# Medical Use of Byproduct Material; Proposed Revision

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URL: https://www.frixlaw.com/law-library/documents/fr%3A98-21459

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** August 13, 1998
- **Citation:** 63 FR 43516

## Text

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

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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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-21459. Public record. Not legal advice.