Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material

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