[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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