[Federal Register Volume 63, Number 156 (Thursday, August 13, 1998)]
[Proposed Rules]
[Pages 43516-43580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21459]
[[Page 43515]]
_______________________________________________________________________
Part III
Nuclear Regulatory Commission
_______________________________________________________________________
10 CFR Parts 20, 32 and 35
Medical Use of Byproduct Material; Proposed Revision
10 CFR Chapter I
Medical Use of Byproduct Material; Draft Policy Statement; Proposed
Rules
Federal Register / Vol. 63, No. 156 / Thursday, August 13, 1998 /
Proposed Rules
[[Page 43516]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 20, 32 and 35
RIN 3150-AF74
Medical Use of Byproduct Material; Proposed Revision
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing a
revision of its regulations governing the medical use of byproduct
material. The proposed rule is one component of the Commission's
overall program for revising its regulatory framework for medical use.
The overall goals of this program are to focus NRC's regulations on
those medical procedures that pose the highest risk to workers,
patients, and the public, and to structure its regulations to be risk-
informed and more performance-based, consistent with the NRC's
``Strategic Plan for Fiscal Year 1997-Fiscal Year 2002.'' A notice in
this issue of the Federal Register announcing the Commission's proposed
revision of its 1979 ``Medical Use Policy Statement'' for public
comment is published elsewhere.
DATES: The comment period expires November 12, 1998. Comments received
after this date will be considered if it is practical to do so, but the
Commission is only able to ensure consideration of comments received on
or before this date.
ADDRESSES: Comments may be sent to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, Attention: Rulemakings and
Adjudications Staff.
Deliver comments to: One White Flint North, 11555 Rockville Pike,
Rockville, Maryland 20852, between 7:30 am and 4:15 pm on Federal
workdays.
Copies of comments received may be examined at: NRC Public Document
Room, 2120 L Street, NW. (Lower Level), Washington, DC.
You may also provide comments via the NRC's interactive rulemaking
web site through the NRC home page (http://www.nrc.gov). From the home
page, select ``Rulemaking'' from the tool bar. The interactive
rulemaking website can then be accessed by selecting ``New Rulemaking
Website.'' This site provides the ability to upload comments as files
(any format), if your web browser supports that function. For
information about the interactive rulemaking web site, contact Ms.
Carol Gallagher, (301) 415-5905; e-mail [email protected]
FOR FURTHER INFORMATION CONTACT: Catherine Haney, Office of Nuclear
Material Safety and Safeguards, Nuclear Regulatory Commission,
Washington, DC 20555-0001, (301) 415-6825, e-mail [email protected] or Diane
Flack, Office of Nuclear Material Safety and Safeguards, Nuclear
Regulatory Commission, Washington, DC 02555-0001, (301) 415-5681, e-
mail [email protected]
SUPPLEMENTARY INFORMATION:
I. Background
II. Petition for Rulemaking
Ill. Discussion and Input to Proposed Rule
IV. Discussion of Text of Proposed Rule
V. Coordination with the Advisory Committee on Medical Uses of
Isotopes
VI. Coordination With NRC Agreement States
VII. Consistency with Medical Policy Statement
VIII. Implementation
IX. Issues of Compatibility for Agreement States
X. Finding of No Significant Environmental Impact: Availability
XI. Paperwork Reduction Act Statement
XII. Regulatory Analysis
XIII. Regulatory Flexibility Analysis
XIV. Backfit Analysis
I. Background
Use of Byproduct Material in Medicine
Since 1946, growth in the medical applications of radioisotopes has
been very rapid as their usefulness has become more apparent in
diagnosis, therapy, and medical research. Current medical procedures
employ a number of radionuclides in a wide variety of chemical and
physical forms. Nuclear medicine procedures for diagnostic and
therapeutic applications involve the internal administration of
radiolabeled tracers. Administration of the radiolabeled tracers, known
as radiopharmaceuticals, may be performed by intravenous injection,
inhalation, or oral ingestion. Diagnostic nuclear medicine in most
cases involves imaging agents used for the delineation and localization
of organ tissues by scintigraphy (e.g., technetium-99m hydroxymethylene
diphosphonate used as a bone seeking radiopharmaceutical). Organ
function may be determined by quantifying the accumulation of
radiopharmaceuticals in organs of interest (e.g., iodine-131 uptake
studies used to assess thyroid function). Therapeutic nuclear medicine
may use various radiopharmaceuticals for the treatment of disease by
selective absorption or concentration (e.g., iodine-131 used to treat
thyroid cancer). Other therapeutic applications may involve the use of
radiopharmaceuticals in colloidal suspensions for the treatment of
malignant tumors (e.g., phosphate-32 infusion for treatment of
peritoneal or pleural effusions associated with malignant tumors).
Since the early 1900s, radiation therapy has become one of the
major modalities of treatment in the management of neoplastic disease,
generally referred to as cancer. Radiation therapy may also be used as
a palliative agent in the medical treatment process. The objective of
conventional radiation therapy using a teletherapy sealed source is to
deliver a precisely measured dose of radiation to a defined tumor
volume. This is usually accomplished by delivering a dose in daily
increments over several weeks. External beam radiation therapy has
evolved using innovative technology that has led to the development of
the gamma stereotactic radiosurgery device used for treatment of
precisely defined intracranial targets (e.g., brain tumors and
arteriovenous malformations).
Brachytherapy uses a variety of smaller sealed sources for
localized treatment of cancer. Typically the sealed sources are either
inserted in a cavity (e.g., cesium-137 sources used for intracavitary
treatment of cervical cancer) or implanted in tissue (e.g., iodine-125
seeds used for interstitial treatment of prostate cancer). Various
remote afterloading devices have been developed for low, medium, and
high dose-rate brachytherapy treatments.
State and Federal Regulations
Byproduct material or radiation from byproduct material is
regulated by either State or Federal Laws. The NRC regulates the
administration of byproduct material or radiation from byproduct
material in 20 States, the District of Columbia, the Commonwealth of
Puerto Rico, and various territories of the United States. There are
approximately 1900 NRC licenses authorizing the medical use of
byproduct material under 10 CFR Part 35, ``Medical Uses of Byproduct
Material.'' Thirty States, known as Agreement States, have entered into
an agreement with the NRC to regulate the use of byproduct material (as
authorized by section 274 of the Atomic Energy Act). These States issue
licenses and currently regulate about 5000 institutions, e.g.,
hospitals, clinics, or physicians in private practice. The use of
byproduct material represents only a small fraction of all medical uses
nationwide of radionuclides or sources of radiation, e.g. x-ray.
Revision of NRC's Regulatory Program
NRC's medical use program includes use of byproduct material in
medical diagnosis, therapy, and research. NRC's requirements for
medical licensees are
[[Page 43517]]
described in 10 CFR Part 35. Approximately eleven million patients
annually undergo medical procedures involving byproduct materials.
The Commission examined the issues surrounding its medical use
program in detail during a 1993 internal senior management review, a
1996 independent external review by the National Academy of Sciences,
Institute of Medicine, and the Commission's Strategic Assessment and
Rebaselining Initiative (SA). In particular, medical oversight was
addressed in the SA Direction-Setting Issue Paper Number 7 (DSI 7)
(released September 16, 1996). In September 1997, the Commission issued
its ``Strategic Plan'' (NUREG-1614, Vol. 1) which stated that its goal
in regulating nuclear materials safety is to ``prevent radiation-
related deaths or illnesses due to civilian use of source, byproduct,
and special nuclear materials.''
In its Staff Requirements Memorandum (SRM)--COMSECY-96-057,
``Materials/Medical Oversight (DSI 7),'' dated March 20,1997, the
Commission stated that it supported continuation of the ongoing medical
use regulatory program with improvements, decreased oversight of low-
risk activities, and continued emphasis on high-risk activities. This
SRM also directed the NRC staff to revise Part 35, associated guidance
documents, and, if necessary, the Commission's 1979 Medical Use Policy
Statement (44 FR 8242; February 9, 1979). The Commission's SRM
specifically directed the restructuring of Part 35 into a risk-
informed, more performance-based regulation. In addition, the
Commission expressed its support for the use of the Advisory Committee
on the Medical Use of Isotopes (ACMUI) and professional medical
organizations and societies in the revision of Part 35 and the medical
policy statement. The Commission specifically directed the NRC staff to
``consider a rulemaking process that provides more opportunity for
input from potentially affected parties than is provided by the normal
notice and comment rulemaking process but would be less consumptive of
resources and time than the process recently used in the development of
NRC's rule on radiological criteria for license termination.''
During development of the rule and associated guidance, as well as
during the review of the Medical Use Policy Statement, the Commission
considered the following issues:
(1) Focusing Part 35 on those procedures that pose the highest
risk;
(2) Regulatory oversight alternatives for diagnostic procedures
that are consistent with the lower overall risk of these procedures;
(3) The best way to capture not only relevant safety-significant
events, but also precursor events;
(4) Changing the nomenclature from ``misadministration'' to
``medical event'' or comparable terminology;
(5) Redesigning Part 35 so that regulatory requirements for new
treatment modalities can be incorporated in a timely manner;
(6) Revising the requirement for a quality management program (10
CFR 35.32) to focus on those requirements that are essential for
patient safety; and
(7) The viability of using or referencing available industry
guidance and standards, within Part 35 and related guidance, to the
extent that they meet NRC's needs.
The proposed rule that would revise Part 35 has been developed in
response to these issues and concerns.
The Commission, in its SRM of June 30, 1997, ``SECY-97-115--
``Program for Revision of 10 CFR Part 35, `Medical Uses of Byproduct
Material' and Associated Federal Register notice,'' approved the NRC
staff's proposed plan for the revision of Part 35. The Federal Register
notice, ``Medical Use of Byproduct Material: Issues and Request for
Public Input'' (62 FR 42219-42220; August 6, 1997), solicited early
public input on the proposed rulemaking.
The NRC staff implemented the approved plan using an approach
involving public Working and Steering Group meetings, with significant
opportunities for input from the public, potentially affected parties,
the ACMUI, and professional medical organizations. Publicly noticed
Working and Steering Group meetings were held in August, September, and
December 1997, and in January, February, March, and April 1998. During
the Working and Steering Group meetings, the groups identified
significant crosscutting issues associated with the rulemaking. These
issues included patient notification, precursor events, Radiation
Safety Committee, quality management program, and training and
experience for authorized users. Rulemaking alternatives were developed
for these crosscutting issues and were made available on the Internet
and in the NRC's Public Document Room for comment. These alternatives
were discussed with (1) the ACMUI at its September 1997 meeting, (2)
the public at facilitated public workshops held in Philadelphia, PA, in
October and in Chicago, IL, in November 1997 (discussed below), (3)
State regulators at a publicly noticed workshop that was conducted
during the October 1997 All Agreement States Meeting, and (4) meetings
of medical professional societies.
In addition to the proposed revision of Part 35, the Commission is
publishing for public comment, in a separate Federal Register notice, a
proposed revision of its 1979 policy statement on the Medical Use of
Byproduct Material (44 FR 8242; February 9, 1979). The proposed
revision of the medical policy statement is another component of the
Commission's overall program for revising its regulatory framework for
medical use, including its regulations in Part 35. The proposed
revision of Part 35 is consistent with the proposed revision of the
Medical Use Policy Statement (MPS) and is generally consistent with the
current MPS (see Section VII of the SUPPLEMENTARY INFORMATION section
of this document).
Workshops
The Commission believes that it is important for interests affected
by the medical use rulemaking to not only have an early opportunity to
comment on the rulemaking issues, but also to have an opportunity to
discuss the rulemaking with one another and the agency. Accordingly,
the Commission convened two public workshops in which the interests
that maybe affected by the rulemaking had the opportunity to discuss
the rulemaking issues. Although the workshops were intended to foster a
clearer understanding of the positions and concerns of the affected
interests, as well as to identify areas of agreement or disagreement,
it was not the intent of the workshop process to develop a consensus
agreement of the participants on rulemaking issues.
In order to have a manageable discussion, the number of invited
participants in the roundtable discussions at each workshop was
limited. The Commission, through a facilitator for each workshop,
attempted to insure participation by a broad spectrum of interests that
may be affected by the rulemaking. These interests included nuclear
medicine physicians, physician specialists such as cardiologists and
radiologists, medical physicists, medical technologists, radiation
safety officers, nurses, medical education and certification
organizations, radiopharmaceutical interests, hospital administrators,
patients rights advocates, Agreement States, Federal agencies, and
experts on risk analysis. Other members of the public were invited to
attend and had the opportunity to comment on the rulemaking issues and
the workshop
[[Page 43518]]
discussions at periodic intervals during the workshops.
The workshops had a common, predefined agenda focused primarily on
alternatives for major (``crosscutting'') issues, some with draft
regulatory text. The workshop format was sufficiently flexible to allow
for the introduction of additional related issues that participants
wanted to raise. The workshop commentary was transcribed and summarized
in ``Summary of Discussion: Facilitated Public Workshop on Revisions to
10 CFR Part 35 Held in Philadelphia, Pennsylvania, on October 28-30,
1997'' (April 17, 1998) and ``Summary of Discussion: Facilitated Public
Workshop on Revisions to 10 CFR Part 35 Held in Chicago, Illinois, on
November 12-14, 1997'' (April 17, 1998). The summary documents are
available for inspection at the NRC Public Document Room, 2120 L Street
NW. (Lower Level), Washington, DC. Single copies of the summary
documents are available as indicated in the For Further Information
Contact section of this document. A brief summary of the participant's
positions on the major crosscutting issues associated with this
rulemaking is provided in Section Ill of the SUPPLEMENTARY INFORMATION
section of this document.
The Commission plans to hold three public workshops during the
formal comment period to facilitate public comments on the proposed
rulemaking. A notice for these workshops was published in the Federal
Register on July 24, 1998 (63 FR 39763).
II. Petition for Rulemaking
The Commission has incorporated into this rulemaking the resolution
of a Petition for Rulemaking (PRM) filed by the University of
Cincinnati dated April 7, 1996 (PRM 20-24), because of its pertinence
to Part 35. On June 21, 1996 (61 FR 31874), the NRC published a notice
of receipt and a request for comment on this petition for rulemaking.
The petitioner requested that the NRC amend 10 CFR 20.1301, ``Dose
limits for individual members of the public'' to:
(1) Provide medical licensees the discretion to permit those
visitors determined by the physician to be necessary for the emotional
or physical support of the patient to receive up to 5 mSv (0.5 rem)
(e.g., parents of very young radiation therapy patients, close family
members of elderly patients, or other persons who could provide
emotional support to the patient);
(2) Exclude pregnant women and individuals younger than 18 years of
age from receiving a dose in excess of 1 mSv (0.1 rem); and
(3) Document compliance by issuing radiation dose monitoring
devices (i.e., pocket dosimeter, film badge, TLD, or electronic
dosimeter) to each specified visitor.
In response to the request for public comments, the Commission
received comments from four members of the general public. All
commenters agreed with the petition. One of the commenters suggested
that the previous 5 mSv (0.5 rem) dose limit for the general public be
reinstated for a ``specific'' public and, under unusual circumstances,
also permit the authorized user to authorize even higher exposure
provided the latter does not ``receive more radiation than a radiation
worker.'' Another commenter suggested permitting the authorized user to
authorize even higher exposure provided it did not exceed the
occupational dose limit of 50 mSv (5 rem).
Although a 50 mSv (5 rem) dose limit for adult visitors exposed to
radionuclide therapy patients is consistent with the recommendations of
the National Council on Radiation Protection and Measurements (NCRP
Commentary No. 11, Dose Limits for Individuals Who Receive Exposure
From Radionuclide Therapy Patients, February 28, 1995), this suggestion
is not consistent with release of patients in accordance with
Sec. 35.75, or with the approach to protection of the public in 10 CFR
Part 20. For this reason, the NRC decided not to adopt the suggested 50
mSv (5 rem) dose limit.
The NRC reviewed the petitioner's request and comments received on
the petition and believes there is merit in granting the petition in
part as discussed in detail later. This proposed rule responds to the
petition by amending 10 CFR Part 20 to allow the licensee the
discretion to permit visitors to receive up to 5 mSv (0.5 rem) in a
year from exposure to hospitalized radiation patients.
III. Discussion and Input to Proposed Rule
The program for revising Part 35 and the associated guidance
documents has provided more opportunity for input from potentially
affected parties (the medical community and the public) than is
provided by the typical notice and comment rulemaking process. Early
public input was solicited through several different mechanisms:
requesting public input through Federal Register notices; holding open
meetings of the government groups developing the revised rule language;
meeting with medical professional societies and boards; putting
background documents, options for the more significant regulatory
issues associated with the rulemaking, and alternatives for revising
the 1979 Medical Use Policy Statement on the Internet; and convening
public workshops. The NRC received approximately 330 letters providing
input to the rulemaking process. The input received from the public
during the development of the proposed rulemaking is categorized and
summarized below, according to the significant regulatory issues that
were identified very early in the rulemaking process.
A. Training and Experience
1. Facilitated Workshops
The issue of training and experience for authorized users generated
the most discussion among workshop participants. Discussion of this
topic was organized into segments that addressed ``key current problems
or advantages identified by participants''; certain ``crosscutting''
training and experience issues (including such questions as the role a
professional degree, medical specialty certification, or testing should
play in qualifying an authorized user); and various specific
alternatives (developed by the Part 35 Working Group) for training and
experience necessary to qualify a physician as an authorized user.
Based on specific questions posed to participants, certain issues
emerged as important in determining the necessary training and
experience for qualifying as an authorized user. For instance, some
participants believed that the current requirements are unrealistically
stringent. Other participants maintained that training and experience
can be varied, based upon the degree of risk posed by a specific
modality. (However, participants did not necessarily agree on how to
rank various modalities based on risk.) One question raised was whether
the training and experience requirements should be different for
physicians already in practice, than for those physicians who are just
starting out. Certain participants viewed Commission specification of
clinical training and experience requirements as a serious intrusion
into the practice of medicine and; therefore, suggested that the term
``clinical training and experience'' should be replaced with the term
``practical training and experience.'' The latter would cover safe
handling of radioactive materials (i.e., such topics as: safe delivery
of radionuclides to patients; time, distance, and shielding; use of a
dose
[[Page 43519]]
calibrator; assessing contamination; decontaminating areas; half-lives
of radionuclides; and consequences of contamination). However, some
therapy practitioners supported the requirement for clinical experience
as part of training and experience. Another suggested approach to
establishing training and experience requirements would be to have
different requirements for physicians who use radionuclides for very
limited purposes (i.e., cardiology and endocrinology), as opposed to
physicians engaged in the general medical use of byproduct material.
The range of options for a physician to become an authorized user
that was discussed at the workshops included--
(1) Status quo (i.e., a physician who is certified in any one of a
number of medical specialities, or has had a set number of hours of
classroom and laboratory training and supervised clinical experience,
or has completed an approved training program that included classroom
and laboratory training, work experience, and supervised clinical
experience);
(2) Medical speciality certification, plus a specified number of
hours of training and experience;
(3) Medical specialty certification plus a specified number of
hours of training and passing an examination;
(4) Possessing an M.D. degree;
(5) Passing an examination focused on radiation safety; and
(6) Passing an examination focused on radiation safety and having
specified clinical experience.
The options were primarily analyzed in terms of therapeutic versus
diagnostic uses of byproduct material. Many participants involved in
therapeutic medical uses supported the status quo requirements for such
uses (generally requiring either medical speciality board certification
or a specified number of hours of classroom and laboratory training)
because such requirements have served patients and the public well.
They maintained that board certification ensures the appropriate level
of training and experience and were cautious about any change that
could diminish assurance of competency. However, some proponents of the
status quo would accept the use of medical specialty boards other than
those currently listed in Part 35. Some participants also felt that
clinical experience in handling radionuclides and patient cases,
especially across a broad range of developing therapy, is crucial.
Representatives of diagnostic uses of byproduct materials asserted that
the status quo effectively prohibits some medical practitioners from
using byproduct materials which they could safely use if the training
requirements were decreased. They believe that an examination component
of the training and experience requirements is extremely important in
setting a standard for authorized users. Some diagnostic users
recommended that about 150 hours of didactic training and associated
clinical experience would be sufficient.
The discussion of training and experience requirements addressed
the viewpoint that all professionals involved in handling
radionuclides, including medical physicists, authorized nuclear
pharmacists, nurses, technologists, dosimetrists, and physician's
assistants, should be subject to the training and experience
requirements. Some participants supported degree requirements, such as
a master's degree in health physics. Opposition to such a requirement
was based on the concept that performance criteria, rather than a
degree, should be the basis for determining competence for certain
positions, such as the Radiation Safety Officer or nuclear
technologist. Another viewpoint expressed was that the nuclear medicine
technologist, rather than the authorized user physician, should be the
focus of training and experience requirements, because the technologist
actually handles the radioactive material.
Participants believed that training and experience requirements are
essential for ensuring the competency of a Radiation Safety Officer.
They generally expressed support for the status quo for training and
experience requirements for the Radiation Safety Officer, but
questioned whether an authorized user should automatically qualify as a
Radiation Safety Officer. Specifically, some participants believed that
an authorized user should not also be the Radiation Safety Officer
because of ``potential conflicts of interest'' (i.e., the Radiation
Safety Officer should not be influenced by the ``administration'' of a
facility). Other participants noted that an authorized user physician
might be a specialist whose practice includes a limited application of
the medical use of byproduct material, and who does not have sufficient
training in radiation safety to address problems that might occur.
Certain participants believed that it may be appropriate for an
authorized user to be a Radiation Safety Officer at a small hospital,
even if that authorized user did not have the breadth of training to be
a Radiation Safety Officer at a large hospital. A concern of some
participants is that there may not be anyone other than the authorized
user to assume the responsibility as a Radiation Safety Officer at
small community hospitals. In those cases, an authorized user, who is
also the Radiation Safety Officer, was seen to be preferable to not
having a Radiation Safety Officer.
Workshop participants generally did not question the current
training and experience requirements for the Radiation Safety Officer.
Some suggested changes for the Radiation Safety Officer's training and
experience were discussed, such as varying the training and experience
to correspond to the type of license or duties performed by an
individual Radiation Safety Officer; to have a ``core competency'' set
of requirements (which could be supplemented with additional
requirements for modalities posing greater risks); or to substitute a
Masters of Science degree for the 200-hour training requirement.
Certain participants involved in ``low-dose'' medical uses
concluded that Part 35 should include training and experience for
medical physicists. They noted that training and experience
requirements should correspond to the duties and responsibilities of
the physicist for different modalities (i.e., instrumentation for
nuclear medicine, radiation treatment planning, or administration of
doses for radiation therapy).
Comments by participants on this issue were favorable regarding
training and experience for the authorized nuclear pharmacists. Some
participants specifically stated that, based on risk, radiopharmacy
training and experience should be handled similarly to other diagnostic
modalities.
Training and experience requirements for ancillary personnel, such
as technologists, were briefly discussed. Some participants supported
training and experience requirements for technologists because the
technologists, rather than the physicians, handle the radioactive
materials. One participant, a nuclear medicine technologist, indicated
that there are already organizations that have established voluntary
training and experience requirements for technologist certification.
The individual did not believe that these organizations would endorse
other exams. The individual also indicated that, if proposed, training
for technologists should be risk-based.
2. Agreement State Workshop
Discussions at the Agreement State Workshop focused on whether
NRC's training and experience requirements should focus exclusively on
the radiation safety aspects of an authorized user's training, leaving
issues such as patient selection and reading scans to be part of the
``practice of medicine.''
[[Page 43520]]
Workshop participants were divided on this issue. Those answering this
question affirmatively believed that NRC should focus on assuring that
physicians are capable of safely handling and using byproduct material.
One participant indicated that the level of education to demonstrate
competence should be uniform regardless of the hazard posed by the
material. Other participants believed that, from the patient's
perspective, the physician's role goes beyond safety and into areas
such as patient selection and scan interpretation.
One member of the public argued that NRC and Agreement States
should require physicians to master quantitative radiation protection
science before permitting them to become authorized users. The
individual also believed that NRC and the Agreement States should rely
solely on physician practice privilege committees, State Boards of
Medicine, and the Joint Commission on the Accreditation of Health Care
Organizations to determine the qualifications of physicians to practice
nuclear medicine.
The Agreement States were concerned about the resources needed to
develop and validate examinations. One participant stated that creating
and validating a new exam would be costly in comparison to seeking out
existing exams that were validated and acceptable to the NRC.
Training and experience requirements for ancillary personnel, such
as technologists, were discussed. A representative of the nuclear
medicine technologist profession stated that the role of the
technologist entailed more than the safe handling of radioactive
materials. The role of the technologist was to provide the physician
with the information needed to treat the patient. The individual went
on to indicate that the success of the entire diagnostic process
correlated with the education and training of the technologist and
physician. The individual indicated that groups currently certifying
technologists support certification for technologists and State
legislation mandating that technologists be licensed. The individual
also indicated that these certifying groups did not favor NRC setting
standards for training and experience for technologists because the NRC
does not have the experience necessary to determine what the training
requirements for technologists should be.
One workshop member confirmed that a number of States require that
technologists be certified. The participant noted that the Conference
of Radiation Control Program Directors (CRCPD) was planning on
discussing minimum training and experience qualification criteria for
technologists. These requirements would be added to the Suggested State
Regulations.
3. Advisory Committee on Medical Uses of lsotopes (ACMUI)
Training and experience requirements have been discussed on
numerous occasions with the ACMUI. The ACMUI most recently discussed
training and experience for authorized users, authorized medical
physicists, authorized nuclear pharmacists, and Radiation Safety
Officers at its March 1-2, 1998, meeting. The ACMUI agreed with the
Commission's proposed general approach to training and experience,
i.e., delete reference in the rule to the speciality boards names,
require preceptor forms, and require that competency be demonstrated by
successful completion of an examination. Members debated whether it is
possible or prudent, with respect to authorized user physician
training, to separate the hours required for radiation safety training
from the entire clinical training period.
The ACMUI unanimously recommended that the current training
requirements for authorized users of sealed sources and devices for
therapeutic applications (proposed Secs. 35.400 and 35.600) be
maintained. Specifically, they recommended retaining the 3-year
clinical training in an accredited program as an alternative to medical
speciality board certification. The ACMUI agreed with the views
expressed by members of the radiation oncology professional societies
who made formal presentations at the March 1998, meeting. Specifically,
they agreed that the current requirements for authorized users of
brachytherapy and therapeutic medical devices should be retained
because of the risk associated with use of these modalities and because
radiation safety training and clinical competence are intertwined for
uses of these devices.
The ACMUI unanimously recommended that the training requirements
for authorized users of unsealed byproduct material for diagnostic uses
(proposed Secs. 35.100 and 35.200) be reduced to the levels proposed by
the NRC staff (120 hours in a structured educational program). The
ACMUI did not reach a consensus on the training requirements for
authorized users of unsealed byproduct material for therapeutic uses.
The NRC staff recommended reducing the training requirements to a 120-
hour structured educational program and limited casework. Some members
of the ACMUI were concerned that training for these uses should be
addressed in a manner similar to that used for the therapeutic uses of
sealed sources. Finally, they unanimously agreed with NRC staff's
recommendation for training requirements for authorized nuclear
pharmacists (700 hours in a structured educational program) and medical
physicists (Masters of Science degree and 2 years).
4. Written Comments
Authorized Users Training and Experience Requirements for Unsealed
Byproduct Material
The Commission received numerous comments from professional
societies and individual physicians on the training and experience
requirements for use of unsealed byproduct material.
Many professional societies, as well as individual physicians, were
concerned that a reduction in training hours, as proposed in a January
20, 1998, ``strawman'' version of the proposed rule, would not provide
adequate training and might result in approval of poorly trained
practitioners. They believe that it is impossible to distinguish
between safety and competence. They indicated that the current
requirement for 500 hours of clinical experience is an important
``patient safety regulation.'' Some professional organizations
recommended that the Commission maintain the current training
requirements in this area for authorized users, but also recommended
that the training be provided only in programs accredited or approved
by the American Council on Graduate Medical Education. Others believed
that training and experience should be developed, administered, and
monitored by medical speciality organizations with experience in
clinical radiation-related technologies.
One professional society supported the reduction in training hours.
This organization recommended that physicians, who are not certified by
an NRC-approved medical speciality board, be required to pass an
examination and to obtain a written certification from a preceptor that
indicates that the individual is able to function independently on all
aspects of radiation safety.
Another society suggested that competence in radiation safety be
demonstrated in a performance-based manner, e.g., NRC would not specify
a specific number of hours, but would assess competency through a
comprehensive examination.
[[Page 43521]]
One society urged the Commission to maintain the current training
and experience requirements for use of byproduct material to treat
hyperthyroidism or thyroid carcinoma. This organization opposed the
proposal in the ``strawman'' proposed rule to increase the number of
training hours needed to use material to treat hyperthyroidism or
thyroid carcinoma and opposed the requirement for an examination. This
organization believed that the proposed increase in training and
experience requirements would have a detrimental effect for patient
care, such as referral of patients to other specialists using less
desirable alternative treatments.
One commenter indicated that a minimum of 120 hours of classroom
and laboratory training and 240 hours supervised practical experience,
or a 3-month training program in nuclear medicine, was appropriate for
diagnostic nuclear medicine.
Training and Experience for Use of Sealed Sources in Therapy
The NRC received approximately 330 letters providing input to the
rulemaking process. Approximately 90 percent of these comments were
from radiation oncologists who feel very strongly that the current
training and experience requirements for authorized users of
brachytherapy and therapeutic medical devices should be retained
because of the high risk associated with use of these modalities and
because radiation safety training and clinical competence are
intertwined for uses of these devices.
Commenters believed that training and experience requirements
should be consistent with that required for certification by the
American Board of Radiology (i.e., 3 years of therapeutic radiology and
at least 6000 hours of direct clinical experience). If the Commission
were to consider other medical speciality boards for certification of
physicians seeking approval as authorized users to perform
brachytherapy and teletherapy, the training required by those boards
should be the same as that required by the American Board of Radiology
for certification in therapeutic radiology. Certain comments
specifically objected to either an NRC-developed or NRC-approved
examination, because that would mean that the standards of the American
Board of Medical Specialities and its twenty-four member boards are
``too high.''
Most commenters believed that thorough training in radiation
oncology should be required for all physicians seeking to perform
applications of ionizing radiation to treat disease. According to
certain comments, therapeutic treatments of the heart and brain are
high-risk procedures and ``relaxing'' these requirements would not be
in the best interest of patients or the medical profession at large.
They maintained that training requirements for coronary artery
brachytherapy and gamma stereotactic radiosurgery should be the same as
those for other brachytherapy and teletherapy modes of treatment,
respectively, and not broken into ``tiny site-specific'' modalities
with different training requirements.
Other commenters noted that radiation oncologists should be
involved, as part of a team with cardiologists and neurosurgeons, in
brachytherapy treatment of the heart and use of gamma stereotactic
radiosurgery of the brain. Other comments described the ``full
complement'' of training for these medical uses as covering radiation
biology, radiation physics, and radiation safety.
A professional organization offered criteria for training and
credentialling of cardiologists performing brachytherapy involving
coronary and vascular interventions. This organization believes that
cardiologists should perform intravascular brachytherapy in
collaboration with medical physicists, Radiation Safety Officers, and
medical dosimetrists.
5. Resolution
The Commission considered all of the input on training and
experience that was provided during the development of this rulemaking.
On the basis of the public input, the Commission is proposing the
following training and experience criteria for authorized users,
authorized medical physicists, authorized nuclear pharmacists, and
Radiation Safety Officers:
(1) The requirements for training and experience should be risk-
informed and focused on radiation safety;
(2) Individuals should complete a structured educational program
that consists of didactic training and practical experience;
(3) Specific reference to speciality boards, by name, should be
deleted;
(4) Speciality boards will be approved by the Commission or an
Agreement State if the board certification process includes all the
training and experience requirements associated with the equivalent
training pathway;
(5) Preceptors, when required, should certify that individuals have
achieved a level of competency sufficient to function independently as
an authorized user for the requested use, an authorized medical
physicist, an authorized nuclear pharmacist, or a Radiation Safety
Officer; and
(6) Individuals should demonstrate sufficient knowledge in
radiation safety by passing an examination given by an organization or
entity approved by the Commission or an Agreement State.
The Commission believes that training and experience criteria
should be risk-informed and focused on radiation safety. In addition,
the Commission believes that, by requiring a combination of a
structured education program, preceptorship, and examination focused on
radiation safety, individuals will be able to safely handle byproduct
material. However, it is important to note that an individual's status
as an authorized user, authorized medical physicist, authorized nuclear
pharmacist, or Radiation Safety Officer means that an individual has
met the requirements to handle byproduct material safely and is not an
assessment of the individual's clinical or professional competency.
The Commission believes that individuals should complete a
structured educational program that consists of didactic training and
practical experience. The number of hours and type of training were
extensively discussed with the medical societies and speciality boards
and have been the primary issue in the public input received on the
rulemaking. However, the Commission recognizes that radiation safety
training and clinical competency may be intertwined, especially for
uses of therapeutic medical devices. Because of the high risk
associated with use of sealed sources in therapeutic medical devices,
the Commission has not proposed significant changes in the current
training requirements for authorized users in this area, with the
exception of the training required for the use of strontium-90 eye
applicators. Under the proposed rule, authorized users of strontium-90
eye applicators will need to meet the training requirements for
authorized users of therapeutic medical devices. The Commission
believes this change is warranted in light of the similarity between
the use of strontium-90 eye applicators and the use of sealed byproduct
material in medical devices and the recent misadministrations involving
strontium-90 eye applicators. It is important that the didactic
training include courses in radiation physics, dosimetry, and radiation
biology so that the authorized users have a clear understanding of what
a dose means in terms of radiation damage to the exposed tissue.
[[Page 43522]]
The Commission has focused the training requirements for use of
unsealed material for diagnostic administrations when a written
directive is not required on radiation safety because of the low risk
posed by the radionuclides. In doing so, the didactic and practical
requirements for authorized users of unsealed byproduct material for
diagnostic procedures were significantly reduced.
The didactic and practical requirements for use of unsealed
byproduct material when a written directive is required were also
reduced because of similarities between the use of unsealed material in
a diagnostic setting and use in a therapeutic setting. However, the
Commission recognized that the use of both therapeutic unsealed sources
and sealed sources involve higher risks and, therefore, retained the
requirement for clinical experience.
The proposed rule would delete the current, specific training and
experience sections that pertain to treatment of hyperthyroidism and
thyroid carcinoma. Under the proposed revision of Part 35, individuals
wishing to become authorized users of byproduct material for these
medical uses would be required to meet the training requirements that
apply to the use of unsealed material for which a written directive is
required (Sec. 35.390). The proposed rule specifies that (1) the
structured educational program for these individuals include an
additional 40 hours of supervised practical experience; (2) these
individuals have experience involving at least five cases for each
procedure with radiation safety hazards similar to that use for which
the individual is requesting authorized user status; and (3) these
individuals pass an examination to demonstrate competency in
radionuclide handling techniques applicable to the use of unsealed
byproduct material.
The Commission recognizes that this proposed rule change places
additional requirements on those individuals that wish to become
authorized users of byproduct material for only the treatment of
hyperthyroidism and thyroid carcinoma. However, it does expect that
many of the practical hours will be obtained concurrently with the
casework, therefore lessening the burden on the individuals. The
Commission recognizes that there have been very few misadministrations
that have occurred in this area (1995 and 1997). However, it believes
that this change is consistent with the Commission's general intent to
(1) focus training and experience criteria on radiation safety; (2)
require that all authorized users have practical experience in the
handling of radionuclides; and (3) require that competency be
demonstrated by passing an examination.
The Commission believes that any reference, by name, to specialty
boards should be deleted from the regulation for two reasons. First,
under the current Part 35, in which speciality boards are listed by
name, a rulemaking is needed to add new boards or to delete existing
boards. This has been a problem with the current Part 35 because on
several occasions individuals requesting authorized user or medical
physicist status have been certified by a speciality board that is not
listed in the regulations. In these cases, NRC has had to evaluate the
training of individuals, with the help of the ACMUI, on a case-by-case
basis. Secondly, the current rule does not provide for periodic review
of certifying boards to determine if any changes have been made in
their certifying programs.
The proposed rule would require that specialty boards be approved
by the NRC or an Agreement State. A specialty board will be approved by
NRC if the certification process includes all of the requirements
listed in the equivalent training pathway, i.e., completion of a
structured educational program of specific duration that covers
specific topics; obtaining a signed preceptor certification; completion
of patient casework, if required; and successful completion of an
examination on radiation safety. The Commission plans to discuss
proposed board approvals with the ACMUI prior to approving the boards.
The NRC staff also plans to conduct periodic reviews of approved
speciality boards to assure that they continue to meet commitments to
NRC. If a board does not meet its previous training and experience
commitments, it will be removed from NRC's list of approved boards. A
list of approved boards will be maintained on the NRC external website.
In addition, the Commission is contemplating noticing the approval of a
speciality board in the Federal Register.
The Commission is proposing that preceptors, when required, should
certify that individuals have achieved a level of competency sufficient
to independently function as an authorized user for the use that they
are requesting: a medical physicist, an authorized nuclear pharmacist,
or a Radiation Safety Officer. In the current Part 35, a preceptorship
is only required for authorized nuclear pharmacists. The current
preceptors for authorized nuclear pharmacists are only required to
attest to the fact that the individual has performed a specified number
of cases/treatments. Preceptor forms will be revised to add a warning
that 18 U.S.C. Section 1001 Act of June 25, 1948, 62 Stat. 749, makes
it a criminal offense to make a willfully false statement or
representation to any department or agency of the United States as to
any matter within its jurisdiction.
The Commission believes that individuals should demonstrate
sufficient knowledge in radiation safety commensurate with the use
requested by passing an examination given by an organization or entity
approved by the Commission or an Agreement State. The Commission is
soliciting specific comment on whether the requirement for an
examination to verify competency is warranted, in light of current
industry practice. Appendix A of the proposed rule provides the
requirements for an examining organization or entity, examination
programs, and written examinations. Of particular note is the
requirement that procedures be established to ensure that examinations
are not given to individuals who have also been instructed by the
examining organization in the same subject area. This proposed
requirement is consistent with current practices of medical specialty
boards and was suggested for inclusion by ACMUI members. The Commission
is also soliciting specific public comment on whether this proposed
requirement is too prescriptive.
It is expected that examinations will be specific to the risk
associated with the medical use of the byproduct material. For example,
it is reasonable to expect that one exam could be used to address an
authorized user's competency for the medical use of material pursuant
to Secs. 35.100, 35.200, and 35.300, and that another examination would
be needed to assess competency for use pursuant to Secs. 35.400 and
35.600. The Commission plans to discuss the examination process with
stakeholders at the facilitated public meetings scheduled to be held
during the comment period of this rulemaking.
NRC expects that it will take approximately 2 years for the
industry to submit required information, to NRC or an Agreement State,
for approval of specialty boards or organizations providing the exam
and for NRC to approve the boards or examining organizations. This
expectation is based on written and verbal support, received from
professional organizations, for training and experience requirements
that would require written examinations to assess competency and, on
statements made by members of specialty boards
[[Page 43523]]
indicating that only minor changes would need to be made to their
current certification process to address the changes proposed by the
Commission. The Commission anticipates that specialty boards and
examining organizations will be prepared to submit requests for
approval immediately following publication of the final rule.
Nevertheless, the Commission is soliciting specific public comment on
the amount of time that specialty boards and examining organizations
will need to prepare and submit an application for approval of the
Commission or an Agreement State.
Since NRC expects that it will take approximately 2 years to
complete approval of most specialty boards and examining organizations,
NRC has maintained the current training requirements in subpart J of
the proposed rule. As discussed under the Supplementary Information
section of this document, for a 2-year period after publication of the
final rule, licensees will have the option of meeting either the
requirements in subpart J or the requirements in subparts B and D-H.
After the 2-year period, the requirements in subpart J will be deleted,
and the licensee will need to comply with the requirements in subparts
B and D-H.
B. Quality Management Program
1. Facilitated Workshops
Workshop participants expressed both support for the quality
management program and opposition to it. Those who support it described
several benefits of the program, including the requirement for
licensees to have a quality management program and related requirements
for ``recordable events'' and written directives. Opponents of the
quality management program rule described it as overly prescriptive,
burdensome on licensees, and ineffective in reducing the number of
misadministrations. According to certain participants, the current
quality management program rule interferes with quality medical care.
Many believed that the current quality management rule did little to
reduce the number of misadministrations.
Some participants who did not support the quality management
program expressed support for a performance-based rule that would not
require licensees to submit the quality management program for
regulatory approval. In their opinion, a performance-based rule would
also provide a licensee with the flexibility to custom-tailor a quality
management program to meet that facility's quality management needs,
including patient verification, ensuring that physician's directions
are written, and verifying doses to patients. Some participants
proposed that NRC work with other organizations or agencies to ensure
quality assurance through other mechanisms in place. Another
recommendation was that the proper way to reduce misadministrations is
through better training and ensuring, during the licensing process,
that personnel are qualified.
2. Agreement States Workshop
Some Agreement States and members of the public agreed that the
current quality management rule has not addressed the problem of
misadministrations. In addition, they do not believe that the quality
management rule goes beyond what would typically be considered
``quality management.'' They believe that modifying the quality
management program will not solve that problem.
Agreement States supported an option that would state the
objectives of a quality management program (without being
prescriptive), but would not require a written quality management
program. Other States believed that the responsibility for quality
management should lie exclusively with the medical facility, not with a
regulatory agency.
A member of the public advocated, in lieu of a quality management
program, a training requirement for technicians and a requirement that
a physician be present whenever a therapeutic dose is administered. The
individual stated that the latter requirement has significantly reduced
the number of misadministrations in her State. Another member of the
public suggested that a proposed rulemaking by the Health Care
Financing Administration (HCFA) was expected to define three levels of
supervision for imaging modalities. He explained that physicians would
be required to be in the facility, if not in the room, when a dose was
being administered in diagnostic nuclear medicine.
3. ACMUI
Requirements for a quality management program have been discussed
on numerous occasions with the ACMUI. At the September 1997 meeting,
the Committee recommended that the Commission pursue development of a
rule that would state only the objectives for a quality management
program. At the March 1998 meeting, the ACMUI discussed the NRC staff's
proposed revisions to the quality management program. The ACMUI agreed
with the NRC staff's proposal to delete the requirements for a quality
management program. Although the ACMUI would have preferred deletion of
the requirement for written directives and the reference to assuring
high confidence that the patient's or human research subject's identity
is verified and that each administration is in accordance with the
written directive, it recognized that the Commission finds these
objectives to be fundamental.
4. Written Comments
Approximately 10 written comments were submitted to the Commission
on the quality management program. The majority of the comments favored
deletion of any requirements in this area. Most believed that there
were industry standards in place that adequately addressed
administration of byproduct material; the rule intruded into medical
practice; and regulation in this area was onerous. One professional
society recommended that the title be changed to ``Quality Assurance
and Patient Safety Regulations'' and believed that the regulations
should be limited to requiring written prescriptions for therapy;
requiring licensees to develop quality assurance programs for treatment
planning and delivery devices; and requiring that independent checks be
made against the written prescription before completion of a treatment.
A limited number of commenters believed that the current requirements
should be maintained because the quality management program provides a
mechanism for reporting events and because licensees have already
developed quality management plans that meet the intent of the rule.
5. Resolution
The Commission has deleted the requirement for a quality management
program. However, the Commission believes there are three elements of
the current quality management program that should be addressed in the
proposed rule: confirming patient identity, requiring written
directives, and verifying dose. The Commission believes that some
elements of the current quality management program requirements will
continue to be implemented as part of the ``standard of care'' in
medicine. In this regard, the Commission acknowledges that other
factors, such as accreditation, have resulted in medical institutions
adopting programs similar to those previously specified in the rule.
[[Page 43524]]
C. Reportable Events
1. Facilitated Workshops
The participants generally agreed that current threshold levels for
reporting are too low and supported raising threshold levels. However,
some participants supported the option of maintaining the current
thresholds, arguing that they were familiar with the levels and reports
and records of misadministrations are necessary. Participants agreed
that threshold levels for recording and reporting events should be
based on risk. Several participants argued that threshold levels for
reportable events and Abnormal Occurrences should be the same. The NRC
was commended for suggesting that the term ``misadministration'' be
replaced with the term ``reportable event.''
2. Agreement State Workshop
Discussion focused on the topic of precursor events, rather than on
the threshold for reportable events. There was, however, a very brief
discussion on reporting of misadministrations. Various statements made
during the discussion included: regulatory agencies did not need to be
informed of misadministrations, unless an event exceeded certain levels
or occurred more than once; licensee management, rather than a
regulatory agency, should be informed of misadministrations; and
regulatory agencies should confirm, during periodic inspections, that
licensee management is informed in cases of misadministrations, and
that proper corrective actions are taken.
3. ACMUI
The ACMUI discussed the threshold for reportable events at the
September 1997 and March 1998 meeting. At the September 1997 meeting,
the Committee reached a consensus, recommending that the current
criteria for radiopharmaceutical misadministrations be reduced from
three categories to two. The two categories would be
``radiopharmaceuticals not requiring a written directive'' and
``radiopharmaceuticals requiring a written directive.'' The Committee
pointed out that there is a major deficiency in the current
misadministration definition, i.e., there is no threshold dose for
wrong treatment site. They also stated that the reporting mechanism
should be decoupled from patient notification. Finally, they agreed
that an underdosage, if corrected in a clinically timely manner, should
not have to be reported.
At the March 1998 ACMUI meeting, the NRC staff presented a proposed
revision of the current reporting criteria. The proposed reporting
requirement contained a dose threshold and modality-based criteria. The
ACMUI discussed the proposed criteria and offered suggestions for minor
technical corrections, but did not make a formal recommendation in this
area. The Committee recognized that the NRC staff was still making
changes in the proposed text to address the wrong treatment site and
patient intervention.
4. Written Comments
Sixteen comments were received in this area. Two of the commenters
recommended raising the reporting threshold to the NRC's Abnormal
Occurrence criteria for misadministrations. Several commenters provided
general comments on the reporting criteria, including a name change
from ``misadministration'' to ``medical event.'' The remainder of the
commenters provided specific recommendations for changes to the current
reporting criteria, including recommendations for addressing patient
intervention and wrong treatment site.
5. Resolution
The Commission has a statutory responsibility to keep Congress and
the public informed of incidents or events which the Commission
considers significant from the standpoint of public health and safety.
These criteria are specified in NRC's Abnormal Occurrence Policy
Statement, dated April 17, 1997 (62 FR 18820). Licensees must provide
NRC with information on events meeting these criteria, in order for NRC
to make needed reports to Congress.
The term ``misadministration'' has been deleted. The proposed rule
would require licensees to report ``medical events.'' The criteria for
a medical event is based on the current requirements in Sec. 35.33,
Notifications, reports, and records of misadministrations. Minor
changes were made to make the reporting threshold dose-based, where
possible, and to address two areas that have caused problems in
implementing the current requirements in Sec. 35.33, Patient
intervention and wrong treatment site.
D. Precursor Events
1. Facilitated Workshops
Participants in the facilitated public workshops, as well as
members of the public, believe that:
(1) There are already adequate mechanisms in place for identifying
precursor events;
(2) Additional requirements for notifying NRC about precursor
events could result in a significant financial burden for both NRC and
licensees without an associated incremental increase in safety;
(3) Because of the nature of precursor events, it will be hard to
precisely define a precursor event in rule language; and
(4) Inclusion of a requirement for reporting precursor events could
lead to an additional basis for enforcement action.
2. Agreement State Workshop
The discussion on this subject focused on how to identify
``precursor events.'' Many of the participants opposed adding
additional requirements for reporting precursor events. According to
some Agreement States, mechanisms are already in place to provide
information to licensees about incidents which may be ``precursors'' to
reportable events. Most States were in favor of identifying precursors,
but believe notification should be limited to facility management
(especially the radiation safety organization). Some participants noted
that reporting those events to a regulatory agency could actually
inhibit their identification. They did, however, support internal
programs for identifying precursor events. Finally, they stated that
reporting to NRC or to the Agreement States would not be helpful unless
a mechanism existed to share the information with the industry.
A member of the public noted that there are numerous event
reporting requirements under which medical institutions document
problem areas and conduct audits of potential problem areas. The
individual encouraged NRC to avoid duplicating already existing
programs.
3. ACMUI
The ACMUl discussed the best way to capture precursor events at its
September 1997 and March 1998 meetings. At the September 1997 meeting,
most Committee members supported voluntary reporting of precursor
events, provided there would be no punitive action taken by NRC against
a licensee as a result of a report. One member recommended against
reporting of precursors, whether mandatory or not, if it was going to
have significant resource implications for NRC or the licensee.
At the March 1998 meeting, the ACMUl considered three alternatives
proposed by NRC staff:
(1) Require reporting of conditions or incidents related to the use
of radionuclides in medicine that caused or could cause serious injury
to a
[[Page 43525]]
patient, human research subject, worker, or the public;
(2) Require reporting deficiencies in equipment or procedures
supplied by a manufacturer or vendor that, in the opinion of the
Radiation Safety Officer, could lead to a medical event at that
facility or could have detrimental health and safety implications
beyond the licensee's facility; and
(3) Rely on current NRC reporting requirements in 10 CFR parts 20,
21, and 30 and the Memorandum of Understanding with the U.S. Food and
Drug Administration and monitor/establish a system with U.S.
Pharmacopeia to review its database on event reports.
The ACMUI acknowledged that the Commission wanted to capture
precursor events. The ACMUI believed that it was appropriate to clearly
define and limit the type of events that would be required to be
reported in order to minimize the resource burden on licensees and the
NRC. The ACMUI recommended that the NRC staff pursue the second
alternative, with minor adjustments.
4. Written Comments
Approximately five written comments were received on capturing
precursor events. One commenter indicated that NRC should develop a
nonpunitive method of capturing information while minimizing the burden
on licensees, citing the FDA device malfunction reporting system as a
model. Three other commenters felt that precursor events were not
specifically enough defined (in an earlier draft of the proposed rule)
and recommended that they not be included in the proposed rule. Of the
remaining two commenters, one commenter did not support reporting
precursor events under any condition, while the other supported
voluntary reporting.
5. Resolution
The proposed rule does not contain a requirement for licensees to
report precursor events to the NRC. Based on comments received from the
public, the Commission believes that there are existing regulations in
place that contain sufficient requirements for licensees to identify
and report events to the Commission. The Commission plans to issue an
Information Notice to remind licensees of the current reporting
requirements and to reinforce the need for compliance with these
requirements.
E. Radiation Safety Committee
1. Facilitated Workshops
Workshop participants expressed different opinions about the
benefits of radiation safety committees. Some participants stated that
although radiation safety committees may be beneficial, the time and
resources that must be devoted to managing the committees are excessive
and the specific requirements in the regulation are overly prescriptive
and not risk-based. Many participants believed that licensees should be
given more flexibility in how they administer radiation safety
programs. Some participants also expressed concern that the radiation
safety committee may not be necessary for effective radiation safety
management at small medical institutions.
Some participants believed that a single committee, focused on
radiation safety, was an important element of a radiation safety
program and, therefore, recommended that the requirement for a
committee be maintained. They believed that the committee enhanced
communication between disciplines and departments. They were concerned
that, without a requirement for a radiation safety committee,
administrative support for the committee would decline and there would
be decreased management involvement in the radiation safety program.
2. Agreement States
Discussions at the workshop centered around two issues:
(1) Whether the radiation safety committee plays a valuable role in
all medical institutions, regardless of size and use of byproduct
material; and
(2) Whether the current radiation safety committee requirements in
Part 35 are too prescriptive and should be relaxed.
The majority of the participants in the workshop argued that the
radiation safety committee requirements should recognize the
differences between large and small institutions and between low-and
high-risk procedures. Participants asserted that a radiation safety
committee is unnecessary at smaller, diagnostic facilities. They
generally supported the lessening of prescriptive requirements for
smaller, diagnostic facilities. They argued that regulations place an
unnecessary burden on facilities that conduct few procedures per year
but still are required to conduct quarterly meetings. Another
participant opposed a prescriptive rule, but acknowledged that it would
be simpler to enforce than a performance-based rule.
3. ACMUI
Requirements for a radiation safety committee were discussed with
the ACMUI at its September 1997 and March 1998 meetings. At the
September 1997 meeting, the ACMUI recommended that the NRC staff pursue
developing a requirement for radiation safety committees at
institutions that perform high-risk procedures. Facilities that use
diagnostic, low-dose, sealed and unsealed byproduct material would not
be required to have a radiation safety committee.
At the March 1998 meeting, the ACMUI agreed with the Commission's
proposed deletion of the requirement for a radiation safety committee.
ACMUI supported the addition of requirements for licensee management to
approve licensing actions and minor revisions to the radiation safety
program; and for a licensee to implement procedures for
interdepartmental/interdisciplinary coordination of the licensee's
radiation protection program. They believed that the proposed language
would not prohibit a large organization from utilizing a radiation
safety committee, but would, at the same time, reduce regulatory burden
on small rural hospitals which have small staffs and where a committee
may not be needed to manage the radiation protection program.
4. Written Comments
Approximately 10 written comments were submitted regarding the
requirement for a radiation safety committee. The majority of the
comments favored retention of the requirement for a radiation safety
committee at larger facilities. These commenters believed that a
committee was an effective way to ensure that management is involved in
the operation of the radiation safety program. They recommended that a
``graded'' approach could be used in determining if a committee was
needed, e.g., small facilities or facilities with limited use of
material would not be required to have a committee. However, two
commenters believed that the requirement for a radiation safety
committee should be deleted in its entirety. Two others believed that
the requirements should not be revised.
The Commission recognizes that medical facilities normally have a
number of committees examining various areas, including safety issues,
in response to accreditation requirements, etc. Specification of the
objectives to be met by the radiation protection program (in the
proposed Sec. 35.24), rather than the particular mechanism to be used
in meeting those objectives, is an effort to provide licensees
flexibility in carrying out the responsibilities for radiation safety.
[[Page 43526]]
5. Resolution
The Commission is proposing deletion of the requirement for a
radiation safety committee. The Commission believes that key functions
of the radiation safety committee could be transferred to licensee
management and that the prescriptive requirements in the current rule
should be deleted. The Commission believes that many institutions will
continue to use a radiation safety committee to oversee use of
radioactive material. However, it recognizes that radiation protection
program oversight may be accomplished by other means. In particular,
the Commission recognizes that medical facilities normally have a
number of committees examining various areas such as environmental
safety. These committees are typically formed in response to hospital
accreditation requirements.
In an effort to afford licensees flexibility in achieving the
objectives of radiation safety, the proposed rule specifies objectives
that must be achieved rather than specifying the mechanism to meet the
objective. The proposed rule would require that the licensee approve
licensing actions; individuals prior to allowing them to work as a
Radiation Safety Officer, authorized user, authorized nuclear
pharmacist, or authorized medical physicist; and radiation protection
program changes that do not require a license amendment. The proposed
rule also contains a requirement for the licensee to develop,
implement, and maintain administrative procedures for
interdepartmental/interdisciplinary coordination of the licensee's
radiation protection program.
F. Notification Following a Misadministration or Medical Event
1. Facilitated Workshops
Many participants believed that the current requirements for
licensees to notify the NRC, the referring physician, and the patient
of a misadministration is an intrusion into both the practice of
medicine and the confidential patient-physician relationship. They
stated that the decision whether to notify the patient should be left
solely to the physician. Those participants asserted that medical
``standards of practice,'' ``risk management'' practices of medical
institutions, and tort law are the mechanisms that should address
notification of patients.
Therefore, according to these participants, Federal or State legal
requirements for such notifications are unnecessary and inappropriate.
Some participants believed that an authorized user would never withhold
information from a referring physician because to do so would destroy
the relationship between the authorized user and the referring
physician.
Workshop participants did not believe that the requirement for a
licensee to provide a written report to the individual was appropriate.
They believed that a report that was submitted to NRC may greatly
magnify, in the patient's mind, the significance of the event, when in
fact, a medical event could be of minimal safety significance. However,
other participants stated that without the NRC requirement for patient
and referring physician notification, the physician's ethical
obligation to make these notifications must be strong. Some commenters
believed that the exchange of information between physicians should
extend to patients as well. The participants espousing this viewpoint
believe that such requirements may be necessary to protect patients and
their right to know of misadministrations.
2. Agreement State Workshop
Some participants noted that legal requirements for protecting the
privacy of patients vary from State to State and may differ from
Federal requirements. Other participants stated that medical standards
of practice, tort law, and medical institution risk management are
mechanisms to address fundamental patient notification and, therefore,
State or Federal requirements for such notification are unnecessary.
3. ACMUI
Notification requirements have been discussed on numerous occasions
with the ACMUI. The ACMUI most recently discussed the requirements in
this area at its March 1998 meeting. The ACMUI continues to affirm its
position that it does not support any Federal regulation requiring
notification of physicians and patients. The committee strongly
believes that patient notification of medical events should occur as
part of the patient-physician ``fiduciary'' relationship, in which the
``standard of care'' for a physician is to provide the patient with
complete and accurate information.
4. Written Comments
Three written comments directly addressed notification following a
medical event. Two professional organizations recommended that the
requirement be deleted. One State recommended that the requirement be
maintained.
5. Resolution
The Commission believes that the current requirements for notifying
individuals following a misadministration should remain unchanged with
the exception of substituting the term ``medical event'' for
``misadministration.'' Changing terminology in this way responds to
objections that the term ``misadministration'' has possible
connotations of carelessness and harm, which is not always the case.
Furthermore, the term ``medical event'' used in the proposed rule is
consistent with the terms used to characterize events in other
activities regulated by the NRC. The proposed rule would require that
the licensee notify the NRC, referring physician, and the individual
who is the subject of a medical event, unless the referring physician
personally informs the licensee that he will inform the individual or
that, based on medical judgment, telling the individual would be
harmful. In the latter case, or if for example, the patient is a minor,
or is unconscious and incapable of comprehending the information. It is
expected that the licensee would report to the patient's responsible
relative or guardian rather than to the patient. This position
reaffirms statements made by the Commission, at the time the
misadministration rule was proposed and/or promulgated (and later
modified), that patient notification ``* * * recognizes the right of
individuals to know information about themselves which is contained in
records both inside and outside the Federal sector.'' ``Human Uses of
Byproduct Material, Misadministration Reporting Requirements,'' (43 FR
2927; May 7, 1978); ``Misadministration Reporting Requirements,'' (45
FR 31701-31702; May 16, 1980); and ``Basic Quality Assurance Program,
Records, and Reports of Misadministrations or Events Relating to the
Medical Use of Byproduct Material,'' (55 FR 1439-1444; January 16,
1990). The Commission also believes that patient notification enables
patients, in consultation with their personal physicians, to make
timely decisions regarding any remedial and prospective medical care.
This approach would also codify existing industry standards [American
Medical Association Principles of Medical Ethics] obligating physicians
to provide complete and accurate information to their patients.
This approach is consistent with the U.S. Food and Drug
Administration (FDA) regulation and with how
[[Page 43527]]
Congress is addressing similar issues in the mammography area. In
October 1992, Congress passed the ``The Mammography Quality Standards
Act'' (Public Law 102-539) to establish national quality standards for
mammography. In December 1993, the FDA promulgated interim regulations
setting forth quality standards for mammography facilities. In October
1997, the FDA issued a final rule that becomes effective in April 1999.
The final rule requires that, in cases where ``FDA determines that the
mammography program at a facility may present a serious risk to human
health, a facility must notify the patients or their designees, their
physicians or the public of action that may be taken to minimize the
effects of the risk.'' Currently, the Senate has passed and the House
is considering bills (S. 537 and H.R. 1289) to amend the Mammography
Quality Standards Act to, inter alia, add a new section to the Act on
patient notification. The bills will provide FDA with the authority to
require a facility to notify patients (and their referring physicians)
of, among other things, the potential harm resulting from mammograms
that may have been of poor quality because of deficiencies in the
mammography program at that facility.
G. General Comments
In addition to the comments on the crosscutting issues discussed
above, NRC received comments on specific sections of the rule and on
several general topical areas. These comments are available for review
in the NRC Public Document Room, 2120 L Street, NW. (Lower Level),
Washington, DC. Comments on specific sections of the rule were taken
into consideration in preparing the proposed rule. General comments are
summarized below.
1. Process for Developing the Risk-Informed, Performance-based Rule
a. Comments.
Workshop participants and written commenters discussed development
of a risk-informed, performance-based rule. Some commenters recommended
that NRC not proceed with any revision of Part 35 until it had
performed an adequate and comprehensive evaluation of the risks
associated with medical use. They recommended that the assessment
should be performed by an ``independent scientific organization'' and
completed in advance of any rulemaking. The risk analysis should follow
the guidelines outlined by the Presidential Commission on Risk
Assessment and Risk Management.
Some commenters did not believe that the current regulatory system
makes optimal use of either NRC or licensee resources. They believed
that NRC regulations and their associated paperwork burden inevitably
contribute to the cost of providing clinically necessary procedures and
may compromise the availability of the benefits of medical use of
byproduct material. They recommended that NRC be guided by the
following basic principles: rules should emphasize training and
credentialling of professional staff deemed essential to safe
operations, quality assurance and technical regulations should be based
on available practice standards, and regulations should not be
promulgated in the absence of a demonstrated risk to the public or
patients.
Some commenters believe that Part 35 is duplicative of the Food and
Drug Administration (FDA) statutes and implementing regulations and
does not provide any added overall benefits to the regulatory
framework. They believed that the FDA regulatory scheme is
comprehensive, requiring documentation of adverse effects relating to
the use of all drug products, including radionuclides; regulations
under 10 CFR Part 20 are adequate to protect health and safety; high-
risk medical use can be regulated on a case-by-case basis through
licensing conditions; and some prescriptive license conditions can be
offset by performance-based flexibility, which is preferable to
prescriptive regulations of medical users.
Finally, some commenters questioned the schedule for completion of
the rulemaking. They believe that sufficient time must be provided to
undertake a thorough effort to change the rule and for public comment
on draft documents, including regulatory guides. They also believe that
reorganization of Part 35 based on ``similar subject areas'' is
appropriate, but the rule should include references to requirements in
Part 20.
b. Resolution.
As a result of the NRC's Strategic Assessment and Rebaselining
efforts, the NRC staff formed the Nuclear Byproduct Material Risk
Review Group to develop a risk-informed, graded approach to regulating
many material uses, including medical uses. The group's final
recommendations are expected in the fall of 1998 and will be considered
by the NRC staff during the Part 35 rulemaking process. The Commission
considered input from a 1993 internal senior management review report;
an external review report by the National Academy of Sciences,
Institute of Medicine; and the information presented in the Strategic
Assessment Direction-Setting Issue Paper Number 7 (DSI-7) prior to
determining the role of NRC regulation in the medical use area. On the
basis of these reviews, the Commission believes that Part 35 should be
restructured into a risk-informed, more performance-based regulation.
In developing the regulation, the Commission considered information on
risk provided by members of the public and professional societies,
professional medical standards of practice, and event databases
maintained by NRC. The draft proposed rule reflects numerous changes
from the existing requirements which reduce the regulatory burden to
the average licensee.
2. Agreement State Compatibility
a. Comments.
Commenters recommended that NRC follow its Strategic Plan to work
with Agreement States to assure protection of the public health and
safety nationwide, especially where constraints due to inconsistent
regulation result in barriers to accessibility of medical use involving
radionuclides. One commenter suggested that Agreement States should not
be required to adopt any of the revised rule or accompanying guidance
documents.
b. Resolution.
The Working Group and Steering Group established to revise Part 35
are comprised of NRC staff, as well as representatives of two Agreement
States and a non-Agreement State. One of the Agreement State
representatives on the Working Group is also a member of the Conference
of Radiation Control Directors' Suggested State Regulation Committee on
Medical Regulation, which is working toward parallel development of
suggested state medical use regulations. The Working and Steering
Groups received input from the Agreement States at several times during
the rulemaking process. NRC representatives met with representatives of
the Agreement States during the October 1997 All Agreement States
Meeting. Agreement State representatives were invited participants at
the facilitated public meetings. One Agreement State representative
provided written comment during the early input stages of the proposed
rule development.
The Commission has reviewed the proposed rule for issues of
compatibility for Agreement States. Specific designations for the
proposed rule are discussed under Section IX of the Supplementary
Information section of this document.
[[Page 43528]]
3. Licensing and Enforcement Actions
a. Comments.
Some commenters believed that NRC must change to a performance-
based compliance system in order to have a significant impact on the
entire medical use program. They believed that no change would occur if
the NRC deleted regulatory requirements but had license reviewers
demand that licensees make equivalent commitments in license
applications or add equivalent conditions to the license. Some
commenters stated that licensees should be allowed to operate their
radiation safety programs without ``procedure-by-procedure'' approval
by NRC and that regulations should cover all necessary requirements.
Commenters recommended that NRC abandon an adversarial enforcement
strategy based on punishment for infractions.
Commenters also believed that no change would occur if inspectors
continued to apply regulatory and license requirements without regard
to fault, and if inspectors continue the practice of issuing citations
for minor regulatory requirements which can be attributed to normal
human error and which have no safety significance. They stated that NRC
must develop an enforcement system that allows for exercising clinical
judgment, evaluating quality assurance policy deviations in terms of
safety rather than legal significance, and accepting voluntary practice
standards and measures of practice quality as the regulatory endpoints.
b. Resolution.
The proposed rule provides for an overall change in regulatory
philosophy. Consistent with a risk-informed, performance-based approach
to medical use licensing, the amount of information needed from an
applicant to possess and use byproduct material would be reduced. An
applicant for an NRC medical use license would have to submit a signed
application, documentation of the training and experience of the
individuals named on the license, and the facility diagram and list of
instrumentation. While licensees would be required to develop,
implement, and maintain procedures required by the regulations, they
would no longer be required to submit these procedures as part of the
license application. Furthermore, licensees will be provided maximum
flexibility in developing their procedures because most of the
requirements for procedures provide performance-based objectives to be
achieved, rather than a list of prescriptive details that need to be
addressed in the procedures.
The NRC plans to review the enforcement policy as part of its
overall revision of Part 35. This review will take into account written
comments as well as those comments received during the facilitated
public meetings that are scheduled to occur during the formal comment
period.
IV. Discussion of Text of Proposed Rule
10 CFR Part 20--Standards for Protection Against Radiation
Section 20.1301, Dose limits for individual members of the public,
would be revised. The proposed rule responds to the petition from the
University of Cincinnati by amending Sec. 20.1301 to allow a licensee
the discretion to permit visitors to receive up to 5 mSv ( 0.5 rem) in
a year from exposure to individuals who are not releasable pursuant to
Sec. 35.75. Currently, visitors are limited to 1 mSv ( 0.1 rem).
The Commission has used 5 mSv (0.5 rem) as a threshold for action
in multiple locations in Parts 20 and 35. This threshold is used as
both a dose limit and a reporting level. For example, Sec. 35.75 uses
the 5 mSv (0.5 rem) as a dose limit for members of the public exposed
to patients released pursuant to Sec. 35.75. The proposed change to
Sec. 20.1301 would also use 5 mSv (0.5 rem) as a dose limit for
visitors of confined patients. In contrast, however, the proposed
changes to Sec. 35.3047, Report of a dose to an embryo/fetus or a
nursing child, would establish a 5 mSv (0.5 rem) reporting threshold
(reference Sec. 35.3047 for a more detailed discussion of the proposed
change).
In accordance with Sec. 35.75, patients containing radioactive
material can be released from licensee control if the total dose to
other individuals from exposure to the released patient is not likely
to exceed 5 mSv ( 0.5 rem). The Commission recognizes that the
provisions of Sec. 35.75 and the proposed revision to Sec. 20.1301(a)
could result in rare instances in which certain individuals could
receive a 10 mSv (1.0 rem) dose. For example, an individual could
receive a 5 mSv (0.5 rem) dose while visiting a patient who can not be
released pursuant to Sec. 35.75, and then later receive a 5 mSv (0.5
rem) because of exposure from the released patient. The Commission
believes that the authorized user is the appropriate individual to
evaluate, on a case-by-case basis, the merits of allowing a visitor to
receive this potential additional dose and would do so only when it is
warranted by the situation.
A potential consequence of this rulemaking is that pregnant
visitors would not be excluded automatically from visiting individuals
who could not be released pursuant to Sec. 35.75. The pregnant visitor
is subject to the same exposure limits that are applied to any other
adult member of the public. The reasons for not excluding pregnant
visitors under this rulemaking are two-fold. First, as noted in NCRP
Commentary No. 11, members of a radionuclide therapy patient's family
are likely to perceive that visitors will benefit from providing
emotional and physical support to the patient during their treatment,
and these visitors are likely to be willing to bear greater risk in
order to achieve that benefit. Second, declaration of pregnancy by a
prospective visitor is strictly voluntary. If a prospective visitor
does not voluntarily declare her pregnant status, the authorized user
is not expected to demand confirmation of the visitor's nonpregnant
status.
As stated earlier, the proposed revision to Sec. 20.1301 differs
from the proposed revision to Sec. 35.3047. The revision to
Sec. 20.1301 would revise the dose limit for a small population of
individuals, namely visitors to individuals who can not be released
pursuant to Sec. 35.75. In contrast, the proposed revision to
Sec. 35.3047 would establish a reporting threshold for doses to an
embryo/fetus or nursing child. For example, under the proposed
Sec. 20.1301, a pregnant visitor could receive 5 mSv (0.5 rem) as a
result of a visit to a patient who has not been released. Under the
proposed revision to Sec. 35.3047, if the dose to an embryo/fetus
exceeds 5 mSv (0.5 rem), as a result of an unintended administration to
the mother, a report must be submitted to NRC. Finally, in the course
of diagnosis and treatment, an authorized user may approve, in advance,
an administration of byproduct material to a pregnant woman that may
result in an absorbed dose to an embryo/fetus that exceeds 5 mSv (0.5
rem).
The Commission does not intend to require monitoring and recording
of individual doses. The NRC evaluated the costs associated with
monitoring individuals versus the benefits derived and determined that,
at these low doses, monitoring is not justified. However, this does not
preclude the licensee from monitoring and recording individual doses.
10 CFR Part 32--Specific Domestic Licenses to Manufacture or Transfer
Certain Items Containing Byproduct Material
Section 32.72, Manufacture, preparation, or transfer for commercial
distribution of radioactive drugs containing byproduct material for
[[Page 43529]]
medical use under Part 35, would be revised as a result of the proposed
revision of Part 35. Paragraph (b)(1) would be revised to reference the
proposed Sec. 35.27 rather than the current Sec. 35.25 which would be
deleted. This change was necessitated because of the proposed
renumbering of some Part 35 sections. Paragraph (b)(2)(ii) would be
revised to include both the proposed and current training and
experience requirements for authorized nuclear pharmacists and to
reference the proposed Sec. 35.59 rather than the current Sec. 35.972
which would be deleted. As discussed in subpart J, the current training
and experience requirements would be deleted 2 years after the
effective date of the final rule.
Section 32.74, Manufacture and distribution of sources or devices
containing byproduct material for medical use, would be revised as a
result of the proposed revision of Part 35. Paragraphs (a) and (a)(3)
would be revised to add a reference to the proposed Sec. 35.600. The
current section does not include a reference to medical use of sealed
sources in therapeutic devices. This oversight would be corrected by
the proposed rule.
10 CFR Part 35--Medical Use of Byproduct Material
Subpart A, General Information, contains general information
regarding medical use of byproduct material.
Section 35.1, Purpose and scope, would be revised to specify that
the requirements and provisions in Part 35 provide for the radiation
safety of workers, the general public, patients, and human research
subjects. Inclusion of the phrase ``patients, and human research
subjects'' makes it clear that the provisions of this rule would apply
to the radiation safety of those individuals. This addition is
consistent with the proposed revision of the Medical Use Policy
Statement that will be published separately in the Federal Register.
The section would also be revised to add a reference to Part 171,
``Annual Fees for Reactor Operating Licenses, and Fuel Cycle Licenses
and Materials Licensed, Including Holders of Certificates of
Compliance, Registrations, and Quality Assurance Program Approvals and
Government Agencies Licensed By NRC.'' This revision would make it
clear that the provisions in Part 171 apply to medical licensees.
Section 35.2, Definitions, would be amended by deleting the
definitions of ``ALARA,'' ``dental use,'' ``ministerial change,''
``misadministration,'' ``podiatric use,'' and ``recordable event''
because they do not appear in the proposed rule.
The definitions for authorized nuclear pharmacist and authorized
user would be revised to eliminate the specific board certifications by
name and to refer to the specific section containing the requirements
that the individual must meet to be considered an authorized nuclear
pharmacist or an authorized user. Reference to the specific board
certifications would be deleted because the proposed rule contains
provisions for NRC to approve boards. The definition of ``authorized
nuclear pharmacist'' would also be revised to recognize nuclear
pharmacists that have been approved by a nuclear pharmacy that has been
authorized by the Commission to approve authorized nuclear pharmacists.
The definition of ``Radiation Safety Officer'' would be revised to
include a reference to the specific requirements that an individual
must meet in order to be authorized as a Radiation Safety Officer. This
change was done to make the definition of Radiation Safety Officer
consistent with the definitions of authorized nuclear pharmacist,
authorized user, and authorized medical physicist.
The definition of ``written directive'' would be revised to delete
the provision for the date the directive was signed, and the signature
of the authorized user before administration of any byproduct material
or radiation from byproduct material to a specific patient or human
research subject. These specific requirements have been moved to
Sec. 35.40.
The definition of ``teletherapy physicist'' would be deleted and
replaced with a definition for ``authorized medical physicist'' because
it is a broader term that includes physicists that work with all types
of therapeutic units.
The definition of ``mobile nuclear medicine'' would be deleted and
replaced with a definition for ``mobile service'' because it is a
broader term that would encompass all modalities that could be
performed by a mobile service. A new definition would be added for
``temporary jobsite.'' This is needed since it is used in defining
``mobile service.'' The definition of ``temporary jobsite'' is based,
in part, on the definition of ``temporary jobsite'' as used in 10 CFR
Part 34, ``Licenses for Industrial Radiography and Radiation Safety
Requirements for Industrial Radiographic Operations.''
Definitions would be added for ``high dose-rate remote
afterloader,'' ``low dose-rate remote afterloader,'' ``pulsed dose-rate
remote afterloader,'' and ``stereotactic radiosurgery'' because use of
these units would be addressed in Part 35. The definitions of ``high
dose-rate remote afterloader'' and ``low dose-rate remote afterloader''
contain dose rates specific to each type of afterloader. The Commission
is not proposing to define the term ``medium dose-rate remote
afterloader'' since it is not used in the proposed rule. The Commission
noted that there was very little difference between the regulatory
requirements for a medium dose-rate remote afterloader and high dose-
rate remote afterloader and, therefore, has chosen to group the units.
The Commission is soliciting public comment on whether the rule should
specifically reference medium dose-rate remote afterloaders.
A definition for ``medical event'' would be added and refers to the
criteria listed in Sec. 35.3045(a), Reports of medical events. A new
definition, ``precursor event,'' would be added and refers to the
criteria listed in Sec. 35.3046(a). (Reference Section III, C, of the
Supplementary Information section of this document for more detailed
discussion.)
A new definition, ``treatment site,'' would be added because it is
used in Sec. 35.2045 of the proposed rule. A new definition, ``unit
dosage,'' was added because it is used in Secs. 35.60 and 35.63 of the
proposed rule.
Section 35.5, Maintenance of records, would be revised to insert
``and'' in the current phrase ``drawings and specifications.''
Section 35.6, Provisions for research involving human subjects,
would be unchanged. However, the Commission is soliciting comment on
whether this section should be revised to require that licensees
develop, implement, and maintain procedures for evaluating when a
medical procedure would be considered to be a research procedure.
Section 35.7, FDA, other Federal, and State requirements, would be
unchanged.
Section 35.8, Information collection requirements; OMB approval,
would be revised to reflect the renumbering of some sections within the
rule and the additional recordkeeping and reporting sections in the
proposed rule.
Section 35.10, Implementation, would be a new section that
discusses the proposed provisions for implementing the final rule. A
detailed discussion of the implementation provisions can be found in
Section VIII of the SUPPLEMENTARY INFORMATION section of this document.
This section would replace the current Sec. 35.999, Resolution of
conflicting requirements during transition period.
[[Page 43530]]
Section 35.11, License required, would be revised to reflect that
the requirements for supervision in the current Sec. 35.25 would be
replaced by the proposed requirements in Sec. 35.27.
Section 35.12, Application of license, amendment, or renewal, would
be revised.
Paragraph (a) would be revised to state that any application for a
license, amendment, or renewal must be signed by the management of the
facility. The current rule indicates that any person may apply if the
application is for medical use not sited in a medical institution and
that only management may apply for a license if the application is for
use in a medical institution. The Commission believes it is important
that facility management apply for a license, regardless of where the
material is used, because NRC holds the licensee responsible for any
actions of its employees. Paragraphs (b) and (c) would be revised to
more clearly state that separate applications must be submitted for
medical uses listed in Sec. 35.600, other than remote afterloaders.
Separate applications must be submitted for teletherapy and gamma
stereotactic radiosurgery units because the scope and nature of
information needed is much different than that needed for the other
types of medical use. This requirement does not imply that the
applicant has separate safety programs. Paragraphs (b) and (c) would
also be revised to delete the reference to the Regulatory Guides.
Guidance for completing an application may be found in draft NUREG-
1556, Vol. 9, ``Consolidated Guidance About Materials Licenses,
Program-Specific Guidance about Medical Use Licenses.'' Draft NUREG-
1556, Vol 9, is available for inspection at the NRC Public Document
Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of
the draft NUREG are available as indicated in the FOR FURTHER
INFORMATION CONTACT section of this document.
Paragraph (d) would be added to address applications for medical
use of byproduct material that are not specifically included in
subparts D through H of the proposed rule, henceforth referred to as
``emerging technologies'' (e.g., intravascular brachytherapy). The
current rule does not provide for efficient licensing of emerging
technologies. Paragraph (d) would provide a generic list of the
information needed by NRC to approve a use that is not specifically
addressed in subparts D through H of the proposed rule.
Section 35.13, License amendments, would be revised to reflect the
new numbering as a result of the overall revision of Part 35. Paragraph
(b) would be revised to indicate that a licensee does not need to amend
its license before allowing anyone to work as an authorized medical
physicist if that individual meets the training and experience
requirements in Sec. 35.51 or Sec. 35.961, and the requirements were
met within the 7 years preceding the date of the application. Paragraph
(c) would be revised to delete the requirement for licensees to amend a
license if the teletherapy physicist changes provided the individual
meets the requirements in Secs. 35.51(a) and 35.59 or Secs. 35.961 and
35.59. This change is consistent with existing licensing requirements
for authorized users and authorized nuclear pharmacists.
The Commission recognizes that unusual conditions may arise when
the Radiation Safety Officer leaves a facility with little to no
advance warning. In this event, the licensee may want to consider using
an authorized user to fill the position, pending appointment of a new
Radiation Safety Officer. Under these conditions, the licensee must
move expeditiously to permanently fill the position of Radiation Safety
Officer. In these situations, the licensee should contact the
appropriate NRC regional office and explain the situation.
In order to reduce regulatory burden, paragraph (e) would be
revised to delete the requirement for a licensee to apply for a license
amendment if there is a change in the areas where byproduct material is
used for diagnostic purposes pursuant to Secs. 35.100 and 35.200. For
example, a licensee would not be required to apply for a license
amendment to move a scan room in a diagnostic nuclear medicine
department that uses byproduct material in quantities that would not
require a written directive. However, this provision does not apply to
any storage or waste areas because of the potential for large
quantities of materials to accumulate in these areas and the
possibility of commingling of radioactive material that is used
pursuant to other sections of the rule. Paragraph (f) would require an
amendment if the licensee changes the address of use. For example, an
amendment would be required if the licensee initiates use or storage of
byproduct material at a new physical location that is under its
control.
Section 35.14, Notifications, would be revised. Paragraph (a) would
be revised to include a requirement for the licensee to notify NRC no
later than 30 days after the date the licensee permits an individual to
work as an authorized medical physicist pursuant to Sec. 35.13(b).
Paragraph (b) would be revised to require that the licensee notify NRC
when an authorized medical physicist permanently discontinues
performance of duties under the license. Paragraph (b) would also be
revised to require that a licensee notify NRC when the licensee changes
its name. This provision applies only if there is no change in
ownership, as described in Sec. 30.34 of this chapter. Otherwise, the
licensee must take appropriate action to have its license amended prior
to such change in ownership. A licensee must also notify NRC of any
changes in areas where materials are used pursuant to Secs. 35.100 and
35.200. These revisions were warranted because of requirements in the
proposed Sec. 35.13.
Section 35.15, Exemptions regarding Type A specific licenses of
broad scope, would be revised to add the term ``authorized medical
physicist'' to paragraph (d). This revision is needed because of the
requirements in the proposed Sec. 35.13. Under this proposed section,
broad scope licensees would have authority to appoint authorized users,
authorized nuclear pharmacists, or authorized medical physicists
without notifying NRC, provided the individuals meet approved criteria
in subparts B, D-H, and J.
A new paragraph (e) would be added to also exempt these licensees
from Sec. 35.49(a). This change would codify in the regulations an
exemption that is currently provided to these licensees through a
standard condition. NRC's medical use licensees with a Type A specific
license of broad scope currently receive a standard license condition
that exempts the licensee from receiving sealed sources or devices
manufactured only from licensees with medical distribution licenses
issued pursuant to Sec. 32.74. This change would replace the license
condition.
Section 35.18, License issuance, would be revised. Requirements for
a mobile service license would be added as paragraph (b). The NRC will
issue a license for mobile service if the applicant meets the
requirements specified in paragraph (a) of the section and if the
individual or human research subject to whom the applicant administers
byproduct material, or radiation from byproduct material, may be
released following treatment in accordance with Sec. 35.75. The later
condition is necessary because mobile service licensees will not have
the capability of controlling individuals that cannot be released
pursuant to Sec. 35.75.
Section 35.19, Specific exemptions, would be revised to delete the
statement that the Commission will review requests for exemptions from
training
[[Page 43531]]
and experience requirements with the assistance of its Advisory
Committee on the Medical Uses of Isotopes. This statement is a matter
of Commission policy rather than a regulatory requirement.
Subpart B, General Administrative Requirements, contains general
administrative requirements regarding medical use of byproduct
material.
Section 35.20, ALARA program, would be deleted in its entirety from
Part 35. ALARA is discussed in 10 CFR 20.1101, ``Radiation protection
programs,'' and medical licensees must comply with the requirements of
that section. That section requires, in part, that a licensee develop,
document, and implement a radiation protection program and use, to the
extent practicable, procedures and engineering controls to achieve
occupational doses and doses to members of the public ALARA. The
Commission does not believe that Sec. 35.20 is needed in light of the
requirements in Sec. 20.1101. A medical use licensee should have
flexibility in developing and implementing a radiation protection
program that meets the requirements of Part 20.
Section 35.21, Radiation Safety Officer, would be deleted in its
entirety from Part 35. The requirements of paragraph (a) would be moved
to the proposed Sec. 35.24. Paragraph (b) would be deleted because it
is overly prescriptive and in some cases overlaps with the requirements
in Sec. 20.1101. The Commission believes that the licensee should have
the flexibility in developing, maintaining, and implementing its
radiation protection program, including establishing the Radiation
Safety Officer's duties.
Section 35.22, Radiation safety committee, would be deleted in its
entirety. The issue of whether NRC should require a Radiation Safety
Committee was identified as a cross-cutting issue and, therefore, was
discussed at the public meetings and workshops held in Fall 1997.
Comments received on this topic are discussed in Section III of the
SUPPLEMENTARY INFORMATION section of this document. Based on the
comments received prior to March 1, 1998, the Commission believes that
key functions of the Radiation Safety Committee could be transferred to
licensee management (reference proposed Sec. 35.24) and that the
prescriptive requirements in the current Sec. 35.22 should be deleted.
The Commission believes that many institutions will continue to use a
Radiation Safety Committee to oversee use of radioactive material.
However, it recognizes that radiation program oversight may be
accomplished by other means. In particular, medical facilities normally
have a number of committees examining various areas, such as
environmental safety. These committees are typically formed in response
to hospital accreditation requirements. Specifying responsibilities and
functions to be accomplished, rather than the particular mechanism to
be used, is an effort to afford licensees flexibility in achieving the
objective of radiation safety (reference Sec. 35.24).
Section 35.23, Statements of authority and responsibilities, would
be deleted in its entirety and the requirements of this section, with
minor modifications, would be moved to the proposed Sec. 35.24.
Section 35.24, Authority and responsibilities for the radiation
protection program, would appear as a new section. This requirement
specifies objectives that must be achieved, rather than specifying how
the objective is to be met, in an effort to afford licensees
flexibility in achieving the objective of radiation safety.
Paragraphs (a) and (b) would replace the current requirements for
the Radiation Safety Committee. The licensee is responsible for
approving licensing actions; individuals before allowing them to work
as a Radiation Safety Officer, authorized user, authorized nuclear
pharmacist, or authorized medical physicist; and radiation protection
program changes that do not require a license amendment.
The licensee must develop, implement, and maintain administrative
procedures for interdepartmental/interdisciplinary coordination of the
licensee's radiation protection program. Interdepartmental/
interdisciplinary coordination is believed to be a major component of
an effective radiation protection program. The Commission recognizes
that there are many ways to meet this objective and believes that the
licensee should have flexibility in identifying and implementing the
most appropriate modes of coordination at its facility. Identified
alternatives include, but are not limited to, meetings, electronic
transfer of information, or verbal communication. This requirement
applies to all medical use licensees and it is expected that the extent
of the coordination will be dependent on the complexity of the
licensee's program.
The requirement in paragraph (c) to appoint a Radiation Safety
Officer is currently required by Sec. 35.21. The proposed paragraph
would require that the Radiation Safety Officer agree, in writing, to
be responsible for implementing the radiation protection program. The
requirements in paragraphs (d) and (e) are similar to the requirements
in the current Sec. 35.23. A record of management's approval of actions
in paragraph (a); written acceptance of Radiation Safety Officer duties
as specified in paragraph (c); and the duties, responsibilities, and
authority of the Radiation Safety Officer specified in paragraph (d)
would have to be maintained in accordance with Sec. 35.2024, Records of
authority and responsibility for radiation protection programs.
The Commission is soliciting specific public comment on changes
made in the rule that could impact the licensee's effectiveness in
carrying out its radiation protection program, e.g., proposed deletion
of the requirement for a Radiation Safety Committee and proposed
requirement for the Radiation Safety Officer to acknowledge, in
writing, responsibility for implementing the radiation protection
program. In particular, the Commission is seeking comment in the
following areas: (1) whether this combination of changes in the
proposed rule may actually reduce the effectiveness of radiation
protection programs; and (2) whether the radiation safety officer will
be provided appropriate tools and channels through which to raise
safety concerns to the highest levels of management. Finally, if the
requirement for a committee, to oversee the radiation protection
program, was included in the final rule, the Commission is seeking
comment on whether the rule language should explicitly require that the
radiation safety officer be a member of that committee.
Section 35.25, Supervision, would be deleted in its entirety and
the requirements of this section, with minor modifications, would be
moved to the proposed Sec. 35.27.
Section 35.26, Radiation protection program changes, would appear
as a new section. The requirements in this section are similar to the
requirements in the current Sec. 35.31, which would be deleted. The
proposed section states that a licensee may revise its radiation
protection program without Commission approval if the revision does not
require an amendment in accordance with Sec. 35.13; the change will not
reduce radiation protection; the change has been reviewed and approved
in writing by the Radiation Safety Officer and licensee management; and
the affected individuals have been instructed on the revised program
before the changes are implemented. This requirement provides the
licensees with flexibility to manage their radiation
[[Page 43532]]
protection programs and clearly defines the situations that will not
require an amendment. The Commission believes that many licensees were
reluctant to make changes to their current program because the term
``ministerial changes,'' as defined in the current Sec. 35.2 and as
used in the current Sec. 35.31, was not clearly understood. This change
is intended to provide clear guidance to a licensee on when it can
revise its radiation protection program without Commission approval.
The Commission believes that it is important to instruct
individuals in program changes, including those permitted under
Sec. 35.26, before they are implemented. This instruction could be
provided in writing or orally and may be conducted on an informal or
formal basis. It is not necessary to document that this training has
been provided to affected parties, because these changes should not
reduce radiation safety. At the time of inspection, NRC inspectors may
question whether this training was provided.
Section 35.27, Supervision, would appear as a new section. The
requirements in this section are similar to the requirements in the
current Sec. 35.25, which would be deleted. Paragraph (a)(1) and (b)(1)
would be revised to delete the requirement to instruct individuals in
the principles of radiation safety. This type of instruction is
adequately addressed by Sec. 19.12, Instructions to workers, of this
chapter. Paragraph (a)(1) would also be revised to require that the
licensee instruct supervised individuals in the written radiation
protection procedures, written directives procedures, regulations of
this chapter, and license conditions. Paragraph (a)(2) would require
the supervised individual to follow the instructions of the supervising
authorized user for medical uses of radioactive material, written
radiation protection procedures, regulations, and license conditions
with respect to the medical use of byproduct material. Paragraphs
(a)(3) and (b)(3) of the current Sec. 35.25 would be deleted because
the licensee should have flexibility in evaluating employee
performance. Paragraph (b)(2) would be revised to require supervised
individuals to follow the instructions of the supervising authorized
user or authorized nuclear pharmacist regarding the preparation of
byproduct material for medical use, the written radiation protection
procedures, and the regulations of this chapter and license conditions.
Paragraph (c) would require that the licensee develop, implement, and
maintain a policy for supervised individuals to request clarification,
as needed, from the authorized user about instructions and requirements
in a written directive prior to administering the byproduct material,
or radiation from the byproduct material, and from the authorized user
or authorized nuclear pharmacist about instructions and requirements
provided in accordance with paragraphs (a) and (b) of the section. This
change would be added so that a licensee's work environment would
encourage supervised individuals to ask questions if they do not
understand the instructions or requirements provided to them by an
authorized nuclear pharmacist or an authorized user, especially when
they have questions regarding administrations of byproduct material to
patients or human research subjects. In the past, failure by licensee
staff to ask questions has been identified as one of the key
contributors to misadministrations.
Section 35.29, Administrative requirements that apply to the
provision of mobile service, would be deleted. The conditions for the
Commission to issue a mobile service license would be moved to
Sec. 35.18. The requirements in paragraphs (b) and (d) would be moved
to the proposed Sec. 35.80. Paragraph (c) would be deleted because this
requirement was viewed as overly prescriptive. Individuals are required
to comply with all provisions of the license that authorizes use,
possession and transfer of material.
Section 35.31, Radiation safety program changes, would be deleted.
The requirements, with minor changes, would be moved to Sec. 35.26.
This change is proposed so that all requirements that pertain to the
management of the licensee's program appear in one area.
Section 35.32, Quality management program, would be deleted. The
issue of whether the Commission should continue to require that a
licensee develop, implement, and maintain a quality management program
was identified as a cross-cutting issue and was discussed at the public
meetings and workshops held in Fall 1997. Comments received on this
topic are discussed in Section III of the Supplementary Information
section of this document. Based on these comments, the Commission has
deleted the requirements for a quality management program. However, the
Commission believes there are three elements of the current quality
management program that should be addressed in the proposed rule:
confirming patient identity, requiring written directives, and
verifying dose. Requirements for these three elements are found in
proposed Secs. 35.40 and 35.41. However, the Commission believes that
some elements of the current quality management program requirements
will continue to be implemented as a part of the ``standard of care''
in medicine. In this regard, the Commission acknowledges that other
factors, such as accreditation, have resulted in medical institutions
to adopting programs similar to those previously specified in the rule.
Section 35.33, Notifications, reports, and records of
misadministrations, would be deleted. In this proposed revision,
recordkeeping and reporting requirements contained in Part 35 would be
moved to subparts L and M, respectively.
Section 35.40, Written directives, would appear as a new section.
This section contains requirements for preparation of written
directives. These requirements are similar to the requirements in the
current Secs. 35.2 and 35.32. Minor changes would be made in the
information that must be placed in a written directive for gamma
stereotactic radiosurgery, remote afterloaders, and brachytherapy.
These changes were based on comments received during public meetings of
the Part 35 Working Group.
Section 35.41, Procedures for administrations requiring a written
directive, would appear as a new section. It would require the licensee
to develop, implement, and maintain written procedures to assure that,
before each administration, the patient's or human research subject's
identity is verified and that each administration is in accordance with
the written directive, including verification of dose. It would also
specify the objectives that should be addressed in the procedures. The
specific details to be included in the written directives are in
Sec. 35.40. The topics identified in Sec. 35.41 are viewed by the
Commission as key elements of a program that will provide high
confidence that byproduct material will be administered as directed by
the authorized user. However, the regulations are not prescriptive as
to how these objectives are met, allowing licensees the flexibility to
develop procedures to meet their needs. There is no requirement for
submittal or approval of the procedures as was previously required by
the quality management rule.
Section 35.49, Suppliers for sealed sources or devices for medical
use, would be unchanged.
Requirements in the current Sec. 35.50, with minor modifications,
would be moved to the proposed Sec. 35.60.
Section 35.50, Training for Radiation Safety Officer, would appear
as a new
[[Page 43533]]
section that would revise the current requirements of Sec. 35.900,
Radiation Safety Officer. Section III of the Supplementary Information
of this document contains a detailed discussion of the Commission's
proposed changes to the training and experience requirements in Part
35. Note, 2 years after the final rule is published in the Federal
Register, this section would replace the current requirements in
Sec. 35.900, Radiation Safety Officer.
Requirements in the current Sec. 35.51, with minor modifications,
would be moved to the proposed Sec. 35.61.
Section 35.51, Training for an authorized medical physicist, would
appear as a new section that would revise the training and experience
requirements found in Sec. 35.961, Training for an authorized medical
physicist. Section III of the Supplementary Information section of this
document contains a detailed discussion of the Commission's proposed
changes to the training and experience requirements in Part 35. Note, 2
years after the final rule is published in the Federal Register, this
section would replace the requirements in Sec. 35.961, Training for
authorized medical physicist.
Section 35.52, Possession, use, calibration, and check of
instruments to measure dosages of alpha- or beta-emitting
radionuclides, would be deleted in its entirely and the requirements of
this section, with minor modifications, would be moved to the proposed
Sec. 35.63.
Section 35.53, Measurements of dosages of unsealed byproduct
material for medical use, would be deleted in its entirety and the
requirements of this section, with minor modifications, would be moved
to the proposed Sec. 35.63.
Section 35.55, Training for an authorized nuclear pharmacist, would
appear as a new section that would revise the training and experience
requirements found in Sec. 35.980, Training for an authorized nuclear
pharmacist. Section III of the Supplementary Information section of
this document contains a detailed discussion of the Commission's
proposed changes to the training and experience requirements in Part
35. Note, 2 years after publication in the Federal Register, this
section would replace the current requirements in Sec. 35.980, Training
for an authorized nuclear pharmacist.
Requirements in the current Sec. 35.57, with minor modifications,
would be moved to the proposed Sec. 35.65.
Section 35.57, Training for an experienced Radiation Safety
Officer, teletherapy or medical physicist, authorized user, and nuclear
pharmacist, would appear as a new section that would replace the
current requirements in Secs. 35.901, 35.970, and 35.981, which would
be deleted. Changes would be made in the regulatory text of this
section to reflect the effective date of the rule.
Requirements in the current Sec. 35.59, with minor modifications,
would be moved to the proposed Sec. 35.67.
Section 35.59, Recentness of training, would appear as a new
section that would replace the current requirements in Sec. 35.972.
Although this is not a new requirement, questions have recently been
raised regarding whether all elements of the requirements must have
been obtained in the last 7 years. It is expected that either the
individual has been board certified or has completed the training
specified in the alternative pathway within the 7 years preceding the
date of the application or must have had related continuing education
and experience since completing the required training and experience
requirements. Continuing education is reviewed on a case-by-case basis.
The text has been revised to reference subparts B, D, E, F, G, H and J
since training and experience requirements appear in multiple subparts.
Subpart C, General Technical Requirements, contains general
technical requirements regarding medical use of byproduct material.
Requirements in the current Sec. 35.60, with minor modifications,
would be moved to the proposed Sec. 35.69.
Section 35.60, Possession, use, calibration, and check of
instruments to measure activity of photon-emitting radionuclides, would
appear as a new section that would replace the current Sec. 35.50. This
section addresses calibration of all instruments used to measure the
activity of photon-emitting radionuclides, rather than only dose
calibrators. The change recognizes that there are various types of
instruments that can be used to measure the activity of photon-emitting
radionuclides.
The proposed rule would require that licensees develop, implement,
and maintain procedures for use of the instrumentation. Licensees would
be required to calibrate all instruments used to measure the activity
of photon-emitting radionuclides.
Licensees would be required by the proposed Sec. 35.63 to determine
the activity of each dosage before medical use. If a licensee uses only
unit dosages of radiopharmaceuticals, Sec. 35.63 would allow the
licensee to determine the dosage by a decay correction based on the
measurement by a manufacturer or preparer licensed pursuant to
Sec. 32.72 or equivalent Agreement State. If a licensee chooses to
determine the dosage using this method, it would not be necessary for
the licensee to possess instrumentation to measure the activity of the
photon-emitter. In this case, the licensee would not be required to
comply with this section. If, however, a licensee chooses to re-assay a
unit dosage to either confirm the activity or for the purpose of
adjusting the dosage, the licensee must comply with this section. This
requirement is appropriate because confirmation of a dosage, or
adjustment of dosages, must be made based on properly-calibrated
equipment.
Many of the prescriptive requirements for calibration would be
deleted from the current requirements in Sec. 35.50. The requirements
that would remain are viewed by the Commission as essential elements of
a calibration program and are generally consistent with the
recommendations of ANSI N42.13-1986 (R 1993), ``Calibration and Usage
of Dose Calibrator Ionization Chambers for the Assay of
Radionuclides.'' Licensees would be required to perform accuracy,
linearity, and geometry dependence tests before initial use and
following repair; perform accuracy tests annually; perform linearity
tests annually over the range of medical use; and check constancy and
proper operation at the beginning of each day of use. Note, it would
not be necessary to test for linearity for all activities that might be
measured, e.g., the first elution from a fresh generator or a multidose
vial, because this would subject the worker to an unnecessary radiation
dose. Paragraph (c) would require that accuracy tests be performed
using a source with a principle photon energy of between 100 and 500
keV whose activity is traceable to the National Institutes of Standards
and Technology (NIST). The allowance for a licensee to mathematically
correct dosage has been revised to raise the level for correction to 30
Ci to make the level consistent with Sec. 35.63. The allowance
for a licensee to mathematically correct dosage readings remains, but
has been re-numbered Sec. 35.60(d). The recordkeeping requirements for
this section would appear in Sec. 35.2060, Records of instrument
calibrations.
Requirements in the current Sec. 35.61, with minor modifications,
would be moved to the proposed Sec. 35.69.
Section 35.61, Calibration and check of survey instruments, would
appear as a new section that would replace the current Sec. 35.51. The
requirement in the current Sec. 35.51(a)(3) to note the
[[Page 43534]]
apparent exposure rate from a dedicated check source, as determined at
the time of calibration, and the daily check source requirement in
paragraph (c) would be deleted. These changes would give the licensee
greater flexibility in instrument calibrations. Paragraph (b) would
require that the licensee attach a correction chart or graph to the
instrument if the indicated exposure rate differs from the calculated
exposure rate by more than 10 percent. Paragraph (c) would require that
survey instruments be removed from use if the indicated exposure rate
differs from the calculated exposure rate by more than 20 percent.
Previously, there was no threshold for attaching a correction chart or
for removing instruments from use. The requirements in this section are
generally consistent with ANSI N323-1978 (R 1993), ``Radiation
Protection Instrumentation Test and Calibration.'' The recordkeeping
requirements for this section would appear in Sec. 35.2061, Records of
radiation survey instrument calibrations.
Section 35.62, Possession, use, calibration, and check of
instruments to measure dosages of alpha- or beta-emitting
radionuclides, would appear as a new section that would replace the
current Sec. 35.52. This section addresses calibration of all
instruments used to measure the activity of alpha- or beta-emitting
radionuclides. Paragraph (a) from the current Sec. 35.52 would be
deleted. This text is no longer needed since the term ``unit dosage''
has been defined in Sec. 35.2. The new paragraph (b) would require that
a licensee develop, implement, and maintain written procedures for use
of the instrumentation. The Commission recognizes that it may not be
possible to test linearity and geometry dependency on all
instrumentation. However, the Commission believes that all instruments
used to measure alpha- or beta-emitting radionuclides can be tested for
accuracy or constancy. The new paragraph (c) would require that
accuracy tests be performed using sources whose activity is traceable
to NIST. The recordkeeping requirements for this section would appear
in Sec. 35.2060, Records of instrument calibrations.
Section 35.63, Determination of dosages of unsealed byproduct
material for medical use, would appear as a new section that would
replace the current Sec. 35.53. This section would require licensees to
determine and record the activity of each dosage before medical use.
For unit dosages of an alpha-, beta-, or photon-emitting radionuclides,
this determination must be made either by direct measurement or by a
decay correction, based on the measurement made by a manufacturer or
preparer licensed pursuant to Sec. 32.72 or equivalent Agreement State
requirements. For other than unit doses, a licensee may determine the
dosage by direct measurement or by combination of measurements and
calculations. Previously, photon measurements could only be made by
direct measurement. This action allows licensees flexibility in
determining dosages and does not distinguish between the type of the
radiation (e.g., alpha, beta, or photon) and the way the determination
is made. Paragraph (d) would not permit a licensee to use a dosage if
it differed from the prescribed dosage by more than 20 percent. This
change would codify requirements that are currently imposed on
licensees by license conditions. This does not prevent an authorized
user from revising the prescribed dosage at any time prior to the
administration. The recordkeeping requirements for this section would
appear in Sec. 35.2063, Records of dosage measurements.
Section 35.65, Authorization for calibration and reference sources,
would appear as a new section that would replace the current
Sec. 35.57. The references in the current Sec. 35.57, to Secs. 35.100
and 35.200, would be deleted because specific radionuclides were not
listed in these sections. Paragraph (b) in the current Sec. 35.57 would
be revised to extend the half-life from 100 days to 120 days to be
consistent with the financial assurance regulations in 10 CFR Part 30.
The limit of 10-3 would be added to the regulation to allow
receipt, possession, and use of radionuclides in quantities that do not
exceed the limits requiring financial assurance. The possession limit
for Tc-99m would be deleted. The Commission believes that it is not
necessary to limit the possession of Tc-99m for calibration and
reference sources because there are no possession limits for Tc-99m
associated with use of Tc-99m pursuant to Secs. 35.100 or 35.200.
Section 35.67, Requirements for possession of sealed sources and
brachytherapy sources, would appear as a new section that would replace
the current Sec. 35.59. Paragraph (b) would require that a source be
tested for leakage before its first use, unless the licensee has a
certificate from the supplier indicating that the source was tested
within 6 months, and the source is tested for leakage at intervals not
to exceed 6 months or at other intervals approved in the Sealed Source
and Device Registry (SSDR).1 The SSDR certificates, in most
cases, will include a requirement for leak-testing. Approved intervals
for testing are based on information regarding source design
construction that is provided by the manufacturer.
---------------------------------------------------------------------------
\1\ A national registry that contains all the registration
certificates generated by both NRC and the Agreement States.
Registration certificates summarize the radiation safety information
submitted by the applicant, and describe the licensing and use
conditions approved for the product.
---------------------------------------------------------------------------
Prescriptive requirements in the current Sec. 35.59(c) would be
deleted to reflect the risk-informed, performance-based nature of this
proposed rule. Paragraph (d) would require that leak test records be
maintained in accordance with Sec. 35.2067, Records of possession of
sealed sources and brachytherapy sources. Paragraph (e) would be
revised to give the licensee two additional alternatives for action
after a leaking source has been identified. The proposed rule would
allow the licensee the added flexibility of repairing or disposing of
the source, in accordance with 10 CFR parts 20 and 30, if the leakage
test reveals the presence of 185 Becquerels (Bq) (0.005 microcuries) or
more of removable contamination. The current rule only allows the
licensee to withdraw the sealed source from use and store it in
accordance with the requirements in 10 CFR parts 20 and 30. The
licensee would still be required to report to NRC if a leakage test
reveals the presence of 0.005 microcuries or more of removable
contamination. Reporting requirements for this section would appear in
Sec. 35.3059, Reports of leaking sources.
Paragraph (g) of the current rule would be revised to change the
frequency for source inventories from quarterly to semi-annually, to
reduce the regulatory burden on licensees. It does not, however,
preclude the licensee from conducting an inventory on a more frequent
basis. Paragraph (h) of the current rule would be deleted because
radiation surveys are addressed under 10 CFR Part 20. The recordkeeping
requirements for this section would appear in Sec. 35.2067, Records of
possession of sealed sources and brachytherapy sources.
Section 35.69, Labeling and shielding of vials and syringes, would
appear as a new section that would replace the current Secs. 35.60 and
35.61. It would require licensees to develop, implement, and maintain
procedures for labeling and shielding radiopharmaceuticals and instruct
individuals in those procedures. Procedures must ensure that a syringe,
syringe shield, or vial shield is conspicuously labeled as containing
radioactive material and is labeled with the radiopharmaceutical
[[Page 43535]]
name. These requirements were needed because the Commission does not
believe that the labeling and shielding requirements in Part 20 are
sufficient to ensure that syringes, syringe shields, or vial shields
are properly labeled to identify radioactive contents. In addition, the
Commission believes that labeling helps to reduce administration
errors. The proposed rule would require that licensees instruct
individuals, commensurate with that individual's assigned duties, on
the labeling and shielding procedures. It is expected that
technologists preparing radiopharmaceuticals and nuclear pharmacists
will be given instruction in the licensee's procedures. Records of
instructions would not be required to be maintained.
Section 35.70 would be retitled, Surveys for ambient radiation
exposure rate, and revised. The proposed rule would require that
licensees survey, at the end of each day of use, all areas where
radiopharmaceuticals requiring a written directive were prepared for
use or administered with an appropriate radiation detection survey
instrument unless the material was prepared for use or administered in
an area where patients or human research subjects could not be released
pursuant to Sec. 35.75. All other requirements in this section would be
deleted. Licensees are required to show compliance with the public and
occupational dose limits specified in Part 20 of this chapter and
specifically to develop, document, and implement a radiation protection
program commensurate with the scope and extent of licensed activities
(10 CFR 20.1101). In situations where radioactive material was used at
levels that would not have required a survey pursuant to this section,
the licensee should be aware that a survey may be required by
Sec. 20.1501, General. Maintaining the requirement for surveys in areas
where radiopharmaceuticals requiring a written directive are used is
consistent with the Commission direction for a risk-informed rule. The
Commission believes that licensees will continue to perform radiation
surveys as dictated by ``good health physics'' practices. Recordkeeping
requirements for this section would appear in Sec. 35.2070, Records of
surveys for ambient radiation exposure rate.
Section 35.75 would be retitled, Release of individuals containing
radiopharmaceuticals or implants, and revised. The title of the section
and paragraph (a) would be revised to delete the term ``permanent.''
This was done to clarify that this section applies to all individuals
released from licensee control. Paragraph (b) would be revised to
specify that licensees may provide instructions to either the released
individual or to the individual's parent or guardian and to replace the
term ``dose'' with the term ``total effective dose equivalent.'' The
first change acknowledges that, in some cases, it is not appropriate to
provide the individual being released with instructions (e.g., the
individual is a minor or incapable of understanding the instructions).
The later term was changed to clarify what was intended by ``dose.''
Paragraph (b)(2) would be modified to state ``potential
consequences, if any,'' of failure to follow the guidance. The
Commission recognizes that, at low doses, there may be no consequences
to continued breast-feeding. A patient may be unnecessarily alarmed if
he/she is provided with information on consequences. Therefore, if
consequences are not anticipated, the licensee would not be required to
provide information to the individual. The Commission has recently
received comments from the public on the provisions in Sec. 35.75 at
the public workshops and in writing. Professional societies and
representatives of the Agreement States have expressed concerns about
the release criteria in Sec. 35.75. It is believed that the new
criteria permit the release of patients with a body burden of as much
as several hundred millicuries of I-131. Commenters believed that the
released individual is a ``leaking-source'' that creates a
contamination and exposure problem that extends beyond the control of
the licensee. There is concern that pressure from those paying for such
medical procedures will undermine the Radiation Safety Officer's
ability to protect the public health and safety and to control
contamination within the medical facility. In addition, there is
concern about the recent increase of radiation alarms going off at
landfills caused by household trash from a released patient. As a
result of these concerns, the Commission is specifically soliciting
public comment on whether any changes need to be made to the release
criteria in this rule. The recordkeeping requirements for this section
would appear in Sec. 35.3075, Records of the release of individuals
containing radiopharmaceuticals or implants.
Section 35.80 would be retitled, Provision of mobile service, and
revised. The title would be changed to make it clear that the
provisions in this part apply to all mobile services and not just to
mobile nuclear medicine services. Current paragraphs (a), (b), and (c)
would be deleted because radiopharmaceutical usage is limited by the
requirements in Secs. 35.100 and 35.200, and control and security of
material are addressed in 10 CFR Part 20.
Proposed paragraph (a) would require the mobile service provider to
obtain a letter from its client, which permits the use of byproduct
material at the client's address of use and that clearly delineates the
authority and responsibility of each entity. Paragraph (c) would
require that the mobile service provider check instruments for proper
function, as described in Secs. 35.60 and 35.62, before use at each
address of use or on each day of use, whichever is more frequent. For
example, if a mobile service licensee provides service to more than one
client in a day, the instruments would need to be checked at each
client's address of use. The Commission recognizes that the standard of
practice is to check other types of equipment, such as gamma cameras,
for proper operation at each place of use. Therefore, the Commission
has not included any requirements to check this type of equipment in
the proposed rule. Currently, mobile nuclear medicine services may be
required by license conditions to check gamma camera operation.
Based on discussions with the States, this section is designated as
a Category D item of compatibility since there is no potential for
medical use of byproduct material in other regulatory jurisdictions
under reciprocity. NRC specifically requests comment on this issue
relative to whether mobile medical licensees operate under reciprocity
in other regulatory jurisdictions.
Paragraph (d) would require that the licensee check survey
instruments for proper operation with a dedicated check source, before
use, at each address of use. The NRC staff believes this is appropriate
because extensive movement in a transport vehicle may cause the
instruments to become damaged or uncalibrated. Paragraph (e) would be
revised to require a licensee to survey all areas of use to comply with
the dose limits in 10 CFR Part 20 before leaving each client's address
of use. This is necessary to assure that all radioactive material is
removed from a client's facility. Recordkeeping requirements for this
section would appear in Sec. 35.2080, Records of administration and
technical requirements that apply to the provision of mobile services.
Section 35.90, Storage of volatiles and gases, would be deleted in
its entirety. Licensees are required to comply with the public and
occupational public dose limits in 10 CFR Part 20 and to maintain
[[Page 43536]]
exposures ALARA. The Commission believes that licensees should have
flexibility in complying with 10 CFR Part 20, and, therefore, a
prescriptive requirement in Part 35 is not needed.
Section 35.92, Decay-in-storage, would be revised to allow decay in
storage for byproduct material with a physical half-life of less than
120 days. If a licensee would like to decay material with a physical
half life greater than 120 days, it would have to apply for and receive
an amendment that would permit the decay-in-storage.
The current Part 35 only permits decay-in-storage for materials
with a half-life of less than 65 days. This change provides licensees
with greater flexibility in handling radioactive waste. NRC has
received multiple requests to amend licenses to allow for decay-in-
storage for materials greater than 65 days, and NRC has amended
licenses to allow for decay-in-storage for materials with half-lives up
to 120 days. This revision to Sec. 35.92 would codify current licensing
practice.
The requirement in the current paragraph (a)(1) to hold byproduct
material for 10 half-lives would be deleted. This requirement is not
needed in light of the requirement in paragraph (a) that precludes
disposal of radioactive material as ordinary trash until radiation
levels adjacent to the material do not exceed background levels. The
Commission is soliciting specific public comment on whether this
provision should be deleted. Concerns have been raised regarding
licensees' ability to detect low levels of some beta-emitters such as
sulfur-35. In this case, the requirement to hold material for 10 half-
lives provides added assurance that material has decayed to background
levels prior to release.
The requirement in paragraph (a)(4) to separate and monitor each
generator column would be deleted. This level of prescriptiveness is
not warranted in light of the requirements in paragraph (a)(1). The
recordkeeping requirements for this section would appear in
Sec. 35.2092, Records of waste disposal.
Subpart D would be retitled Unsealed Byproduct Material--Low Dose.
This subpart would combine the requirements in the current subpart D,
Uptake, dilution, and excretion and subpart E, Imaging and
localization. This change is consistent with the Commission's intent to
make Part 35 modality specific where appropriate.
Section 35.100 would be retitled, Use of unsealed byproduct
material for uptake, dilution, and excretion studies for which a
written directive is not required, and revised. The title would be
changed to clearly state that the provisions in this subpart do not
apply to the medical use of byproduct material that would require a
written directive. Changes would be made to paragraph (b) to reflect
the renumbering of sections in the proposed rule.
Section 35.120, Possession of survey instruments, would be deleted
because these specific requirements are not needed in Part 35. Section
20.1501 of this chapter requires that the licensee make, or cause to be
made, surveys to demonstrate compliance with 10 CFR Part 20, and
requires the licensee to ensure that instruments and equipment used to
show compliance with Part 20 are periodically calibrated. In addition,
Sec. 30.33(a)(2) of this chapter requires licensee to have adequate
instrumentation. Information on the types of instruments recommended
for medical licensees is available in draft NUREG-1556, Vol. 9.
Section 35.200 would be retitled, Use of unsealed byproduct
material for imaging and localization studies for which a written
directive is not required, and revised. The title would be changed to
clearly state that the provisions in this part do not apply to the
medical use of byproduct material that would require a written
directive. Changes would be made to paragraph (b) to reflect the
renumbering of sections in the proposed rule.
Section 35.204, Permissible molybdenum-99 concentration, would be
revised. Paragraph (b) would be revised to require that a licensee
measure the molybdenum-99 concentration of only the first eluate from a
generator. The Commission recognizes that the industry standard for
molybdenum breakthrough is specified in the United States Pharmacopia
(USP) 23 U.S. Pharmacopial Convention, Inc., 1994, page 486-487. The
Commission believes that the licensee should measure the molybdenum-99
concentration in the first elution of a generator after the generator
is received at the licensee's facility. Although the frequency of
molybdenum breakthrough is exceedingly rare, an initial check may
detect generators that have been damaged in transport. The term
``extract'' was deleted because the term is no longer needed. NRC is
not aware of any licensees that prepare technetium-99m by the solvent
extraction method. The recordkeeping requirements for this section
would appear in Sec. 35.2204, Records of molybdenum-99 concentration.
Section 35.205, Control of aerosols and gases, would be deleted in
its entirety. Part 35 licensees must comply with the occupational and
public dose limits of 10 CFR Part 20. Additional prescriptive
requirements for limiting airborne concentrations of radioactive
material are not warranted in Part 35.
Section 35.220, Possession of survey instruments, would be deleted
in its entirety because specific requirements are not needed in Part
35. Section 20.1501 of this chapter requires that the licensee make, or
cause to be made, surveys to demonstrate compliance with 10 CFR Part
20, and requires the licensee to ensure that instruments and equipment
used to show compliance with 10 CFR Part 20 are periodically
calibrated. In addition, Sec. 30.33(a)(2) of this chapter requires
licensees to have adequate instrumentation. Information on the types of
instruments recommended for medical licensees is available in draft
NUREG-1556, Vol. 9.
Section 35.290, Training for uptake, dilution, and excretion
studies, would appear as a new section that would revise the training
and experience requirements found in Sec. 35.910, Training for uptake,
dilution, and excretion studies. Section III of the SUPPLEMENTARY
INFORMATION section of this document contains a detailed discussion of
the Commission's proposed changes to the training and experience
requirements in Part 35. Note, 2 years after publication of the final
rule, this section would replace the current requirements in
Sec. 35.920, Training for uptake, dilution, and excretion studies.
Section 35.292, Training for imaging and localization studies,
would appear as a new section that would revise the training and
experience requirements found in Sec. 35.920, Training for imaging and
localization studies. Section III of the SUPPLEMENTARY INFORMATION
section of this document contains a detailed discussion of the
Commission's proposed changes to the training and experience
requirements in Part 35. Note, 2 years after publication of the final
rule, this section would replace the current requirements in
Sec. 35.920, Training for imaging and localization studies.
Subpart E would be retitled, Unsealed byproduct material--high
dose. The subpart contains the requirements for any medical use of
unsealed byproduct material for which a written directive is required.
This subpart would replace the requirements in the current subpart F,
Radiopharmaceuticals for therapy.
Section 35.300 would be retitled, Use of unsealed byproduct
material for which a written directive is required, and revised. The
title would be changed to clearly state that the provisions in this
subpart apply to the medical use of unsealed byproduct material that
would require a written directive. Changes
[[Page 43537]]
would be made to paragraph (b) to reflect the renumbering of sections
in the proposed rule.
Section 35.310, Safety instruction, would be revised to explicitly
state that the instruction requirements of this section are in addition
to, and not in lieu of, the training requirements in 10 CFR 19.12. The
Commission believes that it is important that personnel caring for
patients or human research subjects that have received
radiopharmaceutical therapy (and cannot be released in accordance with
Sec. 35.75) receive instruction in limiting radiation exposure to the
public or occupational workers and the actions to be taken in the case
of a death or medical emergency. The proposed rule would require that
safety instruction be provided initially and at least annually.
Instruction topics are specific to medical use of unsealed
radiopharmaceuticals. It is not expected that the same level of
training be provided to all individuals caring for the patient. The
level of training should be commensurate with the type of care that the
personnel may render to the patient or human research subject. For
example, the instruction provided to the registered nurse will not
necessarily be the same as the instruction provided to a nursing
assistant.
Paragraph (a) would be revised to require that instruction on
visitor control include instruction on routine visitation authorized
under the provisions in Sec. 20.1301(a)(1), as well as visitation that
is authorized under the proposed provisions of Sec. 20.1301(a)(3).
Paragraph (a) would also be revised to state that personnel should
notify the authorized user and Radiation Safety Officer, or his/her
designee, if the patient or human research subject dies or has a
medical emergency. The recordkeeping requirements for this section
would appear in Sec. 35.2310, Records of instruction and training.
Section 35.315, Safety precautions, would be revised. Paragraph (a)
would be revised to clarify that the requirements in this section only
apply if a patient has been confined pursuant to Sec. 35.75. Paragraph
(a)(2) would be revised to require that the patient's room, rather than
the door, be visibly posted to give the licensee some flexibility in
determining where to place the posting. These requirements are in
addition to the posting requirements in 10 CFR Part 20. The Commission
believes that posting requirements in 10 CFR Part 20 are not adequate
to ensure that individuals entering the room would be aware of the
presence of radioactive materials in the room. The current requirements
in paragraphs (a)(3), (4), (6), (7), and (8) would be deleted because
they are radiation protection requirements that are covered under 10
CFR Part 20. Paragraph (b) would be revised to state that personnel
should notify the authorized user and the Radiation Safety Officer, or
his/her designee, as soon as possible, if the patient or human research
subject dies or has a medical emergency. This change was made to
recognize that the licensee's primary responsibility is the care of the
patient and to provide the Radiation Safety Officer flexibility in
designating who should be notified to address radiation protection
issues.
The Commission is soliciting specific comments on whether the
requirement for a private room with a private sanitary facility in
paragraph (a)(1) should be maintained in the final rule.
Section 35.320, Possession of survey instruments, would be deleted
in its entirety because these specific requirements are not needed in
Part 35. Section 20.1501 of this chapter requires that the licensee
make or cause to be made surveys to demonstrate compliance with 10 CFR
Part 20 and requires the licensee to ensure that instruments and
equipment used to show compliance with Part 20 are periodically
calibrated. In addition, 10 CFR 30.33(a)(2) requires a licensee to have
adequate instrumentation. Information on the types of instruments
recommended for medical licensees is available in draft NUREG-1556,
Vol. 9.
Section 35.390, Training for therapeutic use of unsealed byproduct
material, would appear as a new section that would revise the training
and experience requirements found in Sec. 35.930, Training for
therapeutic use of unsealed byproduct material, and subsumes the
training requirements for treatment of hyperthyroidism and treatment of
thyroid carcinoma. Section III of the SUPPLEMENTARY INFORMATION section
of this document contains a detailed discussion of the Commission's
proposed changes to the training and experience requirements in Part
35. Note, 2 years after publication of the final rule, this section
would replace the current requirements in Sec. 35.930, Training for
therapeutic use of unsealed byproduct material, Sec. 35.932, Training
for treatment of hyperthyroidism, and Sec. 35.934, Training for
treatment of thyroid carcinoma.
Subpart F would be retitled Manual brachytherapy. This subpart
contains the requirements for medical use of sealed sources for manual
brachytherapy and replaces the requirements in the current subpart G,
Sources for brachytherapy.
Section 35.400 would be retitled, Use of sources for manual
brachytherapy, and revised to delete the specific sources and uses
listed in the current paragraphs (a) through (g). This conforms with
the risk-informed, performance-based nature of this proposed rule. The
licensee would have the flexibility to use sealed sources for
therapeutic medical uses as approved in the Sealed Source and Device
Registry.
Section 35.404 would be retitled, Radiation surveys of patients or
human research subjects treated with implants, and revised. Paragraph
(a) would be revised to delete the requirement that a licensee may not
release a patient or a human research subject treated by temporary
implant until all sources have been removed and would be retitled
paragraph (b). Release of patients or human research subjects is
addressed in Sec. 35.75. The proposed paragraph (a) contains
requirements that were previously required by Sec. 35.406(c) with one
modification. Licensees would be required to survey adjacent areas of
use. This change was done to group radiation survey requirements. The
recordkeeping requirements for this section would appear in
Sec. 35.2404, Records of radiation surveys of patients and human
research subjects.
Section 35.406, Brachytherapy sources inventory, would be revised.
Paragraph (a) requires that the licensee maintain accountability for
all brachytherapy sources in storage or use. The majority of the
prescriptive requirements and associated recordkeeping requirements in
the current section would be deleted to give the licensee flexibility
in program management. The requirements in paragraph (c) would be moved
to the proposed Sec. 35.404. The Commission believes that the
requirements that were maintained are essential to the radiation safety
program. The recordkeeping requirements for this section would appear
in Sec. 35.2406, Records of brachytherapy source inventory.
Section 35.410, Safety instruction, would be revised to explicitly
state that the instruction requirements in this section are in addition
to, and not in lieu of, the training requirements of 10 CFR 19.12. The
Commission believes that it is important that personnel caring for
patients or human research subjects, that have received implant therapy
and cannot be released in accordance with Sec. 35.75, receive
instruction in limiting radiation exposure to the public and workers
and the actions to be taken in the case of a death or medical
emergency. The proposed rule would require that safety instruction be
provided initially and at least annually.
[[Page 43538]]
Instruction topics are specific to medical use of manual brachytherapy
sources. It is not expected that the same level of training be provided
to all individuals caring for the patient. The level of training should
be commensurate with the type of care that the personnel may render to
the patient or human research subject. Paragraph (a) would be revised
to require that instruction on visitor control include instruction on
routine visitation authorized under the provisions in the current
Sec. 20.1301(a)(1), as well as visitation that is authorized under the
provisions of revised Sec. 20.1301(a)(3). Paragraph (a) would also be
revised to state that personnel should notify the authorized user and
Radiation Safety Officer, or designee, if the patient or human research
subject dies or has a medical emergency. The recordkeeping requirements
for this section would appear in Sec. 35.2310, Records of instruction
and training.
Section 35.415, Safety precautions, would be revised. Paragraph (a)
would be revised to clarify that the requirements in this section apply
only if a patient or human research subject cannot be released pursuant
to Sec. 35.75. The current requirements in paragraphs (a)(3) and (4)
would be deleted because they are radiation protection requirements
that are covered under 10 CFR Part 20. A new requirement would be added
(paragraph b) to require the licensee to have equipment such as shields
and remote handling tools available near each treatment room. This
change codifies requirements that are currently imposed on licensees by
license conditions. Current paragraph (b) would be redesignated
paragraph (c) and would be revised to state that personnel should
notify the authorized user and the Radiation Safety Officer, or his/her
designee, as soon as possible if the patient or human research subject
dies or has a medical emergency. This change was made to recognize that
the licensee's primary responsibility is the care of the patient and to
provide the Radiation Safety Officer flexibility in who should be
notified to address radiation protection issues. The Commission is
soliciting public comment on whether the requirement for a licensee to
not quarter a patient in the same room as an individual who is not
receiving radiation therapy be maintained in the final rule.
Section 35.420, Possession of survey instruments, would be deleted
in its entirety because these specific requirements are not needed in
Part 35. Section 20.1501 of this chapter requires that the licensee
make, or cause to be made, surveys to demonstrate compliance with 10
CFR Part 20, and requires the licensee to ensure that instruments and
equipment used to show compliance with Part 20 are periodically
calibrated. In addition, 10 CFR 30.33(a)(2) requires licensees to have
adequate equipment. Information on the types of instruments recommended
for medical licensees is available in draft NUREG-1556, Vol. 9.
Section 35.432, Full calibration measurements of brachytherapy
sources, would appear as a new section that would require a licensee
authorized to use brachytherapy sources for medical use to perform full
calibration measurements on brachytherapy sources before the first
medical use. The requirements in this section are based on
recommendations found in American Association of Physicists in Medicine
(AAPM) Task Group 40--Comprehensive QA for Radiation Oncology (1994)
and 56--Code of Practice for Brachytherapy Physics (1997), and are
consistent with the calibration requirements for sealed sources and
devices for therapy. The proposed rule would allow the licensee to rely
on the output measurement provided by the manufacturer or distributor.
The Commission is soliciting specific comment on whether the final rule
should contain a requirement for the licensee to perform full
calibration measurements on brachytherapy sources before first use and
on whether the final rule should allow licensees to rely on the output
measurements provided by the manufacturer or distributor provided the
dosimetry equipment used by the manufacturer or distributor met the
calibration requirements in Sec. 35.630. In addition, the Commission is
soliciting specific public comment on calibration for sources where
there is no standard traceable to the National Institute of Standards
and Technology (e.g. palladium-103).
The Regulatory Analysis for this section of the proposed rule
assumes that the majority of licensees using long-lived radionuclides
will need to calibrate the sources to show compliance with this
section. It is estimated that licensees will spend approximately $1000
to calibrate these sources resulting in a $8M burden on NRC and
Agreement State licensees. The Commission has not calculated the impact
of determining the output of short-lived sealed therapy sources (e.g.
iodine-125, iridium-192) because of the limited information available
on the number of sources and variability in the type of dosimeter
equipment available at a licensee's facility to perform the
calibration. The Commission is soliciting specific public input on the
number of short and long-lived sources that will need to be calibrated
on an annual basis; whether licensees will need to procure additional
equipment to perform the calibrations; and the time needed to calibrate
the sources.
Recordkeeping requirements for this section would appear in
Sec. 35.2432, Records of full calibrations on brachytherapy sources.
Section 35.490, Training for use of manual brachytherapy sources,
would appear as a new section that would revise the training and
experience requirements found in Sec. 35.940, Training for use of
brachytherapy sources, and subsumes the requirements for training for
ophthalmic use of strontium-90. Section III of the Supplementary
Information section of this document contains a detailed discussion of
the Commission's proposed changes to the training and experience
requirements in Part 35. Note, 2 years after publication of the final
rule, this section will replace the current requirements in
Sec. 35.940, Training for use of brachytherapy and in Sec. 35.941,
Training for ophthalmic use of strontium-90.
Subpart G would be retitled Sealed sources for diagnosis. This
subpart would contain the requirements for diagnostic medical use of
sealed sources and replace the requirements in the current subpart H,
Sealed Sources for Diagnosis.
Section 35.500, Use of sealed sources for diagnosis, would be
revised to delete the specific sources and uses listed in paragraphs
(a) and (b). This conforms with the risk-informed, performance-based
nature of this proposed rule. The licensee would have flexibility to
use sealed sources for diagnostic medical uses as approved in the
Sealed Source and Device Registry.
Section 35.520, Availability of survey instruments, would be
deleted in its entirety because these specific requirements are not
needed in Part 35. Section 20.1501 of this chapter requires that the
licensee make or cause to be made surveys to demonstrate compliance
with 10 CFR Part 20 and requires the licensee to ensure that
instruments and equipment used to show compliance with 10 CFR Part 20
are periodically calibrated. In addition, Sec. 30.33(a)(2) of this
chapter requires the licensee to have adequate instrumentation.
Information on the types of instruments recommended for medical
licensees is available in draft NUREG-1556, Vol. 9.
Section 35.590, Training for use of sealed sources for diagnosis,
would appear as a new section. This section is
[[Page 43539]]
a revision of the training and experience requirements found in
Sec. 35.950, Training for use of sealed sources for diagnosis. Section
III of the Supplementary Information section of this document contains
a detailed discussion of the Commission's proposed changes to the
training and experience requirements in Part 35. Note, 2 years after
publication of the final rule, this section would replace the current
requirements in Sec. 35.920, Training for use of sealed sources for
diagnosis.
Subpart H would be retitled, Therapeutic medical devices, and
revised to address all medical uses of sealed sources and devices for
therapy. Devices such as teletherapy, remote afterloaders, and gamma
radiosurgery units are addressed in this subpart. This section does not
contain requirements for manual brachytherapy, which are in subpart F.
This subpart would replace the requirements in the current subpart I,
Teletherapy, and codify requirements for remote afterloaders and gamma
stereotactic radiosurgery units currently imposed by license
conditions.
Section 35.600 would be retitled, Use of a sealed source in a
device for therapeutic medical uses, and revised to delete any
references to specific radionuclides and devices. The licensee would
have the flexibility to use sealed sources and devices for therapeutic
medical uses as approved in the Sealed Source and Device Registry.
Section 35.604, Radiation surveys of patients and human research
subjects treated with remote afterloaders, would appear as a new
section. This section would require that a licensee make a radiation
survey of a patient or human research subject to confirm that the
sources have been removed from the individual and returned to a
shielded position before releasing the individual from licensee
control. For fractionated treatments where the patient is not
releasable pursuant to Sec. 35.75, surveys need only be performed after
the last time the source is returned to the shielded position. For
example, a survey of the patient is not required every time that the
source is retracted into the shielded safe when nursing personnel enter
the patient treatment room to provide care to patients undergoing
fractionated treatments using a low-or pulsed-dose rate remote
afterloader. This new requirement was previously imposed on remote
afterloader licensees by license condition. Recordkeeping requirements
for this section would appear in Sec. 35.2404, Records of radiation
surveys of patients and human research subjects.
Section 35.605 would be retitled, Installation, maintenance and
repair, and revised to clarify that only a person specifically licensed
by the Commission or an Agreement State can install, maintain, adjust,
or repair a device that involves work on the source shielding, source
driving unit, or other electronic or mechanical mechanism that could
expose the source, reduce the shielding around the source, or
compromise the radiation safety of the device or the sources. It would
also be revised to include additional types of devices, rather than
just teletherapy units. The Commission is soliciting specific comment
on whether the restrictions in paragraph (a) should apply to low dose-
rate remote afterloaders.
Paragraph (b) would also specify that, except for low dose-rate
remote afterloaders, only a person specifically licensed by the
Commission or an Agreement State shall install, replace, relocate, or
remove a sealed source or source contained in a device. For a low dose-
rate remote afterloader, installation, replacement, relocation, or
removal of a sealed source must be done by a person specifically
licensed by the Commission or an Agreement State or by an authorized
medical physicist. The exception to allow an authorized medical
physicist to perform these activities for low-dose rate remote
afterloaders was included in the proposed rule because the Commission
believes that the radiation hazards associated with installation,
replacement, relocation, or removal of a sealed source in these devices
are similar to that of manipulation of manual brachytherapy sources.
The recordkeeping requirements for this section would appear in
Sec. 35.2605, Records of installation, maintenance, and repair.
Section 35.606, License amendments, would be deleted in its
entirety. The requirements in the current paragraphs (a), (b), and (d)
would be addressed in the proposed revision to Sec. 35.13(e). Paragraph
(c) would be deleted because the licensees must comply with the dose
limit requirements in 10 CFR Part 20 and no further limitations are
warranted. The requirement in paragraph (e) to file an amendment before
allowing an individual to perform the duties of the authorized medical
physicist is addressed in the proposed Sec. 35.13(b). Paragraph (e)
would be deleted because the proposed requirements in subpart H would
require that the authorized medical physicist perform specific duties.
Any deviations from these requirements would necessitate an exemption
from Part 35.
Section 35.610 would be retitled, Safety procedures and
instructions for remote afterloaders, teletherapy units, and gamma
stereotactic radiosurgery units, and revised to include remote
afterloaders and gamma stereotactic radiosurgery units.
Paragraph (a) would require that a licensee develop, implement, and
maintain safety procedures; locate safety procedures at the unit
console; post safety instructions at the device console; and train
operators.
Paragraphs (a)(1) and (a)(3) would codify requirements that are
currently imposed on licensees by license conditions related to use of
remote afterloaders. Because of the applicability of the requirements
to all therapy device uses, they were added to the rule with the intent
of having the requirements apply to all such device uses. Paragraph
(a)(2) would be expanded to apply to all types of therapy devices.
However, the Commission recognizes that there are certain design
conditions that will necessitate an individual, other than the patient,
being in the treatment room during the treatment. An example of this
condition is use of a low energy beta or gamma source in a therapeutic
medical device where the authorized user may need to be in the room
with the patient. This exception does not relieve the licensees from
complying with the dose limits for occupationally-exposed individuals
or the general public in 10 CFR Part 20.
Paragraph (b) would be revised to require that a copy of the
licensee's procedures be located at the unit console, and paragraph (c)
would be revised to require that the location of the procedures and
emergency response telephone numbers be posted. Previously, all of the
above procedures were required to be posted. This was impractical with
the addition of remote afterloaders because error conditions and
responses are often several pages in length.
Paragraph (d) would be revised to require that, in addition to the
initial instruction required in Sec. 35.610, the licensee must provide
initial instruction, annual training, and annual practice drills, in
specifically identified procedures to all individuals who operate the
device. The level of instruction should be commensurate with the
individual's assigned duties. For example, an individual need not be
instructed in equipment inspection, unless it is expected that during
the normal course of the day, the individual will be required to
inspect the unit. The Commission believes that due to the complexity of
therapeutic treatment devices, refresher training and practice
[[Page 43540]]
drills on emergency response are warranted. The recordkeeping
requirements for this section would appear in Sec. 35.2310, Records of
instruction and training.
Section 35.615 would be retitled, Safety precautions for remote
afterloaders, teletherapy units, and gamma stereotactic radiosurgery
units, and revised to include remote afterloaders and gamma
stereotactic radiosurgery units. Many of the prescriptive requirements
(e.g., beam condition indicator light and radiation monitor) were
deleted from this section because they are currently addressed in 10
CFR Part 20.
The requirement in paragraph (d) for intercom systems, and the
requirements in paragraphs (e), (f) and (g) would be added to codify
requirements that are currently imposed on licensees by license
conditions. Current license conditions were modified when they were
incorporated into the proposed rule. For example, the presence of an
authorized user and medical physicist during patient treatments was
clarified for each type of use. As used in this provision, physically
present means to be within ear shot of normal voice. Immediately
available means that the individual is available on an on-call basis to
respond to an emergency. At a minimum, this person must be available by
telephone.
The Commission believes that the inherent risk of these procedures
justifies the prescriptiveness of this regulation and believes that it
is important that a properly trained physician be available at all
times to respond to an emergency requiring source removal.
New sources, using pure beta emitters, are being considered for use
in low and high dose-rate remote afterloading brachytherapy units.
Because these beta sources present lower radiation risks to medical
personnel and the public, the requirements for some of the safety
precautions in this section may not be appropriate. The Commission is
soliciting specific public comment on whether the requirements in this
section should be waved for licensees that are using remote
afterloaders with beta-emitting sources.
Section 35.620, Possession of survey instruments, would be deleted
in its entirety because these specific requirements are not needed in
Part 35. Section 20.1501 of this chapter requires that the licensee
make, or cause to be made, surveys to demonstrate compliance with 10
CFR Part 20, and requires the licensee to ensure that instruments and
equipment used to show compliance with 10 CFR Part 20 are periodically
calibrated. In addition, Sec. 30.33(a)(2) of this chapter requires
licensees to have adequate equipment. Information on the types of
instruments recommended for medical licensees is available in draft
NUREG-1556, Vol. 9.
Section 35.630, Dosimetry equipment, would be revised to provide
calibration requirements for instruments used in this subpart and
subpart F. Paragraph (a)(1) would require that dosimetry systems be
calibrated using a source whose activity is traceable to NIST and in
accordance with published protocols approved by a nationally recognized
body or by a calibration laboratory approved by AAPM. This change would
give licensees two alternatives for direct traceability of dosimetry
equipment calibration; i.e., either a source or the measurement
instrument (e.g., well chamber) can be calibrated against a national
standard. The Commission acknowledges that the industry standards for
instrument calibration provide adequate assurance that equipment is
properly calibrated. Paragraph (a)(2) would be revised to delete the
reference to intercomparison meetings sanctioned by a calibration
laboratory or radiologic physics centers accredited by the AAPM. This
provision is no longer necessary because the AAPM does not sanction
intercomparison meetings. References to cobalt-60 and cesium-137
contained within teletherapy units were deleted from the rule text to
make the section applicable to dosimetry equipment for all
radionuclides and therapy units. The recordkeeping requirements for
this section would appear in Sec. 35.2630, Records of dosimetry
equipment.
Section 35.632 would be retitled, Full calibration measurements on
teletherapy units, to clarify that the requirements in this section
apply to teletherapy units and be revised. Paragraph (d) would be
revised to delete the reference to the AAPM Task Group Reports and
replace it with a requirement that full calibration measurements be
done in accordance with published protocols approved by nationally
recognized bodies. This allows the licensee more flexibility in
choosing appropriate protocols. The Commission acknowledges that the
industry standards for teletherapy unit calibration provide adequate
assurance that equipment is properly calibrated. Paragraph (f) would be
revised to replace the term ``teletherapy physicist'' with the term
``authorized medical physicist.'' The recordkeeping requirements for
this section would appear in Sec. 35.2632, Records of teletherapy full
calibration.
Section 35.633, Full calibration measurements on remote
afterloaders, would appear as a new section that would contain the
requirements for the calibration of remote afterloaders. This section
is similar in content to Sec. 35.632. Requirements in this section
would be based on recommendations found in AAPM Task Group Report No.
56. Recordkeeping requirements for this section would appear in
Sec. 35.2633, Records of remote afterloader full calibrations.
Section 35.634, Periodic spot-checks, would be deleted in its
entirety and the requirements of this section, with minor
modifications, would be moved to Sec. 35.642.
Section 35.635, Full calibration measurements for gamma
stereotactic radiosurgery units, would appear as a new section. This
section would contain the requirements for the calibration of gamma
stereotactic radiosurgery units and is similar in content to
Sec. 35.632. Requirements in this section are based on recommendations
found in AAPM Report No. 54--Stereotactic Radiosurgery (Task Group 42,
1995). Recordkeeping requirements for this section would appear in
Sec. 35.2635, Records of gamma stereotactic radiosurgery unit full
calibrations.
Section 35.636, Safety checks for teletherapy facilities, would be
deleted in its entirety and the requirements in this section would be
incorporated into proposed Secs. 35.642, 35.643, 35.644, and 35.645.
Section 35.641, Radiation surveys for teletherapy facilities, would
be deleted in its entirety. Radiation surveys at the surface of the
main source safe would be addressed under proposed Sec. 35.652. The
remaining requirements in the current Sec. 35.641 would be deleted to
allow the licensee more flexibility in managing its radiation
protection program.
Section 35.642 would be retitled, Periodic spot-checks for
teletherapy units, and revised. The phrase ``teletherapy physicist''
would be replaced with the term ``authorized medical physicist''
throughout the section. The requirement in paragraph (c) to maintain a
copy of the physicist's notification of the results of spot-checks to
the licensee would be deleted to reduce the recordkeeping requirements
for licensees. Paragraph (d) would be modified to require that the
safety spot-checks be performed monthly and after each source
installation. This revision would replace the safety check requirements
after each source replacement in the current Sec. 35.634, which would
be deleted in the proposed rule. Paragraph (d)(3) would be modified to
replace the term ``beam
[[Page 43541]]
condition indicator'' with ``source exposure indicator'' to clarify
that indicators were needed to note whether the source was exposed and
note to what degree the source was exposed. Paragraph (d)(4) would be
revised to include a requirement for an intercom system that was
previously imposed on licensees by license condition. An intercom is
needed to assure that the licensee's staff and the patients have the
ability to communicate verbally, in addition to the ability to
communicate visually. Paragraph (e) would be revised to require that
the licensee lock the control console in the off position, and not use
the unit except as may be necessary to repair, replace, or check the
malfunctioning system, in case of any malfunction identified during a
safety spot-check. This revision is intended to make Sec. 35.642
consistent with the requirement in the current Sec. 35.636 regarding
immediate actions to be taken when a malfunctioning system is
identified. Recordkeeping requirements for this section would appear in
Sec. 35.2642, Records of periodic spot-checks for teletherapy units.
The requirements in the current Sec. 35.643 would be deleted to
allow a licensee more flexibility in designing a radiation protection
program that is specific to its facility and which ensures that the
dose limits in 10 CFR Part 20 are not exceeded.
Section 35.643, Periodic spot-checks for high and pulsed dose-rate
remote afterloaders, would appear as a new section. This section would
contain the requirements for periodic spot-checks of high and pulsed
dose-rate remote afterloaders, and is similar in content to
Sec. 35.642. Requirements in this section are based on recommendations
in AAPM Task Group Report No. 56. Recordkeeping requirements for this
section would appear in Sec. 35.2643, Records of periodic spot-checks
for remote afterloaders.
Section 35.644, Periodic spot-checks for low-dose rate remote
afterloaders, would appear as a new section. This revised section would
contain the requirements for periodic spot-checks of low dose-rate
remote afterloaders and would be similar in content to Sec. 35.642.
These proposed requirements are based on recommendations found in the
AAPM Task Group Report No. 56. Some requirements were added to make the
safety checks, and associated corrective actions, consistent with the
requirements in Sec. 35.642. The Commission is soliciting comment on
whether the requirements for electrical interlocks should apply to low-
dose rate remote afterloaders. Recordkeeping requirements for this
section would appear in Sec. 35.2643, Records of periodic spot-checks
for remote afterloaders.
The current requirements in Sec. 35.645, would be deleted to reduce
the reporting burden on medical use licensees. Survey results are
maintained by a licensee to show compliance with 10 CFR Part 20 and,
therefore, would be available for review.
Section 35.645, Periodic spot-checks for gamma stereotactic
radiosurgery units, would appear as a new section. This section would
contain requirements for periodic spot-checks of gamma stereotactic
radiosurgery units, and is similar in content to Sec. 35.642.
Requirements in this section are based on recommendations found in AAPM
Report No. 54. Some requirements were added to make the safety checks,
and associated corrective actions, consistent with the requirements in
Sec. 35.642. Recordkeeping requirements for this section would appear
in Sec. 35.2645, Records of periodic spot-checks for gamma stereotactic
radiosurgery units.
The requirements in the current Sec. 35.647 would be moved to the
proposed Sec. 35.655.
Section 35.647, Additional technical requirements for mobile remote
afterloaders, would appear as a new section. This section would contain
the requirements for mobile remote afterloaders which were previously
listed in an internal NRC document entitled, ``Supplement 1 to Policy
and Guidance Directive FC 86-4; Revision 1, Mobile Remote Afterloading
Brachytherapy Licensing Module.'' Recordkeeping requirements for this
section would appear in Sec. 35.2647, Records of additional technical
requirements for mobile remote afterloaders.
Based on discussions with the States, this section is designated as
a Category D item of compatibility since there is no potential for
medical use of byproduct material in other regulatory jurisdictions
under reciprocity. NRC specifically requests comment on this issue
relative to whether mobile medical licensees operate under reciprocity
in other regulatory jurisdictions.
Section 35.652, Radiation surveys, would appear as a new section.
This section would replace the current Sec. 35.641. This section would
require that, in addition to the surveys required by 10 CFR 20.1501,
the licensee make surveys to assure that the maximum radiation levels
and average radiation levels from the surface of the main source safe
do not exceed the levels stated in the Sealed Source and Device
Registry. These surveys provide added assurance that a device has been
manufactured and that source(s) have been installed properly.
Recordkeeping requirements for this section would appear in
Sec. 35.2652, Records of surveys of therapeutic treatment units.
Section 35.655, Five-year inspection for teletherapy and gamma
stereotactic radiosurgery units, would appear as a new section and
would contain the requirements for inspections which are in the current
Sec. 35.647. Proposed Sec. 35.655 would require that teletherapy units
and gamma stereotactic radiosurgery units be inspected and serviced
during source replacement, or at intervals not to exceed 5 years, to
assure proper functioning of the source exposure mechanism. Most gamma
stereotactic radiosurgery licensees are required, by license condition,
to inspect the units every 7 years; however, professionals in the
medical community have indicated that the units are inspected on a more
frequent basis. The Commission believes that the risk associated with
using gamma stereotactic radiosurgery units justifies a change in the
inspection frequency. Recordkeeping requirements for this section would
appear in Sec. 35.2655, Records of 5-year inspection for teletherapy
and gamma stereotactic radiosurgery units.
Section 35.657, Therapy-related computer systems, would appear as a
new section that would require licensees to verify that the
computerized operating system and treatment planning system associated
with a therapy device are operating appropriately and to perform
acceptance testing on the treatment planning systems in accordance with
published protocols approved by nationally recognized bodies. These
changes are consistent with recommendations found in AAPM Task Group
Report No. 40--Comprehensive QA for Radiation Oncology (1994).
This proposed requirement is especially important in light of
recent information on the inability of computers to correctly recognize
dates beyond December 31, 1999. Therapy-related computer systems may
misread the year 2000 and cause the systems to fail, generate faulty
data, or act in an incorrect manner. In particular, computer software
used to calculate dose or to account for radioactive decay may not
recognize the turn of the century, which could lead to incorrectly
calculated doses or exposure times for treatment planning. The
potential for system failures, such as this, would be identified when
determining compliance with this proposed section.
Section 35.690, Training for use of therapeutic medical devices,
would appear as a new section. This section
[[Page 43542]]
would revise the training and experience requirements found in
Sec. 35.960, Training for teletherapy, and would be expanded to include
training for authorized uses of teletherapy, remote afterloaders, and
gamma stereotactic radiosurgery units. Section III of the Supplementary
Information section of this document contains a detailed discussion of
training and experience. Note, 2 years after publication of the final
rule, this section would replace the current requirements in
Sec. 35.960, Training for teletherapy.
Subpart J, Training and Experience Requirements, is in the current
Part 35. Licensees would have the option to comply with the training
and experience requirements in this subpart or in subparts B, and D-H
until 2 years after the final rule is published in the Federal
Register. At that time this subpart will be deleted. A more detailed
discussion of the Commission's proposed changes to the training and
experience requirements is in Section III of the Supplementary
Information section of this document. The proposed schedule for
implementation of the training and experience requirements is in
Section VIII of the SUPPLEMENTARY INFORMATION section of this document.
Section 35.900, Radiation Safety Officer, is in the current Part
35. Two changes would be made in this section to correspond to the
revised numbering system: Sec. 35.57, Training for experienced
Radiation Safety Officer, teletherapy or medical physicist, authorized
user, and nuclear pharmacist; and Sec. 35.24, Authority and
responsibilities for the radiation protection program. This section
would be deleted 2 years after the final rule is published in the
Federal Register at which time licensees would be required to comply
with the training and experience requirements in the new Sec. 35.50,
Training for Radiation Safety Officer. Section VIII of the
Supplementary Information section of this document contains a detailed
discussion of the Commission's proposed implementation of the training
and experience requirements.
Section 35.901, Training for experienced Radiation Safety Officer,
would be deleted in its entirety and the requirements of this section
would be moved to the proposed Sec. 35.57.
Section 35.910, Training for uptake, dilution, and excretion
studies, is in the current Part 35. One change would be made in this
section to correspond to the revised numbering system: Sec. 35.57,
Training for experienced Radiation Safety Officer, teletherapy or
medical physicist, authorized user, and nuclear pharmacist. This
section would be deleted 2 years after the final rule is published in
the Federal Register, at which time licensees would be required to
comply with the training and experience requirements in the new
Sec. 35.290, Training for uptake, dilution, and excretion studies.
Section VIII of the SUPPLEMENTARY INFORMATION section of this document
contains a detailed discussion of the Commission's proposed
implementation of the training and experience requirements.
Section 35.920, Training for imaging and localization studies, is
in the current Part 35. One change would be made in this section to
correspond to the revised numbering system: Sec. 35.57, Training for
Experienced Radiation Safety Officer, teletherapy or medical physicist,
authorized user, and nuclear pharmacist. This section would be deleted
2 years after the final rule is published in the Federal Register, at
which time licensees would be required to comply with the training and
experience requirements in the new Sec. 35.292, Training for imaging
and localization studies. Section VIII of the SUPPLEMENTARY INFORMATION
section of this document contains a detailed discussion of the
Commission's proposed implementation of the training and experience
requirements.
Section 35.930, Training for therapeutic use of unsealed byproduct
material, is in the current Part 35. One change would be made in this
section to correspond to the revised numbering system: Sec. 35.57,
Training for experienced Radiation Safety Officer, teletherapy or
medical physicist, authorized user, and nuclear pharmacist. This
section would be deleted 2 years after the final rule is published in
the Federal Register, at which time licensees would be required to
comply with the training and experience requirements in the new
Sec. 35.390, Training for use of unsealed byproduct material for
therapy or for use of unsealed byproduct material that requires a
written directive. Section VIII of the SUPPLEMENTARY INFORMATION
section of this document contains a detailed discussion of the
Commission's proposed implementation of the training and experience
requirements.
Section 35.932, Training for treatment of hyperthyroidism, is in
the current Part 35. One change would be made in this section to
correspond to the revised numbering system: Sec. 35.57, Training for
experienced Radiation Safety Officer, teletherapy or medical physicist,
authorized user, and nuclear pharmacist. This section would be deleted
2 years after the final rule is published in the Federal Register, at
which time licensees would be required to comply with the training and
experience requirements in the new Sec. 35.390, Training for use of
unsealed byproduct material for therapy or for use of unsealed
byproduct material that requires a written directive. Section VIII of
the Supplementary Information section of this document contains a
detailed discussion of the Commission's proposed implementation of the
training and experience requirements.
Section 35.934, Training for treatment of thyroid carcinoma, is in
the current Part 35. One change would be made in this section to
correspond to the revised numbering system: Sec. 35.57, Training for
experienced Radiation Safety Officer, teletherapy or medical physicist,
authorized user, and nuclear pharmacist. This section would be deleted
2 years after the final rule is published in the Federal Register, at
which time licensees would be required to comply with the training and
experience requirements in the new Sec. 35.390, Training for use of
unsealed byproduct material for therapy or for use of unsealed
byproduct material that requires a written directive. Section VIII of
the Supplementary Information section of this document contains a
detailed discussion of the Commission's proposed implementation of the
training and experience requirements.
Section 35.940, Training for use of brachytherapy sources, is in
the current Part 35. One change would be made in this section to
correspond to the revised numbering system: Sec. 35.57, Training for
experienced Radiation Safety Officer, teletherapy or medical physicist,
authorized user, and nuclear pharmacist. This section would be deleted
2 years after the final rule is published in the Federal Register, at
which time licensees would be required to comply with the training and
experience requirements in the new Sec. 35.490, Training for use of
manual brachytherapy sources. Section VIII of the Supplementary
Information section of this document contains a detailed discussion of
the Commission's proposed implementation of the training and experience
requirements.
Section 35.941, Training for ophthalmic use of strontium-90, is in
the current Part 35. One change would be made in this section to
correspond to the revised numbering system: Sec. 35.57, Training for
experienced Radiation Safety Officer, teletherapy or medical physicist,
authorized user, and nuclear pharmacist. This section would be deleted
2 years after the final rule is published in the Federal Register, at
which time licensees would be required to comply with the training and
experience requirements in the new
[[Page 43543]]
Sec. 35.490, Training for use of manual brachytherapy sources. Section
VIII of the SUPPLEMENTARY INFORMATION section of this document contains
a detailed discussion of the Commission's proposed implementation of
the training and experience requirements.
Section 35.950, Training for use of sealed sources for diagnosis,
is in the current Part 35. One change would be made in this section to
correspond to the revised numbering system: Sec. 35.57, Training for
experienced Radiation Safety Officer, teletherapy or medical physicist,
authorized user, and nuclear pharmacist. This section would be deleted
2 years after the final rule is published in the Federal Register, at
which time licensees would be required to comply with the training and
experience requirements in the new Sec. 35.590, Training for use of
sealed sources for diagnosis. Section VIII of the Supplementary
Information section of this document contains a detailed discussion of
the Commission's proposed implementation of the training and experience
requirements.
Section 35.960, Training for use of therapeutic medical devices, is
in the current Part 35. One change would be made in this section to
correspond to the revised numbering system: Sec. 35.57, Training for
experienced Radiation Safety Officer, teletherapy or medical physicist,
authorized user, and nuclear pharmacist. This section would be deleted
2 years after the final rule is published in the Federal Register, at
which time licensees would be required to comply with the training and
experience requirements in the new Sec. 35.690, Training for use of
therapeutic medical devices. Section VIII of the Supplementary
Information section of this document contains a detailed discussion of
the Commission's proposed implementation of the training and experience
requirements.
Section 35.961 would be retitled, Training for an authorized
medical physicist, to reflect that the training and experience
requirements in this section apply to authorized medical physicists
rather than just teletherapy physicists, and would be revised. In
addition, the list of tasks in paragraph (c) would be changed to
reflect the new numbering system. This section would be deleted 2 years
after the final rule is published in the Federal Register, at which
time licensees would be required to comply with the training and
experience requirements in the new Sec. 35.51, Training for an
authorized medical physicist. Section VIII of the SUPPLEMENTARY
INFORMATION section of this document contains a detailed discussion of
the Commission's proposed implementation of the training and experience
requirements.
Section 35.970, Training for an authorized nuclear pharmacist,
would be deleted in its entirety and the requirements would be moved to
the proposed Sec. 35.57.
Section 35.971, Physicians training in a three month program, would
be deleted in its entirety. Three month nuclear medicine programs are
no longer available. Criteria for authorized users are now specified in
other areas of the rule.
Section 35.980, Training for an authorized nuclear pharmacist,
would not be changed. This section would be deleted 2 years after the
final rule is published in the Federal Register, at which time
licensees would be required to comply with the training and experience
requirements in the new Sec. 35.55, Training for an authorized nuclear
pharmacist. Section VIII of the SUPPLEMENTARY INFORMATION section of
this document contains a detailed discussion of the Commission's
proposed implementation of the training and experience requirements.
Section 35.981, Training for experienced nuclear pharmacists, has
not been changed. This section would be deleted 2 years after the
publication of the final rule in the Federal Register, at which time
licensees would be required to comply with the training and experience
requirements in the new Sec. 35.55, Training for an authorized nuclear
pharmacist. The Commission solicits specific comment on the impact of
deleting this section. Section VIII of the Supplementary Information
section of this document contains a detailed discussion of the
Commission's proposed implementation of the training and experience
requirements.
Section 35.990, Violations, would be deleted in its entirety, and
the requirements of this section, with minor modifications, would be
moved to the proposed Sec. 35.4001
Section 35.991, Criminal penalties, would be deleted in its
entirety, and the requirements of this section, with minor
modifications, would be moved to the proposed Sec. 35.4002.
Section 35.999, Resolution of conflicting requirements during
transition period, would be deleted in its entirety, and the
requirements of this section, with modifications, would be moved to the
proposed Sec. 35.10.
Subpart K, Other Medical Uses of Byproduct Material or Radiation
from Byproduct Material, would be a new subpart. This subpart was
developed to accommodate use of radioactive material in an emerging
technology.
Section 35.1000, Other medical uses of byproduct material or
radiation from byproduct material, is new. It would be added to
accommodate emerging technologies. Specific information that must be
provided to the Commission in support of an application for use under
Sec. 35.1000 is provided in Sec. 35.12(d).
Subpart L, Records, is a new subpart. This subpart would contain
all the specific recordkeeping requirements necessary to implement the
proposed requirements in Part 35. General requirements for record
maintenance, such as electronic storage, are provided in Sec. 35.5.
Grouping of records into one subpart was done to facilitate use by the
licensees, and is consistent with the approach used in part 20. A
licensee may reference this section when determining whether something
must be recorded, rather than having to review the entire regulation to
find out if there is a particular recordkeeping requirement. Many of
the recordkeeping requirements remain unchanged. However, some new
sections have been added as a result of new requirements, especially in
subpart H. The Commission is soliciting public comment on whether all
recordkeeping requirements should be grouped into one subpart or
whether all recordkeeping requirements should be included in the
section requiring the record. In addition, the Commission is soliciting
specific public comment on which recordkeeping requirements could be
deleted in the final rule and the basis for the deletion. For example,
should the recordkeeping requirements in Sec. 35.2063 be retained for
byproduct material administered pursuant to Secs. 35.100 and 35.200
because of the low risk associated with this type of use?
Section 35.2024, Records of authority and responsibility for
radiation protection programs, would require the licensee to retain a
record of actions taken by the licensee's management in accordance with
Sec. 35.24(a) for 5 years. The 5-year retention period is a reduction
from current requirements to maintain records of the approval of
licensing actions, individuals, and radiation protection program
changes. Currently, similar records are required to be maintained for
the duration of the license (reference current Sec. 35.22 and
Sec. 35.31). This period would allow sufficient time for NRC to review
records of licensee actions.
It would also require the licensee to retain the copy of the
authorities, duties, and responsibilities of the Radiation Safety
Officer for the duration of the license. In many cases, these records
would take the place of the Radiation Safety Committee meeting minutes.
The
[[Page 43544]]
Commission believes that it is important to document licensees'
management review and approval of licensing actions, changes to the
radiation protection program, and the authorities, duties, and
responsibilities of the Radiation Safety Officer. The record of
licensing actions and radiation protection program changes must include
a summary of actions and a signature of licensee management.
In addition, this section would require the licensee to retain a
copy of the authorities, duties and responsibilities of the Radiation
Safety Officer that includes the signatures of the radiation safety
officer and licensee management for the duration of the license. This
extended period is warranted in light of the importance of the
functions performed by the Radiation Safety Officer.
Section 35.2026, Records of radiation protection program safety
changes, would require the licensee to retain a record of each
radiation protection program change, as required by Sec. 35.26 for 5
years. The record must include a copy of the old and new procedure, the
effective date of the change, and the signature of the Radiation Safety
Officer and licensee management that reviewed and approved the change.
The Commission recognizes that this requirement for management's
signature is redundant to the requirement in Sec. 35.2024. However, it
believes this approach is warranted in light of the importance of these
actions and the intent to keep requirements that are closely related in
one subject area. Currently, licensees must retain a record of each
``radiation safety program'' change until the license has been renewed
or terminated. Therefore, this proposed change represents a reduction
in burden. This record is needed to document what radiation changes
were made in the program. This record facilitates the Commission's
evaluation of minor radiation safety program changes and provides
licensees with a record of the changes.
Section 35.2040, Records of written directives, would require the
licensee to retain a copy of written directives required by Sec. 35.40
for 3 years. These records will help to ensure that administrations
were in accordance with the written directives. The 3-year
recordkeeping retention period corresponds with the current retention
period for written directives. Only minor changes were made to the
specific items that must currently be recorded in the written
directive. These changes were discussed under Sec. 35.40.
Section 35.2045, Records of medical events, would require that the
licensee maintain a record of medical events reported pursuant to
Sec. 35.3045 for 3 years. This section, in part, is intended to replace
the current recordkeeping requirements in Sec. 35.33. The records made
pursuant to Sec. 35.3045 must contain the licensee's name; the name of
the prescribing physician; the affected or potentially affected
individual's social security number or other identification number if
one has been assigned; a brief description of the medical event; why it
occurred; the effect on the individual; and the actions taken to
prevent recurrence. This record is needed to document medical events
for licensee and Commission review. The requirement to maintain records
of medical events is similar to the current requirement for maintaining
records of misadministrations. This proposed requirement would provide
for a reduction in licensee burden since medical events records would
be required to be maintained for 3 years rather than 5 years.
Section 35.2060, Records of instrument calibrations, would require
the licensee to maintain a record of dose calibrator calibrations
performed in accordance with Secs. 35.60 and 35.62 for 3 years. These
records are required to document that the instruments are functioning
correctly. The name, rather than the signature, of the individual who
performed the calibration would be required so that licensees would
have the flexibility of using paper records or computer-generated
records. This requirement does not prohibit licensees from continuing
to have the individual who performed the calibration sign the record.
The 3-year recordkeeping retention period is consistent with the
current retention period for instrument calibrations.
Section 35.2061, Records of radiation survey instrument
calibrations, would require the licensee to maintain a record of
radiation survey instrument calibrations required by Sec. 35.61 for 3
years. No changes have been made from the current recordkeeping
requirements for radiation survey instrument calibrations. These
records are required to document that the instruments are functioning
correctly. The 3-year recordkeeping retention period is consistent with
the current retention period for instrument calibrations.
Section 35.2063, Records of dosage of unsealed byproduct material
for medical use, would require the licensee to maintain a record of
dosage determinations required by Sec. 35.63 for 3 years. Minor changes
have been made from the current recordkeeping requirements for dosage
measurement to delete the requirement to record the expiration date of
the radiopharmaceutical. This was done because the expiration date is
primarily related to drug stability and sterility. The term ``dosage
measurement'' has been replaced by the term ``dosage determination'' to
be consistent with the change proposed in Sec. 35.63. Finally, a change
would be made to require that the name of the individual who determined
the dosage be documented. The licensee will be required to record
dosages administered to patients or human research subjects. This
record is required for licensees to show that they are maintaining
control of radioactive material. The 3-year recordkeeping retention
period corresponds with the current retention period for dosage
records.
Section 35.2067, Records of possession of sealed sources and
brachytherapy sources, would require the licensee to retain records of
the leak tests and inventory required by Sec. 35.67 (b) and (g) for 3
years. The record retention period would be reduced from 5 years to 3
years to reduce regulatory burden. The Commission does not believe the
extra period is warranted. One change has been made from the current
recordkeeping requirements for leak tests and inventories. The name of
the individual performing the leak test and inventory would be recorded
rather than the signature of the Radiation Safety Officer. Leak test
records are required to show that the leak test was done at the
appropriate time interval and that sealed sources are not leaking.
Inventory records are necessary to show that the possession of sealed
sources did not exceed the amount authorized by the license.
Section 35.2070, Records of surveys for ambient radiation exposure
rate, would require the licensee to maintain records of radiation
surveys for 3 years. One change has been made from the current
recordkeeping requirements for radiation surveys. The name of the
individual performing the survey rather than the initials of the
individual would be required to be recorded. These records are needed
to document that surveys were performed. The 3-year recordkeeping
retention period is consistent with the current retention period for
radiation surveys.
Section 35.2075, Records of the release of individuals containing
radiopharmaceuticals or implants, would require the licensee to
maintain records of patient release required by Sec. 35.75 for 3 years.
No changes have been made from the current recordkeeping requirements
in Sec. 35.75. This record is needed to show
[[Page 43545]]
compliance with the requirements in Sec. 35.75.
Section 35.2080, Records of administrative and technical
requirements that apply to the provision of mobile services, would
require the licensees to maintain a copy of the letter that permits the
use of byproduct material at a client's address of use for 3 years
after the last provision of service; and to retain the records of the
surveys for 3 years. One change has been made in these records that are
required by Sec. 35.80. The name of the individual performing the
survey rather than the initials of the individuals would be required to
be recorded. The records are needed to show compliance with the
requirements in Sec. 35.80.
Section 35.2092, Records of waste disposal, would require the
licensee to maintain records of the disposal of licensed materials made
in accordance with Sec. 35.92 for 3 years. Minor changes have been made
in the recordkeeping requirements in the current Part 35. The licensee
would no longer be required to record the date that the material was
placed in storage because the requirement to store material for 10
half-lives would be deleted in the proposed rule. The record must
include the date of the disposal, the radionuclides disposed, the
survey instrument used, the background dose rate, the dose rate
measured at the surface of each waste container, and the name of the
individual who performed the disposal. This record is needed to
document that radioactive material is not disposed of as ordinary
waste. The 3-year recordkeeping retention period is consistent with the
current retention period for waste disposal records.
Section 35.2204, Records of molybdenum-99 concentration, would
require the licensee to maintain a record of the molybdenum-99
concentration tests required by Sec. 35.204(b) for 3 years. Minor
changes have been made in the recordkeeping requirements from the
current rule. The licensee would no longer be required to record the
measured activity of the technetium expressed in millicuries, and the
measured activity of the molybdenum expressed in microcuries. The
record must include, for each measured elution of technetium-99m, the
ratio for the measures expressed as microcuries of molybdenum per
millicurie of technetium, the time and date of the measure, and the
name of the individual who performed the disposal. This record is
needed to document that the concentration measurement was made and that
the maximum molybdenum-99 concentration level was not exceeded. The 3-
year recordkeeping retention period is consistent with the current
retention period for records of molybdenum-99 concentration.
Section 35.2310, Records of instruction and training, would require
the licensee to maintain a record of radiation safety instructions
required by Secs. 35.310, 35.410, and 35.610 for 3 years. The record
must include a list of the topics covered, the date of the instruction
or training, the name(s) of the attendee(s) and the name of the
individual who gave the instruction. This record is needed to document
that the instruction and training was given. The 3-year recordkeeping
retention period is consistent with the current retention period for
training records.
Section 35.2404, Records of radiation surveys of patients and human
research subjects, would require the licensee to maintain a record of
the radiation surveys required by Sec. 35.404 for 3 years. The licensee
would no longer be required to record the dose rate from the patient or
the human research subject expressed as millirem per hour and measured
at 1 meter from the patient or human research subject. Each record must
include the date, location, results of the survey, an identification of
the patient or the human research subject, survey instrument used, and
the name of the individual who made the survey. These records are used
to show that sources have not been misplaced and that all sources have
been removed from the patient. The 3-year recordkeeping retention
period is consistent with the current retention period for surveys.
Section 35.2406, Records of brachytherapy source inventory, would
require the licensee to maintain a record of brachytherapy source
accountability required by Sec. 35.406 for 3 years. Changes have been
made in the recordkeeping requirements that are in the current rule.
The licensee would no longer be required to record the following items
since they would be deleted from discussion in Sec. 35.406: the names
of the individuals permitted to handle the sources; name and room
number of the patient or the human research subject receiving the
implant; number and activity of the sources in storage after the
removal; and the number and activity of sources in storage after the
return.
The proposed rule would require that, for temporary implants, the
record must include the number and activity of sources removed from and
returned to storage; the time and date they were removed from and
returned to storage; the location of use; and the name of the
individual who removed and returned the sources to storage. For
permanent implants, the record must include the number and activity of
sources removed from and returned to storage; the date they were
removed from and returned to storage; the number and activity of
sources removed from and returned to storage; the number and activity
of sources permanently implanted in the patient or human research
subject; and the name of the individual who removed and returned the
sources to storage. This record is required so that, if a brachytherapy
source is misplaced or missing, the licensee is immediately alerted and
can take appropriate action. The 3-year recordkeeping retention period
is consistent with the current retention period for inventory records.
Section 35.2432, Records of full calibrations on brachytherapy
sources, would require the licensee to retain a record of the results
of brachytherapy source calibrations for 3 years after the last use of
the source. This is a new recordkeeping section. The record must
contain the date of the calibration; the manufacturer's name, model
number, and serial number for the source and instruments used to
calibrate the source; the source output; source positioning accuracy
within applicators; and the name of the individual or source
manufacturer who performed the calibration. These records are needed to
document that the brachytherapy sources have been calibrated.
Section 35.2605, Records of installation, maintenance, and repair,
would require the licensee to retain a record of the installation,
maintenance, and repair of therapeutic medical devices, as required by
Sec. 35.605, for 3 years. This is a new recordkeeping section.
Previously, licensees were not required to keep records of
installation, maintenance, and repair. For each installation,
maintenance, and repair, the record must include the date, description
of the service, and name(s) of the individual(s) who performed the
work. This record is necessary to document that the devices are
properly installed, maintained, and repaired; to establish trends in
device performance; and to establish a service history that may be used
in evaluation of generic equipment problems.
Section 35.2630, Records of dosimetry equipment, would require the
licensee to retain a record of the calibration, intercomparison, and
comparisons of its dosimetry equipment done in accordance with
Sec. 35.630 for the duration of the license. No changes have been made
in the recordkeeping requirements from the current rule. These records
are needed to show that calibrations of medical devices were made with
properly calibrated instruments.
[[Page 43546]]
Section 35.2632, Records of teletherapy full calibrations, would
require the licensee to maintain a record of the teletherapy full
calibrations required by Sec. 35.632 for 3 years. The record retention
period would be decreased from the duration of the use of the
teletherapy unit source to 3 years to reduce regulatory burden. The
term ``teletherapy physicist'' was replaced with the term ``authorized
medical physicist.'' No other changes were made to the current
recordkeeping requirements for this section. These records are needed
to document that calibrations were performed in accordance with
Sec. 35.632.
Section 35.2633, Records of remote afterloader full calibrations,
would require the licensee to maintain a record of the remote
afterloader full calibrations required by Sec. 35.633 for 3 years. This
is a new recordkeeping section. The recordkeeping requirements in this
section are similar to the recordkeeping requirements for teletherapy
units in Sec. 35.2632. The record must include the date of the
calibration; the manufacturer's name, model number, and serial number
for the remote afterloader, source, and instruments used to calibrate
the unit; the source output; an assessment of timer accuracy and
linearity, source positioning accuracy, source guide tube and connector
lengths, source retraction functionality; and the signature of the
authorized medical physicist who performed the full calibration. These
records are needed to document that calibrations were performed in
accordance with Sec. 35.633.
Section 35.2635, Records of gamma stereotactic radiosurgery unit
full calibrations, would require the licensee to maintain a record of
the calibrations required by Sec. 35.635 for 3 years. This is a new
recordkeeping section. The recordkeeping requirements in this section
are similar to the recordkeeping requirements for teletherapy units in
Sec. 35.2632. The record must include the date of the calibration; the
manufacturer's name, model number, and serial number for the gamma
stereotactic radiosurgery unit, source, and instruments used to
calibrate the unit; the unit output; an assessment of the relative
helmet factors, isocenter coincidence, timer accuracy and linearity,
on-off error, and trunnion centricity; and the signature of the
authorized medical physicist who performed the full calibration. These
records are needed to document that calibrations were performed in
accordance with Sec. 35.635. This change reflects corresponding changes
made in Sec. 35.642.
Section 35.2642, Records of periodic spot-checks for teletherapy
units, would require the licensee to retain a record of each periodic
spot-check for teletherapy units required by Sec. 35.642 for 3 years.
Minor changes have been made in the recordkeeping requirements from the
current rule. The licensee would no longer be required to record the
operability of the beam condition indicator light, but would be
required to record the operability of the source exposure indicator
light. This change reflects corresponding changes made in Sec. 35.642.
The record must include the date of the spot-check; the manufacturer's
name, model number, and serial number for the teletherapy unit source,
and instrument used to measure the output of the teletherapy unit; an
assessment of timer linearity and constancy; the calculated on-off
error, a determination of the coincidence of the radiation field and
the field indicated by the light beam localizing device; the determined
accuracy of each distance measuring and localization device; the
difference between the anticipated output and the measured output;
notations indicating the operability of each entrance door electrical
interlock, each electrical or mechanical stop, each source exposure
indicator light, and the viewing and intercom system and doors; name of
the individual who performed the test and the signature of the
authorized medical physicist who reviewed the periodic spot-check.
These records are needed to document that spot-checks were performed in
accordance with Sec. 35.642. The 3-year recordkeeping retention period
is consistent with the current retention period for periodic spot-
checks.
Section 35.2643, Records of periodic spot-checks for remote
afterloaders, would require the licensee to retain a record of each
spot-check for remote afterloaders required by Secs. 35.643 and 35.644
for 3 years. This is a new recordkeeping section. The record must
include the date of the spot-check; the manufacturer's name, model
number, and serial number for both the remote afterloader, source, and
instrument used to measure the output of the remote afterloader; the
difference between the anticipated output and the measured output;
notations indicating the operability of each entrance door electrical
interlock, source retraction mechanism, radiation monitors, source
exposure indicator lights, viewing and intercom, applicators and
connectors, and source positioning accuracy; the name of the individual
who performed the periodic spot-check; and signature of the authorized
medical physicist who reviewed the periodic spot-check. These records
are needed to document that spot-checks were performed in accordance
with Secs. 35.643 and 35.644.
Section 35.2645, Records of periodic spot-checks for gamma
stereotactic radiosurgery units, would require the licensee to retain a
record of each spot-check for gamma stereotactic radiosurgery units
required by Sec. 35.645 for 3 years. This is a new recordkeeping
section. The record must include the date of the spot-check; the
manufacturer's name, model number, and serial number for the gamma
stereotactic radiosurgery unit, and the instrument used to measure the
output of the unit; the measured source output and source output
against computer calculations; notations indicating the operability of
radiation monitors, helmet microswitches, emergency timing circuits,
emergency off buttons, electrical interlocks, source exposure indicator
lights, viewing and intercom systems, timer termination systems,
hydraulic cutoff mechanism, and stereotactic frames and localizing
devices (trunnions); and the name of the individual who performed the
periodic spot-check; and the signature of the authorized medical
physicist who reviewed the periodic spot-check. This record is needed
to show that spot-checks were performed in accordance with Sec. 35.645.
Section 35.2647, Records of additional technical requirements for
mobile remote afterloaders, would require the licensee to retain a
record of each check for mobile remote afterloaders required by
Sec. 35.647 for 3 years. This is a new recordkeeping section. The
record must include the date of the check; the manufacturer's name,
model number, and serial number for the remote afterloader; notations
accounting for all sources before departing from a client's facility;
notations indicating the operability of each entrance door electrical
interlock, radiation monitors, source exposure indicator lights,
viewing and intercom system, applicators and connectors, and source
positioning accuracy; and the signature of the individual who performed
the check. This record is needed to show that required spot-checks were
performed in accordance with Sec. 35.647 and that the unit is operable.
The 3-year recordkeeping retention period is consistent with the
current retention period for checks on mobile remote afterloaders.
Section 35.2652, Records of surveys of therapeutic treatment units,
would require the licensee to maintain a record of radiation surveys
made in accordance
[[Page 43547]]
with Sec. 35.652 for the duration of use of the unit. This
recordkeeping section has been changed to require that the records of
radiation surveys of the treatment unit must be maintained for the
duration of use of the unit, rather than for the duration of the
license, to reduce regulatory burden. In addition, the licensee is no
longer required by this section to maintain a plan of the areas
surrounding the treatment room that were surveyed, the measured dose
rate at several points in each area expressed in millirem per hour, and
the calculated maximum quantity of radiation over a period of 1 week
for each restricted and unrestricted area. This change reflects
corresponding changes made in Sec. 35.652. The record must include the
date of the measurements; the manufacturer's name, model number and
serial number of the treatment unit, source, and instrument used to
measure radiation levels; and each dose rate measured around the source
while the unit is in the off position and the average of all
measurements and the signature of the individual who performed the
surveys. This record is needed to document radiation levels in areas
surrounding therapeutic devices.
Section 35.2655, Records of 5-year inspection for teletherapy and
gamma stereotactic surgery units, would require the licensee to
maintain a record of the 5-year inspection for teletherapy and gamma
stereotactic radiosurgery units required by Sec. 35.655 for the
duration of the unit. This recordkeeping section would be changed to
require that the records of inspections of the treatment units must be
maintained for the duration of use of the unit, rather than for the
duration of the license, to reduce regulatory burden. A minor change
was made to delete the requirement to maintain a record of the
components replaced to also reduce regulatory burden. The record must
contain the inspector's name; the inspector's radioactive materials
license number; the date of inspection; the manufacturer's name and
model number and serial number for both the treatment unit and source;
a list of components inspected and serviced; the type of service; and
the signature of the inspector. This record is needed to document the
type of service that was performed.
Subpart M, Reports, is a new subpart in Part 35. This subpart would
contain all the reporting requirements necessary to implement the
proposed requirements in Part 35. Grouping of reporting requirements
into one subpart was done to facilitate use by the licensee. A licensee
may reference this section when determining whether something must be
reported, rather than having to review the entire regulation to find
out if there is a particular reporting requirement. Many of the
reporting requirements remain unchanged. The Commission is soliciting
public comments on whether the reporting requirements should be
included in the section requiring the report.
Section 35.3045, Reports of medical events, would provide criteria
for reporting medical events. The criteria are based on the current
requirements in Sec. 35.33. Changes would be made to make the reporting
threshold dose-based where possible to add a dose threshold of 0.5 Sv
(50 rem) shallow dose equivalent to the skin; and to address two areas
that have caused problems in implementing the current requirements in
Sec. 35.33--patient intervention and wrong treatment site. With respect
to patient intervention, the licensee is expected to act reasonably, in
accordance with prevailing standards of care, to prevent a medical
event. Generally speaking, patient intervention involves actions by the
patient such as dislodging or removing treatment devices or prematurely
terminating treatment. In cases where patient intervention is probable,
the licensee should take reasonable actions (e.g., extra sutures,
taping, or more frequent checks by the nursing staff) to avoid a
medical event. Factors which may be considered in determining whether a
licensee's actions are reasonable include whether the licensee monitors
the patient routinely and whether the licensee responds properly once
it becomes aware of the disruption of treatment. The Commission is
soliciting input from the public on whether the proposed changes
adequately address patient intervention and wrong treatment site.
The proposed rule would require that licensees notify, by
telephone, the NRC Operations Center no later than the next calendar
day after discovery of the medical event. The licensee would be
required to submit a written report to the appropriate NRC Regional
Office listed in 10 CFR 30.6 within 15 days after discovery of the
medical event. In addition, the licensee would be required to notify
the referring physician and the individual affected by the medical
event, or the responsible relative or guardian, no later than 24 hours
after its discovery, unless the referring physician personally informs
the licensee either that he will inform the individual or that, based
on medical judgment, telling the individual would be harmful. This
reporting requirement is needed to ensure that NRC is aware of medical
events. Section III of the Supplementary Information of this document
contains a detailed discussion of the Commission's views on the
notification requirements.
The proposed rule would require that a written report be furnished
to the individual within 15 days after discovery of the medical event.
This requirement could be met by sending either a copy of the report
that was submitted to the NRC or a brief description of both the event
and the consequences as they may affect the individual. The proposed
rule would delete the current requirement to include a statement that
the report submitted to the NRC can be obtained from the licensee. This
deletion does not preclude the licensee from providing the report to
the individual but provides the licensee flexibility in transmitting
pertinent information to the individual.
Section 35.3047, Report of a dose to an embryo/fetus or a nursing
child, would provide reporting criteria. Paragraph (a) would require
that a licensee report to NRC any administration of byproduct material,
or radiation from byproduct material, to a pregnant woman that results
in a dose to an embryo/fetus that is greater than 5 mSv (500 mrem)
absorbed dose unless specifically approved, in advance, by the
authorized user. It should be emphasized that only unintended exposures
would be reported to NRC. This report does not include exposure of
individuals in excess of the public dose limits in Part 20. Paragraph
(b) would require a licensee to report to NRC any administration of
byproduct material to a breast feeding woman that results in a dose to
the nursing child that is greater than 5 mSv (500 mrem) total effective
dose equivalent. Oral reports must be made to the NRC Operations Center
within 5 days of discovery and followed with a written report no later
than 15 days.
Information required by this section is needed so that NRC can
comply with Section 208 of the Energy Reorganization Act of 1974
(Public Law 93-438), as amended, to submit an annual report to Congress
a report of unscheduled incidents or events which the Commission
considers significant from the standpoint of public health and safety,
e.g., abnormal occurrences.
NRC identifies an abnormal occurrence using the revised abnormal
occurrence criteria that was published in the Federal Register on April
17, 1997 (62 FR 18820). Section II of the policy statement defines
unintended radiation exposure as ``any occupational exposure, exposure
to the general public or exposure as a result of a medical
misadministration (as defined in Sec. 35.2)
[[Page 43548]]
involving the wrong individual that exceeds the reporting values
established in the regulations.'' This section also states that ``All
other reported medical misadministrations will be considered for
reporting as an Abnormal Occurrence under the criteria for medical
licensees. In addition, unintended radiation exposures include any
exposure to a nursing child, fetus, or embryo as a result of an
exposure (other than an occupational exposure to an undeclared pregnant
woman) to a nursing mother or pregnant woman above specified values.''
Appendix A, Section I. A, of the policy statement, states that NRC will
provide information on ``any unintended radiation exposure to any minor
(an individual less than 18 years of age) resulting in an annual total
effective dose equivalent of 50 mSv (5 rem) or more, or to an embryo/
fetus resulting in a dose equivalent of 50 mSv (5 rem) or more.''
At the present time, NRC has no regulatory requirements that would
require reporting of those types of events. The Commission considered
two alternatives that could be pursued: revise the current Abnormal
Occurrence Criteria to delete the requirement to inform Congress of
this type of event; or develop a reporting requirement that would
provide information needed by the Commission to comply with Section
208. The Commission did not pursue the first option because the
Abnormal Occurrence reporting criteria were recently revised.
Only two comments were received on the proposed criteria in this
area. One commenter believed that the threshold for reporting a dose to
any minor or embryo/fetus should be reduced to less than 0.350 rem
instead of the proposed 5 rem. The second commenter recommended that
the criteria related to a nursing infant, fetus or embryo as a result
of an exposure to a nursing mother or a pregnant woman should be
deleted from the criteria until the issue can be resolved through
consultation with the ACMUI and a separate public comment period on
that issue.
The Commission is not inclined to revise the criteria without
public comments indicating that it is not appropriate for NRC to report
this type of event to Congress and that the proposed reporting
requirement in Sec. 35.3047 is overly burdensome or unwarranted. As a
result, the Commission has decided to pursue the second alternative.
However, the Commission does solicit specific comments in this area
regarding whether modification of the Abnormal Occurrence Policy
Statement criteria is needed.
The proposed rule would require that licensees report to NRC any
unintended exposures to an embryo/fetus or nursing child that exceeds
the dose threshold, as specified in the proposed Sec. 35.3047. The
Commission recognizes that the proposed reporting threshold is less
than the Abnormal Occurrence reporting level. This was done to make the
Part 35 reporting threshold consistent with the reporting thresholds in
10 CFR Part 20. The time period for reporting is similar for the
reporting requirements in 10 CFR parts 20 and 35.
The proposed rule would also require the licensee to notify the
referring physician and the pregnant individual or mother within 5 days
of discovery of an event that would require reporting under this
section, unless the referring physician personally informs the licensee
either that he or she will inform the mother or that, based on medical
judgment, telling the mother would be harmful. (Note, it is recognized
that in some cases, the woman may no longer be pregnant or nursing when
the event is discovered. In this situation, it is expected that the
individual responsible for the infant's or child's medical care would
be notified.) In cases where the pregnant individual or mother was not
notified, the notification may be made instead to the mother's or
child's responsible relative or guardian.
The terminology of the notification provisions of Sec. 35.3047 is
similar to Sec. 35.3045. Due to uncertainties on the part of some
licensees as to the scope of the term ``responsible relative or
guardian,'' the Commission is soliciting specific public comment on
whether there is a better term than ``responsible relative or
guardian'' to apply to those situations in which the mother is not
notified, e.g., in the referring physician's medical judgement, telling
the mother would be harmful; the mother is a minor; or the mother is
not competent to make decisions regarding medical care.
The Commission is also concerned about notification in situations
where the pregnant individual has purposely chosen not to tell others
of her pregnancy status and notification to a responsible relative or
guardian would be required by this rule, e.g., the individual is a
minor and does not want others to know of the pregnancy. As a result of
concerns regarding reporting and notification pursuant to this section,
the NRC is soliciting specific public comment on the impacts of this
reporting requirement on licensee procedures, activities, or medical
practices.
The Commission recognizes that the standard of practice for
authorized users is to assess the pregnancy or nursing status of their
patients (reference American College of Radiology ``Standard for the
Performance of Therapy with Unsealed Radionuclide Sources,'' 1996, and
``Society of Nuclear Medicine General Procedure Guidelines for Imaging
with Radionuclides,'' 1997). As a result, NRC does not believe that it
is appropriate to propose a rule that would require a licensee to
assess the pregnancy or nursing status of patients. It does, however,
believe that it is appropriate to propose a rule that would require the
licensee to inform NRC when it learns of an unintended dose to an
embryo/fetus or a nursing child that exceeds the thresholds discussed
above. Reporting under Sec. 35.3047 would not necessarily be subject to
enforcement action if the licensee had complied with Sec. 35.75.
Although the regulation requires that the licensee provide information
on the cause of the incident and corrective actions to prevent
recurrence, NRC acknowledges that in many, and if not all, incidents,
the licensee might not have been able to prevent the incident because
the individual may not have been aware of the pregnancy or may have
opted not to disclose her pregnancy or nursing status.
Section 35.3067, Reports of leaking sources, would require the
licensee to file a report with the appropriate NRC Office listed in
Sec. 30.6 of this chapter, with a copy to Director, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, within 5 days if a leakage test required by
Sec. 35.67 reveals the presence of 185 Bq (0.005 microcurie) or more of
removable contamination. This reporting requirement is similar to the
current requirements for leaking sources. The report must contain the
model number and serial number if assigned, of the leaking source;
Radionuclide and its estimated activity; the measured activity of each
test sample expressed in microcuries; a description of the method used
to measure each test sample; the date of the test; and the action
taken.
Subpart N, Enforcement, contains statements regarding enforcement.
This subpart would replace the statements in the current Subpart K,
Enforcement.
Section 35.4001, Violations, would appear as a new section and
replace the current Sec. 35.990 which would be deleted in the proposed
rule. This section reflects the new numbering system for the revised
Part 35.
Section 35.4002, Criminal penalties, would appear as a new section
and replace the current Sec. 35.991 which would be deleted in the
proposed rule.
[[Page 43549]]
This section reflects the new numbering system for the revised Part 35.
Appendix A to Part 35, Examining Organization or Entity, would
appear as a new appendix. This appendix would provide the requirements
for an examining organization or entity; examination programs; and
written examinations. This appendix is needed because of the proposed
revision to the training and experience criteria for an authorized
user, medical physicist, authorized nuclear pharmacist, and radiation
safety officer that would require an individual to pass an examination
given by an organization or entity approved by NRC or an Agreement
State. All criteria in Appendix A are considered by the Commission as
necessary to assure that an individual's competency is adequately
assessed.
NRC is proposing that an independent examining organization be an
organization that would make its examination process available to the
general public nationwide and not restrict access because of race,
color, religion, sex, age, national origin or disability. The
independent examining organization or entity would need to:
(1) Have adequate staff;
(2) Have a viable system of financing its operations;
(3) Have a policy and decision making review board;
(4) Be governed by written organizational by-laws and policies;
(5) Provide NRC or an Agreement State with a description of its
procedures for choosing examination sites and for providing an
appropriate examination environment;
(6) Submit its request for approval to the Director, Office of
Nuclear Materials Safety and Safeguards.
An independent examining organization or entity would also need to
have:
(1) A committee to review and approve the examination guidelines
and procedures, and to advise the organization's staff in implementing
the examination program;
(2) A committee to review complaints from examined individuals;
(3) Written procedures describing all aspects of its examination
program;
(4) An agreement to exchange information about examined individuals
with the Commission and the Agreement States;
(5) Procedures to ensure that examinations are not given to
individuals who have also been instructed by the examining organization
in the same subject area;
(6) Procedures to ensure that examined individuals are provided due
process with respect to the administration of its examination program;
(7) Procedures for proctoring examinations; and
(8) Procedures to ensure that all examination questions are
protected from disclosure.
NRC is proposing in Section II of Appendix A that all examination
programs must (1) require applicants for examination to receive
training in the topics set forth in Secs. 35.50(b)(1), 35.51(b)(1),
35.55(b)(3), 35.290(b)(1), 35.292(b)(1), 35.390(b)(1), 35.490(b)(1) or
35.690(b)(1) and satisfactorily complete a written examination covering
these topics. NRC is proposing in Section III that:
(1) The written examination must be designed to test an
individual's knowledge and understanding of the topics listed in the
above sections;
(2) The written examination must have test items drawn from a
question bank containing psychometrically valid questions based on the
material in the above listed questions; and
(3) A sample examination must be submitted to the Commission for
review initially and every 5 years.
A 5-year review cycle is consistent with the review of residency
programs by the Accreditation Council for Graduate Medical Education.
Summary of Specific Issues Identified for Public Comment
The Commission is soliciting specific public comment on various
issues associated with this rulemaking action. These issues are
discussed in detail in the noted sections.
1. Training and Experience--Is the proposed requirement for
examining organizations to ensure that examinations are not given to
individuals who have also been instructed by the examining organization
in the same subject area too prescriptive? Is the requirement for an
examination to verify competency warranted, in light of current
industry practice? What is the projected amount of time needed for
specialty boards and examining organizations to prepare and submit an
application to NRC or Agreement States?
2. Section 35.2--Should the term ``medium dose-rate remote
afterloader'' be defined since it not used in the rule? (Requirements
for medium dose-rate remote afterloaders have been grouped with high
dose-rate remote afterloaders in this rulemaking.)
3. Section 35.6--Should this section be revised to require that
licensees develop, implement, and maintain procedures for evaluating
when a medical procedure would be considered to be a research
procedure?
4. Section 35.24--Will the deletion of the requirement for a
Radiation Safety Committee and proposed new requirement for the
Radiation Safety Officer to acknowledge, in writing, responsibility for
implementing the radiation protection program impact the licensee's
effectiveness in carrying out its radiation protection program? In
particular, will this combination of changes actually reduce the
effectiveness of radiation protection programs and will the radiation
safety officer be provided appropriate tools and channels through which
to raise safety concerns to the highest levels of management. If a
requirement for a committee, to oversee the radiation safety program,
was included in the final rule, should the rule language explicitly
require that the radiation safety officer be a member of that
committee?
5. Section 35.75--Should any changes be made to the release
criteria specified in this section?
6. Section 35.92--Is it appropriate to delete the requirement to
hold byproduct material for a minimum of ten half-lives?
7. Section 35.315--Should the requirement for a private room with a
private sanitary facility be maintained in the final rule?
8. Section 35.415--Should the requirement for a licensee to not
quarter a patient in the same room as an individual who is not
receiving radiation therapy be maintained in the final rule?
9. Section 35.432--Should the final rule contain a requirement for
the licensee to perform full calibration measurements on brachytherapy
sources before first use? Should the final rule allow licensees to rely
on the brachytherapy source output provided by the manufacturer or
distributor if the dosimetry equipment used by the manufacturer or
distributor met the calibration requirements in Sec. 35.630? How should
sources be calibrated if there is no standard traceable to the National
Institute of Standards and Technology? What is the estimated number of
short- and long-lived brachytherapy sources that will need to be
calibrated by the licensee on an annual basis and how long will it take
to perform the calibration? Will licensees need to procure additional
equipment to perform the calibrations?
10. Section 35.605--Should the restrictions in paragraph (a) of the
proposed rule apply to low dose-rate remote afterloaders?
[[Page 43550]]
11. Section 35.615--Should the requirements in this section be
waived for licensees that are using remote afterloaders with beta-
emitting sources?
12. Section 35.644--Should the restrictions for electrical
interlocks and audiovisual systems apply to low dose-rate remote
afterloaders?
13. Section 35.981--What is the impact of deleting this section?
14. Subpart L--Should all recordkeeping requirements be grouped
into one subpart or should they be incorporated into the section
requiring the record?
15. Subpart M--Should all reporting requirements be grouped into
one subpart or should they be incorporated into the section requiring
the report?
16. Section 35.3045--Do the proposed rule changes adequately
address patient intervention and wrong treatment site?
17. Section 35.3047--Should the Abnormal Occurrence Policy
Statement criteria for reporting of exposures to an embryo/fetus or
nursing child be modified? Is there a better term than ``responsible
relative or guardian'' that could be applied to those situations where
the mother is not notified, e.g., in the referring physician's medical
judgment telling the mother would be harmful; the mother is a minor; or
the mother is not competent to make decisions regarding medical care?
What is the impact of the proposed reporting requirement on licensee
procedures, activities, or medical practices?
V. Coordination With The Advisory Committee on the Medical Uses of
Isotopes
The Advisory Committee on the Medical Uses of Isotopes (ACMUI) is
an advisory body established to advise the NRC staff on matters that
involve the administration of radioactive material and radiation from
radioactive material. At the public ACMUI meetings on September 25-26,
1997, and March 1-2, 1998, held in Rockville, MD., the NRC staff
presented alternatives for major cross-cutting issues related to
revising Part 35, recommendations for revising the NRC's Medical Use
Policy Statement, and draft proposed rule text.
These meetings were transcribed. The ACMUI's comments at the
September 1997 meeting are summarized in ``Summary of Discussion:
Meeting of the Advisory Committee on the Medical Uses of Isotopes
(ACMUI) Held in Rockville, Maryland on September 25-26, 1997'' (April
17, 1998). The summary document is available for inspection at the NRC
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Single copies of the summary document are available as indicated in the
For Further Information Contact section of this document. A brief
summary of the ACMUI positions on the major crosscutting issues
associated with this rulemaking is provided in Section III of the
Supplementary Information section of this document.
Working group members also met with separate ACMUI subcommittees
for diagnostic and therapeutic medical uses on February 9-10, 1998
(Rockville, MD.) and February 12-13, 1998 (Freeport, IL.),
respectively. The subcommittee meetings provided the Working Group with
an opportunity to discuss in depth the specific provisions of the draft
proposed rule with ACMUI members.
VI. Coordination With NRC Agreement States
NRC staff discussed the proposed revision of Part 35 with
representatives of the Agreement States at a workshop on October 18,
1997. The workshop commentary was transcribed, and the participant's
comments are summarized in ``Summary of Discussion: Facilitated Public
Workshop on NRC's Medical Rulemaking Initiative Held at All Agreement
States Meeting, Los Angeles, California, October 18, 1997'' (April 17,
1998). The summary document is available for inspection at the NRC
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Single copies of the summary document are available as indicated in the
For Further Information Contact section of this document. A brief
summary of the workshop participants' positions on the major cross-
cutting issues associated with this rulemaking is provided in Section
III of the Supplementary Information section of this document.
Both the Working Group and Steering Group that developed the draft
proposed rule included representatives of Agreement States. The
Agreement State representative on the Working Group is also a member of
the Conference of Radiation Control Directors' Suggested State
Regulation Committee on Medical Regulation, which is working toward
parallel development of suggested state medical regulations. State
participation in the process has provided an early opportunity for
State input and should enhance development of corresponding rules in
State regulations. In addition, it will allow the State staff to assess
the potential impacts of NRC draft language on the regulation of non-
Atomic Energy Act materials used in medical diagnosis, treatment, or
research in the States.
VII. Consistency With Medical Policy Statement
The Commission is proposing a revision to its General Policy on the
Regulation of the Medical Uses of Radioisotopes that was issued on
February 9, 1979 (44 FR 8424), as part of the efforts undertaken to
revise 10 CFR Part 35. The proposed revision and detailed discussion on
the need for the revision is being published for comment in the Federal
Register concurrently with the proposed revision to Part 35. Because of
the nature of the proposed revision to the policy, consistency with
each policy will be discussed separately.
Consistency With the Proposed Revision to the Medical Use Policy
Statement
The proposed revision to Part 35 is consistent with the
Commission's proposed revision to the Medical Use Policy Statement.
The first statement of the proposed policy reads ``NRC will
continue to regulate the uses of radionuclides in medicine as necessary
to provide for the radiation safety of workers and the general
public.'' The proposed rule is consistent with the statement because
one of its purposes is to provide for the radiation safety of workers
and individual members of the public, which is central to fulfillment
of the Commission's statutory mandate to ``protect health and minimize
danger to life.''
The second statement of the proposed policy reads ``NRC will not
intrude into medical judgments affecting patients, except as necessary
to provide for the radiation safety of workers and the general
public.'' The proposed rule would also be consistent with this
statement because its focus is on protecting the public and workers
from patients who have been administered byproduct material or
radiation from byproduct material for medical use.
The third statement of the proposed policy reads ``NRC will, when
justified by the risk to patients, regulate the radiation safety of
patients primarily to assure the use of radionuclides is in accordance
with the physician's directions.'' The proposed rule is consistent with
this statement because it includes provisions, where warranted by the
risk, to provide high confidence that the authorized user's directions
for the administration of byproduct material are followed.
The fourth statement of the proposed policy reads ``NRC, in
developing a specific regulatory approach, will consider industry and
professional standards that define acceptable
[[Page 43551]]
approaches of achieving radiation safety.'' The proposed rule is
consistent with this statement because the rulemaking process included
examining relevant industry and professional standards to determine if
specific areas of concern were included in the standards, or whether
regulatory requirements needed to be included in Part 35.
Consistency With the 1979 Medical Use Policy Statement
The proposed revision to Part 35 is generally consistent with the
Commission's General Policy on the Regulation of the Medical Uses of
Radioisotopes issued on February 9, 1979 (44 FR 8242).
The first statement of the policy reads ``The NRC will continue to
regulate the medical uses of radioisotopes as necessary to provide for
the radiation safety of workers and the general public.'' The proposed
rule is consistent with this statement because its purpose is to
provide for the radiation safety of workers and individual members of
the public, which is central to fulfillment of the Commission's
statutory mandate to ``protect health and minimize danger to life.''
The second statement of the policy is ``The NRC will regulate the
radiation safety of patients where justified by the risk to patients
and where voluntary standards, or compliance with these standards, are
inadequate.'' The proposed rule is generally consistent with this
statement. The proposed rule includes requirements to ensure the
radiation safety of patients in areas where justified by the risk to
patients. The rulemaking process included examining relevant industry
and professional standards to determine if specific areas of concern
were included in the standards, or whether additional regulatory
requirements needed to be developed for inclusion in Part 35. The
process did not include an assessment of licensee compliance with these
standards. Where appropriate, the proposed revision includes references
to published protocols approved by nationally recognized bodies. Where
warranted by risk, key elements of the standards were included as
performance objectives. Prescriptive compliance requirements for these
performance objectives were not included in the rule because it is
expected that licensees will use voluntary standards to achieve the
objective. This approach is consistent with a performance-based, risk-
informed rule.
The third statement of the policy reads, ``The NRC will minimize
intrusion into medical judgments affecting patients and into other
areas traditionally considered to be a part of the practice of
medicine.'' The proposed rule is consistent with this statement because
it includes no requirements associated with the diagnosis and treatment
of patients.
VIII. Implementation
The Commission intends to have different implementation dates for
particular requirements of this proposed rule. With one exception
(discussed below), the proposed requirements would be effective 6
months after publication of the final rule in the Federal Register.
Because the consolidated guidance document for medical use licensees is
being developed in parallel with the revised regulatory requirements in
Part 35, the Commission believes that a longer implementation period
will not be necessary. The 6-month implementation period would allow
the NRC time to train licensing and inspecting staff so that the
revised Part 35 will be uniformly implemented; and provide licensees
the time to understand the specific features of the revised Part 35,
and to develop and implement any changes in their radiation safety
programs or procedures that are required to comply with the revised
requirements. NRC workshops might be offered for the benefit of
licensees, Regional Offices, States, and others who are affected by the
revision.
The Commission proposes that licensees would have up to 2 years
after the effective date of the final rule to comply with the proposed
training requirements for authorized users, authorized medical
physicists, authorized nuclear pharmacists, and Radiation Safety
Officers. During this 2-year period, licensees will have the option of
complying with either the existing training requirements, which will be
retained in subpart J, or the training requirements in subparts B and
D-H of the proposed rule.
The 2-year implementation period will allow time for potential
examining organizations and entities to prepare an application in
accordance with Appendix A of the proposed rule; and for NRC to review
and approve the applications submitted in accordance with Appendix A,
and to review and approve certification of the specialty boards in
Secs. 35.50(a), 35.51(a), 35.55(a), 35.290(a), 35.292(a), 35.390(a),
35.490(a), 35.590(a), and 35.690(a). The 2-year time period will also
allow individuals from Agreement States time to satisfy the proposed
training requirements in order to work in NRC jurisdiction. After the
2-year implementation period, the requirements in subpart J will be
deleted.
Section 35.10 of the proposed rule addresses how a licensee can
determine if it must comply with the requirements of its license
conditions or the requirements of the revised Part 35, when it becomes
effective.
The Commission invites comments and suggestions on the effective
date of implementation, including specific information on time and
economic considerations, and on additional guidance or documents that
would be needed or useful in implementing the proposed revision.
IX. Issues of Compatibility for Agreement States
10 CFR Part 35--Medical Use of Byproduct Material
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997
(62 FR 46517), specific requirements within this rule should be adopted
by Agreement States for purposes of compatibility or because of their
health and safety significance. Implementing procedures for the Policy
Statement establish specific categories which have been applied to
categorize the requirements in Part 35. A Category ``A'' designation
means the requirement is a basic radiation protection standard or deals
with related definitions, signs, labels or terms necessary for a common
understanding of radiation protection principles. Category ``A''
designated Agreement State requirements should be essentially identical
to those of the NRC. A Category ``B'' designation means the requirement
has significant direct transboundary implications. Category ``B''
designated Agreement State requirements should be essentially identical
to those of the NRC. A Category ``C'' designation means the essential
objectives of the requirement should be adopted by the State to avoid
conflicts, duplications or gaps. The manner in which the essential
objectives are addressed in the Agreement State requirement need not be
the same as NRC provided the essential objectives are met. A Category
``D'' designation means the requirement does not need to be adopted by
an Agreement State for purposes of compatibility. The Health and Safety
(H&S) Category identifies requirements which are not required for
compatibility, but which have particular health and safety
significance. Agreement States should adopt the essential objectives of
such
[[Page 43552]]
requirements in order to maintain an adequate program.
The following discussion identifies the compatibility designations
for each section:
Subpart A, ``General Information,'' Sec. 35.2, ``Definitions,'' is
assigned to Compatibility Category ``D,'' with the exception of the
terms ``Agreement State'', ``authorized user,'' ``medical use,''
``prescribed dosage,'' ``prescribed dose,'' ``sealed source,''
``treatment site'' and ``written directive.'' The terms ``Agreement
State'' and ``sealed source'' are assigned to Compatibility Category
``B'' because they have significant direct transboundary implications.
The terms ``authorized user,'' ``medical event,'' ``medical use,''
``precursor event,'' ``prescribed dosage,'' ``prescribed dose,''
``treatment site'' and ``written directive'' have been assigned to
Compatibility Category ``C.'' Section 35.11, ``License required,'' is
assigned to Compatibility Category ``C.''
Subpart B, ``General Administrative Requirements,'' is assigned to
Compatibility Category ``D,'' with the exception of nine sections.
Section 35.24, ``Authority and responsibilities for the radiation
protection program'; Sec. 35.27, ``Supervision'; Sec. 35.40, ``Written
directives'; and Sec. 35.41(a), ``Procedures for administrations
requiring a written directive'' are all assigned to the Health and
Safety Category. Section 35.50, ``Training for radiation safety
officer'; Sec. 35.51, ``Training for authorized medical physicist';
Sec. 35.55 ``Training for an authorized nuclear pharmacist';
Sec. 35.57, ``Training for experienced Radiation Safety Officer,
teletherapy or medical physicist, authorized user, and nuclear
pharmacist;'' and Sec. 35.59, ``Recentness of training'' are assigned
to Compatibility Category ``C.''
Subpart C, ``General Technical Requirements,'' is assigned to
Compatibility Category ``D,'' with the exception of five sections.
Section 35.61, ``Calibration and check of survey instruments';
Sec. 35.63(a), ``Determination of dosages of unsealed byproduct
material for medical use'; Sec. 35.67, ``Requirements for possession of
sealed sources and brachytherapy sources'; and Sec. 35.70(a) and (b),
``Surveys of ambient radiation exposure rate'' are assigned to the
Health and Safety Category. Section 35.75, ``Release of individuals
containing radiopharmaceuticals or implants,'' paragraph (a), is
assigned to Compatibility Category ``C.''
Subpart D, ``Unsealed Byproduct Material--Low Dose'; and Subpart E,
``Unsealed Byproduct Material--High Dose'' are assigned to
Compatibility Category ``D,'' except for Sec. 35.100, ``Use of unsealed
byproduct material for uptake, dilution, and excretion studies for
which a written directive is not required'; Sec. 35.200, ``Use of
unsealed byproduct material for imaging and localization studies for
which a written directive is not required'; Sec. 35.204, ``Permissible
molybdenum-99 concentration'; and Sec. 35.300, ``Use of unsealed
byproduct material for which a written directive is required,'' which
are assigned to the Health and Safety Category. Section 35.290,
``Training for uptake, dilution, and excretion studies'; and
Sec. 35.292, ``Training for imaging and localization studies'; and
Sec. 35.390, ``Training for use of unsealed byproduct material for
therapy or for use of unsealed byproduct material that requires a
written directive,'' are assigned to Compatibility Category ``C.''
Subpart F, ``Manual Brachytherapy'' is assigned to Compatibility
Category ``D,'' with the exception of five sections. Section 35.400,
``Use of sources for manual brachytherapy'; Sec. 35.404(a) and (b),
``Radiation surveys of patients or human research subjects treated with
implants'; Sec. 35.406(a) and (b), ``Brachytherapy sources inventory';
and Sec. 35.432(a-e), ``Full calibration measurements of brachytherapy
sources'' are assigned to the Health and Safety Category. Section
35.490, ``Training for use of manual brachytherapy sources,'' is
assigned to Compatibility Category ``C.''
Subpart G, ``Sealed Sources for Diagnosis,'' is assigned to
Compatibility Category ``D,'' with the exception of Section 35.590,
``Training for use of sealed sources for diagnosis'' which is assigned
to Compatibility Category ``C.''
Subpart H, ``Therapeutic Medical Devices,'' is assigned to
Compatibility Category ``D,'' with the exception of 16 sections. The
following sections are assigned to the Health and Safety Category:
Secs. 35.600; 35.604(a); 35.605; 35.610(a)(1), (a)(2), and (a)(4);
35.615(a), (b)(1), (b)(2), (d), and (e); 35.630; 35.632; 35.633;
35.635; 35.642; 35.643; 35.644; 35.645; 35.655; and 35.657. Section
35.690, ``Training for use of therapeutic medical devices'' is assigned
to Compatibility Category ``C.''
Subpart J,'Training and Experience Requirements,'' Subpart K,
``Other Medical Uses of Byproduct Material or Radiation from Byproduct
Material,'' and Subpart L, ``Records,'' are assigned to Compatibility
Category ``D.''
Subpart M, ``Reports,'' is assigned to Compatibility Category
``C.''
Subpart N, ``Enforcement,'' is assigned to Compatibility Category
``D.''
Appendix A, ``Examining Organization or Entity,'' is assigned to
Compatibility Category ``B.''
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
Section 20.1301(a)(3) is assigned to Compatibility Category ``A.''
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
Section 32.72 (b)(1) and (b)(2)(ii) and Sec. 32.74 (a) and (a)(3)
are assigned to Compatibility Category ``B.''
As discussed under Section VIII of this document, the Commission
proposes that licensees would have up to 2 years after the effective
date of the final rule to comply with the proposed training
requirements for authorized users, authorized medical physicists,
authorized nuclear pharmacists, and Radiation Safety Officers. During
this 2-year period, licensees would have the option of complying with
either the existing training requirements in subpart J, or the proposed
training requirements in subparts B and D through H. At the end of the
2 years, subpart J would be deleted and licensees would have to comply
with the proposed training and experience criteria. The training and
experience requirements in the proposed subpart J are assigned to
Compatibility Category ``D,'' as they are in the current rule. Subparts
B and D through H of the proposed rule have been assigned to
Compatibility Category ``C'' for Agreement States. Under the ``Policy
Statement on Adequacy and Compatibility of Agreement State Programs,''
approved by the Commission on June 30, 1997, the Agreement States are
required to adopt NRC program elements (or promulgate regulations)
required for compatibility within 3 years of the effective date of the
NRC rulemaking. Therefore, the Commission recognizes that if an
Agreement State does not revise its regulations until 2 years after the
effective date of the NRC rule, it may choose not to include subpart J
training and experience requirements in the newly promulgated rules,
since the subpart J requirements are assigned to Compatibility Category
``D'' (not required for compatibility). In this case, the Agreement
States would only be expected to adopt the proposed training and
experience requirements in subparts B and D through H.
X. Finding of No Significant Environmental Impact: Availability
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
subpart A
[[Page 43553]]
of 10 CFR Part 51, that the proposed amendments, if adopted, would be a
major Federal action but would not significantly affect the quality of
the human environment, and therefore an environmental impact statement
is not required. The proposed amendments would relax certain
requirements and eliminate other procedural restrictions associated
with the medical use of byproduct material. The Commission believes
these proposed amendments would provide greater flexibility in the
medical use of byproduct material while continuing to adequately
protect public health and safety. The proposed amendments to Part 35,
if adopted, would not cause any significant increase in radiation
exposure to the public or radiation release to the environment beyond
the exposures or releases currently resulting from the medical use of
byproduct material. The proposed amendment to 10 CFR 20.1301 is
expected to result in an increase in radiation exposure to the public.
However, this alternative is consistent with generally accepted
radiation protection principles, such as those expressed by the
International Commission on Radiation Protection (ICRP), the National
Council on Radiation Protection and Measurements (NCRP), and the
International Atomic Energy Agency (IAEA).
The draft environmental assessment on which this determination is
based is available for inspection at the NRC Public Document Room, 2120
L Street NW. (Lower Level), Washington, DC. Single copies of the
environmental assessment are available as indicated in the FOR FURTHER
INFORMATION CONTACT section of this document.
XI. Paperwork Reduction Act Statement
This proposed rule amends information collection requirements that
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.). This rule has been submitted to the Office of Management and
Budget for review and approval of the paperwork requirements.
Because the rule will reduce existing information collection
requirements, the public burden for this information collection is
expected to be decreased by approximately 74 hours per licensee. This
reduction includes the time required for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the information collection. The
U.S. Nuclear Regulatory Commission is seeking public comment on the
potential impact of the information collection in the proposed rule and
on the following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the information collection be minimized,
including the use of automated collection techniques?
Send comments on any aspect of this proposed information
collection, including suggestions for further reducing the burden, to
the Records Management Branch (T-6 F33), U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, or by Internet electronic mail
at BJS1@nrc.gov; and to the Desk Officer, Office of Information and
Regulatory Affairs, NEOB-10202, (3150-0010 and 3150-0120), Office of
Management and Budget, Washington, DC, 20503.
Comments to OMB on the information collections or on the above
issues should be submitted by September 14, 1998. Comments received
after this date will be considered if it is practical to do so, but
assurance of consideration cannot be given to comments received after
this date.
Public Protection Notification
If 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.
XII. Regulatory Analysis
The Commission has prepared a draft regulatory analysis for the
proposed rule. The analysis examines the costs and benefits of the
alternatives considered by the Commission. The draft analysis is
available for inspection at the NRC Public Document Room, 2120 L Street
NW. (Lower Level), Washington, DC. Single copies of the regulatory
analysis are available as indicated in the FOR FURTHER INFORMATION
CONTACT section of this document.
The Commission requests public comment on the draft regulatory
analysis. Comments on the draft regulatory analysis may be submitted to
the NRC as indicated under the ADDRESSES section of this document.
XIII. Regulatory Flexibility Analysis
The NRC has prepared an initial regulatory flexibility analysis of
the impact of this proposed rule on small entities. The preliminary
regulatory flexibility analysis indicates that the proposed rule will
have an economic impact of approximately $8,000 annually on medical
licensees, of which 36 percent are small entities. However, the NRC
notes that this would be a substantial reduction in the cost to the
average licensee under the current regulations. The NRC estimates that
the proposed requirements would reduce the annual cost to an average
medical licensee by approximately $1500. The NRC believes that the
proposed alternative is the least costly alternative that provides
adequate protection from radiation exposure for patients and workers.
The regulatory flexibility analysis appears as Appendix A to this
document.
Because of the widely differing conditions under which small
medical licensees operate, the NRC is seeking comments on the impact of
the rule and any suggested modifications that may affect its economic
impact. Any small medical licensee that would be subject to this
regulation that determines, because of its size, that it is likely to
bear a disproportionate adverse economic impact, should notify the
Commission of this in a comment that indicates--
(a) The licensee's size and how this proposed regulation would
result in a significant economic burden upon the licensee as compared
to the economic burden on a larger licensee;
(b) How the proposed regulations could be modified to take into
account the licensee's differing needs or capabilities;
(c) The benefits that would accrue, or the detriments that would be
avoided, if the proposed regulations were modified as suggested under
paragraph (b) above;
(d) How the proposed regulation, as modified, would more closely
equalize its impact as opposed to providing special advantages to any
individual licensee or groups of licenses; and
(e) How the proposed regulations, as modified, would still
adequately protect the public health and safety.
The comments should be sent to the NRC as indicated under the
ADDRESSES section of this document.
XIV. Backfit Analysis
The NRC has determined that the backfit rule does not apply to this
proposed rule and, therefore, that a backfit analysis is not required
for this proposed rule because these amendments would not involve any
provision that would impose backfits as defined in 10 CFR Chapter I.
[[Page 43554]]
List of Subjects
10 CFR Part 20
Byproduct material, Criminal penalties, Licensed material, Nuclear
materials, Nuclear power plants and reactors, Occupational safety and
health, Packaging and containers, Radiation protection, Reporting and
recordkeeping requirements, Special nuclear material, Source material,
Waste treatment and disposal.
10 CFR Part 32
Byproduct material, Criminal penalties, Labeling, Nuclear
materials, Radiation Protection, Reporting and recordkeeping
requirements.
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. 553, the NRC is proposing to
adopt the following amendments to 10 CFR parts 20, 32 and 35.
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
1. The authority citation for Part 20 continues to read as follows:
Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701,
106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133,
2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88
Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
2. In Sec. 20.1301, paragraph (a)(3) is added to read as follows:
Sec. 20.1301 Dose limits for individual members of the public.
(a) * * *
(3) Notwithstanding paragraph (a)(1) of this section, a licensee
may permit visitors to individuals who are not released in accordance
with Sec. 35.75 to receive a radiation dose greater than (1 mSv) 0.1
rem, but not to exceed (5 mSv) 0.5 rem, if the authorized user, as
defined in 10 CFR part 35, determines that it is appropriate.
* * * * *
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
3. The authority citation for Part 32 continues to read as follows:
Authority: Secs. 81, 82, 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).
Sec. 32.72 [Amended]
4. In Sec. 32.72, in paragraph (b)(1), the reference to ``10 CFR
35.25'' is revised to read ``10 CFR 35.27'' and in paragraph
(b)(2)(ii), the reference to ``10 CFR 35.980(b) and 35.972'' is revised
to read ``10 CFR 35.55(b) and 35.59 or 10 CFR 35.980(b) and 35.972.''
Sec. 32.74 [Amended]
5. In Sec. 32.74, in paragraph (a), the reference to ``Secs. 35.400
and 35.500'' is revised to read ``Secs. 35.400, 35.500, and 35.600''
and in paragraph (a)(3), the reference to ``Secs. 35.57, 35.400, or
35.500'' is revised to read ``Secs. 35.400, 35.500, and 35.600.''
6. 10 CFR Part 35 is revised to read as follows:
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
Subpart A--General Information
Sec.
35.1 Purpose and scope.
35.2 Definitions.
35.5 Maintenance of records.
35.6 Provisions for research involving human subjects.
35.7 FDA, other Federal, and State requirements.
35.8 Information collection requirements: OMB approval.
35.10 Implementation.
35.11 License required.
35.12 Application for license, amendment, or renewal.
35.13 License amendments.
35.14 Notifications.
35.15 Exemptions regarding Type A specific licenses of broad scope.
35.18 License issuance.
35.19 Specific exemptions.
Subpart B--General Administrative Requirements
35.24 Authority and responsibilities for the radiation protection
program.
35.26 Radiation protection program changes.
35.27 Supervision.
35.40 Written directives.
35.41 Procedures for administrations requiring a written directive.
35.49 Suppliers for sealed sources or devices for medical use.
35.50 Training for Radiation Safety Officer.
35.51 Training for an authorized medical physicist.
35.55 Training for an authorized nuclear pharmacist.
35.57 Training for experienced Radiation Safety Officer,
teletherapy or medical physicist, authorized user, and nuclear
pharmacist.
35.59 Recentness of training.
Subpart C--General Technical Requirements
35.60 Possession, use, calibration, and check of instruments to
measure the activity of photon-emitting radionuclides.
35.61 Calibration and check of survey instruments.
35.62 Possession, use, calibration, and check of instruments to
measure dosages of alpha- or beta-emitting radionuclides.
35.63 Determination of dosages of unsealed byproduct material for
medical use.
35.65 Authorization for calibration and reference sources.
35.67 Requirements for possession of sealed sources and
brachytherapy sources.
35.69 Labeling and shielding of vials and syringes.
35.70 Surveys for ambient radiation exposure rate.
35.75 Release of individuals containing radiopharmaceuticals or
implants.
35.80 Provision of mobile service.
35.92 Decay-in-storage.
Subpart D--Unsealed Byproduct Material--Low Dose
35.100 Use of unsealed byproduct material for uptake, dilution, and
excretion studies for which a written directive is not required.
35.200 Use of unsealed byproduct material for imaging and
localization studies for which a written directive is not required.
35.204 Permissible molybdenum-99 concentration.
35.290 Training for uptake, dilution, and excretion studies.
35.292 Training for imaging and localization studies.
Subpart E--Unsealed Byproduct Material--High Dose
35.300 Use of unsealed byproduct material for which a written
directive is required.
35.310 Safety instruction.
35.315 Safety precautions.
35.390 Training for use of unsealed byproduct material for therapy
or for use of unsealed byproduct material that requires a written
directive.
Subpart F--Manual Brachytherapy
35.400 Use of sources for manual brachytherapy.
35.404 Radiation surveys of patients or human research subjects
treated with implants.
35.406 Brachytherapy sources inventory.
35.410 Safety instruction.
35.415 Safety precautions.
35.432 Full calibration measurements of brachytherapy sources.
35.490 Training for use of manual brachytherapy sources.
Subpart G--Sealed Sources for Diagnosis
35.500 Use of sealed sources for diagnosis.
35.590 Training for use of sealed sources for diagnosis.
[[Page 43555]]
Subpart H--Therapeutic Medical Devices
35.600 Use of a sealed source in a device for therapeutic medical
uses.
35.604 Radiation surveys of patients and human research subjects
treated with remote afterloaders.
35.605 Installation, maintenance, and repair.
35.610 Safety procedures and instructions for remote afterloaders,
teletherapy units, and gamma stereotactic radiosurgery units.
35.615 Safety precautions for remote afterloaders, teletherapy
units, and gamma stereotactic radiosurgery units.
35.630 Dosimetry equipment.
35.632 Full calibration measurements on teletherapy units.
35.633 Full calibration measurements on remote afterloaders.
35.635 Full calibration measurements on gamma stereotactic
radiosurgery units.
35.642 Periodic spot-checks for teletherapy units.
35.643 Periodic spot-checks for high dose-rate and pulsed dose-rate
remote afterloaders.
35.644 Periodic spot-checks for low dose-rate remote afterloaders.
35.645 Periodic spot-checks for gamma stereotactic radiosurgery
units.
35.647 Additional technical requirements for mobile remote
afterloaders.
35.652 Radiation surveys.
35.655 Five-year inspection for teletherapy and gamma stereotactic
radiosurgery units.
35.657 Therapy-related computer systems.
35.690 Training for use of therapeutic medical devices.
Subpart I--Reserved
Subpart J--Training and Experience Requirements
35.900 Radiation Safety Officer.
35.910 Training for uptake, dilution, and excretion studies.
35.920 Training for imaging and localization studies.
35.930 Training for therapeutic use of unsealed byproduct material.
35.932 Training for treatment of hyperthyroidism.
35.934 Training for treatment of thyroid carcinoma.
35.940 Training for use of brachytherapy sources.
35.941 Training for ophthalmic use of strontium-90.
35.950 Training for use of sealed sources for diagnosis.
35.960 Training for use of therapeutic medical devices.
35.961 Training for an authorized medical physicist.
35.980 Training for an authorized nuclear pharmacist.
35.981 Training for experienced nuclear pharmacists.
Subpart K--Other Medical Uses of Byproduct Material or Radiation from
Byproduct Material
35.1000 Other medical uses of byproduct material or radiation from
byproduct material.
Subpart L--Records
35.2024 Records of authority and responsibilities for radiation
protection programs.
35.2026 Records of radiation program safety changes.
35.2040 Records of written directives.
35.2045 Records of medical events.
35.2060 Records of instrument calibrations.
35.2061 Records of radiation survey instrument calibrations.
35.2063 Records of dosages of unsealed byproduct material for
medical use.
35.2067 Records for possession of sealed sources and brachytherapy
sources.
35.2070 Records of surveys for ambient radiation exposure rate.
35.2075 Records of the release of individuals containing
radiopharmaceuticals or implants.
35.2080 Records of administrative and technical requirements that
apply to the provision of mobile services.
35.2092 Records of waste disposal.
35.2204 Records of molybdenum-99 concentration.
35.2310 Records of instruction and training.
35.2404 Records of radiation surveys of patients and human research
subjects.
35.2406 Records of brachytherapy source inventory.
35.2432 Records of full calibrations on brachytherapy sources.
35.2605 Records of installation, maintenance, and repair.
35.2630 Records of dosimetry equipment.
35.2632 Records of teletherapy full calibrations.
35.2633 Records of remote afterloader full calibrations.
35.2635 Records of gamma stereotactic radiosurgery unit full
calibrations.
35.2642 Records of periodic spot-checks for teletherapy units.
35.2643 Records of periodic spot-checks for remote afterloaders.
35.2645 Records of periodic spot-checks for gamma stereotactic
radiosurgery units.
35.2647 Records of additional technical requirements for mobile
remote afterloaders.
35.2652 Records of surveys of therapeutic treatment units.
35.2655 Records of 5-year inspection for teletherapy and gamma
stereotactic radiosurgery units.
Subpart M--Reports
35.3045 Reports of medical events.
35.3047 Report of a dose to an embryo/fetus or a nursing child.
35.3067 Reports of leaking sources.
Subpart N--Enforcement
35.4001 Violations.
35.4002 Criminal penalties.
Appendix A to 10 CFR Part 35--Examining Organization or Entity
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).
Subpart A--General Information
Sec. 35.1 Purpose and scope.
This part prescribes requirements and provisions for the medical
use of byproduct material and for issuance of specific licenses
authorizing the medical use of this material. These requirements and
provisions provide for the radiation safety of workers, the general
public, patients, and human research subjects. The requirements and
provisions of this part are in addition to, and not in substitution
for, others in this chapter. The requirements and provisions of parts
19, 20, 21, 30, 71, 170, and 171 of this chapter apply to applicants
and licensees subject to this part unless specifically exempted.
Sec. 35.2 Definitions.
Address of use means the building or buildings that are identified
on the license and where byproduct material may be received, used, or
stored.
Agreement State means any State with which the Commission or the
Atomic Energy Commission has entered into an effective agreement under
subsection 274b of the Atomic Energy Act of 1954, as amended.
Area of use means a portion of an address of use that has been set
aside for the purpose of receiving, using, or storing byproduct
material.
Authorized medical physicist means a physicist who--
(1) Meets the requirements in Secs. 35.51(a) and 35.59 or
Secs. 35.961 and 35.59; or
(2) Is identified as a medical physicist on a Commission or
Agreement State license; or
(3) Is identified as a medical physicist on a permit issued by a
Commission or Agreement State specific licensee of broad scope that is
authorized to permit the use of byproduct material.
Authorized nuclear pharmacist means a pharmacist who--
(1) Meets the requirements in Secs. 35.55(a) and 35.59 or
Secs. 35.980(a) and 35.59; or
(2) Is identified as an authorized nuclear pharmacist on a
Commission or Agreement State license that authorizes the use of
byproduct material in the practice of nuclear pharmacy; or
(3) Is identified as an authorized nuclear pharmacist on a permit
issued by a Commission or Agreement State specific licensee of broad
scope that is authorized to permit the use of byproduct material in the
practice of nuclear pharmacy; or
[[Page 43556]]
(4) Is approved as an authorized nuclear pharmacist by a nuclear
pharmacy authorized by the Commission to approve authorized nuclear
pharmacists.
Authorized user means a physician, dentist, or podiatrist who--
(1) Meets the requirements in Secs. 35.290(a), 35.292(a),
35.390(a), 35.490(a), 35.590(a), or 35.690(a) and Sec. 35.59, or
Secs. 35.910, 35.920, 35.930, 35.932, 35.934, 35.940, 35.941, 35.950,
35.960 and Sec. 35.59; or
(2) Is identified as an authorized user on a Commission or
Agreement State license that authorizes the medical use of byproduct
material; or
(3) Is identified as an authorized user on a permit issued by a
Commission or Agreement State specific licensee of broad scope that is
authorized to permit the medical use of byproduct material.
Brachytherapy source means a radioactive sealed source or a
manufacturer-assembled source train or a combination of these sources
that is designed to deliver a therapeutic dose within a distance of a
few centimeters.
Dedicated check source means a radioactive source that is used to
assure the constant operation of a radiation detection or measurement
device over several months or years.
Dentist means an individual licensed by a State or Territory of the
United States, the District of Columbia, or the Commonwealth of Puerto
Rico to practice dentistry.
Diagnostic clinical procedures manual means a collection of written
procedures that describes each method (and other instructions and
precautions) by which the licensee performs diagnostic clinical
procedures; where each diagnostic clinical procedure has been approved
by the authorized user and includes the radiopharmaceutical, dosage,
and route of administration.
High dose-rate remote afterloader, as used in this part, means a
device that remotely delivers a dose rate in excess of 2 gray (200
rads) per hour at the point or surface where the dose is prescribed.
Low dose-rate remote afterloader as used in this part, means a
device that remotely delivers a dose rate of less than 2 gray (200
rads) per hour at the point or surface where the dose is prescribed.
Management means the chief executive officer or that person's
delegate or delegates.
Medical event means an event that meets the criteria in
Sec. 35.3045(a).
Medical institution means an organization in which several medical
disciplines are practiced.
Medical use means the intentional internal or external
administration of byproduct material or the radiation from byproduct
material to patients or human research subjects under the supervision
of an authorized user.
Mobile service means the transportation and medical use of
byproduct material by the same licensee at temporary jobsites.
Output means the exposure rate, dose rate, or a quantity related in
a known manner to these rates from a teletherapy unit for a specified
set of exposure conditions.
Pharmacist means an individual licensed by a State or Territory of
the United States, the District of Columbia, or the Commonwealth of
Puerto Rico to practice pharmacy.
Physician means a medical doctor or doctor of osteopathy licensed
by a State or Territory of the United States, the District of Columbia,
or the Commonwealth of Puerto Rico to prescribe drugs in the practice
of medicine.
Podiatrist means an individual licensed by a State or Territory of
the United States, the District of Columbia, or the Commonwealth of
Puerto Rico to practice podiatry.
Prescribed dosage means the quantity of radiopharmaceutical
activity as documented--
(1) In a written directive; or
(2) Either in the diagnostic clinical procedures manual or in any
appropriate record in accordance with the directions of the authorized
user for diagnostic procedures.
Prescribed dose means--
(1) For gamma stereotactic radiosurgery, the total dose as
documented in the written directive;
(2) For teletherapy, the total dose and dose per fraction as
documented in the written directive;
(3) For brachytherapy, either the total source strength and
exposure time or the total dose, as documented in the written
directive; or
(4) For remote afterloaders, the total dose as documented in the
written directive.
Pulsed dose-rate remote afterloader means a special type of remote
afterloading device that uses a single source capable of delivering
dose rates in the ``high dose rate'' range, but is used to simulate the
radiobiology of a low dose rate treatment by inserting the source for a
given fraction of each hour.
Radiation Safety Officer means the individual identified as the
Radiation Safety Officer on a Commission license who--
(1) Meets the requirements in Secs. 35.50 and 35.59 or Secs. 35.900
and 35.59; or
(2) Is identified as a Radiation Safety Officer on a Commission or
Agreement State license.
Sealed source means any byproduct material that is encased in a
capsule designed to prevent leakage or escape of the byproduct
material.
Sealed Source and Device Registry means the national registry that
contains all the registration certificates, generated by both NRC and
the Agreement States, that summarize the radiation safety information
for the sealed sources and devices and describe the licensing and use
conditions approved for the product.
Stereotactic radiosurgery means the use of external radiation in
conjunction with a stereotactic guidance device to very precisely
deliver a dose to a tissue volume.
Structured educational program means an educational program
designed to impart particular knowledge and practical education through
interrelated studies and supervised training.
Temporary jobsite means a location where mobile services are
conducted other than those location(s) of use authorized on the
license.
Treatment site means the anatomical description of the tissue
intended to receive a radiation dose, as described in a written
directive.
Unit dosage means a dosage intended for medical use in a single
patient or human research subject that has been obtained from a
manufacturer or preparer licensed pursuant to Sec. 32.72 of this
chapter or equivalent Agreement State requirements.
Written directive means an authorized user's written order for the
administration of byproduct material or radiation from byproduct
material to a specific patient or human research subject, as specified
in Sec. 35.40.
Sec. 35.5 Maintenance of records.
Each record required by this part must be legible throughout the
retention period specified by each Commission regulation. The record
may be the original or a reproduced copy or a microform provided that
the copy or microform is authenticated by authorized personnel and that
the microform is capable of producing a clear copy throughout the
required retention period. The record may also be stored in electronic
media with the capability for producing legible, accurate, and complete
records during the required retention period. Records such as letters,
drawings, and specifications, must include all pertinent information
such as stamps, initials, and signatures. The licensee shall maintain
adequate safeguards against tampering with and loss of records.
[[Page 43557]]
Sec. 35.6 Provisions for research involving human subjects.
A licensee may conduct research involving human subjects using
byproduct material provided that the research is conducted, funded,
supported, or regulated by another Federal Agency which has implemented
the Federal Policy for the Protection of Human Subjects. Otherwise, a
licensee shall apply for and receive approval of a specific amendment
to its NRC license before conducting such research. Both types of
licensees shall, at a minimum, obtain informed consent from the human
subjects and obtain prior review and approval of the research
activities by an ``Institutional Review Board'' in accordance with the
meaning of these terms as defined and described in the Federal Policy
for the Protection of Human Subjects.
Sec. 35.7 FDA, other Federal, and State requirements.
Nothing in this part relieves the licensee from complying with
applicable FDA, other Federal, and State requirements governing
radioactive drugs or devices.
Sec. 35.8 Information collection requirements: OMB approval.
(a) The Commission has submitted the information collection
requirements contained in this part to the Office of Management and
Budget (OMB) for approval as required by the Paperwork Reduction Act
(44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. OMB has
approved the information collection requirements in this part under
control number 3150-0010.
(b) The approved information collection requirements contained in
this part appear in Secs. 35.6, 35.12, 35.13, 35.14, 35.24, 35.26,
35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 35.62, 35.63,
35.67, 35.69, 35.70, 35.75, 35.80, 35.92, 35.204, 35.290, 35.292,
35.310, 35.315, 35.390, 35.404, 35.406, 35.410, 35.415, 35.432, 35.490,
35.590, 35.604, 35.605, 35.610, 35.630, 35.632, 35.633, 35.635, 35.642,
35.643, 35.644, 35.645, 35.647, 35.652, 35.655, 35.690, 35.900, 35.910,
35.920, 35.930, 35.940, 35.950, 35.960, 35.961, 35.980, 35.981,
35.2024, 35.2026, 35.2040, 35.2045, 35.2060, 35.2061, 35.2063, 35.2067,
35.2070, 35.2075, 35.2080, 35.2092, 35.2204, 35.2310, 35.2404, 35.2406,
35.2432, 35.2605, 35.2630, 35.2632, 35.2633, 35.2635, 35.2642, 35.2643,
35.2645, 35.2647, 35.2652, 35.2655, 35.3045, 35.3047, 35,3067, and
Appendix A.
(c) This part contains information collection requirements in
addition to those approved under the control number specified in
paragraph (a) of this section. These information collection
requirements and the control numbers under which they are approved as
follows:
(1) In Sec. 35.12, NRC Form 313, including NRC Forms 313A, and 313B
which licensees may use to provide supplemental information, is
approved under control number 3150-0120.
(2) [Reserved]
Sec. 35.10 Implementation.
(a) A licensee shall implement the provisions in this part on or
before [date 6 months from publication of the Final Rule], with the
exception of the requirements listed in paragraph (b) of this section.
(b) A licensee shall implement the training requirements in
Secs. 35.50(a), 35.51(a), 35.55(a), 35.59, 35.290(a), 35.292(a),
35.390(a), 35.490(a), 35.590(a), and 35.690(a) on or before [date--2
years from publication of the Final Rule].
(c) Prior to [date--2 years from publication of the Final Rule], a
licensee shall satisfy the training requirements of this part for a
Radiation Safety Officer, an authorized medical physicist, an
authorized nuclear pharmacist, or an authorized user by complying with
either:
(1) The appropriate training requirements in subpart J; or
(2) The appropriate training requirements in subpart B or subparts
D through H.
(d) If the requirements of this part are more restrictive than the
existing license condition, the licensee shall comply with this part
unless exempted by paragraph (f) of this section.
(e) Any existing license condition that is more restrictive than a
requirement in this part remains in effect until there is a license
amendment or license renewal.
(f) If a license condition exempted a licensee from a provision of
part 35 on [date--6 months from publication of the Final Rule], it will
continue to exempt a licensee from the corresponding provision in this
part.
(g) If a license condition cites provisions in part 35 that will be
deleted on [date--6 months from publication of the Final Rule], then
the license condition remains in effect until there is a license
amendment or license renewal that modifies or removes this condition.
Sec. 35.11 License required.
(a) A person may not manufacture, produce, acquire, receive,
possess, use, or transfer byproduct material for medical use except in
accordance with a specific license issued by the Commission or an
Agreement State, or as allowed in paragraph (b) or (c) of this section.
(b) An individual may receive, possess, use, or transfer byproduct
material in accordance with the regulations in this chapter under the
supervision of an authorized user as provided in Sec. 35.27, unless
prohibited by license condition.
(c) An individual may prepare unsealed byproduct material for
medical use in accordance with the regulations in this chapter under
the supervision of an authorized nuclear pharmacist or authorized user
as provided in Sec. 35.27, unless prohibited by license condition.
Sec. 35.12 Application for license, amendment, or renewal.
(a) An application must be signed by the management of the
facility.
(b) An application for a license for medical use of byproduct
material as described in Secs. 35.100, 35.200, 35.300, 35.400, and
35.500, and for medical use of remote afterloaders in Sec. 35.600, must
be made by filing an original and one copy of NRC Form 313,
``Application for Material License.'' A request for a license amendment
or renewal may be submitted as an original and one copy in letter
format.
(c) Except for medical use of remote afterloaders, a separate
license application must be filed for each medical use of byproduct
material as described in Sec. 35.600 by filing an original and one copy
of NRC Form 313. A request for a license amendment or renewal may be
submitted as an original and one copy in letter format.
(d) An application for a license for medical use of byproduct
material as described in Sec. 35.1000 must be made by filing an
original and one copy of NRC Form 313.
(1) In addition to the information required in NRC Form 313, the
application must also include information regarding any radiation
safety aspects of the medical use of the material that is not addressed
in subparts A through C of this part, as well as any specific
information necessary for--
(i) Radiation safety precautions and instructions;
(ii) Training and experience of proposed users;
(iii) Methodology for measurement of dosages or doses to be
administered to patients or human research subjects; and
[[Page 43558]]
(iv) Calibration, maintenance, and repair of instruments and
equipment necessary for radiation safety.
(2) The applicant or licensee shall also provide any other
information requested by the Commission in its review of the
application.
(e) An applicant that satisfies the requirements specified in
Sec. 33.13 may apply for a Type A specific license of broad scope.
Sec. 35.13 License amendments.
A licensee shall apply for and must receive a license amendment--
(a) Before it receives or uses byproduct material for a type of use
that is permitted under this part, but that is not authorized on the
licensee's current license issued pursuant to this part;
(b) Before it permits anyone to work as an authorized user,
authorized nuclear pharmacist, or authorized medical physicist under
the license, except an individual who is--
(1) An authorized user who meets the requirements Secs. 35.290(a),
35.292(a), 35.390(a), 35.490(a), 35.590(a), or 35.690(a) and
Sec. 35.59, or Secs. 35.910, 35.920, 35.930, 35.932, 35.934, 35.940,
35.941, 35.950, 35.960 and Sec. 35.59;
(2) An authorized nuclear pharmacist who meets the requirements in
Sec. 35.55(a) and Sec. 35.59; or Secs. 35.980 and 35.59;
(3) An authorized medical physicist who meets the requirements in
Sec. 35.51(a) and Sec. 35.59; or Secs. 35.961 and 35.59;
(4) Identified as an authorized user, an authorized nuclear
pharmacist, or authorized medical physicist on a Commission or
Agreement State license that authorizes the use of byproduct material
in medical use or in the practice of nuclear pharmacy, respectively; or
(5) Identified as an authorized user, an authorized nuclear
pharmacist, or authorized medical physicist on a permit issued by a
Commission or Agreement State specific licensee of broad scope that is
authorized to permit the use of byproduct material in medical use or in
the practice of nuclear pharmacy, respectively.
(c) Before it changes Radiation Safety Officers;
(d) Before it orders byproduct material in excess of the amount, or
radionuclide or form that is different than the radionuclide or form
authorized on the license;
(e) Before it adds to or changes the areas identified in the
application or on the license, except for areas where byproduct
material is used in accordance with Secs. 35.100 and 35.200; and
(f) Before it changes the address(es) of use identified in the
application or on the license.
Sec. 35.14 Notifications.
(a) A licensee shall provide to the Commission a copy of the board
certification, the Commission or Agreement State license, or the permit
issued by a licensee of broad scope for each individual no later than
30 days after the date that the licensee permits the individual to work
as an authorized user, an authorized nuclear pharmacist, an authorized
medical physicist, pursuant to Sec. 35.13 (b)(1) through (b)(5).
(b) A licensee shall notify the Commission by letter no later than
30 days after:
(1) An authorized user, an authorized nuclear pharmacist, a
Radiation Safety Officer, or an authorized medical physicist
permanently discontinues performance of duties under the license or has
a name change;
(2) The licensee's mailing address changes;
(3) The licensee's name changes, but the name change does not
constitute a transfer of control of the license as described in
Sec. 30.34(b) of this chapter; or
(4) The licensee has added to or changed the areas where byproduct
material is used in accordance with Secs. 35.100 and 35.200.
(c) The licensee shall mail the documents required in this section
to the appropriate address identified in Sec. 30.6 of this chapter.
Sec. 35.15 Exemptions regarding Type A specific licenses of broad
scope.
A licensee possessing a Type A specific license of broad scope for
medical use is exempt from--
(a) The provisions of Sec. 35.13(b);
(b) The provisions of Sec. 35.13(e) regarding additions to or
changes in the areas of use only at the addresses specified in the
license;
(c) The provisions of Sec. 35.14(a);
(d) The provisions of Sec. 35.14(b)(1) for an authorized user, an
authorized nuclear pharmacist, or an authorized medical physicist; and
(e) The provisions of Sec. 35.49(a).
Sec. 35.18 License issuance.
(a) The Commission shall issue a license for the medical use of
byproduct material if--
(1) The applicant has filed Form NRC-313 ``Application for
Materials License'' in accordance with the instructions in Sec. 35.12;
(2) The applicant has paid any applicable fee as provided in part
170 of this chapter;
(3) The Commission finds the applicant equipped and committed to
observe the safety standards established by the Commission in this
chapter for the protection of the public health and safety; and
(4) The applicant meets the requirements of part 30 of this
chapter.
(b) The Commission shall issue a license for mobile services if the
applicant:
(1) Meets the requirements in paragraph (a) of this section; and
(2) Assures that individuals or human research subjects to whom
radiopharmaceuticals or radiation from implants will be administered
may be released following treatment in accordance with Sec. 35.75.
Sec. 35.19 Specific exemptions.
The Commission may, upon application of any interested person or
upon its own initiative, grant such exemptions from the regulations in
this part as it determines are authorized by law and will not endanger
life or property or the common defense and security and are otherwise
in the public interest.
Subpart B--General Administrative Requirements
Sec. 35.24 Authority and responsibilities for the radiation protection
program.
(a) In addition to the radiation protection program requirements of
Sec. 20.1101 of this chapter, a licensee's management must approve in
writing--
(1) Requests for license application, renewal, or amendments before
submittal to the Commission;
(2) Any individual before allowing that individual to work as an
authorized user, authorized nuclear pharmacist, authorized medical
physicist; and
(3) Radiation protection program changes that do not require a
license amendment and are permitted under Sec. 35.26;
(b) A licensee with multiple modalities or multiple users shall
also develop, implement, and maintain written administrative procedures
for interdepartmental/interdisciplinary coordination of the licensee's
radiation protection program.
(c) A licensee's management shall appoint a Radiation Safety
Officer, who agrees in writing to be responsible for implementing the
radiation protection program. The licensee, through the Radiation
Safety Officer, shall ensure that radiation safety activities are being
performed in accordance with licensee-approved procedures and
regulatory requirements in the daily operation of the licensee's
radiation protection program.
[[Page 43559]]
(d) A licensee shall establish in writing the authority, duties,
and responsibilities of the Radiation Safety Officer.
(e) A licensee shall provide the Radiation Safety Officer
sufficient authority, organizational freedom, time, resources, and
management prerogative, to--
(1) Identify radiation safety problems;
(2) Initiate, recommend, or provide corrective actions;
(3) Stop unsafe operations; and,
(4) Verify implementation of corrective actions.
(f) A licensee shall retain a record of actions taken pursuant to
paragraphs (a), (c), and (d) of this section in accordance with
Sec. 35.2024.
Sec. 35.26 Radiation protection program changes.
(a) A licensee may revise its radiation protection program without
Commission approval if--
(1) The revisions do not require an amendment under Sec. 35.13;
(2) The revisions do not reduce radiation safety;
(3) The revisions have been reviewed and approved by the Radiation
Safety Officer and licensee management; and
(4) The affected individuals are instructed on the revised program
before the changes are implemented.
(b) A licensee shall retain a record of each change in accordance
with Sec. 35.2026.
Sec. 35.27 Supervision.
(a) A licensee that permits the receipt, possession, use, or
transfer of byproduct material by an individual under the supervision
of an authorized user or as allowed by Sec. 35.11(b) shall--
(1) Instruct the supervised individual in the licensee's written
radiation protection procedures, written directive procedures,
regulations of this chapter, and license conditions with respect to the
use of byproduct material; and
(2) Require the supervised individual to follow the instructions of
the supervising authorized user for medical uses of radioactive
material, written radiation protection procedures established by the
licensee, regulations of this chapter; and license conditions with
respect to the medical use of byproduct material.
(b) A licensee that permits the preparation of byproduct material
for medical use by an individual under the supervision of an authorized
nuclear pharmacist or physician who is an authorized user, as allowed
by Sec. 35.11(c), shall--
(1) Instruct the supervised individual in the preparation of
byproduct material for medical use, as appropriate to that individual's
use of byproduct material; and
(2) Require the supervised individual to follow the instructions of
the supervising authorized user or authorized nuclear pharmacist
regarding the preparation of byproduct material for medical use, the
written radiation protection procedures established by the licensee and
the regulations of this chapter, and license conditions.
(c) A licensee shall establish, implement, and maintain a policy
for all supervised individuals to request clarification, as needed,
from--
(1) The authorized user, before initiating or continuing any
procedure that requires a written directive, if the supervised
individual has any question about what should be done or how it should
be done; and
(2) The authorized user or authorized nuclear pharmacist about the
instructions and requirements provided to the supervised individual in
accordance with paragraphs (a) and (b) of this section.
(d) A licensee that permits supervised activities under paragraph
(a) and (b) of this section is responsible for the acts and omissions
of the supervised individual.
Sec. 35.40 Written directives.
(a) A written directive must be prepared, dated, and signed by an
authorized user prior to administration of I-131 sodium iodide greater
than 1.11 Megabequerels (Mbq) (30 microcuries (Ci) ), any
therapeutic dosage of a radiopharmaceutical, or any therapeutic dose of
radiation from byproduct material.\1\
---------------------------------------------------------------------------
\1\ If, because of the emergent nature of the patient's
condition, a delay in order to provide a written directive would
jeopardize the patient's health, an oral directive will be
acceptable, provided that the information contained in the oral
directive is documented immediately in writing in the patient's
record a written directive is prepared within 48 hours of the oral
directive.
If, because of the patient's condition, a delay in order to
provide a written revision to an existing written directive would
jeopardize the patient's health, an oral revision to an existing
written directive will be acceptable, provided that the oral
revision is documented immediately in the patient's record and a
revised written directive is signed by the authorized user within 48
hours of the oral revision.
Also, a written revision to an existing written directive may be
made by any diagnostic or therapeutic procedure provided that the
revision is dated and signed by an authorized user prior to the
administration of the radiopharmaceutical dosage, the brachytherapy
dose, the gamma stereotactic radiosurgery dose, the teletherapy
dose, or the next teletherapy fractional dose.
---------------------------------------------------------------------------
(b) The written directive must contain the patient or human
research subject's name and the following:
(1) For any administration of quantities greater than 1.11 MBq (30
Ci) of sodium iodide I-131: the dosage;
(2) For a therapeutic administration of a radiopharmaceutical other
than sodium iodide I-131: the radiopharmaceutical, dosage, and route of
administration;
(3) For gamma stereotactic radiosurgery: target coordinates
(including gamma angle), collimator size, plug pattern, total dose for
the treatment, and the total treatment volume;
(4) For teletherapy: the total dose, dose per fraction, number of
fractions, treatment site, and overall treatment period;
(5) For remote afterloading brachytherapy: the radionuclide,
treatment site, dose per fraction, number of fractions, and total dose;
or
(6) For all other brachytherapy:
(i) Prior to implantation: treatment site, the radionuclide, number
of sources and source strengths or dose; and
(ii) After implantation but prior to completion of the procedure:
the radionuclide, treatment site, and total source strength and
exposure time (or, equivalently, the total dose).
(c) The licensee shall retain the written directive in accordance
with Sec. 35.2040.
Sec. 35.41 Procedures for administrations requiring a written
directive.
(a) For any administration requiring a written directive, the
licensee shall develop, implement, and maintain written procedures to
provide high confidence that:
(1) The patient's or human research subject's identity is verified
before each administration; and
(2) Each administration is in accordance with the written
directive.
(b) The procedures required by paragraph (a) of this section must,
at a minimum, address--
(1) Verifying the identity of the patient or human research
subject;
(2) Verifying that the specific details of the administration are
in accordance with the written directive and treatment plan;
(3) Checking both manual and computer-generated dose calculations;
and
(4) Verifying that any computer-generated dose calculations are
correctly transferred into the consoles of therapeutic medical devices
authorized by Sec. 35.600.
Sec. 35.49 Suppliers for sealed sources or devices for medical use.
A licensee may use for medical use only--
[[Page 43560]]
(a) Sealed sources or devices manufactured, labeled, packaged, and
distributed in accordance with a license issued pursuant to 10 CFR part
30 and Sec. 32.74 of this chapter or the equivalent requirements of an
Agreement State; or
(b) Teletherapy sources manufactured and distributed in accordance
with a license issued pursuant to 10 CFR part 30 or the equivalent
requirements of an Agreement State.
Sec. 35.50 Training for Radiation Safety Officer
Except as provided in Sec. 35.57, the licensee shall require an
individual fulfilling the responsibilities of the Radiation Safety
Officer (RSO) as provided in Sec. 35.24 to be an individual who--
(a) Is certified by a speciality board whose certification process
includes all of the requirements in paragraph (b) of this section and
whose certification has been approved by the Commission or;
(b)(1) Has completed a structured educational program consisting of
both:
(i) 200 hours of didactic training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Radiation biology; and
(E) Radiation dosimetry; and
(ii) One year of full-time radiation safety experience under the
supervision of the individual identified as the RSO on a Commission or
Agreement State license that authorizes similar type(s) of use(s) of
byproduct material involving the following;
(A) Shipping, receiving, and performing related radiation surveys;
(B) Using and performing checks for proper operation of dose
calibrators, survey meters, and instruments used to measure
radionuclides;
(C) Securing and controlling byproduct material;
(D) Using administrative controls to avoid mistakes in the
administration of byproduct material;
(E) Using procedures to prevent or minimize radioactive
contamination and using proper decontamination procedures; and
(F) Disposing of byproduct material; and
(2) Has obtained written certification, signed by a preceptor RSO,
that the requirements in paragraph (b)(1) of this section have been
satisfactorily completed and that the individual has achieved a level
of competency sufficient to independently function as an RSO for
medical uses of byproduct material; and
(3) Following completion of the requirements in paragraph (b) of
this section, has demonstrated sufficient knowledge in radiation safety
commensurate with the use requested by passing an examination given by
an organization or entity approved by the Commission in accordance with
appendix A of this part; or
(c) Is an authorized user, authorized medical physicist, or
authorized nuclear pharmacist identified on the licensee's license and
has experience with the radiation safety aspects of similar types of
use of byproduct material for which the individual has RSO
responsibilities.
Sec. 35.51 Training for authorized medical physicist.
The licensee shall require the authorized medical physicist to be
an individual who--
(a) Is certified by a speciality board whose certification process
includes all of the training and experience requirements in paragraph
(b) of this section and whose certification has been approved by the
Commission; or
(b)(1) Holds a master's or doctor's degree in physics, biophysics,
radiological physics, medical physics, or health physics, or an
equivalent training program approved by the NRC, and has completed one
year of full-time training in therapeutic radiological physics and an
additional year of full-time practical experience under the supervision
of a medical physicist at a medical institution that includes the tasks
listed in Secs. 35.67, 35.632, 35.633, 35.635, 35.642, 35.643, 35.644,
35.645 and 35.652, as applicable; and
(2) Has obtained written certification, signed by a preceptor
authorized medical physicist, that the requirements in paragraph (b)(1)
in this section have been satisfactorily completed and that the
individual has achieved a level of competency sufficient to
independently function as an authorized medical physicist; and,
(3) Following completion of the requirements in paragraph (b)(1) of
this section, has demonstrated sufficient knowledge in radiation safety
commensurate with the use requested by passing an examination given by
an organization or entity approved by the Commission in accordance with
appendix A of this part.
Sec. 35.55 Training for an authorized nuclear pharmacist.
The licensee shall require the authorized nuclear pharmacist to be
a pharmacist who--
(a) Is certified as a nuclear pharmacist by a speciality board
whose certification process includes all of the requirements in
paragraph (b) of this section and whose certification has been approved
by the Commission, or
(b)(1) Has completed 700 hours in a structured educational program
consisting of both:
(i) Didactic training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Supervised practical experience in a nuclear pharmacy
involving--
(A) Shipping, receiving, and performing related radiation surveys;
(B) Using and performing checks for proper operation of dose
calibrators, survey meters, and, if appropriate, instruments used to
measure alpha- or beta-emitting radionuclides;
(C) Calculating, assaying, and safely preparing dosages for
patients or human research subjects;
(D) Using administrative controls to avoid medical events in the
administration of byproduct material; and
(E) Using procedures to prevent or minimize radioactive
contamination and using proper decontamination procedures; and
(2) Has obtained written certification, signed by a preceptor
authorized nuclear pharmacist, that the requirements in paragraph
(b)(1) have been satisfactorily completed and that the individual has
achieved a level of competency sufficient to independently operate a
nuclear pharmacy; and
(3) Following completion of the requirements in paragraph (b)(1) of
this section, has demonstrated sufficient knowledge in radiation safety
commensurate with the use requested by passing an examination given by
an organization or entity approved by the Commission in accordance with
appendix A of this part.
Sec. 35.57 Training for experienced Radiation Safety Officer,
teletherapy or medical physicist, authorized user, and nuclear
pharmacist.
(a) An individual identified as a Radiation Safety Officer, a
teletherapy or medical physicist, or a nuclear pharmacist on a
Commission or Agreement State license before [date--6 months from
publication of the Final Rule] need not comply with the training
requirements of Secs. 35.50 and 35.51, respectively.
(b) Physicians, dentists, or podiatrists identified as authorized
users for the
[[Page 43561]]
medical, dental, or podiatric use of byproduct material on a Commission
or Agreement State license issued before [date--6 months from
publication of the Final Rule] who perform only those medical uses for
which they were authorized on that date need not comply with the
training requirements of subparts C through H.
Sec. 35.59 Recentness of training.
The training and experience specified in subparts B, D, E, F, G, H,
and J must have been obtained within the 7 years preceding the date of
application or the individual must have had related continuing
education and experience since the required training and experience was
completed.
Subpart C--General Technical Requirements
Sec. 35.60 Possession, use, calibration, and check of instruments to
measure the activity of photon-emitting radionuclides.
(a) For other than unit dosages, a licensee shall possess and use
instrumentation to measure the activity of photon-emitting
radionuclides prior to administration to each patient or human research
subject.
(b) If a licensee uses instrumentation to measure the activity of
dosages of photon-emitting radionuclides, including unit dosages, it
shall develop, implement, and maintain written procedures for proper
operation of the instrumentation. At a minimum, a licensee shall--
(1) Perform tests, before initial use and following repair, on each
instrument for accuracy, linearity, and geometry dependence;
(2) Perform an accuracy test annually;
(3) Perform a linearity test annually over the range of medical
use; and
(4) Check each instrument for constancy and proper operation at the
beginning of each day of use.
(c) Accuracy tests must be performed with source(s) with a
principal photon energy of between 100 and 500 keV whose activity is
traceable to the National Institute of Standards and Technology (NIST)
or by a supplier who has compared the source to a source that was
calibrated by NIST.
(d) A licensee shall mathematically correct dosage readings for any
geometry or linearity error that exceeds 10 percent if the dosage is
greater than 1.11 MBq (30 Ci) and shall repair or replace the
instrumentation if the accuracy or constancy error exceeds 10 percent.
(e) A licensee shall retain a record of each check and test
required by this section in accordance with Sec. 35.2060.
Sec. 35.61 Calibration and check of survey instruments.
(a) A licensee shall calibrate the survey instruments used to show
compliance with this part and 10 CFR part 20 before first use,
annually, and following repair. A licensee shall--
(1) Calibrate all scales with readings up to 10 mSv (1000 mrem) per
hour with a radiation source;
(2) Calibrate two separated readings on each scale that will be
used to show compliance with this part; and
(3) Conspicuously note on the instrument the date of calibration.
(b) A licensee shall consider a point as calibrated if the
indicated exposure rate differs from the calculated exposure rate by
not more than 20 percent, and conspicuously attach a correction chart
or graph to the instrument if the indicated exposure rate differs from
the calculated exposure rate by more than 10 percent.
(c) Survey instruments must be removed from use if the indicated
exposure rate differs from the calculated exposure rate by more than 20
percent.
(d) A licensee shall retain a record of each survey instrument
calibration in accordance with Sec. 35.2061.
Sec. 35.62 Possession, use, calibration, and check of instruments to
measure dosages of alpha- or beta-emitting radionuclides.
(a) For other than unit dosages, a licensee shall possess and use
instrumentation to measure the radioactivity of alpha- or beta-emitting
radionuclides. A licensee shall measure, by direct measurement or by
combination of measurements and calculations, the amount of
radioactivity in dosages of alpha-or beta-emitting radionuclides prior
to administration to each patient or human research subject.
(b) A licensee shall develop, implement, and maintain written
procedures for use of the instrumentation. At a minimum, a licensee
shall--
(1) Perform tests before initial use, and following repair, on each
instrument for accuracy, linearity, and geometry dependence, unless it
is not appropriate for the use of the instrument; and make adjustments
when necessary;
(2) Perform accuracy annually;
(3) Perform linearity tests annually over the range of medical use;
and
(4) Check each instrument for constancy and proper operation at the
beginning of each day of use.
(c) Accuracy tests must be performed with source(s) that are
traceable to NIST or by a supplier who has compared the source to a
source that was calibrated by NIST.
(d) A licensee shall retain a record of each check and test
required by this section in accordance with Sec. 35.2060.
Sec. 35.63 Determination of dosages of unsealed byproduct material for
medical use.
(a) A licensee shall determine and record the activity of each
dosage prior to medical use.
(b) For a unit dosage of an alpha-, beta-, or photon-emitting
radionuclide, this determination must be made either by direct
measurement or by a decay correction, based on the measurement made by
a manufacturer or preparer licensed pursuant to Sec. 32.72 of this
chapter or equivalent Agreement State requirements.
(c) For a dosage of a alpha-, beta-, or photon-emitting
radionuclide prepared by the licensee, this determination must be made
by direct measurement or by combination of measurements and
calculations.
(d) A licensee shall not use a dosage if the dosage differs from
the prescribed dosage by more than 20 percent.
(e) A licensee shall retain a record of the dosage determination
required by this section in accordance with Sec. 35.2063.
Sec. 35.65 Authorization for calibration and reference sources.
Any person authorized by Sec. 35.11 for medical use of byproduct
material may receive, possess, and use the following byproduct material
for check, calibration, and reference use:
(a) Sealed sources manufactured and distributed by a person
licensed pursuant to Sec. 32.74 of this chapter or equivalent Agreement
State regulations and that do not exceed 1.11 kBq (30 mCi) each;
(b) Any byproduct material with a half-life not longer than 120
days in individual amounts not to exceed 0.555 MBq (15 mCi);
(c) Any byproduct material with a half-life longer than 120 days in
individual amounts not to exceed 7.4 MBq ( 200 Ci) each and
not to exceed 1000 times the quantities in appendix B of Part 30 of
this chapter whichever is more limiting; and
(d) Technetium-99m in amounts as needed.
Sec. 35.67 Requirements for possession of sealed sources and
brachytherapy sources.
(a) A licensee in possession of any sealed source or brachytherapy
source shall follow the radiation safety and handling instructions
supplied by the manufacturer, and shall maintain the instructions for
the duration of source use in a legible form convenient to users.
[[Page 43562]]
(b) A licensee in possession of a sealed source shall--
(1) Test the source for leakage before its first use unless the
licensee has a certificate from the supplier indicating that the source
was tested within 6 months before transfer to the licensee; and
(2) Test the source for leakage at intervals not to exceed 6 months
or at other intervals approved by the Commission or an Agreement State
in the Sealed Source and Device Registry.
(c) To satisfy the leak test requirements of this section, the
licensee shall measure the sample so that the leakage test can detect
the presence of 185 Bq (0.005 Ci) of radioactive material on
the sample.
(d) A licensee shall retain leakage test records in accordance with
Sec. 35.2067.
(e) If the leakage test reveals the presence of 185 Bq (0.005
Ci) or more of removable contamination, the licensee shall--
(1) Immediately withdraw the sealed source from use and store,
dispose, or cause it to be repaired in accordance with the requirements
in parts 20 and 30 of this chapter; and
(2) File a report within 5 days of the leakage test in accordance
with Sec. 35.3067.
(f) A licensee need not perform a leakage test on the following
sources:
(1) Sources containing only byproduct material with a half-life of
less than 30 days;
(2) Sources containing only byproduct material as a gas;
(3) Sources containing 3.7 MBq (100 Ci) or less of beta or
gamma-emitting material or 0.37 MBq (10 Ci) or less of alpha-
emitting material;
(4) Sources stored for less than a 10-year period and not being
used. The licensee shall, however, test each such source for leakage
before any use or transfer unless it has been leakage-tested within 6
months before the date of use or transfer; and
(5) Seeds of iridium-192 encased in nylon ribbon.
(g) A licensee in possession of sealed sources or brachytherapy
sources, except for gamma stereotactic radiosurgery sources, shall
conduct a semi-annual physical inventory of all such sources in its
possession. The licensee shall retain each inventory record in
accordance with Sec. 35.2067.
Sec. 35.69 Labeling and shielding of vials and syringes.
(a) A licensee shall develop, implement, and maintain written
procedures for--
(1) Labeling each syringe, syringe shield, or vial shield that
contains a radiopharmaceutical to identify the radiopharmaceutical
name, or its abbreviation, and to ensure that the contents are
conspicuously identified as containing radioactive material; and
(2) Shielding vials and syringes containing radiopharmaceuticals.
(b) A licensee shall instruct individuals, commensurate with the
individual's assigned duties, in the procedures required by paragraph
(a) of this section.
Sec. 35.70 Surveys for ambient radiation exposure rate.
(a) Except as provided in paragraph (b) of this section, a licensee
shall survey with a radiation detection survey instrument at the end of
each day of use all areas where radiopharmaceuticals requiring a
written directive were prepared for use or administered.
(b) A licensee does not need to perform the surveys required by
paragraph (a) of this section in an area(s) where patients or human
research subjects can not be released pursuant to Sec. 35.75.
(c) A licensee shall retain a record of each survey in accordance
with Sec. 35.2070.
Sec. 35.75 Release of individuals containing radiopharmaceuticals or
implants.
(a) A licensee may authorize the release from its control of any
individual who has been administered radiopharmaceuticals or implants
containing radioactive material if the total effective dose equivalent
to any other individual from exposure to the released individual is not
likely to exceed 5 mSv (0.5 rem).2
---------------------------------------------------------------------------
\2\ Regulatory Guide 8.39, ``Release of Patients Administered
Radioactive Materials,'' describes methods for calculating doses to
other individuals and contains tables of activities not likely to
cause doses exceeding 0.5 rem (5 mSv).
---------------------------------------------------------------------------
(b) A licensee shall provide the released individual, or the
individual's parent or guardian, with instructions, including written
instructions, on actions recommended to maintain doses to other
individuals as low as is reasonably achievable if the total effective
dose equivalent to any other individual is likely to exceed 1 mSv (0.1
rem). If the total effective dose equivalent to a breast-feeding infant
or child could exceed 1 mSv (0.1 rem) assuming there were no
interruption of breast-feeding, the instructions shall also include--
(1) Guidance on the interruption or discontinuation of breast-
feeding; and
(2) Information on the potential consequences, if any, of failure
to follow the guidance.
(c) A licensee shall maintain a record of the basis for authorizing
the release of an individual, in accordance with Sec. 35.2075(a).
(d) The licensee shall maintain a record of instructions provided
to breast-feeding women in accordance with Sec. 35.2075(c).
Sec. 35.80 Provision of mobile service.
(a) A licensee providing mobile service shall--
(1) Obtain a letter signed by the management of each client for
which services are rendered that permits the use of byproduct material
at the client's address of use and clearly delineates the authority and
responsibility of each entity;
(2) Check instruments as described in Secs. 35.60 and 35.62 for
proper function before medical use at each address of use or on each
day of use, whichever is more frequent;
(3) Check survey instruments for proper operation with a dedicated
check source before use at each address of use;
(4) Before leaving a client's address of use, survey all areas of
use to ensure compliance with the requirements in part 20 of this
chapter; and
(b) A mobile nuclear medicine service may not have byproduct
material delivered from the manufacturer or the distributor to the
client's address of use, unless the client has a license allowing
possession of the byproduct material. Radioactive material delivered to
the client's address of use must be received and handled in conformance
with the client's license.
(c) A licensee providing mobile nuclear services shall retain the
letter required in paragraph (a)(1) and the record of each survey
required in paragraph (a)(4) of this section in accordance with
Sec. 35.2080.
Sec. 35.92 Decay-in-storage.
(a) A licensee may hold byproduct material with a physical half-
life of less than 120 days for decay-in-storage before disposal in
ordinary trash if it--
(1) Monitors byproduct material at the surface before disposal as
ordinary trash and determines that its radioactivity cannot be
distinguished from the background radiation level with an appropriate
radiation detection survey meter set on its most sensitive scale and
with no interposed shielding; and
(2) Removes or obliterates all radiation labels;
(b) A licensee shall retain a record of each disposal permitted
under paragraph (a) of this section in accordance with Sec. 35.2092.
[[Page 43563]]
Subpart D--Unsealed Byproduct Material--Low Dose
Sec. 35.100 Use of unsealed byproduct material for uptake, dilution,
and excretion studies for which a written directive is not required.
A licensee may use for uptake, dilution, or excretion studies any
unsealed byproduct material, except in quantities that require a
written directive pursuant to Sec. 35.40, prepared for medical use that
is either--
(a) Obtained from a manufacturer or preparer licensed pursuant to
Sec. 32.72 of this chapter or equivalent Agreement State requirements;
or
(b) Prepared by an authorized nuclear pharmacist, a physician who
is an authorized user and who meets the requirements specified in
Sec. 35.292, or an individual under the supervision of either as
specified in Sec. 35.27.
Sec. 35.200 Use of unsealed byproduct material for imaging and
localization studies for which a written directive is not required.
A licensee may use for imaging and localization studies any
unsealed byproduct material, except in quantities that require a
written directive pursuant to Sec. 35.40, prepared for medical use that
is either--
(a) Obtained from a manufacturer or preparer licensed pursuant to
Sec. 32.72 of this chapter or equivalent Agreement State requirements;
or
(b) Prepared by an authorized nuclear pharmacist, a physician who
is an authorized user and who meets the requirements specified in
Sec. 35.292, or an individual under the supervision of either as
specified in Sec. 35.27.
Sec. 35.204 Permissible molybdenum-99 concentration.
(a) A licensee may not administer to humans a radiopharmaceutical
containing more than 5.55 kBq (0.15 Ci) of molybdenum-99 per
millicurie of technetium-99m.
(b) A licensee that uses molybdenum-99/technetium-99m generators
for preparing a technetium-99m radiopharmaceutical shall measure the
molybdenum-99 concentration of the first eluate after receipt of a
generator to demonstrate compliance with paragraph (a) of this section.
(c) A licensee that must measure molybdenum concentration shall
retain a record of each measurement in accordance with Sec. 35.2204.
Sec. 35.290 Training for uptake, dilution, and excretion studies.
Except as provided in Secs. 35.57, the licensee shall require the
authorized user of a radiopharmaceutical for uses authorized under
Sec. 35.100 to be a physician who--
(a) Is certified by a medical specialty board whose certification
process includes all of the requirements in paragraph (b) of this
section and whose certification has been approved by the Commission
or--
(b)(1) Has completed a structured educational program in basic
radionuclide handling techniques applicable to the use of diagnostic
radiopharmaceuticals, consisting of both--
(i) 40 hours of didactic training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) 20 hours of supervised practical experience under the
supervision of an authorized user involving--
(A) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(B) Calibrating dose calibrators and diagnostic instruments and
performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human
research subject dosages;
(D) Using administrative controls to prevent a medical event
involving the use of byproduct material;
(E) Using procedures to contain spilled byproduct material safely
and using proper decontamination procedures; and
(F) Administering dosages to patients or human research subjects;
and
(2) Has obtained written certification, signed by a preceptor
authorized user, that the requirements in paragraph (b)(1) of this
section have been satisfactorily completed and that the individual has
achieved a level of competency sufficient to independently function as
an authorized user of a diagnostic radiopharmaceutical for the uses
listed in Sec. 35.100; and
(3) Following completion of the requirements in paragraph (b)(1) of
this section, has demonstrated sufficient knowledge in radiation safety
commensurate with the use requested by passing an examination given by
an organization or entity approved by the Commission in accordance with
appendix A of this part.
Sec. 35.292 Training for imaging and localization studies.
Except as provided in Secs. 35.57, the licensee shall require the
authorized user of radiopharmaceuticals and generators for the uses
authorized under Sec. 35.200 to be a physician who--
(a) Is certified by a medical specialty board whose certification
process includes all of the requirements in paragraph (b) of this
section and whose certification has been approved by the Commission; or
(b)(1) Has completed a structured educational program in basic
radionuclide handling techniques applicable to the use of diagnostic
radiopharmaceuticals and generators, consisting of both--
(i) 80 hours of didactic training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) 40 hours of supervised practical experience under the
supervision of an authorized user involving--
(A) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(B) Calibrating dose calibrators and diagnostic instruments and
performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human
research subject dosages;
(D) Using administrative controls to prevent a medical event
involving the use of byproduct material;
(E) Using procedures to contain spilled byproduct material safely
and using proper decontamination procedures;
(F) Eluting technetium-99m from generator systems, measuring and
testing the eluate for molybdenum-99, and processing the eluate with
reagent kits to prepare technetium-99m labeled radiopharmaceuticals;
and
(G) Administering dosages to patients or human research subjects;
and
(2) Has obtained written certification, signed by a preceptor
authorized user, that the requirements in paragraph (b)(1) of this
section have been satisfactorily completed and that the individual has
achieved a level of competency sufficient to independently function as
an authorized user of diagnostic radiopharmaceuticals and generators
for the uses listed in Sec. 35.200; and
(3) Following completion of the requirements in paragraph (b)(1) of
this
[[Page 43564]]
section, has demonstrated sufficient knowledge in radiation safety
commensurate with the use requested by passing an examination given by
an organization or entity approved by the Commission in accordance with
appendix A of this part.
Subpart E--Unsealed Byproduct Material--High Dose
Sec. 35.300 Use of unsealed byproduct material for which a written
directive is required.
A licensee may use any unsealed byproduct material prepared for
medical use and for which a written directive is required that is
either--
(a) Obtained from a manufacturer or preparer licensed pursuant to
Sec. 32.72 of this chapter or equivalent Agreement State requirements;
or
(b) Prepared by an authorized nuclear pharmacist, a physician who
is an authorized user and who meets the requirements specified in
Sec. 35.292, or an individual under the supervision of either as
specified in Sec. 35.27.
Sec. 35.310 Safety instruction.
In addition to the requirements of Sec. 19.12 of this chapter,
(a) A licensee shall provide radiation safety instruction,
initially and at least annually, to personnel caring for patients or
human research subjects that have received radiopharmaceutical therapy
and can not be released in accordance with Sec. 35.75. To satisfy this
requirement, the instruction must be commensurate with the duties of
the personnel and include--
(1) Patient or human research subject control;
(2) Visitor control, including--
(i) Routine visitation to hospitalized individuals in accordance
with Sec. 20.1301(a)(1) of this chapter; and
(ii) Visitation authorized in accordance with Sec. 20.1301(a)(3);
(3) Contamination control;
(4) Waste control; and
(5) Notification of the authorized user and the Radiation Safety
Officer, or his designee, if the patient or the human research subject
dies or has a medical emergency.
(b) A licensee shall retain a record of individuals receiving
instruction in accordance with Sec. 35.2310.
Sec. 35.315 Safety precautions.
(a) For each patient or human research subject that cannot be
released in accordance with Sec. 35.75, a licensee shall--
(1) Provide a private room with a private sanitary facility;
(2) Visibly post the patient's or the human research subject's room
with a ``Radioactive Materials'' sign and note on the door or in the
patient's or human research subject's chart where and how long visitors
may stay in the patient's or the human research subject's room; and
(3) Either monitor material and items removed from the patient's or
the human research subject's room to determine that their radioactivity
cannot be distinguished from the natural background radiation level
with a radiation detection survey instrument set on its most sensitive
scale and with no interposed shielding, or handle such material and
items as radioactive waste.
(b) A licensee shall notify the authorized user and the Radiation
Safety Officer, or his or her designee, as soon as possible, if the
patient or human research subject has a medical emergency and,
immediately, if the patient dies.
Sec. 35.390 Training for use of unsealed byproduct material for
therapy or for use of unsealed byproduct material that requires a
written directive.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of a radiopharmaceutical for the uses authorized under
Sec. 35.300 to be a physician who--
(a) Is certified by a medical specialty board whose certification
process includes all of the requirements in paragraph (b) of this
section and whose certification has been approved by the Commission; or
(b)(1) Has completed a structured educational program in basic
radionuclide handling techniques applicable to the use of unsealed
byproduct material consisting of both--
(i) 80 hours of didactic training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity; and
(D) Radiation biology; and
(ii) 40 hours of supervised practical experience under the
supervision of an authorized user at a medical institution involving--
(A) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(B) Calibrating dose calibrators, as appropriate, and performing
checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human
research subject dosages;
(D) Using administrative controls to prevent a medical event
involving the use of byproduct material;
(E) Using procedures to contain spilled byproduct material safely
and using proper decontamination procedures; and
(2) Has had experience, obtained under the direct supervision of an
authorized user, involving at least five cases for each procedure with
radiation safety hazards similar to that use for which the individual
is requesting authorized user status. This experience may be obtained
concurrently with the supervised practical experience required by
paragraph (b)(1)(ii) of this section;
(3) Has obtained written certification, signed by a preceptor
authorized user, that the requirements in paragraphs (b) (1) and (2) of
this section have been satisfactorily completed and that the individual
has achieved a level of competency sufficient to independently function
as an authorized user of unsealed byproduct material for the uses
listed in Sec. 35.300; and
(4) Following completion of the requirements in paragraph (b) (1)
and (2) of this section, has demonstrated sufficient knowledge in
radiation safety commensurate with the use requested by passing an
examination given by an organization or entity approved by the
Commission in accordance with appendix A of this part.
Subpart F-- Manual Brachytherapy
Sec. 35.400 Use of sources for manual brachytherapy.
A licensee shall use only brachytherapy sources for therapeutic
medical uses as approved in the Sealed Source and Device Registry.
Sec. 35.404 Radiation surveys of patients or human research subjects
treated with implants.
(a) Immediately after implanting sources in a patient or a human
research subject, the licensee shall make a radiation survey of the
patient or the human research subject and the adjacent area of use to
confirm that no sources have been misplaced.
(b) Immediately after removing the last temporary implant source
from a patient or a human research subject, the licensee shall make a
radiation survey of the patient or the human research subject with a
radiation detection survey instrument to confirm that all sources have
been removed.
(c) A licensee shall retain a record of patient or human research
subject surveys in accordance with Sec. 35.2404.
Sec. 35.406 Brachytherapy sources inventory.
(a) A licensee shall maintain accountability at all times for all
brachytherapy sources in storage or use.
(b) Promptly after removing sources from a patient or a human
research
[[Page 43565]]
subject, a licensee shall return brachytherapy sources to a secure
storage area.
(c) A licensee shall maintain a record of the brachytherapy source
accountability in accordance with Sec. 35.2406.
Sec. 35.410 Safety instruction.
In addition to the requirements of Sec. 19.12 of this chapter,
(a) The licensee shall provide radiation safety instruction,
initially and at least annually, to personnel caring for patients or
human research subjects that are undergoing implant therapy and cannot
be released in accordance with Sec. 35.75. To satisfy this requirement,
the instruction must be commensurate with the duties of the personnel
and include the --
(1) Size and appearance of the brachytherapy sources;
(2) Safe handling and shielding instructions;
(3) Patient or human research subject control;
(4) Visitor control, including both--
(i) Routine visitation of hospitalized individuals in accordance
with Sec. 20.1301(a)(1) of this chapter; and
(ii) Visitation authorized in accordance with Sec. 20.1301(a)(3);
and
(5) Notification of the authorized user and Radiation Safety
Officer, or his or her designee, if the patient or the human research
subject dies or has a medical emergency.
(b) A licensee shall retain a record of individuals receiving
instruction in accordance with Sec. 35.2310.
Sec. 35.415 Safety precautions.
(a) For each patient or human research subject receiving
brachytherapy and confined pursuant to Sec. 35.75, a licensee shall--
(1) Not quarter the patient or the human research subject in the
same room as an individual who is not receiving radiation therapy; and
(2) Visibly post the patient's or human research subject's room
with a ``Radioactive Materials'' sign and note on the door or in the
patient's or human research subject's chart where and how long visitors
may stay in the patient's or human research subject's room.
(b) A licensee shall have available, near each treatment room,
emergency response equipment. The emergency response equipment must
include, as applicable--
(1) A device to assist in placing the source(s) in the shielded
position;
(2) A shielded source/applicator storage container;
(3) Remote handling tools; and
(4) Supplies necessary to surgically remove applicators or sources
from a patient or human research subject treated internally with sealed
sources.
(c) A licensee shall notify the authorized user and the Radiation
Safety Officer, or his designee, as soon as possible, if the patient or
human research subject has a medical emergency and, immediately, if the
patient dies.
Sec. 35.432 Full calibration measurements of brachytherapy sources.
(a) A licensee authorized to use brachytherapy sources for medical
use shall perform full calibration measurements on brachytherapy
sources before the first medical use of the source or source/applicator
configuration.
(b) A licensee may use calibration measurements provided by the
source manufacturer that are made in accordance with the requirements
of this section.
(c) To satisfy the requirements of paragraphs (a) and (b) of this
section, full calibration measurements must include determination of--
(1) The output or activity within +/-5 percent; and
(2) Source positioning accuracy within applicators.
(d) A licensee shall use the dosimetry system described in
Sec. 35.630(a) to measure the output or activity of the brachytherapy
source.
(e) A licensee shall make full calibration measurements required by
paragraph (a) of this section in accordance with published protocols by
nationally recognized bodies.
(f) A licensee shall mathematically correct the outputs or
activities determined in paragraph (c) of this section for physical
decay at intervals consistent with 1 percent physical decay.
(g) A licensee shall retain a record of each calibration in
accordance with Sec. 35.2432.
Sec. 35.490 Training for use of manual brachytherapy sources.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of a manual brachytherapy source for the uses
authorized under Sec. 35.400 to be a physician who--
(a) Is certified by a medical specialty board whose certification
process includes all of the requirements in paragraph (b) of this
section and whose certification has been approved by the Commission; or
(b)(1) Has completed a structured educational program in basic
radionuclide handling techniques applicable to the use of manual
brachytherapy sources consisting of both--
(i) 200 hours of didactic training in the following areas --
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity; and
(D) Radiation biology;
(ii) 500 hours of supervised practical experience, under the
supervision of an authorized user at a medical institution, involving--
(A) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(B) Checking survey meters for proper operation;
(C) Preparing, implanting, and removing sealed sources;
(D) Maintaining running inventories of material on hand;
(E) Using administrative controls to prevent a medical event
involving the use of byproduct material;
(F) Using emergency procedures to control byproduct material; and
(2) Three years of supervised clinical experience that includes one
year in a formal training program approved by the Residency Review
Committee for Radiology of the Accreditation Council for Graduate
Medical Education or the Committee on Postdoctoral Training of the
American Osteopathic Association or equivalent program approved by the
NRC, and an additional two years of clinical experience under the
supervision of an authorized user; and
(3) Has obtained written certification, signed by a preceptor
authorized user, that the requirements in paragraphs (b)(1) and (2) of
this section have been satisfactorily completed and that the individual
has achieved a level of competency sufficient to independently function
as an authorized user of manual brachytherapy sources for the uses
listed in Sec. 35.400; and, (4) Following completion of the
requirements in paragraph (b)(1) and (2) of this section, has
demonstrated sufficient knowledge in radiation safety commensurate with
the use requested by passing an examination given by an organization or
entity approved by the Commission in accordance with appendix A of this
part.
Subpart G--Sealed Sources for Diagnosis
Sec. 35.500 Use of sealed sources for diagnosis.
A licensee shall use only sealed sources for diagnostic medical
uses as approved in the Sealed Source and Device Registry.
[[Page 43566]]
Sec. 35.590 Training for use of sealed sources for diagnosis.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of a diagnostic sealed source for the use in a device
authorized under Sec. 35.500 to be a physician, dentist, or podiatrist
who--
(a) Is certified by a speciality board whose certification process
includes all of the requirements in paragraph (b) of this section and
whose certification has been approved by the Commission; or
(b) Has had 8 hours of classroom and laboratory training in basic
radionuclide handling techniques specifically applicable to the use of
the device that includes--
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of
radioactivity;
(4) Radiation biology; and
(5) Training in the use of the device for the uses requested.
Subpart H--Therapeutic Medical Devices
Sec. 35.600 Use of a sealed source in a device for therapeutic medical
uses.
A licensee shall use sealed sources and devices for therapy as
approved in the Sealed Source and Device Registry for medical use.
Sec. 35.604 Radiation surveys of patients and human research subjects
treated with remote afterloaders.
(a) Before releasing a patient or a human research subject from
licensee control, a licensee shall make a survey of the patient or the
human research subject and the afterloader device with a portable
radiation detection survey instrument to confirm that the source(s) has
been removed from the patient or human research subject and returned to
the safe shielded position.
(b) A licensee shall retain a record of patient or human research
subject surveys in accordance with Sec. 35.2404.
Sec. 35.605 Installation, maintenance, and repair.
(a) Only a person specifically licensed by the Commission or an
Agreement State shall install, maintain, adjust, or repair a device
that involves work on the source(s) shielding, the source(s) driving
unit, or other electronic or mechanical component that could expose the
source, reduce the shielding around the source(s), or compromise the
radiation safety of the device or the source(s).
(b) Except for low dose-rate remote afterloader devices, only a
person specifically licensed by the Commission or an Agreement State
shall install, replace, relocate, or remove a sealed source or source
contained in a device,
(c) For a low dose-rate remote afterloader device, only a person
specifically licensed by the Commission or an Agreement State or an
authorized medical physicist shall perform the functions listed in
paragraph (b) of this section.
(d) A licensee shall retain a record of the installation,
maintenance, and repair done on therapeutic medical devices in
accordance with Sec. 35.2605.
Sec. 35.610 Safety procedures and instructions for remote
afterloaders, teletherapy units, and gamma stereotactic radiosurgery
units.
(a) A licensee shall develop, implement, and maintain written
procedures for--
(1) Securing the device, the console, the console keys, and the
treatment room when not in use or unattended;
(2) Except for low dose-rate remote afterloaders, ensuring that
only the patient or the human research subject is in the treatment room
before initiating treatment with the source(s), unless contraindicated,
or after a door interlock interruption;
(3) Preventing dual operation of more than one radiation producing
device in a treatment room if applicable; and
(4) Responding to an abnormal situation when the operator is unable
to place the source(s) in the shielded position, or remove the patient
or human research subject from the radiation field with controls from
outside the treatment room. This procedure must include--
(i) Instructions for responding to equipment failures and the names
of the individuals responsible for implementing corrective actions;
(ii) The process for restricting access to and posting of the
treatment area to minimize the risk of inadvertent exposure; and
(iii) The names and telephone numbers of the authorized users, the
authorized medical physicist, and the Radiation Safety Officer to be
contacted if the device or console operates abnormally.
(b) A copy of the procedures required by Sec. 35.610(a) must be
physically located at the unit console.
(c) A licensee shall post instructions at the device console to
inform the operator of--
(1) The location of the procedures required by Sec. 35.610(a); and
(2) The names and telephone numbers of the authorized users, the
authorized medical physicist, and the Radiation Safety Officer to be
contacted if the device or console unit or console operates abnormally.
(d) A licensee shall provide instruction and practice drills,
initially and at least annually, in the procedures identified in
paragraph (a) of this section and the operating procedures to all
individuals who operate the device, as appropriate to the individual's
assigned duties. A licensee shall ensure that operators receive
refresher training in the operation of the unit and procedures for
periodic spot-checks and full calibrations; and that operators,
authorized medical physicists, and authorized users participate in
drills of the emergency procedures.
(e) A licensee shall retain a record of individuals receiving
instruction required by paragraph (d) of this section, in accordance
with Sec. 35.2310.
Sec. 35.615 Safety precautions for remote afterloaders, teletherapy
units, and gamma stereotactic radiosurgery units.
(a) A licensee shall control access to the treatment room by a door
at each entrance.
(b) A licensee shall equip each entrance to the treatment room with
an electrical interlock system that will--
(1) Prevent the operator from initiating the treatment cycle unless
each treatment room entrance door is closed;
(2) Cause the sources to be shielded immediately when an entrance
door is opened; and
(3) Prevent the primary beam of radiation from being turned on
following an interlock interruption until all treatment room entrance
doors are closed and the beam on-off control is reset at the console.
(c) A licensee shall require any individual entering the treatment
room to assure, through the use of appropriate radiation monitors, that
radiation levels have returned to ambient levels.
(d) Except for low-dose remote afterloaders, a licensee shall
construct or equip each treatment room with viewing and intercom
systems to permit continuous observation of the patient or the human
research subject from the treatment console during irradiation.
(e) For licensed activities where sources are placed within the
patient's or human research subject's body, a licensee shall only
conduct treatments which allow for expeditious removal of a decoupled
or jammed source.
(f) In addition to the requirements specified in paragraphs (a)
through (e) of this section, a licensee shall--
(1) For low dose-rate remote afterloader devices, require--
(i) An authorized user or an authorized medical physicist to be
[[Page 43567]]
physically present during the initiation of all patient treatments
involving the device; and
(ii) An authorized medical physicist and an authorized user or a
physician, who has been designated by the authorized user and who is a
radiation oncology physician trained in emergency response for the
device, to be immediately available during continuation of all patient
treatments involving the device.
(2) For high dose-rate remote afterloader devices, require--
(i) An authorized user and an authorized medical physicist to be
physically present during the initiation of all patient treatments
involving the device; and
(ii) An authorized medical physicist and an authorized user or a
physician, who has been designated by the authorized user and who is a
radiation oncology physician that has been trained in emergency
response for the device, to be physically present during continuation
of all patient treatments involving the device.
(3) For pulsed dose-rate remote afterloader devices, require--
(i) An authorized user and an authorized medical physicist to be
physically present during the initiation of all patient treatments
involving the device; and
(ii) An authorized medical physicist and an authorized user or a
physician, who has been designated by the authorized user and who is a
radiation oncology physician that has been trained in emergency
response for the device, to be immediately available during
continuation of all patient treatments involving the device.
(4) For gamma stereotactic radiosurgery units, require an
authorized user and an authorized medical physicist to be physically
present throughout all patient treatments involving the unit.
(g) The licensee shall have emergency response equipment available
near each treatment room. The emergency response equipment must
include, as applicable--
(1) A device to assist in placing the source(s) in the shielded
position;
(2) A shielded source/applicator storage container;
(3) Remote handling tools; and
(4) Supplies necessary to surgically remove applicators or sources
from a patient or human research subject treated internally with sealed
sources.
Sec. 35.630 Dosimetry equipment.
(a) A licensee shall have a calibrated dosimetry system available
for use. To satisfy this requirement, one of the following two
conditions must be met.
(1) The system must have been calibrated using a source traceable
to the National Institute of Standards and Technology and published
protocols approved by nationally recognized bodies or by a calibration
laboratory accredited by the American Association of Physicists in
Medicine (AAPM). The calibration must have been performed within the
previous 2 years and after any servicing that may have affected system
calibration; or
(2) The system must have been calibrated within the previous 4
years; 18 to 30 months after that calibration, the system must have
been intercompared with another dosimetry system that was calibrated
within the past 24 months by the National Institute of Standards and
Technology or by a calibration laboratory accredited by the AAPM. The
results of the intercomparison must have indicated that the calibration
factor of the licensee's system had not changed by more than 2 percent.
The licensee may not use the intercomparison result to change the
calibration factor. When intercomparing dosimetry systems to be used
for calibrating sealed sources for therapeutic devices, the licensee
shall use a comparable device with beam attenuators or collimators, as
applicable, and sources of the same radionuclide as the source used at
the licensee's facility.
(b) The licensee shall have available for use a dosimetry system
for spot-check measurements. To satisfy this requirement, the system
may be compared with a system that has been calibrated in accordance
with paragraph (a) of this section. This comparison must have been
performed within the previous year and after each servicing that may
have affected system calibration. The spot-check system may be the same
system used to meet the requirement in paragraph (a) of this section.
(c) The licensee shall retain a record of each calibration,
intercomparison, and comparison in accordance with Sec. 35.2630.
Sec. 35.632 Full calibration measurements on teletherapy units.
(a) A licensee authorized to use a teletherapy unit for medical use
shall perform full calibration measurements on each teletherapy unit--
(1) Before the first medical use of the unit; and
(2) Before medical use under the following conditions:
(i) Whenever spot-check measurements indicate that the output
differs by more than 5 percent from the output obtained at the last
full calibration corrected mathematically for radioactive decay;
(ii) Following replacement of the source or following
reinstallation of the teletherapy unit in a new location;
(iii) Following any repair of the teletherapy unit that includes
removal of the source or major repair of the components associated with
the source exposure assembly; and
(3) At intervals not exceeding 1 year.
(b) To satisfy the requirement of paragraph (a) of this section,
full calibration measurements must include determination of--
(1) The output within +/-3 percent for the range of field sizes and
for the distance or range of distances used for medical use;
(2) The coincidence of the radiation field and the field indicated
by the light beam localizing device;
(3) The uniformity of the radiation field and its dependence on the
orientation of the useful beam;
(4) Timer accuracy and linearity over the range of use;
(5) On-off error; and
(6) The accuracy of all distance measuring and localization devices
in medical use.
(c) A licensee shall use the dosimetry system described in
Sec. 35.630(a) to measure the output for one set of exposure
conditions. The remaining radiation measurements required in paragraph
(b)(1) of this section may be made using a dosimetry system that
indicates relative dose rates.
(d) A licensee shall make full calibration measurements required by
paragraph (a) of this section in accordance with published protocols
approved by nationally recognized bodies.
(e) A licensee shall mathematically correct the outputs determined
in paragraph (b)(1) of this section for physical decay for intervals
not exceeding 1 month for cobalt-60, 6 months for cesium-137, or at
intervals consistent with 1 percent decay for all other nuclides.
(f) Full calibration measurements required by paragraph (a) of this
section and physical decay corrections required by paragraph (e) of
this section must be performed by the authorized medical physicist.
(g) A licensee shall retain a record of each calibration in
accordance with Sec. 35.2632.
Sec. 35.633 Full calibration measurements on remote afterloaders.
(a) A licensee authorized to use a remote afterloader for medical
use shall perform full calibration measurements on each unit--
[[Page 43568]]
(1) Before the first medical use of the unit;
(2) Before medical use under the following conditions:
(i) Whenever spot-check measurements indicate that the output
differs by more than 5 percent from the output obtained at the last
full calibration corrected mathematically for radioactive decay;
(ii) Following replacement of the source or following
reinstallation of the unit in a new location outside the facility; and
(iii) Following any repair of the unit that includes removal of the
source or major repair of the components associated with the source
exposure assembly; and
(3) At intervals not exceeding 120 days for high dose-rate and
pulsed dose-rate remote afterloaders; and
(4) At intervals not exceeding 1 year for low dose-rate remote
afterloaders.
(b) To satisfy the requirement of paragraph (a) of this section,
full calibration measurements must include determination of:
(1) The output within +/-5 percent;
(2) Source positioning accuracy to within +/-1 millimeter;
(3) Source retraction with backup battery upon power failure; and
(4) The operability of the electrically assisted treatment room
doors with the high-dose rate remote afterloader unit electrical power
turned off.
(c) In addition to the requirements for full calibrations for all
remote afterloaders in paragraph (b) of this section, a licensee shall:
(1) For high dose-rate and pulsed dose-rate remote afterloaders,
calibrate--
(i) At intervals not exceeding one quarter:
(A) The source guide tubes;
(B) Timer accuracy and linearity over the typical range of use; and
(C) Length of the connectors; and
(ii) Annually, the function of the source tube guides and
connectors.
(2) For low dose-rate remote afterloaders, perform an
autoradiograph of the source(s) to verify inventory and source(s)
arrangement and a spot check of the absolute timer accuracy at
intervals not exceeding one quarter.
(d) A licensee shall use the dosimetry system described in
Sec. 35.630(a) to measure the output.
(e) A licensee shall make full calibration measurements required by
paragraph (a) of this section in accordance with published protocols
approved by nationally recognized bodies.
(f) A licensee shall mathematically correct the outputs determined
in paragraph (b)(1) of this section for physical decay at intervals
consistent with 1 percent physical decay.
(g) Full calibration measurements required by paragraph (a) of this
section and physical decay corrections required by paragraph (f) of
this section must be performed by the authorized medical physicist.
(h) A licensee shall retain a record of each calibration in
accordance with Sec. 35.2633.
Sec. 35.635 Full calibration measurements on gamma stereotactic
radiosurgery units.
(a) A licensee authorized to use a gamma stereotactic radiosurgery
unit for medical use shall perform full calibration measurements on
each unit--
(1) Before the first medical use of the unit;
(2) Before medical use under the following conditions--
(i) Whenever spot-check measurements indicate that the output
differs by more than 5 percent from the output obtained at the last
full calibration corrected mathematically for radioactive decay;
(ii) Following replacement of the sources or following
reinstallation of the gamma stereotactic radiosurgery unit in a new
location; and
(iii) Following any repair of the gamma stereotactic radiosurgery
unit that includes removal of the sources or major repair of the
components associated with the source assembly; and
(3) At intervals not exceeding 1 year.
(b) To satisfy the requirement of paragraph (a) of this section,
full calibration measurements must include determination of--
(1) The output within +/-3 percent;
(2) Relative helmet factors;
(3) Isocenter coincidence;
(4) Timer accuracy and linearity over the range of use;
(5) On-off error; and
(6) Trunnion centricity.
(c) A licensee shall use the dosimetry system described in
Sec. 35.630(a) to measure the output for one set of exposure
conditions. The remaining radiation measurements required in paragraph
(b)(1) of this section may be made using a dosimetry system that
indicates relative dose rates.
(d) A licensee shall make full calibration measurements required by
paragraph (a) of this section in accordance with published protocols
approved by nationally recognized bodies.
(e) A licensee shall mathematically correct the outputs determined
in paragraph (b)(1) of this section at intervals not exceeding 1 month
for cobalt-60 and at intervals consistent with 1 percent physical decay
for all other radionuclides.
(f) Full calibration measurements required by paragraph (a) of this
section and physical decay corrections required by paragraph (e) of
this section must be performed by the authorized medical physicist.
(g) A licensee shall retain a record of each calibration in
accordance with Sec. 35.2635.
Sec. 35.642 Periodic spot-checks for teletherapy units.
(a) A licensee authorized to use teletherapy units for medical use
shall perform output spot-checks on each teletherapy unit once in each
calendar month that include determination of--
(1) Timer constancy, and timer linearity over the range of use;
(2) On-off error;
(3) The coincidence of the radiation field and the field indicated
by the light beam localizing device;
(4) The accuracy of all distance measuring and localization devices
used for medical use;
(5) The output for one typical set of operating conditions measured
with the dosimetry system described in Sec. 35.630(b); and
(6) The difference between the measurement made in paragraph (b)(5)
of this section and the anticipated output, expressed as a percentage
of the anticipated output (i.e., the value obtained at last full
calibration corrected mathematically for physical decay).
(b) A licensee shall perform measurements required by paragraph (a)
of this section in accordance with written procedures established by
the authorized medical physicist. That individual need not actually
perform the spot check measurements.
(c) A licensee shall have the authorized medical physicist review
the results of each spot-check within 15 days. The authorized medical
physicist shall promptly notify the licensee in writing of the results
of each spot-check.
(d) A licensee authorized to use a teletherapy unit for medical use
shall perform safety spot-checks of each teletherapy facility once in
each calendar month and after each source installation to assure proper
operation of--
(1) Electrical interlocks at each teletherapy room entrance;
(2) Electrical or mechanical stops installed for the purpose of
limiting use of the primary beam of radiation (restriction of source
housing angulation or elevation, carriage or stand travel and operation
of the beam on-off mechanism);
[[Page 43569]]
(3) Source exposure indicator lights on the teletherapy unit, on
the control console, and in the facility;
(4) Viewing and intercom systems;
(5) Treatment room doors from inside and outside the treatment
room; and
(6) Electrically assisted treatment room doors with the teletherapy
unit electrical power turned off.
(e) If the results of the checks required in paragraph (d) of this
section indicate the malfunction of any system, a licensee shall lock
the control console in the off position and not use the unit except as
may be necessary to repair, replace, or check the malfunctioning
system.
(f) A licensee shall retain a record of each spot-check required by
paragraphs (a) and (d), in accordance with Sec. 35.2642
Sec. 35.643 Periodic spot-checks for high dose-rate and pulsed dose-
rate remote afterloaders.
(a) A licensee authorized to use high dose-rate or pulsed dose-rate
remote afterloaders for medical use shall perform spot-checks on each
unit:
(1) At the beginning of each week of use;
(2) At the beginning of each day of use; and
(3) After each source installation.
(b) The licensee shall have the authorized medical physicist:
(1) Establish written procedures for performing the spot-checks
required in paragraph (a) of this section; and
(2) Review the results of each spot-check required by paragraph
(a)(1) of this section within 15 days of the check. The authorized
medical physicist need not actually perform the spot-check
measurements.
(c) To satisfy the requirements of paragraphs (a)(1) of this
section, spot-checks must, at a minimum--
(1) Verify source positioning accuracy;
(2) Determine output with the dosimetry system described in
Sec. 35.630(b); and
(3) Calculate the difference between the measurement made in
paragraph (c)(2) of this section and the anticipated output, expressed
as a percentage of the anticipated output (i.e., the value obtained at
last full calibration mathematically corrected for physical decay).
(d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of
this section, spot-checks must, at a minimum, assure proper operation
of--
(1) Electrical interlocks at each remote afterloader room entrance;
(2) Source exposure indicator lights on the remote afterloader
unit, on the control console, and in the facility;
(3) Viewing and intercom systems;
(4) Emergency response equipment;
(5) Radiation monitors used to indicate the source position;
(6) Timer constancy; and
(7) Clock (date and time) in the unit's computer.
(e) In addition to the requirements for spot checks in paragraph
(d) of this section, a licensee shall ensure overall proper operation
of the unit by conducting a simulated cycle of treatment as part of the
spot-checks.
(f) A licensee shall arrange for prompt repair of any system
identified in paragraph (c) of this section that is not operating.
(g) If the results of the checks required in paragraph (d) of this
section indicate the malfunction of any system, a licensee shall lock
the control console in the off position and not use the unit except as
may be necessary to repair, replace, or check the malfunctioning
system.
(h) A licensee shall retain a record of each check required by
paragraphs (c) and (d) of this section in accordance with Sec. 35.2643.
Sec. 35.644 Periodic spot-checks for low dose-rate remote
afterloaders.
(a) A licensee authorized to use low dose-rate remote afterloaders
for medical use shall perform spot-checks on each unit prior to each
patient treatment and after each source installation that include
proper operation of--
(1) Electrical interlocks at each remote afterloader room entrance;
(2) Source exposure indicator lights on the remote afterloader
unit, on the control console, and in the facility;
(3) Emergency response equipment;
(4) Radiation monitors used to indicate the source position;
(5) Timer constancy; and
(6) Clock (date and time) in the unit's computer.
(b) In addition to the requirements for spot checks in paragraph
(a) of this section, a licensee shall ensure overall proper operation
of the unit by conducting a simulated cycle of treatment as part of the
spot-checks.
(c) The licensee shall have the authorized medical physicist--
(1) Establish written procedures for performing the spot-checks
required in paragraph (a) of this section; and
(2) Review the results of each spot-check required by paragraph (a)
of this section within 15 days of the check. The authorized medical
physicist need not actually perform the spot-check measurements.
(d) If the results of the checks required in paragraph (a) of this
section indicate the malfunction of any system, a licensee shall lock
the control console in the off position and not use the unit except as
may be necessary to repair, replace, or check the malfunctioning
system.
(e) A licensee shall retain a record of each check required by
paragraph (a) of this section in accordance with Sec. 35.2643.
Sec. 35.645 Periodic spot-checks for gamma stereotactic radiosurgery
units.
(a) A licensee authorized to use gamma stereotactic radiosurgery
units for medical use shall perform spot-checks on each unit--
(1) Monthly,
(2) At the beginning of each day of use, and
(3) After each source installation.
(b) The licensee shall have the authorized medical physicist--
(1) Establish written procedures for performing the spot-checks
required in paragraph (a) of this section; and
(2) Review the results of each spot-check required by paragraph
(a)(1) of this section within 15 days of the check. The authorized
medical physicist need not actually perform the spot-check
measurements.
(c) To satisfy the requirements of paragraph (a)(1) of this
section, spot-checks must, at a minimum--
(1) Assure proper operation of--
(i) Treatment table retraction mechanism, using backup battery
power or hydraulic/electrical backups with the unit off;
(ii) Helmet microswitchs;
(iii) Emergency timing circuits;
(iv) Emergency off buttons; and
(v) Stereotactic frames and localizing devices (trunnions).
(2) Determine--
(i) The output for one typical set of operating conditions measured
with the dosimetry system described in Sec. 35.630(b);
(ii) The difference between the measurement made in paragraph
(c)(2)(i) of this section and the anticipated output, expressed as a
percentage of the anticipated output (i.e., the value obtained at last
full calibration corrected mathematically for physical decay);
(iii) Source output against computer calculation;
(iv) Timer accuracy and linearity over the range of use;
(v) On-off error; and
(vi) Trunnion centricity.
(d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of
this section, spot-checks must assure proper operation of--
[[Page 43570]]
(1) Electrical interlocks at each gamma stereotactic radiosurgery
room entrance;
(2) Source exposure indicator lights on the gamma stereotactic
radiosurgery unit, on the control console, and in the facility;
(3) Viewing and intercom systems;
(4) Timer termination;
(5) Radiation monitors used to indicate room exposures; and
(6) Hydraulic cutoff mechanism (if applicable).
(e) A licensee shall arrange for prompt repair of any system
identified in paragraph (c) of this section that is not operating
properly.
(f) If the results of the checks required in paragraph (d) of this
section indicate the malfunction of any system, a licensee shall lock
the control console in the off position and not use the unit except as
may be necessary to repair, replace, or check the malfunctioning
system.
(g) A licensee shall retain a record of each check required by
paragraphs (c) and (d) of this section in accordance with Sec. 35.2645.
Sec. 35.647 Additional technical requirements for mobile remote
afterloaders.
(a) A licensee providing mobile remote afterloader service shall--
(1) Check survey instruments before medical use at each address of
use or on each day of use, which ever is more frequent; and
(2) Account for all sources before departure from a client's
address of use.
(b) In addition to the periodic spot-checks required by
Sec. 35.643, a licensee authorized to use mobile afterloaders for
medical use shall perform checks on each remote afterloader before each
address of use. At a minimum, checks must be made to verify the
operation of--
(1) Electrical interlocks on treatment area access points;
(2) Source exposure indicator lights on the remote afterloader, on
the control console, and in the facility;
(3) Viewing and intercom systems;
(4) Applicators and connectors;
(5) Radiation monitors used to indicate room exposures;
(6) Source positioning (accuracy); and
(7) Radiation monitors used to indicate whether the source has
returned to a safe shielded position.
(c) In addition to the requirements for checks in paragraph (b) of
this section, a licensee shall ensure overall proper operation of the
remote afterloader unit by conducting a simulated cycle of treatment
before use at each address of use.
(d) A licensee shall arrange for prompt repair of any system
identified in paragraph (b) of this section that is not operating
properly.
(e) A licensee shall retain a record of each check required by
paragraph (b) of this section in accordance with Sec. 35.2647.
Sec. 35.652 Radiation surveys.
(a) In addition to the survey requirement in Sec. 20.1501 of this
chapter, a licensee shall make such surveys as defined in the Sealed
Source and Device Registry to assure that the maximum radiation levels
and average radiation levels from the surface of the main source safe
with the source(s) in the shielded position does not exceed the levels
stated in the Registry.
(b) The licensee shall make the survey required by paragraph (a) of
this section at installation of a new source and following repairs to
the source(s) shielding, the source(s) driving unit, or other
electronic or mechanical component that could expose the source, reduce
the shielding around the source(s), or compromise the radiation safety
of the device or the source(s).
(c) A licensee shall retain a record of the radiation surveys
required by paragraph (a) of this section in accordance with
Sec. 35.2652.
Sec. 35.655 Five-year inspection for teletherapy and gamma
stereotactic radiosurgery units.
(a) A licensee shall 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.
(b) This inspection and servicing may only be performed by persons
specifically licensed to do so by the Commission or an Agreement State.
(c) A licensee shall keep a record of the inspection and servicing
in accordance with Sec. 35.2655.
Sec. 35.657 Therapy-related computer systems.
The licensee shall:
(a) Verify that the computerized operating system and treatment
planning system associated with the therapy device are operating
appropriately; and
(b) Perform acceptance testing on the treatment planning system in
accordance with published protocols approved by nationally recognized
bodies.
Sec. 35.690 Training for use of therapeutic medical devices.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of a sealed source for a use authorized under
Sec. 35.600 to be a physician who--
(a) Is certified by a specialty board whose certification process
includes all of the requirements in paragraph (b) of this section and
whose certification has been approved by the Commission; or
(b)(1) Has completed a structured educational program in basic
radionuclide techniques applicable to the use of a sealed source in a
therapeutic medical device consisting of both--
(i) 200 hours of didactic training in the following areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity; and
(D) Radiation biology; and
(ii) 500 hours of supervised practical experience, under the
supervision of an authorized user at a medical institution, involving--
(A) Review of the full calibration measurements and periodic spot
checks;
(B) Preparing treatment plans and calculating treatment doses and
times;
(C) Using administrative controls to prevent a medical event
involving the use of byproduct material;
(D) Implementing emergency procedures to be followed in the event
of the abnormal operation of the medical device or console;
(E) Checking and using survey meters; and
(F) Selecting the proper dose and how it is to be administered; and
(2) Three years of supervised clinical experience that includes one
year in a formal training program approved by the Residency Review
Committee for Radiology of the Accreditation Council for Graduate
Medical Education or the Committee on Postdoctoral Training of the
American Osteopathic Association or equivalent program approved by the
NRC and an additional two years of clinical experience under the
supervision of an authorized user; and
(3) Has obtained written certification, signed by a preceptor
authorized user, that the required training in paragraphs (b)(1) and
(b)(2) of this section has been satisfactorily completed and that the
individual has achieved a level of competency sufficient to
independently function as an authorized user of the therapeutic medical
device for which the individual is requesting authorized user status;
and
(4) Following completion of the requirements in paragraph (b)(1)
and (2) of this section, has demonstrated sufficient knowledge in
radiation safety commensurate with the use requested
[[Page 43571]]
by passing an examination given by an organization or entity approved
by the Commission in accordance with appendix A of this part.
Subpart I--Reserved
Subpart J--Training and Experience Requirements
Sec. 35.900 Radiation Safety Officer.
Except as provided in Sec. 35.57, the licensee shall require an
individual fulfilling the responsibilities of the Radiation Safety
Officer as provided in Sec. 35.24 to be an individual who--
(a) Is certified by the--
(1) American Board of Health Physics in Comprehensive Health
Physics;
(2) American Board of Radiology;
(3) American Board of Nuclear Medicine;
(4) American Board of Science in Nuclear Medicine;
(5) Board of Pharmaceutical Specialties in Nuclear Pharmacy;
(6) American Board of Medical Physics in radiation oncology
physics;
(7) Royal College of Physicians and Surgeons of Canada in nuclear
medicine;
(8) American Osteopathic Board of Radiology; or
(9) American Osteopathic Board of Nuclear Medicine; or
(b) Has had classroom and laboratory training and experience as
follows--
(1) 200 hours of classroom and laboratory training that includes--
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of
radioactivity;
(iv) Radiation biology; and
(v) Radiopharmaceutical chemistry; and
(2) One year of full time experience as a radiation safety
technologist at a medical institution under the supervision of the
individual identified as the Radiation Safety Officer on a Commission
or Agreement State license that authorizes the medical use of byproduct
material; or
(c) Is an authorized user identified on the licensee's license.
Sec. 35.910 Training for uptake, dilution, and excretion studies.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of a radiopharmaceutical in Sec. 35.100(a) to be a
physician who--
(a) Is certified in--
(1) Nuclear medicine by the American Board of Nuclear Medicine;
(2) Diagnostic radiology by the American Board of Radiology;
(3) Diagnostic radiology or radiology by the American Osteopathic
Board of Radiology;
(4) Nuclear medicine by the Royal College of Physicians and
Surgeons of Canada; or
(5) American Osteopathic Board of Nuclear Medicine in nuclear
medicine; or
(b) Has had classroom and laboratory training in basic radioisotope
handling techniques applicable to the use of prepared
radiopharmaceuticals, and supervised clinical experience as follows--
(1) 40 hours of classroom and laboratory training that includes--
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of
radioactivity;
(iv) Radiation biology; and
(v) Radiopharmaceutical chemistry; and
(2) 20 hours of supervised clinical experience under the
supervision of an authorized user and that includes--
(i) Examining patients or human research subjects and reviewing
their case histories to determine their suitability for radioisotope
diagnosis, limitations, or contraindications;
(ii) Selecting the suitable radiopharmaceuticals and calculating
and measuring the dosages;
(iii) Administering dosages to patients or human research subjects
and using syringe radiation shields;
(iv) Collaborating with the authorized user in the interpretation
of radioisotope test results; and
(v) Patient or human research subject follow up; or
(c) Has successfully completed a 6-month training program in
nuclear medicine as part of a training program that has been approved
by the Accreditation Council for Graduate Medical Education and that
included classroom and laboratory training, work experience, and
supervised clinical experience in all the topics identified in
paragraph (b) of this section.
Sec. 35.920 Training for imaging and localization studies.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of a radiopharmaceutical, generator, or reagent kit in
Sec. 35.200(a) to be a physician who--
(a) Is certified in--
(1) Nuclear medicine by the American Board of Nuclear Medicine;
(2) Diagnostic radiology by the American Board of Radiology;
(3) Diagnostic radiology or radiology by the American Osteopathic
Board of Radiology;
(4) Nuclear medicine by the Royal College of Physicians and
Surgeons of Canada; or
(5) American Osteopathic Board of Nuclear Medicine in nuclear
medicine; or
(b) Has had classroom and laboratory training in basic radioisotope
handling techniques applicable to the use of prepared
radiopharmaceuticals, generators, and reagent kits, supervised work
experience, and supervised clinical experience as follows--
(1) 200 hours of classroom and laboratory training that includes--
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of
radioactivity;
(iv) Radiopharmaceutical chemistry; and
(v) Radiation biology; and
(2) 500 hours of supervised work experience under the supervision
of an authorized user that includes--
(i) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(ii) Calibrating dose calibrators and diagnostic instruments and
performing checks for proper operation of survey meters;
(iii) Calculating and safely preparing patient or human research
subject dosages;
(iv) Using administrative controls to prevent the medical event of
byproduct material;
(v) Using procedures to contain spilled byproduct material safely
and using proper decontamination procedures; and
(vi) Eluting technetium-99m from generator systems, measuring and
testing the eluate for molybdenum-99 and alumina contamination, and
processing the eluate with reagent kits to prepare technetium-99m
labeled radiopharmaceuticals; and
(3) 500 hours of supervised clinical experience under the
supervision of an authorized user that includes--
(i) Examining patients or human research subjects and reviewing
their case histories to determine their suitability for radioisotope
diagnosis, limitations, or contraindications;
(ii) Selecting the suitable radiopharmaceuticals and calculating
and measuring the dosages;
(iii) Administering dosages to patients or human research subjects
and using syringe radiation shields;
(iv) Collaborating with the authorized user in the interpretation
of radioisotope test results; and
(v) Patient or human research subject follow up; or
[[Page 43572]]
(c) Has successfully completed a 6-month training program in
nuclear medicine that has been approved by the Accreditation Council
for Graduate Medical Education and that included classroom and
laboratory training, work experience, and supervised clinical
experience in all the topics identified in paragraph (b) of this
section.
Sec. 35.930 Training for therapeutic use of unsealed byproduct
material.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of radiopharmaceuticals in Sec. 35.300 to be a
physician who--
(a) Is certified by--
(1) The American Board of Nuclear Medicine;
(2) The American Board of Radiology in radiology, therapeutic
radiology, or radiation oncology;
(3) The Royal College of Physicians and Surgeons of Canada in
nuclear medicine; or
(4) The American Osteopathic Board of Radiology after 1984; or
(b) Has had classroom and laboratory training in basic radioisotope
handling techniques applicable to the use of therapeutic
radiopharmaceuticals, and supervised clinical experience as follows--
(1) 80 hours of classroom and laboratory training that includes--
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of
radioactivity; and
(iv) Radiation biology; and
(2) Supervised clinical experience under the supervision of an
authorized user at a medical institution that includes--
(i) Use of iodine-131 for diagnosis of thyroid function and the
treatment of hyperthyroidism or cardiac dysfunction in 10 individuals;
and
(ii) Use of iodine-131 for treatment of thyroid carcinoma in 3
individuals.
Sec. 35.932 Training for treatment of hyperthyroidism.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of only iodine-131 for the treatment of hyperthyroidism
to be a physician with special experience in thyroid disease who has
had classroom and laboratory training in basic radioisotope handling
techniques applicable to the use of iodine-131 for treating
hyperthyroidism, and supervised clinical experience as follows--
(a) 80 hours of classroom and laboratory training that includes--
(1) Radiation physics and instrumentation;
(2) Radiation protection,
(3) Mathematics pertaining to the use and measurement of
radioactivity; and
(4) Radiation biology; and
(b) Supervised clinical experience under the supervision of an
authorized user that includes the use of iodine-131 for diagnosis of
thyroid function, and the treatment of hyperthyroidism in 10
individuals.
Sec. 35.934 Training for treatment of thyroid carcinoma.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of only iodine-131 for the treatment of thyroid
carcinoma to be a physician with special experience in thyroid disease
who has had classroom and laboratory training in basic radioisotope
handling techniques applicable to the use of iodine-131 for treating
thyroid carcinoma, and supervised clinical experience as follows--
(a) 80 hours of classroom and laboratory training that includes--
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of
radioactivity; and
(4) Radiation biology; and
(b) Supervised clinical experience under the supervision of an
authorized user that includes the use of iodine-131 for the treatment
of thyroid carcinoma in 3 individuals.
Sec. 35.940 Training for use of brachytherapy sources.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of a brachytherapy source listed in Sec. 35.400 for
therapy to be a physician who--
(a) Is certified in--
(1) Radiology, therapeutic radiology, or radiation oncology by the
American Board of Radiology;
(2) Radiation oncology by the American Osteopathic Board of
Radiology;
(3) Radiology, with specialization in radiotherapy, as a British
``Fellow of the Faculty of Radiology'' or ``Fellow of the Royal College
of Radiology''; or
(4) Therapeutic radiology by the Canadian Royal College of
Physicians and Surgeons; or
(b) Is in the active practice of therapeutic radiology, has had
classroom and laboratory training in radioisotope handling techniques
applicable to the therapeutic use of brachytherapy sources, supervised
work experience, and supervised clinical experience as follows--
(1) 200 hours of classroom and laboratory training that includes--
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of
radioactivity; and
(iv) Radiation biology;
(2) 500 hours of supervised work experience under the supervision
of an authorized user at a medical institution that includes--
(i) Ordering, receiving, and unpacking radioactive materials safely
and performing the related radiation surveys;
(ii) Checking survey meters for proper operation;
(iii) Preparing, implanting, and removing sealed sources;
(iv) Maintaining running inventories of material on hand;
(v) Using administrative controls to prevent a medical event
involving byproduct material; and
(vi) Using emergency procedures to control byproduct material; and
(3) Three years of supervised clinical experience that includes one
year in a formal training program approved by the Residency Review
Committee for Radiology of the Accreditation Council for Graduate
Medical Education or the Committee on Postdoctoral Training of the
American Osteopathic Association, and an additional two years of
clinical experience in therapeutic radiology under the supervision of
an authorized user at a medical institution that includes--
(i) Examining individuals and reviewing their case histories to
determine their suitability for brachytherapy treatment, and any
limitations or contraindications;
(ii) Selecting the proper brachytherapy sources and dose and method
of administration;
(iii) Calculating the dose; and
(iv) Post-administration follow up and review of case histories in
collaboration with the authorized user.
Sec. 35.941 Training for ophthalmic use of strontium-90.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of only strontium-90 for ophthalmic radiotherapy to be
a physician who is in the active practice of therapeutic radiology or
ophthalmology, and has had classroom and laboratory training in basic
radioisotope handling techniques applicable to the use of strontium-90
for ophthalmic radiotherapy, and a period of supervised clinical
training in ophthalmic radiotherapy as follows--
(a) 24 hours of classroom and laboratory training that includes--
(1) Radiation physics and instrumentation;
[[Page 43573]]
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of
radioactivity; and
(4) Radiation biology;
(b) Supervised clinical training in ophthalmic radiotherapy under
the supervision of an authorized user at a medical institution that
includes the use of strontium-90 for the ophthalmic treatment of five
individuals that includes--
(1) Examination of each individual to be treated;
(2) Calculation of the dose to be administered;
(3) Administration of the dose; and
(4) Follow up and review of each individual's case history.
Sec. 35.950 Training for use of sealed sources for diagnosis.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of a sealed source in a device listed in Sec. 35.500 to
be a physician, dentist, or podiatrist who--
(a) Is certified in--
(1) Radiology, diagnostic radiology, therapeutic radiology, or
radiation oncology by the American Board of Radiology;
(2) Nuclear medicine by the American Board of Nuclear Medicine;
(3) Diagnostic radiology or radiology by the American Osteopathic
Board of Radiology; or
(4) Nuclear medicine by the Royal College of Physicians and
Surgeons of Canada; or
(b) Has had 8 hours of classroom and laboratory training in basic
radioisotope handling techniques specifically applicable to the use of
the device that includes--
(1) Radiation physics, mathematics pertaining to the use and
measurement of radioactivity, and instrumentation;
(2) Radiation biology;
(3) Radiation protection; and
(4) Training in the use of the device for the uses requested.
Sec. 35.960 Training for use of therapeutic medical devices.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of a sealed source listed in Sec. 35.600 to be a
physician who--
(a) Is certified in--
(1) Radiology, therapeutic radiology, or radiation oncology by the
American Board of Radiology;
(2) Radiation oncology by the American Osteopathic Board of
Radiology;
(3) Radiology, with specialization in radiotherapy, as a British
``Fellow of the Faculty of Radiology'' or ``Fellow of the Royal College
of Radiology''; or
(4) Therapeutic radiology by the Canadian Royal College of
Physicians and Surgeons; or
(b) Is in the active practice of therapeutic radiology, and has had
classroom and laboratory training in basic radioisotope techniques
applicable to the use of a sealed source in a therapeutic medical
device, supervised work experience, and supervised clinical experience
as follows--
(1) 200 hours of classroom and laboratory training that includes--
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of
radioactivity; and
(iv) Radiation biology;
(2) 500 hours of supervised work experience under the supervision
of an authorized user at a medical institution that includes--
(i) Review of the full calibration measurements and periodic spot-
checks;
(ii) Preparing treatment plans and calculating treatment times;
(iii) Using administrative controls to prevent medical events;
(iv) Implementing emergency procedures to be followed in the event
of the abnormal operation of the medical device or console; and
(v) Checking and using survey meters; and
(3) Three years of supervised clinical experience that includes one
year in a formal training program approved by the Residency Review
Committee for Radiology of the Accreditation Council for Graduate
Medical Education or the Committee on Postdoctoral Training of the
American Osteopathic Association and an additional two years of
clinical experience in therapeutic radiology under the supervision of
an authorized user at a medical institution that includes--
(i) Examining individuals and reviewing their case histories to
determine their suitability for teletherapy, remote afterloader, or
gamma stereotactic radiosurgery treatment, and any limitations or
contraindications;
(ii) Selecting the proper dose and how it is to be administered;
(iii) Calculating the doses and collaborating with the authorized
user in the review of patients' or human research subjects' progress
and consideration of the need to modify originally prescribed doses as
warranted by patients' or human research subjects' reaction to
radiation; and
(iv) Post-administration follow up and review of case histories.
Sec. 35.961 Training for authorized medical physicist.
The licensee shall require the authorized medical physicist to be
an individual who--
(a) Is certified by the American Board of Radiology in--
(1) Therapeutic radiological physics;
(2) Roentgen ray and gamma ray physics;
(3) X-ray and radium physics; or
(4) Radiological physics; or
(b) Is certified by the American Board of Medical Physics in
radiation oncology physics; or
(c) Holds a master's or doctor's degree in physics, biophysics,
radiological physics, or health physics, and has completed 1 year of
full time training in therapeutic radiological physics and an
additional year of full time work experience under the supervision of a
medical physicist at a medical institution that includes the tasks
listed in Secs. 35.67, 35.632, 35.633, 35.635, 35.642, 35.643, 35.644,
35.645 and 35.652, as applicable.
Sec. 35.980 Training for an authorized nuclear pharmacist.
The licensee shall require the authorized nuclear pharmacist to be
a pharmacist who--
(a) Has current board certification as a nuclear pharmacist by the
Board of Pharmaceutical Specialties; or
(b)(1) Has completed 700 hours in a structured educational program
consisting of both--
(i) Didactic training in the following areas:
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Supervised experience in a nuclear pharmacy involving the
following--
(A) Shipping, receiving, and performing related radiation surveys;
(B) Using and performing checks for proper operation of dose
calibrators, survey meters, and, if appropriate, instruments used to
measure alpha- or beta-emitting radionuclides;
(C) Calculating, assaying, and safely preparing dosages for
patients or human research subjects;
(D) Using administrative controls to avoid mistakes in the
administration of byproduct material;
(E) Using procedures to prevent or minimize contamination and using
proper decontamination procedures; and
[[Page 43574]]
(2) Has obtained written certification, signed by a preceptor
authorized nuclear pharmacist, that the above training has been
satisfactorily completed and that the individual has achieved a level
of competency sufficient to independently operate a nuclear pharmacy.
Sec. 35.981 Training for experienced nuclear pharmacists.
A licensee may apply for and must receive a license amendment
identifying an experienced nuclear pharmacist as an authorized nuclear
pharmacist before it allows this individual to work as an authorized
nuclear pharmacist. A pharmacist who has completed a structured
educational program as specified in Sec. 35.980(b)(1) before December
2, 1994, and who is working in a nuclear pharmacy would qualify as an
experienced nuclear pharmacist. An experienced nuclear pharmacist need
not comply with the requirements for a preceptor statement
(Sec. 35.980(b)(2)) and recentness of training (Sec. 35.59) to qualify
as an authorized nuclear pharmacist.
Subpart K--Other Medical Uses of Byproduct Material or Radiation
From Byproduct Material
Sec. 35.1000 Other medical uses of byproduct material or radiation
from byproduct material.
A licensee may use byproduct material or a radiation source
approved for medical use which is not specifically addressed in
subparts D through H of this part if--
(a) The applicant or licensee has submitted the information
required by Sec. 35.12(d); and
(b) The applicant or licensee has received written approval from
the Commission in a license and uses the material in accordance with
the regulations and specific conditions the Commission considers
necessary for the medical use of the material.
Subpart L--Records
Sec. 35.2024 Records of authority and responsibilities for radiation
protection programs.
(a) A licensee shall retain a record of actions taken by the
licensee's management in accordance with Sec. 35.24(a) for 5 years. The
record must include a summary of the actions taken and a signature of
licensee management.
(b) The licensee shall retain a current copy of the authorities,
duties and responsibilities of the radiation safety officer, as
required by Sec. 35.24(d), and a signed copy of the radiation safety
officer's willingness to be responsible for implementing the radiation
safety program, as required by Sec. 35.24(b). The records must include
the signature of the radiation safety officer and licensee management.
Sec. 35.2026 Records of radiation protection program safety changes.
A licensee shall retain a record of each radiation protection
program change made in accordance with Sec. 35.26(a) for 5 years. The
record must include a copy of the old and new procedures; the effective
date of the change; and the signature of the radiation safety officer
and the licensee management that reviewed and approved the change.
Sec. 35.2040 Records of written directives.
A licensee shall retain a copy of each written directive as
required by Sec. 35.40 for 3 years.
Sec. 35.2045 Records of medical events.
A licensee shall retain a record of medical events reported
pursuant to Sec. 35.3045 for 3 years. The record must contain the
licensee's name, names of all the individuals involved, the affected or
potentially affected individual's social security number or other
identification number if one has been assigned, a brief description of
the medical event, why it occurred, the effect on the individual, and
the actions taken to prevent recurrence.
Sec. 35.2060 Records of instrument calibrations.
A licensee shall maintain a record of instrument calibrations
required by Secs. 35.60 and 35.62 for 3 years. The records must
include--
(a) For constancy, the model and serial number of the instrument,
the identity of the radionuclide contained in the check source, the
date of the check, and the activity measured, and the name of the
individual who performed the check;
(b) For accuracy, the model and serial number of the instrument,
the model and serial number of each source used, the identity of the
radionuclide contained in the source and its activity, the date of the
test, and the results of the test, and the name of the individual who
performed the test;
(c) For linearity, the model and serial number of the instrument,
the calculated activities, the measured activities, and the date of the
test, and the name of the individual who performed the test; and
(d) For geometric dependence, the model and serial number of the
instrument, the configuration of the source measured, the activity
measured for each volume measured, and the date of the test, and the
name of the individual who performed the test.
Sec. 35.2061 Records of radiation survey instrument calibrations.
A licensee shall maintain a record of radiation survey instrument
calibrations required by Sec. 35.61 for 3 years. The record must
include--
(a) A description of the calibration procedure; and
(b) The date of the calibration, a description of the source used
and the certified exposure rates from the source, and the rates
indicated by the instrument being calibrated, the correction factors
deduced from the calibration data, and the name of the individual who
performed the calibration.
Sec. 35.2063 Records of dosages of unsealed byproduct material for
medical use.
(a) A licensee shall maintain a record of dosage determinations
required by Sec. 35.63 for 3 years.
(b) To satisfy this requirement, the record must contain the--
(1) Radionuclide, generic name, trade name, or abbreviation of the
radiopharmaceutical, and its lot number;
(2) Patient's or human research subject's name, or identification
number if one has been assigned;
(3) Prescribed dosage and activity of the dosage at the time of
determination, or a notation that the total activity is less than 1.1
MBq (30 Ci);
(4) Date and time of the dosage determination; and
(5) Name of the individual who determined the dosage.
Sec. 35.2067 Records of possession of sealed sources and brachytherapy
sources.
(a) A licensee shall retain records of leak tests required by
Sec. 35.67(b) for 3 years. The records must contain the model number,
and serial number if one has been assigned, of each source tested, the
identity of each source radionuclide and its estimated activity, the
measured activity of each test sample, a description of the method used
to measure each test sample, the date of the test, and the name of the
individual who performed the test.
(b) A licensee shall retain records of the semi-annual physical
inventory of sealed sources and brachytherapy sources required by
Sec. 35.67(g) for 3 years. The inventory records must contain the model
number of each source, and serial number if one has been assigned, the
identity of each source radionuclide and its nominal activity, the
location of each source, and the name of the individual who performed
the inventory.
[[Page 43575]]
Sec. 35.2070 Records of surveys for ambient radiation exposure rate.
A licensee shall retain a record of each survey required by
Sec. 35.70 for 3 years. The record must include the date of the survey,
a plan of each area surveyed, the trigger level established for each
area, the detected dose rate at several points in each area expressed
in millirem per hour or the removable contamination in each area
expressed in disintegrations per minute per 100 square centimeters, the
instrument used to make the survey or analyze the samples, and the name
of the individual who performed the survey.
Sec. 35.2075 Records of the release of individuals containing
radiopharmaceuticals or implants.
(a) A licensee shall retain records of the release of individuals
containing pharmaceuticals or implants in accordance with Sec. 35.75
for 3 years after the date of release.
(b) A licensee shall retain a record in accordance with paragraph
(a) of this section that describes the basis for authorizing the
release of individuals if the total effective dose equivalent is
calculated by--
(1) Using the retained activity rather than the activity
administered;
(2) Using an occupancy factor less than 0.25 at 1 meter;
(3) Using the biological or effective half-life; or
(4) Considering the shielding by tissue.
(c) A licensee shall retain a record that the instructions required
by Sec. 35.75(b) were provided to a breast-feeding woman if the
radiation dose to the infant or child from continued breast-feeding
could result in a total effective dose equivalent exceeding 5 mSv (0.5
rem).
Sec. 35.2080 Records of administrative and technical requirements that
apply to the provision of mobile services.
(a) A licensee shall retain a copy of the letter(s) that permits
the use of byproduct material at a client's address of use, in
accordance with Sec. 35.80(a)(1). This letter must clearly delineate
the authority and responsibility of each entity and must be retained
for 3 years after the last provision of service.
(b) A licensee shall retain the record of each survey required by
Sec. 35.80(a)(4) for 3 years. The record must include the date of the
survey, a plan of each area that was surveyed, the measured dose rate
at several points in each area of use expressed in millirem per hour,
the instrument used to make the survey, and the name of the individual
who performed the survey.
Sec. 35.2092 Records of waste disposal.
A licensee shall maintain records of the disposal of licensed
materials made in accordance with Sec. 35.92 for 3 years. The record
must include the date of the disposal, the radionuclides disposed, the
survey instrument used, the background dose rate, the dose rate
measured at the surface of each waste container, and the name of the
individual who performed the disposal.
Sec. 35.2204 Records of molybdenum-99 concentrations.
A licensee shall maintain a record of the molybdenum-99
concentration tests required by Sec. 35.204(b) for 3 years. The record
must include, for each measured elution of technetium-99m, the ratio of
the measures expressed as microcuries of molybdenum per millicurie of
technetium, the time and date of the measurement, and the name of the
individual who made the measurement.
Sec. 35.2310 Records of instruction and training.
A licensee shall maintain a record of instructions and training
required by Secs. 35.310, 35.410, and 35.610 for 3 years. The record
must include a list of the topics covered, the date of the instruction
or training, the name(s) of the attendee(s), and the name(s) of the
individual(s) who provided the instruction.
Sec. 35.2404 Records of radiation surveys of patients and human
research subjects.
A licensee shall maintain a record of the radiation surveys of
patients and human research subjects required by Secs. 35.404 and
35.604 for 3 years. Each record must include the date, location, and
results of the survey, an identifier for the patient or the human
research subject, the survey instrument used, and the name of the
individual who made the survey.
Sec. 35.2406 Records of brachytherapy source inventory.
(a) A licensee shall maintain a record of brachytherapy source
accountability required by Sec. 35.406 for 3 years.
(b) For temporary implants, the record must include--
(1) The number and activity of sources removed from storage, the
time and date they were removed from storage, the name of the
individual who removed them from storage, and the location of use; and
(2) The number and activity of sources returned to storage, the
time and date they were returned to storage, and the name of the
individual who returned them from storage.
(c) For permanent implants, the record must include--
(1) The number and activity of sources removed from storage, the
date they were removed from storage, and the name of the individual who
removed them from storage;
(2) The number and activity of sources returned to storage, the
date they were returned to storage, and the name of the individual who
returned them to storage; and
(3) The number and activity of sources permanently implanted in the
patient or human research subject.
Sec. 35.2432 Records of full calibrations on brachytherapy sources.
A licensee shall maintain a record of the full calibrations on
brachytherapy sources required by Sec. 35.432 for 3 years after the
last use of the source. The record must include the date of the
calibration; the manufacturer's name, model number, and serial number
for the source and instruments used to calibrate the source; the source
output; source positioning accuracy within applicators; and the name of
the individual or the source manufacturer who performed the
calibration.
Sec. 35.2605 Records of installation, maintenance, and repair.
A licensee shall retain a record of the installation, maintenance,
and repair of therapeutic medical devices as required by Sec. 35.605
for 3 years. For each installation, maintenance, and repair, the record
must include the date, description of the service, and name(s) of the
individual(s) who performed the work.
Sec. 35.2630 Records of dosimetry equipment.
(a) A licensee shall retain a record of the calibration,
intercomparison, and comparisons of its dosimetry equipment done in
accordance with Sec. 35.630 for the duration of the license.
(b) For each calibration, intercomparison, or comparison, the
record must include--
(1) The date;
(2) The model numbers and serial numbers of the instruments that
were calibrated, intercompared, or compared as required by paragraphs
(a) and (b) of Sec. 35.630;
(3) The correction factor that was determined from the calibration
or comparison or the apparent correction factor that was determined
from an intercomparison; and
(4) The name(s) of the individual(s) who performed the calibration,
intercomparison, or comparison.
[[Page 43576]]
Sec. 35.2632 Records of teletherapy full calibrations.
(a) A licensee shall maintain a record of the teletherapy full
calibrations required by Sec. 35.632 for 3 years.
(b) The record must include--
(1) The date of the calibration;
(2) The manufacturer's name, model number, and serial number for
the teletherapy unit, source, and instruments used to calibrate the
teletherapy unit;
(3) Tables that describe the output of the unit over the range of
field sizes and for the range of distances used in radiation therapy;
(4) A determination of the coincidence of the radiation field and
the field indicated by the light beam localizing device;
(5) An assessment of timer accuracy and linearity;
(6) The calculated on-off error;
(7) The estimated accuracy of each distance measuring and
localization device; and
(8) The signature of the authorized medical physicist who performed
the full calibration.
Sec. 35.2633 Records of remote afterloader full calibrations.
(a) A licensee shall maintain a record of the remote afterloader
full calibrations required by Sec. 35.633 for 3 years.
(b) The record must include--
(1) The date of the calibration;
(2) The manufacturer's name, model number, and serial number for
the remote afterloader, source, and instruments used to calibrate the
unit; the source output;
(3) An assessment of timer accuracy and linearity, source
positioning accuracy, source guide tube and connector lengths, and
source retraction functionality; and
(4) The signature of the authorized medical physicist who performed
the full calibration.
Sec. 35.2635 Records of gamma stereotactic radiosurgery unit full
calibrations.
(a) A licensee shall maintain a record of the gamma stereotactic
radiosurgery full calibrations required by Sec. 35.635 for 3 years.
(b) The record must include--
(1) The date of the calibration;
(2) The manufacturer's name, model number, and serial number for
the gamma stereotactic radiosurgery unit, source, and instruments used
to calibrate the unit;
(3) The unit output;
(4) An assessment of the relative helmet factors, isocenter
coincidence, timer accuracy and linearity, on-off error, and trunnion
centricity; and
(5) The signature of the authorized medical physicist who performed
the full calibration.
Sec. 35.2642 Records of periodic spot-checks for teletherapy units.
(a) A licensee shall retain a record of each periodic spot-check
for teletherapy units required by Sec. 35.642 for 3 years.
(b) The record must include --
(1) The date of the spot-check;
(2) The manufacturer's name, model number, and serial number for
the teletherapy unit, source and instrument used to measure the output
of the teletherapy unit;
(3) An assessment of timer linearity and constancy;
(4) The calculated on-off error;
(5) A determination of the coincidence of the radiation field and
the field indicated by the light beam localizing device;
(6) The determined accuracy of each distance measuring and
localization device;
(7) The difference between the anticipated output and the measured
output;
(8) Notations indicating the operability of each entrance door
electrical interlock, each electrical or mechanical stop, each source
exposure indicator light, and the viewing and intercom system and
doors; and
(9) The name of the individual who performed the periodic spot-
check and the signature of the authorized medical physicist who
reviewed the record of the spot-check.
Sec. 35.2643 Records of periodic spot-checks for remote afterloaders.
(a) A licensee shall retain a record of each spot-check for remote
afterloaders required by Secs. 35.643 and 35.644 for 3 years.
(b) The record must include--
(1) The date of the spot-check;
(2) The manufacturer's name, model number, and serial number for
the remote afterloader, source, and instrument used to measure the
output of the remote afterloader;
(3) The difference between the anticipated output and the measured
output;
(4) Notations indicating the operability of each entrance door
electrical interlock, source retraction mechanism, radiation monitors,
source exposure indicator lights, viewing and intercom systems if
applicable, applicators and connectors, and source positioning
accuracy; and
(5) The name of the individual who performed the periodic spot-
check and the signature of the authorized medical physicist who
reviewed the record of the spot-check.
Sec. 35.2645 Records of periodic spot-checks for gamma stereotactic
radiosurgery units.
(a) A licensee shall retain a record of each spot-check for gamma
stereotactic radiosurgery units required by Sec. 35.645 for 3 years.
(b) The record must include--
(1) The date of the spot-check;
(2) The manufacturer's name, model number, and serial number for
the gamma stereotactic radiosurgery unit and the instrument used to
measure the output of the unit;
(3) The measured source output and source output against computer
calculations;
(4) Notations indicating the operability of radiation monitors,
helmet microswitchs, emergency timing circuits, emergency off buttons,
electrical interlocks, source exposure indicator lights, viewing and
intercom systems, timer termination systems, hydraulic cutoff switch
and stereotactic frames and localizing devices (trunnions); and
(5) The name of the individual who performed the periodic spot-
check and the signature of the authorized medical physicist who
reviewed the record of the spot-check.
Sec. 35.2647 Records of additional technical requirements for mobile
remote afterloaders.
(a) A licensee shall retain a record of each check for mobile
remote afterloaders required by Sec. 35.647 for 3 years.
(b) The record must include--
(1) The date of the check;
(2) The manufacturer's name, model number, and serial number of the
remote afterloader;
(3) Notations accounting for all sources before the licensee
departs from a facility;
(4) Notations indicating the operability of each entrance door
electrical interlock, radiation monitors, source exposure indicator
lights, viewing and intercom system, applicators and connectors, and
source positioning accuracy; and
(5) The signature of the individual who performed the check.
Sec. 35.2652 Records of surveys of therapeutic treatment units.
(a) A licensee shall maintain a record of radiation surveys of
treatment units made in accordance with Sec. 35.652 for the duration of
use of the unit.
(b) The record must include--
(1) The date of the measurements;
(2) The manufacturer's name, model number and serial number of the
treatment unit, source, and instrument used to measure radiation
levels;
[[Page 43577]]
(3) Each dose rate measured around the source while the unit is in
the off position and the average of all measurements; and
(4) The signature of the individual who performed the test.
Sec. 35.2655 Records of 5-year inspection for teletherapy and gamma
stereotactic surgery units.
(a) A licensee shall maintain a record of the 5-year inspections
for teletherapy and gamma stereotactic radiosurgery units required by
Sec. 35.655 for the duration of use of the unit.
(b) The record must contain--
(1) The inspector's radioactive materials license number;
(2) The date of inspection;
(3) The manufacturer's name and model number and serial number of
both the treatment unit and source;
(4) A list of components inspected and serviced, and the type of
service; and
(5) The signature of the inspector.
Subpart M--Reports
Sec. 35.3045 Reports of medical events.
(a) A licensee shall report any administration, except for
administrations resulting from a direct intervention of a patient or
human research subject that could not have been reasonably prevented by
the licensee, that results in either--
(1) A dose that differs from the prescribed dose by more than 0.05
Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or
tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and
(i) The total dose or dosage delivered differs from the prescribed
dose or dosage by 20 percent or more; or
(ii) The fractionated dose delivered differs from the prescribed
dose, for a single fraction, by 50 percent or more.
(2) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent,
0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose
equivalent to the skin from any of the following--
(i) An administration of a wrong pharmaceutical;
(ii) An administration of a radiopharmaceutical by the wrong route
of administration;
(iii) An administration of a dose or dosage to the wrong individual
or human research subject;
(iv) An administration of a dose or dosage delivered by the wrong
treatment mode; or
(v) A leaking sealed source.
(3) A dose to the skin or an organ or tissue other than the
treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue
and 20 percent the dose expected from the administration defined in the
written directive.
(b) The licensee shall notify by telephone the NRC Operations
Center (301-951-0550) no later than the next calendar day after
discovery of the medical event.
(c) The licensee shall submit a written report to the appropriate
NRC Regional Office listed in Sec. 30.6 of this chapter within 15 days
after discovery of the medical event.
(1) The written report must include--
(i) The licensee's name;
(ii) The name of the prescribing physician;
(iii) A brief description of the event;
(iv) Why the event occurred;
(v) The effect on the individual(s) who received the
administration;
(vi) What improvements are needed to prevent recurrence;
(vii) Actions taken to prevent recurrence;
(viii) Whether the licensee notified the individual (or the
individual's responsible relative or guardian), and if not, why not;
and
(ix) If there was notification, what information was provided.
(2) The report must not contain the individual's name or any other
information that could lead to identification of the individual.
(d) The licensee shall notify the referring physician and also
notify the individual affected by the medical event no later than 24
hours after its discovery, unless the referring physician personally
informs the licensee either that he or she will inform the individual
or that, based on medical judgement, telling the individual would be
harmful. The licensee is not required to notify the individual without
first consulting the referring physician. If the referring physician or
the affected individual cannot be reached within 24 hours, the licensee
shall notify the individual as soon as possible thereafter. The
licensee may not delay any appropriate medical care for the individual,
including any necessary remedial care as a result of the medical event,
because of any delay in notification. To meet the requirements of this
section, the notification of the individual receiving the medical event
may be made instead to that individual's responsible relative or
guardian, when appropriate.
(e) If the individual was notified pursuant to paragraph (d) of
this section, the licensee shall also furnish, within 15 days after
discovery of the medical event, a written report to the individual by
sending either--
(1) A copy of the report that was submitted to the NRC; or
(2) A brief description of both the event and the consequences as
they may affect the individual.
(f) Aside from the notification requirement, nothing in this
section affects any rights or duties of licensees and physicians in
relation to each other, to individuals affected by the medical event,
or to that individual's responsible relatives or guardians.
Sec. 35.3047 Report of a dose to an embryo/fetus or a nursing child.
(a) A licensee shall report any dose to an embryo/fetus that is
greater than 5 mSv (500 mrem) absorbed dose that is a result of an
administration of byproduct material or radiation from byproduct
material to a pregnant individual unless the dose to the embryo/fetus
was specifically approved, in advance, by the authorized user.
(b) A licensee shall report any dose to a nursing child that is
greater than 5 mSv (500 mrem) total effective dose equivalent that is a
result of an administration of byproduct material to a breast feeding
individual.
(c) The licensee shall notify by telephone the NRC Operations
Center within 5 days after discovery of a dose to the embryo/fetus or
nursing child that requires a report in paragraphs (a) or (b) in this
section.
(d) The licensee shall submit a written report to the appropriate
NRC Regional Office listed in Sec. 30.6 no later than 15 days after
discovery of a dose to the embryo/fetus or nursing child that requires
a report in paragraphs (a) or (b) in this section.
(1) The written report must include--
(i) The licensee's name;
(ii) The name of the prescribing physician;
(iii) A brief description of the event;
(iv) Why the event occurred;
(v) The effect on the embryo/fetus or the nursing child;
(vi) What improvements are needed to prevent recurrence; and
(vii) Actions taken to prevent recurrence.
(2) The report must not contain the individual's or child's name or
any other information that could lead to identification of the
individual or child.
(e) The licensee shall notify the referring physician and also
notify the pregnant individual or mother, hereafter referred to as the
mother, within 5 days of discovery of an event that would require
reporting under paragraph (a) or (b) of this section, unless the
referring physician personally informs the licensee either that he or
she will inform the mother or that, based on medical judgment, telling
the mother would be harmful;
[[Page 43578]]
(f) To meet the requirements of this section, the notification of
the mother may be made instead to the mother's or child's responsible
relative or guardian, when appropriate.
(g) The licensee is not required to notify the mother without first
consulting the referring physician. If the referring physician or
mother cannot be reached within 5 days, the licensee shall make the
appropriate notifications as soon as possible thereafter. The licensee
may not delay any appropriate medical care for the embryo/fetus or for
the nursing child, including any necessary remedial care as a result of
the event, because of any delay in notification.
(h) If notification was made pursuant to paragraphs (e) and (f) of
this section, the licensee shall also furnish, within 15 days after
discovery of the event, a written report to the mother or responsible
relative or guardian, by sending either--
(1) A copy of the report that was submitted to the NRC; or
(2) A brief description of both the event and the consequences as
they may affect the embryo/fetus or nursing child.
Sec. 35.3067 Reports of leaking sources.
A licensee shall file a report within 5 days if a leakage test
required by Sec. 35.67 reveals the presence of 185 Bq ( 0.005
Ci) or more of removable contamination. The report must be
filed with the appropriate NRC Regional Office listed in Sec. 30.6 of
this chapter, with a copy to the Director, Office of Nuclear Material
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001. The written report must include the model number and
serial number if assigned, of the leaking source; the radionuclide and
its estimated activity; the measured activity of each test sample
expressed in microcuries; a description of the method used to measure
each test sample; the date of the test; and the action taken.
Subpart N--Enforcement
Sec. 35.4001 Violations.
(a) The Commission may obtain an injunction or other court order to
prevent a violation of the provisions of--
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended;
or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a
civil penalty imposed under Section 234 of the Atomic Energy Act:
(1) For violations of--
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of
the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the
sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under
the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under
Section 186 of the Atomic Energy Act of 1954, as amended.
Sec. 35.4002 Criminal penalties.
(a) Section 223 of the Atomic Energy Act of 1954, as amended,
provides for criminal sanctions for willful violation of, attempted
violation of, or conspiracy to violate, any regulation issued under
sections 161b, 161i, or 161o of the Act. For purposes of Section 223,
all the regulations in 10 CFR part 35 are issued under one or more of
sections 161b, 161i, or 161o, except for the sections listed in
paragraph (b) of this section.
(b) The regulations in 10 CFR part 35 that are not issued under
subsections 161b, 161i, or 161o for the purposes of Section 223 are as
follows: Secs. 35.1, 35.2, 35.7, 35.8, 35.12, 35.15, 35.18, 35.19,
35.65, 35.100, 35.200, 35.300, 35.600, 35.4001, and 35.4002.
Appendix A to 10 CFR Part 35--Examining Organization or Entity
I. Requirements for an examining organization or entity.
An independent organization or entity that submits an
application for approval of the Commission to examine individuals
pursuant to Secs. 35.50(b)(3), 35.51(b)(3), 35.55(b)(3),
35.290(b)(3), 35.292(b)(3), 35.390(b)(4), 35.490(b)(4), or
35.690(b)(4) shall:
1. Make its examination process available to the general public
nationwide and ensure that it is not restricted because of race,
color, religion, sex, age, national origin, or disability;
2. Have an adequate staff, a viable system for financing its
operations, and a policy-and decision-making review board;
3. Have a set of written organizational by-laws and policies
that provide adequate assurance of lack of conflict of interest and
a system for monitoring and enforcing those by-laws and policies;
4. Have a committee, whose members can carry out their
responsibilities impartially, to review and approve the examination
guidelines and procedures, and to advise the organization's staff in
implementing the examination program;
5. Have a committee, whose members can carry out their
responsibilities impartially, to review complaints by examined
individuals;
6. Have written procedures describing all aspects of its
examination program, maintain records of the current status of each
individual's examination and the administration of its examination
program;
7. Have procedures to ensure that examinations are not given to
individuals who have also been instructed by the examining
organization in the same subject area;
8. Have procedures to ensure that examined individuals are
provided due process with respect to the administration of its
examination program, including the process of being examined;
9. Have procedures for proctoring examinations, including
qualifications for proctors.
10. Exchange information about examined individuals with the
Commission and other independent examining organizations and/or
Agreement States and allow periodic review of its examination
program and related records;
11. Provide a description to the Commission of its procedures
for choosing examination sites and for providing an appropriate
examination environment; and
12. Submit its request to the Director, Office of Nuclear
Materials Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001.
II. Requirements for Examination Programs.
All examination programs must--
1. Require applicants for examination to receive training in the
topics set forth in Secs. 35.50(b)(1), 35.51(b)(1), 35.55(b)(1),
35.290(b)(1), 35.292(b)(1), 35.390(b)(1), 35.490(b)(1) or
35.690(b)(1), or equivalent Agreement State regulations, and
satisfactorily complete a written examination covering these topics;
and
2. Include procedures to ensure that all examination questions
are protected from improper disclosure.
III. Requirements for Written Examinations.
1. All examinations must be designed to test an individual's
knowledge and understanding of the topics listed in
Secs. 35.50(b)(1), 35.51(b)(1), 35.55(b)(1), 35.290(b)(1),
35.292(b)(1), 35.390(b)(1), 35.490(b)(1) or 35.690(b)(1), or
equivalent Agreement State regulations;
2. Test questions must be drawn from a question bank containing
psychometrically valid questions based on the material in
Secs. 35.50(b)(1), 35.51(b)(1), 35.55(b)(1), 35.290(b)(1),
35.292(b)(1), 35.390(b)(1), 35.490(b)(1) or 35.690(b)(1), or
equivalent Agreement State regulations; and
3. Sample examinations must be submitted to the Commission for
review initially and every 5 years.
Dated at Rockville, Maryland, this 5th day of August, 1998.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
Note: This appendix will not appear in the Code of Federal
Regulations.
Appendix A--Preliminary Regulatory Flexibility Analysis
The NRC is required by the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) as
[[Page 43579]]
amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA) to consider the impact of their rulemakings on small
entities and evaluate alternatives that would accomplish regulatory
objectives without unduly burdening small entities or erecting
barriers to competition. This analysis describes the assessment of
the small entity impacts expected to be incurred by 10 CFR Part 35
licensees as a result of the comprehensive revisions to Part 35
being proposed.
An assessment of small entity impacts involves three major
tasks: (1) defining ``small entities'' for the rule being analyzed,
including ``small businesses,'' ``small governments,'' and ``small
organizations;'' (2) determining what number constitutes a
``substantial number'' of these entities; and (3) determining if
``significant impacts'' will be incurred by licensees under the
proposed rule.
1.1 Defining ``Small Entities'' Affected by the Rule
The NRC has established size standards that it uses to determine
which NRC licensees qualify as small entities (60 FR 18344; April
11, 1995). These size standards are codified in 10 CFR 2.810. The
size standards pertinent to Part 35 licensees include the following:
Under 10 CFR 2.810(a)(1), a small business is a for-profit
concern and is a concern that provides a service or a concern not
engaged in manufacturing with average gross receipts of $5 million
or less over its last 3 completed fiscal years. (The Small Business
Administration size standards for the ``health services'' category,
including ``offices and clinics of doctors of medicine'' and all
other health services subcategories also establish $5 million as the
cut off point for ``small entities.'')
Under 10 CFR 2.810 (b) a small organization is a not-for-profit
organization which is independently owned and operated and has
annual gross receipts of $5 million or less.
For purposes of this analysis, therefore, ``small entity''
refers to any specific licensee under 10 CFR Part 35 with annual
gross receipts of $5 million or less.
The proposed rule would affect 1902 NRC licensees. These
licenses are issued principally to medical institutions, with at
least 1216 of the Part 35 licensees classified as medical
institutions (codes 2110, 2120, and 2121 in NRC's licensee tracking
system). Review of available data indicates that at most 8 of these
medical institutions had operating revenues of less than $5 million
in 1996.
First, all hospitals in States in which Part 35 licensees are
regulated by NRC were screened for revenues, using data obtained
from Profiles of U.S. Hospitals, 1996, HCIA Inc. HCIA collects,
analyzes, and publishes data on hospitals, based on financial
submissions to the Health Care Financing Administration (HCFA).
Revenues were measured as operating revenue, which is the sum of net
patient revenue and other operating revenue, such as revenue from
sources such as cafeterias and parking facilities, but which does
not include revenue from non-operating sources such as investment
income or donations. Operating revenue therefore is a less inclusive
measure of revenues than gross revenues. All hospitals identified as
having operating revenues less than $5 million then were checked
against the NRC License Tracking System to identify those medical
institutions that both had revenues less than $5 million and were
regulated by NRC under Part 35. Of the eight institutions that were
identified as meeting both criteria, three had operating revenues
above $4.4 million, and therefore may have gross revenues above $5
million. They have, however, been included in the group of
institutions with less than $5 million in revenues for this
analysis.
The balance of the licenses, approximately 686 licenses, are
issued principally to physicians in private practice. Information on
gross revenues for such physicians suggests that all may be ``small
entities.''
First, data from the AMA's Socioeconomic Monitoring System,
provided in Physician Marketplace Statistics 1996: Profiles for
Detailed Specialties, Selected States and Practice Arrangements,
Center for Health Policy Research, American Medical Association,
were reviewed for physicians' revenues or income. Table 89 of that
source, which reports ``Total Practice Revenue per Self-Employed
Nonfederal Physician (in thousands of dollars), 1995'' indicates
that even at the 75th percentile no physician specialty, geographic
area, or practice arrangement exceeded even $1 million in revenues.
Similar data from the Physician Compensation and Production Survey:
1996 Report Based on 1995 Data, Medical Group Management
Association, indicate that the median for ``production,'' defined as
gross charges, for all physicians was $422,937 in 1995 (p. 10).
Although ``production'' generally is larger for specialists than all
physicians, the difference is too small to place specialists above
the $5 million criterion.
In total, therefore, an upper bound estimate of 36 percent of
Part 35 licensees, or approximately 686 licensees, may be ``small
entities.''
1.2 Determining What Number Constitutes a Substantial Number
This analysis applied a figure corresponding to 20 percent of
small entities in determining whether a ``substantial number'' of
small entities are likely to be impacted by the rule. Therefore,
based on the analysis in section 1.1, the proposed rule would affect
a substantial number of small entities.
1.3 Measuring ``Significant Impacts''
To evaluate the impact that a small entity is expected to incur
as a result of the rule, the analysis should calculate the entity's
ratio of annualized compliance costs as a percentage of gross
receipts. Entities are classified as facing potentially
``significant'' impacts if this ratio exceeds one percent.
Determining annual compliance costs for the revisions to Part
35, however, is complicated by the fact that the proposed rule would
comprehensively address a wide variety of uses of byproduct
materials in medicine. The entities likely to be most affected by
the rule are broad scope medical institutions with a large number of
different modalities and conducting a large number of medical
procedures involving byproduct material or radiation from byproduct
material. However, the preceding analysis indicated that such broad
scope licensees are not small entities. The costs attributable to
Part 35 compliance for such broad scope licensees will be
substantially greater than the annual compliance costs likely to be
incurred by those licensees most likely to be small entities (i.e.,
single private practice physicians performing diagnostic
procedures).
The Part 35 rule addresses contingent actions as well as actions
that must be carried out by all licensees. In particular, the lower
risk posed by diagnostic procedures reduces the likelihood that
private practice physicians performing diagnostic procedures will
experience medical events involving costs of reporting and follow
up.
All licensees will incur annual compliance costs for general
administrative and technical requirements established by Part 35,
although the level of such compliance costs will vary significantly
depending on certain contingencies and on the activities being
performed by the licensee. Annual compliance costs for licensees are
expected, in all cases, to involve compliance with requirements to
establish and maintain a radiation protection program; possess, use,
calibrate, and check survey instruments, and satisfy the
requirements pertinent to the modality or modalities used by the
licensee.
NRC estimates that annual compliance costs for a licensee
carrying out any level of activities under Part 35 will in all cases
exceed 80 hours annually at $100 per hour, or $8,000. Assuming
annual revenues of $244,000 for a single private practitioner
subject to Part 35, as estimated in Socioeconomic Characteristics of
Medical Practice, 1997, American Medical Association, Center for
Health Policy Research, Table 43. ``Mean Physician Net Income (in
thousands of dollars) after Expenses before Taxes, 1995,'' for the
net income for ``all physicians-rad,'' a very conservative surrogate
for gross revenues, these annual compliance costs exceed both the
one percent cutoff level and the three percent cutoff level under
SBREFA for ``significant impacts.'' Assuming an average
``production'' of $423,000, (Section 1.1 of this analysis), however,
the 1 percent but not the 3 percent cutoff is exceeded. Therefore,
the proposed rule appears to have significant impacts on a
significant number of licensees.
NRC has taken a number of actions in this proposed rule to
ensure that the proposed alternative is the least costly alternative
that adequately protects workers and patients from radiation
exposure. As the Regulatory Analysis prepared for the proposed rule
demonstrates, the total annual cost to licensees of compliance with
the proposed rule would be approximately $9.87 million less than the
cost of compliance with the current rule (See XII. Regulatory
Analysis of the Supplementary Information section of this document).
This is equivalent to savings of approximately $1500 per licensee.
Although savings to small licensees can be expected to be
proportionately less than
[[Page 43580]]
savings to licensees with more extensive operations, smaller
licensees also can be expected to incur smaller compliance costs.
In order to assist small licensees, the NRC has sought in the
proposed rule to eliminate prescriptive requirements wherever
possible, and to allow for much greater flexibility in compliance.
Such flexibility is particularly helpful to small licensees in
reducing their cost of compliance, because it will enable them to
avoid the costs of radiation safety measures, such as the detailed
requirements for Radiation Safety Committees, that were especially
oriented toward larger licensees with numerous modalities and
activities in the same institution. NRC has reduced the training and
experience requirements applicable to the diagnostic use of
byproduct material by focusing those requirements on radiation
safety and by reducing the number of hours of training required. NRC
has also sought to reduce the prescriptive nature of requirements
for testing and calibration, and to reduce reporting and
recordkeeping burdens, which can have an especially strong impact on
small entities.
Finally, the program for revising Part 35 and the associated
guidance documents has involved more interactions and consultations
with potentially affected parties (the medical community and the
public, including representatives of small licensees) than is
provided by the typical notice and comment rulemaking process. Early
public input was solicited through several different mechanisms:
requesting public input through Federal Register notices; holding
open meetings of the government groups developing the revised rule
language; meeting with medical professional societies and boards;
putting background documents, options for the more significant
regulatory issues associated with the rulemaking, and a ``strawman''
draft proposed rule on the Internet; and convening public workshops.
Participants from the broad spectrum of interests that may be
affected by the rulemaking were invited to attend the public
workshops in Philadelphia, PA., and Chicago, IL., held in October
and November 1997. The public was also welcome to attend these
workshops, as well as the Part 35 Workshop that was held in
conjunction with the All Agreement States Meeting in October 1997,
and the NRC's Advisory Committee on the Medical Uses of Isotopes
meetings in September 1997 and March 1998.
As indicated in the Regulatory Flexibility Analysis statement
included in the proposed rule, the NRC requests comments from small
medical licensees concerning the impacts of the proposed rule and
any suggested modifications that may affect the economic impact of
the proposed requirements.
[FR Doc. 98-21459 Filed 8-12-98; 8:45 am]
BILLING CODE 7590-01-P
