, DC 20503.
    Comments to OMB on the information collections or on the above 
issues should be submitted by August 25, 1999. Comments received after 
this date will be considered if it is practical to do so, but assurance 
of consideration cannot be given to comments received after this date.

Public Protection Notification

    If a means used to impose an information collection does not 
display a currently valid OMB control number, the NRC may not conduct 
or sponsor, and a person is not required to respond to, the information 
collection.

Regulatory Analysis

    The NRC has prepared a draft regulatory analysis for this proposed 
regulation. The analysis examines the cost and benefits of the 
alternatives considered by the NRC. The comments received on the draft 
regulatory analysis associated with the proposed rule of December 27, 
1991, have been considered to the extent that they apply to this 
action. The regulatory analysis is available for inspection in the NRC 
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. 
Single copies of the analysis may be obtained by calling Catherine R. 
Mattsen, U.S. Nuclear Regulatory Commission, Office of Nuclear Material 
Safety and Safeguards, Washington, DC 20555-0001; telephone (301) 415-
6264; or e-mail at [email protected].

Regulatory Flexibility Certification

    As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), 
the Commission has evaluated the impact of this rule on small entities. 
The NRC has established standards for determining which NRC licensees 
qualify as small entities (10 CFR 2.810). The Commission certifies that 
this proposed rule, if adopted, would not have a significant economic 
impact on a substantial number of small entities. The most significant 
cost of this proposed rule would be the proposed $420 fee to be 
assessed for each registration. Portions of the proposed rule would 
apply to the approximately 45,000 persons possessing products under an 
NRC general license, many of whom may be classified as small entities. 
However, the annual registration requirement and associated fee would 
apply to about 5100 of these general licensees. Based on input received 
previously from small entities who hold specific materials licenses, 
the NRC believes that the proposed $420 part 170 registration fee would 
not have a significant economic impact on a substantial number of small 
entities. The NRC believes that the economic impact of the other 
proposed requirements on any general licensee would be a negligible 
increase in administrative burden. The NRC is soliciting comment from 
the general licensees who meet the NRC's small entity size standards 
and would be required to register their devices pursuant to part 31 on 
whether the proposed part 170 fee for their annual registration would 
have a significant economic impact on their business.
    The proposed rule would also revise requirements for specifically 
licensed distributors of certain generally licensed devices. Currently, 
there are 28 NRC licensed distributors and approximately 61 Agreement 
State licensed distributors. Many of these licensees are not small 
entities and the impact to any of these distributors is not expected to 
be significant in any case. Distributors who are small entities are 
also invited to comment on whether they believe the economic impact 
would be significant.
    Those small entities that offer comments on the potential impact on 
small entities and how that might be minimized should specifically 
include information on the type and size of their business and how the 
proposed

[[Page 40306]]

regulations would result in a significant economic impact on them as 
compared to larger organizations in the same business community. To the 
extent possible, the commenter should provide relevant economic data, 
such as the licensee's gross annual receipts, as well as number of 
employees.

Backfit Analysis

    The NRC has determined that the backfit rule, Sec. 50.109, does not 
apply to this proposed rule and, therefore, a backfit analysis is not 
required because these amendments would not involve any provisions that 
would impose backfits as defined in Sec. 50.109(a)(1).

List of Subjects

10 CFR Part 30

    Byproduct material, Criminal penalties, Government contracts, 
Intergovernmental relations, Isotopes, Nuclear materials, Radiation 
protection, Reporting and recordkeeping requirements.

10 CFR Part 31

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Packaging and containers, Radiation protection, Reporting 
and recordkeeping requirements, Scientific equipment.

10 CFR Part 32

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Radiation protection, Reporting and recordkeeping 
requirements.

10 CFR Part 170

    Byproduct material, Import and export licenses, Intergovernmental 
relations, Non-payment penalties, Nuclear materials, Nuclear power 
plants and reactors, Source material, Special nuclear material.

10 CFR Part 171

    Annual charges, Byproduct material, Holders of certificates, 
registrations, approvals, Intergovernmental relations, Non-payment 
penalties, Nuclear materials, Nuclear power plants and reactors, Source 
material, Special nuclear material.

    For the reasons set out above and under the authority of the Atomic 
Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, 
as amended; and 5 U.S.C. 553, the NRC is proposing to adopt the 
following amendments to 10 CFR parts 30, 31, 32, 170, and 171.

PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF 
BYPRODUCT MATERIAL

    1. The authority citation for part 30 continues to read as follows:

    Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 
953, 954, 955, as amended, sec. 234, 83, Stat. 444, as amended, (42 
U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201 as 
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 
5841, 5842, 5846).
    Sec. 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 as amended by Pub. L. 102-486; sec. 2902, 106 Stat. 3123, (42 
U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat. 
954, as amended (42 U.S.C. 2234). Section 30.61 also issued under 
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

    2. Section 30.31 is revised to read as follows:


Sec. 30.31  Types of licenses.

    Licenses for byproduct material are of two types: General and 
specific.
    (a) The Commission issues a specific license to a named person who 
has filed an application for the license under the provisions of this 
part and parts 32-36, and 39 of this chapter.
    (b) A general license is provided by regulation, grants authority 
to a person for certain activities involving byproduct material, and is 
effective without the filing of an application with the Commission or 
the issuance of a licensing document to a particular person. However, 
registration with the Commission may be required by the particular 
general license.
    3. In Sec. 30.34, paragraph (h)(1) is revised to read as follows:


Sec. 30.34  Terms and conditions of licenses.

* * * * *
    (h)(1) Each general licensee that is required to register by 
Sec. 31.5(c)(13) of this chapter and each specific licensee shall 
notify the appropriate NRC Regional Administrator, in writing, 
immediately following the filing of a voluntary or involuntary petition 
for bankruptcy under any chapter of title 11 (Bankruptcy) of the United 
States Code by or against:
    (i) The licensee;
    (ii) An entity (as that term is defined in 11 U.S.C. 101(14)) 
controlling the licensee or listing the license or licensee as property 
of the estate; or
    (iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of 
the licensee.
* * * * *

PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

    4. The authority citation for part 31 continues to read as follows:

    Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as 
amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 
Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842).
    Section 31.6 also issued under sec. 274, 73 Stat. 688 (42 U.S.C. 
2021).

    5. Section 31.1 is revised to read as follows:


Sec. 31.1  Purpose and scope.

    This part establishes general licenses for the possession and use 
of byproduct material and a general license for ownership of byproduct 
material. Specific provisions of 10 CFR part 30 are applicable to 
general licenses established by this part. These provisions are 
specified in Sec. 31.2 or in the particular general license.
    6. Section 31.2 is revised to read as follows:


Sec. 31.2  Terms and conditions.

    The general licenses provided in this part are subject to the 
general provisions of Part 30 of this chapter (Secs. 30.1 through 
30.10), the provisions of Secs. 30.14(d), 30.34(a) to (e), 30.41, 30.50 
to 30.53, 30.61 to 30.63, and parts 19, 20, and 21, of this chapter 
1 unless indicated otherwise in the specific provision of 
the general license.
---------------------------------------------------------------------------

    \1\ Attention is directed particularly to the provisions of part 
20 of this chapter concerning labeling of containers.
---------------------------------------------------------------------------

    7. In Sec. 31.5, paragraphs (b), (c)(5), (c)(8), and (c)(9) are 
revised and paragraphs (c)(12), (13), (14), and (15) are added to read 
as follows:


Sec. 31.5  Certain measuring, gauging, or controlling 
devices.2
---------------------------------------------------------------------------

    \2\ Persons possessing byproduct material in devices under a 
general license in Sec. 31.5 before January 15, 1975, may continue 
to possess, use, or transfer that material in accordance with the 
labeling requirements of Sec. 31.5 in effect on January 14, 1975.
---------------------------------------------------------------------------

* * * * *
    (b)(1) The general license in paragraph (a) of this section applies 
only to byproduct material contained in devices which have been 
manufactured or initially transferred and labeled in accordance with 
the specifications contained in--
    (i) A specific license issued under Sec. 32.51 of this chapter; or
    (ii) An equivalent specific license issued by an Agreement State.
    (2) The devices must have been received from one of the specific 
licensees described in paragraph (b)(1)

[[Page 40307]]

of this section or through a transfer made under paragraph (c)(9) of 
this section.
    (c) * * *
* * * * *
    (5) Shall immediately suspend operation of the device if there is a 
failure of, or damage to, or any indication of a possible failure of or 
damage to, the shielding of the radioactive material or the on-off 
mechanism or indicator, or upon the detection of 0.005 microcurie or 
more removable radioactive material. The device may not be operated 
until it has been repaired by the manufacturer or other person holding 
a specific license to repair such devices that was issued under parts 
30 and 32 of this chapter or by an Agreement State. The device may be 
disposed of by transfer to a person authorized by a specific license to 
receive the byproduct material contained in the device. A report 
containing a brief description of the event and the remedial action 
taken; and, in the case of detection of 0.005 microcurie or more 
removable radioactive material or failure of or damage to a source 
likely to result in contamination of the premises or the environs, a 
plan for ensuring that the premises and environs are acceptable for 
unrestricted use, must be furnished to the Director of Nuclear Material 
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001 within 30 days. Under these circumstances, the criteria 
set out in Sec. 20.1402, ``Radiological criteria for unrestricted 
use.'' may be applicable, as determined by the Commission on a case-by-
case basis;
* * * * *
    (8)(i) Shall transfer or dispose of the device containing byproduct 
material only by transfer to another general licensee as authorized in 
paragraph (c)(9) of this section or to a person authorized to receive 
the device by a specific license issued under parts 30 and 32 of this 
chapter, part 30 of this chapter that authorizes waste collection, or 
equivalent regulations of an Agreement State, or as approved under 
paragraph (c)(8)(iii) of this section.
    (ii) Shall furnish a report to the Director of Nuclear Material 
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001 within 30 days after the transfer of a device to a 
specific licensee. A report is not required if the device is 
transferred to the specific licensee in order to obtain a replacement 
device from the same specific licensee. The report must contain--
    (A) The identification of the device by manufacturer's name, model 
number, and serial number;
    (B) The name, address, and license number of the person receiving 
the device; and
    (C) The date of the transfer.
    (iii) Shall obtain written NRC approval before transferring the 
device to any other specific licensee.
    (9) Shall transfer the device to another general licensee only if--
    (i) The device remains in use at a particular location. In this 
case, the transferor shall give the transferee a copy of this section 
and any safety documents identified in the label of the device. Within 
30 days of the transfer, the transferor shall report the manufacturer's 
name and the model number and the serial number of the device 
transferred, the name and address of the transferee, and the name and 
phone number of the responsible individual identified by the transferee 
in accordance with paragraph (c)(12) of this section to have knowledge 
of and authority to take actions to ensure compliance with the 
appropriate regulations and requirements to the Director of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; or
    (ii) The device is held in storage by an intermediate person in the 
original shipping container at its intended location of use prior to 
initial use by a general licensee.
* * * * *
    (12) Shall appoint an individual responsible for having knowledge 
of the appropriate regulations and requirements and the authority for 
taking required actions to comply with appropriate regulations and 
requirements. The general licensee, through this individual, shall 
ensure the day-to-day compliance with appropriate regulations and 
requirements. This appointment does not relieve the general licensee of 
responsibility in this regard.
    (13)(i) Shall register, in accordance with paragraphs (c)(13)(ii) 
and (iii) of this section, devices containing at least 370 MBq (10 mCi) 
of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of 
cobalt-60, or 37 MBq (1 mCi) of americium-241 or any other transuranic, 
i.e., element with atomic number greater than uranium (92), based on 
the activity indicated on the label.
    (ii) If in possession of a device meeting the criteria of paragraph 
(c)(13)(i) of this section, shall register these devices annually with 
the Commission and shall pay the fee required by Sec. 170.31 of this 
chapter. Registration must be done by verifying, correcting, and/or 
adding to the information provided in a request for registration 
received from the Commission. The registration information must be 
submitted to the NRC within 30 days of the date of the request for 
registration or as otherwise indicated in the request. In addition, a 
general licensee holding devices meeting the criteria of paragraph 
(c)(13)(i) of this section is subject to the bankruptcy notification 
requirement in Sec. 30.34(h) of this chapter.
    (iii) In registering devices, the general licensee shall furnish 
the following information and any other information specifically 
requested by the Commission--
    (A) Name and mailing address of the general licensee.
    (B) Information about each device: The manufacturer, model number, 
serial number, the radioisotope and activity (as indicated on the 
label).
    (C) Name and telephone number of the responsible person designated 
as a representative of the general licensee under paragraph (c)(12) of 
this section.
    (D) Address at which the device(s) are used and/or stored. For 
portable devices, the address of the primary place of storage.
    (E) Certification by the responsible representative of the general 
licensee that the information concerning the device(s) has been 
verified through a physical inventory and checking of label 
information.
    (F) Certification by the responsible representative of the general 
licensee that they are aware of the requirements of the general 
license.
    (14) Shall report changes of address (including change in name of 
general licensee) to the Director of Nuclear Material Safety and 
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001 within 30 days of the effective date of the change. If it is a 
portable device, a report of address change is only required for a 
change in the device's primary place of storage.
    (15) May not hold devices that are not in use for longer than 2 
years. If devices with shutters are not being used, the shutter must be 
locked in the closed position. The testing required by paragraph (c)(2) 
of this section need not be performed during the period of storage 
only. However, when devices are put back into service or transferred to 
another person, and have not been tested within the required test 
interval, they must be tested for leakage before

[[Page 40308]]

use or transfer and the shutter tested before use.
* * * * *

PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER 
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

    8. The authority citation for part 32 continues to read as follows:

    Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, 
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 
1242, as amended (42 U.S.C. 5841).

    9. In Sec. 32.51, paragraphs (a)(4) and (5) are added to read as 
follows:


Sec. 32.51  Byproduct material contained in devices for use under 
Sec. 31.5; requirements for license to manufacture, or initially 
transfer.

    (a) * * *
    (4) Each device having a separable source housing that provides the 
primary shielding for the source also bears, on the source housing, a 
durable label containing the device model number and serial number, the 
isotope and quantity, the words, ``Caution--Radioactive Material,'' the 
radiation symbol described in Sec. 20.1901 of this chapter, and the 
name of the manufacturer or initial distributor.
    (5) Each device meeting the criteria of Sec. 31.5(c)(13)(i) of this 
chapter, bears a permanent (e.g., embossed, etched, stamped, or 
engraved) label affixed to the source housing if separable, or the 
device if the source housing is not separable, that includes the words, 
``Caution--Radioactive Material,'' and, if practicable, the radiation 
symbol described in Sec. 20.1901 of this chapter.
* * * * *
    10. Section 32.51a is revised to read as follows:


Sec. 32.51a  Same: Conditions of licenses.

    (a) If a device containing byproduct material is to be transferred 
for use under the general license contained in Sec. 31.5 of this 
chapter, each person that is licensed under Sec. 32.51 shall provide 
the information specified in this paragraph to each person to whom a 
device is to be transferred. This information must be provided before 
the device may be transferred. In the case of a transfer through an 
intermediate person, the information must also be provided to the 
intended user prior to initial transfer to the intermediate person. The 
required information includes--
    (1) A copy of the general license contained in Sec. 31.5 of this 
chapter;
    (2) A copy of Secs. 31.2, 30.51, 20.2201, and 20.2202 of this 
chapter;
    (3) A list of the services that can only be performed by a specific 
licensee; and (4) Information on acceptable disposal options including 
estimated costs of disposal.
    (b) If byproduct material is to be transferred in a device for use 
under an equivalent general license of an Agreement State, each person 
that is licensed under Sec. 32.51 shall provide the information 
specified in this paragraph to each person to whom a device is to be 
transferred. This information must be provided before the device may be 
transferred. In the case of a transfer through an intermediate person, 
the information must also be provided to the intended user prior to 
initial transfer to the intermediate person. The required information 
includes --
    (1) A copy of the Agreement State's regulations equivalent to 
Secs. 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter or a copy 
of Secs. 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter. If a 
copy of the NRC regulations is provided to a prospective general 
licensee, it shall be accompanied by a note explaining that use of the 
device is regulated by the Agreement State;
    (2) A list of the services that can only be performed by a specific 
licensee;
    (3) Information on acceptable disposal options including estimated 
costs of disposal; and (4) The name, address, and phone number of the 
contact at the Agreement State regulatory agency from which additional 
information may be obtained.
    (c) Each device that is transferred after (insert date 1 year after 
the effective date of this rule) must meet the labeling requirements in 
Sec. 32.51(a)(3) through (5).
    (d) If a notification of bankruptcy has been made under 
Sec. 30.34(h) or the license is to be terminated, each person licensed 
under Sec. 32.51 shall provide, upon request, to the NRC and to any 
appropriate Agreement State, records of final disposition required 
under Sec. 32.52(c).
    11. Section 32.52 is revised to read as follows:


Sec. 32.52  Same: Material transfer reports and records.

    Each person licensed under Sec. 32.51 to initially transfer devices 
to generally licensed persons shall comply with the requirements of 
this section.
    (a) The person shall report all transfers of devices to persons for 
use under the general license in Sec. 31.5 of this chapter to the 
Director of the Office of Nuclear Material Safety and Safeguards, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001. The report 
must be submitted on a quarterly basis on Form 653--``Transfers of 
Industrial Devices Report'' or in a clear and legible report containing 
all of the data required by the form.
    (1) The required information includes--
    (i) The identity of each general licensee by name and mailing 
address for the location of use;
    (ii) The name and phone number of the person identified by the 
general licensee as having knowledge of and authority to take required 
actions to ensure compliance with the appropriate regulations and 
requirements;
    (iii) The date of transfer;
    (iv) The type, model number, and serial number of the device 
transferred; and
    (v) The quantity and type of byproduct material contained in the 
device.
    (2) If one or more intermediate persons will temporarily possess 
the device at the intended place of use before its possession by the 
user, the report must include the same information for both the 
intended user and each intermediate person, and clearly designate the 
intermediate person(s).
    (3) If a device transferred replaced another returned by the 
general licensee, the report must also include the type, model number, 
and serial number of the one returned.
    (4) The report must cover each calendar quarter, must be filed 
within 30 days of the end of the calendar quarter, and must clearly 
indicate the period covered by the report.
    (5) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (6) If no transfers have been made to persons generally licensed 
under Sec. 31.5 of this chapter during the reporting period, the report 
must so indicate.
    (b) The person shall report all transfers of devices to persons for 
use under a general license in an Agreement State's regulations that 
are equivalent to Sec. 31.5 of this chapter to the responsible 
Agreement State agency. The report must be submitted on Form 653--
``Transfers of Industrial Devices Report'' or in a clear and legible 
report containing all of the data required by the form.
    (1) The required information includes--
    (i) The identity of each general licensee by name and mailing 
address for the location of use;
    (ii) The name and phone number of the person identified by the 
general licensee as having knowledge of and

[[Page 40309]]

authority to take required actions to ensure compliance with the 
appropriate regulations and requirements;
    (iii) The date of transfer;
    (iv) The type, model number, and serial number of the device 
transferred; and
    (v) The quantity and type of byproduct material contained in the 
device.
    (2) If one or more intermediate persons will temporarily possess 
the device at the intended place of use before its possession by the 
user, the report must include the same information for both the 
intended user and each intermediate person, and clearly designate the 
intermediate person(s).
    (3) If a device transferred replaced another returned by the 
general licensee, the report must also include the type, model number, 
and serial number of the one returned.
    (4) The report must be submitted within 30 days after the end of 
each calendar quarter in which such a device is transferred to the 
generally licensed person and clearly indicate the period covered by 
the report.
    (5) The report must clearly identify the specific licensee 
submitting the report and must include the license number of the 
specific licensee.
    (6) If no transfers have been made to a particular Agreement State 
during the reporting period, this information shall be reported to the 
responsible Agreement State agency upon request of the agency.
    (c) The person shall keep records of all transfers of devices for 
each general licensee including all the information in the reports 
required by this section and records of final disposition. Records 
required by this paragraph must be maintained for a period of 3 years 
following the estimated useful life of the device or the date of final 
disposition, if known.

PART 170--FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT 
LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT 
OF 1954, AS AMENDED

    12. The authority citation for part 170 continues to read as 
follows:

    Authority: 31 U.S.C. 9701; sec. 301, Pub. L. 92--314, 86 Stat. 
222 (42 U.S.C. 2201w); sec. 201, 88 Stat. 1242, as amended (42 
U.S.C. 5841); sec. 205, Pub. L. 101-576, 104 Stat. 2842, (31 U.S.C. 
9012).

    13. Section 170.2 is amended by adding a paragraph (r) to read as 
follows:


Sec. 170.2  Scope.

* * * * *
    (r) A holder of a general license granted by 10 CFR part 31 who is 
required to register a device(s).
    14. In Sec. 170.3, the definition of Materials License is revised 
to read as follows:


Sec. 170.3  Definitions.

* * * * *
    Materials License means a license, certificate, approval, 
registration, or other form of permission issued or granted by the NRC 
pursuant to the regulations in 10 CFR parts 30, 31 through 36, 39, 40, 
61, 70, 71 and 72.
* * * * *
    15. Section 170.31 is amended by adding a fee category, 3. Q. to 
the schedule of materials fees and amending footnote 1 to add a 
paragraph (f).


Sec. 170.31  Schedule of fees for materials licenses and other 
regulatory services, including inspections, and import and export 
licenses.

* * * * *

                       Schedule of Materials Fees
                     [See footnotes at end of table]
------------------------------------------------------------------------
 Category of materials licenses and type of fees
                       \1\                                Fee 2,3
------------------------------------------------------------------------
 
*                  *                  *                  *
                                     *
3. * * *
  Q. Registration of a device(s) generally         $420
   licensed pursuant to Part 31.
 
*                  *                  *                  *
                                     *
------------------------------------------------------------------------
\1\ Types of fees.

* * *
    (f) Generally licensed device registrations under 10 CFR 31.5. 
Submittals of registration information must be accompanied by the 
prescribed fee.
* * * * *

PART 171--ANNUAL FEES FOR REACTOR OPERATING LICENSES, AND FUEL 
CYCLE LICENSES AND MATERIALS LICENSES, INCLUDING HOLDERS OF 
CERTIFICATES OF COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE 
PROGRAM APPROVALS AND GOVERNMENT AGENCIES LICENSED BY THE NRC

    16. The authority citation for part 171 continues to read as 
follows:

    Authority: Sec. 7601, Pub. L. 99-272, 100 Stat. 146, as amended 
by sec. 5601, Pub. L. 100-203, 101 Stat. 1330, as amended by sec. 
3201, Pub. L. 101-239, 103 Stat. 2106 as amended by sec. 6101, Pub. 
L. 101-508, 104 Stat. 1388 (42 U.S.C. 2213); sec. 301, Pub. L. 92-
314, 86 Stat. 222 (42 U.S.C. 2201(w)); sec. 201, 88 Stat. 1242 as 
amended (42 U.S.C. 5841; sec. 2903, Pub. L. 102-486, 106 Stat. 3125 
(42 U.S.C. 2214 note).

    17. In Sec. 171.5, the definition of Materials License is revised 
to read as follows:


Sec. 171.5  Definitions.

* * * * *
    Materials License means a license, certificate, approval, 
registration, or other form of permission issued or granted by the NRC 
pursuant to the regulations in 10 CFR parts 30, 31 through 36, 39, 40, 
61, 70, 71, and 72.
* * * * *
    18. In Sec. 171.16, paragraph (d) is amended by adding a fee 
category, 3. Q. to the schedule of annual fees.


Sec. 171.16  Annual fees: Material Licensees, Holders of Certificates 
of Compliance, Holders of Sealed Source and Device Registrations, 
Holders of Quality Assurance Program Approvals and Government Agencies 
Licensed by the NRC.

* * * * *
    (d) * * *

[[Page 40310]]



   Schedule of Materials Annual Fees and Fees for Government Agencies
                             Licensed by NRC
                     [See footnotes at end of table]
------------------------------------------------------------------------
          Category of materials license               Annual fees 1,2,3
------------------------------------------------------------------------
 
*                  *                  *                  *
                                     *
3. * * *
  Q. Registration of devices generally licensed    \11\N/A
   pursuant to part 31.
 
*                  *                  *                  *
                                     *
------------------------------------------------------------------------
\11\ No annual fee is charged for this category since the cost of the
  general license registration program will be recovered through 10 CFR
  part 170 fees.

    Dated at Rockville, MD., this 19th day of July, 1999.

    For the Nuclear Regulatory Commission.
J. Samuel Walker,
Acting Secretary of the Commission.
[FR Doc. 99-18981 Filed 7-23-99; 8:45 am]
BILLING CODE 7590-01-P