[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
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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.
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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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