Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested Information

NUCLEAR REGULATORY COMMISSION

10 CFR Part 31

RIN 3150--AG06

Requirements for Those Who Possess Certain Industrial Devices

Containing Byproduct Material to Provide Requested Information

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its

regulations to add an explicit requirement that general licensees, who

possess certain measuring, gauging, or controlling devices that contain

byproduct material, provide the NRC with information concerning these

devices. The NRC intends to use this provision to request information

concerning devices that present a comparatively higher risk of exposure

to the public or property damage. The final rule is intended to help

ensure that devices containing byproduct material are maintained and

transferred properly and are not inadvertently discarded.

EFFECTIVE DATE: October 4, 1999.

FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of

Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory

Commission, Washington, DC 20555-0001, telephone (301) 415-6264, or e-

mail at [email protected]; or Jayne McCausland, Office of Nuclear Material

Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington,

DC 20555-0001, telephone (301) 415-6219, or e-mail at JMM[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 for the use

of byproduct material contained in certain measuring, gauging, or

controlling devices (10 CFR 30.21(c)). 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 the specifications contained

in a specific license issued by the NRC or by an Agreement State. A

specific license authorizing distribution of generally licensed devices

is issued if a regulatory authority determines that the safety features

of the device and the instructions for safe operation of that device

are adequate and meet regulatory requirements.

The person or firm who receives such a device is a general

licensee. The general licensee is subject to requirements for

maintaining labels, following instructions for 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 leak testing requirements. The general licensee is

also subject to the terms and conditions in 10 CFR 31.2 concerning

general license requirements, transfer of byproduct material, reporting

and recordkeeping, and inspection. The general licensee must comply

with the safety instructions contained in or referenced on the label of

the device and must have the testing or servicing of the device

performed by an individual who is authorized to manufacture, install,

or service these devices.

A generally licensed device usually consists of radioactive

material, contained in a sealed source, within a shielded device. The

device is designed with inherent radiation safety features so that it

can be used by persons with no radiation training or experience. Thus,

the general license is meant to simplify the licensing process so that

a case-by-case determination of the adequacy of the radiation training

or experience of each user is not necessary.

There are about 45,000 general licensees under 10 CFR 31.5. These

licensees possess about 600,000 devices that contain byproduct

material. The NRC has not contacted general licensees on a regular

basis because of the relatively small radiation exposure risk posed by

these devices and the very large number of general licensees. However,

general licensees are not always aware of applicable regulations and

thus are not necessarily complying with all of the applicable

requirements. The NRC is particularly concerned about occurrences where

generally licensed devices containing radioactive material have not

been properly handled or properly disposed of. In some cases, this has

resulted in radiation exposure to the public and contamination of

property. Although known exposures generally have not exceeded the

public dose limit, there is a potential for significant exposures. When

a source is accidentally melted in a steel mill, considerable

contamination of the mill, the steel product, and the wastes from the

process, the slag and the baghouse dust, can result.

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 use of

generally licensed devices. In particular, the NRC concluded that many

general licensees are not aware of the appropriate regulations. Also,

approximately 15 percent of all general licensees sampled could not

account for all of their generally licensed devices. The NRC concluded

that these problems could be remedied by more frequent and timely

contact between the general licensee and the NRC.

On December 27, 1991 (56 FR 67011), the NRC published a notice of

proposed rulemaking concerning the accountability of generally licensed

devices. The proposed rule contained a number of provisions, including

a requirement for general licensees under 10 CFR 31.5 to provide

information to the NRC upon request, through which a device registry

could be developed. The proposed rule also included requirements in 10

CFR 32.51a and 32.52 for the specific licensees who manufacture or

initially transfer generally licensed devices. Although the public

comments received were reviewed and a final rule developed, a final

rule was not issued because the resources needed to implement the

proposed rule properly were not available.

The NRC continued to consider the issues related to the loss of

control of generally licensed, as well as

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specifically licensed, sources of radioactivity. In July 1995, the NRC,

with assistance from the Organization of Agreement States, formed a

working group to evaluate these issues. A final report was completed in

July 1996 and published in October 1996 as NUREG-1551, ``Final Report

of the NRC-Agreement State Working Group to Evaluate Control and

Accountability of Licensed Devices.''

In considering the recommendations of the working group, the NRC

decided, among other things, to again initiate rulemaking to establish

an annual registration program of devices generally licensed under 10

CFR 31.5 that would be similar to the program originally proposed in

the December 27, 1991, proposed rule. However, the NRC decided to do so

only for those devices that present a higher risk, compared to other

generally licensed devices, of potential exposure to the public and

property loss if control of the device were lost. The NRC found the

working group process valuable in identifying criteria for categorizing

devices that are more likely to present a significant risk by exposure

of the public or through contamination of property.

On December 2, 1998 (63 FR 66492), the Commission again proposed

the addition of an explicit requirement to provide information in

response to requests made by the NRC. While the rule applies to all 10

CFR 31.5 general licensees, the NRC plans to contact only those general

licensees identified by the working group for the purpose of the

registration program. For the most part, general licensees using

devices meeting these criteria have a limited number of devices that

will require registration.

In that notice (at 63 FR 66493), the NRC also withdrew the December

27, 1991, proposed rule. The NRC has reviewed the other provisions

contained in the December 27, 1991, proposed rule and the

recommendations of the working group and developed additional

requirements in a separate proposed rule published July 26, 1999 (64 FR

40295). The recommendations made in NUREG-1551 were considered in

developing the separate, more comprehensive proposed rule issued July

26, 1999. That proposed rule addresses fees for registration,

additional reporting, recordkeeping, and labeling requirements for 10

CFR 32.51 licensees, and compatibility of Agreement State regulations

in this area.

On March 9, 1999 (64 FR 11508), the Commission established an

interim enforcement policy for violations of 10 CFR 31.5 that are

discovered and reported by licensees during the initial cycle of the

registration program. The initial cycle is considered to be the

issuance of one round of registration requests to all affected general

licensees. 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 10 CFR 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

Has undertaken good faith efforts to respond to NRC notices and

provide requested information.

This change from the Commission's normal enforcement policy is

intended to remove the potential for the threat of enforcement action

to be a disincentive for the licensee to identify deficiencies.

Under the interim enforcement policy, enforcement action, including

issuance of civil penalties and Orders, may be taken where there is --

(1) Failure to take appropriate corrective action to prevent

recurrence of similar violations;

(2) Failure to respond and provide the information required by

regulation;

(3) Willful failure to provide complete and accurate information to

the NRC; or

(4) Other willful violations, such as willfully disposing of

generally licensed material in an unauthorized manner.

As noted in the December 2, 1998, proposed rule, and discussed

further in the separate, more comprehensive proposed rule of July 26,

1999, 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 of 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 higher tiers would be for sources that

are relatively costly to dispose of.

Discussion

The Atomic Energy Act of 1954 (AEA), as amended, authorizes the NRC

to request appropriate information from its licensees concerning

licensed activities. However, the Commission had not included such an

explicit provision in the regulations governing 10 CFR 31.5 general

licensees.

This final rule adds an explicit requirement to 10 CFR 31.5 that

requires general licensees who possess certain measuring, gauging, and

controlling devices to respond in a timely way to written requests from

the NRC for information concerning products that they have received for

use under a general license.

The final rule requires a response to requests within 30 days or

such other time as specified in the request. For routine requests for

information, 30 days should be adequate in most instances, and an

extension can be obtained for good cause. If more complicated requests

are made or circumstances recognized that may require a longer time,

the Commission may provide a longer response time. In the unusual

circumstance of a significant safety concern, the Commission could

demand information in a shorter time. The NRC will provide a phone

number in the request for information in case additional guidance is

necessary.

The NRC intends to use this provision primarily to institute an

annual registration program for devices using certain quantities of

specific radionuclides. The registration program is primarily intended

to ensure that general licensees are aware of and understand the

requirements for the possession of devices containing byproduct

material. The registration process will allow NRC to account for

devices that have been distributed for use under the general license.

The NRC believes that, if general licensees are aware of their

responsibilities, they will comply with the requirements for proper

handling and disposal of generally licensed devices. This should help

reduce the potential for incidents that could result in unnecessary

radiation exposure to the public as well as contamination of property.

The general licensees covered by the registration program will be

asked to account for the devices in their possession and to verify, as

well as certify, information concerning--

(1) The identification of devices, such as the manufacturer, model,

and serial numbers;

(2) The persons knowledgeable of the device and the applicable

regulations;

(3) The disposition of the devices; and

(4) The location of the devices.

An organization which uses generally licensed devices at numerous

locations is usually considered a separate general licensee at each

location (except in the case of different facilities at the same

complex or campus). In the case of

[[Page 42271]]

portable devices that are routinely used at multiple sites, there is

one general licensee for each primary place of storage, not for each

place of use. Thus, an organization may be required to complete more

than one registration, if it possess devices subject to registration at

multiple locations.

While the final rule applies to all 10 CFR 31.5 general licensees

(about 45,000), the NRC will contact only approximately 5100 general

licensees, possessing about 20,000 devices, for registration purposes.

This category of general licensees is based on the criteria recommended

by the working group for determining which sources should have

increased oversight. The 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. Other States are

expected to become Agreement States in the near future which will

affect the number of general licensees under NRC jurisdiction, but not

the overall number nationally. The separate, more comprehensive

proposed rule published July 26, 1999, indicated that Agreement States

will be required to achieve a compatible level of accountability over

generally licensed devices. Thus, following State implementation of

compatible programs in conjunction with that rule, further changes in

the number of generally licensed devices within NRC jurisdiction should

not adversely affect accountability.

Requests for information will be sent to general licensees who are

expected, based on current NRC records, to possess devices containing

(as indicated on the label) at least--

370 MBq (10 mCi) of cesium-137;

3.7 MBq (0.1 mCi) of strontium-90;

37 MBq (1 mCi) of cobalt-60; or

37 MBq (1 mCi) of any transuranic (at this time, the only generally

licensed devices meeting this criterion contain curium-244 and

americium-241).

Most of the devices meeting these criteria are used in commercial

and industrial applications measuring thickness, density, or chemical

composition in petrochemical and steel manufacturing industries. The

requests will include the information contained in NRC records

concerning the possession of these devices. The licensees will be asked

to verify, correct, and add to that information. The NRC records are

based on information provided to the NRC by distributors under 10 CFR

32.52(a) and compatible Agreement State regulations and from general

licensees as required by 10 CFR 31.5(c) (8) or (9) regarding transfer

of generally licensed devices. If a general licensee no longer

possesses devices meeting the criteria, it will be expected to provide

information about the disposition of the devices previously possessed.

Errors in current NRC records concerning these general licensees could

be the result of--

(1) Errors made in the quarterly reports of manufacturers or

initial distributors;

(2) General licensees not reporting transfers; or

(3) Errors made by NRC or its contractors in recording transfer

information.

In addition to the 5100 general licensees identified for

registration, the NRC may occasionally request information from other

general licensees on a case-by-case basis as necessary or appropriate.

For example, this might involve investigating the extent that other

users have experienced a problem that has been identified with the

design of a particular device model. However, significant modifications

to the registration program to include a larger class of licensees

would be done through rulemaking.

Although the amendment to the regulations imposes some additional

costs on licensees, the NRC has estimated these costs to be minimal.

This cost is the estimated administrative cost expended by general

licensees to verify the information requested by the NRC regarding

licensed devices. The NRC believes that the rule's intended effect of

increased compliance by general licensees with regulatory requirements,

and resulting NRC and public confidence in the general license program

potentially afforded by these new requirements, outweigh this nominal

administrative cost.

Public Comments on the Proposed Rule

The NRC reviewed the public comments received on the December 2,

1998, proposed rule. Seven comment letters were received from: the

State of Illinois (an Agreement State), National Steel Pellet Company,

Steel Manufacturers Association (SMA), the Commonwealth of

Massachusetts (an Agreement State), the State of New Jersey (a non-

Agreement State), American Iron and Steel Institute (AISI), and one

private citizen.

All commenters supported the proposed rule. One commenter agreed

with the NRC that the proposed change would increase accountability and

control over generally licensed radioactive devices. Another commenter

supported the proposed regulation as a step in the right direction, if

not completely solving the regulatory problems of the NRC. The steel

industry supported the proposed rule as a positive, although small,

step toward minimizing the risk associated with improper disposal of

spent sources in the scrap supply.

Agreement was expressed by two commenters that the administrative

burden on general licensees to provide the minimal information

requested by the NRC is reasonable, as is the 30-day period in which

general licensees have to respond, with extensions granted for good

cause.

Several commenters voiced agreement with the interim enforcement

policy. One commenter, the State of New Jersey, believes that it is

extremely important to remove any incentive for a general licensee to

attempt to discard its source rather than comply with the reporting

requirement. The commenter stated that when people get rid of their

generally licensed devices in a hurry, the State has to go out and find

them in mountains of trash or scrap metal.

Two other commenters, the SMA and AISI, stated that they would

support any enforcement program that deters improper disposal of

radioactive sources. They also endorse the provision allowing general

licensees to report and correct violations without incurring penalties.

These commenters believe that this provision would encourage licensees,

who are not sure about sources they hold, to remedy the problem rather

than improperly dispose of the sources in an attempt to avoid high

penalties.

A. Current NRC General Licensing Process and Cost Shift

Comment: In general, the three representatives of the steel

industry expressed similar concerns regarding the current NRC general

licensing process. One commenter, the SMA, stated that the proposed

rule did not address the fact that the current regulatory regime has

shifted the costs of lax accountability and control onto steel makers,

insurers, and the taxpayers. This commenter stated that general

licensees do not pay for their licenses nor provide information

directly to NRC about the sources they hold. Instead, the cost has

fallen on steel producers to detect the sources, on steel producers and

taxpayers to arrange for proper disposal, and on steel producers and

their insurers to pay the cost when a source is inadvertently melted.

This commenter believed that general

[[Page 42272]]

licensees should be required to shoulder their fair share.

Similarly, the AISI pointed out that current NRC regulations have

inadvertently and improperly shifted the costs for accountability and

control onto hot metal producers, insurers, and taxpayers and that

steel producers are being forced to pay the cost of detecting orphaned

sources, to arrange for proper disposal, and to pay for the cleanup

when a source is inadvertently melted. This commenter also believed

that general licensees should be required to pay their fair share of

these costs and stated that improving licensee accountability would

also reduce the risk of the illegal release of generally licensed

material into the public scrap supply. In addition, the AISI noted that

the inadvertent melting of orphaned sources by domestic steel producers

has resulted in decontamination, disposal, and lost production costs

ranging between $10 million and $24 million at electric furnace mills

and that the cost of a similar incident occurring in a major integrated

steel mill could easily exceed $100 million.

Response: The Commission recognizes the expense to the steel

industry when generally licensed devices containing radioactive

material are not properly disposed of or properly handled. The NRC

believes that this rulemaking will reduce the probability of lost and

improperly disposed of sources, and ultimately the number of incidents

of inadvertent meltings. This would reduce the total expense to the

steel industry, insurers, and taxpayers resulting from such incidents.

A separate, more comprehensive rulemaking on this subject (proposed on

July 26, 1999) is expected to further improve accountability for

devices and reduce the impact of improperly disposed of sources to the

steel industry. In addition, that rule would establish a registration

fee to recover the cost of the NRC enhanced oversight program for those

general licensees being required to register their devices.

B. Reporting Electronically and Data Verification

Comment: Two commenters recommended that the NRC provide a means

for electronically reporting the information requested by the NRC in

order to save time, mailing expenses, and paper. They also indicated

that the NRC should ensure that its database has an adequate data

quality verification system and can easily flag inconsistencies.

One commenter suggested that the electronic filing could be

accomplished through a secure page on the NRC Internet Web Site and

that the NRC could use the employer's tax identification number and a

password to secure the information. This commenter also recommended

that the NRC database include a data quality verification system to

quickly identify and immediately notify licensees of any reporting

inconsistencies and that employers could also be required to annually

verify the accuracy of the inventory.

Response: The submission of electronic applications and reports is

a generic issue that impacts more than the general license registration

program. The NRC has evaluated the issue of permitting licensees to

file applications and reports electronically and plans to publish an

amendment to the regulations to allow such submissions. The NRC expects

to publish the amendment next year. At that time, the NRC will evaluate

how this change will impact implementation of the registration program

and future enhancements to the design of the automated system. However,

the NRC currently expects that the initial registration program would

require submission of hard copies of the registration forms.

The NRC is in the process of upgrading its information technology

systems to facilitate processing of annual registrations. The upgrades

will include adequate data verification for distributor, general

licensee, and registration information and will include automated

readers for processing the large volume of registration forms. The

automated readers will identify changes and inconsistencies with the

database, convert changes to electronic form, and incorporate the new

data.

C. Control and Accountability

Comment: One commenter believed that a great deal of improvement is

needed in the regulations governing licensed radioactive devices

concerning their location and whether they are being disposed of

properly. This commenter felt that a license should not be given out to

persons to own as many devices as they please; instead a license should

be given out per device, thereby limiting the number of devices

available and making known the number of devices in use. This commenter

felt that radioactive material presents an extreme threat to health and

safety even if disposed of properly.

Response: The Commission does not believe it is necessary,

appropriate, or practical to limit the number of devices going out to

general licensees to one per licensee. Tracking the number of devices

in use and who has them is achievable without such a restriction.

Generally licensed devices are designed to be inherently safe and do

not present nearly as great a risk to health and safety as the

commenter suggests. Given the nature of the general license,

restrictions on numbers of devices that can be possessed would be

difficult to enforce and would likely lead to difficulties in getting

accurate information on devices possessed.

Comment: Another commenter recommended that the NRC not target

businesses with specific licenses, pointing out that they are required

to--

(1) Have a Radiation Safety Officer;

(2) Actively perform testing and inspections; and

(3) Maintain written documentation.

Therefore, specific licensees are almost always aware of the

byproduct material regulations applicable to byproduct material managed

under a general license as well and are more likely to adequately

account for and handle devices containing byproduct material in

accordance with the regulatory requirements. The commenter recommended

that the NRC instead target general licensees that do not currently

maintain byproduct material under a specific NRC license because these

general licensees are more likely to be unaware of the appropriate

regulations and are more likely to inappropriately account for and

handle devices containing byproduct material.

Response: Specific licensees who also have generally licensed

devices are subject to any regulations applicable to the general

license. Therefore, these specific licensees will be subject to

registration. Given the approach of this first rule, it would be

possible for NRC to simply not make this request for information from

those who also hold specific licenses. However, this would require

additional effort to cross reference data on specific licensees with

that on general licensees. Specific licensees, while generally more

aware of applicable regulations, do have problems with incomplete

accountability for devices. The potential improvement in accountability

should justify the limited administrative effort of providing

registration information even in the case of those holding specific

licenses.

If the additional rulemaking concerning registration is made final,

specific licensees holding generally licensed devices subject to

registration may wish to avoid the additional fee. If so, they would

have the option of amending their specific license, if necessary, to

include the devices, and thereby remove the devices from the

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general license status. In this case, labels may have to be changed to

be consistent with the device's regulatory status.

Comment: The State of Illinois indicated that a group of general

licensees in Illinois possesses devices containing curium-244 in

quantities that would require registration under the proposed rule.

This commenter recommended that the NRC contact licensees possessing

not only americium-241 but also curium-244, and noted that the

statement in the December 2, 1998, proposed rule (63 FR 66493) that

americium-241 is the only transuranic radionuclide found in generally

licensed devices in quantities exceeding 37 megabecquerels (1

millicurie), is in error.

Response: The Commission agrees. The omission in that statement, of

curium-244 as a transuranic element used in generally licensed devices

meeting the criteria for registration, was an oversight. Devices

containing curium-244 with quantities meeting the criterion for

transuranics will be included in the registration requirement.

Comment: Several commenters stated that the NRC should give serious

consideration to the NRC-Agreement State Working Group recommendations

as contained in NUREG-1551, ``Final Report of the NRC-Agreement State

Working Group to Evaluate Control and Accountability of Licensed

Devices.'' Specifically, one commenter stated that there should be a

Responsible Individual (RI) and a Backup Responsible Individual (BRI)

for each general license. This commenter stated that, unlike a specific

license where there are a Radiation Safety Officer and Authorized

Users, there may be only one person (RI) who has a real understanding

that his or her company possesses a generally licensed device that

contains a radioactive source. When that RI dies, retires, resigns, or

is laid off, there may be no one at the facility with any understanding

or appreciation of the significance of the generally licensed device.

The commenter stated that the addition of one extra name and phone

number to the records should not be too burdensome on the licensee and

may help avoid the burden of responding to a radiation incident

involving the device.

Two other commenters recommended that the NRC consider the Working

Group's recommended comprehensive measures, including requirements for

the NRC to maintain inventory records, to compare and reconcile related

discrepancies, and to mandate reporting the bankruptcy of a licensee to

the NRC. The commenters also recommended State/NRC site inspections and

inventories at regular intervals. These commenters felt that serious

consideration should be given to each of these measures in order to

prevent the continued loss of licensed sources into the scrap stream.

One of these commenters also urged the NRC to move forward with the

planned additional regulations amending or establishing requirements

for registration fees, labeling, and compatibility with Agreement State

requirements. The commenter stated that the limited registration

program would have minimal impact on the radioactive scrap problem if

it is the only amendment the NRC proposes.

Response: The more comprehensive measures recommended by the NRC-

Agreement State Working Group are being considered in the separate,

more comprehensive rule proposed on July 26, 1999. Comments on these

issues will be considered as part of that rulemaking process.

D. Registration Program

Comment: One commenter noted that the language of the proposal did

not call for a periodic registration program requiring reporting at

least annually. Rather, the proposed amendment would merely restate

NRC's authority to collect information from licensees. The commenter

pointed out that the NRC already has this authority under 42 U.S.C.

2095 and in its own regulations at 10 CFR 30.34. This commenter urged

the NRC to explicitly call for a periodic registration program in the

amended regulation stating that this would remind general licensees

that they have licensed radioactive sources and that there are

responsibilities attached to their licenses. It would also indicate

that the Government has knowledge of their sources and the authority to

enforce prohibitions on improper disposal.

Response: The NRC has proposed explicit provisions for an annual

registration requirement in the separate, more comprehensive rule on

this subject.

Comment: A commenter suggested that the NRC reconsider one of the

provisions in a proposed rule published February 5, 1974 (39 FR 4583),

that would have required registration of the generally licensed devices

before customers are allowed to receive them. This commenter stated

that this would ensure and document that general licensees have

received copies of the regulations and that they are aware of their

rights and responsibilities.

Response: The Commission does not believe preregistration is

necessary to ensure and document that general licensees have received

copies of the regulations and that they are aware of their rights and

responsibilities. However, the Commission has proposed amendments to

address the need for customers to receive additional information prior

to purchases of generally licensed devices in the separate, more

comprehensive rule.

Comment: Another commenter strongly encouraged the NRC to adopt a

mandatory registration program for all sources, not merely those that

pose the greatest risk to steel mills.

Response: The Commission has decided to use the criteria developed

by the NRC/Agreement State Working Group to determine which sources

should be subject to the registration program. These criteria were

based on considerations of relative risk and were limited to

radionuclides currently in use in devices considered to present a

higher risk of potential exposure, as well as potential for

contamination of property.

E. Fee-Based System

Comment: One commenter believed that a fee-based system for all

general licensees would ensure that the NRC recovers the minimal cost

to initiate and maintain the reporting program. The commenter stated

that such a registration program would enable the NRC to account for

all sources that have been distributed. The commenter further suggested

that the program could be designed to allow steel companies and the

general public to trace the origins of an improperly disposed of

source. This would help steel companies in determining liability for

the multimillion-dollar clean-up costs that the steel companies and

their insurers incur when sources are inadvertently melted. It would

also provide Federal and State nuclear regulators that handle orphan

sources a means to obtain reimbursement resulting in an additional

deterrent against improper source disposition.

Another commenter was concerned that, even though a fee-based

system for all general licensees would permit the NRC to recover the

anticipated cost of initiating and maintaining the reporting program, a

fee schedule could slow or prevent implementation of the entire

proposal. If this is correct, the commenter recommended that the NRC

retain the proposal as published.

Response: The Commission is not addressing comments on its proposed

fee-based system as part of this rulemaking process. The separate, more

[[Page 42274]]

comprehensive rule addresses fees for registration and the comments

will be considered in connection with that rulemaking.

F. Registration Information Available on the Internet

Comment: One commenter was opposed to making the registration

information available on the Internet because such posting would

unnecessarily cause public concern over the presence and use of low

level devices. The commenter believes that this information should be

available only through the Freedom of Information Act request process.

Response: Some of the information submitted in distributor

quarterly reports and entered into the general license tracking system

that is to be used for handling registration information would be

considered proprietary. This database will be designed with security

features in order to protect proprietary information. It will not be

available on the Internet. The NRC would post information on its

website concerning lost or unaccounted for devices.

G. Civil Penalty Amounts

Comment: One commenter agreed with the NRC's intent to increase the

civil penalty amounts for violations involving lost or improperly

disposed of sources or devices. The commenter stated that the penalties

must be significantly higher than the costs avoided by the failure to

properly dispose of the source or device.

A second commenter supported fining general licensees who violate

their general licenses by using a schedule that is proportionate to the

damage actually caused by the lost source. The commenter used the

example of the cost for cleaning a steel mill contaminated by melting

such a source. This commenter believed that because the NRC's proposed

penalty is not much higher than the current fine of $2500 per loss that

has been assessed to licensees, it would not significantly deter

illegal behavior. The commenter believes that increasing the current

relatively minimal penalty levels to amounts that reflect the real

world damage caused by loss of a licensed source will provide general

licensees with a substantive economic incentive to dispose of their

sources legally.

Response: As discussed in the July 26, 1999 (64 FR 40295) proposed

rule, the Commission is considering raising civil penalties for

violations involving lost or improperly disposed of sources or devices

and may use a tiered approach with higher than usual civil penalties

for sources that are relatively costly to dispose of. This is to ensure

that such civil penalties better relate to the costs avoided by the

failure to properly dispose of the source or device. The cost of

cleaning a contaminated steel mill would not be an appropriate basis

for setting fees.

No comments were made concerning the specific wording of the

proposed amendment. No change to the rule has been made as a result of

these comments.

Agreement State Compatibility

Under the ``Policy Statement on Adequacy and Compatibility of

Agreement State Programs'' approved by the Commission on June 30, 1997

(62 FR 46517), this final rule is classified as Compatibility Category

D. Category D means the provisions are not required for purposes of

compatibility; however, if adopted by the State, the provisions should

not create any conflicts, duplications, or gaps in the regulation of

AEA material. Ultimately, an enhanced oversight program is expected to

include provisions that will require a higher degree of compatibility.

This is being considered in the separate, more comprehensive rulemaking

that would add more explicit requirements for the registration program

and additional provisions concerning accountability of generally

licensed devices.

Voluntary Consensus Standards

The National Technology Transfer and Advancement Act of 1995, Pub.

L. 104-113, requires that agencies use technical standards that are

developed or adopted by voluntary consensus standards bodies unless the

use of such a standard is inconsistent with applicable law or otherwise

impractical. In this final rule, the NRC is amending its regulations to

require that those who possess certain industrial devices containing

byproduct material provide requested information. The amendments are

administrative in nature and require certain types of specific entities

to provide information concerning specific devices in their possession.

Therefore, this action does not constitute the establishment of a

standard that establishes generally applicable requirements.

Environmental Impact: Categorical Exclusion

The NRC has determined that this final rule is the type of action

described in the categorical exclusion in 10 CFR 51.22(c)(3)(iii).

Therefore, neither an environmental impact statement nor an

environmental assessment has been prepared for this regulation.

Paperwork Reduction Act Statement

This final rule amends information collection requirements that are

subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et

seq.). The information collection requirements in this rule have been

approved by the Office of Management and Budget, approval number 3150-

0016.

The public reporting burden for this information collection is

estimated to average 20 minutes per response, including the time for

reviewing instructions, searching existing data sources, gathering and

maintaining the data needed, and completing and reviewing the

information collection. Send comments on any aspect of this information

collection, including suggestion for reducing the burden, to the

Records Management Branch (T-6 E6), U.S. Nuclear Regulatory Commission,

Washington, DC 20555-0001, or by Internet electronic mail at

[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.

Public Protection Notification

If a means used to impose an information collection does not

display a currently valid OMB control number, the NRC may not conduct

or sponsor, and a person is not required to respond to, the information

collection.

Regulatory Analysis

The NRC has prepared a regulatory analysis for this regulation. The

analysis examines the cost and benefits of the alternatives considered

by the NRC. The regulatory analysis is available for inspection in the

NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington,

DC. Single copies of the analysis may be obtained by calling Jayne

McCausland, U.S. Nuclear Regulatory Commission, Office of Nuclear

Material Safety and Safeguards, Washington, DC, 20555-0001; telephone

(301) 415-6219; or e-mail at JMM[email protected].

Regulatory Flexibility Certification

As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)),

the Commission certifies that this final rule does not have a

significant economic impact on a substantial number of small entities.

This rule requires general licensees who have received specific devices

to respond to requests for information from NRC. The final rule applies

to the approximately 45,000 persons using products under an NRC general

license, many of whom may be classified as small entities. However, the

[[Page 42275]]

NRC intends to request registration information from only approximately

5100 of these general licensees. Registration information to be

obtained will include identification of the devices, accountability for

the devices, the persons knowledgeable of the device and the applicable

regulations, and the disposition of the devices. The NRC believes that

the economic impact that any general licensee incurs as a result of

supplying this information constitutes a negligible increase in

administrative burden. It is estimated that there are approximately

20,000 devices in the possession of the Commission's general licensees

which will come under the registration requirement. The average cost to

the general licensee per device per year is about $4.00. Therefore, the

action will not have a significant economic impact on small entities.

The final rule is intended to ensure that general licensees understand

and comply with regulatory responsibilities regarding the generally

licensed radioactive devices in their possession.

Backfit Analysis

The NRC has determined that the backfit rule, 10 CFR 50.109, does

not apply to this rule, because these amendments do not involve any

provisions that impose backfits as defined in 10 CFR 50.109(a)(1) and,

therefore, a backfit analysis is not required.

Small Business Regulatory Enforcement Fairness Act

In accordance with the Small Business Regulatory Enforcement

Fairness Act of 1996, the NRC has determined that this action is not a

major rule and has verified this determination with the Office of

Information and Regulatory Affairs, Office of Management and Budget.

List of Subjects in 10 CFR Part 31

Byproduct material, Criminal penalties, Labeling, Nuclear

materials, Packaging and containers, Radiation protection, Reporting

and recordkeeping requirements, Scientific equipment.

For the reasons set out above and under the authority of the Atomic

Energy Act of 1954, as amended, the Energy Reorganization Act of 1974,

as amended, and 5 U.S.C. 552 and 553, the NRC is adopting the following

amendments to 10 CFR Part 31.

PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

1. The authority citation for Part 31 continues to read as follows:

Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as

amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88

Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842).

Section 31.6 also issued under sec. 274, 73 Stat. 688 (42 U.S.C.

2021).

2. Section 31.5 is amended by adding paragraph (c)(11) to read as

follows:

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

* * * * *

(c) * * *

(11) Shall respond to written requests from the Nuclear Regulatory

Commission to provide information relating to the general license

within 30 calendar days of the date of the request, or other time

specified in the request. If the general licensee cannot provide the

requested information within the allotted time, it shall, within that

same time period, request a longer period to supply the information by

submitting a letter to the Director, Office of Nuclear Material Safety

and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC

20555-0001 and provide written justification as to why it cannot

comply.

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\2\ Persons possessing byproduct material in devices under a

general license in 10 CFR 31.5 before January 15, 1975, may continue

to possess, use, or transfer that material in accordance with the

labeling requirements of 10 CFR 31.5 in effect on January 14, 1975.

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* * * * *

Dated at Rockville, Maryland, this 1st day of July, 1999.

For the Nuclear Regulatory Commission.

William D. Travers,

Executive Director for Operations.

[FR Doc. 99-19984 Filed 8-3-99; 8:45 am]

BILLING CODE 7590-01-P