[Federal Register Volume 62, Number 147 (Thursday, July 31, 1997)]
[Proposed Rules]
[Pages 40975-40978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20189]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / 
Proposed Rules  

[[Page 40975]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

RIN AF77


License Term for Medical Use Licenses

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The U.S. Nuclear Regulatory Commission is proposing to amend 
10 CFR part 35 to eliminate the five-year term limit for medical use 
licenses in 10 CFR 35.18. License terms for licenses issued pursuant to 
part 35 would be set, by policy up to ten years, as are the license 
terms for other materials licenses. The NRC would issue some licenses 
for shorter terms, if warranted by the individual circumstances of 
license applicants. The amendment would reduce the administrative 
burden of license renewals for both NRC and licensees, and would 
support NRC's goal of streamlining the licensing process.

DATES: Submit comments by October 14, 1997. Comments received after 
this date will be considered, if it is practical to do so, but the NRC 
is able to assure consideration only for comments received on or before 
this date.

ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001. Hand-deliver comments to: 11555 
Rockville Pike, Rockville, Maryland, between 7:45 a.m. and 4:15 p.m., 
Federal workdays.
    Copies of any comments received may be examined at the NRC Public 
Document Room, 2120 L Street NW (lower level), Washington, DC.
    For information on submitting comments electronically, see the 
discussion under Electronic Access in the Supplementary Information 
section.

FOR FURTHER INFORMATION CONTACT: William B. McCarthy, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-7894; e-mail 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In 1995, the NRC Office of Nuclear Material Safety and Safeguards 
(NMSS) initiated a review to determine whether the license term for 
material licenses could be increased so that NRC's licensing resources 
could be redirected to other areas of the materials program. 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: (1) The history of the licensee's operating 
performance (e.g., the record on compliance with regulatory 
requirements); and (2) the licensee's 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, 
most of the proposed changes are identified and requested by licensees 
as 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 three-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 this rule, dated December 22, 1966, NRC indicated that if the 
proposed amendment to eliminate the three-year restriction were 
adopted, licenses would be issued for five-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 five 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. Licenses have been issued for five-year terms 
since 1967.
    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 five-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 five-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 five 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 five 
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 
five-year term to a ten-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,

[[Page 40976]]

and that licensees would be required to update the safety demonstration 
sections of their licenses every two years.
    On July 2, 1996, the Commission approved the NRC staff's proposal 
to extend the license term for uranium recovery facilities from five 
years to ten years. Extending the license terms reduces the 
administrative burden associated with the license renewal process for 
both the NRC staff and the uranium recovery licensees. Also, the 
extension reduces the licensee fees, brings 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 of the 
policy that the license term for material licenses issued pursuant to 
10 CFR parts 30, 40, or 70 would be increased from a five-year term to 
up to a ten-year term at the next renewal of the affected licenses. The 
term for licenses issued pursuant to 10 CFR part 35 is established by 
regulation at five years. The ten-year term for other licenses has been 
set by policy. Part 35 license terms would be set by this policy after 
the final rule is effective that removes the reference to a five-year 
license term from 10 CFR 35.18. The NRC may issue a license for a 
shorter term, depending on the individual circumstances of the license 
applicant.

II. Discussion

    The change in policy under which the license term for materials 
licenses is up to ten years, has created an inconsistency between the 
license terms for medical use and non-medical use materials licenses. 
NRC believes that the license duration period 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 the position to identify, by 
inspection or other means, violations 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 follow-up;
    (5) The 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 efforts are moving to a more performance-based regulatory 
approach, where emphasis is placed on the licensee's execution of 
commitments rather than on re-review of the details of the licensee's 
program.

III. Proposed Regulatory Action

    The NRC is proposing to revise Part 35 to eliminate the five-year 
term limit in 10 CFR 35.18 for medical use licenses, so that the term 
for medical licenses can be set by policy for up to ten years.

IV. Compatibility for Agreement States

    No problems have been identified regarding Agreement State 
implementation of this rule change. Section 35.18 is a Division 3 
requirement. For purposes of NRC and Agreement State compatibility 
requirements, Division 3 rules apply to a number of the provisions in 
NRC regulations that would be appropriate for Agreement States to 
adopt, but they do not require any degree of uniformity between NRC and 
State rules. Such rules are strictly matters for the regulatory agency 
and the regulatory community within its jurisdiction. NRC encourages 
states to adopt the regulatory approach taken by NRC in such rules, but 
states are not required to do so. Under the new Commission Policy 
Statement on Agreement State Compatibility, Division 3 rules will be 
classified as compatibility category D with the same description as 
Division 3.

V. Electronic Access

    Comments may be submitted electronically, in either ASCII text or 
WordPerfect format, by calling the NRC Electronic Bulletin Board on 
FedWorld. The bulletin board may be accessed using a personal computer, 
a modem, and one of the commonly available communications software 
packages, or directly via Internet. Background documents on the 
rulemaking are also available, as practical, for downloading and 
viewing on the bulletin board.
    If using a personal computer and modem, the NRC rulemaking 
subsystem on FedWorld can be accessed directly by dialing the toll-free 
number (800) 303-9672. Communication software parameters should be set 
as follows: parity to none, data bits to 8, and stop bits to 1 (N,8,1). 
Using ANSI or VT-100 terminal emulation, the NRC rulemaking subsystem 
can then be accessed by selecting the ``Rules Menu'' option from the 
``NRC Main Menu.'' Users will find the ``FedWorld Online User's 
Guides'' particularly helpful. Many NRC subsystems and data bases also 
have a ``Help/Information Center'' option that is tailored to the 
particular subsystem.
    The NRC subsystem on FedWorld can be accessed by a direct dial 
phone number for the main FedWorld BBS (703) 321-3339, or by using 
Telnet via Internet: fedworld.gov. If using (703) 321-3339 to contact 
FedWorld, the NRC subsystem will be accessed from the main FedWorld 
menu by selecting the ``Regulatory, Government Administration and State 
Systems,'' then selecting ``Regulatory Information Mall.'' At that 
point, a menu will be displayed that has an option ``US Nuclear 
Regulatory Commission'' that will take you to the NRC Online main menu. 
The NRC Online area also can be accessed directly by typing ``/go nrc'' 
at a FedWorld command line. If you access NRC from FedWorld's main 
menu, you may return to FedWorld by selecting the ``Return to 
FedWorld'' option from the NRC Online main menu. However, if you access 
NRC at FedWorld by using NRC's toll-free number, you will have full 
access to all NRC systems, but you will not have access to the main 
FedWorld systems.
    If you contact FedWorld using Telnet, you will see the NRC area and 
menus, including the Rules menu. Although you will be able to download 
documents and leave messages, you will not be able to write comments or 
upload files (comments). If you contact FedWorld using FTP, all files 
can be accessed and downloaded but uploads are not allowed; all you 
will see is a list of files without descriptions (normal Gopher look). 
An index file listing all files within a subdirectory, with 
description, is available. There is a 15-minute time limit for FTP 
access.
    Although FedWorld also can be accessed through the World Wide Web, 
like FTP, that mode only provides access for downloading files and does 
not display NRC Rules menu.
    You may also access the NRC's interactive rulemaking web site 
through the NRC home page (http://www.nrc.gov). This site provides the 
same access as the FedWorld bulletin board, including the facility to 
upload comments as files (any format), if your web browser supports 
that function.
    For more information on the NRC bulletin boards call Mr. Arthur 
Davis.

[[Page 40977]]

Systems Integration and Development Branch, NRC, Washington DC 20555-
0001, telephone (301) 415-5780; e-mail [email protected]. For information 
about the interactive rulemaking site, contact Ms. Carol Gallagher 
(301) 415-6215; e-mail [email protected].

VI. Finding of No Significant Environmental Impact: Availability

    No Environmental Assessment will be needed because the rulemaking 
is covered by the categorical exclusion in 10 CFR 51.22(c)(3)(i) for 
amendments to Part 35 that relate to renewals of licenses.

VII. Paperwork Reduction Act Statement

    This proposed rule will reduce the burden for both medical 
licensees and NRC, because terms could be established by policy, for up 
to ten years, as is the case for other material 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 
five-year extension of their current licenses which were 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 expires on July 31, 1999. 
The data on the reduced burden from extension of the license term for 
all material licenses, as well as 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, during which time the medical licenses currently under 
the five year extension will expire and be affected by this rulemaking.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, an information collection unless it displays a currently 
valid OMB control number.

VIII. Regulatory Analysis

Problem

    The current rule requirement, regarding the term of medical 
licenses, is codified in Section 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 ten 
years. There is thus an inconsistency as to duration and manner of 
determination of the license term 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 five years.
    This option would continue the inconsistency between how license 
terms for medical licenses, and all other materials licenses, are 
established. Terms for medical use licenses are established in codified 
regulations, whereas the term for other materials licenses are set by 
policy. Also, this option would result in disparities in the duration 
of the term for material licenses, because medical use licenses would 
continue to be issued for five-year terms whereas the duration of the 
term for other materials licenses would be up to ten 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 material licenses are established 
and in the duration of such licenses. Commission decisions regarding 
the duration of a materials license could therefore apply uniformly to 
all types of material 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 already established policy for up to ten 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 five-year license term for medical use of byproduct material 
would not change the health and safety requirements imposed on 
licensees.
    If the reference to the five-year term in 10 CFR 35.18 is removed, 
and with the Commission's approval (February 1997) given to extend the 
license term up to ten years for all material licenses issued pursuant 
to Parts 30, 40, and 70, there would be a reduction in the regulatory 
burden for approximately 2,000 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 ten years as opposed to every five years, 
resulting, on average, in a savings of 200 applications per year. 
However, countervailing these savings, medical licensees may need to 
submit an average of one additional amendment during the ten year 
period to account for changes in operations that would have routinely 
been addressed when the license was renewed on a five year cycle. 
Assuming that a typical license renewal application and typical 
amendment involves ten hours and two hours of licensee professional 
effort, respectively, there would be a net savings per licensee of 
eight hours. Based on an industry professional labor rate of $70 per 
hour, the annual industry-wide savings would approximate $112,000. Over 
a 30-year time frame, based on a 7 percent real discount rate, the 
present worth savings to industry would approximate $1.4 million.
    Similarly, this rulemaking would also be 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 four hours to review 
an amendment. This translates to a net savings to the NRC of 10 hours 
per license. Assuming an NRC labor rate of $70 per hour, and on 
average, 200 application per year, the annual NRC savings would equal 
$140,000. The 30 year present worth savings to the NRC would 
approximate $1.7 million.

Conclusion

    This rulemaking, to remove the five-year license term for medical 
use of byproduct material, is proposed so the term for medical licenses 
will be consistent with that of other materials licenses (set by policy 
to be up to 10 years). The extension will reduce the administrative 
burden of license renewals for both NRC and the licensee 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.

[[Page 40978]]

Decisional Rationale

    Based on the consistency which is created between license terms for 
medical licenses and all other material licenses by the rulemaking, and 
the cost effectiveness of a license term of up to ten years, the NRC is 
proposing to amend 10 CFR part 35 to eliminate the five-year term limit 
for medical use licenses and allow the license term to be set by the 
established policy for up to ten years.

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, if adopted, will not 
have a significant impact on a substantial number of small entities. If 
any small entity subject to this regulation determines that, because of 
its size, it is likely to bear a disproportionate adverse economic 
impact, the entity should notify the Commission of this in a comment 
that indicates the following:
    (a) The licensee's size and how the proposed regulation would 
result in a significant economic burden upon the license compared to 
the economic burden on a larger licensee;
    (b) How the proposed regulation could be modified to take into 
account the licensee's differing needs and capabilities;
    (c) The benefits that would accrue, or the detriments that would be 
avoided, if the proposed rule were modified as suggested by the 
licensee;
    (d) How the proposed regulation, as modified, would more closely 
equalize the impact of NRC regulations or create more equal access to 
the benefits of Federal programs, as opposed to providing special 
advantages to any one individual or group; and
    (e) How the proposed regulation, as modified, would still 
adequately protect public health and safety.

X. Backfit Analysis

    The NRC has determined that the backfit rule, 10 CFR 50.109, does 
not apply to this rule, and therefore a backfit analysis is not 
required because the amendment does not involve any provisions that 
would impose backfits as defined in 10 CFR 50.109(a)(1).

List of Subjects in 10 CFR Part 35

    Byproduct material, Criminal penalties, Drugs, Health facilities, 
Health professions, Nuclear materials, Occupational safety and health, 
Radiation protection, Reporting and record 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 amendments 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, Maryland, this 10th day of July, 1997.

    For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Acting Executive Director for Operations.
[FR Doc. 97-20189 Filed 7-30-97; 8:45 am]
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