[Federal Register Volume 64, Number 149 (Wednesday, August 4, 1999)]
[Rules and Regulations]
[Pages 42269-42275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19984]
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Rules and Regulations
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Federal Register / Vol. 64, No. 149 / Wednesday, August 4, 1999 /
Rules and Regulations
[[Page 42269]]
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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 JMM2@nrc.gov.
SUPPLEMENTARY INFORMATION:
Background
On February 12, 1959 (24 FR 1089), the Atomic Energy Commission
(AEC) amended its regulations to provide a general license 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
[[Page 42270]]
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
[[Page 42273]]
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 JMM2@nrc.gov.
Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)),
the Commission certifies that this final rule does not have a
significant economic impact on a substantial number of small entities.
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
