[Federal Register Volume 63, Number 111 (Wednesday, June 10, 1998)]
[Rules and Regulations]
[Pages 31604-31607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15400]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
RIN 3150-AF77
License Term for Medical Use Licenses
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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SUMMARY: The Nuclear Regulatory Commission is amending its regulations
pertaining to the medical use of byproduct material to eliminate the 5-
year term limit for medical use licenses. License terms for licenses
issued under these regulations will be set by policy. Other materials
licenses are issued for up to 10 years. The NRC will issue some
licenses for shorter terms if warranted by the individual circumstances
of license applicants. The amendment reduces the administrative burden
of license renewals on a 5-year cycle for both NRC and licensees and
supports NRC's goal of streamlining the licensing process.
EFFECTIVE DATE: This regulation becomes effective on July 10, 1998.
FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, telephone (301) 415-6219, e-mail JMM2 @ nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Background.
II. Discussion.
III. Statement of Regulatory Action.
IV. Discussion of Public Comments.
V. Agreement State Compatibility.
VI. Environmental Impact: Categorical Exclusion.
VII. Paperwork Reduction Act Statement.
VIII. Regulatory Analysis.
IX. Regulatory Flexibility Certification.
X. Backfit Analysis.
I. Background
In 1995, the NRC's Office of Nuclear Material Safety and Safeguards
(NMSS) initiated a review to determine whether the license term for
materials licenses could be lengthened so that NRC's licensing
resources could be redirected to other areas of the materials program.
At that time, the resources devoted to renewals constituted over 50
percent of the total resources expended for licensing. NMSS undertook
this review as a part of NRC's ``business process redesign'' efforts.
The license renewal process has been used as an opportunity for the
Commission to review the history of the licensee's operating
performance (e.g., the record on compliance with regulatory
requirements) and the licensee's overall materials safety program. This
review is performed to ascertain if the licensee employs up-to-date
technology and practices in the protection of health, safety, and the
environment, and complies with any new or amended regulations. As part
of a license renewal, the licensee is asked to provide information on
the current status of its program as well as any proposed changes in
operations (types and quantities of authorized materials), personnel
(authorized users and radiation safety officers), facility, equipment,
or applicable procedures. The renewal process has been perceived to
benefit both the licensee and NRC because it requires both to take a
comprehensive look at the licensed operation. However, in practice,
comprehensive program reviews occur when proposed changes are
identified and requested by licensees as license amendments rather than
during the license renewal process.
License terms have been reviewed on numerous occasions since 1967.
On May 12, 1967 (32 FR 7172), the Commission amended 10 CFR part 40 to
eliminate a 3-year limit on the term of source material licenses. At
that time, there was no restriction on the term of byproduct licenses
under 10 CFR part 30 or special nuclear material licenses under 10 CFR
part 70. In the notice of proposed rulemaking associated with amending
10 CFR part 40, dated December 22, 1966, NRC indicated that if the
proposed amendment to eliminate the 3-year restriction were adopted,
licenses would be issued for 5-year terms, except when the nature of
the applicant's proposed activities indicated a need for a shorter
license period. At that time, the Commission believed there was little
justification for granting licenses under 10 CFR parts 30, 40, and 70
for terms of less than 5 years, in view of the cumulative experience up
to that time and the means available to NRC to suspend, revoke, or
modify such licenses if public health and safety or environment so
required.
In March 1978, NMSS conducted a study (SECY-78-284, ``The License
Renewal Study for parts 30, 40, and 70 Licenses'') to consider changing
the 5-year renewal period for parts 30, 40, and 70 licenses. The study
concluded, in part, that the NRC should continue its practice of
issuing specific licenses for 5-year terms and should retain an option
to write licenses for shorter terms, if deemed necessary, for new types
of operations or if circumstances warranted.
On July 26, 1985 (50 FR 30616), NRC proposed revising 10 CFR part
35, ``Medical Use of Byproduct Material.'' The proposed rulemaking
indicated that the Commission had selected a term of five years for a
license. It was believed that a term shorter than 5 years would not
benefit health and safety because past experience indicated that
medical programs did not generally change significantly over that
period of time. The notice also indicated that a longer term may
occasionally result in unintentional abandonment of the license. On
October 16, 1986 (51 FR 36932), NRC issued the final rule that
consolidated and clarified radiation safety requirements related to the
medical use of byproduct materials, and included a license term of 5
years.
On June 19, 1990 (55 FR 24948), the Commission announced that the
license term for major operating fuel cycle licensees (i.e., licenses
issued pursuant to 10 CFR parts 40 or 70) would be increased from a 5-
year term to a 10-year term at the next renewal of the affected
licenses. This change enabled NRC resources to be used to improve the
licensing and inspection programs. The bases for this change were that
major operating fuel cycle facilities had become stable in terms of
significant changes to their licenses and operations and that licensees
would be required to update the safety demonstration sections of their
licenses every 2 years.
On July 2, 1996, the Commission approved the NRC staff's proposal
to extend the license term for uranium recovery facilities from 5 years
to 10 years. Extending the license term reduces the administrative
burden associated with the license renewal process for both the NRC
staff and the uranium recovery licensees. Also, the extension reduces
licensee fees, makes the license term for these facilities more
commensurate with the level of risk, and supports NRC's goal of
streamlining the licensing process. Licensees were informed of the
extensions in July 1996.
On February 6, 1997 (62 FR 5656), the Commission gave notice that
the license term for materials licenses issued pursuant to 10 CFR parts
30, 40, or 70 would be increased from a 5-year term to up to a 10-year
term at the next renewal of the affected licenses. However, whereas the
10-year term for
[[Page 31605]]
other licenses was set by this policy, the term for licenses issued
pursuant to 10 CFR part 35 was established by regulation at 5 years.
On July 31, 1997 (62 FR 40975), the NRC published a proposed rule
to revise 10 CFR part 35 to eliminate the 5-year term limit in 10 CFR
35.18 for medical use licenses. The term for medical licenses could
then be set by policy for up to 10 years. The NRC could issue a license
for a shorter term, depending on the individual circumstances of the
license applicant. The public comment period closed on October 14,
1997. A summary of the public comments is provided in Section IV,
below.
II. Discussion
The change described above (i.e., increasing the license term for
materials licenses issued under 10 CFR parts 30, 40, and 70 to up to 10
years) has created an inconsistency between the license terms for
medical use and nonmedical use materials licenses. NRC believes that
the license duration period for medical use licenses may also be
extended without adverse impacts on public health and safety, such as
increases in the unintentional abandonment of licensed material or
decreases in the licensees' attention to licensed activities, for the
following reasons:
(1) Licensees would continue to be required to adhere to the
regulations and their license conditions, and to apply for license
amendments for certain proposed changes to their programs;
(2) No changes in either the frequency or elements of the medical
inspection program are being proposed;
(3) NRC would continue to be in a position to identify, by
inspection or other means, violations of its regulations or the license
conditions that affect public health and safety, and to take
appropriate enforcement actions;
(4) Cases of abandonment of NRC licenses would be identified
through nonpayment of the annual licensing fees and regional NRC office
follow-up;
(5) The NRC staff would continue to make licensees aware of health
and safety issues through the issuance of generic communications (such
as information notices, generic letters, bulletins, and the NMSS
Licensee Newsletter); and
(6) NRC is moving to a more performance-based regulatory approach,
where emphasis is placed on the licensee's execution of commitments
rather than on rereview of the details of the licensee's program.
III. Statement of Regulatory Action
The NRC is revising part 35 to eliminate the 5-year term limit in
10 CFR 35.18 for medical use licenses so that the term for medical use
licenses will be set by policy.
IV. Discussion of Public Comments
Five letters of public comment were received on the proposed rule.
Comments were received from National Physics Consultants, Ltd., the
American Association of Clinical Endocrinologists, the Mayo Clinic, the
University of Cincinnati, and the American Hospital Association.
All commenters fully supported the proposed amendment to eliminate
the reference to the 5-year term limit for medical use licenses in 10
CFR 35.18. In addition, the commenters endorsed the change in license
terms for licenses issued pursuant to part 35, to be set by policy for
as many as 10 years, as are the license terms for other material
licenses.
In general, commenters disparaged the license renewal process, on a
5-year frequency, as requiring a significant expenditure of time and
fees with minimal benefit, and supported NRC's proposal to eliminate
this requirement, citing a reduction of staff time and costs for both
the NRC and individual licensees with no decrease in public health and
safety. Commenters recognized that the NRC may issue some licenses for
shorter terms if warranted by the individual circumstances of license
applicants.
One commenter stated that routine license reviews by the local
Radiation Safety Committee will ensure operation of a radiation safety
program that protects public health and safety.
Another commenter indicated that because the NRC is in contact with
the licensees on an ongoing basis, any changes in operations,
personnel, facility, equipment, or applicable procedures are identified
during the inspection and license amendment process.
One of the commenters agreed that the radiation safety programs at
most medical facilities are very stable and pointed out that
significant changes in the radiation safety program require license
amendments.
Another commenter recommended that NRC extend the license term for
medical use licenses from 5 years to 10 years as soon as possible to
reduce the license fees and achieve further cost savings. This
commenter expressed support for the NRC's ``business process redesign''
efforts to reduce both the administrative burden of license renewals
and license fees. According to the commenter, this will allow that
organization's members to redirect their resources to support and
implement NRC's initiative to move to a more performance-based
regulatory approach.
V. Agreement States Compatibility
This rulemaking will be a matter of compatibility between the NRC
and the Agreement States. Compatibility Category D has been assigned to
the changes in 10 CFR 35.18. Category D means the provisions are not
required for purposes of compatibility. No problems have been
identified regarding Agreement State compatibility implementation of
this rule change.
VI. Environmental Impact: Categorical Exclusion
The Commission has determined that this final rule is the type of
action described in categorical exclusion 10 CFR 51.22(c)(3)(i) for
amendments to Part 35 that relate to renewals of licenses. Therefore,
neither an environmental statement nor an environmental assessment has
been prepared for this final regulation.
VII. Paperwork Reduction Act Statement
This final rule reduces the burden for both medical licensees and
the NRC because license terms for Part 35 licensees could be
established by policy, for as many as 10 years, as is the case for
other materials licensees. However, the reduced burden from less
frequent license renewal will not be realized in the near future
because the affected licenses are operating under a 5-year extension of
current licenses granted in 1995. The impact of that one-time extension
is addressed in the current supporting statement for NRC Form 313,
``Application for Material License,'' which was approved by the Office
of Management and Budget (OMB) under OMB Clearance No. 3150-0120 and
which expires on July 31, 1999. The data on reduced burden from
extension of the license term for all material licenses and from other
actions taken to streamline the licensing process will be included in
the request for renewal of the information collection requirements on
NRC Form 313 in 1999. This is appropriate because the next OMB
clearance extension will cover 1999-2002, when the medical licenses
currently under the 5-year extension will expire and will be affected
by this rulemaking. Send comments on any aspect of this information
collection, including suggestions for further reducing the burden, to
the Information and Records Management Branch (T-6F33), U.S. Nuclear
Regulatory
[[Page 31606]]
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 (3150-0014), Office of Management and
Budget, Washington, DC 20503.
Public Protection Notification
If a document 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.
VIII. Regulatory Analysis
Problem
The current rule requirement, regarding the term of medical
licenses, is codified in 10 CFR 35.18 and states that ``The Commission
shall issue a license for the medical use of byproduct material for a
term of five years.'' The license term of other materials licenses, as
established by Commission policy, is up to 10 years. There is an
inconsistency as to duration and manner of specifying the license terms
of medical use licenses and all other materials licenses. Based on the
above, the following options were considered.
Alternative Approaches
1. Take no Action: Maintain the requirement that licenses issued
pursuant to Part 35 would be issued for 5 years.
This option would continue the inconsistencies between medical
licenses and all other materials licenses as to the duration and
specification of license terms. Terms for medical use licenses are
established in codified regulations, whereas the term for other
materials licenses is now set by policy. Also, this option would result
in disparities in the duration of the term for materials licenses.
Medical use licenses would continue to be issued for 5-year terms
whereas the duration of the term for other materials licenses is up to
10 years.
2. Revise 10 CFR 35.18: Revise the regulations to delete any
reference to the license term for licenses issued pursuant to part 35.
This option would result in consistency between how license terms
for medical licenses and all other materials licenses are established
and in the duration of these licenses. Commission decisions regarding
the duration of a materials license could therefore apply uniformly to
all types of materials licenses. After final rulemaking action to
revise 10 CFR 35.18, the license term for licenses issued pursuant to
part 35 would be set by the already established policy for as many as
10 years.
Value and Impact
The license renewal process is resource-intensive for both the
licensee and NRC. At the time of license renewal, licensees submit to
NRC any changes in operations, personnel, facility, equipment, or
applicable procedures. Because NRC is in contact with the licensees on
an ongoing basis, many of these changes are identified during the
inspection and license amendment process. Therefore, the rulemaking to
remove the 5-year license term for medical use of byproduct material
would not change the health and safety requirements imposed on
licensees.
By removing the reference to the 5-year term in 10 CFR 35.18 and,
with the Commission's February 1997 extension of the license term for
as many as 10 years for all materials licenses issued pursuant to parts
30, 40, and 70, there is a reduction in the regulatory burden for
approximately 1,900 NRC licensees that use byproduct material for
medical procedures. Estimated savings are based on the assumption that
these licensees would only be required to submit a renewal application
every 10 years as opposed to every 5 years, resulting, on average, in a
savings of 190 applications per year. However, offsetting these
savings, medical licensees may need to submit an average of one
additional amendment during the 10-year period to account for changes
in operations that would have routinely been addressed when the license
was renewed on a 5-year cycle. Assuming that a typical license renewal
application and typical amendment involves 19 hours and 4 hours of
licensee professional effort, respectively, there would be a net
savings per licensee of 15 hours. Based on an industry professional
labor rate of $125 per hour, the annual industry-wide savings would
approximate $356,000. Over a 30-year time frame, based on a 7-percent
real discount rate, the present worth savings to industry would
approximate $4.4 million.
Similarly, this rulemaking is also cost effective for the NRC
because fewer resources would be required to review and process renewal
applications. On average, it takes approximately 14 hours of NRC
professional time to renew a medical license and 4 hours to review and
issue a license amendment. This means a net savings to the NRC of 10
hours per licensee. Assuming an NRC labor rate of $125 per hour, and on
average, 190 applications per year, the annual NRC savings would equal
$237,000. The 30-year present worth savings to the NRC would
approximate $2.9 million.
Conclusion
This rulemaking, to remove the 5-year license term for medical use
of byproduct material, is promulgated so the term for medical licenses
will be consistent with that of other materials licenses (set by policy
to be as many as 10 years). The extension will reduce the
administrative burden of license renewals for both NRC and licensees
and will support NRC's goal of streamlining the licensing process
without any reduction in health and safety. NRC may issue some licenses
for shorter terms if warranted by the individual circumstances of
license applicants.
Decisional Rationale
Based on the desire to reduce burden whenever it is possible to do
so without reducing protection of public health and safety, to maintain
consistency among license terms for materials licensees, and the cost
effectiveness of longer license terms, the NRC is amending 10 CFR part
35 to eliminate the 5-year term limit for medical use licenses and
allow the license term to be set by policy, as is the case for other
materials licenses.
IX. Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the Commission certifies that this rule will not have a
significant economic impact on a substantial number of small entities.
By removing the reference to the 5-year license term in 10 CFR 35.18,
the duration of medical use licenses will be set by policy, resulting
in a reduction in the regulatory burden for NRC medical use licensees.
X. Backfit Analysis
The NRC has determined that the backfit rule, 10 CFR 50.109, does
not apply to this final rule and, therefore, that a backfit analysis is
not required for this final rule because the amendment does not involve
any provision that would impose backfits as defined in 10 CFR
50.109(a)(1).
Small Business Regulatory Enforcement Fairness Act
In accordance with the Small Business Regulatory Enforcement
Fairness Act of 1996, the NRC has determined that this action is not a
``major rule'' and has verified this determination with the Office of
Information and Regulatory Affairs, Office of Management and Budget.
[[Page 31607]]
List of Subjects in 10 CFR Part 35
Byproduct material, Criminal penalties, Drugs, Health facilities,
Health professions, Medical devices, Nuclear materials, Occupational
safety and health, Radiation protection, Reporting and recordkeeping
requirements.
For the reasons set out in the preamble 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 amendment to 10 CFR part 35.
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
1. The authority citation for part 35 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841).
2. The introductory text of Sec. 35.18 is revised to read as
follows:
Sec. 35.18 License issuance.
The Commission shall issue a license for the medical use of
byproduct material if:
* * * * *
Dated at Rockville, Md., this 20th day of May 1998.
For the Nuclear Regulatory Commission.
L. Joseph Callan,
Executive Director for Operations.
[FR Doc. 98-15400 Filed 6-9-98; 8:45 am]
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