[Federal Register Volume 76, Number 98 (Friday, May 20, 2011)]
[Proposed Rules]
[Pages 29171-29176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12048]
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Proposed Rules
Federal Register
________________________________________________________________________
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. 76, No. 98 / Friday, May 20, 2011 / Proposed
Rules
[[Page 29171]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
[NRC-2008-0071 and NRC-2008-0175]
RIN 3150-AI28, RIN 3150-AI63
Medical Use Regulations
AGENCY: Nuclear Regulatory Commission.
ACTION: Availability of preliminary draft rule language and notice of
public workshops.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or Commission)
plans to hold a public workshop on June 20-21, 2011, in New York, New
York, to solicit comments on certain issues under consideration to
amend the medical use regulations, including reporting and
notifications of Medical Events (MEs) for permanent implant
brachytherapy. The NRC plans to hold a second public workshop on the
same subject matter in August 2011 in Houston, Texas. The specific
location and dates for the second workshop in Houston are currently
being determined. The NRC is also making available for comment
preliminary draft rule language concerning the NRC's proposed
amendments to the medical use regulations. This document briefly
summarizes the proposed amendments.
DATES: The first public workshop is planned for June 20-21, 2011, and
the second public workshop is planned for August 2011. See
SUPPLEMENTARY INFORMATION section for public meeting information.
ADDRESSES: The first public workshop is scheduled to be held at the
Flatotel Hotel, http://www.flatotel.com/loction_apartment_hotels.shtml 135 West 52nd Street, New York, NY 10019. The second
public meeting is scheduled to be held in Houston, TX (specific
location and dates to be determined).
FOR FURTHER INFORMATION CONTACT: Varughese Kurian, telephone: 301-415-
7426, e-mail: [email protected] or Michael Fuller, telephone:
301-415-0520, e-mail: [email protected] of the U.S. Nuclear
Regulatory Commission, Office of Federal and State Materials and
Environmental Management Programs, Division of Materials Safety and
State Agreements, Mail Stop T-8 F5, 11545 Rockville Pike, Rockville,
Maryland 20852-0001.
SUPPLEMENTARY INFORMATION:
I. Background Information
In SRM-SECY-10-0062, dated August 10, 2010, the Commission directed
the staff to work closely with the NRC's Advisory Committee for the
Medical Uses of Isotopes (ACMUI) and the broader medical and
stakeholder community to develop event definitions that will protect
the interests of patients and allow physicians the flexibility to take
actions that they deem medically necessary, while continuing to enable
the agency to detect failures in process, procedure, and training, as
well as any misapplication of byproduct materials by authorized users.
Additionally, the staff was directed to hold a series of stakeholder
workshops to discuss methods for defining MEs which continue to ensure
the safe use of radioactive materials while providing flexibility to
account for medically necessary adjustments and the terms and
thresholds for reporting medical events to the NRC and patients.
II. Purpose of the Public Workshops
In selecting the dates for these public workshops, the staff has
taken into consideration and has made efforts to accommodate, as much
as possible, the schedules of the major professional society meetings.
It is the goal of the NRC staff to organize and execute a facilitated
discussion through which comments and suggestions can be obtained from
the participants and attendees on the topics and issues identified in
this document. The information obtained will help the NRC to better
understand the views of the medical community and broader stakeholder
community on these issues as proposed rulemaking language is developed
to amend certain sections of 10 CFR part 35.
Each workshop is planned for 2 days; from 8:30 a.m. to 5 p.m. The
NRC has developed a designated Web site for the purposes of these
meetings and will update it as information becomes available. The Web
address is http://www.blsmeetings.net/NRCMedicalRulemakingWorkshop/.
The final agenda for the workshops will be available on the NRC Public
Meeting Schedule Web site at http://www.nrc.gov/public-involve/public-meetings/index.cfm at least ten days prior to the meeting. Those
members of the public unable to travel to the workshop location but
still wishing to participate may do so via Web-broadcast via Internet
connection, or by telephone via a conference bridgeline. Information
about how to participate via Web cast or telephone is available at
http://www.blsmeetings.net/NRCMedicalRulemakingWorkshop/, or by
contacting the NRC as noted in this document.
Prior to the meeting, attendees are required to register with the
meeting organizer to ensure sufficient accommodations can be made for
their participation. Please let the contact know if special services
are needed (hearing impaired, etc.) as well as your planned method for
attendance (i.e., in person, via telephone, or via Web cast).
III. Topics of Discussion
The following format is used in the presentation of the issues that
follow. Each topic is assigned a number, a short title, and questions
for discussion. These topics and questions are not meant to be a
complete or final list, but are intended to initiate discussion.
Interested stakeholders are welcome to recommend additions, deletions,
or modifications of these general ideas for NRC's consideration. These
topics and questions will serve as the basis for discussion at the
public meetings. Meeting participants, and those wishing to make
comments, can find additional background information on each of these
topics through the designated workshop Web site.
Topic 1. Medical Event Reporting Requirements for Permanent Implant
Brachytherapy
The current regulations in 10 CFR part 35 related to MEs associated
with permanent implant brachytherapy are recognized by the NRC, ACMUI,
and the broader medical and stakeholder community to be inadequate.
There are many areas that need to be addressed including written
directive (WD) requirements, training issues, and the basis for
defining an ME. The NRC
[[Page 29172]]
needs the ability to detect failures in process, procedure, and
training, as well as any misapplication of byproduct materials by
authorized users (AU), without impeding on the practice of medicine. A
proposed rule published on August 6, 2008 (73 FR 45635), was an attempt
to balance the goal of achieving the NRC's needs with the medical
community's desire to change the basis for defining an ME (dose-base
vs. activity-base). A significant number of MEs reported in 2008 gave
the NRC a larger data set to analyze, which led to the staff's
initiative to re-propose the rule. However, the Commission disapproved,
and instead directed the staff to hold public workshops to discuss
further methods for defining MEs.
Questions for Discussion
The NRC staff has developed the following questions to provide
context for discussion during the public meeting:
Should the regulations have a specific section for
prostate implant brachytherapy rather than combined with all other
permanent implant brachytherapy?
Should the criterion for defining an ME for permanent
implant brachytherapy be activity-based only?
Should the criterion for defining an ME for permanent
implant brachytherapy be dose-based only?
Should the criteria for defining an ME for permanent
implant brachytherapy be a combination activity- and dose-based
criterion?
Should the NRC require training on how to identify MEs?
Many professional organizations have recommended standards
for when a dose to the treatment site for permanent prostate implants
is assessed. The NRC staff is considering adding a time requirement to
the regulations for this purpose. What is the appropriate time frame?
Members of the public may have different or additional questions
that should be considered, and are encouraged to raise them during the
public workshop. Members of the public are also encouraged to provide
for consideration comments that they believe are important.
Topic 2. Amending Preceptor Attestation Requirements
Currently, 10 CFR part 35 provides three pathways for individuals
to satisfy training and experience (T&E) requirements to be approved as
a Radiation Safety Officer (RSO), authorized medical physicist (AMP),
authorized nuclear pharmacist (ANP), or authorized user (AU). These
pathways are: (1) Approval of an individual who is certified by a
specialty board whose certification process has been recognized by the
NRC or an Agreement State; (2) approval based on an evaluation of an
individual's training and experience; or (3) identification of an
individual's name on an existing NRC or Agreement State license. (For
this discussion, pathway (1) will be referred to as the certification
pathway, and pathway (2) as the alternate pathway.)
Under the certification and alternate pathways, the individual
seeking authorization must obtain written attestation signed by a
preceptor with the same authorization. The attestation must state that
the individual has satisfactorily completed the necessary T&E
requirements and has achieved a level of competency sufficient to
function independently in the position for which authorization is
sought. Prior to the 2002 major revision of 10 CFR part 35, there was
no requirement for a board certified individual (except nuclear
pharmacists) to provide a preceptor attestation in order to be
authorized on an NRC or Agreement State license.
The ACMUI briefed the Commission in April 2008, and recommended
that the attestation requirements in 10 CFR part 35 be modified. Based
on ACMUI recommendations, NRC staff in SECY-08-0179, ``Recommendations
on Amending Preceptor Attestation Requirements in 10 CFR part 35,
Medical Use of Byproduct Material'' made the following recommendations:
a. Eliminate the attestation requirement for individuals seeking
authorized status via the board certification pathway.
b. Retain the attestation requirement for individuals seeking
authorized status via the alternate pathway, and modify the text
stating that the attestation demonstrates that the individual ``has
achieved a level of competency to function independently.''
c. Accept attestations from residency program directors,
representing consensus of residency program faculties.
In SRM-SECY-08-0179, dated January 16, 2009, the Commission
approved these recommendations and directed the staff to develop the
proposed rule language for the alternate pathway attestation
requirements.
Questions for Discussion
The NRC staff has developed the following questions to provide
context for discussion during the public meeting:
Should the NRC eliminate the attestation requirement for
individuals seeking authorized status via the board certification
pathways?
Should the NRC eliminate the attestation requirement for
boards whose processes have been recognized by the NRC or Agreement
States?
Should the NRC eliminate the attestation requirement for
individuals ``grandfathered'' under 10 CFR 35.57?
Should the NRC eliminate the attestation requirements for
all boards?
For the alternate pathway, should the NRC amend the
language for attestation requirements from the current text that states
the individual ``has achieved a level of competency to function
independently'' with alternative text such as ``has demonstrated the
ability to function independently to fulfill the radiation-safety-
related duties required by the license, or has received the requisite
training and experience in order to fulfill the radiation safety duties
required by the licensee?''
If the attestation is retained for the alternate pathway,
who should be allowed to provide the attestations? Should it be the
residency program directors representing consensus of residency program
faculties, and/or medical institution administrators familiar with the
applicant?
Members of the public may have different or additional questions
that should be considered, and are encouraged to raise them during the
public workshop. Members of the public are also encouraged to provide
comments that they believe are important to consider.
Topic 3. Extending Grandfathering to Certified Individuals
The NRC received a petition for rulemaking dated September 10,
2006, filed by E. Russell Ritenour, PhD on behalf of the American
Association of Physicists in Medicine. The petitioner requested that 10
CFR 35.57, ``Training for experienced Radiation Safety Officer,
teletherapy or medical physicist, authorized medical physicist,
authorized user, nuclear pharmacist, and authorized nuclear
pharmacist'' be revised to recognize medical physicists certified by
either the American Board of Radiology (ABR) or the American Board of
Medical Physics (ABMP) on or before October 24, 2005, as
``grandfathered'' for the modalities that they practiced as of October
24, 2005.
In its review and resolution of the petition, the NRC concluded
that revisions made to the regulations in 2005 may have inadvertently
affected a group of board certified professionals
[[Page 29173]]
who were not listed on an NRC or Agreement State license as October 24,
2005. The NRC concluded that the issues raised in the petition would be
considered in the rulemaking process, provided a technical basis could
be developed. The NRC staff surveyed the certification boards and based
upon their responses has concluded that pursuing a rulemaking is
warranted.
Issue No. 1: Individuals certified by boards that had been listed
in the NRC's former regulations found in 10 CFR part 35, Subpart J, who
had not been named on an NRC or Agreement State license or permit prior
to October 25, 2005, were not grandfathered under 10 CFR 35.57, and
cannot use their board issued certifications to qualify them as AMPs or
RSOs.
Questions for Discussion
The NRC staff has developed the following questions to provide
context for discussion during the public meeting:
Should only AMPs and RSOs be grandfathered per the
petition request?
Should the NRC recognize all individuals certified by
boards that had been listed in NRC's regulations, and who had not been
named on an NRC or Agreement State license or permit prior to October
25, 2005?
Members of the public may have different or additional questions
that should be considered, and are encouraged to raise them during the
public workshop. Members of the public are also encouraged to provide
comments that they believe are important to consider.
Issue No. 2: In support of the petition, the petitioner stated that
for the RSO preceptor attestations would be provided with the board
certification for listing on an NRC or Agreement State license.
Additionally, the petitioner requested that medical physicists
certified by the ABR or ABMP on or before October 24, 2005, be
grandfathered for the modalities they practiced as of that date.
The NRC, in resolving the petition, noted that the rationale for
grandfathering individuals under Sec. 35.57 was that their credentials
had been reviewed and accepted during the licensing process and that
they had been functioning in their positions and had established an
acceptable record of performance. For individuals to be grandfathered
under 10 CFR 35.57, an attestation would serve as an acceptable record
of performance.
The NRC agreed with the petitioner for requiring an attestation for
an individual applying to be named as an RSO on a license.
Additionally, in expanding the petitioners request for grandfathering
medical physicists to include all individuals certified by boards that
had been listed in the NRC's regulations, the NRC considered an
attestation to be a necessary requirement.
Questions for Discussion
The NRC staff has developed the following questions to provide
context for discussion during the public meeting:
Should the NRC require preceptor attestations for
grandfathering under 10 CFR 35.57 for only RSOs per the petition
request?
Should the NRC require an attestation for all individuals
to be grandfathered under 10 CFR 35.57?
Should the NRC require no attestations for individuals to
be grandfathered under 10 CFR 35.57?
Should the NRC require some other means other than an
attestation to establish an acceptable record of performance?
If the NRC adopts the ACMUI recommendation to remove
attestation requirements for all board certified individuals, how
should the NRC proceed with the grandfathering under the Ritenour
petition?
Members of the public may have different or additional questions
that should be considered, and are encouraged to raise them during the
public workshop. Members of the public are also encouraged to provide
comments that they believe are important to consider.
Topic 4. Revise Part 35 To Allow Assistant/Associate RSOs on a License
Currently, regulations in 10 CFR part 35 do not allow licensees to
have more than one permanent RSO. Section 35.24(c) allows licensees to
simultaneously appoint more than one temporary RSO, if necessary, to
make sure that the licensee has an individual that is qualified to be
an RSO for each of the different types and uses of byproduct material
permitted by the licensee.
The NRC is considering amending the regulations to add assistant/
associate RSOs on a license. The intent of this proposed change to the
regulations would be to allow licensees to appoint qualified
individuals with expertise in certain uses of byproduct material to
serve as assistant/associate RSOs who would be assigned duties and
tasks while reporting to the primary RSO. The primary RSO would
continue to be the individual named on the license that is responsible
for the day-to-day oversight of the entire radiation safety program.
Licensees with multiple operating locations could have a qualified
assistant/associate RSO at each location of byproduct use.
Questions for Discussion
The NRC staff has developed the following questions to provide
context for discussion during the public meeting:
What should the qualifications be for an Assistant/
Assistant RSO? Should they be the same as the RSO?
Should there be a limitation on the number of Assistant/
Associate RSOs on a License?
Should the RSO continue to be the one person that the
regulations hold responsible for the day-to-day oversight of the
licensee's radiation safety program, or should the regulations be
changed to allow for Assistant/Associate RSO to have some
accountability?
Should the title of the additional named supporting RSOs
be Assistant RSO, or Associate RSO? Does the title matter?
Members of the public may have different or additional questions
that should be considered, and are encouraged to raise them during the
public workshop. Members of the public are also encouraged to provide
comments that they believe are important to consider.
Topic 5. Require Molybdenum Breakthrough Tests After Each Elution and
Require Reporting of Failed Molybdenum Breakthrough Tests
Currently, 10 CFR 35.204(b) requires that a licensee that uses
molybdenum-99/technetium-99m generators for preparing a technetium-99m
radiopharmaceutical must measure the molybdenum-99 concentration of
only the first eluate. Prior to 2002, 10 CFR 35.204 required the
licensee to measure the molybdenum-99 concentration of each eluate. In
the April 2002 revision, the NRC decided to require this test to be
made only for the first eluate because the frequency of molybdenum
breakthrough was considered to be rare by the medical and
pharmaceutical industries.
During October 2006 through February 2007, and again in January
2008, medical licensees reported generators that failed the molybdenum-
99 breakthrough tests. Some licensees were reporting the failures
detected from measuring the first elution, and others were reporting a
normal first elution with subsequent elutions.
Generator manufacturers have always recommended testing each
elution prior to use in humans. In addition, while Sec. 35.204(d)
requires that a licensee
[[Page 29174]]
retain a record of each molybdenum-99 concentration measurement and
retain the record for three years, there is no requirement that an
elution that exceeds the regulatory limit of 0.15 microCuries of
molybdenum-99 per milliCurie of technetium-99m must be reported.
Questions for Discussion
The NRC staff has developed the following questions to provide
context for discussion during the public meeting.
Should the NRC require licensees perform the test for each
eluate as recommended by the generator manufacturers?
Should the NRC require reporting of a failed test? If so,
how soon should after the failed test is discovered, should the
licensee be required to make a report?
Members of the public may have different or additional questions
that should be considered, and are encouraged to raise them during the
public workshop. Members of the public are also encouraged to provide
comments that they believe are important to consider.
Topic 6. Additional Items Under Consideration for Rulemaking
The NRC is also considering amending the regulations to address the
following 18 items. Members of the public may have questions or
comments about these additional items, and are encouraged to raise them
during the public workshop.
The following section under consideration relates to the authorized
medical physicist issues.
1. Section to be amended: 10 CFR 35.433(a).
Issue: 10 CFR 35.433 requires an authorized medical physicist to
perform the task described in this section, i.e., calculate the
activity of each strontium-90 source that is used to determine the
treatment times for ophthalmic treatments. The Sr-90 eye applicators
are typically used in geographic locations that may not have access to
an authorized medical physicist and further description of the tasks
required of a physicist during the eye applicator use would make it
easier to permit other physicists to perform the tasks.
Revising 10 CFR 35.433 to add a description of the tasks required
and to permit a medical physicist with training and experience in these
specific tasks to perform the tasks in Sec. 35.433 would provide
relief to licensees in remote areas.
(Reviewed with ACMUI during its May 23, 2006 meeting).
The following sections under consideration relate to training and
experience issues.
2. Section to be amended: 10 CFR 35.51(a)(2)(i).
Issue: One of the conditions for recognition of board certification
in Sec. 35.51(a)(2)(i) is that all candidates have 2 years of full-
time practical training and/or supervised experience in medical
physics--under the supervision of a medical physicist who is certified
in medical physics by a specialty board recognized by the Commission or
an Agreement State. This has been interpreted to mean that a diagnostic
medical physicist certified by a board recognized in Sec. 35.50 can
serve as the supervising medical physicist under Sec. 35.51. NRC staff
believes that a therapy medical physicist should receive supervised
experience under a therapy medical physicist.
(Reviewed with ACMUI during its May 23, 2006 meeting).
3. Section to be amended: 10 CFR 35.50(c)(2).
Issue: 10 CFR 35.50(c)(2) permits an AU, AMP, or ANP identified on
the licensee's license and with experience with the radiation safety
aspects of similar types of use of byproduct material for which the
individual has RSO responsibilities to be an RSO. This restricts the
licensee from naming a qualified AU, AMP, or ANP identified on another
licensee's license as an RSO. It also prohibits an individual who meets
the requirements to be an AU, AMP, or ANP that has not been listed on a
license to be an RSO.
(Reviewed with ACMUI during its April 26, 2006 meeting).
4. Section to be amended: 10 CFR 35.290(b)(ii)(G).
Issue: 10 CFR 35.290(b)(ii) requires the supervised work experience
to be under the supervision of an AU. Most facilities that provide the
supervised work experience training required in 10 CFR 35.290(b)(ii)(G)
for generator elution do not have generators available or prepare kits.
The effect is that these facilities usually make arrangements with a
nuclear pharmacy to obtain this hands-on training and experience from
an ANP. Although the supervising AU can make an arrangement for the ANP
to provide the training under the AU's supervision, it would be simpler
if the ANP providing the training could be recognized as the
supervising individual.
(The ACMUI approved the change during its October 22, 2007
meeting).
5. Section to be amended: 10 CFR 35.390(b)(1).
Issue: The NRC currently recognizes the residency program approved
by the Royal college of Physicians and Surgeons of Canada for
physicians seeking authorized user status under Sec. Sec. 35.390,
35.490, and 35.690. But in each case, the NRC's regulations require
supervised work experience under an authorized user. The Canadian
residency program does not appear to meet this criterion. The challenge
is to determine how to assure physicians going through the Canadian
residency programs receive training and supervised work experience in
the radiation safety issues unique to the U.S. regulations for medical
uses.
6. Section to be amended: 10 CFR 35.390(b)(1)(ii)(G).
Issue: Work experience for parenteral administration of alpha
emitters: Based upon the interpretation of the regulations, the staff
has determined that the current language of 10 CFR 35.390(b)(1)(ii)(G)
is insufficient. Contrary to what had been intended, the current
language in category 4 does not allow the category to encompass any
byproduct material, since the NRC staff has determined that no pure
alpha emitter exists. The staff is proposing a change to the regulation
to reflect the original intent of placing the parenteral administration
of alpha emitters into a separate category from the parenteral
administration of beta emitting and low energy photon-emitting
byproduct material. References to that section in 10 CFR 35.396(d)(2)
and (d)(2)(vi) would also be amended.
7. Section to be amended: 10 CFR 35.490(b)(1)(ii).
Issue: Change site requirements for AU work experience. The
amendment would allow supervised work experience to be obtained at
places other than medical institutions, i.e. clinics.
(Reviewed with the ACMUI at the October 19, 2009 meeting).
8. Section to be amended: 10 CFR 35.491(b)(3).
Issue: There is an error in 10 CFR 35.491(b)(3). Section 35.491
states the AU of strontium-90 for ophthalmic radiotherapy is a
physician who meets the requirements in paragraph (a) or (b). However
the attestation statement in 10 CFR 35.491(b)(3) requires the preceptor
AU to attest that the individual meets the requirements in paragraphs
(a) and (b). The effect is that paragraph (b)(3) requires an
attestation statement for the individual that is already an AU under
the requirements of 10 CFR 35.490. The statements of consideration (67
FR 20310) state that physicians who meet the requirements in 10 CFR
35.490 automatically meet the requirements to
[[Page 29175]]
become an AU under 10 CFR 35.491 which means an attestation is not
required under the paragraph (a) pathway. To support this
interpretation, the regulations that are structured similar to 10 CFR
35.491(a) (e.g., Sec. Sec. 35.190(b), 35.290(b), 35.392(b), and
35.394(b)) that require a physician to be a specific AU do not refer to
the section requiring an attestation and the corresponding attestation
paragraph does not reference the authorized user paragraphs.
(Not reviewed by ACMUI).
9. Section to be amended: 10 CFR 35.610(d).
Issue: It is recommended that Sec. 35.610(d) be revised to include
a new section on vendor training and distinguish this training from
licensee provided ``initial'' training. The differentiation should be
based upon the licensee experience with the unit, i.e., new units and
units with significant manufacturer upgrades. The vendor training needs
to be provided before first patient treatment using the unit. The
vendor training needs to be provided by the device manufacturer or by
individuals certified by the device manufacturer.
(Reviewed with the ACMUI during its March 1-2, 2004 meeting).
10. Section to be amended: 10 CFR 35.690(b)(1).
Issue: Change site requirements for AU work experience. The
amendment would allow supervised work experience to be obtained at
places other than medical institutions, i.e. clinics.
(Reviewed with the ACMUI at the October 19, 2009 meeting).
The following sections under consideration relate to the Sealed
Sources/Device issues.
11. Section to be amended: 10 CFR 35.13.
Issue: 10 CFR 30.32 requires that an application for a specific
license to use byproduct material in the form of a sealed source or in
a device that contains the sealed source either (1) identify the source
or device by manufacturer and model number as registered with the
Commission under Sec. 32.210 or with an Agreement State; or (2)
contain the information identified in Sec. 32.210(c). Therefore, an
amendment is needed every time the licensee changes the manufacturer or
model of a bracytherapy source.
NRC staff is also considering revising Sec. 35.14,
``Notifications,'' to permit medical use licensees to notify the NRC
within 30 days of when the licensee obtains sealed sources from a new
manufacturer or new model of sealed sources from a manufacturer listed
on the license for a use already authorized in the license.
(Reviewed with the ACMUI at the November 12-13, 2003 meeting).
12. Section to be amended: 10 CFR 35.14.
Issue: Conforming changes for Sec. 35.13.
13. Section to be amended: 10 CFR 35.65(a) through (d).
Issue: 10 CFR 35.65 authorizes a medical use licensee to possess
certain calibration, transmission and reference sources if each sealed
source or individual amounts of other forms of byproduct material do
not exceed a specific activity. A manufacturer of attenuation sources
used for SPEC or PET scanners believes this authorization includes its
array of 28 sources, since each does not exceed the individual limits
specified. The requirement needs to be clarified to exclude bundling or
aggregating the sources for one device.
(Reviewed with ACMUI during its April 26, 2006 meeting).
14. Section to be amended: 10 CFR 35.65(a)-(d).
Issue: Move transmission sources that are used on patients or human
research subjects to Subpart G.
15. Sections to be amended: 10 CFR 35.400, 35.500, and 35.600.
Issue: 10 CFR 35.400, 35.500, and 35.600 require licensees to only
use the sealed sources and devices in these sections as approved in the
Sealed Source and Device Registry (SSDR). Some of the SSDR certificates
include specific medical procedures or treatment of specific diseases
or treatment areas listed by the manufacturer. If ``only as approved in
the SSDR'' means only for the treatments described in the SSDR, other
accepted uses under the practice of medicine would be either for
research or not permitted by the regulations. The staff is considering
more flexible wording to ensure uses under the practice of medicine are
included.
(The ACMUI approved the change during its October 22, 2007
meeting).
16. Section to be amended: 10 CFR 35.655(a).
Issue: 10 CFR 35.655(a) requires a licensee to have each
teletherapy unit and gamma stereotactic radiosurgery unit fully
inspected and serviced during source replacement or at intervals not to
exceed 5 years, whichever comes first, to assure proper functioning of
the source exposure mechanism. This regulation requires a gamma
stereotactic radiosurgery unit to be fully inspected and serviced at 5
years if the source replacement is delayed. However, the type of
inspection and full servicing expected can only be done during source
replacement for the gamma stereotactic radiosurgery unit.
(Reviewed with the ACMUI during its November 12-13, 2003 meeting).)
In addition, the following sections are also under consideration
for amendments.
17. Section to be amended: 10 CFR 35.12(c).
Issue 1: 10 CFR 35.12(d) requires an applicant for a license or
amendment for a Sec. 35.1000 medical use to meet the requirements in
Sec. 35.12(b) and (c). 10 CFR 35.12(b) requires an applicant for a
license for medical use of byproduct material as described in Sec.
35.1000 to file an original and one copy of NRC Form 313, ``Application
for Material License,'' that includes the facility diagram, equipment,
and training and experience qualifications of the RSO, AU(s), AMP(s),
and ANP(s). 10 CFR 35.12(c) requires an applicant for a license
amendment or renewal to submit an original and one copy of either NRC
Form 313 or a letter requesting the amendment or renewal but is silent
on the need to submit the facility diagram or the training and
experience of the RSO, AU(s), AMP(s), and ANP(s). It is unclear whether
the information specified in Sec. 35.12(b) is included in Sec.
35.12(c).
(Reviewed with ACMUI during its April 26, 2006 meeting).)
Issue 2: 10 CFR 35.12(c)(1) indicates that the application will be
either on NRC Form 313 or in a letter but does not indicate that the
information submitted in the letter must be equivalent to the
information submitted on the NRC Form 313. By adding ``or equivalent''
the burden associated with the letter submission is captured in the
information collection and recordkeeping burden of the NRC Form 313.
This will also capture the burden on the NRC Form 313 for completing
the NRC Form 313A series or letters containing equivalent information
to that in the NRC Form 313A series.
(The ACMUI approved the change during its June 13, 2007 meeting).)
18. Section to be amended: 10 CFR 35.12(d).
Issue 1: 10 CFR 35.12(d) does not address all the radiation safety
aspects for medical use of byproduct material as described in Sec.
35.1000 and, as written, may imply that only the radiation safety
aspects in Subparts A through C apply to Sec. 35.1000 medical uses.
(Reviewed with the ACMUI during its March 1-2, 2004 meeting).)
Issue 2: 10 CFR 35.12(d) and 10 CFR 35.12(d)(1) are confusing
because there are radiation safety aspects that are neither addressed
in Subparts A through C of this part nor included in the list
[[Page 29176]]
that the Supplemental Information section for Sec. 35.12(d)(1)
considers to be all the information NRC needs to approve a Sec.
35.1000 medical use.
(Reviewed with the ACMUI during its March 1-2, 2004 meeting).)
During the two-day workshops, the NRC will be available to discuss
preliminary draft rule language under consideration for new and amended
sections of 10 CFR part 35. The preliminary draft rule language, and
any public comments on that language, can be found at http://www.regulations.gov by searching on Docket ID NRC-2008-0175.
Dated at Rockville, Maryland, this 5th day of May 2011.
For the Nuclear Regulatory Commission.
Michael Fuller,
Acting Branch Chief, Radioactive Materials Safety Branch, Division of
Materials Safety and State Agreements, Office of Federal and State
Materials and Environmental Management Program.
[FR Doc. 2011-12048 Filed 5-19-11; 8:45 am]
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