[Federal Register Volume 63, Number 156 (Thursday, August 13, 1998)]
[Proposed Rules]
[Pages 43516-43580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21459]



[[Page 43515]]

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Part III





Nuclear Regulatory Commission





_______________________________________________________________________



10 CFR Parts 20, 32 and 35



Medical Use of Byproduct Material; Proposed Revision



10 CFR Chapter I



Medical Use of Byproduct Material; Draft Policy Statement; Proposed 
Rules

  Federal Register / Vol. 63, No. 156 / Thursday, August 13, 1998 / 
Proposed Rules  

[[Page 43516]]



NUCLEAR REGULATORY COMMISSION

10 CFR Parts 20, 32 and 35

RIN 3150-AF74


Medical Use of Byproduct Material; Proposed Revision

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing a 
revision of its regulations governing the medical use of byproduct 
material. The proposed rule is one component of the Commission's 
overall program for revising its regulatory framework for medical use. 
The overall goals of this program are to focus NRC's regulations on 
those medical procedures that pose the highest risk to workers, 
patients, and the public, and to structure its regulations to be risk-
informed and more performance-based, consistent with the NRC's 
``Strategic Plan for Fiscal Year 1997-Fiscal Year 2002.'' A notice in 
this issue of the Federal Register announcing the Commission's proposed 
revision of its 1979 ``Medical Use Policy Statement'' for public 
comment is published elsewhere.

DATES: The comment period expires November 12, 1998. Comments received 
after this date will be considered if it is practical to do so, but the 
Commission is only able to ensure consideration of comments received on 
or before this date.

ADDRESSES: Comments may be sent to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, Attention: Rulemakings and 
Adjudications Staff.
    Deliver comments to: One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland 20852, between 7:30 am and 4:15 pm on Federal 
workdays.
    Copies of comments received may be examined at: NRC Public Document 
Room, 2120 L Street, NW. (Lower Level), Washington, DC.
    You may also provide comments via the NRC's interactive rulemaking 
web site through the NRC home page (http://www.nrc.gov). From the home 
page, select ``Rulemaking'' from the tool bar. The interactive 
rulemaking website can then be accessed by selecting ``New Rulemaking 
Website.'' This site provides the ability to upload comments as files 
(any format), if your web browser supports that function. For 
information about the interactive rulemaking web site, contact Ms. 
Carol Gallagher, (301) 415-5905; e-mail [email protected].

FOR FURTHER INFORMATION CONTACT: Catherine Haney, Office of Nuclear 
Material Safety and Safeguards, Nuclear Regulatory Commission, 
Washington, DC 20555-0001, (301) 415-6825, e-mail [email protected] or Diane 
Flack, Office of Nuclear Material Safety and Safeguards, Nuclear 
Regulatory Commission, Washington, DC 02555-0001, (301) 415-5681, e-
mail [email protected].

SUPPLEMENTARY INFORMATION:

I. Background
II. Petition for Rulemaking
Ill. Discussion and Input to Proposed Rule
IV. Discussion of Text of Proposed Rule
V. Coordination with the Advisory Committee on Medical Uses of 
Isotopes
VI. Coordination With NRC Agreement States
VII. Consistency with Medical Policy Statement
VIII. Implementation
IX. Issues of Compatibility for Agreement States
X. Finding of No Significant Environmental Impact: Availability
XI. Paperwork Reduction Act Statement
XII. Regulatory Analysis
XIII. Regulatory Flexibility Analysis
XIV. Backfit Analysis

I. Background

Use of Byproduct Material in Medicine

    Since 1946, growth in the medical applications of radioisotopes has 
been very rapid as their usefulness has become more apparent in 
diagnosis, therapy, and medical research. Current medical procedures 
employ a number of radionuclides in a wide variety of chemical and 
physical forms. Nuclear medicine procedures for diagnostic and 
therapeutic applications involve the internal administration of 
radiolabeled tracers. Administration of the radiolabeled tracers, known 
as radiopharmaceuticals, may be performed by intravenous injection, 
inhalation, or oral ingestion. Diagnostic nuclear medicine in most 
cases involves imaging agents used for the delineation and localization 
of organ tissues by scintigraphy (e.g., technetium-99m hydroxymethylene 
diphosphonate used as a bone seeking radiopharmaceutical). Organ 
function may be determined by quantifying the accumulation of 
radiopharmaceuticals in organs of interest (e.g., iodine-131 uptake 
studies used to assess thyroid function). Therapeutic nuclear medicine 
may use various radiopharmaceuticals for the treatment of disease by 
selective absorption or concentration (e.g., iodine-131 used to treat 
thyroid cancer). Other therapeutic applications may involve the use of 
radiopharmaceuticals in colloidal suspensions for the treatment of 
malignant tumors (e.g., phosphate-32 infusion for treatment of 
peritoneal or pleural effusions associated with malignant tumors).
    Since the early 1900s, radiation therapy has become one of the 
major modalities of treatment in the management of neoplastic disease, 
generally referred to as cancer. Radiation therapy may also be used as 
a palliative agent in the medical treatment process. The objective of 
conventional radiation therapy using a teletherapy sealed source is to 
deliver a precisely measured dose of radiation to a defined tumor 
volume. This is usually accomplished by delivering a dose in daily 
increments over several weeks. External beam radiation therapy has 
evolved using innovative technology that has led to the development of 
the gamma stereotactic radiosurgery device used for treatment of 
precisely defined intracranial targets (e.g., brain tumors and 
arteriovenous malformations).
    Brachytherapy uses a variety of smaller sealed sources for 
localized treatment of cancer. Typically the sealed sources are either 
inserted in a cavity (e.g., cesium-137 sources used for intracavitary 
treatment of cervical cancer) or implanted in tissue (e.g., iodine-125 
seeds used for interstitial treatment of prostate cancer). Various 
remote afterloading devices have been developed for low, medium, and 
high dose-rate brachytherapy treatments.

State and Federal Regulations

    Byproduct material or radiation from byproduct material is 
regulated by either State or Federal Laws. The NRC regulates the 
administration of byproduct material or radiation from byproduct 
material in 20 States, the District of Columbia, the Commonwealth of 
Puerto Rico, and various territories of the United States. There are 
approximately 1900 NRC licenses authorizing the medical use of 
byproduct material under 10 CFR Part 35, ``Medical Uses of Byproduct 
Material.'' Thirty States, known as Agreement States, have entered into 
an agreement with the NRC to regulate the use of byproduct material (as 
authorized by section 274 of the Atomic Energy Act). These States issue 
licenses and currently regulate about 5000 institutions, e.g., 
hospitals, clinics, or physicians in private practice. The use of 
byproduct material represents only a small fraction of all medical uses 
nationwide of radionuclides or sources of radiation, e.g. x-ray.

Revision of NRC's Regulatory Program

    NRC's medical use program includes use of byproduct material in 
medical diagnosis, therapy, and research. NRC's requirements for 
medical licensees are

[[Page 43517]]

described in 10 CFR Part 35. Approximately eleven million patients 
annually undergo medical procedures involving byproduct materials.
    The Commission examined the issues surrounding its medical use 
program in detail during a 1993 internal senior management review, a 
1996 independent external review by the National Academy of Sciences, 
Institute of Medicine, and the Commission's Strategic Assessment and 
Rebaselining Initiative (SA). In particular, medical oversight was 
addressed in the SA Direction-Setting Issue Paper Number 7 (DSI 7) 
(released September 16, 1996). In September 1997, the Commission issued 
its ``Strategic Plan'' (NUREG-1614, Vol. 1) which stated that its goal 
in regulating nuclear materials safety is to ``prevent radiation-
related deaths or illnesses due to civilian use of source, byproduct, 
and special nuclear materials.''
    In its Staff Requirements Memorandum (SRM)--COMSECY-96-057, 
``Materials/Medical Oversight (DSI 7),'' dated March 20,1997, the 
Commission stated that it supported continuation of the ongoing medical 
use regulatory program with improvements, decreased oversight of low-
risk activities, and continued emphasis on high-risk activities. This 
SRM also directed the NRC staff to revise Part 35, associated guidance 
documents, and, if necessary, the Commission's 1979 Medical Use Policy 
Statement (44 FR 8242; February 9, 1979). The Commission's SRM 
specifically directed the restructuring of Part 35 into a risk-
informed, more performance-based regulation. In addition, the 
Commission expressed its support for the use of the Advisory Committee 
on the Medical Use of Isotopes (ACMUI) and professional medical 
organizations and societies in the revision of Part 35 and the medical 
policy statement. The Commission specifically directed the NRC staff to 
``consider a rulemaking process that provides more opportunity for 
input from potentially affected parties than is provided by the normal 
notice and comment rulemaking process but would be less consumptive of 
resources and time than the process recently used in the development of 
NRC's rule on radiological criteria for license termination.''
    During development of the rule and associated guidance, as well as 
during the review of the Medical Use Policy Statement, the Commission 
considered the following issues:
    (1) Focusing Part 35 on those procedures that pose the highest 
risk;
    (2) Regulatory oversight alternatives for diagnostic procedures 
that are consistent with the lower overall risk of these procedures;
    (3) The best way to capture not only relevant safety-significant 
events, but also precursor events;
    (4) Changing the nomenclature from ``misadministration'' to 
``medical event'' or comparable terminology;
    (5) Redesigning Part 35 so that regulatory requirements for new 
treatment modalities can be incorporated in a timely manner;
    (6) Revising the requirement for a quality management program (10 
CFR 35.32) to focus on those requirements that are essential for 
patient safety; and
    (7) The viability of using or referencing available industry 
guidance and standards, within Part 35 and related guidance, to the 
extent that they meet NRC's needs.
    The proposed rule that would revise Part 35 has been developed in 
response to these issues and concerns.
    The Commission, in its SRM of June 30, 1997, ``SECY-97-115--
``Program for Revision of 10 CFR Part 35, `Medical Uses of Byproduct 
Material' and Associated Federal Register notice,'' approved the NRC 
staff's proposed plan for the revision of Part 35. The Federal Register 
notice, ``Medical Use of Byproduct Material: Issues and Request for 
Public Input'' (62 FR 42219-42220; August 6, 1997), solicited early 
public input on the proposed rulemaking.
    The NRC staff implemented the approved plan using an approach 
involving public Working and Steering Group meetings, with significant 
opportunities for input from the public, potentially affected parties, 
the ACMUI, and professional medical organizations. Publicly noticed 
Working and Steering Group meetings were held in August, September, and 
December 1997, and in January, February, March, and April 1998. During 
the Working and Steering Group meetings, the groups identified 
significant crosscutting issues associated with the rulemaking. These 
issues included patient notification, precursor events, Radiation 
Safety Committee, quality management program, and training and 
experience for authorized users. Rulemaking alternatives were developed 
for these crosscutting issues and were made available on the Internet 
and in the NRC's Public Document Room for comment. These alternatives 
were discussed with (1) the ACMUI at its September 1997 meeting, (2) 
the public at facilitated public workshops held in Philadelphia, PA, in 
October and in Chicago, IL, in November 1997 (discussed below), (3) 
State regulators at a publicly noticed workshop that was conducted 
during the October 1997 All Agreement States Meeting, and (4) meetings 
of medical professional societies.
    In addition to the proposed revision of Part 35, the Commission is 
publishing for public comment, in a separate Federal Register notice, a 
proposed revision of its 1979 policy statement on the Medical Use of 
Byproduct Material (44 FR 8242; February 9, 1979). The proposed 
revision of the medical policy statement is another component of the 
Commission's overall program for revising its regulatory framework for 
medical use, including its regulations in Part 35. The proposed 
revision of Part 35 is consistent with the proposed revision of the 
Medical Use Policy Statement (MPS) and is generally consistent with the 
current MPS (see Section VII of the SUPPLEMENTARY INFORMATION section 
of this document).

Workshops

    The Commission believes that it is important for interests affected 
by the medical use rulemaking to not only have an early opportunity to 
comment on the rulemaking issues, but also to have an opportunity to 
discuss the rulemaking with one another and the agency. Accordingly, 
the Commission convened two public workshops in which the interests 
that maybe affected by the rulemaking had the opportunity to discuss 
the rulemaking issues. Although the workshops were intended to foster a 
clearer understanding of the positions and concerns of the affected 
interests, as well as to identify areas of agreement or disagreement, 
it was not the intent of the workshop process to develop a consensus 
agreement of the participants on rulemaking issues.
    In order to have a manageable discussion, the number of invited 
participants in the roundtable discussions at each workshop was 
limited. The Commission, through a facilitator for each workshop, 
attempted to insure participation by a broad spectrum of interests that 
may be affected by the rulemaking. These interests included nuclear 
medicine physicians, physician specialists such as cardiologists and 
radiologists, medical physicists, medical technologists, radiation 
safety officers, nurses, medical education and certification 
organizations, radiopharmaceutical interests, hospital administrators, 
patients rights advocates, Agreement States, Federal agencies, and 
experts on risk analysis. Other members of the public were invited to 
attend and had the opportunity to comment on the rulemaking issues and 
the workshop

[[Page 43518]]

discussions at periodic intervals during the workshops.
    The workshops had a common, predefined agenda focused primarily on 
alternatives for major (``crosscutting'') issues, some with draft 
regulatory text. The workshop format was sufficiently flexible to allow 
for the introduction of additional related issues that participants 
wanted to raise. The workshop commentary was transcribed and summarized 
in ``Summary of Discussion: Facilitated Public Workshop on Revisions to 
10 CFR Part 35 Held in Philadelphia, Pennsylvania, on October 28-30, 
1997'' (April 17, 1998) and ``Summary of Discussion: Facilitated Public 
Workshop on Revisions to 10 CFR Part 35 Held in Chicago, Illinois, on 
November 12-14, 1997'' (April 17, 1998). The summary documents are 
available for inspection at the NRC Public Document Room, 2120 L Street 
NW. (Lower Level), Washington, DC. Single copies of the summary 
documents are available as indicated in the For Further Information 
Contact section of this document. A brief summary of the participant's 
positions on the major crosscutting issues associated with this 
rulemaking is provided in Section Ill of the SUPPLEMENTARY INFORMATION 
section of this document.
    The Commission plans to hold three public workshops during the 
formal comment period to facilitate public comments on the proposed 
rulemaking. A notice for these workshops was published in the Federal 
Register on July 24, 1998 (63 FR 39763).

II. Petition for Rulemaking

    The Commission has incorporated into this rulemaking the resolution 
of a Petition for Rulemaking (PRM) filed by the University of 
Cincinnati dated April 7, 1996 (PRM 20-24), because of its pertinence 
to Part 35. On June 21, 1996 (61 FR 31874), the NRC published a notice 
of receipt and a request for comment on this petition for rulemaking.
    The petitioner requested that the NRC amend 10 CFR 20.1301, ``Dose 
limits for individual members of the public'' to:
    (1) Provide medical licensees the discretion to permit those 
visitors determined by the physician to be necessary for the emotional 
or physical support of the patient to receive up to 5 mSv (0.5 rem) 
(e.g., parents of very young radiation therapy patients, close family 
members of elderly patients, or other persons who could provide 
emotional support to the patient);
    (2) Exclude pregnant women and individuals younger than 18 years of 
age from receiving a dose in excess of 1 mSv (0.1 rem); and
    (3) Document compliance by issuing radiation dose monitoring 
devices (i.e., pocket dosimeter, film badge, TLD, or electronic 
dosimeter) to each specified visitor.
    In response to the request for public comments, the Commission 
received comments from four members of the general public. All 
commenters agreed with the petition. One of the commenters suggested 
that the previous 5 mSv (0.5 rem) dose limit for the general public be 
reinstated for a ``specific'' public and, under unusual circumstances, 
also permit the authorized user to authorize even higher exposure 
provided the latter does not ``receive more radiation than a radiation 
worker.'' Another commenter suggested permitting the authorized user to 
authorize even higher exposure provided it did not exceed the 
occupational dose limit of 50 mSv (5 rem).
    Although a 50 mSv (5 rem) dose limit for adult visitors exposed to 
radionuclide therapy patients is consistent with the recommendations of 
the National Council on Radiation Protection and Measurements (NCRP 
Commentary No. 11, Dose Limits for Individuals Who Receive Exposure 
From Radionuclide Therapy Patients, February 28, 1995), this suggestion 
is not consistent with release of patients in accordance with 
Sec. 35.75, or with the approach to protection of the public in 10 CFR 
Part 20. For this reason, the NRC decided not to adopt the suggested 50 
mSv (5 rem) dose limit.
    The NRC reviewed the petitioner's request and comments received on 
the petition and believes there is merit in granting the petition in 
part as discussed in detail later. This proposed rule responds to the 
petition by amending 10 CFR Part 20 to allow the licensee the 
discretion to permit visitors to receive up to 5 mSv (0.5 rem) in a 
year from exposure to hospitalized radiation patients.

III. Discussion and Input to Proposed Rule

    The program for revising Part 35 and the associated guidance 
documents has provided more opportunity for input from potentially 
affected parties (the medical community and the public) than is 
provided by the typical notice and comment rulemaking process. Early 
public input was solicited through several different mechanisms: 
requesting public input through Federal Register notices; holding open 
meetings of the government groups developing the revised rule language; 
meeting with medical professional societies and boards; putting 
background documents, options for the more significant regulatory 
issues associated with the rulemaking, and alternatives for revising 
the 1979 Medical Use Policy Statement on the Internet; and convening 
public workshops. The NRC received approximately 330 letters providing 
input to the rulemaking process. The input received from the public 
during the development of the proposed rulemaking is categorized and 
summarized below, according to the significant regulatory issues that 
were identified very early in the rulemaking process.

A. Training and Experience

1. Facilitated Workshops
    The issue of training and experience for authorized users generated 
the most discussion among workshop participants. Discussion of this 
topic was organized into segments that addressed ``key current problems 
or advantages identified by participants''; certain ``crosscutting'' 
training and experience issues (including such questions as the role a 
professional degree, medical specialty certification, or testing should 
play in qualifying an authorized user); and various specific 
alternatives (developed by the Part 35 Working Group) for training and 
experience necessary to qualify a physician as an authorized user.
    Based on specific questions posed to participants, certain issues 
emerged as important in determining the necessary training and 
experience for qualifying as an authorized user. For instance, some 
participants believed that the current requirements are unrealistically 
stringent. Other participants maintained that training and experience 
can be varied, based upon the degree of risk posed by a specific 
modality. (However, participants did not necessarily agree on how to 
rank various modalities based on risk.) One question raised was whether 
the training and experience requirements should be different for 
physicians already in practice, than for those physicians who are just 
starting out. Certain participants viewed Commission specification of 
clinical training and experience requirements as a serious intrusion 
into the practice of medicine and; therefore, suggested that the term 
``clinical training and experience'' should be replaced with the term 
``practical training and experience.'' The latter would cover safe 
handling of radioactive materials (i.e., such topics as: safe delivery 
of radionuclides to patients; time, distance, and shielding; use of a 
dose

[[Page 43519]]

calibrator; assessing contamination; decontaminating areas; half-lives 
of radionuclides; and consequences of contamination). However, some 
therapy practitioners supported the requirement for clinical experience 
as part of training and experience. Another suggested approach to 
establishing training and experience requirements would be to have 
different requirements for physicians who use radionuclides for very 
limited purposes (i.e., cardiology and endocrinology), as opposed to 
physicians engaged in the general medical use of byproduct material.
    The range of options for a physician to become an authorized user 
that was discussed at the workshops included--
    (1) Status quo (i.e., a physician who is certified in any one of a 
number of medical specialities, or has had a set number of hours of 
classroom and laboratory training and supervised clinical experience, 
or has completed an approved training program that included classroom 
and laboratory training, work experience, and supervised clinical 
experience);
    (2) Medical speciality certification, plus a specified number of 
hours of training and experience;
    (3) Medical specialty certification plus a specified number of 
hours of training and passing an examination;
    (4) Possessing an M.D. degree;
    (5) Passing an examination focused on radiation safety; and
    (6) Passing an examination focused on radiation safety and having 
specified clinical experience.
    The options were primarily analyzed in terms of therapeutic versus 
diagnostic uses of byproduct material. Many participants involved in 
therapeutic medical uses supported the status quo requirements for such 
uses (generally requiring either medical speciality board certification 
or a specified number of hours of classroom and laboratory training) 
because such requirements have served patients and the public well. 
They maintained that board certification ensures the appropriate level 
of training and experience and were cautious about any change that 
could diminish assurance of competency. However, some proponents of the 
status quo would accept the use of medical specialty boards other than 
those currently listed in Part 35. Some participants also felt that 
clinical experience in handling radionuclides and patient cases, 
especially across a broad range of developing therapy, is crucial. 
Representatives of diagnostic uses of byproduct materials asserted that 
the status quo effectively prohibits some medical practitioners from 
using byproduct materials which they could safely use if the training 
requirements were decreased. They believe that an examination component 
of the training and experience requirements is extremely important in 
setting a standard for authorized users. Some diagnostic users 
recommended that about 150 hours of didactic training and associated 
clinical experience would be sufficient.
    The discussion of training and experience requirements addressed 
the viewpoint that all professionals involved in handling 
radionuclides, including medical physicists, authorized nuclear 
pharmacists, nurses, technologists, dosimetrists, and physician's 
assistants, should be subject to the training and experience 
requirements. Some participants supported degree requirements, such as 
a master's degree in health physics. Opposition to such a requirement 
was based on the concept that performance criteria, rather than a 
degree, should be the basis for determining competence for certain 
positions, such as the Radiation Safety Officer or nuclear 
technologist. Another viewpoint expressed was that the nuclear medicine 
technologist, rather than the authorized user physician, should be the 
focus of training and experience requirements, because the technologist 
actually handles the radioactive material.
    Participants believed that training and experience requirements are 
essential for ensuring the competency of a Radiation Safety Officer. 
They generally expressed support for the status quo for training and 
experience requirements for the Radiation Safety Officer, but 
questioned whether an authorized user should automatically qualify as a 
Radiation Safety Officer. Specifically, some participants believed that 
an authorized user should not also be the Radiation Safety Officer 
because of ``potential conflicts of interest'' (i.e., the Radiation 
Safety Officer should not be influenced by the ``administration'' of a 
facility). Other participants noted that an authorized user physician 
might be a specialist whose practice includes a limited application of 
the medical use of byproduct material, and who does not have sufficient 
training in radiation safety to address problems that might occur. 
Certain participants believed that it may be appropriate for an 
authorized user to be a Radiation Safety Officer at a small hospital, 
even if that authorized user did not have the breadth of training to be 
a Radiation Safety Officer at a large hospital. A concern of some 
participants is that there may not be anyone other than the authorized 
user to assume the responsibility as a Radiation Safety Officer at 
small community hospitals. In those cases, an authorized user, who is 
also the Radiation Safety Officer, was seen to be preferable to not 
having a Radiation Safety Officer.
    Workshop participants generally did not question the current 
training and experience requirements for the Radiation Safety Officer. 
Some suggested changes for the Radiation Safety Officer's training and 
experience were discussed, such as varying the training and experience 
to correspond to the type of license or duties performed by an 
individual Radiation Safety Officer; to have a ``core competency'' set 
of requirements (which could be supplemented with additional 
requirements for modalities posing greater risks); or to substitute a 
Masters of Science degree for the 200-hour training requirement.
    Certain participants involved in ``low-dose'' medical uses 
concluded that Part 35 should include training and experience for 
medical physicists. They noted that training and experience 
requirements should correspond to the duties and responsibilities of 
the physicist for different modalities (i.e., instrumentation for 
nuclear medicine, radiation treatment planning, or administration of 
doses for radiation therapy).
    Comments by participants on this issue were favorable regarding 
training and experience for the authorized nuclear pharmacists. Some 
participants specifically stated that, based on risk, radiopharmacy 
training and experience should be handled similarly to other diagnostic 
modalities.
    Training and experience requirements for ancillary personnel, such 
as technologists, were briefly discussed. Some participants supported 
training and experience requirements for technologists because the 
technologists, rather than the physicians, handle the radioactive 
materials. One participant, a nuclear medicine technologist, indicated 
that there are already organizations that have established voluntary 
training and experience requirements for technologist certification. 
The individual did not believe that these organizations would endorse 
other exams. The individual also indicated that, if proposed, training 
for technologists should be risk-based.
2. Agreement State Workshop
    Discussions at the Agreement State Workshop focused on whether 
NRC's training and experience requirements should focus exclusively on 
the radiation safety aspects of an authorized user's training, leaving 
issues such as patient selection and reading scans to be part of the 
``practice of medicine.''

[[Page 43520]]

Workshop participants were divided on this issue. Those answering this 
question affirmatively believed that NRC should focus on assuring that 
physicians are capable of safely handling and using byproduct material. 
One participant indicated that the level of education to demonstrate 
competence should be uniform regardless of the hazard posed by the 
material. Other participants believed that, from the patient's 
perspective, the physician's role goes beyond safety and into areas 
such as patient selection and scan interpretation.
    One member of the public argued that NRC and Agreement States 
should require physicians to master quantitative radiation protection 
science before permitting them to become authorized users. The 
individual also believed that NRC and the Agreement States should rely 
solely on physician practice privilege committees, State Boards of 
Medicine, and the Joint Commission on the Accreditation of Health Care 
Organizations to determine the qualifications of physicians to practice 
nuclear medicine.
    The Agreement States were concerned about the resources needed to 
develop and validate examinations. One participant stated that creating 
and validating a new exam would be costly in comparison to seeking out 
existing exams that were validated and acceptable to the NRC.
    Training and experience requirements for ancillary personnel, such 
as technologists, were discussed. A representative of the nuclear 
medicine technologist profession stated that the role of the 
technologist entailed more than the safe handling of radioactive 
materials. The role of the technologist was to provide the physician 
with the information needed to treat the patient. The individual went 
on to indicate that the success of the entire diagnostic process 
correlated with the education and training of the technologist and 
physician. The individual indicated that groups currently certifying 
technologists support certification for technologists and State 
legislation mandating that technologists be licensed. The individual 
also indicated that these certifying groups did not favor NRC setting 
standards for training and experience for technologists because the NRC 
does not have the experience necessary to determine what the training 
requirements for technologists should be.
    One workshop member confirmed that a number of States require that 
technologists be certified. The participant noted that the Conference 
of Radiation Control Program Directors (CRCPD) was planning on 
discussing minimum training and experience qualification criteria for 
technologists. These requirements would be added to the Suggested State 
Regulations.
3. Advisory Committee on Medical Uses of lsotopes (ACMUI)
    Training and experience requirements have been discussed on 
numerous occasions with the ACMUI. The ACMUI most recently discussed 
training and experience for authorized users, authorized medical 
physicists, authorized nuclear pharmacists, and Radiation Safety 
Officers at its March 1-2, 1998, meeting. The ACMUI agreed with the 
Commission's proposed general approach to training and experience, 
i.e., delete reference in the rule to the speciality boards names, 
require preceptor forms, and require that competency be demonstrated by 
successful completion of an examination. Members debated whether it is 
possible or prudent, with respect to authorized user physician 
training, to separate the hours required for radiation safety training 
from the entire clinical training period.
    The ACMUI unanimously recommended that the current training 
requirements for authorized users of sealed sources and devices for 
therapeutic applications (proposed Secs. 35.400 and 35.600) be 
maintained. Specifically, they recommended retaining the 3-year 
clinical training in an accredited program as an alternative to medical 
speciality board certification. The ACMUI agreed with the views 
expressed by members of the radiation oncology professional societies 
who made formal presentations at the March 1998, meeting. Specifically, 
they agreed that the current requirements for authorized users of 
brachytherapy and therapeutic medical devices should be retained 
because of the risk associated with use of these modalities and because 
radiation safety training and clinical competence are intertwined for 
uses of these devices.
    The ACMUI unanimously recommended that the training requirements 
for authorized users of unsealed byproduct material for diagnostic uses 
(proposed Secs. 35.100 and 35.200) be reduced to the levels proposed by 
the NRC staff (120 hours in a structured educational program). The 
ACMUI did not reach a consensus on the training requirements for 
authorized users of unsealed byproduct material for therapeutic uses. 
The NRC staff recommended reducing the training requirements to a 120-
hour structured educational program and limited casework. Some members 
of the ACMUI were concerned that training for these uses should be 
addressed in a manner similar to that used for the therapeutic uses of 
sealed sources. Finally, they unanimously agreed with NRC staff's 
recommendation for training requirements for authorized nuclear 
pharmacists (700 hours in a structured educational program) and medical 
physicists (Masters of Science degree and 2 years).
4. Written Comments

Authorized Users Training and Experience Requirements for Unsealed 
Byproduct Material

    The Commission received numerous comments from professional 
societies and individual physicians on the training and experience 
requirements for use of unsealed byproduct material.
    Many professional societies, as well as individual physicians, were 
concerned that a reduction in training hours, as proposed in a January 
20, 1998, ``strawman'' version of the proposed rule, would not provide 
adequate training and might result in approval of poorly trained 
practitioners. They believe that it is impossible to distinguish 
between safety and competence. They indicated that the current 
requirement for 500 hours of clinical experience is an important 
``patient safety regulation.'' Some professional organizations 
recommended that the Commission maintain the current training 
requirements in this area for authorized users, but also recommended 
that the training be provided only in programs accredited or approved 
by the American Council on Graduate Medical Education. Others believed 
that training and experience should be developed, administered, and 
monitored by medical speciality organizations with experience in 
clinical radiation-related technologies.
    One professional society supported the reduction in training hours. 
This organization recommended that physicians, who are not certified by 
an NRC-approved medical speciality board, be required to pass an 
examination and to obtain a written certification from a preceptor that 
indicates that the individual is able to function independently on all 
aspects of radiation safety.
    Another society suggested that competence in radiation safety be 
demonstrated in a performance-based manner, e.g., NRC would not specify 
a specific number of hours, but would assess competency through a 
comprehensive examination.

[[Page 43521]]

    One society urged the Commission to maintain the current training 
and experience requirements for use of byproduct material to treat 
hyperthyroidism or thyroid carcinoma. This organization opposed the 
proposal in the ``strawman'' proposed rule to increase the number of 
training hours needed to use material to treat hyperthyroidism or 
thyroid carcinoma and opposed the requirement for an examination. This 
organization believed that the proposed increase in training and 
experience requirements would have a detrimental effect for patient 
care, such as referral of patients to other specialists using less 
desirable alternative treatments.
    One commenter indicated that a minimum of 120 hours of classroom 
and laboratory training and 240 hours supervised practical experience, 
or a 3-month training program in nuclear medicine, was appropriate for 
diagnostic nuclear medicine.

Training and Experience for Use of Sealed Sources in Therapy

    The NRC received approximately 330 letters providing input to the 
rulemaking process. Approximately 90 percent of these comments were 
from radiation oncologists who feel very strongly that the current 
training and experience requirements for authorized users of 
brachytherapy and therapeutic medical devices should be retained 
because of the high risk associated with use of these modalities and 
because radiation safety training and clinical competence are 
intertwined for uses of these devices.
    Commenters believed that training and experience requirements 
should be consistent with that required for certification by the 
American Board of Radiology (i.e., 3 years of therapeutic radiology and 
at least 6000 hours of direct clinical experience). If the Commission 
were to consider other medical speciality boards for certification of 
physicians seeking approval as authorized users to perform 
brachytherapy and teletherapy, the training required by those boards 
should be the same as that required by the American Board of Radiology 
for certification in therapeutic radiology. Certain comments 
specifically objected to either an NRC-developed or NRC-approved 
examination, because that would mean that the standards of the American 
Board of Medical Specialities and its twenty-four member boards are 
``too high.''
    Most commenters believed that thorough training in radiation 
oncology should be required for all physicians seeking to perform 
applications of ionizing radiation to treat disease. According to 
certain comments, therapeutic treatments of the heart and brain are 
high-risk procedures and ``relaxing'' these requirements would not be 
in the best interest of patients or the medical profession at large. 
They maintained that training requirements for coronary artery 
brachytherapy and gamma stereotactic radiosurgery should be the same as 
those for other brachytherapy and teletherapy modes of treatment, 
respectively, and not broken into ``tiny site-specific'' modalities 
with different training requirements.
    Other commenters noted that radiation oncologists should be 
involved, as part of a team with cardiologists and neurosurgeons, in 
brachytherapy treatment of the heart and use of gamma stereotactic 
radiosurgery of the brain. Other comments described the ``full 
complement'' of training for these medical uses as covering radiation 
biology, radiation physics, and radiation safety.
    A professional organization offered criteria for training and 
credentialling of cardiologists performing brachytherapy involving 
coronary and vascular interventions. This organization believes that 
cardiologists should perform intravascular brachytherapy in 
collaboration with medical physicists, Radiation Safety Officers, and 
medical dosimetrists.
5. Resolution
    The Commission considered all of the input on training and 
experience that was provided during the development of this rulemaking. 
On the basis of the public input, the Commission is proposing the 
following training and experience criteria for authorized users, 
authorized medical physicists, authorized nuclear pharmacists, and 
Radiation Safety Officers:
    (1) The requirements for training and experience should be risk-
informed and focused on radiation safety;
    (2) Individuals should complete a structured educational program 
that consists of didactic training and practical experience;
    (3) Specific reference to speciality boards, by name, should be 
deleted;
    (4) Speciality boards will be approved by the Commission or an 
Agreement State if the board certification process includes all the 
training and experience requirements associated with the equivalent 
training pathway;
    (5) Preceptors, when required, should certify that individuals have 
achieved a level of competency sufficient to function independently as 
an authorized user for the requested use, an authorized medical 
physicist, an authorized nuclear pharmacist, or a Radiation Safety 
Officer; and
    (6) Individuals should demonstrate sufficient knowledge in 
radiation safety by passing an examination given by an organization or 
entity approved by the Commission or an Agreement State.
    The Commission believes that training and experience criteria 
should be risk-informed and focused on radiation safety. In addition, 
the Commission believes that, by requiring a combination of a 
structured education program, preceptorship, and examination focused on 
radiation safety, individuals will be able to safely handle byproduct 
material. However, it is important to note that an individual's status 
as an authorized user, authorized medical physicist, authorized nuclear 
pharmacist, or Radiation Safety Officer means that an individual has 
met the requirements to handle byproduct material safely and is not an 
assessment of the individual's clinical or professional competency.
    The Commission believes that individuals should complete a 
structured educational program that consists of didactic training and 
practical experience. The number of hours and type of training were 
extensively discussed with the medical societies and speciality boards 
and have been the primary issue in the public input received on the 
rulemaking. However, the Commission recognizes that radiation safety 
training and clinical competency may be intertwined, especially for 
uses of therapeutic medical devices. Because of the high risk 
associated with use of sealed sources in therapeutic medical devices, 
the Commission has not proposed significant changes in the current 
training requirements for authorized users in this area, with the 
exception of the training required for the use of strontium-90 eye 
applicators. Under the proposed rule, authorized users of strontium-90 
eye applicators will need to meet the training requirements for 
authorized users of therapeutic medical devices. The Commission 
believes this change is warranted in light of the similarity between 
the use of strontium-90 eye applicators and the use of sealed byproduct 
material in medical devices and the recent misadministrations involving 
strontium-90 eye applicators. It is important that the didactic 
training include courses in radiation physics, dosimetry, and radiation 
biology so that the authorized users have a clear understanding of what 
a dose means in terms of radiation damage to the exposed tissue.

[[Page 43522]]

    The Commission has focused the training requirements for use of 
unsealed material for diagnostic administrations when a written 
directive is not required on radiation safety because of the low risk 
posed by the radionuclides. In doing so, the didactic and practical 
requirements for authorized users of unsealed byproduct material for 
diagnostic procedures were significantly reduced.
    The didactic and practical requirements for use of unsealed 
byproduct material when a written directive is required were also 
reduced because of similarities between the use of unsealed material in 
a diagnostic setting and use in a therapeutic setting. However, the 
Commission recognized that the use of both therapeutic unsealed sources 
and sealed sources involve higher risks and, therefore, retained the 
requirement for clinical experience.
    The proposed rule would delete the current, specific training and 
experience sections that pertain to treatment of hyperthyroidism and 
thyroid carcinoma. Under the proposed revision of Part 35, individuals 
wishing to become authorized users of byproduct material for these 
medical uses would be required to meet the training requirements that 
apply to the use of unsealed material for which a written directive is 
required (Sec. 35.390). The proposed rule specifies that (1) the 
structured educational program for these individuals include an 
additional 40 hours of supervised practical experience; (2) these 
individuals have experience involving at least five cases for each 
procedure with radiation safety hazards similar to that use for which 
the individual is requesting authorized user status; and (3) these 
individuals pass an examination to demonstrate competency in 
radionuclide handling techniques applicable to the use of unsealed 
byproduct material.
    The Commission recognizes that this proposed rule change places 
additional requirements on those individuals that wish to become 
authorized users of byproduct material for only the treatment of 
hyperthyroidism and thyroid carcinoma. However, it does expect that 
many of the practical hours will be obtained concurrently with the 
casework, therefore lessening the burden on the individuals. The 
Commission recognizes that there have been very few misadministrations 
that have occurred in this area (1995 and 1997). However, it believes 
that this change is consistent with the Commission's general intent to 
(1) focus training and experience criteria on radiation safety; (2) 
require that all authorized users have practical experience in the 
handling of radionuclides; and (3) require that competency be 
demonstrated by passing an examination.
    The Commission believes that any reference, by name, to specialty 
boards should be deleted from the regulation for two reasons. First, 
under the current Part 35, in which speciality boards are listed by 
name, a rulemaking is needed to add new boards or to delete existing 
boards. This has been a problem with the current Part 35 because on 
several occasions individuals requesting authorized user or medical 
physicist status have been certified by a speciality board that is not 
listed in the regulations. In these cases, NRC has had to evaluate the 
training of individuals, with the help of the ACMUI, on a case-by-case 
basis. Secondly, the current rule does not provide for periodic review 
of certifying boards to determine if any changes have been made in 
their certifying programs.
    The proposed rule would require that specialty boards be approved 
by the NRC or an Agreement State. A specialty board will be approved by 
NRC if the certification process includes all of the requirements 
listed in the equivalent training pathway, i.e., completion of a 
structured educational program of specific duration that covers 
specific topics; obtaining a signed preceptor certification; completion 
of patient casework, if required; and successful completion of an 
examination on radiation safety. The Commission plans to discuss 
proposed board approvals with the ACMUI prior to approving the boards. 
The NRC staff also plans to conduct periodic reviews of approved 
speciality boards to assure that they continue to meet commitments to 
NRC. If a board does not meet its previous training and experience 
commitments, it will be removed from NRC's list of approved boards. A 
list of approved boards will be maintained on the NRC external website. 
In addition, the Commission is contemplating noticing the approval of a 
speciality board in the Federal Register.
    The Commission is proposing that preceptors, when required, should 
certify that individuals have achieved a level of competency sufficient 
to independently function as an authorized user for the use that they 
are requesting: a medical physicist, an authorized nuclear pharmacist, 
or a Radiation Safety Officer. In the current Part 35, a preceptorship 
is only required for authorized nuclear pharmacists. The current 
preceptors for authorized nuclear pharmacists are only required to 
attest to the fact that the individual has performed a specified number 
of cases/treatments. Preceptor forms will be revised to add a warning 
that 18 U.S.C. Section 1001 Act of June 25, 1948, 62 Stat. 749, makes 
it a criminal offense to make a willfully false statement or 
representation to any department or agency of the United States as to 
any matter within its jurisdiction.
    The Commission believes that individuals should demonstrate 
sufficient knowledge in radiation safety commensurate with the use 
requested by passing an examination given by an organization or entity 
approved by the Commission or an Agreement State. The Commission is 
soliciting specific comment on whether the requirement for an 
examination to verify competency is warranted, in light of current 
industry practice. Appendix A of the proposed rule provides the 
requirements for an examining organization or entity, examination 
programs, and written examinations. Of particular note is the 
requirement that procedures be established to ensure that examinations 
are not given to individuals who have also been instructed by the 
examining organization in the same subject area. This proposed 
requirement is consistent with current practices of medical specialty 
boards and was suggested for inclusion by ACMUI members. The Commission 
is also soliciting specific public comment on whether this proposed 
requirement is too prescriptive.
    It is expected that examinations will be specific to the risk 
associated with the medical use of the byproduct material. For example, 
it is reasonable to expect that one exam could be used to address an 
authorized user's competency for the medical use of material pursuant 
to Secs. 35.100, 35.200, and 35.300, and that another examination would 
be needed to assess competency for use pursuant to Secs. 35.400 and 
35.600. The Commission plans to discuss the examination process with 
stakeholders at the facilitated public meetings scheduled to be held 
during the comment period of this rulemaking.
    NRC expects that it will take approximately 2 years for the 
industry to submit required information, to NRC or an Agreement State, 
for approval of specialty boards or organizations providing the exam 
and for NRC to approve the boards or examining organizations. This 
expectation is based on written and verbal support, received from 
professional organizations, for training and experience requirements 
that would require written examinations to assess competency and, on 
statements made by members of specialty boards

[[Page 43523]]

indicating that only minor changes would need to be made to their 
current certification process to address the changes proposed by the 
Commission. The Commission anticipates that specialty boards and 
examining organizations will be prepared to submit requests for 
approval immediately following publication of the final rule. 
Nevertheless, the Commission is soliciting specific public comment on 
the amount of time that specialty boards and examining organizations 
will need to prepare and submit an application for approval of the 
Commission or an Agreement State.
    Since NRC expects that it will take approximately 2 years to 
complete approval of most specialty boards and examining organizations, 
NRC has maintained the current training requirements in subpart J of 
the proposed rule. As discussed under the Supplementary Information 
section of this document, for a 2-year period after publication of the 
final rule, licensees will have the option of meeting either the 
requirements in subpart J or the requirements in subparts B and D-H. 
After the 2-year period, the requirements in subpart J will be deleted, 
and the licensee will need to comply with the requirements in subparts 
B and D-H.

B. Quality Management Program

1. Facilitated Workshops
    Workshop participants expressed both support for the quality 
management program and opposition to it. Those who support it described 
several benefits of the program, including the requirement for 
licensees to have a quality management program and related requirements 
for ``recordable events'' and written directives. Opponents of the 
quality management program rule described it as overly prescriptive, 
burdensome on licensees, and ineffective in reducing the number of 
misadministrations. According to certain participants, the current 
quality management program rule interferes with quality medical care. 
Many believed that the current quality management rule did little to 
reduce the number of misadministrations.
    Some participants who did not support the quality management 
program expressed support for a performance-based rule that would not 
require licensees to submit the quality management program for 
regulatory approval. In their opinion, a performance-based rule would 
also provide a licensee with the flexibility to custom-tailor a quality 
management program to meet that facility's quality management needs, 
including patient verification, ensuring that physician's directions 
are written, and verifying doses to patients. Some participants 
proposed that NRC work with other organizations or agencies to ensure 
quality assurance through other mechanisms in place. Another 
recommendation was that the proper way to reduce misadministrations is 
through better training and ensuring, during the licensing process, 
that personnel are qualified.
2. Agreement States Workshop
    Some Agreement States and members of the public agreed that the 
current quality management rule has not addressed the problem of 
misadministrations. In addition, they do not believe that the quality 
management rule goes beyond what would typically be considered 
``quality management.'' They believe that modifying the quality 
management program will not solve that problem.
    Agreement States supported an option that would state the 
objectives of a quality management program (without being 
prescriptive), but would not require a written quality management 
program. Other States believed that the responsibility for quality 
management should lie exclusively with the medical facility, not with a 
regulatory agency.
    A member of the public advocated, in lieu of a quality management 
program, a training requirement for technicians and a requirement that 
a physician be present whenever a therapeutic dose is administered. The 
individual stated that the latter requirement has significantly reduced 
the number of misadministrations in her State. Another member of the 
public suggested that a proposed rulemaking by the Health Care 
Financing Administration (HCFA) was expected to define three levels of 
supervision for imaging modalities. He explained that physicians would 
be required to be in the facility, if not in the room, when a dose was 
being administered in diagnostic nuclear medicine.
3. ACMUI
    Requirements for a quality management program have been discussed 
on numerous occasions with the ACMUI. At the September 1997 meeting, 
the Committee recommended that the Commission pursue development of a 
rule that would state only the objectives for a quality management 
program. At the March 1998 meeting, the ACMUI discussed the NRC staff's 
proposed revisions to the quality management program. The ACMUI agreed 
with the NRC staff's proposal to delete the requirements for a quality 
management program. Although the ACMUI would have preferred deletion of 
the requirement for written directives and the reference to assuring 
high confidence that the patient's or human research subject's identity 
is verified and that each administration is in accordance with the 
written directive, it recognized that the Commission finds these 
objectives to be fundamental.
4. Written Comments
    Approximately 10 written comments were submitted to the Commission 
on the quality management program. The majority of the comments favored 
deletion of any requirements in this area. Most believed that there 
were industry standards in place that adequately addressed 
administration of byproduct material; the rule intruded into medical 
practice; and regulation in this area was onerous. One professional 
society recommended that the title be changed to ``Quality Assurance 
and Patient Safety Regulations'' and believed that the regulations 
should be limited to requiring written prescriptions for therapy; 
requiring licensees to develop quality assurance programs for treatment 
planning and delivery devices; and requiring that independent checks be 
made against the written prescription before completion of a treatment. 
A limited number of commenters believed that the current requirements 
should be maintained because the quality management program provides a 
mechanism for reporting events and because licensees have already 
developed quality management plans that meet the intent of the rule.
5. Resolution
    The Commission has deleted the requirement for a quality management 
program. However, the Commission believes there are three elements of 
the current quality management program that should be addressed in the 
proposed rule: confirming patient identity, requiring written 
directives, and verifying dose. The Commission believes that some 
elements of the current quality management program requirements will 
continue to be implemented as part of the ``standard of care'' in 
medicine. In this regard, the Commission acknowledges that other 
factors, such as accreditation, have resulted in medical institutions 
adopting programs similar to those previously specified in the rule.

[[Page 43524]]

C. Reportable Events

1. Facilitated Workshops
    The participants generally agreed that current threshold levels for 
reporting are too low and supported raising threshold levels. However, 
some participants supported the option of maintaining the current 
thresholds, arguing that they were familiar with the levels and reports 
and records of misadministrations are necessary. Participants agreed 
that threshold levels for recording and reporting events should be 
based on risk. Several participants argued that threshold levels for 
reportable events and Abnormal Occurrences should be the same. The NRC 
was commended for suggesting that the term ``misadministration'' be 
replaced with the term ``reportable event.''
2. Agreement State Workshop
    Discussion focused on the topic of precursor events, rather than on 
the threshold for reportable events. There was, however, a very brief 
discussion on reporting of misadministrations. Various statements made 
during the discussion included: regulatory agencies did not need to be 
informed of misadministrations, unless an event exceeded certain levels 
or occurred more than once; licensee management, rather than a 
regulatory agency, should be informed of misadministrations; and 
regulatory agencies should confirm, during periodic inspections, that 
licensee management is informed in cases of misadministrations, and 
that proper corrective actions are taken.
3. ACMUI
    The ACMUI discussed the threshold for reportable events at the 
September 1997 and March 1998 meeting. At the September 1997 meeting, 
the Committee reached a consensus, recommending that the current 
criteria for radiopharmaceutical misadministrations be reduced from 
three categories to two. The two categories would be 
``radiopharmaceuticals not requiring a written directive'' and 
``radiopharmaceuticals requiring a written directive.'' The Committee 
pointed out that there is a major deficiency in the current 
misadministration definition, i.e., there is no threshold dose for 
wrong treatment site. They also stated that the reporting mechanism 
should be decoupled from patient notification. Finally, they agreed 
that an underdosage, if corrected in a clinically timely manner, should 
not have to be reported.
    At the March 1998 ACMUI meeting, the NRC staff presented a proposed 
revision of the current reporting criteria. The proposed reporting 
requirement contained a dose threshold and modality-based criteria. The 
ACMUI discussed the proposed criteria and offered suggestions for minor 
technical corrections, but did not make a formal recommendation in this 
area. The Committee recognized that the NRC staff was still making 
changes in the proposed text to address the wrong treatment site and 
patient intervention.
4. Written Comments
    Sixteen comments were received in this area. Two of the commenters 
recommended raising the reporting threshold to the NRC's Abnormal 
Occurrence criteria for misadministrations. Several commenters provided 
general comments on the reporting criteria, including a name change 
from ``misadministration'' to ``medical event.'' The remainder of the 
commenters provided specific recommendations for changes to the current 
reporting criteria, including recommendations for addressing patient 
intervention and wrong treatment site.
5. Resolution
    The Commission has a statutory responsibility to keep Congress and 
the public informed of incidents or events which the Commission 
considers significant from the standpoint of public health and safety. 
These criteria are specified in NRC's Abnormal Occurrence Policy 
Statement, dated April 17, 1997 (62 FR 18820). Licensees must provide 
NRC with information on events meeting these criteria, in order for NRC 
to make needed reports to Congress.
    The term ``misadministration'' has been deleted. The proposed rule 
would require licensees to report ``medical events.'' The criteria for 
a medical event is based on the current requirements in Sec. 35.33, 
Notifications, reports, and records of misadministrations. Minor 
changes were made to make the reporting threshold dose-based, where 
possible, and to address two areas that have caused problems in 
implementing the current requirements in Sec. 35.33, Patient 
intervention and wrong treatment site.

D. Precursor Events

1. Facilitated Workshops
    Participants in the facilitated public workshops, as well as 
members of the public, believe that:
    (1) There are already adequate mechanisms in place for identifying 
precursor events;
    (2) Additional requirements for notifying NRC about precursor 
events could result in a significant financial burden for both NRC and 
licensees without an associated incremental increase in safety;
    (3) Because of the nature of precursor events, it will be hard to 
precisely define a precursor event in rule language; and
    (4) Inclusion of a requirement for reporting precursor events could 
lead to an additional basis for enforcement action.
2. Agreement State Workshop
    The discussion on this subject focused on how to identify 
``precursor events.'' Many of the participants opposed adding 
additional requirements for reporting precursor events. According to 
some Agreement States, mechanisms are already in place to provide 
information to licensees about incidents which may be ``precursors'' to 
reportable events. Most States were in favor of identifying precursors, 
but believe notification should be limited to facility management 
(especially the radiation safety organization). Some participants noted 
that reporting those events to a regulatory agency could actually 
inhibit their identification. They did, however, support internal 
programs for identifying precursor events. Finally, they stated that 
reporting to NRC or to the Agreement States would not be helpful unless 
a mechanism existed to share the information with the industry.
    A member of the public noted that there are numerous event 
reporting requirements under which medical institutions document 
problem areas and conduct audits of potential problem areas. The 
individual encouraged NRC to avoid duplicating already existing 
programs.
3. ACMUI
    The ACMUl discussed the best way to capture precursor events at its 
September 1997 and March 1998 meetings. At the September 1997 meeting, 
most Committee members supported voluntary reporting of precursor 
events, provided there would be no punitive action taken by NRC against 
a licensee as a result of a report. One member recommended against 
reporting of precursors, whether mandatory or not, if it was going to 
have significant resource implications for NRC or the licensee.
    At the March 1998 meeting, the ACMUl considered three alternatives 
proposed by NRC staff:
    (1) Require reporting of conditions or incidents related to the use 
of radionuclides in medicine that caused or could cause serious injury 
to a

[[Page 43525]]

patient, human research subject, worker, or the public;
    (2) Require reporting deficiencies in equipment or procedures 
supplied by a manufacturer or vendor that, in the opinion of the 
Radiation Safety Officer, could lead to a medical event at that 
facility or could have detrimental health and safety implications 
beyond the licensee's facility; and
    (3) Rely on current NRC reporting requirements in 10 CFR parts 20, 
21, and 30 and the Memorandum of Understanding with the U.S. Food and 
Drug Administration and monitor/establish a system with U.S. 
Pharmacopeia to review its database on event reports.
    The ACMUI acknowledged that the Commission wanted to capture 
precursor events. The ACMUI believed that it was appropriate to clearly 
define and limit the type of events that would be required to be 
reported in order to minimize the resource burden on licensees and the 
NRC. The ACMUI recommended that the NRC staff pursue the second 
alternative, with minor adjustments.
4. Written Comments
    Approximately five written comments were received on capturing 
precursor events. One commenter indicated that NRC should develop a 
nonpunitive method of capturing information while minimizing the burden 
on licensees, citing the FDA device malfunction reporting system as a 
model. Three other commenters felt that precursor events were not 
specifically enough defined (in an earlier draft of the proposed rule) 
and recommended that they not be included in the proposed rule. Of the 
remaining two commenters, one commenter did not support reporting 
precursor events under any condition, while the other supported 
voluntary reporting.
5. Resolution
    The proposed rule does not contain a requirement for licensees to 
report precursor events to the NRC. Based on comments received from the 
public, the Commission believes that there are existing regulations in 
place that contain sufficient requirements for licensees to identify 
and report events to the Commission. The Commission plans to issue an 
Information Notice to remind licensees of the current reporting 
requirements and to reinforce the need for compliance with these 
requirements.

E. Radiation Safety Committee

1. Facilitated Workshops
    Workshop participants expressed different opinions about the 
benefits of radiation safety committees. Some participants stated that 
although radiation safety committees may be beneficial, the time and 
resources that must be devoted to managing the committees are excessive 
and the specific requirements in the regulation are overly prescriptive 
and not risk-based. Many participants believed that licensees should be 
given more flexibility in how they administer radiation safety 
programs. Some participants also expressed concern that the radiation 
safety committee may not be necessary for effective radiation safety 
management at small medical institutions.
    Some participants believed that a single committee, focused on 
radiation safety, was an important element of a radiation safety 
program and, therefore, recommended that the requirement for a 
committee be maintained. They believed that the committee enhanced 
communication between disciplines and departments. They were concerned 
that, without a requirement for a radiation safety committee, 
administrative support for the committee would decline and there would 
be decreased management involvement in the radiation safety program.
2. Agreement States
    Discussions at the workshop centered around two issues:
    (1) Whether the radiation safety committee plays a valuable role in 
all medical institutions, regardless of size and use of byproduct 
material; and
    (2) Whether the current radiation safety committee requirements in 
Part 35 are too prescriptive and should be relaxed.
    The majority of the participants in the workshop argued that the 
radiation safety committee requirements should recognize the 
differences between large and small institutions and between low-and 
high-risk procedures. Participants asserted that a radiation safety 
committee is unnecessary at smaller, diagnostic facilities. They 
generally supported the lessening of prescriptive requirements for 
smaller, diagnostic facilities. They argued that regulations place an 
unnecessary burden on facilities that conduct few procedures per year 
but still are required to conduct quarterly meetings. Another 
participant opposed a prescriptive rule, but acknowledged that it would 
be simpler to enforce than a performance-based rule.
3. ACMUI
    Requirements for a radiation safety committee were discussed with 
the ACMUI at its September 1997 and March 1998 meetings. At the 
September 1997 meeting, the ACMUI recommended that the NRC staff pursue 
developing a requirement for radiation safety committees at 
institutions that perform high-risk procedures. Facilities that use 
diagnostic, low-dose, sealed and unsealed byproduct material would not 
be required to have a radiation safety committee.
    At the March 1998 meeting, the ACMUI agreed with the Commission's 
proposed deletion of the requirement for a radiation safety committee. 
ACMUI supported the addition of requirements for licensee management to 
approve licensing actions and minor revisions to the radiation safety 
program; and for a licensee to implement procedures for 
interdepartmental/interdisciplinary coordination of the licensee's 
radiation protection program. They believed that the proposed language 
would not prohibit a large organization from utilizing a radiation 
safety committee, but would, at the same time, reduce regulatory burden 
on small rural hospitals which have small staffs and where a committee 
may not be needed to manage the radiation protection program.
4. Written Comments
    Approximately 10 written comments were submitted regarding the 
requirement for a radiation safety committee. The majority of the 
comments favored retention of the requirement for a radiation safety 
committee at larger facilities. These commenters believed that a 
committee was an effective way to ensure that management is involved in 
the operation of the radiation safety program. They recommended that a 
``graded'' approach could be used in determining if a committee was 
needed, e.g., small facilities or facilities with limited use of 
material would not be required to have a committee. However, two 
commenters believed that the requirement for a radiation safety 
committee should be deleted in its entirety. Two others believed that 
the requirements should not be revised.
    The Commission recognizes that medical facilities normally have a 
number of committees examining various areas, including safety issues, 
in response to accreditation requirements, etc. Specification of the 
objectives to be met by the radiation protection program (in the 
proposed Sec. 35.24), rather than the particular mechanism to be used 
in meeting those objectives, is an effort to provide licensees 
flexibility in carrying out the responsibilities for radiation safety.

[[Page 43526]]

5. Resolution
    The Commission is proposing deletion of the requirement for a 
radiation safety committee. The Commission believes that key functions 
of the radiation safety committee could be transferred to licensee 
management and that the prescriptive requirements in the current rule 
should be deleted. The Commission believes that many institutions will 
continue to use a radiation safety committee to oversee use of 
radioactive material. However, it recognizes that radiation protection 
program oversight may be accomplished by other means. In particular, 
the Commission recognizes that medical facilities normally have a 
number of committees examining various areas such as environmental 
safety. These committees are typically formed in response to hospital 
accreditation requirements.
    In an effort to afford licensees flexibility in achieving the 
objectives of radiation safety, the proposed rule specifies objectives 
that must be achieved rather than specifying the mechanism to meet the 
objective. The proposed rule would require that the licensee approve 
licensing actions; individuals prior to allowing them to work as a 
Radiation Safety Officer, authorized user, authorized nuclear 
pharmacist, or authorized medical physicist; and radiation protection 
program changes that do not require a license amendment. The proposed 
rule also contains a requirement for the licensee to develop, 
implement, and maintain administrative procedures for 
interdepartmental/interdisciplinary coordination of the licensee's 
radiation protection program.

F. Notification Following a Misadministration or Medical Event

1. Facilitated Workshops
    Many participants believed that the current requirements for 
licensees to notify the NRC, the referring physician, and the patient 
of a misadministration is an intrusion into both the practice of 
medicine and the confidential patient-physician relationship. They 
stated that the decision whether to notify the patient should be left 
solely to the physician. Those participants asserted that medical 
``standards of practice,'' ``risk management'' practices of medical 
institutions, and tort law are the mechanisms that should address 
notification of patients.
    Therefore, according to these participants, Federal or State legal 
requirements for such notifications are unnecessary and inappropriate. 
Some participants believed that an authorized user would never withhold 
information from a referring physician because to do so would destroy 
the relationship between the authorized user and the referring 
physician.
    Workshop participants did not believe that the requirement for a 
licensee to provide a written report to the individual was appropriate. 
They believed that a report that was submitted to NRC may greatly 
magnify, in the patient's mind, the significance of the event, when in 
fact, a medical event could be of minimal safety significance. However, 
other participants stated that without the NRC requirement for patient 
and referring physician notification, the physician's ethical 
obligation to make these notifications must be strong. Some commenters 
believed that the exchange of information between physicians should 
extend to patients as well. The participants espousing this viewpoint 
believe that such requirements may be necessary to protect patients and 
their right to know of misadministrations.
2. Agreement State Workshop
    Some participants noted that legal requirements for protecting the 
privacy of patients vary from State to State and may differ from 
Federal requirements. Other participants stated that medical standards 
of practice, tort law, and medical institution risk management are 
mechanisms to address fundamental patient notification and, therefore, 
State or Federal requirements for such notification are unnecessary.
3. ACMUI
    Notification requirements have been discussed on numerous occasions 
with the ACMUI. The ACMUI most recently discussed the requirements in 
this area at its March 1998 meeting. The ACMUI continues to affirm its 
position that it does not support any Federal regulation requiring 
notification of physicians and patients. The committee strongly 
believes that patient notification of medical events should occur as 
part of the patient-physician ``fiduciary'' relationship, in which the 
``standard of care'' for a physician is to provide the patient with 
complete and accurate information.
4. Written Comments
    Three written comments directly addressed notification following a 
medical event. Two professional organizations recommended that the 
requirement be deleted. One State recommended that the requirement be 
maintained.
5. Resolution
    The Commission believes that the current requirements for notifying 
individuals following a misadministration should remain unchanged with 
the exception of substituting the term ``medical event'' for 
``misadministration.'' Changing terminology in this way responds to 
objections that the term ``misadministration'' has possible 
connotations of carelessness and harm, which is not always the case. 
Furthermore, the term ``medical event'' used in the proposed rule is 
consistent with the terms used to characterize events in other 
activities regulated by the NRC. The proposed rule would require that 
the licensee notify the NRC, referring physician, and the individual 
who is the subject of a medical event, unless the referring physician 
personally informs the licensee that he will inform the individual or 
that, based on medical judgment, telling the individual would be 
harmful. In the latter case, or if for example, the patient is a minor, 
or is unconscious and incapable of comprehending the information. It is 
expected that the licensee would report to the patient's responsible 
relative or guardian rather than to the patient. This position 
reaffirms statements made by the Commission, at the time the 
misadministration rule was proposed and/or promulgated (and later 
modified), that patient notification ``* * * recognizes the right of 
individuals to know information about themselves which is contained in 
records both inside and outside the Federal sector.'' ``Human Uses of 
Byproduct Material, Misadministration Reporting Requirements,'' (43 FR 
2927; May 7, 1978); ``Misadministration Reporting Requirements,'' (45 
FR 31701-31702; May 16, 1980); and ``Basic Quality Assurance Program, 
Records, and Reports of Misadministrations or Events Relating to the 
Medical Use of Byproduct Material,'' (55 FR 1439-1444; January 16, 
1990). The Commission also believes that patient notification enables 
patients, in consultation with their personal physicians, to make 
timely decisions regarding any remedial and prospective medical care. 
This approach would also codify existing industry standards [American 
Medical Association Principles of Medical Ethics] obligating physicians 
to provide complete and accurate information to their patients.
    This approach is consistent with the U.S. Food and Drug 
Administration (FDA) regulation and with how

[[Page 43527]]

Congress is addressing similar issues in the mammography area. In 
October 1992, Congress passed the ``The Mammography Quality Standards 
Act'' (Public Law 102-539) to establish national quality standards for 
mammography. In December 1993, the FDA promulgated interim regulations 
setting forth quality standards for mammography facilities. In October 
1997, the FDA issued a final rule that becomes effective in April 1999. 
The final rule requires that, in cases where ``FDA determines that the 
mammography program at a facility may present a serious risk to human 
health, a facility must notify the patients or their designees, their 
physicians or the public of action that may be taken to minimize the 
effects of the risk.'' Currently, the Senate has passed and the House 
is considering bills (S. 537 and H.R. 1289) to amend the Mammography 
Quality Standards Act to, inter alia, add a new section to the Act on 
patient notification. The bills will provide FDA with the authority to 
require a facility to notify patients (and their referring physicians) 
of, among other things, the potential harm resulting from mammograms 
that may have been of poor quality because of deficiencies in the 
mammography program at that facility.

G. General Comments

    In addition to the comments on the crosscutting issues discussed 
above, NRC received comments on specific sections of the rule and on 
several general topical areas. These comments are available for review 
in the NRC Public Document Room, 2120 L Street, NW. (Lower Level), 
Washington, DC. Comments on specific sections of the rule were taken 
into consideration in preparing the proposed rule. General comments are 
summarized below.
1. Process for Developing the Risk-Informed, Performance-based Rule
    a. Comments.
    Workshop participants and written commenters discussed development 
of a risk-informed, performance-based rule. Some commenters recommended 
that NRC not proceed with any revision of Part 35 until it had 
performed an adequate and comprehensive evaluation of the risks 
associated with medical use. They recommended that the assessment 
should be performed by an ``independent scientific organization'' and 
completed in advance of any rulemaking. The risk analysis should follow 
the guidelines outlined by the Presidential Commission on Risk 
Assessment and Risk Management.
    Some commenters did not believe that the current regulatory system 
makes optimal use of either NRC or licensee resources. They believed 
that NRC regulations and their associated paperwork burden inevitably 
contribute to the cost of providing clinically necessary procedures and 
may compromise the availability of the benefits of medical use of 
byproduct material. They recommended that NRC be guided by the 
following basic principles: rules should emphasize training and 
credentialling of professional staff deemed essential to safe 
operations, quality assurance and technical regulations should be based 
on available practice standards, and regulations should not be 
promulgated in the absence of a demonstrated risk to the public or 
patients.
    Some commenters believe that Part 35 is duplicative of the Food and 
Drug Administration (FDA) statutes and implementing regulations and 
does not provide any added overall benefits to the regulatory 
framework. They believed that the FDA regulatory scheme is 
comprehensive, requiring documentation of adverse effects relating to 
the use of all drug products, including radionuclides; regulations 
under 10 CFR Part 20 are adequate to protect health and safety; high-
risk medical use can be regulated on a case-by-case basis through 
licensing conditions; and some prescriptive license conditions can be 
offset by performance-based flexibility, which is preferable to 
prescriptive regulations of medical users.
    Finally, some commenters questioned the schedule for completion of 
the rulemaking. They believe that sufficient time must be provided to 
undertake a thorough effort to change the rule and for public comment 
on draft documents, including regulatory guides. They also believe that 
reorganization of Part 35 based on ``similar subject areas'' is 
appropriate, but the rule should include references to requirements in 
Part 20.
    b. Resolution.
    As a result of the NRC's Strategic Assessment and Rebaselining 
efforts, the NRC staff formed the Nuclear Byproduct Material Risk 
Review Group to develop a risk-informed, graded approach to regulating 
many material uses, including medical uses. The group's final 
recommendations are expected in the fall of 1998 and will be considered 
by the NRC staff during the Part 35 rulemaking process. The Commission 
considered input from a 1993 internal senior management review report; 
an external review report by the National Academy of Sciences, 
Institute of Medicine; and the information presented in the Strategic 
Assessment Direction-Setting Issue Paper Number 7 (DSI-7) prior to 
determining the role of NRC regulation in the medical use area. On the 
basis of these reviews, the Commission believes that Part 35 should be 
restructured into a risk-informed, more performance-based regulation. 
In developing the regulation, the Commission considered information on 
risk provided by members of the public and professional societies, 
professional medical standards of practice, and event databases 
maintained by NRC. The draft proposed rule reflects numerous changes 
from the existing requirements which reduce the regulatory burden to 
the average licensee.
2. Agreement State Compatibility
    a. Comments.
    Commenters recommended that NRC follow its Strategic Plan to work 
with Agreement States to assure protection of the public health and 
safety nationwide, especially where constraints due to inconsistent 
regulation result in barriers to accessibility of medical use involving 
radionuclides. One commenter suggested that Agreement States should not 
be required to adopt any of the revised rule or accompanying guidance 
documents.
    b. Resolution.
    The Working Group and Steering Group established to revise Part 35 
are comprised of NRC staff, as well as representatives of two Agreement 
States and a non-Agreement State. One of the Agreement State 
representatives on the Working Group is also a member of the Conference 
of Radiation Control Directors' Suggested State Regulation Committee on 
Medical Regulation, which is working toward parallel development of 
suggested state medical use regulations. The Working and Steering 
Groups received input from the Agreement States at several times during 
the rulemaking process. NRC representatives met with representatives of 
the Agreement States during the October 1997 All Agreement States 
Meeting. Agreement State representatives were invited participants at 
the facilitated public meetings. One Agreement State representative 
provided written comment during the early input stages of the proposed 
rule development.
    The Commission has reviewed the proposed rule for issues of 
compatibility for Agreement States. Specific designations for the 
proposed rule are discussed under Section IX of the Supplementary 
Information section of this document.

[[Page 43528]]

3. Licensing and Enforcement Actions
    a. Comments.
    Some commenters believed that NRC must change to a performance-
based compliance system in order to have a significant impact on the 
entire medical use program. They believed that no change would occur if 
the NRC deleted regulatory requirements but had license reviewers 
demand that licensees make equivalent commitments in license 
applications or add equivalent conditions to the license. Some 
commenters stated that licensees should be allowed to operate their 
radiation safety programs without ``procedure-by-procedure'' approval 
by NRC and that regulations should cover all necessary requirements. 
Commenters recommended that NRC abandon an adversarial enforcement 
strategy based on punishment for infractions.
    Commenters also believed that no change would occur if inspectors 
continued to apply regulatory and license requirements without regard 
to fault, and if inspectors continue the practice of issuing citations 
for minor regulatory requirements which can be attributed to normal 
human error and which have no safety significance. They stated that NRC 
must develop an enforcement system that allows for exercising clinical 
judgment, evaluating quality assurance policy deviations in terms of 
safety rather than legal significance, and accepting voluntary practice 
standards and measures of practice quality as the regulatory endpoints.
    b. Resolution.
    The proposed rule provides for an overall change in regulatory 
philosophy. Consistent with a risk-informed, performance-based approach 
to medical use licensing, the amount of information needed from an 
applicant to possess and use byproduct material would be reduced. An 
applicant for an NRC medical use license would have to submit a signed 
application, documentation of the training and experience of the 
individuals named on the license, and the facility diagram and list of 
instrumentation. While licensees would be required to develop, 
implement, and maintain procedures required by the regulations, they 
would no longer be required to submit these procedures as part of the 
license application. Furthermore, licensees will be provided maximum 
flexibility in developing their procedures because most of the 
requirements for procedures provide performance-based objectives to be 
achieved, rather than a list of prescriptive details that need to be 
addressed in the procedures.
    The NRC plans to review the enforcement policy as part of its 
overall revision of Part 35. This review will take into account written 
comments as well as those comments received during the facilitated 
public meetings that are scheduled to occur during the formal comment 
period.

IV. Discussion of Text of Proposed Rule

10 CFR Part 20--Standards for Protection Against Radiation

    Section 20.1301, Dose limits for individual members of the public, 
would be revised. The proposed rule responds to the petition from the 
University of Cincinnati by amending Sec. 20.1301 to allow a licensee 
the discretion to permit visitors to receive up to 5 mSv ( 0.5 rem) in 
a year from exposure to individuals who are not releasable pursuant to 
Sec. 35.75. Currently, visitors are limited to 1 mSv ( 0.1 rem).
    The Commission has used 5 mSv (0.5 rem) as a threshold for action 
in multiple locations in Parts 20 and 35. This threshold is used as 
both a dose limit and a reporting level. For example, Sec. 35.75 uses 
the 5 mSv (0.5 rem) as a dose limit for members of the public exposed 
to patients released pursuant to Sec. 35.75. The proposed change to 
Sec. 20.1301 would also use 5 mSv (0.5 rem) as a dose limit for 
visitors of confined patients. In contrast, however, the proposed 
changes to Sec. 35.3047, Report of a dose to an embryo/fetus or a 
nursing child, would establish a 5 mSv (0.5 rem) reporting threshold 
(reference Sec. 35.3047 for a more detailed discussion of the proposed 
change).
    In accordance with Sec. 35.75, patients containing radioactive 
material can be released from licensee control if the total dose to 
other individuals from exposure to the released patient is not likely 
to exceed 5 mSv ( 0.5 rem). The Commission recognizes that the 
provisions of Sec. 35.75 and the proposed revision to Sec. 20.1301(a) 
could result in rare instances in which certain individuals could 
receive a 10 mSv (1.0 rem) dose. For example, an individual could 
receive a 5 mSv (0.5 rem) dose while visiting a patient who can not be 
released pursuant to Sec. 35.75, and then later receive a 5 mSv (0.5 
rem) because of exposure from the released patient. The Commission 
believes that the authorized user is the appropriate individual to 
evaluate, on a case-by-case basis, the merits of allowing a visitor to 
receive this potential additional dose and would do so only when it is 
warranted by the situation.
    A potential consequence of this rulemaking is that pregnant 
visitors would not be excluded automatically from visiting individuals 
who could not be released pursuant to Sec. 35.75. The pregnant visitor 
is subject to the same exposure limits that are applied to any other 
adult member of the public. The reasons for not excluding pregnant 
visitors under this rulemaking are two-fold. First, as noted in NCRP 
Commentary No. 11, members of a radionuclide therapy patient's family 
are likely to perceive that visitors will benefit from providing 
emotional and physical support to the patient during their treatment, 
and these visitors are likely to be willing to bear greater risk in 
order to achieve that benefit. Second, declaration of pregnancy by a 
prospective visitor is strictly voluntary. If a prospective visitor 
does not voluntarily declare her pregnant status, the authorized user 
is not expected to demand confirmation of the visitor's nonpregnant 
status.
    As stated earlier, the proposed revision to Sec. 20.1301 differs 
from the proposed revision to Sec. 35.3047. The revision to 
Sec. 20.1301 would revise the dose limit for a small population of 
individuals, namely visitors to individuals who can not be released 
pursuant to Sec. 35.75. In contrast, the proposed revision to 
Sec. 35.3047 would establish a reporting threshold for doses to an 
embryo/fetus or nursing child. For example, under the proposed 
Sec. 20.1301, a pregnant visitor could receive 5 mSv (0.5 rem) as a 
result of a visit to a patient who has not been released. Under the 
proposed revision to Sec. 35.3047, if the dose to an embryo/fetus 
exceeds 5 mSv (0.5 rem), as a result of an unintended administration to 
the mother, a report must be submitted to NRC. Finally, in the course 
of diagnosis and treatment, an authorized user may approve, in advance, 
an administration of byproduct material to a pregnant woman that may 
result in an absorbed dose to an embryo/fetus that exceeds 5 mSv (0.5 
rem).
    The Commission does not intend to require monitoring and recording 
of individual doses. The NRC evaluated the costs associated with 
monitoring individuals versus the benefits derived and determined that, 
at these low doses, monitoring is not justified. However, this does not 
preclude the licensee from monitoring and recording individual doses.

10 CFR Part 32--Specific Domestic Licenses to Manufacture or Transfer 
Certain Items Containing Byproduct Material

    Section 32.72, Manufacture, preparation, or transfer for commercial 
distribution of radioactive drugs containing byproduct material for

[[Page 43529]]

medical use under Part 35, would be revised as a result of the proposed 
revision of Part 35. Paragraph (b)(1) would be revised to reference the 
proposed Sec. 35.27 rather than the current Sec. 35.25 which would be 
deleted. This change was necessitated because of the proposed 
renumbering of some Part 35 sections. Paragraph (b)(2)(ii) would be 
revised to include both the proposed and current training and 
experience requirements for authorized nuclear pharmacists and to 
reference the proposed Sec. 35.59 rather than the current Sec. 35.972 
which would be deleted. As discussed in subpart J, the current training 
and experience requirements would be deleted 2 years after the 
effective date of the final rule.
    Section 32.74, Manufacture and distribution of sources or devices 
containing byproduct material for medical use, would be revised as a 
result of the proposed revision of Part 35. Paragraphs (a) and (a)(3) 
would be revised to add a reference to the proposed Sec. 35.600. The 
current section does not include a reference to medical use of sealed 
sources in therapeutic devices. This oversight would be corrected by 
the proposed rule.

10 CFR Part 35--Medical Use of Byproduct Material

    Subpart A, General Information, contains general information 
regarding medical use of byproduct material.
    Section 35.1, Purpose and scope, would be revised to specify that 
the requirements and provisions in Part 35 provide for the radiation 
safety of workers, the general public, patients, and human research 
subjects. Inclusion of the phrase ``patients, and human research 
subjects'' makes it clear that the provisions of this rule would apply 
to the radiation safety of those individuals. This addition is 
consistent with the proposed revision of the Medical Use Policy 
Statement that will be published separately in the Federal Register. 
The section would also be revised to add a reference to Part 171, 
``Annual Fees for Reactor Operating Licenses, and Fuel Cycle Licenses 
and Materials Licensed, Including Holders of Certificates of 
Compliance, Registrations, and Quality Assurance Program Approvals and 
Government Agencies Licensed By NRC.'' This revision would make it 
clear that the provisions in Part 171 apply to medical licensees.
    Section 35.2, Definitions, would be amended by deleting the 
definitions of ``ALARA,'' ``dental use,'' ``ministerial change,'' 
``misadministration,'' ``podiatric use,'' and ``recordable event'' 
because they do not appear in the proposed rule.
    The definitions for authorized nuclear pharmacist and authorized 
user would be revised to eliminate the specific board certifications by 
name and to refer to the specific section containing the requirements 
that the individual must meet to be considered an authorized nuclear 
pharmacist or an authorized user. Reference to the specific board 
certifications would be deleted because the proposed rule contains 
provisions for NRC to approve boards. The definition of ``authorized 
nuclear pharmacist'' would also be revised to recognize nuclear 
pharmacists that have been approved by a nuclear pharmacy that has been 
authorized by the Commission to approve authorized nuclear pharmacists.
    The definition of ``Radiation Safety Officer'' would be revised to 
include a reference to the specific requirements that an individual 
must meet in order to be authorized as a Radiation Safety Officer. This 
change was done to make the definition of Radiation Safety Officer 
consistent with the definitions of authorized nuclear pharmacist, 
authorized user, and authorized medical physicist.
    The definition of ``written directive'' would be revised to delete 
the provision for the date the directive was signed, and the signature 
of the authorized user before administration of any byproduct material 
or radiation from byproduct material to a specific patient or human 
research subject. These specific requirements have been moved to 
Sec. 35.40.
    The definition of ``teletherapy physicist'' would be deleted and 
replaced with a definition for ``authorized medical physicist'' because 
it is a broader term that includes physicists that work with all types 
of therapeutic units.
    The definition of ``mobile nuclear medicine'' would be deleted and 
replaced with a definition for ``mobile service'' because it is a 
broader term that would encompass all modalities that could be 
performed by a mobile service. A new definition would be added for 
``temporary jobsite.'' This is needed since it is used in defining 
``mobile service.'' The definition of ``temporary jobsite'' is based, 
in part, on the definition of ``temporary jobsite'' as used in 10 CFR 
Part 34, ``Licenses for Industrial Radiography and Radiation Safety 
Requirements for Industrial Radiographic Operations.''
    Definitions would be added for ``high dose-rate remote 
afterloader,'' ``low dose-rate remote afterloader,'' ``pulsed dose-rate 
remote afterloader,'' and ``stereotactic radiosurgery'' because use of 
these units would be addressed in Part 35. The definitions of ``high 
dose-rate remote afterloader'' and ``low dose-rate remote afterloader'' 
contain dose rates specific to each type of afterloader. The Commission 
is not proposing to define the term ``medium dose-rate remote 
afterloader'' since it is not used in the proposed rule. The Commission 
noted that there was very little difference between the regulatory 
requirements for a medium dose-rate remote afterloader and high dose-
rate remote afterloader and, therefore, has chosen to group the units. 
The Commission is soliciting public comment on whether the rule should 
specifically reference medium dose-rate remote afterloaders.
    A definition for ``medical event'' would be added and refers to the 
criteria listed in Sec. 35.3045(a), Reports of medical events. A new 
definition, ``precursor event,'' would be added and refers to the 
criteria listed in Sec. 35.3046(a). (Reference Section III, C, of the 
Supplementary Information section of this document for more detailed 
discussion.)
    A new definition, ``treatment site,'' would be added because it is 
used in Sec. 35.2045 of the proposed rule. A new definition, ``unit 
dosage,'' was added because it is used in Secs. 35.60 and 35.63 of the 
proposed rule.
    Section 35.5, Maintenance of records, would be revised to insert 
``and'' in the current phrase ``drawings and specifications.''
    Section 35.6, Provisions for research involving human subjects, 
would be unchanged. However, the Commission is soliciting comment on 
whether this section should be revised to require that licensees 
develop, implement, and maintain procedures for evaluating when a 
medical procedure would be considered to be a research procedure.
    Section 35.7, FDA, other Federal, and State requirements, would be 
unchanged.
    Section 35.8, Information collection requirements; OMB approval, 
would be revised to reflect the renumbering of some sections within the 
rule and the additional recordkeeping and reporting sections in the 
proposed rule.
    Section 35.10, Implementation, would be a new section that 
discusses the proposed provisions for implementing the final rule. A 
detailed discussion of the implementation provisions can be found in 
Section VIII of the SUPPLEMENTARY INFORMATION section of this document. 
This section would replace the current Sec. 35.999, Resolution of 
conflicting requirements during transition period.

[[Page 43530]]

    Section 35.11, License required, would be revised to reflect that 
the requirements for supervision in the current Sec. 35.25 would be 
replaced by the proposed requirements in Sec. 35.27.
    Section 35.12, Application of license, amendment, or renewal, would 
be revised.
    Paragraph (a) would be revised to state that any application for a 
license, amendment, or renewal must be signed by the management of the 
facility. The current rule indicates that any person may apply if the 
application is for medical use not sited in a medical institution and 
that only management may apply for a license if the application is for 
use in a medical institution. The Commission believes it is important 
that facility management apply for a license, regardless of where the 
material is used, because NRC holds the licensee responsible for any 
actions of its employees. Paragraphs (b) and (c) would be revised to 
more clearly state that separate applications must be submitted for 
medical uses listed in Sec. 35.600, other than remote afterloaders. 
Separate applications must be submitted for teletherapy and gamma 
stereotactic radiosurgery units because the scope and nature of 
information needed is much different than that needed for the other 
types of medical use. This requirement does not imply that the 
applicant has separate safety programs. Paragraphs (b) and (c) would 
also be revised to delete the reference to the Regulatory Guides. 
Guidance for completing an application may be found in draft NUREG-
1556, Vol. 9, ``Consolidated Guidance About Materials Licenses, 
Program-Specific Guidance about Medical Use Licenses.'' Draft NUREG-
1556, Vol 9, is available for inspection at the NRC Public Document 
Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of 
the draft NUREG are available as indicated in the FOR FURTHER 
INFORMATION CONTACT section of this document.
    Paragraph (d) would be added to address applications for medical 
use of byproduct material that are not specifically included in 
subparts D through H of the proposed rule, henceforth referred to as 
``emerging technologies'' (e.g., intravascular brachytherapy). The 
current rule does not provide for efficient licensing of emerging 
technologies. Paragraph (d) would provide a generic list of the 
information needed by NRC to approve a use that is not specifically 
addressed in subparts D through H of the proposed rule.
    Section 35.13, License amendments, would be revised to reflect the 
new numbering as a result of the overall revision of Part 35. Paragraph 
(b) would be revised to indicate that a licensee does not need to amend 
its license before allowing anyone to work as an authorized medical 
physicist if that individual meets the training and experience 
requirements in Sec. 35.51 or Sec. 35.961, and the requirements were 
met within the 7 years preceding the date of the application. Paragraph 
(c) would be revised to delete the requirement for licensees to amend a 
license if the teletherapy physicist changes provided the individual 
meets the requirements in Secs. 35.51(a) and 35.59 or Secs. 35.961 and 
35.59. This change is consistent with existing licensing requirements 
for authorized users and authorized nuclear pharmacists.
    The Commission recognizes that unusual conditions may arise when 
the Radiation Safety Officer leaves a facility with little to no 
advance warning. In this event, the licensee may want to consider using 
an authorized user to fill the position, pending appointment of a new 
Radiation Safety Officer. Under these conditions, the licensee must 
move expeditiously to permanently fill the position of Radiation Safety 
Officer. In these situations, the licensee should contact the 
appropriate NRC regional office and explain the situation.
    In order to reduce regulatory burden, paragraph (e) would be 
revised to delete the requirement for a licensee to apply for a license 
amendment if there is a change in the areas where byproduct material is 
used for diagnostic purposes pursuant to Secs. 35.100 and 35.200. For 
example, a licensee would not be required to apply for a license 
amendment to move a scan room in a diagnostic nuclear medicine 
department that uses byproduct material in quantities that would not 
require a written directive. However, this provision does not apply to 
any storage or waste areas because of the potential for large 
quantities of materials to accumulate in these areas and the 
possibility of commingling of radioactive material that is used 
pursuant to other sections of the rule. Paragraph (f) would require an 
amendment if the licensee changes the address of use. For example, an 
amendment would be required if the licensee initiates use or storage of 
byproduct material at a new physical location that is under its 
control.
    Section 35.14, Notifications, would be revised. Paragraph (a) would 
be revised to include a requirement for the licensee to notify NRC no 
later than 30 days after the date the licensee permits an individual to 
work as an authorized medical physicist pursuant to Sec. 35.13(b). 
Paragraph (b) would be revised to require that the licensee notify NRC 
when an authorized medical physicist permanently discontinues 
performance of duties under the license. Paragraph (b) would also be 
revised to require that a licensee notify NRC when the licensee changes 
its name. This provision applies only if there is no change in 
ownership, as described in Sec. 30.34 of this chapter. Otherwise, the 
licensee must take appropriate action to have its license amended prior 
to such change in ownership. A licensee must also notify NRC of any 
changes in areas where materials are used pursuant to Secs. 35.100 and 
35.200. These revisions were warranted because of requirements in the 
proposed Sec. 35.13.
    Section 35.15, Exemptions regarding Type A specific licenses of 
broad scope, would be revised to add the term ``authorized medical 
physicist'' to paragraph (d). This revision is needed because of the 
requirements in the proposed Sec. 35.13. Under this proposed section, 
broad scope licensees would have authority to appoint authorized users, 
authorized nuclear pharmacists, or authorized medical physicists 
without notifying NRC, provided the individuals meet approved criteria 
in subparts B, D-H, and J.
    A new paragraph (e) would be added to also exempt these licensees 
from Sec. 35.49(a). This change would codify in the regulations an 
exemption that is currently provided to these licensees through a 
standard condition. NRC's medical use licensees with a Type A specific 
license of broad scope currently receive a standard license condition 
that exempts the licensee from receiving sealed sources or devices 
manufactured only from licensees with medical distribution licenses 
issued pursuant to Sec. 32.74. This change would replace the license 
condition.
    Section 35.18, License issuance, would be revised. Requirements for 
a mobile service license would be added as paragraph (b). The NRC will 
issue a license for mobile service if the applicant meets the 
requirements specified in paragraph (a) of the section and if the 
individual or human research subject to whom the applicant administers 
byproduct material, or radiation from byproduct material, may be 
released following treatment in accordance with Sec. 35.75. The later 
condition is necessary because mobile service licensees will not have 
the capability of controlling individuals that cannot be released 
pursuant to Sec. 35.75.
    Section 35.19, Specific exemptions, would be revised to delete the 
statement that the Commission will review requests for exemptions from 
training

[[Page 43531]]

and experience requirements with the assistance of its Advisory 
Committee on the Medical Uses of Isotopes. This statement is a matter 
of Commission policy rather than a regulatory requirement.
    Subpart B, General Administrative Requirements, contains general 
administrative requirements regarding medical use of byproduct 
material.
    Section 35.20, ALARA program, would be deleted in its entirety from 
Part 35. ALARA is discussed in 10 CFR 20.1101, ``Radiation protection 
programs,'' and medical licensees must comply with the requirements of 
that section. That section requires, in part, that a licensee develop, 
document, and implement a radiation protection program and use, to the 
extent practicable, procedures and engineering controls to achieve 
occupational doses and doses to members of the public ALARA. The 
Commission does not believe that Sec. 35.20 is needed in light of the 
requirements in Sec. 20.1101. A medical use licensee should have 
flexibility in developing and implementing a radiation protection 
program that meets the requirements of Part 20.
    Section 35.21, Radiation Safety Officer, would be deleted in its 
entirety from Part 35. The requirements of paragraph (a) would be moved 
to the proposed Sec. 35.24. Paragraph (b) would be deleted because it 
is overly prescriptive and in some cases overlaps with the requirements 
in Sec. 20.1101. The Commission believes that the licensee should have 
the flexibility in developing, maintaining, and implementing its 
radiation protection program, including establishing the Radiation 
Safety Officer's duties.
    Section 35.22, Radiation safety committee, would be deleted in its 
entirety. The issue of whether NRC should require a Radiation Safety 
Committee was identified as a cross-cutting issue and, therefore, was 
discussed at the public meetings and workshops held in Fall 1997. 
Comments received on this topic are discussed in Section III of the 
SUPPLEMENTARY INFORMATION section of this document. Based on the 
comments received prior to March 1, 1998, the Commission believes that 
key functions of the Radiation Safety Committee could be transferred to 
licensee management (reference proposed Sec. 35.24) and that the 
prescriptive requirements in the current Sec. 35.22 should be deleted. 
The Commission believes that many institutions will continue to use a 
Radiation Safety Committee to oversee use of radioactive material. 
However, it recognizes that radiation program oversight may be 
accomplished by other means. In particular, medical facilities normally 
have a number of committees examining various areas, such as 
environmental safety. These committees are typically formed in response 
to hospital accreditation requirements. Specifying responsibilities and 
functions to be accomplished, rather than the particular mechanism to 
be used, is an effort to afford licensees flexibility in achieving the 
objective of radiation safety (reference Sec. 35.24).
    Section 35.23, Statements of authority and responsibilities, would 
be deleted in its entirety and the requirements of this section, with 
minor modifications, would be moved to the proposed Sec. 35.24.
    Section 35.24, Authority and responsibilities for the radiation 
protection program, would appear as a new section. This requirement 
specifies objectives that must be achieved, rather than specifying how 
the objective is to be met, in an effort to afford licensees 
flexibility in achieving the objective of radiation safety.
    Paragraphs (a) and (b) would replace the current requirements for 
the Radiation Safety Committee. The licensee is responsible for 
approving licensing actions; individuals before allowing them to work 
as a Radiation Safety Officer, authorized user, authorized nuclear 
pharmacist, or authorized medical physicist; and radiation protection 
program changes that do not require a license amendment.
    The licensee must develop, implement, and maintain administrative 
procedures for interdepartmental/interdisciplinary coordination of the 
licensee's radiation protection program. Interdepartmental/
interdisciplinary coordination is believed to be a major component of 
an effective radiation protection program. The Commission recognizes 
that there are many ways to meet this objective and believes that the 
licensee should have flexibility in identifying and implementing the 
most appropriate modes of coordination at its facility. Identified 
alternatives include, but are not limited to, meetings, electronic 
transfer of information, or verbal communication. This requirement 
applies to all medical use licensees and it is expected that the extent 
of the coordination will be dependent on the complexity of the 
licensee's program.
    The requirement in paragraph (c) to appoint a Radiation Safety 
Officer is currently required by Sec. 35.21. The proposed paragraph 
would require that the Radiation Safety Officer agree, in writing, to 
be responsible for implementing the radiation protection program. The 
requirements in paragraphs (d) and (e) are similar to the requirements 
in the current Sec. 35.23. A record of management's approval of actions 
in paragraph (a); written acceptance of Radiation Safety Officer duties 
as specified in paragraph (c); and the duties, responsibilities, and 
authority of the Radiation Safety Officer specified in paragraph (d) 
would have to be maintained in accordance with Sec. 35.2024, Records of 
authority and responsibility for radiation protection programs.
    The Commission is soliciting specific public comment on changes 
made in the rule that could impact the licensee's effectiveness in 
carrying out its radiation protection program, e.g., proposed deletion 
of the requirement for a Radiation Safety Committee and proposed 
requirement for the Radiation Safety Officer to acknowledge, in 
writing, responsibility for implementing the radiation protection 
program. In particular, the Commission is seeking comment in the 
following areas: (1) whether this combination of changes in the 
proposed rule may actually reduce the effectiveness of radiation 
protection programs; and (2) whether the radiation safety officer will 
be provided appropriate tools and channels through which to raise 
safety concerns to the highest levels of management. Finally, if the 
requirement for a committee, to oversee the radiation protection 
program, was included in the final rule, the Commission is seeking 
comment on whether the rule language should explicitly require that the 
radiation safety officer be a member of that committee.
    Section 35.25, Supervision, would be deleted in its entirety and 
the requirements of this section, with minor modifications, would be 
moved to the proposed Sec. 35.27.
    Section 35.26, Radiation protection program changes, would appear 
as a new section. The requirements in this section are similar to the 
requirements in the current Sec. 35.31, which would be deleted. The 
proposed section states that a licensee may revise its radiation 
protection program without Commission approval if the revision does not 
require an amendment in accordance with Sec. 35.13; the change will not 
reduce radiation protection; the change has been reviewed and approved 
in writing by the Radiation Safety Officer and licensee management; and 
the affected individuals have been instructed on the revised program 
before the changes are implemented. This requirement provides the 
licensees with flexibility to manage their radiation

[[Page 43532]]

protection programs and clearly defines the situations that will not 
require an amendment. The Commission believes that many licensees were 
reluctant to make changes to their current program because the term 
``ministerial changes,'' as defined in the current Sec. 35.2 and as 
used in the current Sec. 35.31, was not clearly understood. This change 
is intended to provide clear guidance to a licensee on when it can 
revise its radiation protection program without Commission approval.
    The Commission believes that it is important to instruct 
individuals in program changes, including those permitted under 
Sec. 35.26, before they are implemented. This instruction could be 
provided in writing or orally and may be conducted on an informal or 
formal basis. It is not necessary to document that this training has 
been provided to affected parties, because these changes should not 
reduce radiation safety. At the time of inspection, NRC inspectors may 
question whether this training was provided.
    Section 35.27, Supervision, would appear as a new section. The 
requirements in this section are similar to the requirements in the 
current Sec. 35.25, which would be deleted. Paragraph (a)(1) and (b)(1) 
would be revised to delete the requirement to instruct individuals in 
the principles of radiation safety. This type of instruction is 
adequately addressed by Sec. 19.12, Instructions to workers, of this 
chapter. Paragraph (a)(1) would also be revised to require that the 
licensee instruct supervised individuals in the written radiation 
protection procedures, written directives procedures, regulations of 
this chapter, and license conditions. Paragraph (a)(2) would require 
the supervised individual to follow the instructions of the supervising 
authorized user for medical uses of radioactive material, written 
radiation protection procedures, regulations, and license conditions 
with respect to the medical use of byproduct material. Paragraphs 
(a)(3) and (b)(3) of the current Sec. 35.25 would be deleted because 
the licensee should have flexibility in evaluating employee 
performance. Paragraph (b)(2) would be revised to require supervised 
individuals to follow the instructions of the supervising authorized 
user or authorized nuclear pharmacist regarding the preparation of 
byproduct material for medical use, the written radiation protection 
procedures, and the regulations of this chapter and license conditions. 
Paragraph (c) would require that the licensee develop, implement, and 
maintain a policy for supervised individuals to request clarification, 
as needed, from the authorized user about instructions and requirements 
in a written directive prior to administering the byproduct material, 
or radiation from the byproduct material, and from the authorized user 
or authorized nuclear pharmacist about instructions and requirements 
provided in accordance with paragraphs (a) and (b) of the section. This 
change would be added so that a licensee's work environment would 
encourage supervised individuals to ask questions if they do not 
understand the instructions or requirements provided to them by an 
authorized nuclear pharmacist or an authorized user, especially when 
they have questions regarding administrations of byproduct material to 
patients or human research subjects. In the past, failure by licensee 
staff to ask questions has been identified as one of the key 
contributors to misadministrations.
    Section 35.29, Administrative requirements that apply to the 
provision of mobile service, would be deleted. The conditions for the 
Commission to issue a mobile service license would be moved to 
Sec. 35.18. The requirements in paragraphs (b) and (d) would be moved 
to the proposed Sec. 35.80. Paragraph (c) would be deleted because this 
requirement was viewed as overly prescriptive. Individuals are required 
to comply with all provisions of the license that authorizes use, 
possession and transfer of material.
    Section 35.31, Radiation safety program changes, would be deleted. 
The requirements, with minor changes, would be moved to Sec. 35.26. 
This change is proposed so that all requirements that pertain to the 
management of the licensee's program appear in one area.
    Section 35.32, Quality management program, would be deleted. The 
issue of whether the Commission should continue to require that a 
licensee develop, implement, and maintain a quality management program 
was identified as a cross-cutting issue and was discussed at the public 
meetings and workshops held in Fall 1997. Comments received on this 
topic are discussed in Section III of the Supplementary Information 
section of this document. Based on these comments, the Commission has 
deleted the requirements for a quality management program. However, the 
Commission believes there are three elements of the current quality 
management program that should be addressed in the proposed rule: 
confirming patient identity, requiring written directives, and 
verifying dose. Requirements for these three elements are found in 
proposed Secs. 35.40 and 35.41. However, the Commission believes that 
some elements of the current quality management program requirements 
will continue to be implemented as a part of the ``standard of care'' 
in medicine. In this regard, the Commission acknowledges that other 
factors, such as accreditation, have resulted in medical institutions 
to adopting programs similar to those previously specified in the rule.
    Section 35.33, Notifications, reports, and records of 
misadministrations, would be deleted. In this proposed revision, 
recordkeeping and reporting requirements contained in Part 35 would be 
moved to subparts L and M, respectively.
    Section 35.40, Written directives, would appear as a new section. 
This section contains requirements for preparation of written 
directives. These requirements are similar to the requirements in the 
current Secs. 35.2 and 35.32. Minor changes would be made in the 
information that must be placed in a written directive for gamma 
stereotactic radiosurgery, remote afterloaders, and brachytherapy. 
These changes were based on comments received during public meetings of 
the Part 35 Working Group.
    Section 35.41, Procedures for administrations requiring a written 
directive, would appear as a new section. It would require the licensee 
to develop, implement, and maintain written procedures to assure that, 
before each administration, the patient's or human research subject's 
identity is verified and that each administration is in accordance with 
the written directive, including verification of dose. It would also 
specify the objectives that should be addressed in the procedures. The 
specific details to be included in the written directives are in 
Sec. 35.40. The topics identified in Sec. 35.41 are viewed by the 
Commission as key elements of a program that will provide high 
confidence that byproduct material will be administered as directed by 
the authorized user. However, the regulations are not prescriptive as 
to how these objectives are met, allowing licensees the flexibility to 
develop procedures to meet their needs. There is no requirement for 
submittal or approval of the procedures as was previously required by 
the quality management rule.
    Section 35.49, Suppliers for sealed sources or devices for medical 
use, would be unchanged.
    Requirements in the current Sec. 35.50, with minor modifications, 
would be moved to the proposed Sec. 35.60.
    Section 35.50, Training for Radiation Safety Officer, would appear 
as a new

[[Page 43533]]

section that would revise the current requirements of Sec. 35.900, 
Radiation Safety Officer. Section III of the Supplementary Information 
of this document contains a detailed discussion of the Commission's 
proposed changes to the training and experience requirements in Part 
35. Note, 2 years after the final rule is published in the Federal 
Register, this section would replace the current requirements in 
Sec. 35.900, Radiation Safety Officer.
    Requirements in the current Sec. 35.51, with minor modifications, 
would be moved to the proposed Sec. 35.61.
    Section 35.51, Training for an authorized medical physicist, would 
appear as a new section that would revise the training and experience 
requirements found in Sec. 35.961, Training for an authorized medical 
physicist. Section III of the Supplementary Information section of this 
document contains a detailed discussion of the Commission's proposed 
changes to the training and experience requirements in Part 35. Note, 2 
years after the final rule is published in the Federal Register, this 
section would replace the requirements in Sec. 35.961, Training for 
authorized medical physicist.
    Section 35.52, Possession, use, calibration, and check of 
instruments to measure dosages of alpha- or beta-emitting 
radionuclides, would be deleted in its entirely and the requirements of 
this section, with minor modifications, would be moved to the proposed 
Sec. 35.63.
    Section 35.53, Measurements of dosages of unsealed byproduct 
material for medical use, would be deleted in its entirety and the 
requirements of this section, with minor modifications, would be moved 
to the proposed Sec. 35.63.
    Section 35.55, Training for an authorized nuclear pharmacist, would 
appear as a new section that would revise the training and experience 
requirements found in Sec. 35.980, Training for an authorized nuclear 
pharmacist. Section III of the Supplementary Information section of 
this document contains a detailed discussion of the Commission's 
proposed changes to the training and experience requirements in Part 
35. Note, 2 years after publication in the Federal Register, this 
section would replace the current requirements in Sec. 35.980, Training 
for an authorized nuclear pharmacist.
    Requirements in the current Sec. 35.57, with minor modifications, 
would be moved to the proposed Sec. 35.65.
    Section 35.57, Training for an experienced Radiation Safety 
Officer, teletherapy or medical physicist, authorized user, and nuclear 
pharmacist, would appear as a new section that would replace the 
current requirements in Secs. 35.901, 35.970, and 35.981, which would 
be deleted. Changes would be made in the regulatory text of this 
section to reflect the effective date of the rule.
    Requirements in the current Sec. 35.59, with minor modifications, 
would be moved to the proposed Sec. 35.67.
    Section 35.59, Recentness of training, would appear as a new 
section that would replace the current requirements in Sec. 35.972. 
Although this is not a new requirement, questions have recently been 
raised regarding whether all elements of the requirements must have 
been obtained in the last 7 years. It is expected that either the 
individual has been board certified or has completed the training 
specified in the alternative pathway within the 7 years preceding the 
date of the application or must have had related continuing education 
and experience since completing the required training and experience 
requirements. Continuing education is reviewed on a case-by-case basis. 
The text has been revised to reference subparts B, D, E, F, G, H and J 
since training and experience requirements appear in multiple subparts.
    Subpart C, General Technical Requirements, contains general 
technical requirements regarding medical use of byproduct material.
    Requirements in the current Sec. 35.60, with minor modifications, 
would be moved to the proposed Sec. 35.69.
    Section 35.60, Possession, use, calibration, and check of 
instruments to measure activity of photon-emitting radionuclides, would 
appear as a new section that would replace the current Sec. 35.50. This 
section addresses calibration of all instruments used to measure the 
activity of photon-emitting radionuclides, rather than only dose 
calibrators. The change recognizes that there are various types of 
instruments that can be used to measure the activity of photon-emitting 
radionuclides.
    The proposed rule would require that licensees develop, implement, 
and maintain procedures for use of the instrumentation. Licensees would 
be required to calibrate all instruments used to measure the activity 
of photon-emitting radionuclides.
    Licensees would be required by the proposed Sec. 35.63 to determine 
the activity of each dosage before medical use. If a licensee uses only 
unit dosages of radiopharmaceuticals, Sec. 35.63 would allow the 
licensee to determine the dosage by a decay correction based on the 
measurement by a manufacturer or preparer licensed pursuant to 
Sec. 32.72 or equivalent Agreement State. If a licensee chooses to 
determine the dosage using this method, it would not be necessary for 
the licensee to possess instrumentation to measure the activity of the 
photon-emitter. In this case, the licensee would not be required to 
comply with this section. If, however, a licensee chooses to re-assay a 
unit dosage to either confirm the activity or for the purpose of 
adjusting the dosage, the licensee must comply with this section. This 
requirement is appropriate because confirmation of a dosage, or 
adjustment of dosages, must be made based on properly-calibrated 
equipment.
    Many of the prescriptive requirements for calibration would be 
deleted from the current requirements in Sec. 35.50. The requirements 
that would remain are viewed by the Commission as essential elements of 
a calibration program and are generally consistent with the 
recommendations of ANSI N42.13-1986 (R 1993), ``Calibration and Usage 
of Dose Calibrator Ionization Chambers for the Assay of 
Radionuclides.'' Licensees would be required to perform accuracy, 
linearity, and geometry dependence tests before initial use and 
following repair; perform accuracy tests annually; perform linearity 
tests annually over the range of medical use; and check constancy and 
proper operation at the beginning of each day of use. Note, it would 
not be necessary to test for linearity for all activities that might be 
measured, e.g., the first elution from a fresh generator or a multidose 
vial, because this would subject the worker to an unnecessary radiation 
dose. Paragraph (c) would require that accuracy tests be performed 
using a source with a principle photon energy of between 100 and 500 
keV whose activity is traceable to the National Institutes of Standards 
and Technology (NIST). The allowance for a licensee to mathematically 
correct dosage has been revised to raise the level for correction to 30 
Ci to make the level consistent with Sec. 35.63. The allowance 
for a licensee to mathematically correct dosage readings remains, but 
has been re-numbered Sec. 35.60(d). The recordkeeping requirements for 
this section would appear in Sec. 35.2060, Records of instrument 
calibrations.
    Requirements in the current Sec. 35.61, with minor modifications, 
would be moved to the proposed Sec. 35.69.
    Section 35.61, Calibration and check of survey instruments, would 
appear as a new section that would replace the current Sec. 35.51. The 
requirement in the current Sec. 35.51(a)(3) to note the

[[Page 43534]]

apparent exposure rate from a dedicated check source, as determined at 
the time of calibration, and the daily check source requirement in 
paragraph (c) would be deleted. These changes would give the licensee 
greater flexibility in instrument calibrations. Paragraph (b) would 
require that the licensee attach a correction chart or graph to the 
instrument if the indicated exposure rate differs from the calculated 
exposure rate by more than 10 percent. Paragraph (c) would require that 
survey instruments be removed from use if the indicated exposure rate 
differs from the calculated exposure rate by more than 20 percent. 
Previously, there was no threshold for attaching a correction chart or 
for removing instruments from use. The requirements in this section are 
generally consistent with ANSI N323-1978 (R 1993), ``Radiation 
Protection Instrumentation Test and Calibration.'' The recordkeeping 
requirements for this section would appear in Sec. 35.2061, Records of 
radiation survey instrument calibrations.
    Section 35.62, Possession, use, calibration, and check of 
instruments to measure dosages of alpha- or beta-emitting 
radionuclides, would appear as a new section that would replace the 
current Sec. 35.52. This section addresses calibration of all 
instruments used to measure the activity of alpha- or beta-emitting 
radionuclides. Paragraph (a) from the current Sec. 35.52 would be 
deleted. This text is no longer needed since the term ``unit dosage'' 
has been defined in Sec. 35.2. The new paragraph (b) would require that 
a licensee develop, implement, and maintain written procedures for use 
of the instrumentation. The Commission recognizes that it may not be 
possible to test linearity and geometry dependency on all 
instrumentation. However, the Commission believes that all instruments 
used to measure alpha- or beta-emitting radionuclides can be tested for 
accuracy or constancy. The new paragraph (c) would require that 
accuracy tests be performed using sources whose activity is traceable 
to NIST. The recordkeeping requirements for this section would appear 
in Sec. 35.2060, Records of instrument calibrations.
    Section 35.63, Determination of dosages of unsealed byproduct 
material for medical use, would appear as a new section that would 
replace the current Sec. 35.53. This section would require licensees to 
determine and record the activity of each dosage before medical use. 
For unit dosages of an alpha-, beta-, or photon-emitting radionuclides, 
this determination must be made either by direct measurement or by a 
decay correction, based on the measurement made by a manufacturer or 
preparer licensed pursuant to Sec. 32.72 or equivalent Agreement State 
requirements. For other than unit doses, a licensee may determine the 
dosage by direct measurement or by combination of measurements and 
calculations. Previously, photon measurements could only be made by 
direct measurement. This action allows licensees flexibility in 
determining dosages and does not distinguish between the type of the 
radiation (e.g., alpha, beta, or photon) and the way the determination 
is made. Paragraph (d) would not permit a licensee to use a dosage if 
it differed from the prescribed dosage by more than 20 percent. This 
change would codify requirements that are currently imposed on 
licensees by license conditions. This does not prevent an authorized 
user from revising the prescribed dosage at any time prior to the 
administration. The recordkeeping requirements for this section would 
appear in Sec. 35.2063, Records of dosage measurements.
    Section 35.65, Authorization for calibration and reference sources, 
would appear as a new section that would replace the current 
Sec. 35.57. The references in the current Sec. 35.57, to Secs. 35.100 
and 35.200, would be deleted because specific radionuclides were not 
listed in these sections. Paragraph (b) in the current Sec. 35.57 would 
be revised to extend the half-life from 100 days to 120 days to be 
consistent with the financial assurance regulations in 10 CFR Part 30. 
The limit of 10-3 would be added to the regulation to allow 
receipt, possession, and use of radionuclides in quantities that do not 
exceed the limits requiring financial assurance. The possession limit 
for Tc-99m would be deleted. The Commission believes that it is not 
necessary to limit the possession of Tc-99m for calibration and 
reference sources because there are no possession limits for Tc-99m 
associated with use of Tc-99m pursuant to Secs. 35.100 or 35.200.
    Section 35.67, Requirements for possession of sealed sources and 
brachytherapy sources, would appear as a new section that would replace 
the current Sec. 35.59. Paragraph (b) would require that a source be 
tested for leakage before its first use, unless the licensee has a 
certificate from the supplier indicating that the source was tested 
within 6 months, and the source is tested for leakage at intervals not 
to exceed 6 months or at other intervals approved in the Sealed Source 
and Device Registry (SSDR).1 The SSDR certificates, in most 
cases, will include a requirement for leak-testing. Approved intervals 
for testing are based on information regarding source design 
construction that is provided by the manufacturer.
---------------------------------------------------------------------------

    \1\ A national registry that contains all the registration 
certificates generated by both NRC and the Agreement States. 
Registration certificates summarize the radiation safety information 
submitted by the applicant, and describe the licensing and use 
conditions approved for the product.
---------------------------------------------------------------------------

    Prescriptive requirements in the current Sec. 35.59(c) would be 
deleted to reflect the risk-informed, performance-based nature of this 
proposed rule. Paragraph (d) would require that leak test records be 
maintained in accordance with Sec. 35.2067, Records of possession of 
sealed sources and brachytherapy sources. Paragraph (e) would be 
revised to give the licensee two additional alternatives for action 
after a leaking source has been identified. The proposed rule would 
allow the licensee the added flexibility of repairing or disposing of 
the source, in accordance with 10 CFR parts 20 and 30, if the leakage 
test reveals the presence of 185 Becquerels (Bq) (0.005 microcuries) or 
more of removable contamination. The current rule only allows the 
licensee to withdraw the sealed source from use and store it in 
accordance with the requirements in 10 CFR parts 20 and 30. The 
licensee would still be required to report to NRC if a leakage test 
reveals the presence of 0.005 microcuries or more of removable 
contamination. Reporting requirements for this section would appear in 
Sec. 35.3059, Reports of leaking sources.
    Paragraph (g) of the current rule would be revised to change the 
frequency for source inventories from quarterly to semi-annually, to 
reduce the regulatory burden on licensees. It does not, however, 
preclude the licensee from conducting an inventory on a more frequent 
basis. Paragraph (h) of the current rule would be deleted because 
radiation surveys are addressed under 10 CFR Part 20. The recordkeeping 
requirements for this section would appear in Sec. 35.2067, Records of 
possession of sealed sources and brachytherapy sources.
    Section 35.69, Labeling and shielding of vials and syringes, would 
appear as a new section that would replace the current Secs. 35.60 and 
35.61. It would require licensees to develop, implement, and maintain 
procedures for labeling and shielding radiopharmaceuticals and instruct 
individuals in those procedures. Procedures must ensure that a syringe, 
syringe shield, or vial shield is conspicuously labeled as containing 
radioactive material and is labeled with the radiopharmaceutical

[[Page 43535]]

name. These requirements were needed because the Commission does not 
believe that the labeling and shielding requirements in Part 20 are 
sufficient to ensure that syringes, syringe shields, or vial shields 
are properly labeled to identify radioactive contents. In addition, the 
Commission believes that labeling helps to reduce administration 
errors. The proposed rule would require that licensees instruct 
individuals, commensurate with that individual's assigned duties, on 
the labeling and shielding procedures. It is expected that 
technologists preparing radiopharmaceuticals and nuclear pharmacists 
will be given instruction in the licensee's procedures. Records of 
instructions would not be required to be maintained.
    Section 35.70 would be retitled, Surveys for ambient radiation 
exposure rate, and revised. The proposed rule would require that 
licensees survey, at the end of each day of use, all areas where 
radiopharmaceuticals requiring a written directive were prepared for 
use or administered with an appropriate radiation detection survey 
instrument unless the material was prepared for use or administered in 
an area where patients or human research subjects could not be released 
pursuant to Sec. 35.75. All other requirements in this section would be 
deleted. Licensees are required to show compliance with the public and 
occupational dose limits specified in Part 20 of this chapter and 
specifically to develop, document, and implement a radiation protection 
program commensurate with the scope and extent of licensed activities 
(10 CFR 20.1101). In situations where radioactive material was used at 
levels that would not have required a survey pursuant to this section, 
the licensee should be aware that a survey may be required by 
Sec. 20.1501, General. Maintaining the requirement for surveys in areas 
where radiopharmaceuticals requiring a written directive are used is 
consistent with the Commission direction for a risk-informed rule. The 
Commission believes that licensees will continue to perform radiation 
surveys as dictated by ``good health physics'' practices. Recordkeeping 
requirements for this section would appear in Sec. 35.2070, Records of 
surveys for ambient radiation exposure rate.
    Section 35.75 would be retitled, Release of individuals containing 
radiopharmaceuticals or implants, and revised. The title of the section 
and paragraph (a) would be revised to delete the term ``permanent.'' 
This was done to clarify that this section applies to all individuals 
released from licensee control. Paragraph (b) would be revised to 
specify that licensees may provide instructions to either the released 
individual or to the individual's parent or guardian and to replace the 
term ``dose'' with the term ``total effective dose equivalent.'' The 
first change acknowledges that, in some cases, it is not appropriate to 
provide the individual being released with instructions (e.g., the 
individual is a minor or incapable of understanding the instructions). 
The later term was changed to clarify what was intended by ``dose.''
    Paragraph (b)(2) would be modified to state ``potential 
consequences, if any,'' of failure to follow the guidance. The 
Commission recognizes that, at low doses, there may be no consequences 
to continued breast-feeding. A patient may be unnecessarily alarmed if 
he/she is provided with information on consequences. Therefore, if 
consequences are not anticipated, the licensee would not be required to 
provide information to the individual. The Commission has recently 
received comments from the public on the provisions in Sec. 35.75 at 
the public workshops and in writing. Professional societies and 
representatives of the Agreement States have expressed concerns about 
the release criteria in Sec. 35.75. It is believed that the new 
criteria permit the release of patients with a body burden of as much 
as several hundred millicuries of I-131. Commenters believed that the 
released individual is a ``leaking-source'' that creates a 
contamination and exposure problem that extends beyond the control of 
the licensee. There is concern that pressure from those paying for such 
medical procedures will undermine the Radiation Safety Officer's 
ability to protect the public health and safety and to control 
contamination within the medical facility. In addition, there is 
concern about the recent increase of radiation alarms going off at 
landfills caused by household trash from a released patient. As a 
result of these concerns, the Commission is specifically soliciting 
public comment on whether any changes need to be made to the release 
criteria in this rule. The recordkeeping requirements for this section 
would appear in Sec. 35.3075, Records of the release of individuals 
containing radiopharmaceuticals or implants.
    Section 35.80 would be retitled, Provision of mobile service, and 
revised. The title would be changed to make it clear that the 
provisions in this part apply to all mobile services and not just to 
mobile nuclear medicine services. Current paragraphs (a), (b), and (c) 
would be deleted because radiopharmaceutical usage is limited by the 
requirements in Secs. 35.100 and 35.200, and control and security of 
material are addressed in 10 CFR Part 20.
    Proposed paragraph (a) would require the mobile service provider to 
obtain a letter from its client, which permits the use of byproduct 
material at the client's address of use and that clearly delineates the 
authority and responsibility of each entity. Paragraph (c) would 
require that the mobile service provider check instruments for proper 
function, as described in Secs. 35.60 and 35.62, before use at each 
address of use or on each day of use, whichever is more frequent. For 
example, if a mobile service licensee provides service to more than one 
client in a day, the instruments would need to be checked at each 
client's address of use. The Commission recognizes that the standard of 
practice is to check other types of equipment, such as gamma cameras, 
for proper operation at each place of use. Therefore, the Commission 
has not included any requirements to check this type of equipment in 
the proposed rule. Currently, mobile nuclear medicine services may be 
required by license conditions to check gamma camera operation.
    Based on discussions with the States, this section is designated as 
a Category D item of compatibility since there is no potential for 
medical use of byproduct material in other regulatory jurisdictions 
under reciprocity. NRC specifically requests comment on this issue 
relative to whether mobile medical licensees operate under reciprocity 
in other regulatory jurisdictions.
    Paragraph (d) would require that the licensee check survey 
instruments for proper operation with a dedicated check source, before 
use, at each address of use. The NRC staff believes this is appropriate 
because extensive movement in a transport vehicle may cause the 
instruments to become damaged or uncalibrated. Paragraph (e) would be 
revised to require a licensee to survey all areas of use to comply with 
the dose limits in 10 CFR Part 20 before leaving each client's address 
of use. This is necessary to assure that all radioactive material is 
removed from a client's facility. Recordkeeping requirements for this 
section would appear in Sec. 35.2080, Records of administration and 
technical requirements that apply to the provision of mobile services.
    Section 35.90, Storage of volatiles and gases, would be deleted in 
its entirety. Licensees are required to comply with the public and 
occupational public dose limits in 10 CFR Part 20 and to maintain

[[Page 43536]]

exposures ALARA. The Commission believes that licensees should have 
flexibility in complying with 10 CFR Part 20, and, therefore, a 
prescriptive requirement in Part 35 is not needed.
    Section 35.92, Decay-in-storage, would be revised to allow decay in 
storage for byproduct material with a physical half-life of less than 
120 days. If a licensee would like to decay material with a physical 
half life greater than 120 days, it would have to apply for and receive 
an amendment that would permit the decay-in-storage.
    The current Part 35 only permits decay-in-storage for materials 
with a half-life of less than 65 days. This change provides licensees 
with greater flexibility in handling radioactive waste. NRC has 
received multiple requests to amend licenses to allow for decay-in-
storage for materials greater than 65 days, and NRC has amended 
licenses to allow for decay-in-storage for materials with half-lives up 
to 120 days. This revision to Sec. 35.92 would codify current licensing 
practice.
    The requirement in the current paragraph (a)(1) to hold byproduct 
material for 10 half-lives would be deleted. This requirement is not 
needed in light of the requirement in paragraph (a) that precludes 
disposal of radioactive material as ordinary trash until radiation 
levels adjacent to the material do not exceed background levels. The 
Commission is soliciting specific public comment on whether this 
provision should be deleted. Concerns have been raised regarding 
licensees' ability to detect low levels of some beta-emitters such as 
sulfur-35. In this case, the requirement to hold material for 10 half-
lives provides added assurance that material has decayed to background 
levels prior to release.
    The requirement in paragraph (a)(4) to separate and monitor each 
generator column would be deleted. This level of prescriptiveness is 
not warranted in light of the requirements in paragraph (a)(1). The 
recordkeeping requirements for this section would appear in 
Sec. 35.2092, Records of waste disposal.
    Subpart D would be retitled Unsealed Byproduct Material--Low Dose. 
This subpart would combine the requirements in the current subpart D, 
Uptake, dilution, and excretion and subpart E, Imaging and 
localization. This change is consistent with the Commission's intent to 
make Part 35 modality specific where appropriate.
    Section 35.100 would be retitled, Use of unsealed byproduct 
material for uptake, dilution, and excretion studies for which a 
written directive is not required, and revised. The title would be 
changed to clearly state that the provisions in this subpart do not 
apply to the medical use of byproduct material that would require a 
written directive. Changes would be made to paragraph (b) to reflect 
the renumbering of sections in the proposed rule.
    Section 35.120, Possession of survey instruments, would be deleted 
because these specific requirements are not needed in Part 35. Section 
20.1501 of this chapter requires that the licensee make, or cause to be 
made, surveys to demonstrate compliance with 10 CFR Part 20, and 
requires the licensee to ensure that instruments and equipment used to 
show compliance with Part 20 are periodically calibrated. In addition, 
Sec. 30.33(a)(2) of this chapter requires licensee to have adequate 
instrumentation. Information on the types of instruments recommended 
for medical licensees is available in draft NUREG-1556, Vol. 9.
    Section 35.200 would be retitled, Use of unsealed byproduct 
material for imaging and localization studies for which a written 
directive is not required, and revised. The title would be changed to 
clearly state that the provisions in this part do not apply to the 
medical use of byproduct material that would require a written 
directive. Changes would be made to paragraph (b) to reflect the 
renumbering of sections in the proposed rule.
    Section 35.204, Permissible molybdenum-99 concentration, would be 
revised. Paragraph (b) would be revised to require that a licensee 
measure the molybdenum-99 concentration of only the first eluate from a 
generator. The Commission recognizes that the industry standard for 
molybdenum breakthrough is specified in the United States Pharmacopia 
(USP) 23 U.S. Pharmacopial Convention, Inc., 1994, page 486-487. The 
Commission believes that the licensee should measure the molybdenum-99 
concentration in the first elution of a generator after the generator 
is received at the licensee's facility. Although the frequency of 
molybdenum breakthrough is exceedingly rare, an initial check may 
detect generators that have been damaged in transport. The term 
``extract'' was deleted because the term is no longer needed. NRC is 
not aware of any licensees that prepare technetium-99m by the solvent 
extraction method. The recordkeeping requirements for this section 
would appear in Sec. 35.2204, Records of molybdenum-99 concentration.
    Section 35.205, Control of aerosols and gases, would be deleted in 
its entirety. Part 35 licensees must comply with the occupational and 
public dose limits of 10 CFR Part 20. Additional prescriptive 
requirements for limiting airborne concentrations of radioactive 
material are not warranted in Part 35.
    Section 35.220, Possession of survey instruments, would be deleted 
in its entirety because specific requirements are not needed in Part 
35. Section 20.1501 of this chapter requires that the licensee make, or 
cause to be made, surveys to demonstrate compliance with 10 CFR Part 
20, and requires the licensee to ensure that instruments and equipment 
used to show compliance with 10 CFR Part 20 are periodically 
calibrated. In addition, Sec. 30.33(a)(2) of this chapter requires 
licensees to have adequate instrumentation. Information on the types of 
instruments recommended for medical licensees is available in draft 
NUREG-1556, Vol. 9.
    Section 35.290, Training for uptake, dilution, and excretion 
studies, would appear as a new section that would revise the training 
and experience requirements found in Sec. 35.910, Training for uptake, 
dilution, and excretion studies. Section III of the SUPPLEMENTARY 
INFORMATION section of this document contains a detailed discussion of 
the Commission's proposed changes to the training and experience 
requirements in Part 35. Note, 2 years after publication of the final 
rule, this section would replace the current requirements in 
Sec. 35.920, Training for uptake, dilution, and excretion studies.
    Section 35.292, Training for imaging and localization studies, 
would appear as a new section that would revise the training and 
experience requirements found in Sec. 35.920, Training for imaging and 
localization studies. Section III of the SUPPLEMENTARY INFORMATION 
section of this document contains a detailed discussion of the 
Commission's proposed changes to the training and experience 
requirements in Part 35. Note, 2 years after publication of the final 
rule, this section would replace the current requirements in 
Sec. 35.920, Training for imaging and localization studies.
    Subpart E would be retitled, Unsealed byproduct material--high 
dose. The subpart contains the requirements for any medical use of 
unsealed byproduct material for which a written directive is required. 
This subpart would replace the requirements in the current subpart F, 
Radiopharmaceuticals for therapy.
    Section 35.300 would be retitled, Use of unsealed byproduct 
material for which a written directive is required, and revised. The 
title would be changed to clearly state that the provisions in this 
subpart apply to the medical use of unsealed byproduct material that 
would require a written directive. Changes

[[Page 43537]]

would be made to paragraph (b) to reflect the renumbering of sections 
in the proposed rule.
    Section 35.310, Safety instruction, would be revised to explicitly 
state that the instruction requirements of this section are in addition 
to, and not in lieu of, the training requirements in 10 CFR 19.12. The 
Commission believes that it is important that personnel caring for 
patients or human research subjects that have received 
radiopharmaceutical therapy (and cannot be released in accordance with 
Sec. 35.75) receive instruction in limiting radiation exposure to the 
public or occupational workers and the actions to be taken in the case 
of a death or medical emergency. The proposed rule would require that 
safety instruction be provided initially and at least annually. 
Instruction topics are specific to medical use of unsealed 
radiopharmaceuticals. It is not expected that the same level of 
training be provided to all individuals caring for the patient. The 
level of training should be commensurate with the type of care that the 
personnel may render to the patient or human research subject. For 
example, the instruction provided to the registered nurse will not 
necessarily be the same as the instruction provided to a nursing 
assistant.
    Paragraph (a) would be revised to require that instruction on 
visitor control include instruction on routine visitation authorized 
under the provisions in Sec. 20.1301(a)(1), as well as visitation that 
is authorized under the proposed provisions of Sec. 20.1301(a)(3). 
Paragraph (a) would also be revised to state that personnel should 
notify the authorized user and Radiation Safety Officer, or his/her 
designee, if the patient or human research subject dies or has a 
medical emergency. The recordkeeping requirements for this section 
would appear in Sec. 35.2310, Records of instruction and training.
    Section 35.315, Safety precautions, would be revised. Paragraph (a) 
would be revised to clarify that the requirements in this section only 
apply if a patient has been confined pursuant to Sec. 35.75. Paragraph 
(a)(2) would be revised to require that the patient's room, rather than 
the door, be visibly posted to give the licensee some flexibility in 
determining where to place the posting. These requirements are in 
addition to the posting requirements in 10 CFR Part 20. The Commission 
believes that posting requirements in 10 CFR Part 20 are not adequate 
to ensure that individuals entering the room would be aware of the 
presence of radioactive materials in the room. The current requirements 
in paragraphs (a)(3), (4), (6), (7), and (8) would be deleted because 
they are radiation protection requirements that are covered under 10 
CFR Part 20. Paragraph (b) would be revised to state that personnel 
should notify the authorized user and the Radiation Safety Officer, or 
his/her designee, as soon as possible, if the patient or human research 
subject dies or has a medical emergency. This change was made to 
recognize that the licensee's primary responsibility is the care of the 
patient and to provide the Radiation Safety Officer flexibility in 
designating who should be notified to address radiation protection 
issues.
    The Commission is soliciting specific comments on whether the 
requirement for a private room with a private sanitary facility in 
paragraph (a)(1) should be maintained in the final rule.
    Section 35.320, Possession of survey instruments, would be deleted 
in its entirety because these specific requirements are not needed in 
Part 35. Section 20.1501 of this chapter requires that the licensee 
make or cause to be made surveys to demonstrate compliance with 10 CFR 
Part 20 and requires the licensee to ensure that instruments and 
equipment used to show compliance with Part 20 are periodically 
calibrated. In addition, 10 CFR 30.33(a)(2) requires a licensee to have 
adequate instrumentation. Information on the types of instruments 
recommended for medical licensees is available in draft NUREG-1556, 
Vol. 9.
    Section 35.390, Training for therapeutic use of unsealed byproduct 
material, would appear as a new section that would revise the training 
and experience requirements found in Sec. 35.930, Training for 
therapeutic use of unsealed byproduct material, and subsumes the 
training requirements for treatment of hyperthyroidism and treatment of 
thyroid carcinoma. Section III of the SUPPLEMENTARY INFORMATION section 
of this document contains a detailed discussion of the Commission's 
proposed changes to the training and experience requirements in Part 
35. Note, 2 years after publication of the final rule, this section 
would replace the current requirements in Sec. 35.930, Training for 
therapeutic use of unsealed byproduct material, Sec. 35.932, Training 
for treatment of hyperthyroidism, and Sec. 35.934, Training for 
treatment of thyroid carcinoma.
    Subpart F would be retitled Manual brachytherapy. This subpart 
contains the requirements for medical use of sealed sources for manual 
brachytherapy and replaces the requirements in the current subpart G, 
Sources for brachytherapy.
    Section 35.400 would be retitled, Use of sources for manual 
brachytherapy, and revised to delete the specific sources and uses 
listed in the current paragraphs (a) through (g). This conforms with 
the risk-informed, performance-based nature of this proposed rule. The 
licensee would have the flexibility to use sealed sources for 
therapeutic medical uses as approved in the Sealed Source and Device 
Registry.
    Section 35.404 would be retitled, Radiation surveys of patients or 
human research subjects treated with implants, and revised. Paragraph 
(a) would be revised to delete the requirement that a licensee may not 
release a patient or a human research subject treated by temporary 
implant until all sources have been removed and would be retitled 
paragraph (b). Release of patients or human research subjects is 
addressed in Sec. 35.75. The proposed paragraph (a) contains 
requirements that were previously required by Sec. 35.406(c) with one 
modification. Licensees would be required to survey adjacent areas of 
use. This change was done to group radiation survey requirements. The 
recordkeeping requirements for this section would appear in 
Sec. 35.2404, Records of radiation surveys of patients and human 
research subjects.
    Section 35.406, Brachytherapy sources inventory, would be revised. 
Paragraph (a) requires that the licensee maintain accountability for 
all brachytherapy sources in storage or use. The majority of the 
prescriptive requirements and associated recordkeeping requirements in 
the current section would be deleted to give the licensee flexibility 
in program management. The requirements in paragraph (c) would be moved 
to the proposed Sec. 35.404. The Commission believes that the 
requirements that were maintained are essential to the radiation safety 
program. The recordkeeping requirements for this section would appear 
in Sec. 35.2406, Records of brachytherapy source inventory.
    Section 35.410, Safety instruction, would be revised to explicitly 
state that the instruction requirements in this section are in addition 
to, and not in lieu of, the training requirements of 10 CFR 19.12. The 
Commission believes that it is important that personnel caring for 
patients or human research subjects, that have received implant therapy 
and cannot be released in accordance with Sec. 35.75, receive 
instruction in limiting radiation exposure to the public and workers 
and the actions to be taken in the case of a death or medical 
emergency. The proposed rule would require that safety instruction be 
provided initially and at least annually.

[[Page 43538]]

Instruction topics are specific to medical use of manual brachytherapy 
sources. It is not expected that the same level of training be provided 
to all individuals caring for the patient. The level of training should 
be commensurate with the type of care that the personnel may render to 
the patient or human research subject. Paragraph (a) would be revised 
to require that instruction on visitor control include instruction on 
routine visitation authorized under the provisions in the current 
Sec. 20.1301(a)(1), as well as visitation that is authorized under the 
provisions of revised Sec. 20.1301(a)(3). Paragraph (a) would also be 
revised to state that personnel should notify the authorized user and 
Radiation Safety Officer, or designee, if the patient or human research 
subject dies or has a medical emergency. The recordkeeping requirements 
for this section would appear in Sec. 35.2310, Records of instruction 
and training.
    Section 35.415, Safety precautions, would be revised. Paragraph (a) 
would be revised to clarify that the requirements in this section apply 
only if a patient or human research subject cannot be released pursuant 
to Sec. 35.75. The current requirements in paragraphs (a)(3) and (4) 
would be deleted because they are radiation protection requirements 
that are covered under 10 CFR Part 20. A new requirement would be added 
(paragraph b) to require the licensee to have equipment such as shields 
and remote handling tools available near each treatment room. This 
change codifies requirements that are currently imposed on licensees by 
license conditions. Current paragraph (b) would be redesignated 
paragraph (c) and would be revised to state that personnel should 
notify the authorized user and the Radiation Safety Officer, or his/her 
designee, as soon as possible if the patient or human research subject 
dies or has a medical emergency. This change was made to recognize that 
the licensee's primary responsibility is the care of the patient and to 
provide the Radiation Safety Officer flexibility in who should be 
notified to address radiation protection issues. The Commission is 
soliciting public comment on whether the requirement for a licensee to 
not quarter a patient in the same room as an individual who is not 
receiving radiation therapy be maintained in the final rule.
    Section 35.420, Possession of survey instruments, would be deleted 
in its entirety because these specific requirements are not needed in 
Part 35. Section 20.1501 of this chapter requires that the licensee 
make, or cause to be made, surveys to demonstrate compliance with 10 
CFR Part 20, and requires the licensee to ensure that instruments and 
equipment used to show compliance with Part 20 are periodically 
calibrated. In addition, 10 CFR 30.33(a)(2) requires licensees to have 
adequate equipment. Information on the types of instruments recommended 
for medical licensees is available in draft NUREG-1556, Vol. 9.
    Section 35.432, Full calibration measurements of brachytherapy 
sources, would appear as a new section that would require a licensee 
authorized to use brachytherapy sources for medical use to perform full 
calibration measurements on brachytherapy sources before the first 
medical use. The requirements in this section are based on 
recommendations found in American Association of Physicists in Medicine 
(AAPM) Task Group 40--Comprehensive QA for Radiation Oncology (1994) 
and 56--Code of Practice for Brachytherapy Physics (1997), and are 
consistent with the calibration requirements for sealed sources and 
devices for therapy. The proposed rule would allow the licensee to rely 
on the output measurement provided by the manufacturer or distributor. 
The Commission is soliciting specific comment on whether the final rule 
should contain a requirement for the licensee to perform full 
calibration measurements on brachytherapy sources before first use and 
on whether the final rule should allow licensees to rely on the output 
measurements provided by the manufacturer or distributor provided the 
dosimetry equipment used by the manufacturer or distributor met the 
calibration requirements in Sec. 35.630. In addition, the Commission is 
soliciting specific public comment on calibration for sources where 
there is no standard traceable to the National Institute of Standards 
and Technology (e.g. palladium-103).
    The Regulatory Analysis for this section of the proposed rule 
assumes that the majority of licensees using long-lived radionuclides 
will need to calibrate the sources to show compliance with this 
section. It is estimated that licensees will spend approximately $1000 
to calibrate these sources resulting in a $8M burden on NRC and 
Agreement State licensees. The Commission has not calculated the impact 
of determining the output of short-lived sealed therapy sources (e.g. 
iodine-125, iridium-192) because of the limited information available 
on the number of sources and variability in the type of dosimeter 
equipment available at a licensee's facility to perform the 
calibration. The Commission is soliciting specific public input on the 
number of short and long-lived sources that will need to be calibrated 
on an annual basis; whether licensees will need to procure additional 
equipment to perform the calibrations; and the time needed to calibrate 
the sources.
    Recordkeeping requirements for this section would appear in 
Sec. 35.2432, Records of full calibrations on brachytherapy sources.
    Section 35.490, Training for use of manual brachytherapy sources, 
would appear as a new section that would revise the training and 
experience requirements found in Sec. 35.940, Training for use of 
brachytherapy sources, and subsumes the requirements for training for 
ophthalmic use of strontium-90. Section III of the Supplementary 
Information section of this document contains a detailed discussion of 
the Commission's proposed changes to the training and experience 
requirements in Part 35. Note, 2 years after publication of the final 
rule, this section will replace the current requirements in 
Sec. 35.940, Training for use of brachytherapy and in Sec. 35.941, 
Training for ophthalmic use of strontium-90.
    Subpart G would be retitled Sealed sources for diagnosis. This 
subpart would contain the requirements for diagnostic medical use of 
sealed sources and replace the requirements in the current subpart H, 
Sealed Sources for Diagnosis.
    Section 35.500, Use of sealed sources for diagnosis, would be 
revised to delete the specific sources and uses listed in paragraphs 
(a) and (b). This conforms with the risk-informed, performance-based 
nature of this proposed rule. The licensee would have flexibility to 
use sealed sources for diagnostic medical uses as approved in the 
Sealed Source and Device Registry.
    Section 35.520, Availability of survey instruments, would be 
deleted in its entirety because these specific requirements are not 
needed in Part 35. Section 20.1501 of this chapter requires that the 
licensee make or cause to be made surveys to demonstrate compliance 
with 10 CFR Part 20 and requires the licensee to ensure that 
instruments and equipment used to show compliance with 10 CFR Part 20 
are periodically calibrated. In addition, Sec. 30.33(a)(2) of this 
chapter requires the licensee to have adequate instrumentation. 
Information on the types of instruments recommended for medical 
licensees is available in draft NUREG-1556, Vol. 9.
    Section 35.590, Training for use of sealed sources for diagnosis, 
would appear as a new section. This section is

[[Page 43539]]

a revision of the training and experience requirements found in 
Sec. 35.950, Training for use of sealed sources for diagnosis. Section 
III of the Supplementary Information section of this document contains 
a detailed discussion of the Commission's proposed changes to the 
training and experience requirements in Part 35. Note, 2 years after 
publication of the final rule, this section would replace the current 
requirements in Sec. 35.920, Training for use of sealed sources for 
diagnosis.
    Subpart H would be retitled, Therapeutic medical devices, and 
revised to address all medical uses of sealed sources and devices for 
therapy. Devices such as teletherapy, remote afterloaders, and gamma 
radiosurgery units are addressed in this subpart. This section does not 
contain requirements for manual brachytherapy, which are in subpart F. 
This subpart would replace the requirements in the current subpart I, 
Teletherapy, and codify requirements for remote afterloaders and gamma 
stereotactic radiosurgery units currently imposed by license 
conditions.
    Section 35.600 would be retitled, Use of a sealed source in a 
device for therapeutic medical uses, and revised to delete any 
references to specific radionuclides and devices. The licensee would 
have the flexibility to use sealed sources and devices for therapeutic 
medical uses as approved in the Sealed Source and Device Registry.
    Section 35.604, Radiation surveys of patients and human research 
subjects treated with remote afterloaders, would appear as a new 
section. This section would require that a licensee make a radiation 
survey of a patient or human research subject to confirm that the 
sources have been removed from the individual and returned to a 
shielded position before releasing the individual from licensee 
control. For fractionated treatments where the patient is not 
releasable pursuant to Sec. 35.75, surveys need only be performed after 
the last time the source is returned to the shielded position. For 
example, a survey of the patient is not required every time that the 
source is retracted into the shielded safe when nursing personnel enter 
the patient treatment room to provide care to patients undergoing 
fractionated treatments using a low-or pulsed-dose rate remote 
afterloader. This new requirement was previously imposed on remote 
afterloader licensees by license condition. Recordkeeping requirements 
for this section would appear in Sec. 35.2404, Records of radiation 
surveys of patients and human research subjects.
    Section 35.605 would be retitled, Installation, maintenance and 
repair, and revised to clarify that only a person specifically licensed 
by the Commission or an Agreement State can install, maintain, adjust, 
or repair a device that involves work on the source shielding, source 
driving unit, or other electronic or mechanical mechanism that could 
expose the source, reduce the shielding around the source, or 
compromise the radiation safety of the device or the sources. It would 
also be revised to include additional types of devices, rather than 
just teletherapy units. The Commission is soliciting specific comment 
on whether the restrictions in paragraph (a) should apply to low dose-
rate remote afterloaders.
    Paragraph (b) would also specify that, except for low dose-rate 
remote afterloaders, only a person specifically licensed by the 
Commission or an Agreement State shall install, replace, relocate, or 
remove a sealed source or source contained in a device. For a low dose-
rate remote afterloader, installation, replacement, relocation, or 
removal of a sealed source must be done by a person specifically 
licensed by the Commission or an Agreement State or by an authorized 
medical physicist. The exception to allow an authorized medical 
physicist to perform these activities for low-dose rate remote 
afterloaders was included in the proposed rule because the Commission 
believes that the radiation hazards associated with installation, 
replacement, relocation, or removal of a sealed source in these devices 
are similar to that of manipulation of manual brachytherapy sources. 
The recordkeeping requirements for this section would appear in 
Sec. 35.2605, Records of installation, maintenance, and repair.
    Section 35.606, License amendments, would be deleted in its 
entirety. The requirements in the current paragraphs (a), (b), and (d) 
would be addressed in the proposed revision to Sec. 35.13(e). Paragraph 
(c) would be deleted because the licensees must comply with the dose 
limit requirements in 10 CFR Part 20 and no further limitations are 
warranted. The requirement in paragraph (e) to file an amendment before 
allowing an individual to perform the duties of the authorized medical 
physicist is addressed in the proposed Sec. 35.13(b). Paragraph (e) 
would be deleted because the proposed requirements in subpart H would 
require that the authorized medical physicist perform specific duties. 
Any deviations from these requirements would necessitate an exemption 
from Part 35.
    Section 35.610 would be retitled, Safety procedures and 
instructions for remote afterloaders, teletherapy units, and gamma 
stereotactic radiosurgery units, and revised to include remote 
afterloaders and gamma stereotactic radiosurgery units.
    Paragraph (a) would require that a licensee develop, implement, and 
maintain safety procedures; locate safety procedures at the unit 
console; post safety instructions at the device console; and train 
operators.
    Paragraphs (a)(1) and (a)(3) would codify requirements that are 
currently imposed on licensees by license conditions related to use of 
remote afterloaders. Because of the applicability of the requirements 
to all therapy device uses, they were added to the rule with the intent 
of having the requirements apply to all such device uses. Paragraph 
(a)(2) would be expanded to apply to all types of therapy devices. 
However, the Commission recognizes that there are certain design 
conditions that will necessitate an individual, other than the patient, 
being in the treatment room during the treatment. An example of this 
condition is use of a low energy beta or gamma source in a therapeutic 
medical device where the authorized user may need to be in the room 
with the patient. This exception does not relieve the licensees from 
complying with the dose limits for occupationally-exposed individuals 
or the general public in 10 CFR Part 20.
    Paragraph (b) would be revised to require that a copy of the 
licensee's procedures be located at the unit console, and paragraph (c) 
would be revised to require that the location of the procedures and 
emergency response telephone numbers be posted. Previously, all of the 
above procedures were required to be posted. This was impractical with 
the addition of remote afterloaders because error conditions and 
responses are often several pages in length.
    Paragraph (d) would be revised to require that, in addition to the 
initial instruction required in Sec. 35.610, the licensee must provide 
initial instruction, annual training, and annual practice drills, in 
specifically identified procedures to all individuals who operate the 
device. The level of instruction should be commensurate with the 
individual's assigned duties. For example, an individual need not be 
instructed in equipment inspection, unless it is expected that during 
the normal course of the day, the individual will be required to 
inspect the unit. The Commission believes that due to the complexity of 
therapeutic treatment devices, refresher training and practice

[[Page 43540]]

drills on emergency response are warranted. The recordkeeping 
requirements for this section would appear in Sec. 35.2310, Records of 
instruction and training.
    Section 35.615 would be retitled, Safety precautions for remote 
afterloaders, teletherapy units, and gamma stereotactic radiosurgery 
units, and revised to include remote afterloaders and gamma 
stereotactic radiosurgery units. Many of the prescriptive requirements 
(e.g., beam condition indicator light and radiation monitor) were 
deleted from this section because they are currently addressed in 10 
CFR Part 20.
    The requirement in paragraph (d) for intercom systems, and the 
requirements in paragraphs (e), (f) and (g) would be added to codify 
requirements that are currently imposed on licensees by license 
conditions. Current license conditions were modified when they were 
incorporated into the proposed rule. For example, the presence of an 
authorized user and medical physicist during patient treatments was 
clarified for each type of use. As used in this provision, physically 
present means to be within ear shot of normal voice. Immediately 
available means that the individual is available on an on-call basis to 
respond to an emergency. At a minimum, this person must be available by 
telephone.
    The Commission believes that the inherent risk of these procedures 
justifies the prescriptiveness of this regulation and believes that it 
is important that a properly trained physician be available at all 
times to respond to an emergency requiring source removal.
    New sources, using pure beta emitters, are being considered for use 
in low and high dose-rate remote afterloading brachytherapy units. 
Because these beta sources present lower radiation risks to medical 
personnel and the public, the requirements for some of the safety 
precautions in this section may not be appropriate. The Commission is 
soliciting specific public comment on whether the requirements in this 
section should be waved for licensees that are using remote 
afterloaders with beta-emitting sources.
    Section 35.620, Possession of survey instruments, would be deleted 
in its entirety because these specific requirements are not needed in 
Part 35. Section 20.1501 of this chapter requires that the licensee 
make, or cause to be made, surveys to demonstrate compliance with 10 
CFR Part 20, and requires the licensee to ensure that instruments and 
equipment used to show compliance with 10 CFR Part 20 are periodically 
calibrated. In addition, Sec. 30.33(a)(2) of this chapter requires 
licensees to have adequate equipment. Information on the types of 
instruments recommended for medical licensees is available in draft 
NUREG-1556, Vol. 9.
    Section 35.630, Dosimetry equipment, would be revised to provide 
calibration requirements for instruments used in this subpart and 
subpart F. Paragraph (a)(1) would require that dosimetry systems be 
calibrated using a source whose activity is traceable to NIST and in 
accordance with published protocols approved by a nationally recognized 
body or by a calibration laboratory approved by AAPM. This change would 
give licensees two alternatives for direct traceability of dosimetry 
equipment calibration; i.e., either a source or the measurement 
instrument (e.g., well chamber) can be calibrated against a national 
standard. The Commission acknowledges that the industry standards for 
instrument calibration provide adequate assurance that equipment is 
properly calibrated. Paragraph (a)(2) would be revised to delete the 
reference to intercomparison meetings sanctioned by a calibration 
laboratory or radiologic physics centers accredited by the AAPM. This 
provision is no longer necessary because the AAPM does not sanction 
intercomparison meetings. References to cobalt-60 and cesium-137 
contained within teletherapy units were deleted from the rule text to 
make the section applicable to dosimetry equipment for all 
radionuclides and therapy units. The recordkeeping requirements for 
this section would appear in Sec. 35.2630, Records of dosimetry 
equipment.
    Section 35.632 would be retitled, Full calibration measurements on 
teletherapy units, to clarify that the requirements in this section 
apply to teletherapy units and be revised. Paragraph (d) would be 
revised to delete the reference to the AAPM Task Group Reports and 
replace it with a requirement that full calibration measurements be 
done in accordance with published protocols approved by nationally 
recognized bodies. This allows the licensee more flexibility in 
choosing appropriate protocols. The Commission acknowledges that the 
industry standards for teletherapy unit calibration provide adequate 
assurance that equipment is properly calibrated. Paragraph (f) would be 
revised to replace the term ``teletherapy physicist'' with the term 
``authorized medical physicist.'' The recordkeeping requirements for 
this section would appear in Sec. 35.2632, Records of teletherapy full 
calibration.
    Section 35.633, Full calibration measurements on remote 
afterloaders, would appear as a new section that would contain the 
requirements for the calibration of remote afterloaders. This section 
is similar in content to Sec. 35.632. Requirements in this section 
would be based on recommendations found in AAPM Task Group Report No. 
56. Recordkeeping requirements for this section would appear in 
Sec. 35.2633, Records of remote afterloader full calibrations.
    Section 35.634, Periodic spot-checks, would be deleted in its 
entirety and the requirements of this section, with minor 
modifications, would be moved to Sec. 35.642.
    Section 35.635, Full calibration measurements for gamma 
stereotactic radiosurgery units, would appear as a new section. This 
section would contain the requirements for the calibration of gamma 
stereotactic radiosurgery units and is similar in content to 
Sec. 35.632. Requirements in this section are based on recommendations 
found in AAPM Report No. 54--Stereotactic Radiosurgery (Task Group 42, 
1995). Recordkeeping requirements for this section would appear in 
Sec. 35.2635, Records of gamma stereotactic radiosurgery unit full 
calibrations.
    Section 35.636, Safety checks for teletherapy facilities, would be 
deleted in its entirety and the requirements in this section would be 
incorporated into proposed Secs. 35.642, 35.643, 35.644, and 35.645.
    Section 35.641, Radiation surveys for teletherapy facilities, would 
be deleted in its entirety. Radiation surveys at the surface of the 
main source safe would be addressed under proposed Sec. 35.652. The 
remaining requirements in the current Sec. 35.641 would be deleted to 
allow the licensee more flexibility in managing its radiation 
protection program.
    Section 35.642 would be retitled, Periodic spot-checks for 
teletherapy units, and revised. The phrase ``teletherapy physicist'' 
would be replaced with the term ``authorized medical physicist'' 
throughout the section. The requirement in paragraph (c) to maintain a 
copy of the physicist's notification of the results of spot-checks to 
the licensee would be deleted to reduce the recordkeeping requirements 
for licensees. Paragraph (d) would be modified to require that the 
safety spot-checks be performed monthly and after each source 
installation. This revision would replace the safety check requirements 
after each source replacement in the current Sec. 35.634, which would 
be deleted in the proposed rule. Paragraph (d)(3) would be modified to 
replace the term ``beam

[[Page 43541]]

condition indicator'' with ``source exposure indicator'' to clarify 
that indicators were needed to note whether the source was exposed and 
note to what degree the source was exposed. Paragraph (d)(4) would be 
revised to include a requirement for an intercom system that was 
previously imposed on licensees by license condition. An intercom is 
needed to assure that the licensee's staff and the patients have the 
ability to communicate verbally, in addition to the ability to 
communicate visually. Paragraph (e) would be revised to require that 
the licensee lock the control console in the off position, and not use 
the unit except as may be necessary to repair, replace, or check the 
malfunctioning system, in case of any malfunction identified during a 
safety spot-check. This revision is intended to make Sec. 35.642 
consistent with the requirement in the current Sec. 35.636 regarding 
immediate actions to be taken when a malfunctioning system is 
identified. Recordkeeping requirements for this section would appear in 
Sec. 35.2642, Records of periodic spot-checks for teletherapy units.
    The requirements in the current Sec. 35.643 would be deleted to 
allow a licensee more flexibility in designing a radiation protection 
program that is specific to its facility and which ensures that the 
dose limits in 10 CFR Part 20 are not exceeded.
    Section 35.643, Periodic spot-checks for high and pulsed dose-rate 
remote afterloaders, would appear as a new section. This section would 
contain the requirements for periodic spot-checks of high and pulsed 
dose-rate remote afterloaders, and is similar in content to 
Sec. 35.642. Requirements in this section are based on recommendations 
in AAPM Task Group Report No. 56. Recordkeeping requirements for this 
section would appear in Sec. 35.2643, Records of periodic spot-checks 
for remote afterloaders.
    Section 35.644, Periodic spot-checks for low-dose rate remote 
afterloaders, would appear as a new section. This revised section would 
contain the requirements for periodic spot-checks of low dose-rate 
remote afterloaders and would be similar in content to Sec. 35.642. 
These proposed requirements are based on recommendations found in the 
AAPM Task Group Report No. 56. Some requirements were added to make the 
safety checks, and associated corrective actions, consistent with the 
requirements in Sec. 35.642. The Commission is soliciting comment on 
whether the requirements for electrical interlocks should apply to low-
dose rate remote afterloaders. Recordkeeping requirements for this 
section would appear in Sec. 35.2643, Records of periodic spot-checks 
for remote afterloaders.
    The current requirements in Sec. 35.645, would be deleted to reduce 
the reporting burden on medical use licensees. Survey results are 
maintained by a licensee to show compliance with 10 CFR Part 20 and, 
therefore, would be available for review.
    Section 35.645, Periodic spot-checks for gamma stereotactic 
radiosurgery units, would appear as a new section. This section would 
contain requirements for periodic spot-checks of gamma stereotactic 
radiosurgery units, and is similar in content to Sec. 35.642. 
Requirements in this section are based on recommendations found in AAPM 
Report No. 54. Some requirements were added to make the safety checks, 
and associated corrective actions, consistent with the requirements in 
Sec. 35.642. Recordkeeping requirements for this section would appear 
in Sec. 35.2645, Records of periodic spot-checks for gamma stereotactic 
radiosurgery units.
    The requirements in the current Sec. 35.647 would be moved to the 
proposed Sec. 35.655.
    Section 35.647, Additional technical requirements for mobile remote 
afterloaders, would appear as a new section. This section would contain 
the requirements for mobile remote afterloaders which were previously 
listed in an internal NRC document entitled, ``Supplement 1 to Policy 
and Guidance Directive FC 86-4; Revision 1, Mobile Remote Afterloading 
Brachytherapy Licensing Module.'' Recordkeeping requirements for this 
section would appear in Sec. 35.2647, Records of additional technical 
requirements for mobile remote afterloaders.
    Based on discussions with the States, this section is designated as 
a Category D item of compatibility since there is no potential for 
medical use of byproduct material in other regulatory jurisdictions 
under reciprocity. NRC specifically requests comment on this issue 
relative to whether mobile medical licensees operate under reciprocity 
in other regulatory jurisdictions.
    Section 35.652, Radiation surveys, would appear as a new section. 
This section would replace the current Sec. 35.641. This section would 
require that, in addition to the surveys required by 10 CFR 20.1501, 
the licensee make surveys to assure that the maximum radiation levels 
and average radiation levels from the surface of the main source safe 
do not exceed the levels stated in the Sealed Source and Device 
Registry. These surveys provide added assurance that a device has been 
manufactured and that source(s) have been installed properly. 
Recordkeeping requirements for this section would appear in 
Sec. 35.2652, Records of surveys of therapeutic treatment units.
    Section 35.655, Five-year inspection for teletherapy and gamma 
stereotactic radiosurgery units, would appear as a new section and 
would contain the requirements for inspections which are in the current 
Sec. 35.647. Proposed Sec. 35.655 would require that teletherapy units 
and gamma stereotactic radiosurgery units be inspected and serviced 
during source replacement, or at intervals not to exceed 5 years, to 
assure proper functioning of the source exposure mechanism. Most gamma 
stereotactic radiosurgery licensees are required, by license condition, 
to inspect the units every 7 years; however, professionals in the 
medical community have indicated that the units are inspected on a more 
frequent basis. The Commission believes that the risk associated with 
using gamma stereotactic radiosurgery units justifies a change in the 
inspection frequency. Recordkeeping requirements for this section would 
appear in Sec. 35.2655, Records of 5-year inspection for teletherapy 
and gamma stereotactic radiosurgery units.
    Section 35.657, Therapy-related computer systems, would appear as a 
new section that would require licensees to verify that the 
computerized operating system and treatment planning system associated 
with a therapy device are operating appropriately and to perform 
acceptance testing on the treatment planning systems in accordance with 
published protocols approved by nationally recognized bodies. These 
changes are consistent with recommendations found in AAPM Task Group 
Report No. 40--Comprehensive QA for Radiation Oncology (1994).
    This proposed requirement is especially important in light of 
recent information on the inability of computers to correctly recognize 
dates beyond December 31, 1999. Therapy-related computer systems may 
misread the year 2000 and cause the systems to fail, generate faulty 
data, or act in an incorrect manner. In particular, computer software 
used to calculate dose or to account for radioactive decay may not 
recognize the turn of the century, which could lead to incorrectly 
calculated doses or exposure times for treatment planning. The 
potential for system failures, such as this, would be identified when 
determining compliance with this proposed section.
    Section 35.690, Training for use of therapeutic medical devices, 
would appear as a new section. This section

[[Page 43542]]

would revise the training and experience requirements found in 
Sec. 35.960, Training for teletherapy, and would be expanded to include 
training for authorized uses of teletherapy, remote afterloaders, and 
gamma stereotactic radiosurgery units. Section III of the Supplementary 
Information section of this document contains a detailed discussion of 
training and experience. Note, 2 years after publication of the final 
rule, this section would replace the current requirements in 
Sec. 35.960, Training for teletherapy.
    Subpart J, Training and Experience Requirements, is in the current 
Part 35. Licensees would have the option to comply with the training 
and experience requirements in this subpart or in subparts B, and D-H 
until 2 years after the final rule is published in the Federal 
Register. At that time this subpart will be deleted. A more detailed 
discussion of the Commission's proposed changes to the training and 
experience requirements is in Section III of the Supplementary 
Information section of this document. The proposed schedule for 
implementation of the training and experience requirements is in 
Section VIII of the SUPPLEMENTARY INFORMATION section of this document.
    Section 35.900, Radiation Safety Officer, is in the current Part 
35. Two changes would be made in this section to correspond to the 
revised numbering system: Sec. 35.57, Training for experienced 
Radiation Safety Officer, teletherapy or medical physicist, authorized 
user, and nuclear pharmacist; and Sec. 35.24, Authority and 
responsibilities for the radiation protection program. This section 
would be deleted 2 years after the final rule is published in the 
Federal Register at which time licensees would be required to comply 
with the training and experience requirements in the new Sec. 35.50, 
Training for Radiation Safety Officer. Section VIII of the 
Supplementary Information section of this document contains a detailed 
discussion of the Commission's proposed implementation of the training 
and experience requirements.
    Section 35.901, Training for experienced Radiation Safety Officer, 
would be deleted in its entirety and the requirements of this section 
would be moved to the proposed Sec. 35.57.
    Section 35.910, Training for uptake, dilution, and excretion 
studies, is in the current Part 35. One change would be made in this 
section to correspond to the revised numbering system: Sec. 35.57, 
Training for experienced Radiation Safety Officer, teletherapy or 
medical physicist, authorized user, and nuclear pharmacist. This 
section would be deleted 2 years after the final rule is published in 
the Federal Register, at which time licensees would be required to 
comply with the training and experience requirements in the new 
Sec. 35.290, Training for uptake, dilution, and excretion studies. 
Section VIII of the SUPPLEMENTARY INFORMATION section of this document 
contains a detailed discussion of the Commission's proposed 
implementation of the training and experience requirements.
    Section 35.920, Training for imaging and localization studies, is 
in the current Part 35. One change would be made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
Experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section would be deleted 
2 years after the final rule is published in the Federal Register, at 
which time licensees would be required to comply with the training and 
experience requirements in the new Sec. 35.292, Training for imaging 
and localization studies. Section VIII of the SUPPLEMENTARY INFORMATION 
section of this document contains a detailed discussion of the 
Commission's proposed implementation of the training and experience 
requirements.
    Section 35.930, Training for therapeutic use of unsealed byproduct 
material, is in the current Part 35. One change would be made in this 
section to correspond to the revised numbering system: Sec. 35.57, 
Training for experienced Radiation Safety Officer, teletherapy or 
medical physicist, authorized user, and nuclear pharmacist. This 
section would be deleted 2 years after the final rule is published in 
the Federal Register, at which time licensees would be required to 
comply with the training and experience requirements in the new 
Sec. 35.390, Training for use of unsealed byproduct material for 
therapy or for use of unsealed byproduct material that requires a 
written directive. Section VIII of the SUPPLEMENTARY INFORMATION 
section of this document contains a detailed discussion of the 
Commission's proposed implementation of the training and experience 
requirements.
    Section 35.932, Training for treatment of hyperthyroidism, is in 
the current Part 35. One change would be made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section would be deleted 
2 years after the final rule is published in the Federal Register, at 
which time licensees would be required to comply with the training and 
experience requirements in the new Sec. 35.390, Training for use of 
unsealed byproduct material for therapy or for use of unsealed 
byproduct material that requires a written directive. Section VIII of 
the Supplementary Information section of this document contains a 
detailed discussion of the Commission's proposed implementation of the 
training and experience requirements.
    Section 35.934, Training for treatment of thyroid carcinoma, is in 
the current Part 35. One change would be made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section would be deleted 
2 years after the final rule is published in the Federal Register, at 
which time licensees would be required to comply with the training and 
experience requirements in the new Sec. 35.390, Training for use of 
unsealed byproduct material for therapy or for use of unsealed 
byproduct material that requires a written directive. Section VIII of 
the Supplementary Information section of this document contains a 
detailed discussion of the Commission's proposed implementation of the 
training and experience requirements.
    Section 35.940, Training for use of brachytherapy sources, is in 
the current Part 35. One change would be made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section would be deleted 
2 years after the final rule is published in the Federal Register, at 
which time licensees would be required to comply with the training and 
experience requirements in the new Sec. 35.490, Training for use of 
manual brachytherapy sources. Section VIII of the Supplementary 
Information section of this document contains a detailed discussion of 
the Commission's proposed implementation of the training and experience 
requirements.
    Section 35.941, Training for ophthalmic use of strontium-90, is in 
the current Part 35. One change would be made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section would be deleted 
2 years after the final rule is published in the Federal Register, at 
which time licensees would be required to comply with the training and 
experience requirements in the new

[[Page 43543]]

Sec. 35.490, Training for use of manual brachytherapy sources. Section 
VIII of the SUPPLEMENTARY INFORMATION section of this document contains 
a detailed discussion of the Commission's proposed implementation of 
the training and experience requirements.
    Section 35.950, Training for use of sealed sources for diagnosis, 
is in the current Part 35. One change would be made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section would be deleted 
2 years after the final rule is published in the Federal Register, at 
which time licensees would be required to comply with the training and 
experience requirements in the new Sec. 35.590, Training for use of 
sealed sources for diagnosis. Section VIII of the Supplementary 
Information section of this document contains a detailed discussion of 
the Commission's proposed implementation of the training and experience 
requirements.
    Section 35.960, Training for use of therapeutic medical devices, is 
in the current Part 35. One change would be made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section would be deleted 
2 years after the final rule is published in the Federal Register, at 
which time licensees would be required to comply with the training and 
experience requirements in the new Sec. 35.690, Training for use of 
therapeutic medical devices. Section VIII of the Supplementary 
Information section of this document contains a detailed discussion of 
the Commission's proposed implementation of the training and experience 
requirements.
    Section 35.961 would be retitled, Training for an authorized 
medical physicist, to reflect that the training and experience 
requirements in this section apply to authorized medical physicists 
rather than just teletherapy physicists, and would be revised. In 
addition, the list of tasks in paragraph (c) would be changed to 
reflect the new numbering system. This section would be deleted 2 years 
after the final rule is published in the Federal Register, at which 
time licensees would be required to comply with the training and 
experience requirements in the new Sec. 35.51, Training for an 
authorized medical physicist. Section VIII of the SUPPLEMENTARY 
INFORMATION section of this document contains a detailed discussion of 
the Commission's proposed implementation of the training and experience 
requirements.
    Section 35.970, Training for an authorized nuclear pharmacist, 
would be deleted in its entirety and the requirements would be moved to 
the proposed Sec. 35.57.
    Section 35.971, Physicians training in a three month program, would 
be deleted in its entirety. Three month nuclear medicine programs are 
no longer available. Criteria for authorized users are now specified in 
other areas of the rule.
    Section 35.980, Training for an authorized nuclear pharmacist, 
would not be changed. This section would be deleted 2 years after the 
final rule is published in the Federal Register, at which time 
licensees would be required to comply with the training and experience 
requirements in the new Sec. 35.55, Training for an authorized nuclear 
pharmacist. Section VIII of the SUPPLEMENTARY INFORMATION section of 
this document contains a detailed discussion of the Commission's 
proposed implementation of the training and experience requirements.
    Section 35.981, Training for experienced nuclear pharmacists, has 
not been changed. This section would be deleted 2 years after the 
publication of the final rule in the Federal Register, at which time 
licensees would be required to comply with the training and experience 
requirements in the new Sec. 35.55, Training for an authorized nuclear 
pharmacist. The Commission solicits specific comment on the impact of 
deleting this section. Section VIII of the Supplementary Information 
section of this document contains a detailed discussion of the 
Commission's proposed implementation of the training and experience 
requirements.
    Section 35.990, Violations, would be deleted in its entirety, and 
the requirements of this section, with minor modifications, would be 
moved to the proposed Sec. 35.4001
    Section 35.991, Criminal penalties, would be deleted in its 
entirety, and the requirements of this section, with minor 
modifications, would be moved to the proposed Sec. 35.4002.
    Section 35.999, Resolution of conflicting requirements during 
transition period, would be deleted in its entirety, and the 
requirements of this section, with modifications, would be moved to the 
proposed Sec. 35.10.
    Subpart K, Other Medical Uses of Byproduct Material or Radiation 
from Byproduct Material, would be a new subpart. This subpart was 
developed to accommodate use of radioactive material in an emerging 
technology.
    Section 35.1000, Other medical uses of byproduct material or 
radiation from byproduct material, is new. It would be added to 
accommodate emerging technologies. Specific information that must be 
provided to the Commission in support of an application for use under 
Sec. 35.1000 is provided in Sec. 35.12(d).
    Subpart L, Records, is a new subpart. This subpart would contain 
all the specific recordkeeping requirements necessary to implement the 
proposed requirements in Part 35. General requirements for record 
maintenance, such as electronic storage, are provided in Sec. 35.5. 
Grouping of records into one subpart was done to facilitate use by the 
licensees, and is consistent with the approach used in part 20. A 
licensee may reference this section when determining whether something 
must be recorded, rather than having to review the entire regulation to 
find out if there is a particular recordkeeping requirement. Many of 
the recordkeeping requirements remain unchanged. However, some new 
sections have been added as a result of new requirements, especially in 
subpart H. The Commission is soliciting public comment on whether all 
recordkeeping requirements should be grouped into one subpart or 
whether all recordkeeping requirements should be included in the 
section requiring the record. In addition, the Commission is soliciting 
specific public comment on which recordkeeping requirements could be 
deleted in the final rule and the basis for the deletion. For example, 
should the recordkeeping requirements in Sec. 35.2063 be retained for 
byproduct material administered pursuant to Secs. 35.100 and 35.200 
because of the low risk associated with this type of use?
    Section 35.2024, Records of authority and responsibility for 
radiation protection programs, would require the licensee to retain a 
record of actions taken by the licensee's management in accordance with 
Sec. 35.24(a) for 5 years. The 5-year retention period is a reduction 
from current requirements to maintain records of the approval of 
licensing actions, individuals, and radiation protection program 
changes. Currently, similar records are required to be maintained for 
the duration of the license (reference current Sec. 35.22 and 
Sec. 35.31). This period would allow sufficient time for NRC to review 
records of licensee actions.
    It would also require the licensee to retain the copy of the 
authorities, duties, and responsibilities of the Radiation Safety 
Officer for the duration of the license. In many cases, these records 
would take the place of the Radiation Safety Committee meeting minutes. 
The

[[Page 43544]]

Commission believes that it is important to document licensees' 
management review and approval of licensing actions, changes to the 
radiation protection program, and the authorities, duties, and 
responsibilities of the Radiation Safety Officer. The record of 
licensing actions and radiation protection program changes must include 
a summary of actions and a signature of licensee management.
    In addition, this section would require the licensee to retain a 
copy of the authorities, duties and responsibilities of the Radiation 
Safety Officer that includes the signatures of the radiation safety 
officer and licensee management for the duration of the license. This 
extended period is warranted in light of the importance of the 
functions performed by the Radiation Safety Officer.
    Section 35.2026, Records of radiation protection program safety 
changes, would require the licensee to retain a record of each 
radiation protection program change, as required by Sec. 35.26 for 5 
years. The record must include a copy of the old and new procedure, the 
effective date of the change, and the signature of the Radiation Safety 
Officer and licensee management that reviewed and approved the change. 
The Commission recognizes that this requirement for management's 
signature is redundant to the requirement in Sec. 35.2024. However, it 
believes this approach is warranted in light of the importance of these 
actions and the intent to keep requirements that are closely related in 
one subject area. Currently, licensees must retain a record of each 
``radiation safety program'' change until the license has been renewed 
or terminated. Therefore, this proposed change represents a reduction 
in burden. This record is needed to document what radiation changes 
were made in the program. This record facilitates the Commission's 
evaluation of minor radiation safety program changes and provides 
licensees with a record of the changes.
    Section 35.2040, Records of written directives, would require the 
licensee to retain a copy of written directives required by Sec. 35.40 
for 3 years. These records will help to ensure that administrations 
were in accordance with the written directives. The 3-year 
recordkeeping retention period corresponds with the current retention 
period for written directives. Only minor changes were made to the 
specific items that must currently be recorded in the written 
directive. These changes were discussed under Sec. 35.40.
    Section 35.2045, Records of medical events, would require that the 
licensee maintain a record of medical events reported pursuant to 
Sec. 35.3045 for 3 years. This section, in part, is intended to replace 
the current recordkeeping requirements in Sec. 35.33. The records made 
pursuant to Sec. 35.3045 must contain the licensee's name; the name of 
the prescribing physician; the affected or potentially affected 
individual's social security number or other identification number if 
one has been assigned; a brief description of the medical event; why it 
occurred; the effect on the individual; and the actions taken to 
prevent recurrence. This record is needed to document medical events 
for licensee and Commission review. The requirement to maintain records 
of medical events is similar to the current requirement for maintaining 
records of misadministrations. This proposed requirement would provide 
for a reduction in licensee burden since medical events records would 
be required to be maintained for 3 years rather than 5 years.
    Section 35.2060, Records of instrument calibrations, would require 
the licensee to maintain a record of dose calibrator calibrations 
performed in accordance with Secs. 35.60 and 35.62 for 3 years. These 
records are required to document that the instruments are functioning 
correctly. The name, rather than the signature, of the individual who 
performed the calibration would be required so that licensees would 
have the flexibility of using paper records or computer-generated 
records. This requirement does not prohibit licensees from continuing 
to have the individual who performed the calibration sign the record. 
The 3-year recordkeeping retention period is consistent with the 
current retention period for instrument calibrations.
    Section 35.2061, Records of radiation survey instrument 
calibrations, would require the licensee to maintain a record of 
radiation survey instrument calibrations required by Sec. 35.61 for 3 
years. No changes have been made from the current recordkeeping 
requirements for radiation survey instrument calibrations. These 
records are required to document that the instruments are functioning 
correctly. The 3-year recordkeeping retention period is consistent with 
the current retention period for instrument calibrations.
    Section 35.2063, Records of dosage of unsealed byproduct material 
for medical use, would require the licensee to maintain a record of 
dosage determinations required by Sec. 35.63 for 3 years. Minor changes 
have been made from the current recordkeeping requirements for dosage 
measurement to delete the requirement to record the expiration date of 
the radiopharmaceutical. This was done because the expiration date is 
primarily related to drug stability and sterility. The term ``dosage 
measurement'' has been replaced by the term ``dosage determination'' to 
be consistent with the change proposed in Sec. 35.63. Finally, a change 
would be made to require that the name of the individual who determined 
the dosage be documented. The licensee will be required to record 
dosages administered to patients or human research subjects. This 
record is required for licensees to show that they are maintaining 
control of radioactive material. The 3-year recordkeeping retention 
period corresponds with the current retention period for dosage 
records.
    Section 35.2067, Records of possession of sealed sources and 
brachytherapy sources, would require the licensee to retain records of 
the leak tests and inventory required by Sec. 35.67 (b) and (g) for 3 
years. The record retention period would be reduced from 5 years to 3 
years to reduce regulatory burden. The Commission does not believe the 
extra period is warranted. One change has been made from the current 
recordkeeping requirements for leak tests and inventories. The name of 
the individual performing the leak test and inventory would be recorded 
rather than the signature of the Radiation Safety Officer. Leak test 
records are required to show that the leak test was done at the 
appropriate time interval and that sealed sources are not leaking. 
Inventory records are necessary to show that the possession of sealed 
sources did not exceed the amount authorized by the license.
    Section 35.2070, Records of surveys for ambient radiation exposure 
rate, would require the licensee to maintain records of radiation 
surveys for 3 years. One change has been made from the current 
recordkeeping requirements for radiation surveys. The name of the 
individual performing the survey rather than the initials of the 
individual would be required to be recorded. These records are needed 
to document that surveys were performed. The 3-year recordkeeping 
retention period is consistent with the current retention period for 
radiation surveys.
    Section 35.2075, Records of the release of individuals containing 
radiopharmaceuticals or implants, would require the licensee to 
maintain records of patient release required by Sec. 35.75 for 3 years. 
No changes have been made from the current recordkeeping requirements 
in Sec. 35.75. This record is needed to show

[[Page 43545]]

compliance with the requirements in Sec. 35.75.
    Section 35.2080, Records of administrative and technical 
requirements that apply to the provision of mobile services, would 
require the licensees to maintain a copy of the letter that permits the 
use of byproduct material at a client's address of use for 3 years 
after the last provision of service; and to retain the records of the 
surveys for 3 years. One change has been made in these records that are 
required by Sec. 35.80. The name of the individual performing the 
survey rather than the initials of the individuals would be required to 
be recorded. The records are needed to show compliance with the 
requirements in Sec. 35.80.
    Section 35.2092, Records of waste disposal, would require the 
licensee to maintain records of the disposal of licensed materials made 
in accordance with Sec. 35.92 for 3 years. Minor changes have been made 
in the recordkeeping requirements in the current Part 35. The licensee 
would no longer be required to record the date that the material was 
placed in storage because the requirement to store material for 10 
half-lives would be deleted in the proposed rule. The record must 
include the date of the disposal, the radionuclides disposed, the 
survey instrument used, the background dose rate, the dose rate 
measured at the surface of each waste container, and the name of the 
individual who performed the disposal. This record is needed to 
document that radioactive material is not disposed of as ordinary 
waste. The 3-year recordkeeping retention period is consistent with the 
current retention period for waste disposal records.
    Section 35.2204, Records of molybdenum-99 concentration, would 
require the licensee to maintain a record of the molybdenum-99 
concentration tests required by Sec. 35.204(b) for 3 years. Minor 
changes have been made in the recordkeeping requirements from the 
current rule. The licensee would no longer be required to record the 
measured activity of the technetium expressed in millicuries, and the 
measured activity of the molybdenum expressed in microcuries. The 
record must include, for each measured elution of technetium-99m, the 
ratio for the measures expressed as microcuries of molybdenum per 
millicurie of technetium, the time and date of the measure, and the 
name of the individual who performed the disposal. This record is 
needed to document that the concentration measurement was made and that 
the maximum molybdenum-99 concentration level was not exceeded. The 3-
year recordkeeping retention period is consistent with the current 
retention period for records of molybdenum-99 concentration.
    Section 35.2310, Records of instruction and training, would require 
the licensee to maintain a record of radiation safety instructions 
required by Secs. 35.310, 35.410, and 35.610 for 3 years. The record 
must include a list of the topics covered, the date of the instruction 
or training, the name(s) of the attendee(s) and the name of the 
individual who gave the instruction. This record is needed to document 
that the instruction and training was given. The 3-year recordkeeping 
retention period is consistent with the current retention period for 
training records.
    Section 35.2404, Records of radiation surveys of patients and human 
research subjects, would require the licensee to maintain a record of 
the radiation surveys required by Sec. 35.404 for 3 years. The licensee 
would no longer be required to record the dose rate from the patient or 
the human research subject expressed as millirem per hour and measured 
at 1 meter from the patient or human research subject. Each record must 
include the date, location, results of the survey, an identification of 
the patient or the human research subject, survey instrument used, and 
the name of the individual who made the survey. These records are used 
to show that sources have not been misplaced and that all sources have 
been removed from the patient. The 3-year recordkeeping retention 
period is consistent with the current retention period for surveys.
    Section 35.2406, Records of brachytherapy source inventory, would 
require the licensee to maintain a record of brachytherapy source 
accountability required by Sec. 35.406 for 3 years. Changes have been 
made in the recordkeeping requirements that are in the current rule. 
The licensee would no longer be required to record the following items 
since they would be deleted from discussion in Sec. 35.406: the names 
of the individuals permitted to handle the sources; name and room 
number of the patient or the human research subject receiving the 
implant; number and activity of the sources in storage after the 
removal; and the number and activity of sources in storage after the 
return.
    The proposed rule would require that, for temporary implants, the 
record must include the number and activity of sources removed from and 
returned to storage; the time and date they were removed from and 
returned to storage; the location of use; and the name of the 
individual who removed and returned the sources to storage. For 
permanent implants, the record must include the number and activity of 
sources removed from and returned to storage; the date they were 
removed from and returned to storage; the number and activity of 
sources removed from and returned to storage; the number and activity 
of sources permanently implanted in the patient or human research 
subject; and the name of the individual who removed and returned the 
sources to storage. This record is required so that, if a brachytherapy 
source is misplaced or missing, the licensee is immediately alerted and 
can take appropriate action. The 3-year recordkeeping retention period 
is consistent with the current retention period for inventory records.
    Section 35.2432, Records of full calibrations on brachytherapy 
sources, would require the licensee to retain a record of the results 
of brachytherapy source calibrations for 3 years after the last use of 
the source. This is a new recordkeeping section. The record must 
contain the date of the calibration; the manufacturer's name, model 
number, and serial number for the source and instruments used to 
calibrate the source; the source output; source positioning accuracy 
within applicators; and the name of the individual or source 
manufacturer who performed the calibration. These records are needed to 
document that the brachytherapy sources have been calibrated.
    Section 35.2605, Records of installation, maintenance, and repair, 
would require the licensee to retain a record of the installation, 
maintenance, and repair of therapeutic medical devices, as required by 
Sec. 35.605, for 3 years. This is a new recordkeeping section. 
Previously, licensees were not required to keep records of 
installation, maintenance, and repair. For each installation, 
maintenance, and repair, the record must include the date, description 
of the service, and name(s) of the individual(s) who performed the 
work. This record is necessary to document that the devices are 
properly installed, maintained, and repaired; to establish trends in 
device performance; and to establish a service history that may be used 
in evaluation of generic equipment problems.
    Section 35.2630, Records of dosimetry equipment, would require the 
licensee to retain a record of the calibration, intercomparison, and 
comparisons of its dosimetry equipment done in accordance with 
Sec. 35.630 for the duration of the license. No changes have been made 
in the recordkeeping requirements from the current rule. These records 
are needed to show that calibrations of medical devices were made with 
properly calibrated instruments.

[[Page 43546]]

    Section 35.2632, Records of teletherapy full calibrations, would 
require the licensee to maintain a record of the teletherapy full 
calibrations required by Sec. 35.632 for 3 years. The record retention 
period would be decreased from the duration of the use of the 
teletherapy unit source to 3 years to reduce regulatory burden. The 
term ``teletherapy physicist'' was replaced with the term ``authorized 
medical physicist.'' No other changes were made to the current 
recordkeeping requirements for this section. These records are needed 
to document that calibrations were performed in accordance with 
Sec. 35.632.
    Section 35.2633, Records of remote afterloader full calibrations, 
would require the licensee to maintain a record of the remote 
afterloader full calibrations required by Sec. 35.633 for 3 years. This 
is a new recordkeeping section. The recordkeeping requirements in this 
section are similar to the recordkeeping requirements for teletherapy 
units in Sec. 35.2632. The record must include the date of the 
calibration; the manufacturer's name, model number, and serial number 
for the remote afterloader, source, and instruments used to calibrate 
the unit; the source output; an assessment of timer accuracy and 
linearity, source positioning accuracy, source guide tube and connector 
lengths, source retraction functionality; and the signature of the 
authorized medical physicist who performed the full calibration. These 
records are needed to document that calibrations were performed in 
accordance with Sec. 35.633.
    Section 35.2635, Records of gamma stereotactic radiosurgery unit 
full calibrations, would require the licensee to maintain a record of 
the calibrations required by Sec. 35.635 for 3 years. This is a new 
recordkeeping section. The recordkeeping requirements in this section 
are similar to the recordkeeping requirements for teletherapy units in 
Sec. 35.2632. The record must include the date of the calibration; the 
manufacturer's name, model number, and serial number for the gamma 
stereotactic radiosurgery unit, source, and instruments used to 
calibrate the unit; the unit output; an assessment of the relative 
helmet factors, isocenter coincidence, timer accuracy and linearity, 
on-off error, and trunnion centricity; and the signature of the 
authorized medical physicist who performed the full calibration. These 
records are needed to document that calibrations were performed in 
accordance with Sec. 35.635. This change reflects corresponding changes 
made in Sec. 35.642.
    Section 35.2642, Records of periodic spot-checks for teletherapy 
units, would require the licensee to retain a record of each periodic 
spot-check for teletherapy units required by Sec. 35.642 for 3 years. 
Minor changes have been made in the recordkeeping requirements from the 
current rule. The licensee would no longer be required to record the 
operability of the beam condition indicator light, but would be 
required to record the operability of the source exposure indicator 
light. This change reflects corresponding changes made in Sec. 35.642. 
The record must include the date of the spot-check; the manufacturer's 
name, model number, and serial number for the teletherapy unit source, 
and instrument used to measure the output of the teletherapy unit; an 
assessment of timer linearity and constancy; the calculated on-off 
error, a determination of the coincidence of the radiation field and 
the field indicated by the light beam localizing device; the determined 
accuracy of each distance measuring and localization device; the 
difference between the anticipated output and the measured output; 
notations indicating the operability of each entrance door electrical 
interlock, each electrical or mechanical stop, each source exposure 
indicator light, and the viewing and intercom system and doors; name of 
the individual who performed the test and the signature of the 
authorized medical physicist who reviewed the periodic spot-check. 
These records are needed to document that spot-checks were performed in 
accordance with Sec. 35.642. The 3-year recordkeeping retention period 
is consistent with the current retention period for periodic spot-
checks.
    Section 35.2643, Records of periodic spot-checks for remote 
afterloaders, would require the licensee to retain a record of each 
spot-check for remote afterloaders required by Secs. 35.643 and 35.644 
for 3 years. This is a new recordkeeping section. The record must 
include the date of the spot-check; the manufacturer's name, model 
number, and serial number for both the remote afterloader, source, and 
instrument used to measure the output of the remote afterloader; the 
difference between the anticipated output and the measured output; 
notations indicating the operability of each entrance door electrical 
interlock, source retraction mechanism, radiation monitors, source 
exposure indicator lights, viewing and intercom, applicators and 
connectors, and source positioning accuracy; the name of the individual 
who performed the periodic spot-check; and signature of the authorized 
medical physicist who reviewed the periodic spot-check. These records 
are needed to document that spot-checks were performed in accordance 
with Secs. 35.643 and 35.644.
    Section 35.2645, Records of periodic spot-checks for gamma 
stereotactic radiosurgery units, would require the licensee to retain a 
record of each spot-check for gamma stereotactic radiosurgery units 
required by Sec. 35.645 for 3 years. This is a new recordkeeping 
section. The record must include the date of the spot-check; the 
manufacturer's name, model number, and serial number for the gamma 
stereotactic radiosurgery unit, and the instrument used to measure the 
output of the unit; the measured source output and source output 
against computer calculations; notations indicating the operability of 
radiation monitors, helmet microswitches, emergency timing circuits, 
emergency off buttons, electrical interlocks, source exposure indicator 
lights, viewing and intercom systems, timer termination systems, 
hydraulic cutoff mechanism, and stereotactic frames and localizing 
devices (trunnions); and the name of the individual who performed the 
periodic spot-check; and the signature of the authorized medical 
physicist who reviewed the periodic spot-check. This record is needed 
to show that spot-checks were performed in accordance with Sec. 35.645.
    Section 35.2647, Records of additional technical requirements for 
mobile remote afterloaders, would require the licensee to retain a 
record of each check for mobile remote afterloaders required by 
Sec. 35.647 for 3 years. This is a new recordkeeping section. The 
record must include the date of the check; the manufacturer's name, 
model number, and serial number for the remote afterloader; notations 
accounting for all sources before departing from a client's facility; 
notations indicating the operability of each entrance door electrical 
interlock, radiation monitors, source exposure indicator lights, 
viewing and intercom system, applicators and connectors, and source 
positioning accuracy; and the signature of the individual who performed 
the check. This record is needed to show that required spot-checks were 
performed in accordance with Sec. 35.647 and that the unit is operable. 
The 3-year recordkeeping retention period is consistent with the 
current retention period for checks on mobile remote afterloaders.
    Section 35.2652, Records of surveys of therapeutic treatment units, 
would require the licensee to maintain a record of radiation surveys 
made in accordance

[[Page 43547]]

with Sec. 35.652 for the duration of use of the unit. This 
recordkeeping section has been changed to require that the records of 
radiation surveys of the treatment unit must be maintained for the 
duration of use of the unit, rather than for the duration of the 
license, to reduce regulatory burden. In addition, the licensee is no 
longer required by this section to maintain a plan of the areas 
surrounding the treatment room that were surveyed, the measured dose 
rate at several points in each area expressed in millirem per hour, and 
the calculated maximum quantity of radiation over a period of 1 week 
for each restricted and unrestricted area. This change reflects 
corresponding changes made in Sec. 35.652. The record must include the 
date of the measurements; the manufacturer's name, model number and 
serial number of the treatment unit, source, and instrument used to 
measure radiation levels; and each dose rate measured around the source 
while the unit is in the off position and the average of all 
measurements and the signature of the individual who performed the 
surveys. This record is needed to document radiation levels in areas 
surrounding therapeutic devices.
    Section 35.2655, Records of 5-year inspection for teletherapy and 
gamma stereotactic surgery units, would require the licensee to 
maintain a record of the 5-year inspection for teletherapy and gamma 
stereotactic radiosurgery units required by Sec. 35.655 for the 
duration of the unit. This recordkeeping section would be changed to 
require that the records of inspections of the treatment units must be 
maintained for the duration of use of the unit, rather than for the 
duration of the license, to reduce regulatory burden. A minor change 
was made to delete the requirement to maintain a record of the 
components replaced to also reduce regulatory burden. The record must 
contain the inspector's name; the inspector's radioactive materials 
license number; the date of inspection; the manufacturer's name and 
model number and serial number for both the treatment unit and source; 
a list of components inspected and serviced; the type of service; and 
the signature of the inspector. This record is needed to document the 
type of service that was performed.
    Subpart M, Reports, is a new subpart in Part 35. This subpart would 
contain all the reporting requirements necessary to implement the 
proposed requirements in Part 35. Grouping of reporting requirements 
into one subpart was done to facilitate use by the licensee. A licensee 
may reference this section when determining whether something must be 
reported, rather than having to review the entire regulation to find 
out if there is a particular reporting requirement. Many of the 
reporting requirements remain unchanged. The Commission is soliciting 
public comments on whether the reporting requirements should be 
included in the section requiring the report.
    Section 35.3045, Reports of medical events, would provide criteria 
for reporting medical events. The criteria are based on the current 
requirements in Sec. 35.33. Changes would be made to make the reporting 
threshold dose-based where possible to add a dose threshold of 0.5 Sv 
(50 rem) shallow dose equivalent to the skin; and to address two areas 
that have caused problems in implementing the current requirements in 
Sec. 35.33--patient intervention and wrong treatment site. With respect 
to patient intervention, the licensee is expected to act reasonably, in 
accordance with prevailing standards of care, to prevent a medical 
event. Generally speaking, patient intervention involves actions by the 
patient such as dislodging or removing treatment devices or prematurely 
terminating treatment. In cases where patient intervention is probable, 
the licensee should take reasonable actions (e.g., extra sutures, 
taping, or more frequent checks by the nursing staff) to avoid a 
medical event. Factors which may be considered in determining whether a 
licensee's actions are reasonable include whether the licensee monitors 
the patient routinely and whether the licensee responds properly once 
it becomes aware of the disruption of treatment. The Commission is 
soliciting input from the public on whether the proposed changes 
adequately address patient intervention and wrong treatment site.
    The proposed rule would require that licensees notify, by 
telephone, the NRC Operations Center no later than the next calendar 
day after discovery of the medical event. The licensee would be 
required to submit a written report to the appropriate NRC Regional 
Office listed in 10 CFR 30.6 within 15 days after discovery of the 
medical event. In addition, the licensee would be required to notify 
the referring physician and the individual affected by the medical 
event, or the responsible relative or guardian, no later than 24 hours 
after its discovery, unless the referring physician personally informs 
the licensee either that he will inform the individual or that, based 
on medical judgment, telling the individual would be harmful. This 
reporting requirement is needed to ensure that NRC is aware of medical 
events. Section III of the Supplementary Information of this document 
contains a detailed discussion of the Commission's views on the 
notification requirements.
    The proposed rule would require that a written report be furnished 
to the individual within 15 days after discovery of the medical event. 
This requirement could be met by sending either a copy of the report 
that was submitted to the NRC or a brief description of both the event 
and the consequences as they may affect the individual. The proposed 
rule would delete the current requirement to include a statement that 
the report submitted to the NRC can be obtained from the licensee. This 
deletion does not preclude the licensee from providing the report to 
the individual but provides the licensee flexibility in transmitting 
pertinent information to the individual.
    Section 35.3047, Report of a dose to an embryo/fetus or a nursing 
child, would provide reporting criteria. Paragraph (a) would require 
that a licensee report to NRC any administration of byproduct material, 
or radiation from byproduct material, to a pregnant woman that results 
in a dose to an embryo/fetus that is greater than 5 mSv (500 mrem) 
absorbed dose unless specifically approved, in advance, by the 
authorized user. It should be emphasized that only unintended exposures 
would be reported to NRC. This report does not include exposure of 
individuals in excess of the public dose limits in Part 20. Paragraph 
(b) would require a licensee to report to NRC any administration of 
byproduct material to a breast feeding woman that results in a dose to 
the nursing child that is greater than 5 mSv (500 mrem) total effective 
dose equivalent. Oral reports must be made to the NRC Operations Center 
within 5 days of discovery and followed with a written report no later 
than 15 days.
    Information required by this section is needed so that NRC can 
comply with Section 208 of the Energy Reorganization Act of 1974 
(Public Law 93-438), as amended, to submit an annual report to Congress 
a report of unscheduled incidents or events which the Commission 
considers significant from the standpoint of public health and safety, 
e.g., abnormal occurrences.
    NRC identifies an abnormal occurrence using the revised abnormal 
occurrence criteria that was published in the Federal Register on April 
17, 1997 (62 FR 18820). Section II of the policy statement defines 
unintended radiation exposure as ``any occupational exposure, exposure 
to the general public or exposure as a result of a medical 
misadministration (as defined in Sec. 35.2)

[[Page 43548]]

involving the wrong individual that exceeds the reporting values 
established in the regulations.'' This section also states that ``All 
other reported medical misadministrations will be considered for 
reporting as an Abnormal Occurrence under the criteria for medical 
licensees. In addition, unintended radiation exposures include any 
exposure to a nursing child, fetus, or embryo as a result of an 
exposure (other than an occupational exposure to an undeclared pregnant 
woman) to a nursing mother or pregnant woman above specified values.'' 
Appendix A, Section I. A, of the policy statement, states that NRC will 
provide information on ``any unintended radiation exposure to any minor 
(an individual less than 18 years of age) resulting in an annual total 
effective dose equivalent of 50 mSv (5 rem) or more, or to an embryo/
fetus resulting in a dose equivalent of 50 mSv (5 rem) or more.''
    At the present time, NRC has no regulatory requirements that would 
require reporting of those types of events. The Commission considered 
two alternatives that could be pursued: revise the current Abnormal 
Occurrence Criteria to delete the requirement to inform Congress of 
this type of event; or develop a reporting requirement that would 
provide information needed by the Commission to comply with Section 
208. The Commission did not pursue the first option because the 
Abnormal Occurrence reporting criteria were recently revised.
    Only two comments were received on the proposed criteria in this 
area. One commenter believed that the threshold for reporting a dose to 
any minor or embryo/fetus should be reduced to less than 0.350 rem 
instead of the proposed 5 rem. The second commenter recommended that 
the criteria related to a nursing infant, fetus or embryo as a result 
of an exposure to a nursing mother or a pregnant woman should be 
deleted from the criteria until the issue can be resolved through 
consultation with the ACMUI and a separate public comment period on 
that issue.
    The Commission is not inclined to revise the criteria without 
public comments indicating that it is not appropriate for NRC to report 
this type of event to Congress and that the proposed reporting 
requirement in Sec. 35.3047 is overly burdensome or unwarranted. As a 
result, the Commission has decided to pursue the second alternative. 
However, the Commission does solicit specific comments in this area 
regarding whether modification of the Abnormal Occurrence Policy 
Statement criteria is needed.
    The proposed rule would require that licensees report to NRC any 
unintended exposures to an embryo/fetus or nursing child that exceeds 
the dose threshold, as specified in the proposed Sec. 35.3047. The 
Commission recognizes that the proposed reporting threshold is less 
than the Abnormal Occurrence reporting level. This was done to make the 
Part 35 reporting threshold consistent with the reporting thresholds in 
10 CFR Part 20. The time period for reporting is similar for the 
reporting requirements in 10 CFR parts 20 and 35.
    The proposed rule would also require the licensee to notify the 
referring physician and the pregnant individual or mother within 5 days 
of discovery of an event that would require reporting under this 
section, unless the referring physician personally informs the licensee 
either that he or she will inform the mother or that, based on medical 
judgment, telling the mother would be harmful. (Note, it is recognized 
that in some cases, the woman may no longer be pregnant or nursing when 
the event is discovered. In this situation, it is expected that the 
individual responsible for the infant's or child's medical care would 
be notified.) In cases where the pregnant individual or mother was not 
notified, the notification may be made instead to the mother's or 
child's responsible relative or guardian.
    The terminology of the notification provisions of Sec. 35.3047 is 
similar to Sec. 35.3045. Due to uncertainties on the part of some 
licensees as to the scope of the term ``responsible relative or 
guardian,'' the Commission is soliciting specific public comment on 
whether there is a better term than ``responsible relative or 
guardian'' to apply to those situations in which the mother is not 
notified, e.g., in the referring physician's medical judgement, telling 
the mother would be harmful; the mother is a minor; or the mother is 
not competent to make decisions regarding medical care.
    The Commission is also concerned about notification in situations 
where the pregnant individual has purposely chosen not to tell others 
of her pregnancy status and notification to a responsible relative or 
guardian would be required by this rule, e.g., the individual is a 
minor and does not want others to know of the pregnancy. As a result of 
concerns regarding reporting and notification pursuant to this section, 
the NRC is soliciting specific public comment on the impacts of this 
reporting requirement on licensee procedures, activities, or medical 
practices.
    The Commission recognizes that the standard of practice for 
authorized users is to assess the pregnancy or nursing status of their 
patients (reference American College of Radiology ``Standard for the 
Performance of Therapy with Unsealed Radionuclide Sources,'' 1996, and 
``Society of Nuclear Medicine General Procedure Guidelines for Imaging 
with Radionuclides,'' 1997). As a result, NRC does not believe that it 
is appropriate to propose a rule that would require a licensee to 
assess the pregnancy or nursing status of patients. It does, however, 
believe that it is appropriate to propose a rule that would require the 
licensee to inform NRC when it learns of an unintended dose to an 
embryo/fetus or a nursing child that exceeds the thresholds discussed 
above. Reporting under Sec. 35.3047 would not necessarily be subject to 
enforcement action if the licensee had complied with Sec. 35.75. 
Although the regulation requires that the licensee provide information 
on the cause of the incident and corrective actions to prevent 
recurrence, NRC acknowledges that in many, and if not all, incidents, 
the licensee might not have been able to prevent the incident because 
the individual may not have been aware of the pregnancy or may have 
opted not to disclose her pregnancy or nursing status.
    Section 35.3067, Reports of leaking sources, would require the 
licensee to file a report with the appropriate NRC Office listed in 
Sec. 30.6 of this chapter, with a copy to Director, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, within 5 days if a leakage test required by 
Sec. 35.67 reveals the presence of 185 Bq (0.005 microcurie) or more of 
removable contamination. This reporting requirement is similar to the 
current requirements for leaking sources. The report must contain the 
model number and serial number if assigned, of the leaking source; 
Radionuclide and its estimated activity; the measured activity of each 
test sample expressed in microcuries; a description of the method used 
to measure each test sample; the date of the test; and the action 
taken.
    Subpart N, Enforcement, contains statements regarding enforcement. 
This subpart would replace the statements in the current Subpart K, 
Enforcement.
    Section 35.4001, Violations, would appear as a new section and 
replace the current Sec. 35.990 which would be deleted in the proposed 
rule. This section reflects the new numbering system for the revised 
Part 35.
    Section 35.4002, Criminal penalties, would appear as a new section 
and replace the current Sec. 35.991 which would be deleted in the 
proposed rule.

[[Page 43549]]

This section reflects the new numbering system for the revised Part 35.
    Appendix A to Part 35, Examining Organization or Entity, would 
appear as a new appendix. This appendix would provide the requirements 
for an examining organization or entity; examination programs; and 
written examinations. This appendix is needed because of the proposed 
revision to the training and experience criteria for an authorized 
user, medical physicist, authorized nuclear pharmacist, and radiation 
safety officer that would require an individual to pass an examination 
given by an organization or entity approved by NRC or an Agreement 
State. All criteria in Appendix A are considered by the Commission as 
necessary to assure that an individual's competency is adequately 
assessed.
    NRC is proposing that an independent examining organization be an 
organization that would make its examination process available to the 
general public nationwide and not restrict access because of race, 
color, religion, sex, age, national origin or disability. The 
independent examining organization or entity would need to:
    (1) Have adequate staff;
    (2) Have a viable system of financing its operations;
    (3) Have a policy and decision making review board;
    (4) Be governed by written organizational by-laws and policies;
    (5) Provide NRC or an Agreement State with a description of its 
procedures for choosing examination sites and for providing an 
appropriate examination environment;
    (6) Submit its request for approval to the Director, Office of 
Nuclear Materials Safety and Safeguards.
    An independent examining organization or entity would also need to 
have:
    (1) A committee to review and approve the examination guidelines 
and procedures, and to advise the organization's staff in implementing 
the examination program;
    (2) A committee to review complaints from examined individuals;
    (3) Written procedures describing all aspects of its examination 
program;
    (4) An agreement to exchange information about examined individuals 
with the Commission and the Agreement States;
    (5) Procedures to ensure that examinations are not given to 
individuals who have also been instructed by the examining organization 
in the same subject area;
    (6) Procedures to ensure that examined individuals are provided due 
process with respect to the administration of its examination program;
    (7) Procedures for proctoring examinations; and
    (8) Procedures to ensure that all examination questions are 
protected from disclosure.
    NRC is proposing in Section II of Appendix A that all examination 
programs must (1) require applicants for examination to receive 
training in the topics set forth in Secs. 35.50(b)(1), 35.51(b)(1), 
35.55(b)(3), 35.290(b)(1), 35.292(b)(1), 35.390(b)(1), 35.490(b)(1) or 
35.690(b)(1) and satisfactorily complete a written examination covering 
these topics. NRC is proposing in Section III that:
    (1) The written examination must be designed to test an 
individual's knowledge and understanding of the topics listed in the 
above sections;
    (2) The written examination must have test items drawn from a 
question bank containing psychometrically valid questions based on the 
material in the above listed questions; and
    (3) A sample examination must be submitted to the Commission for 
review initially and every 5 years.
    A 5-year review cycle is consistent with the review of residency 
programs by the Accreditation Council for Graduate Medical Education.

Summary of Specific Issues Identified for Public Comment

    The Commission is soliciting specific public comment on various 
issues associated with this rulemaking action. These issues are 
discussed in detail in the noted sections.
    1. Training and Experience--Is the proposed requirement for 
examining organizations to ensure that examinations are not given to 
individuals who have also been instructed by the examining organization 
in the same subject area too prescriptive? Is the requirement for an 
examination to verify competency warranted, in light of current 
industry practice? What is the projected amount of time needed for 
specialty boards and examining organizations to prepare and submit an 
application to NRC or Agreement States?
    2. Section 35.2--Should the term ``medium dose-rate remote 
afterloader'' be defined since it not used in the rule? (Requirements 
for medium dose-rate remote afterloaders have been grouped with high 
dose-rate remote afterloaders in this rulemaking.)
    3. Section 35.6--Should this section be revised to require that 
licensees develop, implement, and maintain procedures for evaluating 
when a medical procedure would be considered to be a research 
procedure?
    4. Section 35.24--Will the deletion of the requirement for a 
Radiation Safety Committee and proposed new requirement for the 
Radiation Safety Officer to acknowledge, in writing, responsibility for 
implementing the radiation protection program impact the licensee's 
effectiveness in carrying out its radiation protection program? In 
particular, will this combination of changes actually reduce the 
effectiveness of radiation protection programs and will the radiation 
safety officer be provided appropriate tools and channels through which 
to raise safety concerns to the highest levels of management. If a 
requirement for a committee, to oversee the radiation safety program, 
was included in the final rule, should the rule language explicitly 
require that the radiation safety officer be a member of that 
committee?
    5. Section 35.75--Should any changes be made to the release 
criteria specified in this section?
    6. Section 35.92--Is it appropriate to delete the requirement to 
hold byproduct material for a minimum of ten half-lives?
    7. Section 35.315--Should the requirement for a private room with a 
private sanitary facility be maintained in the final rule?
    8. Section 35.415--Should the requirement for a licensee to not 
quarter a patient in the same room as an individual who is not 
receiving radiation therapy be maintained in the final rule?
    9. Section 35.432--Should the final rule contain a requirement for 
the licensee to perform full calibration measurements on brachytherapy 
sources before first use? Should the final rule allow licensees to rely 
on the brachytherapy source output provided by the manufacturer or 
distributor if the dosimetry equipment used by the manufacturer or 
distributor met the calibration requirements in Sec. 35.630? How should 
sources be calibrated if there is no standard traceable to the National 
Institute of Standards and Technology? What is the estimated number of 
short- and long-lived brachytherapy sources that will need to be 
calibrated by the licensee on an annual basis and how long will it take 
to perform the calibration? Will licensees need to procure additional 
equipment to perform the calibrations?
    10. Section 35.605--Should the restrictions in paragraph (a) of the 
proposed rule apply to low dose-rate remote afterloaders?

[[Page 43550]]

    11. Section 35.615--Should the requirements in this section be 
waived for licensees that are using remote afterloaders with beta-
emitting sources?
    12. Section 35.644--Should the restrictions for electrical 
interlocks and audiovisual systems apply to low dose-rate remote 
afterloaders?
    13. Section 35.981--What is the impact of deleting this section?
    14. Subpart L--Should all recordkeeping requirements be grouped 
into one subpart or should they be incorporated into the section 
requiring the record?
    15. Subpart M--Should all reporting requirements be grouped into 
one subpart or should they be incorporated into the section requiring 
the report?
    16. Section 35.3045--Do the proposed rule changes adequately 
address patient intervention and wrong treatment site?
    17. Section 35.3047--Should the Abnormal Occurrence Policy 
Statement criteria for reporting of exposures to an embryo/fetus or 
nursing child be modified? Is there a better term than ``responsible 
relative or guardian'' that could be applied to those situations where 
the mother is not notified, e.g., in the referring physician's medical 
judgment telling the mother would be harmful; the mother is a minor; or 
the mother is not competent to make decisions regarding medical care? 
What is the impact of the proposed reporting requirement on licensee 
procedures, activities, or medical practices?

V. Coordination With The Advisory Committee on the Medical Uses of 
Isotopes

    The Advisory Committee on the Medical Uses of Isotopes (ACMUI) is 
an advisory body established to advise the NRC staff on matters that 
involve the administration of radioactive material and radiation from 
radioactive material. At the public ACMUI meetings on September 25-26, 
1997, and March 1-2, 1998, held in Rockville, MD., the NRC staff 
presented alternatives for major cross-cutting issues related to 
revising Part 35, recommendations for revising the NRC's Medical Use 
Policy Statement, and draft proposed rule text.
    These meetings were transcribed. The ACMUI's comments at the 
September 1997 meeting are summarized in ``Summary of Discussion: 
Meeting of the Advisory Committee on the Medical Uses of Isotopes 
(ACMUI) Held in Rockville, Maryland on September 25-26, 1997'' (April 
17, 1998). The summary document is available for inspection at the NRC 
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. 
Single copies of the summary document are available as indicated in the 
For Further Information Contact section of this document. A brief 
summary of the ACMUI positions on the major crosscutting issues 
associated with this rulemaking is provided in Section III of the 
Supplementary Information section of this document.
    Working group members also met with separate ACMUI subcommittees 
for diagnostic and therapeutic medical uses on February 9-10, 1998 
(Rockville, MD.) and February 12-13, 1998 (Freeport, IL.), 
respectively. The subcommittee meetings provided the Working Group with 
an opportunity to discuss in depth the specific provisions of the draft 
proposed rule with ACMUI members.

VI. Coordination With NRC Agreement States

    NRC staff discussed the proposed revision of Part 35 with 
representatives of the Agreement States at a workshop on October 18, 
1997. The workshop commentary was transcribed, and the participant's 
comments are summarized in ``Summary of Discussion: Facilitated Public 
Workshop on NRC's Medical Rulemaking Initiative Held at All Agreement 
States Meeting, Los Angeles, California, October 18, 1997'' (April 17, 
1998). The summary document is available for inspection at the NRC 
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. 
Single copies of the summary document are available as indicated in the 
For Further Information Contact section of this document. A brief 
summary of the workshop participants' positions on the major cross-
cutting issues associated with this rulemaking is provided in Section 
III of the Supplementary Information section of this document.
    Both the Working Group and Steering Group that developed the draft 
proposed rule included representatives of Agreement States. The 
Agreement State representative on the Working Group is also a member of 
the Conference of Radiation Control Directors' Suggested State 
Regulation Committee on Medical Regulation, which is working toward 
parallel development of suggested state medical regulations. State 
participation in the process has provided an early opportunity for 
State input and should enhance development of corresponding rules in 
State regulations. In addition, it will allow the State staff to assess 
the potential impacts of NRC draft language on the regulation of non-
Atomic Energy Act materials used in medical diagnosis, treatment, or 
research in the States.

VII. Consistency With Medical Policy Statement

    The Commission is proposing a revision to its General Policy on the 
Regulation of the Medical Uses of Radioisotopes that was issued on 
February 9, 1979 (44 FR 8424), as part of the efforts undertaken to 
revise 10 CFR Part 35. The proposed revision and detailed discussion on 
the need for the revision is being published for comment in the Federal 
Register concurrently with the proposed revision to Part 35. Because of 
the nature of the proposed revision to the policy, consistency with 
each policy will be discussed separately.

Consistency With the Proposed Revision to the Medical Use Policy 
Statement

    The proposed revision to Part 35 is consistent with the 
Commission's proposed revision to the Medical Use Policy Statement.
    The first statement of the proposed policy reads ``NRC will 
continue to regulate the uses of radionuclides in medicine as necessary 
to provide for the radiation safety of workers and the general 
public.'' The proposed rule is consistent with the statement because 
one of its purposes is to provide for the radiation safety of workers 
and individual members of the public, which is central to fulfillment 
of the Commission's statutory mandate to ``protect health and minimize 
danger to life.''
    The second statement of the proposed policy reads ``NRC will not 
intrude into medical judgments affecting patients, except as necessary 
to provide for the radiation safety of workers and the general 
public.'' The proposed rule would also be consistent with this 
statement because its focus is on protecting the public and workers 
from patients who have been administered byproduct material or 
radiation from byproduct material for medical use.
    The third statement of the proposed policy reads ``NRC will, when 
justified by the risk to patients, regulate the radiation safety of 
patients primarily to assure the use of radionuclides is in accordance 
with the physician's directions.'' The proposed rule is consistent with 
this statement because it includes provisions, where warranted by the 
risk, to provide high confidence that the authorized user's directions 
for the administration of byproduct material are followed.
    The fourth statement of the proposed policy reads ``NRC, in 
developing a specific regulatory approach, will consider industry and 
professional standards that define acceptable

[[Page 43551]]

approaches of achieving radiation safety.'' The proposed rule is 
consistent with this statement because the rulemaking process included 
examining relevant industry and professional standards to determine if 
specific areas of concern were included in the standards, or whether 
regulatory requirements needed to be included in Part 35.

Consistency With the 1979 Medical Use Policy Statement

    The proposed revision to Part 35 is generally consistent with the 
Commission's General Policy on the Regulation of the Medical Uses of 
Radioisotopes issued on February 9, 1979 (44 FR 8242).
    The first statement of the policy reads ``The NRC will continue to 
regulate the medical uses of radioisotopes as necessary to provide for 
the radiation safety of workers and the general public.'' The proposed 
rule is consistent with this statement because its purpose is to 
provide for the radiation safety of workers and individual members of 
the public, which is central to fulfillment of the Commission's 
statutory mandate to ``protect health and minimize danger to life.''
    The second statement of the policy is ``The NRC will regulate the 
radiation safety of patients where justified by the risk to patients 
and where voluntary standards, or compliance with these standards, are 
inadequate.'' The proposed rule is generally consistent with this 
statement. The proposed rule includes requirements to ensure the 
radiation safety of patients in areas where justified by the risk to 
patients. The rulemaking process included examining relevant industry 
and professional standards to determine if specific areas of concern 
were included in the standards, or whether additional regulatory 
requirements needed to be developed for inclusion in Part 35. The 
process did not include an assessment of licensee compliance with these 
standards. Where appropriate, the proposed revision includes references 
to published protocols approved by nationally recognized bodies. Where 
warranted by risk, key elements of the standards were included as 
performance objectives. Prescriptive compliance requirements for these 
performance objectives were not included in the rule because it is 
expected that licensees will use voluntary standards to achieve the 
objective. This approach is consistent with a performance-based, risk-
informed rule.
    The third statement of the policy reads, ``The NRC will minimize 
intrusion into medical judgments affecting patients and into other 
areas traditionally considered to be a part of the practice of 
medicine.'' The proposed rule is consistent with this statement because 
it includes no requirements associated with the diagnosis and treatment 
of patients.

VIII. Implementation

    The Commission intends to have different implementation dates for 
particular requirements of this proposed rule. With one exception 
(discussed below), the proposed requirements would be effective 6 
months after publication of the final rule in the Federal Register. 
Because the consolidated guidance document for medical use licensees is 
being developed in parallel with the revised regulatory requirements in 
Part 35, the Commission believes that a longer implementation period 
will not be necessary. The 6-month implementation period would allow 
the NRC time to train licensing and inspecting staff so that the 
revised Part 35 will be uniformly implemented; and provide licensees 
the time to understand the specific features of the revised Part 35, 
and to develop and implement any changes in their radiation safety 
programs or procedures that are required to comply with the revised 
requirements. NRC workshops might be offered for the benefit of 
licensees, Regional Offices, States, and others who are affected by the 
revision.
    The Commission proposes that licensees would have up to 2 years 
after the effective date of the final rule to comply with the proposed 
training requirements for authorized users, authorized medical 
physicists, authorized nuclear pharmacists, and Radiation Safety 
Officers. During this 2-year period, licensees will have the option of 
complying with either the existing training requirements, which will be 
retained in subpart J, or the training requirements in subparts B and 
D-H of the proposed rule.
    The 2-year implementation period will allow time for potential 
examining organizations and entities to prepare an application in 
accordance with Appendix A of the proposed rule; and for NRC to review 
and approve the applications submitted in accordance with Appendix A, 
and to review and approve certification of the specialty boards in 
Secs. 35.50(a), 35.51(a), 35.55(a), 35.290(a), 35.292(a), 35.390(a), 
35.490(a), 35.590(a), and 35.690(a). The 2-year time period will also 
allow individuals from Agreement States time to satisfy the proposed 
training requirements in order to work in NRC jurisdiction. After the 
2-year implementation period, the requirements in subpart J will be 
deleted.
    Section 35.10 of the proposed rule addresses how a licensee can 
determine if it must comply with the requirements of its license 
conditions or the requirements of the revised Part 35, when it becomes 
effective.
    The Commission invites comments and suggestions on the effective 
date of implementation, including specific information on time and 
economic considerations, and on additional guidance or documents that 
would be needed or useful in implementing the proposed revision.

IX. Issues of Compatibility for Agreement States

10 CFR Part 35--Medical Use of Byproduct Material
    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' approved by the Commission on June 30, 1997 
(62 FR 46517), specific requirements within this rule should be adopted 
by Agreement States for purposes of compatibility or because of their 
health and safety significance. Implementing procedures for the Policy 
Statement establish specific categories which have been applied to 
categorize the requirements in Part 35. A Category ``A'' designation 
means the requirement is a basic radiation protection standard or deals 
with related definitions, signs, labels or terms necessary for a common 
understanding of radiation protection principles. Category ``A'' 
designated Agreement State requirements should be essentially identical 
to those of the NRC. A Category ``B'' designation means the requirement 
has significant direct transboundary implications. Category ``B'' 
designated Agreement State requirements should be essentially identical 
to those of the NRC. A Category ``C'' designation means the essential 
objectives of the requirement should be adopted by the State to avoid 
conflicts, duplications or gaps. The manner in which the essential 
objectives are addressed in the Agreement State requirement need not be 
the same as NRC provided the essential objectives are met. A Category 
``D'' designation means the requirement does not need to be adopted by 
an Agreement State for purposes of compatibility. The Health and Safety 
(H&S) Category identifies requirements which are not required for 
compatibility, but which have particular health and safety 
significance. Agreement States should adopt the essential objectives of 
such

[[Page 43552]]

requirements in order to maintain an adequate program.
    The following discussion identifies the compatibility designations 
for each section:
    Subpart A, ``General Information,'' Sec. 35.2, ``Definitions,'' is 
assigned to Compatibility Category ``D,'' with the exception of the 
terms ``Agreement State'', ``authorized user,'' ``medical use,'' 
``prescribed dosage,'' ``prescribed dose,'' ``sealed source,'' 
``treatment site'' and ``written directive.'' The terms ``Agreement 
State'' and ``sealed source'' are assigned to Compatibility Category 
``B'' because they have significant direct transboundary implications. 
The terms ``authorized user,'' ``medical event,'' ``medical use,'' 
``precursor event,'' ``prescribed dosage,'' ``prescribed dose,'' 
``treatment site'' and ``written directive'' have been assigned to 
Compatibility Category ``C.'' Section 35.11, ``License required,'' is 
assigned to Compatibility Category ``C.''
    Subpart B, ``General Administrative Requirements,'' is assigned to 
Compatibility Category ``D,'' with the exception of nine sections. 
Section 35.24, ``Authority and responsibilities for the radiation 
protection program'; Sec. 35.27, ``Supervision'; Sec. 35.40, ``Written 
directives'; and Sec. 35.41(a), ``Procedures for administrations 
requiring a written directive'' are all assigned to the Health and 
Safety Category. Section 35.50, ``Training for radiation safety 
officer'; Sec. 35.51, ``Training for authorized medical physicist'; 
Sec. 35.55 ``Training for an authorized nuclear pharmacist'; 
Sec. 35.57, ``Training for experienced Radiation Safety Officer, 
teletherapy or medical physicist, authorized user, and nuclear 
pharmacist;'' and Sec. 35.59, ``Recentness of training'' are assigned 
to Compatibility Category ``C.''
    Subpart C, ``General Technical Requirements,'' is assigned to 
Compatibility Category ``D,'' with the exception of five sections. 
Section 35.61, ``Calibration and check of survey instruments'; 
Sec. 35.63(a), ``Determination of dosages of unsealed byproduct 
material for medical use'; Sec. 35.67, ``Requirements for possession of 
sealed sources and brachytherapy sources'; and Sec. 35.70(a) and (b), 
``Surveys of ambient radiation exposure rate'' are assigned to the 
Health and Safety Category. Section 35.75, ``Release of individuals 
containing radiopharmaceuticals or implants,'' paragraph (a), is 
assigned to Compatibility Category ``C.''
    Subpart D, ``Unsealed Byproduct Material--Low Dose'; and Subpart E, 
``Unsealed Byproduct Material--High Dose'' are assigned to 
Compatibility Category ``D,'' except for Sec. 35.100, ``Use of unsealed 
byproduct material for uptake, dilution, and excretion studies for 
which a written directive is not required'; Sec. 35.200, ``Use of 
unsealed byproduct material for imaging and localization studies for 
which a written directive is not required'; Sec. 35.204, ``Permissible 
molybdenum-99 concentration'; and Sec. 35.300, ``Use of unsealed 
byproduct material for which a written directive is required,'' which 
are assigned to the Health and Safety Category. Section 35.290, 
``Training for uptake, dilution, and excretion studies'; and 
Sec. 35.292, ``Training for imaging and localization studies'; and 
Sec. 35.390, ``Training for use of unsealed byproduct material for 
therapy or for use of unsealed byproduct material that requires a 
written directive,'' are assigned to Compatibility Category ``C.''
    Subpart F, ``Manual Brachytherapy'' is assigned to Compatibility 
Category ``D,'' with the exception of five sections. Section 35.400, 
``Use of sources for manual brachytherapy'; Sec. 35.404(a) and (b), 
``Radiation surveys of patients or human research subjects treated with 
implants'; Sec. 35.406(a) and (b), ``Brachytherapy sources inventory'; 
and Sec. 35.432(a-e), ``Full calibration measurements of brachytherapy 
sources'' are assigned to the Health and Safety Category. Section 
35.490, ``Training for use of manual brachytherapy sources,'' is 
assigned to Compatibility Category ``C.''
    Subpart G, ``Sealed Sources for Diagnosis,'' is assigned to 
Compatibility Category ``D,'' with the exception of Section 35.590, 
``Training for use of sealed sources for diagnosis'' which is assigned 
to Compatibility Category ``C.''
    Subpart H, ``Therapeutic Medical Devices,'' is assigned to 
Compatibility Category ``D,'' with the exception of 16 sections. The 
following sections are assigned to the Health and Safety Category: 
Secs. 35.600; 35.604(a); 35.605; 35.610(a)(1), (a)(2), and (a)(4); 
35.615(a), (b)(1), (b)(2), (d), and (e); 35.630; 35.632; 35.633; 
35.635; 35.642; 35.643; 35.644; 35.645; 35.655; and 35.657. Section 
35.690, ``Training for use of therapeutic medical devices'' is assigned 
to Compatibility Category ``C.''
    Subpart J,'Training and Experience Requirements,'' Subpart K, 
``Other Medical Uses of Byproduct Material or Radiation from Byproduct 
Material,'' and Subpart L, ``Records,'' are assigned to Compatibility 
Category ``D.''
    Subpart M, ``Reports,'' is assigned to Compatibility Category 
``C.''
    Subpart N, ``Enforcement,'' is assigned to Compatibility Category 
``D.''
    Appendix A, ``Examining Organization or Entity,'' is assigned to 
Compatibility Category ``B.''

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

    Section 20.1301(a)(3) is assigned to Compatibility Category ``A.''

PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER 
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

    Section 32.72 (b)(1) and (b)(2)(ii) and Sec. 32.74 (a) and (a)(3) 
are assigned to Compatibility Category ``B.''
    As discussed under Section VIII of this document, the Commission 
proposes that licensees would have up to 2 years after the effective 
date of the final rule to comply with the proposed training 
requirements for authorized users, authorized medical physicists, 
authorized nuclear pharmacists, and Radiation Safety Officers. During 
this 2-year period, licensees would have the option of complying with 
either the existing training requirements in subpart J, or the proposed 
training requirements in subparts B and D through H. At the end of the 
2 years, subpart J would be deleted and licensees would have to comply 
with the proposed training and experience criteria. The training and 
experience requirements in the proposed subpart J are assigned to 
Compatibility Category ``D,'' as they are in the current rule. Subparts 
B and D through H of the proposed rule have been assigned to 
Compatibility Category ``C'' for Agreement States. Under the ``Policy 
Statement on Adequacy and Compatibility of Agreement State Programs,'' 
approved by the Commission on June 30, 1997, the Agreement States are 
required to adopt NRC program elements (or promulgate regulations) 
required for compatibility within 3 years of the effective date of the 
NRC rulemaking. Therefore, the Commission recognizes that if an 
Agreement State does not revise its regulations until 2 years after the 
effective date of the NRC rule, it may choose not to include subpart J 
training and experience requirements in the newly promulgated rules, 
since the subpart J requirements are assigned to Compatibility Category 
``D'' (not required for compatibility). In this case, the Agreement 
States would only be expected to adopt the proposed training and 
experience requirements in subparts B and D through H.

X. Finding of No Significant Environmental Impact: Availability

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the Commission's regulations in 
subpart A

[[Page 43553]]

of 10 CFR Part 51, that the proposed amendments, if adopted, would be a 
major Federal action but would not significantly affect the quality of 
the human environment, and therefore an environmental impact statement 
is not required. The proposed amendments would relax certain 
requirements and eliminate other procedural restrictions associated 
with the medical use of byproduct material. The Commission believes 
these proposed amendments would provide greater flexibility in the 
medical use of byproduct material while continuing to adequately 
protect public health and safety. The proposed amendments to Part 35, 
if adopted, would not cause any significant increase in radiation 
exposure to the public or radiation release to the environment beyond 
the exposures or releases currently resulting from the medical use of 
byproduct material. The proposed amendment to 10 CFR 20.1301 is 
expected to result in an increase in radiation exposure to the public. 
However, this alternative is consistent with generally accepted 
radiation protection principles, such as those expressed by the 
International Commission on Radiation Protection (ICRP), the National 
Council on Radiation Protection and Measurements (NCRP), and the 
International Atomic Energy Agency (IAEA).
    The draft environmental assessment on which this determination is 
based is available for inspection at the NRC Public Document Room, 2120 
L Street NW. (Lower Level), Washington, DC. Single copies of the 
environmental assessment are available as indicated in the FOR FURTHER 
INFORMATION CONTACT section of this document.

XI. Paperwork Reduction Act Statement

    This proposed rule amends information collection requirements that 
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). This rule has been submitted to the Office of Management and 
Budget for review and approval of the paperwork requirements.
    Because the rule will reduce existing information collection 
requirements, the public burden for this information collection is 
expected to be decreased by approximately 74 hours per licensee. This 
reduction includes the time required for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing the information collection. The 
U.S. Nuclear Regulatory Commission is seeking public comment on the 
potential impact of the information collection in the proposed rule and 
on the following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the NRC, including whether the 
information will have practical utility?
    2. Is the estimate of burden accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques?
    Send comments on any aspect of this proposed information 
collection, including suggestions for further reducing the burden, to 
the Records Management Branch (T-6 F33), U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, or by Internet electronic mail 
at BJS[email protected]; and to the Desk Officer, Office of Information and 
Regulatory Affairs, NEOB-10202, (3150-0010 and 3150-0120), Office of 
Management and Budget, Washington, DC, 20503.
    Comments to OMB on the information collections or on the above 
issues should be submitted by September 14, 1998. Comments received 
after this date will be considered if it is practical to do so, but 
assurance of consideration cannot be given to comments received after 
this date.

Public Protection Notification

    If an information collection does not display a currently valid OMB 
control number, the NRC may not conduct or sponsor, and a person is not 
required to respond to, the information collection.

XII. Regulatory Analysis

    The Commission has prepared a draft regulatory analysis for the 
proposed rule. The analysis examines the costs and benefits of the 
alternatives considered by the Commission. The draft analysis is 
available for inspection at the NRC Public Document Room, 2120 L Street 
NW. (Lower Level), Washington, DC. Single copies of the regulatory 
analysis are available as indicated in the FOR FURTHER INFORMATION 
CONTACT section of this document.
    The Commission requests public comment on the draft regulatory 
analysis. Comments on the draft regulatory analysis may be submitted to 
the NRC as indicated under the ADDRESSES section of this document.

XIII. Regulatory Flexibility Analysis

    The NRC has prepared an initial regulatory flexibility analysis of 
the impact of this proposed rule on small entities. The preliminary 
regulatory flexibility analysis indicates that the proposed rule will 
have an economic impact of approximately $8,000 annually on medical 
licensees, of which 36 percent are small entities. However, the NRC 
notes that this would be a substantial reduction in the cost to the 
average licensee under the current regulations. The NRC estimates that 
the proposed requirements would reduce the annual cost to an average 
medical licensee by approximately $1500. The NRC believes that the 
proposed alternative is the least costly alternative that provides 
adequate protection from radiation exposure for patients and workers. 
The regulatory flexibility analysis appears as Appendix A to this 
document.
    Because of the widely differing conditions under which small 
medical licensees operate, the NRC is seeking comments on the impact of 
the rule and any suggested modifications that may affect its economic 
impact. Any small medical licensee that would be subject to this 
regulation that determines, because of its size, that it is likely to 
bear a disproportionate adverse economic impact, should notify the 
Commission of this in a comment that indicates--
    (a) The licensee's size and how this proposed regulation would 
result in a significant economic burden upon the licensee as compared 
to the economic burden on a larger licensee;
    (b) How the proposed regulations could be modified to take into 
account the licensee's differing needs or capabilities;
    (c) The benefits that would accrue, or the detriments that would be 
avoided, if the proposed regulations were modified as suggested under 
paragraph (b) above;
    (d) How the proposed regulation, as modified, would more closely 
equalize its impact as opposed to providing special advantages to any 
individual licensee or groups of licenses; and
    (e) How the proposed regulations, as modified, would still 
adequately protect the public health and safety.
    The comments should be sent to the NRC as indicated under the 
ADDRESSES section of this document.

XIV. Backfit Analysis

    The NRC has determined that the backfit rule does not apply to this 
proposed rule and, therefore, that a backfit analysis is not required 
for this proposed rule because these amendments would not involve any 
provision that would impose backfits as defined in 10 CFR Chapter I.

[[Page 43554]]

List of Subjects

10 CFR Part 20

    Byproduct material, Criminal penalties, Licensed material, Nuclear 
materials, Nuclear power plants and reactors, Occupational safety and 
health, Packaging and containers, Radiation protection, Reporting and 
recordkeeping requirements, Special nuclear material, Source material, 
Waste treatment and disposal.

10 CFR Part 32

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Radiation Protection, Reporting and recordkeeping 
requirements.

10 CFR Part 35

    Byproduct material, Criminal penalties, Drugs, Health facilities, 
Health professions, Medical devices, Nuclear materials, Occupational 
safety and health, Radiation protection, Reporting and recordkeeping 
requirements.

    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended, the Energy Reorganization 
Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to 
adopt the following amendments to 10 CFR parts 20, 32 and 35.

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

    1. The authority citation for Part 20 continues to read as follows:

    Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 
106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 
2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 
Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

    2. In Sec. 20.1301, paragraph (a)(3) is added to read as follows:


Sec. 20.1301  Dose limits for individual members of the public.

    (a) * * *
    (3) Notwithstanding paragraph (a)(1) of this section, a licensee 
may permit visitors to individuals who are not released in accordance 
with Sec. 35.75 to receive a radiation dose greater than (1 mSv) 0.1 
rem, but not to exceed (5 mSv) 0.5 rem, if the authorized user, as 
defined in 10 CFR part 35, determines that it is appropriate.
* * * * *

PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER 
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

    3. The authority citation for Part 32 continues to read as follows:

    Authority: Secs. 81, 82, 161, 182, 183, 68 Stat. 935, 948, 953, 
954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 
Stat. 1242, as amended (42 U.S.C. 5841).


Sec. 32.72  [Amended]

    4. In Sec. 32.72, in paragraph (b)(1), the reference to ``10 CFR 
35.25'' is revised to read ``10 CFR 35.27'' and in paragraph 
(b)(2)(ii), the reference to ``10 CFR 35.980(b) and 35.972'' is revised 
to read ``10 CFR 35.55(b) and 35.59 or 10 CFR 35.980(b) and 35.972.''


Sec. 32.74  [Amended]

    5. In Sec. 32.74, in paragraph (a), the reference to ``Secs. 35.400 
and 35.500'' is revised to read ``Secs. 35.400, 35.500, and 35.600'' 
and in paragraph (a)(3), the reference to ``Secs. 35.57, 35.400, or 
35.500'' is revised to read ``Secs. 35.400, 35.500, and 35.600.''
    6. 10 CFR Part 35 is revised to read as follows:

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

Subpart A--General Information

Sec.
35.1  Purpose and scope.
35.2  Definitions.
35.5  Maintenance of records.
35.6  Provisions for research involving human subjects.
35.7  FDA, other Federal, and State requirements.
35.8  Information collection requirements: OMB approval.
35.10  Implementation.
35.11  License required.
35.12  Application for license, amendment, or renewal.
35.13  License amendments.
35.14  Notifications.
35.15  Exemptions regarding Type A specific licenses of broad scope.
35.18  License issuance.
35.19  Specific exemptions.

Subpart B--General Administrative Requirements

35.24  Authority and responsibilities for the radiation protection 
program.
35.26  Radiation protection program changes.
35.27  Supervision.
35.40  Written directives.
35.41  Procedures for administrations requiring a written directive.
35.49  Suppliers for sealed sources or devices for medical use.
35.50  Training for Radiation Safety Officer.
35.51  Training for an authorized medical physicist.
35.55  Training for an authorized nuclear pharmacist.
35.57  Training for experienced Radiation Safety Officer, 
teletherapy or medical physicist, authorized user, and nuclear 
pharmacist.
35.59  Recentness of training.

Subpart C--General Technical Requirements

35.60  Possession, use, calibration, and check of instruments to 
measure the activity of photon-emitting radionuclides.
35.61  Calibration and check of survey instruments.
35.62  Possession, use, calibration, and check of instruments to 
measure dosages of alpha- or beta-emitting radionuclides.
35.63  Determination of dosages of unsealed byproduct material for 
medical use.
35.65  Authorization for calibration and reference sources.
35.67  Requirements for possession of sealed sources and 
brachytherapy sources.
35.69  Labeling and shielding of vials and syringes.
35.70  Surveys for ambient radiation exposure rate.
35.75  Release of individuals containing radiopharmaceuticals or 
implants.
35.80  Provision of mobile service.
35.92  Decay-in-storage.

Subpart D--Unsealed Byproduct Material--Low Dose

35.100  Use of unsealed byproduct material for uptake, dilution, and 
excretion studies for which a written directive is not required.
35.200  Use of unsealed byproduct material for imaging and 
localization studies for which a written directive is not required.
35.204  Permissible molybdenum-99 concentration.
35.290  Training for uptake, dilution, and excretion studies.
35.292  Training for imaging and localization studies.

Subpart E--Unsealed Byproduct Material--High Dose

35.300  Use of unsealed byproduct material for which a written 
directive is required.
35.310  Safety instruction.
35.315  Safety precautions.
35.390  Training for use of unsealed byproduct material for therapy 
or for use of unsealed byproduct material that requires a written 
directive.

Subpart F--Manual Brachytherapy

35.400  Use of sources for manual brachytherapy.
35.404  Radiation surveys of patients or human research subjects 
treated with implants.
35.406  Brachytherapy sources inventory.
35.410  Safety instruction.
35.415  Safety precautions.
35.432  Full calibration measurements of brachytherapy sources.
35.490  Training for use of manual brachytherapy sources.

Subpart G--Sealed Sources for Diagnosis

35.500  Use of sealed sources for diagnosis.
35.590  Training for use of sealed sources for diagnosis.

[[Page 43555]]

Subpart H--Therapeutic Medical Devices

35.600  Use of a sealed source in a device for therapeutic medical 
uses.
35.604  Radiation surveys of patients and human research subjects 
treated with remote afterloaders.
35.605  Installation, maintenance, and repair.
35.610  Safety procedures and instructions for remote afterloaders, 
teletherapy units, and gamma stereotactic radiosurgery units.
35.615  Safety precautions for remote afterloaders, teletherapy 
units, and gamma stereotactic radiosurgery units.
35.630  Dosimetry equipment.
35.632  Full calibration measurements on teletherapy units.
35.633  Full calibration measurements on remote afterloaders.
35.635  Full calibration measurements on gamma stereotactic 
radiosurgery units.
35.642  Periodic spot-checks for teletherapy units.
35.643  Periodic spot-checks for high dose-rate and pulsed dose-rate 
remote afterloaders.
35.644  Periodic spot-checks for low dose-rate remote afterloaders.
35.645  Periodic spot-checks for gamma stereotactic radiosurgery 
units.
35.647  Additional technical requirements for mobile remote 
afterloaders.
35.652  Radiation surveys.
35.655  Five-year inspection for teletherapy and gamma stereotactic 
radiosurgery units.
35.657  Therapy-related computer systems.
35.690  Training for use of therapeutic medical devices.

Subpart I--Reserved

Subpart J--Training and Experience Requirements

35.900  Radiation Safety Officer.
35.910  Training for uptake, dilution, and excretion studies.
35.920  Training for imaging and localization studies.
35.930  Training for therapeutic use of unsealed byproduct material.
35.932  Training for treatment of hyperthyroidism.
35.934  Training for treatment of thyroid carcinoma.
35.940  Training for use of brachytherapy sources.
35.941  Training for ophthalmic use of strontium-90.
35.950  Training for use of sealed sources for diagnosis.
35.960  Training for use of therapeutic medical devices.
35.961  Training for an authorized medical physicist.
35.980  Training for an authorized nuclear pharmacist.
35.981  Training for experienced nuclear pharmacists.

Subpart K--Other Medical Uses of Byproduct Material or Radiation from 
Byproduct Material

35.1000  Other medical uses of byproduct material or radiation from 
byproduct material.

Subpart L--Records

35.2024  Records of authority and responsibilities for radiation 
protection programs.
35.2026  Records of radiation program safety changes.
35.2040  Records of written directives.
35.2045  Records of medical events.
35.2060  Records of instrument calibrations.
35.2061  Records of radiation survey instrument calibrations.
35.2063  Records of dosages of unsealed byproduct material for 
medical use.
35.2067  Records for possession of sealed sources and brachytherapy 
sources.
35.2070  Records of surveys for ambient radiation exposure rate.
35.2075  Records of the release of individuals containing 
radiopharmaceuticals or implants.
35.2080  Records of administrative and technical requirements that 
apply to the provision of mobile services.
35.2092  Records of waste disposal.
35.2204  Records of molybdenum-99 concentration.
35.2310  Records of instruction and training.
35.2404  Records of radiation surveys of patients and human research 
subjects.
35.2406  Records of brachytherapy source inventory.
35.2432  Records of full calibrations on brachytherapy sources.
35.2605  Records of installation, maintenance, and repair.
35.2630  Records of dosimetry equipment.
35.2632  Records of teletherapy full calibrations.
35.2633  Records of remote afterloader full calibrations.
35.2635  Records of gamma stereotactic radiosurgery unit full 
calibrations.
35.2642  Records of periodic spot-checks for teletherapy units.
35.2643  Records of periodic spot-checks for remote afterloaders.
35.2645  Records of periodic spot-checks for gamma stereotactic 
radiosurgery units.
35.2647  Records of additional technical requirements for mobile 
remote afterloaders.
35.2652  Records of surveys of therapeutic treatment units.
35.2655  Records of 5-year inspection for teletherapy and gamma 
stereotactic radiosurgery units.

Subpart M--Reports

35.3045  Reports of medical events.
35.3047  Report of a dose to an embryo/fetus or a nursing child.
35.3067  Reports of leaking sources.

Subpart N--Enforcement

35.4001  Violations.
35.4002  Criminal penalties.
Appendix A to 10 CFR Part 35--Examining Organization or Entity

    Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, 
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 
1242, as amended (42 U.S.C. 5841).

Subpart A--General Information


Sec. 35.1  Purpose and scope.

    This part prescribes requirements and provisions for the medical 
use of byproduct material and for issuance of specific licenses 
authorizing the medical use of this material. These requirements and 
provisions provide for the radiation safety of workers, the general 
public, patients, and human research subjects. The requirements and 
provisions of this part are in addition to, and not in substitution 
for, others in this chapter. The requirements and provisions of parts 
19, 20, 21, 30, 71, 170, and 171 of this chapter apply to applicants 
and licensees subject to this part unless specifically exempted.


Sec. 35.2  Definitions.

    Address of use means the building or buildings that are identified 
on the license and where byproduct material may be received, used, or 
stored.
    Agreement State means any State with which the Commission or the 
Atomic Energy Commission has entered into an effective agreement under 
subsection 274b of the Atomic Energy Act of 1954, as amended.
    Area of use means a portion of an address of use that has been set 
aside for the purpose of receiving, using, or storing byproduct 
material.
    Authorized medical physicist means a physicist who--
    (1) Meets the requirements in Secs. 35.51(a) and 35.59 or 
Secs. 35.961 and 35.59; or
    (2) Is identified as a medical physicist on a Commission or 
Agreement State license; or
    (3) Is identified as a medical physicist on a permit issued by a 
Commission or Agreement State specific licensee of broad scope that is 
authorized to permit the use of byproduct material.
    Authorized nuclear pharmacist means a pharmacist who--
    (1) Meets the requirements in Secs. 35.55(a) and 35.59 or 
Secs. 35.980(a) and 35.59; or
    (2) Is identified as an authorized nuclear pharmacist on a 
Commission or Agreement State license that authorizes the use of 
byproduct material in the practice of nuclear pharmacy; or
    (3) Is identified as an authorized nuclear pharmacist on a permit 
issued by a Commission or Agreement State specific licensee of broad 
scope that is authorized to permit the use of byproduct material in the 
practice of nuclear pharmacy; or

[[Page 43556]]

    (4) Is approved as an authorized nuclear pharmacist by a nuclear 
pharmacy authorized by the Commission to approve authorized nuclear 
pharmacists.
    Authorized user means a physician, dentist, or podiatrist who--
    (1) Meets the requirements in Secs. 35.290(a), 35.292(a), 
35.390(a), 35.490(a), 35.590(a), or 35.690(a) and Sec. 35.59, or 
Secs. 35.910, 35.920, 35.930, 35.932, 35.934, 35.940, 35.941, 35.950, 
35.960 and Sec. 35.59; or
    (2) Is identified as an authorized user on a Commission or 
Agreement State license that authorizes the medical use of byproduct 
material; or
    (3) Is identified as an authorized user on a permit issued by a 
Commission or Agreement State specific licensee of broad scope that is 
authorized to permit the medical use of byproduct material.
    Brachytherapy source means a radioactive sealed source or a 
manufacturer-assembled source train or a combination of these sources 
that is designed to deliver a therapeutic dose within a distance of a 
few centimeters.
    Dedicated check source means a radioactive source that is used to 
assure the constant operation of a radiation detection or measurement 
device over several months or years.
    Dentist means an individual licensed by a State or Territory of the 
United States, the District of Columbia, or the Commonwealth of Puerto 
Rico to practice dentistry.
    Diagnostic clinical procedures manual means a collection of written 
procedures that describes each method (and other instructions and 
precautions) by which the licensee performs diagnostic clinical 
procedures; where each diagnostic clinical procedure has been approved 
by the authorized user and includes the radiopharmaceutical, dosage, 
and route of administration.
    High dose-rate remote afterloader, as used in this part, means a 
device that remotely delivers a dose rate in excess of 2 gray (200 
rads) per hour at the point or surface where the dose is prescribed.
    Low dose-rate remote afterloader as used in this part, means a 
device that remotely delivers a dose rate of less than 2 gray (200 
rads) per hour at the point or surface where the dose is prescribed.
    Management means the chief executive officer or that person's 
delegate or delegates.
    Medical event means an event that meets the criteria in 
Sec. 35.3045(a).
    Medical institution means an organization in which several medical 
disciplines are practiced.
    Medical use means the intentional internal or external 
administration of byproduct material or the radiation from byproduct 
material to patients or human research subjects under the supervision 
of an authorized user.
    Mobile service means the transportation and medical use of 
byproduct material by the same licensee at temporary jobsites.
    Output means the exposure rate, dose rate, or a quantity related in 
a known manner to these rates from a teletherapy unit for a specified 
set of exposure conditions.
    Pharmacist means an individual licensed by a State or Territory of 
the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico to practice pharmacy.
    Physician means a medical doctor or doctor of osteopathy licensed 
by a State or Territory of the United States, the District of Columbia, 
or the Commonwealth of Puerto Rico to prescribe drugs in the practice 
of medicine.
    Podiatrist means an individual licensed by a State or Territory of 
the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico to practice podiatry.
    Prescribed dosage means the quantity of radiopharmaceutical 
activity as documented--
    (1) In a written directive; or
    (2) Either in the diagnostic clinical procedures manual or in any 
appropriate record in accordance with the directions of the authorized 
user for diagnostic procedures.
    Prescribed dose means--
    (1) For gamma stereotactic radiosurgery, the total dose as 
documented in the written directive;
    (2) For teletherapy, the total dose and dose per fraction as 
documented in the written directive;
    (3) For brachytherapy, either the total source strength and 
exposure time or the total dose, as documented in the written 
directive; or
    (4) For remote afterloaders, the total dose as documented in the 
written directive.
    Pulsed dose-rate remote afterloader means a special type of remote 
afterloading device that uses a single source capable of delivering 
dose rates in the ``high dose rate'' range, but is used to simulate the 
radiobiology of a low dose rate treatment by inserting the source for a 
given fraction of each hour.
    Radiation Safety Officer means the individual identified as the 
Radiation Safety Officer on a Commission license who--
    (1) Meets the requirements in Secs. 35.50 and 35.59 or Secs. 35.900 
and 35.59; or
    (2) Is identified as a Radiation Safety Officer on a Commission or 
Agreement State license.
    Sealed source means any byproduct material that is encased in a 
capsule designed to prevent leakage or escape of the byproduct 
material.
    Sealed Source and Device Registry means the national registry that 
contains all the registration certificates, generated by both NRC and 
the Agreement States, that summarize the radiation safety information 
for the sealed sources and devices and describe the licensing and use 
conditions approved for the product.
    Stereotactic radiosurgery means the use of external radiation in 
conjunction with a stereotactic guidance device to very precisely 
deliver a dose to a tissue volume.
    Structured educational program means an educational program 
designed to impart particular knowledge and practical education through 
interrelated studies and supervised training.
    Temporary jobsite means a location where mobile services are 
conducted other than those location(s) of use authorized on the 
license.
    Treatment site means the anatomical description of the tissue 
intended to receive a radiation dose, as described in a written 
directive.
    Unit dosage means a dosage intended for medical use in a single 
patient or human research subject that has been obtained from a 
manufacturer or preparer licensed pursuant to Sec. 32.72 of this 
chapter or equivalent Agreement State requirements.
    Written directive means an authorized user's written order for the 
administration of byproduct material or radiation from byproduct 
material to a specific patient or human research subject, as specified 
in Sec. 35.40.


Sec. 35.5  Maintenance of records.

    Each record required by this part must be legible throughout the 
retention period specified by each Commission regulation. The record 
may be the original or a reproduced copy or a microform provided that 
the copy or microform is authenticated by authorized personnel and that 
the microform is capable of producing a clear copy throughout the 
required retention period. The record may also be stored in electronic 
media with the capability for producing legible, accurate, and complete 
records during the required retention period. Records such as letters, 
drawings, and specifications, must include all pertinent information 
such as stamps, initials, and signatures. The licensee shall maintain 
adequate safeguards against tampering with and loss of records.

[[Page 43557]]

Sec. 35.6  Provisions for research involving human subjects.

    A licensee may conduct research involving human subjects using 
byproduct material provided that the research is conducted, funded, 
supported, or regulated by another Federal Agency which has implemented 
the Federal Policy for the Protection of Human Subjects. Otherwise, a 
licensee shall apply for and receive approval of a specific amendment 
to its NRC license before conducting such research. Both types of 
licensees shall, at a minimum, obtain informed consent from the human 
subjects and obtain prior review and approval of the research 
activities by an ``Institutional Review Board'' in accordance with the 
meaning of these terms as defined and described in the Federal Policy 
for the Protection of Human Subjects.


Sec. 35.7  FDA, other Federal, and State requirements.

    Nothing in this part relieves the licensee from complying with 
applicable FDA, other Federal, and State requirements governing 
radioactive drugs or devices.


Sec. 35.8  Information collection requirements: OMB approval.

    (a) The Commission has submitted the information collection 
requirements contained in this part to the Office of Management and 
Budget (OMB) for approval as required by the Paperwork Reduction Act 
(44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a 
person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. OMB has 
approved the information collection requirements in this part under 
control number 3150-0010.
    (b) The approved information collection requirements contained in 
this part appear in Secs. 35.6, 35.12, 35.13, 35.14, 35.24, 35.26, 
35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 35.62, 35.63, 
35.67, 35.69, 35.70, 35.75, 35.80, 35.92, 35.204, 35.290, 35.292, 
35.310, 35.315, 35.390, 35.404, 35.406, 35.410, 35.415, 35.432, 35.490, 
35.590, 35.604, 35.605, 35.610, 35.630, 35.632, 35.633, 35.635, 35.642, 
35.643, 35.644, 35.645, 35.647, 35.652, 35.655, 35.690, 35.900, 35.910, 
35.920, 35.930, 35.940, 35.950, 35.960, 35.961, 35.980, 35.981, 
35.2024, 35.2026, 35.2040, 35.2045, 35.2060, 35.2061, 35.2063, 35.2067, 
35.2070, 35.2075, 35.2080, 35.2092, 35.2204, 35.2310, 35.2404, 35.2406, 
35.2432, 35.2605, 35.2630, 35.2632, 35.2633, 35.2635, 35.2642, 35.2643, 
35.2645, 35.2647, 35.2652, 35.2655, 35.3045, 35.3047, 35,3067, and 
Appendix A.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection 
requirements and the control numbers under which they are approved as 
follows:
    (1) In Sec. 35.12, NRC Form 313, including NRC Forms 313A, and 313B 
which licensees may use to provide supplemental information, is 
approved under control number 3150-0120.
    (2) [Reserved]


Sec. 35.10  Implementation.

    (a) A licensee shall implement the provisions in this part on or 
before [date 6 months from publication of the Final Rule], with the 
exception of the requirements listed in paragraph (b) of this section.
    (b) A licensee shall implement the training requirements in 
Secs. 35.50(a), 35.51(a), 35.55(a), 35.59, 35.290(a), 35.292(a), 
35.390(a), 35.490(a), 35.590(a), and 35.690(a) on or before [date--2 
years from publication of the Final Rule].
    (c) Prior to [date--2 years from publication of the Final Rule], a 
licensee shall satisfy the training requirements of this part for a 
Radiation Safety Officer, an authorized medical physicist, an 
authorized nuclear pharmacist, or an authorized user by complying with 
either:
    (1) The appropriate training requirements in subpart J; or
    (2) The appropriate training requirements in subpart B or subparts 
D through H.
    (d) If the requirements of this part are more restrictive than the 
existing license condition, the licensee shall comply with this part 
unless exempted by paragraph (f) of this section.
    (e) Any existing license condition that is more restrictive than a 
requirement in this part remains in effect until there is a license 
amendment or license renewal.
    (f) If a license condition exempted a licensee from a provision of 
part 35 on [date--6 months from publication of the Final Rule], it will 
continue to exempt a licensee from the corresponding provision in this 
part.
    (g) If a license condition cites provisions in part 35 that will be 
deleted on [date--6 months from publication of the Final Rule], then 
the license condition remains in effect until there is a license 
amendment or license renewal that modifies or removes this condition.


Sec. 35.11  License required.

    (a) A person may not manufacture, produce, acquire, receive, 
possess, use, or transfer byproduct material for medical use except in 
accordance with a specific license issued by the Commission or an 
Agreement State, or as allowed in paragraph (b) or (c) of this section.
    (b) An individual may receive, possess, use, or transfer byproduct 
material in accordance with the regulations in this chapter under the 
supervision of an authorized user as provided in Sec. 35.27, unless 
prohibited by license condition.
    (c) An individual may prepare unsealed byproduct material for 
medical use in accordance with the regulations in this chapter under 
the supervision of an authorized nuclear pharmacist or authorized user 
as provided in Sec. 35.27, unless prohibited by license condition.


Sec. 35.12  Application for license, amendment, or renewal.

    (a) An application must be signed by the management of the 
facility.
    (b) An application for a license for medical use of byproduct 
material as described in Secs. 35.100, 35.200, 35.300, 35.400, and 
35.500, and for medical use of remote afterloaders in Sec. 35.600, must 
be made by filing an original and one copy of NRC Form 313, 
``Application for Material License.'' A request for a license amendment 
or renewal may be submitted as an original and one copy in letter 
format.
    (c) Except for medical use of remote afterloaders, a separate 
license application must be filed for each medical use of byproduct 
material as described in Sec. 35.600 by filing an original and one copy 
of NRC Form 313. A request for a license amendment or renewal may be 
submitted as an original and one copy in letter format.
    (d) An application for a license for medical use of byproduct 
material as described in Sec. 35.1000 must be made by filing an 
original and one copy of NRC Form 313.
    (1) In addition to the information required in NRC Form 313, the 
application must also include information regarding any radiation 
safety aspects of the medical use of the material that is not addressed 
in subparts A through C of this part, as well as any specific 
information necessary for--
    (i) Radiation safety precautions and instructions;
    (ii) Training and experience of proposed users;
    (iii) Methodology for measurement of dosages or doses to be 
administered to patients or human research subjects; and

[[Page 43558]]

    (iv) Calibration, maintenance, and repair of instruments and 
equipment necessary for radiation safety.
    (2) The applicant or licensee shall also provide any other 
information requested by the Commission in its review of the 
application.
    (e) An applicant that satisfies the requirements specified in 
Sec. 33.13 may apply for a Type A specific license of broad scope.


Sec. 35.13  License amendments.

    A licensee shall apply for and must receive a license amendment--
    (a) Before it receives or uses byproduct material for a type of use 
that is permitted under this part, but that is not authorized on the 
licensee's current license issued pursuant to this part;
    (b) Before it permits anyone to work as an authorized user, 
authorized nuclear pharmacist, or authorized medical physicist under 
the license, except an individual who is--
    (1) An authorized user who meets the requirements Secs. 35.290(a), 
35.292(a), 35.390(a), 35.490(a), 35.590(a), or 35.690(a) and 
Sec. 35.59, or Secs. 35.910, 35.920, 35.930, 35.932, 35.934, 35.940, 
35.941, 35.950, 35.960 and Sec. 35.59;
    (2) An authorized nuclear pharmacist who meets the requirements in 
Sec. 35.55(a) and Sec. 35.59; or Secs. 35.980 and 35.59;
    (3) An authorized medical physicist who meets the requirements in 
Sec. 35.51(a) and Sec. 35.59; or Secs. 35.961 and 35.59;
    (4) Identified as an authorized user, an authorized nuclear 
pharmacist, or authorized medical physicist on a Commission or 
Agreement State license that authorizes the use of byproduct material 
in medical use or in the practice of nuclear pharmacy, respectively; or
    (5) Identified as an authorized user, an authorized nuclear 
pharmacist, or authorized medical physicist on a permit issued by a 
Commission or Agreement State specific licensee of broad scope that is 
authorized to permit the use of byproduct material in medical use or in 
the practice of nuclear pharmacy, respectively.
    (c) Before it changes Radiation Safety Officers;
    (d) Before it orders byproduct material in excess of the amount, or 
radionuclide or form that is different than the radionuclide or form 
authorized on the license;
    (e) Before it adds to or changes the areas identified in the 
application or on the license, except for areas where byproduct 
material is used in accordance with Secs. 35.100 and 35.200; and
    (f) Before it changes the address(es) of use identified in the 
application or on the license.


Sec. 35.14  Notifications.

    (a) A licensee shall provide to the Commission a copy of the board 
certification, the Commission or Agreement State license, or the permit 
issued by a licensee of broad scope for each individual no later than 
30 days after the date that the licensee permits the individual to work 
as an authorized user, an authorized nuclear pharmacist, an authorized 
medical physicist, pursuant to Sec. 35.13 (b)(1) through (b)(5).
    (b) A licensee shall notify the Commission by letter no later than 
30 days after:
    (1) An authorized user, an authorized nuclear pharmacist, a 
Radiation Safety Officer, or an authorized medical physicist 
permanently discontinues performance of duties under the license or has 
a name change;
    (2) The licensee's mailing address changes;
    (3) The licensee's name changes, but the name change does not 
constitute a transfer of control of the license as described in 
Sec. 30.34(b) of this chapter; or
    (4) The licensee has added to or changed the areas where byproduct 
material is used in accordance with Secs. 35.100 and 35.200.
    (c) The licensee shall mail the documents required in this section 
to the appropriate address identified in Sec. 30.6 of this chapter.


Sec. 35.15  Exemptions regarding Type A specific licenses of broad 
scope.

    A licensee possessing a Type A specific license of broad scope for 
medical use is exempt from--
    (a) The provisions of Sec. 35.13(b);
    (b) The provisions of Sec. 35.13(e) regarding additions to or 
changes in the areas of use only at the addresses specified in the 
license;
    (c) The provisions of Sec. 35.14(a);
    (d) The provisions of Sec. 35.14(b)(1) for an authorized user, an 
authorized nuclear pharmacist, or an authorized medical physicist; and
    (e) The provisions of Sec. 35.49(a).


Sec. 35.18  License issuance.

    (a) The Commission shall issue a license for the medical use of 
byproduct material if--
    (1) The applicant has filed Form NRC-313 ``Application for 
Materials License'' in accordance with the instructions in Sec. 35.12;
    (2) The applicant has paid any applicable fee as provided in part 
170 of this chapter;
    (3) The Commission finds the applicant equipped and committed to 
observe the safety standards established by the Commission in this 
chapter for the protection of the public health and safety; and
    (4) The applicant meets the requirements of part 30 of this 
chapter.
    (b) The Commission shall issue a license for mobile services if the 
applicant:
    (1) Meets the requirements in paragraph (a) of this section; and
    (2) Assures that individuals or human research subjects to whom 
radiopharmaceuticals or radiation from implants will be administered 
may be released following treatment in accordance with Sec. 35.75.


Sec. 35.19  Specific exemptions.

    The Commission may, upon application of any interested person or 
upon its own initiative, grant such exemptions from the regulations in 
this part as it determines are authorized by law and will not endanger 
life or property or the common defense and security and are otherwise 
in the public interest.

Subpart B--General Administrative Requirements


Sec. 35.24  Authority and responsibilities for the radiation protection 
program.

    (a) In addition to the radiation protection program requirements of 
Sec. 20.1101 of this chapter, a licensee's management must approve in 
writing--
    (1) Requests for license application, renewal, or amendments before 
submittal to the Commission;
    (2) Any individual before allowing that individual to work as an 
authorized user, authorized nuclear pharmacist, authorized medical 
physicist; and
    (3) Radiation protection program changes that do not require a 
license amendment and are permitted under Sec. 35.26;
    (b) A licensee with multiple modalities or multiple users shall 
also develop, implement, and maintain written administrative procedures 
for interdepartmental/interdisciplinary coordination of the licensee's 
radiation protection program.
    (c) A licensee's management shall appoint a Radiation Safety 
Officer, who agrees in writing to be responsible for implementing the 
radiation protection program. The licensee, through the Radiation 
Safety Officer, shall ensure that radiation safety activities are being 
performed in accordance with licensee-approved procedures and 
regulatory requirements in the daily operation of the licensee's 
radiation protection program.

[[Page 43559]]

    (d) A licensee shall establish in writing the authority, duties, 
and responsibilities of the Radiation Safety Officer.
    (e) A licensee shall provide the Radiation Safety Officer 
sufficient authority, organizational freedom, time, resources, and 
management prerogative, to--
    (1) Identify radiation safety problems;
    (2) Initiate, recommend, or provide corrective actions;
    (3) Stop unsafe operations; and,
    (4) Verify implementation of corrective actions.
    (f) A licensee shall retain a record of actions taken pursuant to 
paragraphs (a), (c), and (d) of this section in accordance with 
Sec. 35.2024.


Sec. 35.26  Radiation protection program changes.

    (a) A licensee may revise its radiation protection program without 
Commission approval if--
    (1) The revisions do not require an amendment under Sec. 35.13;
    (2) The revisions do not reduce radiation safety;
    (3) The revisions have been reviewed and approved by the Radiation 
Safety Officer and licensee management; and
    (4) The affected individuals are instructed on the revised program 
before the changes are implemented.
    (b) A licensee shall retain a record of each change in accordance 
with Sec. 35.2026.


Sec. 35.27  Supervision.

    (a) A licensee that permits the receipt, possession, use, or 
transfer of byproduct material by an individual under the supervision 
of an authorized user or as allowed by Sec. 35.11(b) shall--
    (1) Instruct the supervised individual in the licensee's written 
radiation protection procedures, written directive procedures, 
regulations of this chapter, and license conditions with respect to the 
use of byproduct material; and
    (2) Require the supervised individual to follow the instructions of 
the supervising authorized user for medical uses of radioactive 
material, written radiation protection procedures established by the 
licensee, regulations of this chapter; and license conditions with 
respect to the medical use of byproduct material.
    (b) A licensee that permits the preparation of byproduct material 
for medical use by an individual under the supervision of an authorized 
nuclear pharmacist or physician who is an authorized user, as allowed 
by Sec. 35.11(c), shall--
    (1) Instruct the supervised individual in the preparation of 
byproduct material for medical use, as appropriate to that individual's 
use of byproduct material; and
    (2) Require the supervised individual to follow the instructions of 
the supervising authorized user or authorized nuclear pharmacist 
regarding the preparation of byproduct material for medical use, the 
written radiation protection procedures established by the licensee and 
the regulations of this chapter, and license conditions.
    (c) A licensee shall establish, implement, and maintain a policy 
for all supervised individuals to request clarification, as needed, 
from--
    (1) The authorized user, before initiating or continuing any 
procedure that requires a written directive, if the supervised 
individual has any question about what should be done or how it should 
be done; and
    (2) The authorized user or authorized nuclear pharmacist about the 
instructions and requirements provided to the supervised individual in 
accordance with paragraphs (a) and (b) of this section.
    (d) A licensee that permits supervised activities under paragraph 
(a) and (b) of this section is responsible for the acts and omissions 
of the supervised individual.


Sec. 35.40  Written directives.

    (a) A written directive must be prepared, dated, and signed by an 
authorized user prior to administration of I-131 sodium iodide greater 
than 1.11 Megabequerels (Mbq) (30 microcuries (Ci) ), any 
therapeutic dosage of a radiopharmaceutical, or any therapeutic dose of 
radiation from byproduct material.\1\
---------------------------------------------------------------------------

    \1\ If, because of the emergent nature of the patient's 
condition, a delay in order to provide a written directive would 
jeopardize the patient's health, an oral directive will be 
acceptable, provided that the information contained in the oral 
directive is documented immediately in writing in the patient's 
record a written directive is prepared within 48 hours of the oral 
directive.
    If, because of the patient's condition, a delay in order to 
provide a written revision to an existing written directive would 
jeopardize the patient's health, an oral revision to an existing 
written directive will be acceptable, provided that the oral 
revision is documented immediately in the patient's record and a 
revised written directive is signed by the authorized user within 48 
hours of the oral revision.
    Also, a written revision to an existing written directive may be 
made by any diagnostic or therapeutic procedure provided that the 
revision is dated and signed by an authorized user prior to the 
administration of the radiopharmaceutical dosage, the brachytherapy 
dose, the gamma stereotactic radiosurgery dose, the teletherapy 
dose, or the next teletherapy fractional dose.
---------------------------------------------------------------------------

    (b) The written directive must contain the patient or human 
research subject's name and the following:
    (1) For any administration of quantities greater than 1.11 MBq (30 
Ci) of sodium iodide I-131: the dosage;
    (2) For a therapeutic administration of a radiopharmaceutical other 
than sodium iodide I-131: the radiopharmaceutical, dosage, and route of 
administration;
    (3) For gamma stereotactic radiosurgery: target coordinates 
(including gamma angle), collimator size, plug pattern, total dose for 
the treatment, and the total treatment volume;
    (4) For teletherapy: the total dose, dose per fraction, number of 
fractions, treatment site, and overall treatment period;
    (5) For remote afterloading brachytherapy: the radionuclide, 
treatment site, dose per fraction, number of fractions, and total dose; 
or
    (6) For all other brachytherapy:
    (i) Prior to implantation: treatment site, the radionuclide, number 
of sources and source strengths or dose; and
    (ii) After implantation but prior to completion of the procedure: 
the radionuclide, treatment site, and total source strength and 
exposure time (or, equivalently, the total dose).
    (c) The licensee shall retain the written directive in accordance 
with Sec. 35.2040.


Sec. 35.41  Procedures for administrations requiring a written 
directive.

    (a) For any administration requiring a written directive, the 
licensee shall develop, implement, and maintain written procedures to 
provide high confidence that:
    (1) The patient's or human research subject's identity is verified 
before each administration; and
    (2) Each administration is in accordance with the written 
directive.
    (b) The procedures required by paragraph (a) of this section must, 
at a minimum, address--
    (1) Verifying the identity of the patient or human research 
subject;
    (2) Verifying that the specific details of the administration are 
in accordance with the written directive and treatment plan;
    (3) Checking both manual and computer-generated dose calculations; 
and
    (4) Verifying that any computer-generated dose calculations are 
correctly transferred into the consoles of therapeutic medical devices 
authorized by Sec. 35.600.


Sec. 35.49  Suppliers for sealed sources or devices for medical use.

    A licensee may use for medical use only--

[[Page 43560]]

    (a) Sealed sources or devices manufactured, labeled, packaged, and 
distributed in accordance with a license issued pursuant to 10 CFR part 
30 and Sec. 32.74 of this chapter or the equivalent requirements of an 
Agreement State; or
    (b) Teletherapy sources manufactured and distributed in accordance 
with a license issued pursuant to 10 CFR part 30 or the equivalent 
requirements of an Agreement State.


Sec. 35.50  Training for Radiation Safety Officer

    Except as provided in Sec. 35.57, the licensee shall require an 
individual fulfilling the responsibilities of the Radiation Safety 
Officer (RSO) as provided in Sec. 35.24 to be an individual who--
    (a) Is certified by a speciality board whose certification process 
includes all of the requirements in paragraph (b) of this section and 
whose certification has been approved by the Commission or;
    (b)(1) Has completed a structured educational program consisting of 
both:
    (i) 200 hours of didactic training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Radiation biology; and
    (E) Radiation dosimetry; and
    (ii) One year of full-time radiation safety experience under the 
supervision of the individual identified as the RSO on a Commission or 
Agreement State license that authorizes similar type(s) of use(s) of 
byproduct material involving the following;
    (A) Shipping, receiving, and performing related radiation surveys;
    (B) Using and performing checks for proper operation of dose 
calibrators, survey meters, and instruments used to measure 
radionuclides;
    (C) Securing and controlling byproduct material;
    (D) Using administrative controls to avoid mistakes in the 
administration of byproduct material;
    (E) Using procedures to prevent or minimize radioactive 
contamination and using proper decontamination procedures; and
    (F) Disposing of byproduct material; and
    (2) Has obtained written certification, signed by a preceptor RSO, 
that the requirements in paragraph (b)(1) of this section have been 
satisfactorily completed and that the individual has achieved a level 
of competency sufficient to independently function as an RSO for 
medical uses of byproduct material; and
    (3) Following completion of the requirements in paragraph (b) of 
this section, has demonstrated sufficient knowledge in radiation safety 
commensurate with the use requested by passing an examination given by 
an organization or entity approved by the Commission in accordance with 
appendix A of this part; or
    (c) Is an authorized user, authorized medical physicist, or 
authorized nuclear pharmacist identified on the licensee's license and 
has experience with the radiation safety aspects of similar types of 
use of byproduct material for which the individual has RSO 
responsibilities.


Sec. 35.51  Training for authorized medical physicist.

    The licensee shall require the authorized medical physicist to be 
an individual who--
    (a) Is certified by a speciality board whose certification process 
includes all of the training and experience requirements in paragraph 
(b) of this section and whose certification has been approved by the 
Commission; or
    (b)(1) Holds a master's or doctor's degree in physics, biophysics, 
radiological physics, medical physics, or health physics, or an 
equivalent training program approved by the NRC, and has completed one 
year of full-time training in therapeutic radiological physics and an 
additional year of full-time practical experience under the supervision 
of a medical physicist at a medical institution that includes the tasks 
listed in Secs. 35.67, 35.632, 35.633, 35.635, 35.642, 35.643, 35.644, 
35.645 and 35.652, as applicable; and
    (2) Has obtained written certification, signed by a preceptor 
authorized medical physicist, that the requirements in paragraph (b)(1) 
in this section have been satisfactorily completed and that the 
individual has achieved a level of competency sufficient to 
independently function as an authorized medical physicist; and,
    (3) Following completion of the requirements in paragraph (b)(1) of 
this section, has demonstrated sufficient knowledge in radiation safety 
commensurate with the use requested by passing an examination given by 
an organization or entity approved by the Commission in accordance with 
appendix A of this part.


Sec. 35.55  Training for an authorized nuclear pharmacist.

    The licensee shall require the authorized nuclear pharmacist to be 
a pharmacist who--
    (a) Is certified as a nuclear pharmacist by a speciality board 
whose certification process includes all of the requirements in 
paragraph (b) of this section and whose certification has been approved 
by the Commission, or
    (b)(1) Has completed 700 hours in a structured educational program 
consisting of both:
    (i) Didactic training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use; and
    (E) Radiation biology; and
    (ii) Supervised practical experience in a nuclear pharmacy 
involving--
    (A) Shipping, receiving, and performing related radiation surveys;
    (B) Using and performing checks for proper operation of dose 
calibrators, survey meters, and, if appropriate, instruments used to 
measure alpha- or beta-emitting radionuclides;
    (C) Calculating, assaying, and safely preparing dosages for 
patients or human research subjects;
    (D) Using administrative controls to avoid medical events in the 
administration of byproduct material; and
    (E) Using procedures to prevent or minimize radioactive 
contamination and using proper decontamination procedures; and
    (2) Has obtained written certification, signed by a preceptor 
authorized nuclear pharmacist, that the requirements in paragraph 
(b)(1) have been satisfactorily completed and that the individual has 
achieved a level of competency sufficient to independently operate a 
nuclear pharmacy; and
    (3) Following completion of the requirements in paragraph (b)(1) of 
this section, has demonstrated sufficient knowledge in radiation safety 
commensurate with the use requested by passing an examination given by 
an organization or entity approved by the Commission in accordance with 
appendix A of this part.


Sec. 35.57  Training for experienced Radiation Safety Officer, 
teletherapy or medical physicist, authorized user, and nuclear 
pharmacist.

    (a) An individual identified as a Radiation Safety Officer, a 
teletherapy or medical physicist, or a nuclear pharmacist on a 
Commission or Agreement State license before [date--6 months from 
publication of the Final Rule] need not comply with the training 
requirements of Secs. 35.50 and 35.51, respectively.
    (b) Physicians, dentists, or podiatrists identified as authorized 
users for the

[[Page 43561]]

medical, dental, or podiatric use of byproduct material on a Commission 
or Agreement State license issued before [date--6 months from 
publication of the Final Rule] who perform only those medical uses for 
which they were authorized on that date need not comply with the 
training requirements of subparts C through H.


Sec. 35.59  Recentness of training.

    The training and experience specified in subparts B, D, E, F, G, H, 
and J must have been obtained within the 7 years preceding the date of 
application or the individual must have had related continuing 
education and experience since the required training and experience was 
completed.

Subpart C--General Technical Requirements


Sec. 35.60  Possession, use, calibration, and check of instruments to 
measure the activity of photon-emitting radionuclides.

    (a) For other than unit dosages, a licensee shall possess and use 
instrumentation to measure the activity of photon-emitting 
radionuclides prior to administration to each patient or human research 
subject.
    (b) If a licensee uses instrumentation to measure the activity of 
dosages of photon-emitting radionuclides, including unit dosages, it 
shall develop, implement, and maintain written procedures for proper 
operation of the instrumentation. At a minimum, a licensee shall--
    (1) Perform tests, before initial use and following repair, on each 
instrument for accuracy, linearity, and geometry dependence;
    (2) Perform an accuracy test annually;
    (3) Perform a linearity test annually over the range of medical 
use; and
    (4) Check each instrument for constancy and proper operation at the 
beginning of each day of use.
    (c) Accuracy tests must be performed with source(s) with a 
principal photon energy of between 100 and 500 keV whose activity is 
traceable to the National Institute of Standards and Technology (NIST) 
or by a supplier who has compared the source to a source that was 
calibrated by NIST.
    (d) A licensee shall mathematically correct dosage readings for any 
geometry or linearity error that exceeds 10 percent if the dosage is 
greater than 1.11 MBq (30 Ci) and shall repair or replace the 
instrumentation if the accuracy or constancy error exceeds 10 percent.
    (e) A licensee shall retain a record of each check and test 
required by this section in accordance with Sec. 35.2060.


Sec. 35.61  Calibration and check of survey instruments.

    (a) A licensee shall calibrate the survey instruments used to show 
compliance with this part and 10 CFR part 20 before first use, 
annually, and following repair. A licensee shall--
    (1) Calibrate all scales with readings up to 10 mSv (1000 mrem) per 
hour with a radiation source;
    (2) Calibrate two separated readings on each scale that will be 
used to show compliance with this part; and
    (3) Conspicuously note on the instrument the date of calibration.
    (b) A licensee shall consider a point as calibrated if the 
indicated exposure rate differs from the calculated exposure rate by 
not more than 20 percent, and conspicuously attach a correction chart 
or graph to the instrument if the indicated exposure rate differs from 
the calculated exposure rate by more than 10 percent.
    (c) Survey instruments must be removed from use if the indicated 
exposure rate differs from the calculated exposure rate by more than 20 
percent.
    (d) A licensee shall retain a record of each survey instrument 
calibration in accordance with Sec. 35.2061.


Sec. 35.62  Possession, use, calibration, and check of instruments to 
measure dosages of alpha- or beta-emitting radionuclides.

    (a) For other than unit dosages, a licensee shall possess and use 
instrumentation to measure the radioactivity of alpha- or beta-emitting 
radionuclides. A licensee shall measure, by direct measurement or by 
combination of measurements and calculations, the amount of 
radioactivity in dosages of alpha-or beta-emitting radionuclides prior 
to administration to each patient or human research subject.
    (b) A licensee shall develop, implement, and maintain written 
procedures for use of the instrumentation. At a minimum, a licensee 
shall--
    (1) Perform tests before initial use, and following repair, on each 
instrument for accuracy, linearity, and geometry dependence, unless it 
is not appropriate for the use of the instrument; and make adjustments 
when necessary;
    (2) Perform accuracy annually;
    (3) Perform linearity tests annually over the range of medical use; 
and
    (4) Check each instrument for constancy and proper operation at the 
beginning of each day of use.
    (c) Accuracy tests must be performed with source(s) that are 
traceable to NIST or by a supplier who has compared the source to a 
source that was calibrated by NIST.
    (d) A licensee shall retain a record of each check and test 
required by this section in accordance with Sec. 35.2060.


Sec. 35.63  Determination of dosages of unsealed byproduct material for 
medical use.

    (a) A licensee shall determine and record the activity of each 
dosage prior to medical use.
    (b) For a unit dosage of an alpha-, beta-, or photon-emitting 
radionuclide, this determination must be made either by direct 
measurement or by a decay correction, based on the measurement made by 
a manufacturer or preparer licensed pursuant to Sec. 32.72 of this 
chapter or equivalent Agreement State requirements.
    (c) For a dosage of a alpha-, beta-, or photon-emitting 
radionuclide prepared by the licensee, this determination must be made 
by direct measurement or by combination of measurements and 
calculations.
    (d) A licensee shall not use a dosage if the dosage differs from 
the prescribed dosage by more than 20 percent.
    (e) A licensee shall retain a record of the dosage determination 
required by this section in accordance with Sec. 35.2063.


Sec. 35.65  Authorization for calibration and reference sources.

    Any person authorized by Sec. 35.11 for medical use of byproduct 
material may receive, possess, and use the following byproduct material 
for check, calibration, and reference use:
    (a) Sealed sources manufactured and distributed by a person 
licensed pursuant to Sec. 32.74 of this chapter or equivalent Agreement 
State regulations and that do not exceed 1.11 kBq (30 mCi) each;
    (b) Any byproduct material with a half-life not longer than 120 
days in individual amounts not to exceed 0.555 MBq (15 mCi);
    (c) Any byproduct material with a half-life longer than 120 days in 
individual amounts not to exceed 7.4 MBq ( 200 Ci) each and 
not to exceed 1000 times the quantities in appendix B of Part 30 of 
this chapter whichever is more limiting; and
    (d) Technetium-99m in amounts as needed.


Sec. 35.67  Requirements for possession of sealed sources and 
brachytherapy sources.

    (a) A licensee in possession of any sealed source or brachytherapy 
source shall follow the radiation safety and handling instructions 
supplied by the manufacturer, and shall maintain the instructions for 
the duration of source use in a legible form convenient to users.

[[Page 43562]]

    (b) A licensee in possession of a sealed source shall--
    (1) Test the source for leakage before its first use unless the 
licensee has a certificate from the supplier indicating that the source 
was tested within 6 months before transfer to the licensee; and
    (2) Test the source for leakage at intervals not to exceed 6 months 
or at other intervals approved by the Commission or an Agreement State 
in the Sealed Source and Device Registry.
    (c) To satisfy the leak test requirements of this section, the 
licensee shall measure the sample so that the leakage test can detect 
the presence of 185 Bq (0.005 Ci) of radioactive material on 
the sample.
    (d) A licensee shall retain leakage test records in accordance with 
Sec. 35.2067.
    (e) If the leakage test reveals the presence of 185 Bq (0.005 
Ci) or more of removable contamination, the licensee shall--
    (1) Immediately withdraw the sealed source from use and store, 
dispose, or cause it to be repaired in accordance with the requirements 
in parts 20 and 30 of this chapter; and
    (2) File a report within 5 days of the leakage test in accordance 
with Sec. 35.3067.
    (f) A licensee need not perform a leakage test on the following 
sources:
    (1) Sources containing only byproduct material with a half-life of 
less than 30 days;
    (2) Sources containing only byproduct material as a gas;
    (3) Sources containing 3.7 MBq (100 Ci) or less of beta or 
gamma-emitting material or 0.37 MBq (10 Ci) or less of alpha-
emitting material;
    (4) Sources stored for less than a 10-year period and not being 
used. The licensee shall, however, test each such source for leakage 
before any use or transfer unless it has been leakage-tested within 6 
months before the date of use or transfer; and
    (5) Seeds of iridium-192 encased in nylon ribbon.
    (g) A licensee in possession of sealed sources or brachytherapy 
sources, except for gamma stereotactic radiosurgery sources, shall 
conduct a semi-annual physical inventory of all such sources in its 
possession. The licensee shall retain each inventory record in 
accordance with Sec. 35.2067.


Sec. 35.69  Labeling and shielding of vials and syringes.

    (a) A licensee shall develop, implement, and maintain written 
procedures for--
    (1) Labeling each syringe, syringe shield, or vial shield that 
contains a radiopharmaceutical to identify the radiopharmaceutical 
name, or its abbreviation, and to ensure that the contents are 
conspicuously identified as containing radioactive material; and
    (2) Shielding vials and syringes containing radiopharmaceuticals.
    (b) A licensee shall instruct individuals, commensurate with the 
individual's assigned duties, in the procedures required by paragraph 
(a) of this section.


Sec. 35.70  Surveys for ambient radiation exposure rate.

    (a) Except as provided in paragraph (b) of this section, a licensee 
shall survey with a radiation detection survey instrument at the end of 
each day of use all areas where radiopharmaceuticals requiring a 
written directive were prepared for use or administered.
    (b) A licensee does not need to perform the surveys required by 
paragraph (a) of this section in an area(s) where patients or human 
research subjects can not be released pursuant to Sec. 35.75.
    (c) A licensee shall retain a record of each survey in accordance 
with Sec. 35.2070.


Sec. 35.75  Release of individuals containing radiopharmaceuticals or 
implants.

    (a) A licensee may authorize the release from its control of any 
individual who has been administered radiopharmaceuticals or implants 
containing radioactive material if the total effective dose equivalent 
to any other individual from exposure to the released individual is not 
likely to exceed 5 mSv (0.5 rem).2
---------------------------------------------------------------------------

    \2\ Regulatory Guide 8.39, ``Release of Patients Administered 
Radioactive Materials,'' describes methods for calculating doses to 
other individuals and contains tables of activities not likely to 
cause doses exceeding 0.5 rem (5 mSv).
---------------------------------------------------------------------------

    (b) A licensee shall provide the released individual, or the 
individual's parent or guardian, with instructions, including written 
instructions, on actions recommended to maintain doses to other 
individuals as low as is reasonably achievable if the total effective 
dose equivalent to any other individual is likely to exceed 1 mSv (0.1 
rem). If the total effective dose equivalent to a breast-feeding infant 
or child could exceed 1 mSv (0.1 rem) assuming there were no 
interruption of breast-feeding, the instructions shall also include--
    (1) Guidance on the interruption or discontinuation of breast-
feeding; and
    (2) Information on the potential consequences, if any, of failure 
to follow the guidance.
    (c) A licensee shall maintain a record of the basis for authorizing 
the release of an individual, in accordance with Sec. 35.2075(a).
    (d) The licensee shall maintain a record of instructions provided 
to breast-feeding women in accordance with Sec. 35.2075(c).


Sec. 35.80  Provision of mobile service.

    (a) A licensee providing mobile service shall--
    (1) Obtain a letter signed by the management of each client for 
which services are rendered that permits the use of byproduct material 
at the client's address of use and clearly delineates the authority and 
responsibility of each entity;
    (2) Check instruments as described in Secs. 35.60 and 35.62 for 
proper function before medical use at each address of use or on each 
day of use, whichever is more frequent;
    (3) Check survey instruments for proper operation with a dedicated 
check source before use at each address of use;
    (4) Before leaving a client's address of use, survey all areas of 
use to ensure compliance with the requirements in part 20 of this 
chapter; and
    (b) A mobile nuclear medicine service may not have byproduct 
material delivered from the manufacturer or the distributor to the 
client's address of use, unless the client has a license allowing 
possession of the byproduct material. Radioactive material delivered to 
the client's address of use must be received and handled in conformance 
with the client's license.
    (c) A licensee providing mobile nuclear services shall retain the 
letter required in paragraph (a)(1) and the record of each survey 
required in paragraph (a)(4) of this section in accordance with 
Sec. 35.2080.


Sec. 35.92  Decay-in-storage.

    (a) A licensee may hold byproduct material with a physical half-
life of less than 120 days for decay-in-storage before disposal in 
ordinary trash if it--
    (1) Monitors byproduct material at the surface before disposal as 
ordinary trash and determines that its radioactivity cannot be 
distinguished from the background radiation level with an appropriate 
radiation detection survey meter set on its most sensitive scale and 
with no interposed shielding; and
    (2) Removes or obliterates all radiation labels;
    (b) A licensee shall retain a record of each disposal permitted 
under paragraph (a) of this section in accordance with Sec. 35.2092.

[[Page 43563]]

Subpart D--Unsealed Byproduct Material--Low Dose


Sec. 35.100  Use of unsealed byproduct material for uptake, dilution, 
and excretion studies for which a written directive is not required.

    A licensee may use for uptake, dilution, or excretion studies any 
unsealed byproduct material, except in quantities that require a 
written directive pursuant to Sec. 35.40, prepared for medical use that 
is either--
    (a) Obtained from a manufacturer or preparer licensed pursuant to 
Sec. 32.72 of this chapter or equivalent Agreement State requirements; 
or
    (b) Prepared by an authorized nuclear pharmacist, a physician who 
is an authorized user and who meets the requirements specified in 
Sec. 35.292, or an individual under the supervision of either as 
specified in Sec. 35.27.


Sec. 35.200  Use of unsealed byproduct material for imaging and 
localization studies for which a written directive is not required.

    A licensee may use for imaging and localization studies any 
unsealed byproduct material, except in quantities that require a 
written directive pursuant to Sec. 35.40, prepared for medical use that 
is either--
    (a) Obtained from a manufacturer or preparer licensed pursuant to 
Sec. 32.72 of this chapter or equivalent Agreement State requirements; 
or
    (b) Prepared by an authorized nuclear pharmacist, a physician who 
is an authorized user and who meets the requirements specified in 
Sec. 35.292, or an individual under the supervision of either as 
specified in Sec. 35.27.


Sec. 35.204  Permissible molybdenum-99 concentration.

    (a) A licensee may not administer to humans a radiopharmaceutical 
containing more than 5.55 kBq (0.15 Ci) of molybdenum-99 per 
millicurie of technetium-99m.
    (b) A licensee that uses molybdenum-99/technetium-99m generators 
for preparing a technetium-99m radiopharmaceutical shall measure the 
molybdenum-99 concentration of the first eluate after receipt of a 
generator to demonstrate compliance with paragraph (a) of this section.
    (c) A licensee that must measure molybdenum concentration shall 
retain a record of each measurement in accordance with Sec. 35.2204.


Sec. 35.290  Training for uptake, dilution, and excretion studies.

    Except as provided in Secs. 35.57, the licensee shall require the 
authorized user of a radiopharmaceutical for uses authorized under 
Sec. 35.100 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (b) of this 
section and whose certification has been approved by the Commission 
or--
    (b)(1) Has completed a structured educational program in basic 
radionuclide handling techniques applicable to the use of diagnostic 
radiopharmaceuticals,  consisting  of both--
    (i) 40 hours of didactic training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use; and
    (E) Radiation biology; and
    (ii) 20 hours of supervised practical experience under the 
supervision of an authorized user involving--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Calibrating dose calibrators and diagnostic instruments and 
performing checks for proper operation of survey meters;
    (C) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (D) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (E) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (F) Administering dosages to patients or human research subjects; 
and
    (2) Has obtained written certification, signed by a preceptor 
authorized user, that the requirements in paragraph (b)(1) of this 
section have been satisfactorily completed and that the individual has 
achieved a level of competency sufficient to independently function as 
an authorized user of a diagnostic radiopharmaceutical for the uses 
listed in Sec. 35.100; and
    (3) Following completion of the requirements in paragraph (b)(1) of 
this section, has demonstrated sufficient knowledge in radiation safety 
commensurate with the use requested by passing an examination given by 
an organization or entity approved by the Commission in accordance with 
appendix A of this part.


Sec. 35.292  Training for imaging and localization studies.

    Except as provided in Secs. 35.57, the licensee shall require the 
authorized user of radiopharmaceuticals and generators for the uses 
authorized under Sec. 35.200 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (b) of this 
section and whose certification has been approved by the Commission; or
    (b)(1) Has completed a structured educational program in basic 
radionuclide handling techniques applicable to the use of diagnostic 
radiopharmaceuticals and generators, consisting of both--
    (i) 80 hours of didactic training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use; and
    (E) Radiation biology; and
    (ii) 40 hours of supervised practical experience under the 
supervision of an authorized user involving--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Calibrating dose calibrators and diagnostic instruments and 
performing checks for proper operation of survey meters;
    (C) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (D) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (E) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures;
    (F) Eluting technetium-99m from generator systems, measuring and 
testing the eluate for molybdenum-99, and processing the eluate with 
reagent kits to prepare technetium-99m labeled radiopharmaceuticals; 
and
    (G) Administering dosages to patients or human research subjects; 
and
    (2) Has obtained written certification, signed by a preceptor 
authorized user, that the requirements in paragraph (b)(1) of this 
section have been satisfactorily completed and that the individual has 
achieved a level of competency sufficient to independently function as 
an authorized user of diagnostic radiopharmaceuticals and generators 
for the uses listed in Sec. 35.200; and
    (3) Following completion of the requirements in paragraph (b)(1) of 
this

[[Page 43564]]

section, has demonstrated sufficient knowledge in radiation safety 
commensurate with the use requested by passing an examination given by 
an organization or entity approved by the Commission in accordance with 
appendix A of this part.

Subpart E--Unsealed Byproduct Material--High Dose


Sec. 35.300  Use of unsealed byproduct material for which a written 
directive is required.

    A licensee may use any unsealed byproduct material prepared for 
medical use and for which a written directive is required that is 
either--
    (a) Obtained from a manufacturer or preparer licensed pursuant to 
Sec. 32.72 of this chapter or equivalent Agreement State requirements; 
or
    (b) Prepared by an authorized nuclear pharmacist, a physician who 
is an authorized user and who meets the requirements specified in 
Sec. 35.292, or an individual under the supervision of either as 
specified in Sec. 35.27.


Sec. 35.310  Safety instruction.

    In addition to the requirements of Sec. 19.12 of this chapter,
    (a) A licensee shall provide radiation safety instruction, 
initially and at least annually, to personnel caring for patients or 
human research subjects that have received radiopharmaceutical therapy 
and can not be released in accordance with Sec. 35.75. To satisfy this 
requirement, the instruction must be commensurate with the duties of 
the personnel and include--
    (1) Patient or human research subject control;
    (2) Visitor control, including--
    (i) Routine visitation to hospitalized individuals in accordance 
with Sec. 20.1301(a)(1) of this chapter; and
    (ii) Visitation authorized in accordance with Sec. 20.1301(a)(3);
    (3) Contamination control;
    (4) Waste control; and
    (5) Notification of the authorized user and the Radiation Safety 
Officer, or his designee, if the patient or the human research subject 
dies or has a medical emergency.
    (b) A licensee shall retain a record of individuals receiving 
instruction in accordance with Sec. 35.2310.


Sec. 35.315  Safety precautions.

    (a) For each patient or human research subject that cannot be 
released in accordance with Sec. 35.75, a licensee shall--
    (1) Provide a private room with a private sanitary facility;
    (2) Visibly post the patient's or the human research subject's room 
with a ``Radioactive Materials'' sign and note on the door or in the 
patient's or human research subject's chart where and how long visitors 
may stay in the patient's or the human research subject's room; and
    (3) Either monitor material and items removed from the patient's or 
the human research subject's room to determine that their radioactivity 
cannot be distinguished from the natural background radiation level 
with a radiation detection survey instrument set on its most sensitive 
scale and with no interposed shielding, or handle such material and 
items as radioactive waste.
    (b) A licensee shall notify the authorized user and the Radiation 
Safety Officer, or his or her designee, as soon as possible, if the 
patient or human research subject has a medical emergency and, 
immediately, if the patient dies.


Sec. 35.390  Training for use of unsealed byproduct material for 
therapy or for use of unsealed byproduct material that requires a 
written directive.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a radiopharmaceutical for the uses authorized under 
Sec. 35.300 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (b) of this 
section and whose certification has been approved by the Commission; or
    (b)(1) Has completed a structured educational program in basic 
radionuclide handling techniques applicable to the use of unsealed 
byproduct material consisting of both--
    (i) 80 hours of didactic training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (D) Radiation biology; and
    (ii) 40 hours of supervised practical experience under the 
supervision of an authorized user at a medical institution involving--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Calibrating dose calibrators, as appropriate, and performing 
checks for proper operation of survey meters;
    (C) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (D) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (E) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (2) Has had experience, obtained under the direct supervision of an 
authorized user, involving at least five cases for each procedure with 
radiation safety hazards similar to that use for which the individual 
is requesting authorized user status. This experience may be obtained 
concurrently with the supervised practical experience required by 
paragraph (b)(1)(ii) of this section;
    (3) Has obtained written certification, signed by a preceptor 
authorized user, that the requirements in paragraphs (b) (1) and (2) of 
this section have been satisfactorily completed and that the individual 
has achieved a level of competency sufficient to independently function 
as an authorized user of unsealed byproduct material for the uses 
listed in Sec. 35.300; and
    (4) Following completion of the requirements in paragraph (b) (1) 
and (2) of this section, has demonstrated sufficient knowledge in 
radiation safety commensurate with the use requested by passing an 
examination given by an organization or entity approved by the 
Commission in accordance with appendix A of this part.

Subpart F-- Manual Brachytherapy


Sec. 35.400  Use of sources for manual brachytherapy.

    A licensee shall use only brachytherapy sources for therapeutic 
medical uses as approved in the Sealed Source and Device Registry.


Sec. 35.404  Radiation surveys of patients or human research subjects 
treated with implants.

    (a) Immediately after implanting sources in a patient or a human 
research subject, the licensee shall make a radiation survey of the 
patient or the human research subject and the adjacent area of use to 
confirm that no sources have been misplaced.
    (b) Immediately after removing the last temporary implant source 
from a patient or a human research subject, the licensee shall make a 
radiation survey of the patient or the human research subject with a 
radiation detection survey instrument to confirm that all sources have 
been removed.
    (c) A licensee shall retain a record of patient or human research 
subject surveys in accordance with Sec. 35.2404.


Sec. 35.406  Brachytherapy sources inventory.

    (a) A licensee shall maintain accountability at all times for all 
brachytherapy sources in storage or use.
    (b) Promptly after removing sources from a patient or a human 
research

[[Page 43565]]

subject, a licensee shall return brachytherapy sources to a secure 
storage area.
    (c) A licensee shall maintain a record of the brachytherapy source 
accountability in accordance with Sec. 35.2406.


Sec. 35.410  Safety instruction.

    In addition to the requirements of Sec. 19.12 of this chapter,
    (a) The licensee shall provide radiation safety instruction, 
initially and at least annually, to personnel caring for patients or 
human research subjects that are undergoing implant therapy and cannot 
be released in accordance with Sec. 35.75. To satisfy this requirement, 
the instruction must be commensurate with the duties of the personnel 
and include the --
    (1) Size and appearance of the brachytherapy sources;
    (2) Safe handling and shielding instructions;
    (3) Patient or human research subject control;
    (4) Visitor control, including both--
    (i) Routine visitation of hospitalized individuals in accordance 
with Sec. 20.1301(a)(1) of this chapter; and
    (ii) Visitation authorized in accordance with Sec. 20.1301(a)(3); 
and
    (5) Notification of the authorized user and Radiation Safety 
Officer, or his or her designee, if the patient or the human research 
subject dies or has a medical emergency.
    (b) A licensee shall retain a record of individuals receiving 
instruction in accordance with Sec. 35.2310.


Sec. 35.415  Safety precautions.

    (a) For each patient or human research subject receiving 
brachytherapy and confined pursuant to Sec. 35.75, a licensee shall--
    (1) Not quarter the patient or the human research subject in the 
same room as an individual who is not receiving radiation therapy; and
    (2) Visibly post the patient's or human research subject's room 
with a ``Radioactive Materials'' sign and note on the door or in the 
patient's or human research subject's chart where and how long visitors 
may stay in the patient's or human research subject's room.
    (b) A licensee shall have available, near each treatment room, 
emergency response equipment. The emergency response equipment must 
include, as applicable--
    (1) A device to assist in placing the source(s) in the shielded 
position;
    (2) A shielded source/applicator storage container;
    (3) Remote handling tools; and
    (4) Supplies necessary to surgically remove applicators or sources 
from a patient or human research subject treated internally with sealed 
sources.
    (c) A licensee shall notify the authorized user and the Radiation 
Safety Officer, or his designee, as soon as possible, if the patient or 
human research subject has a medical emergency and, immediately, if the 
patient dies.


Sec. 35.432  Full calibration measurements of brachytherapy sources.

    (a) A licensee authorized to use brachytherapy sources for medical 
use shall perform full calibration measurements on brachytherapy 
sources before the first medical use of the source or source/applicator 
configuration.
    (b) A licensee may use calibration measurements provided by the 
source manufacturer that are made in accordance with the requirements 
of this section.
    (c) To satisfy the requirements of paragraphs (a) and (b) of this 
section, full calibration measurements must include determination of--
    (1) The output or activity within +/-5 percent; and
    (2) Source positioning accuracy within applicators.
    (d) A licensee shall use the dosimetry system described in 
Sec. 35.630(a) to measure the output or activity of the brachytherapy 
source.
    (e) A licensee shall make full calibration measurements required by 
paragraph (a) of this section in accordance with published protocols by 
nationally recognized bodies.
    (f) A licensee shall mathematically correct the outputs or 
activities determined in paragraph (c) of this section for physical 
decay at intervals consistent with 1 percent physical decay.
    (g) A licensee shall retain a record of each calibration in 
accordance with Sec. 35.2432.


Sec. 35.490  Training for use of manual brachytherapy sources.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a manual brachytherapy source for the uses 
authorized under Sec. 35.400 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (b) of this 
section and whose certification has been approved by the Commission; or
    (b)(1) Has completed a structured educational program in basic 
radionuclide handling techniques applicable to the use of manual 
brachytherapy sources consisting of both--
    (i) 200 hours of didactic training in the following areas --
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (D) Radiation biology;
    (ii) 500 hours of supervised practical experience, under the 
supervision of an authorized user at a medical institution, involving--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Checking survey meters for proper operation;
    (C) Preparing, implanting, and removing sealed sources;
    (D) Maintaining running inventories of material on hand;
    (E) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (F) Using emergency procedures to control byproduct material; and
    (2) Three years of supervised clinical experience that includes one 
year in a formal training program approved by the Residency Review 
Committee for Radiology of the Accreditation Council for Graduate 
Medical Education or the Committee on Postdoctoral Training of the 
American Osteopathic Association or equivalent program approved by the 
NRC, and an additional two years of clinical experience under the 
supervision of an authorized user; and
    (3) Has obtained written certification, signed by a preceptor 
authorized user, that the requirements in paragraphs (b)(1) and (2) of 
this section have been satisfactorily completed and that the individual 
has achieved a level of competency sufficient to independently function 
as an authorized user of manual brachytherapy sources for the uses 
listed in Sec. 35.400; and, (4) Following completion of the 
requirements in paragraph (b)(1) and (2) of this section, has 
demonstrated sufficient knowledge in radiation safety commensurate with 
the use requested by passing an examination given by an organization or 
entity approved by the Commission in accordance with appendix A of this 
part.

Subpart G--Sealed Sources for Diagnosis


Sec. 35.500  Use of sealed sources for diagnosis.

    A licensee shall use only sealed sources for diagnostic medical 
uses as approved in the Sealed Source and Device Registry.

[[Page 43566]]

Sec. 35.590  Training for use of sealed sources for diagnosis.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a diagnostic sealed source for the use in a device 
authorized under Sec. 35.500 to be a physician, dentist, or podiatrist 
who--
    (a) Is certified by a speciality board whose certification process 
includes all of the requirements in paragraph (b) of this section and 
whose certification has been approved by the Commission; or
    (b) Has had 8 hours of classroom and laboratory training in basic 
radionuclide handling techniques specifically applicable to the use of 
the device that includes--
    (1) Radiation physics and instrumentation;
    (2) Radiation protection;
    (3) Mathematics pertaining to the use and measurement of 
radioactivity;
    (4) Radiation biology; and
    (5) Training in the use of the device for the uses requested.

Subpart H--Therapeutic Medical Devices


Sec. 35.600  Use of a sealed source in a device for therapeutic medical 
uses.

    A licensee shall use sealed sources and devices for therapy as 
approved in the Sealed Source and Device Registry for medical use.


Sec. 35.604  Radiation surveys of patients and human research subjects 
treated with remote afterloaders.

    (a) Before releasing a patient or a human research subject from 
licensee control, a licensee shall make a survey of the patient or the 
human research subject and the afterloader device with a portable 
radiation detection survey instrument to confirm that the source(s) has 
been removed from the patient or human research subject and returned to 
the safe shielded position.
    (b) A licensee shall retain a record of patient or human research 
subject surveys in accordance with Sec. 35.2404.


Sec. 35.605  Installation, maintenance, and repair.

    (a) Only a person specifically licensed by the Commission or an 
Agreement State shall install, maintain, adjust, or repair a device 
that involves work on the source(s) shielding, the source(s) driving 
unit, or other electronic or mechanical component that could expose the 
source, reduce the shielding around the source(s), or compromise the 
radiation safety of the device or the source(s).
    (b) Except for low dose-rate remote afterloader devices, only a 
person specifically licensed by the Commission or an Agreement State 
shall install, replace, relocate, or remove a sealed source or source 
contained in a device,
    (c) For a low dose-rate remote afterloader device, only a person 
specifically licensed by the Commission or an Agreement State or an 
authorized medical physicist shall perform the functions listed in 
paragraph (b) of this section.
    (d) A licensee shall retain a record of the installation, 
maintenance, and repair done on therapeutic medical devices in 
accordance with Sec. 35.2605.


Sec. 35.610  Safety procedures and instructions for remote 
afterloaders, teletherapy units, and gamma stereotactic radiosurgery 
units.

    (a) A licensee shall develop, implement, and maintain written 
procedures for--
    (1) Securing the device, the console, the console keys, and the 
treatment room when not in use or unattended;
    (2) Except for low dose-rate remote afterloaders, ensuring that 
only the patient or the human research subject is in the treatment room 
before initiating treatment with the source(s), unless contraindicated, 
or after a door interlock interruption;
    (3) Preventing dual operation of more than one radiation producing 
device in a treatment room if applicable; and
    (4) Responding to an abnormal situation when the operator is unable 
to place the source(s) in the shielded position, or remove the patient 
or human research subject from the radiation field with controls from 
outside the treatment room. This procedure must include--
    (i) Instructions for responding to equipment failures and the names 
of the individuals responsible for implementing corrective actions;
    (ii) The process for restricting access to and posting of the 
treatment area to minimize the risk of inadvertent exposure; and
    (iii) The names and telephone numbers of the authorized users, the 
authorized medical physicist, and the Radiation Safety Officer to be 
contacted if the device or console operates abnormally.
    (b) A copy of the procedures required by Sec. 35.610(a) must be 
physically located at the unit console.
    (c) A licensee shall post instructions at the device console to 
inform the operator of--
    (1) The location of the procedures required by Sec. 35.610(a); and
    (2) The names and telephone numbers of the authorized users, the 
authorized medical physicist, and the Radiation Safety Officer to be 
contacted if the device or console unit or console operates abnormally.
    (d) A licensee shall provide instruction and practice drills, 
initially and at least annually, in the procedures identified in 
paragraph (a) of this section and the operating procedures to all 
individuals who operate the device, as appropriate to the individual's 
assigned duties. A licensee shall ensure that operators receive 
refresher training in the operation of the unit and procedures for 
periodic spot-checks and full calibrations; and that operators, 
authorized medical physicists, and authorized users participate in 
drills of the emergency procedures.
    (e) A licensee shall retain a record of individuals receiving 
instruction required by paragraph (d) of this section, in accordance 
with Sec. 35.2310.


Sec. 35.615  Safety precautions for remote afterloaders, teletherapy 
units, and gamma stereotactic radiosurgery units.

    (a) A licensee shall control access to the treatment room by a door 
at each entrance.
    (b) A licensee shall equip each entrance to the treatment room with 
an electrical interlock system that will--
    (1) Prevent the operator from initiating the treatment cycle unless 
each treatment room entrance door is closed;
    (2) Cause the sources to be shielded immediately when an entrance 
door is opened; and
    (3) Prevent the primary beam of radiation from being turned on 
following an interlock interruption until all treatment room entrance 
doors are closed and the beam on-off control is reset at the console.
    (c) A licensee shall require any individual entering the treatment 
room to assure, through the use of appropriate radiation monitors, that 
radiation levels have returned to ambient levels.
    (d) Except for low-dose remote afterloaders, a licensee shall 
construct or equip each treatment room with viewing and intercom 
systems to permit continuous observation of the patient or the human 
research subject from the treatment console during irradiation.
    (e) For licensed activities where sources are placed within the 
patient's or human research subject's body, a licensee shall only 
conduct treatments which allow for expeditious removal of a decoupled 
or jammed source.
    (f) In addition to the requirements specified in paragraphs (a) 
through (e) of this section, a licensee shall--
    (1) For low dose-rate remote afterloader devices, require--
    (i) An authorized user or an authorized medical physicist to be

[[Page 43567]]

physically present during the initiation of all patient treatments 
involving the device; and
    (ii) An authorized medical physicist and an authorized user or a 
physician, who has been designated by the authorized user and who is a 
radiation oncology physician trained in emergency response for the 
device, to be immediately available during continuation of all patient 
treatments involving the device.
    (2) For high dose-rate remote afterloader devices, require--
    (i) An authorized user and an authorized medical physicist to be 
physically present during the initiation of all patient treatments 
involving the device; and
    (ii) An authorized medical physicist and an authorized user or a 
physician, who has been designated by the authorized user and who is a 
radiation oncology physician that has been trained in emergency 
response for the device, to be physically present during continuation 
of all patient treatments involving the device.
    (3) For pulsed dose-rate remote afterloader devices, require--
    (i) An authorized user and an authorized medical physicist to be 
physically present during the initiation of all patient treatments 
involving the device; and
    (ii) An authorized medical physicist and an authorized user or a 
physician, who has been designated by the authorized user and who is a 
radiation oncology physician that has been trained in emergency 
response for the device, to be immediately available during 
continuation of all patient treatments involving the device.
    (4) For gamma stereotactic radiosurgery units, require an 
authorized user and an authorized medical physicist to be physically 
present throughout all patient treatments involving the unit.
    (g) The licensee shall have emergency response equipment available 
near each treatment room. The emergency response equipment must 
include, as applicable--
    (1) A device to assist in placing the source(s) in the shielded 
position;
    (2) A shielded source/applicator storage container;
    (3) Remote handling tools; and
    (4) Supplies necessary to surgically remove applicators or sources 
from a patient or human research subject treated internally with sealed 
sources.


Sec. 35.630  Dosimetry equipment.

    (a) A licensee shall have a calibrated dosimetry system available 
for use. To satisfy this requirement, one of the following two 
conditions must be met.
    (1) The system must have been calibrated using a source traceable 
to the National Institute of Standards and Technology and published 
protocols approved by nationally recognized bodies or by a calibration 
laboratory accredited by the American Association of Physicists in 
Medicine (AAPM). The calibration must have been performed within the 
previous 2 years and after any servicing that may have affected system 
calibration; or
    (2) The system must have been calibrated within the previous 4 
years; 18 to 30 months after that calibration, the system must have 
been intercompared with another dosimetry system that was calibrated 
within the past 24 months by the National Institute of Standards and 
Technology or by a calibration laboratory accredited by the AAPM. The 
results of the intercomparison must have indicated that the calibration 
factor of the licensee's system had not changed by more than 2 percent. 
The licensee may not use the intercomparison result to change the 
calibration factor. When intercomparing dosimetry systems to be used 
for calibrating sealed sources for therapeutic devices, the licensee 
shall use a comparable device with beam attenuators or collimators, as 
applicable, and sources of the same radionuclide as the source used at 
the licensee's facility.
    (b) The licensee shall have available for use a dosimetry system 
for spot-check measurements. To satisfy this requirement, the system 
may be compared with a system that has been calibrated in accordance 
with paragraph (a) of this section. This comparison must have been 
performed within the previous year and after each servicing that may 
have affected system calibration. The spot-check system may be the same 
system used to meet the requirement in paragraph (a) of this section.
    (c) The licensee shall retain a record of each calibration, 
intercomparison, and comparison in accordance with Sec. 35.2630.


Sec. 35.632  Full calibration measurements on teletherapy units.

    (a) A licensee authorized to use a teletherapy unit for medical use 
shall perform full calibration measurements on each teletherapy unit--
    (1) Before the first medical use of the unit; and
    (2) Before medical use under the following conditions:
    (i) Whenever spot-check measurements indicate that the output 
differs by more than 5 percent from the output obtained at the last 
full calibration corrected mathematically for radioactive decay;
    (ii) Following replacement of the source or following 
reinstallation of the teletherapy unit in a new location;
    (iii) Following any repair of the teletherapy unit that includes 
removal of the source or major repair of the components associated with 
the source exposure assembly; and
    (3) At intervals not exceeding 1 year.
    (b) To satisfy the requirement of paragraph (a) of this section, 
full calibration measurements must include determination of--
    (1) The output within +/-3 percent for the range of field sizes and 
for the distance or range of distances used for medical use;
    (2) The coincidence of the radiation field and the field indicated 
by the light beam localizing device;
    (3) The uniformity of the radiation field and its dependence on the 
orientation of the useful beam;
    (4) Timer accuracy and linearity over the range of use;
    (5) On-off error; and
    (6) The accuracy of all distance measuring and localization devices 
in medical use.
    (c) A licensee shall use the dosimetry system described in 
Sec. 35.630(a) to measure the output for one set of exposure 
conditions. The remaining radiation measurements required in paragraph 
(b)(1) of this section may be made using a dosimetry system that 
indicates relative dose rates.
    (d) A licensee shall make full calibration measurements required by 
paragraph (a) of this section in accordance with published protocols 
approved by nationally recognized bodies.
    (e) A licensee shall mathematically correct the outputs determined 
in paragraph (b)(1) of this section for physical decay for intervals 
not exceeding 1 month for cobalt-60, 6 months for cesium-137, or at 
intervals consistent with 1 percent decay for all other nuclides.
    (f) Full calibration measurements required by paragraph (a) of this 
section and physical decay corrections required by paragraph (e) of 
this section must be performed by the authorized medical physicist.
    (g) A licensee shall retain a record of each calibration in 
accordance with Sec. 35.2632.


Sec. 35.633  Full calibration measurements on remote afterloaders.

    (a) A licensee authorized to use a remote afterloader for medical 
use shall perform full calibration measurements on each unit--

[[Page 43568]]

    (1) Before the first medical use of the unit;
    (2) Before medical use under the following conditions:
    (i) Whenever spot-check measurements indicate that the output 
differs by more than 5 percent from the output obtained at the last 
full calibration corrected mathematically for radioactive decay;
    (ii) Following replacement of the source or following 
reinstallation of the unit in a new location outside the facility; and
    (iii) Following any repair of the unit that includes removal of the 
source or major repair of the components associated with the source 
exposure assembly; and
    (3) At intervals not exceeding 120 days for high dose-rate and 
pulsed dose-rate remote afterloaders; and
    (4) At intervals not exceeding 1 year for low dose-rate remote 
afterloaders.
    (b) To satisfy the requirement of paragraph (a) of this section, 
full calibration measurements must include determination of:
    (1) The output within +/-5 percent;
    (2) Source positioning accuracy to within +/-1 millimeter;
    (3) Source retraction with backup battery upon power failure; and
    (4) The operability of the electrically assisted treatment room 
doors with the high-dose rate remote afterloader unit electrical power 
turned off.
    (c) In addition to the requirements for full calibrations for all 
remote afterloaders in paragraph (b) of this section, a licensee shall:
    (1) For high dose-rate and pulsed dose-rate remote afterloaders, 
calibrate--
    (i) At intervals not exceeding one quarter:
    (A) The source guide tubes;
    (B) Timer accuracy and linearity over the typical range of use; and
    (C) Length of the connectors; and
    (ii) Annually, the function of the source tube guides and 
connectors.
    (2) For low dose-rate remote afterloaders, perform an 
autoradiograph of the source(s) to verify inventory and source(s) 
arrangement and a spot check of the absolute timer accuracy at 
intervals not exceeding one quarter.
    (d) A licensee shall use the dosimetry system described in 
Sec. 35.630(a) to measure the output.
    (e) A licensee shall make full calibration measurements required by 
paragraph (a) of this section in accordance with published protocols 
approved by nationally recognized bodies.
    (f) A licensee shall mathematically correct the outputs determined 
in paragraph (b)(1) of this section for physical decay at intervals 
consistent with 1 percent physical decay.
    (g) Full calibration measurements required by paragraph (a) of this 
section and physical decay corrections required by paragraph (f) of 
this section must be performed by the authorized medical physicist.
    (h) A licensee shall retain a record of each calibration in 
accordance with Sec. 35.2633.


Sec. 35.635  Full calibration measurements on gamma stereotactic 
radiosurgery units.

    (a) A licensee authorized to use a gamma stereotactic radiosurgery 
unit for medical use shall perform full calibration measurements on 
each unit--
    (1) Before the first medical use of the unit;
    (2) Before medical use under the following conditions--
    (i) Whenever spot-check measurements indicate that the output 
differs by more than 5 percent from the output obtained at the last 
full calibration corrected mathematically for radioactive decay;
    (ii) Following replacement of the sources or following 
reinstallation of the gamma stereotactic radiosurgery unit in a new 
location; and
    (iii) Following any repair of the gamma stereotactic radiosurgery 
unit that includes removal of the sources or major repair of the 
components associated with the source assembly; and
    (3) At intervals not exceeding 1 year.
    (b) To satisfy the requirement of paragraph (a) of this section, 
full calibration measurements must include determination of--
    (1) The output within +/-3 percent;
    (2) Relative helmet factors;
    (3) Isocenter coincidence;
    (4) Timer accuracy and linearity over the range of use;
    (5) On-off error; and
    (6) Trunnion centricity.
    (c) A licensee shall use the dosimetry system described in 
Sec. 35.630(a) to measure the output for one set of exposure 
conditions. The remaining radiation measurements required in paragraph 
(b)(1) of this section may be made using a dosimetry system that 
indicates relative dose rates.
    (d) A licensee shall make full calibration measurements required by 
paragraph (a) of this section in accordance with published protocols 
approved by nationally recognized bodies.
    (e) A licensee shall mathematically correct the outputs determined 
in paragraph (b)(1) of this section at intervals not exceeding 1 month 
for cobalt-60 and at intervals consistent with 1 percent physical decay 
for all other radionuclides.
    (f) Full calibration measurements required by paragraph (a) of this 
section and physical decay corrections required by paragraph (e) of 
this section must be performed by the authorized medical physicist.
    (g) A licensee shall retain a record of each calibration in 
accordance with Sec. 35.2635.


Sec. 35.642  Periodic spot-checks for teletherapy units.

    (a) A licensee authorized to use teletherapy units for medical use 
shall perform output spot-checks on each teletherapy unit once in each 
calendar month that include determination of--
    (1) Timer constancy, and timer linearity over the range of use;
    (2) On-off error;
    (3) The coincidence of the radiation field and the field indicated 
by the light beam localizing device;
    (4) The accuracy of all distance measuring and localization devices 
used for medical use;
    (5) The output for one typical set of operating conditions measured 
with the dosimetry system described in Sec. 35.630(b); and
    (6) The difference between the measurement made in paragraph (b)(5) 
of this section and the anticipated output, expressed as a percentage 
of the anticipated output (i.e., the value obtained at last full 
calibration corrected mathematically for physical decay).
    (b) A licensee shall perform measurements required by paragraph (a) 
of this section in accordance with written procedures established by 
the authorized medical physicist. That individual need not actually 
perform the spot check measurements.
    (c) A licensee shall have the authorized medical physicist review 
the results of each spot-check within 15 days. The authorized medical 
physicist shall promptly notify the licensee in writing of the results 
of each spot-check.
    (d) A licensee authorized to use a teletherapy unit for medical use 
shall perform safety spot-checks of each teletherapy facility once in 
each calendar month and after each source installation to assure proper 
operation of--
    (1) Electrical interlocks at each teletherapy room entrance;
    (2) Electrical or mechanical stops installed for the purpose of 
limiting use of the primary beam of radiation (restriction of source 
housing angulation or elevation, carriage or stand travel and operation 
of the beam on-off mechanism);

[[Page 43569]]

    (3) Source exposure indicator lights on the teletherapy unit, on 
the control console, and in the facility;
    (4) Viewing and intercom systems;
    (5) Treatment room doors from inside and outside the treatment 
room; and
    (6) Electrically assisted treatment room doors with the teletherapy 
unit electrical power turned off.
    (e) If the results of the checks required in paragraph (d) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning 
system.
    (f) A licensee shall retain a record of each spot-check required by 
paragraphs (a) and (d), in accordance with Sec. 35.2642


Sec. 35.643  Periodic spot-checks for high dose-rate and pulsed dose-
rate remote afterloaders.

    (a) A licensee authorized to use high dose-rate or pulsed dose-rate 
remote afterloaders for medical use shall perform spot-checks on each 
unit:
    (1) At the beginning of each week of use;
    (2) At the beginning of each day of use; and
    (3) After each source installation.
    (b) The licensee shall have the authorized medical physicist:
    (1) Establish written procedures for performing the spot-checks 
required in paragraph (a) of this section; and
    (2) Review the results of each spot-check required by paragraph 
(a)(1) of this section within 15 days of the check. The authorized 
medical physicist need not actually perform the spot-check 
measurements.
    (c) To satisfy the requirements of paragraphs (a)(1) of this 
section, spot-checks must, at a minimum--
    (1) Verify source positioning accuracy;
    (2) Determine output with the dosimetry system described in 
Sec. 35.630(b); and
    (3) Calculate the difference between the measurement made in 
paragraph (c)(2) of this section and the anticipated output, expressed 
as a percentage of the anticipated output (i.e., the value obtained at 
last full calibration mathematically corrected for physical decay).
    (d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of 
this section, spot-checks must, at a minimum, assure proper operation 
of--
    (1) Electrical interlocks at each remote afterloader room entrance;
    (2) Source exposure indicator lights on the remote afterloader 
unit, on the control console, and in the facility;
    (3) Viewing and intercom systems;
    (4) Emergency response equipment;
    (5) Radiation monitors used to indicate the source position;
    (6) Timer constancy; and
    (7) Clock (date and time) in the unit's computer.
    (e) In addition to the requirements for spot checks in paragraph 
(d) of this section, a licensee shall ensure overall proper operation 
of the unit by conducting a simulated cycle of treatment as part of the 
spot-checks.
    (f) A licensee shall arrange for prompt repair of any system 
identified in paragraph (c) of this section that is not operating.
    (g) If the results of the checks required in paragraph (d) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning 
system.
    (h) A licensee shall retain a record of each check required by 
paragraphs (c) and (d) of this section in accordance with Sec. 35.2643.


Sec. 35.644  Periodic spot-checks for low dose-rate remote 
afterloaders.

    (a) A licensee authorized to use low dose-rate remote afterloaders 
for medical use shall perform spot-checks on each unit prior to each 
patient treatment and after each source installation that include 
proper operation of--
    (1) Electrical interlocks at each remote afterloader room entrance;
    (2) Source exposure indicator lights on the remote afterloader 
unit, on the control console, and in the facility;
    (3) Emergency response equipment;
    (4) Radiation monitors used to indicate the source position;
    (5) Timer constancy; and
    (6) Clock (date and time) in the unit's computer.
    (b) In addition to the requirements for spot checks in paragraph 
(a) of this section, a licensee shall ensure overall proper operation 
of the unit by conducting a simulated cycle of treatment as part of the 
spot-checks.
    (c) The licensee shall have the authorized medical physicist--
    (1) Establish written procedures for performing the spot-checks 
required in paragraph (a) of this section; and
    (2) Review the results of each spot-check required by paragraph (a) 
of this section within 15 days of the check. The authorized medical 
physicist need not actually perform the spot-check measurements.
    (d) If the results of the checks required in paragraph (a) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning 
system.
    (e) A licensee shall retain a record of each check required by 
paragraph (a) of this section in accordance with Sec. 35.2643.


Sec. 35.645  Periodic spot-checks for gamma stereotactic radiosurgery 
units.

    (a) A licensee authorized to use gamma stereotactic radiosurgery 
units for medical use shall perform spot-checks on each unit--
    (1) Monthly,
    (2) At the beginning of each day of use, and
    (3) After each source installation.
    (b) The licensee shall have the authorized medical physicist--
    (1) Establish written procedures for performing the spot-checks 
required in paragraph (a) of this section; and
    (2) Review the results of each spot-check required by paragraph 
(a)(1) of this section within 15 days of the check. The authorized 
medical physicist need not actually perform the spot-check 
measurements.
    (c) To satisfy the requirements of paragraph (a)(1) of this 
section, spot-checks must, at a minimum--
    (1) Assure proper operation of--
    (i) Treatment table retraction mechanism, using backup battery 
power or hydraulic/electrical backups with the unit off;
    (ii) Helmet microswitchs;
    (iii) Emergency timing circuits;
    (iv) Emergency off buttons; and
    (v) Stereotactic frames and localizing devices (trunnions).
    (2) Determine--
    (i) The output for one typical set of operating conditions measured 
with the dosimetry system described in Sec. 35.630(b);
    (ii) The difference between the measurement made in paragraph 
(c)(2)(i) of this section and the anticipated output, expressed as a 
percentage of the anticipated output (i.e., the value obtained at last 
full calibration corrected mathematically for physical decay);
    (iii) Source output against computer calculation;
    (iv) Timer accuracy and linearity over the range of use;
    (v) On-off error; and
    (vi) Trunnion centricity.
    (d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of 
this section, spot-checks must assure proper operation of--

[[Page 43570]]

    (1) Electrical interlocks at each gamma stereotactic radiosurgery 
room entrance;
    (2) Source exposure indicator lights on the gamma stereotactic 
radiosurgery unit, on the control console, and in the facility;
    (3) Viewing and intercom systems;
    (4) Timer termination;
    (5) Radiation monitors used to indicate room exposures; and
    (6) Hydraulic cutoff mechanism (if applicable).
    (e) A licensee shall arrange for prompt repair of any system 
identified in paragraph (c) of this section that is not operating 
properly.
    (f) If the results of the checks required in paragraph (d) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning 
system.
    (g) A licensee shall retain a record of each check required by 
paragraphs (c) and (d) of this section in accordance with Sec. 35.2645.


Sec. 35.647  Additional technical requirements for mobile remote 
afterloaders.

    (a) A licensee providing mobile remote afterloader service shall--
    (1) Check survey instruments before medical use at each address of 
use or on each day of use, which ever is more frequent; and
    (2) Account for all sources before departure from a client's 
address of use.
    (b) In addition to the periodic spot-checks required by 
Sec. 35.643, a licensee authorized to use mobile afterloaders for 
medical use shall perform checks on each remote afterloader before each 
address of use. At a minimum, checks must be made to verify the 
operation of--
    (1) Electrical interlocks on treatment area access points;
    (2) Source exposure indicator lights on the remote afterloader, on 
the control console, and in the facility;
    (3) Viewing and intercom systems;
    (4) Applicators and connectors;
    (5) Radiation monitors used to indicate room exposures;
    (6) Source positioning (accuracy); and
    (7) Radiation monitors used to indicate whether the source has 
returned to a safe shielded position.
    (c) In addition to the requirements for checks in paragraph (b) of 
this section, a licensee shall ensure overall proper operation of the 
remote afterloader unit by conducting a simulated cycle of treatment 
before use at each address of use.
    (d) A licensee shall arrange for prompt repair of any system 
identified in paragraph (b) of this section that is not operating 
properly.
    (e) A licensee shall retain a record of each check required by 
paragraph (b) of this section in accordance with Sec. 35.2647.


Sec. 35.652  Radiation surveys.

    (a) In addition to the survey requirement in Sec. 20.1501 of this 
chapter, a licensee shall make such surveys as defined in the Sealed 
Source and Device Registry to assure that the maximum radiation levels 
and average radiation levels from the surface of the main source safe 
with the source(s) in the shielded position does not exceed the levels 
stated in the Registry.
    (b) The licensee shall make the survey required by paragraph (a) of 
this section at installation of a new source and following repairs to 
the source(s) shielding, the source(s) driving unit, or other 
electronic or mechanical component that could expose the source, reduce 
the shielding around the source(s), or compromise the radiation safety 
of the device or the source(s).
    (c) A licensee shall retain a record of the radiation surveys 
required by paragraph (a) of this section in accordance with 
Sec. 35.2652.


Sec. 35.655  Five-year inspection for teletherapy and gamma 
stereotactic radiosurgery units.

    (a) A licensee shall have each teletherapy unit and gamma 
stereotactic radiosurgery unit fully inspected and serviced during 
source replacement or at intervals not to exceed 5 years, whichever 
comes first, to assure proper functioning of the source exposure 
mechanism.
    (b) This inspection and servicing may only be performed by persons 
specifically licensed to do so by the Commission or an Agreement State.
    (c) A licensee shall keep a record of the inspection and servicing 
in accordance with Sec. 35.2655.


Sec. 35.657  Therapy-related computer systems.

    The licensee shall:
    (a) Verify that the computerized operating system and treatment 
planning system associated with the therapy device are operating 
appropriately; and
    (b) Perform acceptance testing on the treatment planning system in 
accordance with published protocols approved by nationally recognized 
bodies.


Sec. 35.690  Training for use of therapeutic medical devices.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a sealed source for a use authorized under 
Sec. 35.600 to be a physician who--
    (a) Is certified by a specialty board whose certification process 
includes all of the requirements in paragraph (b) of this section and 
whose certification has been approved by the Commission; or
    (b)(1) Has completed a structured educational program in basic 
radionuclide techniques applicable to the use of a sealed source in a 
therapeutic medical device consisting of both--
    (i) 200 hours of didactic training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (D) Radiation biology; and
    (ii) 500 hours of supervised practical experience, under the 
supervision of an authorized user at a medical institution, involving--
    (A) Review of the full calibration measurements and periodic spot 
checks;
    (B) Preparing treatment plans and calculating treatment doses and 
times;
    (C) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (D) Implementing emergency procedures to be followed in the event 
of the abnormal operation of the medical device or console;
    (E) Checking and using survey meters; and
    (F) Selecting the proper dose and how it is to be administered; and
    (2) Three years of supervised clinical experience that includes one 
year in a formal training program approved by the Residency Review 
Committee for Radiology of the Accreditation Council for Graduate 
Medical Education or the Committee on Postdoctoral Training of the 
American Osteopathic Association or equivalent program approved by the 
NRC and an additional two years of clinical experience under the 
supervision of an authorized user; and
    (3) Has obtained written certification, signed by a preceptor 
authorized user, that the required training in paragraphs (b)(1) and 
(b)(2) of this section has been satisfactorily completed and that the 
individual has achieved a level of competency sufficient to 
independently function as an authorized user of the therapeutic medical 
device for which the individual is requesting authorized user status; 
and
    (4) Following completion of the requirements in paragraph (b)(1) 
and (2) of this section, has demonstrated sufficient knowledge in 
radiation safety commensurate with the use requested

[[Page 43571]]

by passing an examination given by an organization or entity approved 
by the Commission in accordance with appendix A of this part.

Subpart I--Reserved

Subpart J--Training and Experience Requirements


Sec. 35.900  Radiation Safety Officer.

    Except as provided in Sec. 35.57, the licensee shall require an 
individual fulfilling the responsibilities of the Radiation Safety 
Officer as provided in Sec. 35.24 to be an individual who--
    (a) Is certified by the--
    (1) American Board of Health Physics in Comprehensive Health 
Physics;
    (2) American Board of Radiology;
    (3) American Board of Nuclear Medicine;
    (4) American Board of Science in Nuclear Medicine;
    (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy;
    (6) American Board of Medical Physics in radiation oncology 
physics;
    (7) Royal College of Physicians and Surgeons of Canada in nuclear 
medicine;
    (8) American Osteopathic Board of Radiology; or
    (9) American Osteopathic Board of Nuclear Medicine; or
    (b) Has had classroom and laboratory training and experience as 
follows--
    (1) 200 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Radiation biology; and
    (v) Radiopharmaceutical chemistry; and
    (2) One year of full time experience as a radiation safety 
technologist at a medical institution under the supervision of the 
individual identified as the Radiation Safety Officer on a Commission 
or Agreement State license that authorizes the medical use of byproduct 
material; or
    (c) Is an authorized user identified on the licensee's license.


Sec. 35.910  Training for uptake, dilution, and excretion studies.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a radiopharmaceutical in Sec. 35.100(a) to be a 
physician who--
    (a) Is certified in--
    (1) Nuclear medicine by the American Board of Nuclear Medicine;
    (2) Diagnostic radiology by the American Board of Radiology;
    (3) Diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology;
    (4) Nuclear medicine by the Royal College of Physicians and 
Surgeons of Canada; or
    (5) American Osteopathic Board of Nuclear Medicine in nuclear 
medicine; or
    (b) Has had classroom and laboratory training in basic radioisotope 
handling techniques applicable to the use of prepared 
radiopharmaceuticals, and supervised clinical experience as follows--
    (1) 40 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Radiation biology; and
    (v) Radiopharmaceutical chemistry; and
    (2) 20 hours of supervised clinical experience under the 
supervision of an authorized user and that includes--
    (i) Examining patients or human research subjects and reviewing 
their case histories to determine their suitability for radioisotope 
diagnosis, limitations, or contraindications;
    (ii) Selecting the suitable radiopharmaceuticals and calculating 
and measuring the dosages;
    (iii) Administering dosages to patients or human research subjects 
and using syringe radiation shields;
    (iv) Collaborating with the authorized user in the interpretation 
of radioisotope test results; and
    (v) Patient or human research subject follow up; or
    (c) Has successfully completed a 6-month training program in 
nuclear medicine as part of a training program that has been approved 
by the Accreditation Council for Graduate Medical Education and that 
included classroom and laboratory training, work experience, and 
supervised clinical experience in all the topics identified in 
paragraph (b) of this section.


Sec. 35.920  Training for imaging and localization studies.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a radiopharmaceutical, generator, or reagent kit in 
Sec. 35.200(a) to be a physician who--
    (a) Is certified in--
    (1) Nuclear medicine by the American Board of Nuclear Medicine;
    (2) Diagnostic radiology by the American Board of Radiology;
    (3) Diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology;
    (4) Nuclear medicine by the Royal College of Physicians and 
Surgeons of Canada; or
    (5) American Osteopathic Board of Nuclear Medicine in nuclear 
medicine; or
    (b) Has had classroom and laboratory training in basic radioisotope 
handling techniques applicable to the use of prepared 
radiopharmaceuticals, generators, and reagent kits, supervised work 
experience, and supervised clinical experience as follows--
    (1) 200 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Radiopharmaceutical chemistry; and
    (v) Radiation biology; and
    (2) 500 hours of supervised work experience under the supervision 
of an authorized user that includes--
    (i) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (ii) Calibrating dose calibrators and diagnostic instruments and 
performing checks for proper operation of survey meters;
    (iii) Calculating and safely preparing patient or human research 
subject dosages;
    (iv) Using administrative controls to prevent the medical event of 
byproduct material;
    (v) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (vi) Eluting technetium-99m from generator systems, measuring and 
testing the eluate for molybdenum-99 and alumina contamination, and 
processing the eluate with reagent kits to prepare technetium-99m 
labeled radiopharmaceuticals; and
    (3) 500 hours of supervised clinical experience under the 
supervision of an authorized user that includes--
    (i) Examining patients or human research subjects and reviewing 
their case histories to determine their suitability for radioisotope 
diagnosis, limitations, or contraindications;
    (ii) Selecting the suitable radiopharmaceuticals and calculating 
and measuring the dosages;
    (iii) Administering dosages to patients or human research subjects 
and using syringe radiation shields;
    (iv) Collaborating with the authorized user in the interpretation 
of radioisotope test results; and
    (v) Patient or human research subject follow up; or

[[Page 43572]]

    (c) Has successfully completed a 6-month training program in 
nuclear medicine that has been approved by the Accreditation Council 
for Graduate Medical Education and that included classroom and 
laboratory training, work experience, and supervised clinical 
experience in all the topics identified in paragraph (b) of this 
section.


Sec. 35.930  Training for therapeutic use of unsealed byproduct 
material.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of radiopharmaceuticals in Sec. 35.300 to be a 
physician who--
    (a) Is certified by--
    (1) The American Board of Nuclear Medicine;
    (2) The American Board of Radiology in radiology, therapeutic 
radiology, or radiation oncology;
    (3) The Royal College of Physicians and Surgeons of Canada in 
nuclear medicine; or
    (4) The American Osteopathic Board of Radiology after 1984; or
    (b) Has had classroom and laboratory training in basic radioisotope 
handling techniques applicable to the use of therapeutic 
radiopharmaceuticals, and supervised clinical experience as follows--
    (1) 80 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (iv) Radiation biology; and
    (2) Supervised clinical experience under the supervision of an 
authorized user at a medical institution that includes--
    (i) Use of iodine-131 for diagnosis of thyroid function and the 
treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; 
and
    (ii) Use of iodine-131 for treatment of thyroid carcinoma in 3 
individuals.


Sec. 35.932  Training for treatment of hyperthyroidism.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of only iodine-131 for the treatment of hyperthyroidism 
to be a physician with special experience in thyroid disease who has 
had classroom and laboratory training in basic radioisotope handling 
techniques applicable to the use of iodine-131 for treating 
hyperthyroidism, and supervised clinical experience as follows--
    (a) 80 hours of classroom and laboratory training that includes--
    (1) Radiation physics and instrumentation;
    (2) Radiation protection,
    (3) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (4) Radiation biology; and
    (b) Supervised clinical experience under the supervision of an 
authorized user that includes the use of iodine-131 for diagnosis of 
thyroid function, and the treatment of hyperthyroidism in 10 
individuals.


Sec. 35.934  Training for treatment of thyroid carcinoma.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of only iodine-131 for the treatment of thyroid 
carcinoma to be a physician with special experience in thyroid disease 
who has had classroom and laboratory training in basic radioisotope 
handling techniques applicable to the use of iodine-131 for treating 
thyroid carcinoma, and supervised clinical experience as follows--
    (a) 80 hours of classroom and laboratory training that includes--
    (1) Radiation physics and instrumentation;
    (2) Radiation protection;
    (3) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (4) Radiation biology; and
    (b) Supervised clinical experience under the supervision of an 
authorized user that includes the use of iodine-131 for the treatment 
of thyroid carcinoma in 3 individuals.


Sec. 35.940  Training for use of brachytherapy sources.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a brachytherapy source listed in Sec. 35.400 for 
therapy to be a physician who--
    (a) Is certified in--
    (1) Radiology, therapeutic radiology, or radiation oncology by the 
American Board of Radiology;
    (2) Radiation oncology by the American Osteopathic Board of 
Radiology;
    (3) Radiology, with specialization in radiotherapy, as a British 
``Fellow of the Faculty of Radiology'' or ``Fellow of the Royal College 
of Radiology''; or
    (4) Therapeutic radiology by the Canadian Royal College of 
Physicians and Surgeons; or
    (b) Is in the active practice of therapeutic radiology, has had 
classroom and laboratory training in radioisotope handling techniques 
applicable to the therapeutic use of brachytherapy sources, supervised 
work experience, and supervised clinical experience as follows--
    (1) 200 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (iv) Radiation biology;
    (2) 500 hours of supervised work experience under the supervision 
of an authorized user at a medical institution that includes--
    (i) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (ii) Checking survey meters for proper operation;
    (iii) Preparing, implanting, and removing sealed sources;
    (iv) Maintaining running inventories of material on hand;
    (v) Using administrative controls to prevent a medical event 
involving byproduct material; and
    (vi) Using emergency procedures to control byproduct material; and
    (3) Three years of supervised clinical experience that includes one 
year in a formal training program approved by the Residency Review 
Committee for Radiology of the Accreditation Council for Graduate 
Medical Education or the Committee on Postdoctoral Training of the 
American Osteopathic Association, and an additional two years of 
clinical experience in therapeutic radiology under the supervision of 
an authorized user at a medical institution that includes--
    (i) Examining individuals and reviewing their case histories to 
determine their suitability for brachytherapy treatment, and any 
limitations or contraindications;
    (ii) Selecting the proper brachytherapy sources and dose and method 
of administration;
    (iii) Calculating the dose; and
    (iv) Post-administration follow up and review of case histories in 
collaboration with the authorized user.


Sec. 35.941  Training for ophthalmic use of strontium-90.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of only strontium-90 for ophthalmic radiotherapy to be 
a physician who is in the active practice of therapeutic radiology or 
ophthalmology, and has had classroom and laboratory training in basic 
radioisotope handling techniques applicable to the use of strontium-90 
for ophthalmic radiotherapy, and a period of supervised clinical 
training in ophthalmic radiotherapy as follows--
    (a) 24 hours of classroom and laboratory training that includes--
    (1) Radiation physics and instrumentation;

[[Page 43573]]

    (2) Radiation protection;
    (3) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (4) Radiation biology;
    (b) Supervised clinical training in ophthalmic radiotherapy under 
the supervision of an authorized user at a medical institution that 
includes the use of strontium-90 for the ophthalmic treatment of five 
individuals that includes--
    (1) Examination of each individual to be treated;
    (2) Calculation of the dose to be administered;
    (3) Administration of the dose; and
    (4) Follow up and review of each individual's case history.


Sec. 35.950  Training for use of sealed sources for diagnosis.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a sealed source in a device listed in Sec. 35.500 to 
be a physician, dentist, or podiatrist who--
    (a) Is certified in--
    (1) Radiology, diagnostic radiology, therapeutic radiology, or 
radiation oncology by the American Board of Radiology;
    (2) Nuclear medicine by the American Board of Nuclear Medicine;
    (3) Diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology; or
    (4) Nuclear medicine by the Royal College of Physicians and 
Surgeons of Canada; or
    (b) Has had 8 hours of classroom and laboratory training in basic 
radioisotope handling techniques specifically applicable to the use of 
the device that includes--
    (1) Radiation physics, mathematics pertaining to the use and 
measurement of radioactivity, and instrumentation;
    (2) Radiation biology;
    (3) Radiation protection; and
    (4) Training in the use of the device for the uses requested.


Sec. 35.960  Training for use of therapeutic medical devices.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a sealed source listed in Sec. 35.600 to be a 
physician who--
    (a) Is certified in--
    (1) Radiology, therapeutic radiology, or radiation oncology by the 
American Board of Radiology;
    (2) Radiation oncology by the American Osteopathic Board of 
Radiology;
    (3) Radiology, with specialization in radiotherapy, as a British 
``Fellow of the Faculty of Radiology'' or ``Fellow of the Royal College 
of Radiology''; or
    (4) Therapeutic radiology by the Canadian Royal College of 
Physicians and Surgeons; or
    (b) Is in the active practice of therapeutic radiology, and has had 
classroom and laboratory training in basic radioisotope techniques 
applicable to the use of a sealed source in a therapeutic medical 
device, supervised work experience, and supervised clinical experience 
as follows--
    (1) 200 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (iv) Radiation biology;
    (2) 500 hours of supervised work experience under the supervision 
of an authorized user at a medical institution that includes--
    (i) Review of the full calibration measurements and periodic spot-
checks;
    (ii) Preparing treatment plans and calculating treatment times;
    (iii) Using administrative controls to prevent medical events;
    (iv) Implementing emergency procedures to be followed in the event 
of the abnormal operation of the medical device or console; and
    (v) Checking and using survey meters; and
    (3) Three years of supervised clinical experience that includes one 
year in a formal training program approved by the Residency Review 
Committee for Radiology of the Accreditation Council for Graduate 
Medical Education or the Committee on Postdoctoral Training of the 
American Osteopathic Association and an additional two years of 
clinical experience in therapeutic radiology under the supervision of 
an authorized user at a medical institution that includes--
    (i) Examining individuals and reviewing their case histories to 
determine their suitability for teletherapy, remote afterloader, or 
gamma stereotactic radiosurgery treatment, and any limitations or 
contraindications;
    (ii) Selecting the proper dose and how it is to be administered;
    (iii) Calculating the doses and collaborating with the authorized 
user in the review of patients' or human research subjects' progress 
and consideration of the need to modify originally prescribed doses as 
warranted by patients' or human research subjects' reaction to 
radiation; and
    (iv) Post-administration follow up and review of case histories.


Sec. 35.961  Training for authorized medical physicist.

    The licensee shall require the authorized medical physicist to be 
an individual who--
    (a) Is certified by the American Board of Radiology in--
    (1) Therapeutic radiological physics;
    (2) Roentgen ray and gamma ray physics;
    (3) X-ray and radium physics; or
    (4) Radiological physics; or
    (b) Is certified by the American Board of Medical Physics in 
radiation oncology physics; or
    (c) Holds a master's or doctor's degree in physics, biophysics, 
radiological physics, or health physics, and has completed 1 year of 
full time training in therapeutic radiological physics and an 
additional year of full time work experience under the supervision of a 
medical physicist at a medical institution that includes the tasks 
listed in Secs. 35.67, 35.632, 35.633, 35.635, 35.642, 35.643, 35.644, 
35.645 and 35.652, as applicable.


Sec. 35.980  Training for an authorized nuclear pharmacist.

    The licensee shall require the authorized nuclear pharmacist to be 
a pharmacist who--
    (a) Has current board certification as a nuclear pharmacist by the 
Board of Pharmaceutical Specialties; or
    (b)(1) Has completed 700 hours in a structured educational program 
consisting of both--
    (i) Didactic training in the following areas:
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use; and
    (E) Radiation biology; and
    (ii) Supervised experience in a nuclear pharmacy involving the 
following--
    (A) Shipping, receiving, and performing related radiation surveys;
    (B) Using and performing checks for proper operation of dose 
calibrators, survey meters, and, if appropriate, instruments used to 
measure alpha- or beta-emitting radionuclides;
    (C) Calculating, assaying, and safely preparing dosages for 
patients or human research subjects;
    (D) Using administrative controls to avoid mistakes in the 
administration of byproduct material;
    (E) Using procedures to prevent or minimize contamination and using 
proper decontamination procedures; and

[[Page 43574]]

    (2) Has obtained written certification, signed by a preceptor 
authorized nuclear pharmacist, that the above training has been 
satisfactorily completed and that the individual has achieved a level 
of competency sufficient to independently operate a nuclear pharmacy.


Sec. 35.981  Training for experienced nuclear pharmacists.

    A licensee may apply for and must receive a license amendment 
identifying an experienced nuclear pharmacist as an authorized nuclear 
pharmacist before it allows this individual to work as an authorized 
nuclear pharmacist. A pharmacist who has completed a structured 
educational program as specified in Sec. 35.980(b)(1) before December 
2, 1994, and who is working in a nuclear pharmacy would qualify as an 
experienced nuclear pharmacist. An experienced nuclear pharmacist need 
not comply with the requirements for a preceptor statement 
(Sec. 35.980(b)(2)) and recentness of training (Sec. 35.59) to qualify 
as an authorized nuclear pharmacist.

Subpart K--Other Medical Uses of Byproduct Material or Radiation 
From Byproduct Material


Sec. 35.1000  Other medical uses of byproduct material or radiation 
from byproduct material.

    A licensee may use byproduct material or a radiation source 
approved for medical use which is not specifically addressed in 
subparts D through H of this part if--
    (a) The applicant or licensee has submitted the information 
required by Sec. 35.12(d); and
    (b) The applicant or licensee has received written approval from 
the Commission in a license and uses the material in accordance with 
the regulations and specific conditions the Commission considers 
necessary for the medical use of the material.

Subpart L--Records


Sec. 35.2024  Records of authority and responsibilities for radiation 
protection programs.

    (a) A licensee shall retain a record of actions taken by the 
licensee's management in accordance with Sec. 35.24(a) for 5 years. The 
record must include a summary of the actions taken and a signature of 
licensee management.
    (b) The licensee shall retain a current copy of the authorities, 
duties and responsibilities of the radiation safety officer, as 
required by Sec. 35.24(d), and a signed copy of the radiation safety 
officer's willingness to be responsible for implementing the radiation 
safety program, as required by Sec. 35.24(b). The records must include 
the signature of the radiation safety officer and licensee management.


Sec. 35.2026  Records of radiation protection program safety changes.

    A licensee shall retain a record of each radiation protection 
program change made in accordance with Sec. 35.26(a) for 5 years. The 
record must include a copy of the old and new procedures; the effective 
date of the change; and the signature of the radiation safety officer 
and the licensee management that reviewed and approved the change.


Sec. 35.2040  Records of written directives.

    A licensee shall retain a copy of each written directive as 
required by Sec. 35.40 for 3 years.


Sec. 35.2045  Records of medical events.

    A licensee shall retain a record of medical events reported 
pursuant to Sec. 35.3045 for 3 years. The record must contain the 
licensee's name, names of all the individuals involved, the affected or 
potentially affected individual's social security number or other 
identification number if one has been assigned, a brief description of 
the medical event, why it occurred, the effect on the individual, and 
the actions taken to prevent recurrence.


Sec. 35.2060  Records of instrument calibrations.

    A licensee shall maintain a record of instrument calibrations 
required by Secs. 35.60 and 35.62 for 3 years. The records must 
include--
    (a) For constancy, the model and serial number of the instrument, 
the identity of the radionuclide contained in the check source, the 
date of the check, and the activity measured, and the name of the 
individual who performed the check;
    (b) For accuracy, the model and serial number of the instrument, 
the model and serial number of each source used, the identity of the 
radionuclide contained in the source and its activity, the date of the 
test, and the results of the test, and the name of the individual who 
performed the test;
    (c) For linearity, the model and serial number of the instrument, 
the calculated activities, the measured activities, and the date of the 
test, and the name of the individual who performed the test; and
    (d) For geometric dependence, the model and serial number of the 
instrument, the configuration of the source measured, the activity 
measured for each volume measured, and the date of the test, and the 
name of the individual who performed the test.


Sec. 35.2061  Records of radiation survey instrument calibrations.

    A licensee shall maintain a record of radiation survey instrument 
calibrations required by Sec. 35.61 for 3 years. The record must 
include--
    (a) A description of the calibration procedure; and
    (b) The date of the calibration, a description of the source used 
and the certified exposure rates from the source, and the rates 
indicated by the instrument being calibrated, the correction factors 
deduced from the calibration data, and the name of the individual who 
performed the calibration.


Sec. 35.2063  Records of dosages of unsealed byproduct material for 
medical use.

    (a) A licensee shall maintain a record of dosage determinations 
required by Sec. 35.63 for 3 years.
    (b) To satisfy this requirement, the record must contain the--
    (1) Radionuclide, generic name, trade name, or abbreviation of the 
radiopharmaceutical, and its lot number;
    (2) Patient's or human research subject's name, or identification 
number if one has been assigned;
    (3) Prescribed dosage and activity of the dosage at the time of 
determination, or a notation that the total activity is less than 1.1 
MBq (30 Ci);
    (4) Date and time of the dosage determination; and
    (5) Name of the individual who determined the dosage.


Sec. 35.2067  Records of possession of sealed sources and brachytherapy 
sources.

    (a) A licensee shall retain records of leak tests required by 
Sec. 35.67(b) for 3 years. The records must contain the model number, 
and serial number if one has been assigned, of each source tested, the 
identity of each source radionuclide and its estimated activity, the 
measured activity of each test sample, a description of the method used 
to measure each test sample, the date of the test, and the name of the 
individual who performed the test.
    (b) A licensee shall retain records of the semi-annual physical 
inventory of sealed sources and brachytherapy sources required by 
Sec. 35.67(g) for 3 years. The inventory records must contain the model 
number of each source, and serial number if one has been assigned, the 
identity of each source radionuclide and its nominal activity, the 
location of each source, and the name of the individual who performed 
the inventory.

[[Page 43575]]

Sec. 35.2070  Records of surveys for ambient radiation exposure rate.

    A licensee shall retain a record of each survey required by 
Sec. 35.70 for 3 years. The record must include the date of the survey, 
a plan of each area surveyed, the trigger level established for each 
area, the detected dose rate at several points in each area expressed 
in millirem per hour or the removable contamination in each area 
expressed in disintegrations per minute per 100 square centimeters, the 
instrument used to make the survey or analyze the samples, and the name 
of the individual who performed the survey.


Sec. 35.2075  Records of the release of individuals containing 
radiopharmaceuticals or implants.

    (a) A licensee shall retain records of the release of individuals 
containing pharmaceuticals or implants in accordance with Sec. 35.75 
for 3 years after the date of release.
    (b) A licensee shall retain a record in accordance with paragraph 
(a) of this section that describes the basis for authorizing the 
release of individuals if the total effective dose equivalent is 
calculated by--
    (1) Using the retained activity rather than the activity 
administered;
    (2) Using an occupancy factor less than 0.25 at 1 meter;
    (3) Using the biological or effective half-life; or
    (4) Considering the shielding by tissue.
    (c) A licensee shall retain a record that the instructions required 
by Sec. 35.75(b) were provided to a breast-feeding woman if the 
radiation dose to the infant or child from continued breast-feeding 
could result in a total effective dose equivalent exceeding 5 mSv (0.5 
rem).


Sec. 35.2080  Records of administrative and technical requirements that 
apply to the provision of mobile services.

    (a) A licensee shall retain a copy of the letter(s) that permits 
the use of byproduct material at a client's address of use, in 
accordance with Sec. 35.80(a)(1). This letter must clearly delineate 
the authority and responsibility of each entity and must be retained 
for 3 years after the last provision of service.
    (b) A licensee shall retain the record of each survey required by 
Sec. 35.80(a)(4) for 3 years. The record must include the date of the 
survey, a plan of each area that was surveyed, the measured dose rate 
at several points in each area of use expressed in millirem per hour, 
the instrument used to make the survey, and the name of the individual 
who performed the survey.


Sec. 35.2092  Records of waste disposal.

    A licensee shall maintain records of the disposal of licensed 
materials made in accordance with Sec. 35.92 for 3 years. The record 
must include the date of the disposal, the radionuclides disposed, the 
survey instrument used, the background dose rate, the dose rate 
measured at the surface of each waste container, and the name of the 
individual who performed the disposal.


Sec. 35.2204  Records of molybdenum-99 concentrations.

    A licensee shall maintain a record of the molybdenum-99 
concentration tests required by Sec. 35.204(b) for 3 years. The record 
must include, for each measured elution of technetium-99m, the ratio of 
the measures expressed as microcuries of molybdenum per millicurie of 
technetium, the time and date of the measurement, and the name of the 
individual who made the measurement.


Sec. 35.2310  Records of instruction and training.

    A licensee shall maintain a record of instructions and training 
required by Secs. 35.310, 35.410, and 35.610 for 3 years. The record 
must include a list of the topics covered, the date of the instruction 
or training, the name(s) of the attendee(s), and the name(s) of the 
individual(s) who provided the instruction.


Sec. 35.2404  Records of radiation surveys of patients and human 
research subjects.

    A licensee shall maintain a record of the radiation surveys of 
patients and human research subjects required by Secs. 35.404 and 
35.604 for 3 years. Each record must include the date, location, and 
results of the survey, an identifier for the patient or the human 
research subject, the survey instrument used, and the name of the 
individual who made the survey.


Sec. 35.2406  Records of brachytherapy source inventory.

    (a) A licensee shall maintain a record of brachytherapy source 
accountability required by Sec. 35.406 for 3 years.
    (b) For temporary implants, the record must include--
    (1) The number and activity of sources removed from storage, the 
time and date they were removed from storage, the name of the 
individual who removed them from storage, and the location of use; and
    (2) The number and activity of sources returned to storage, the 
time and date they were returned to storage, and the name of the 
individual who returned them from storage.
    (c) For permanent implants, the record must include--
    (1) The number and activity of sources removed from storage, the 
date they were removed from storage, and the name of the individual who 
removed them from storage;
    (2) The number and activity of sources returned to storage, the 
date they were returned to storage, and the name of the individual who 
returned them to storage; and
    (3) The number and activity of sources permanently implanted in the 
patient or human research subject.


Sec. 35.2432  Records of full calibrations on brachytherapy sources.

    A licensee shall maintain a record of the full calibrations on 
brachytherapy sources required by Sec. 35.432 for 3 years after the 
last use of the source. The record must include the date of the 
calibration; the manufacturer's name, model number, and serial number 
for the source and instruments used to calibrate the source; the source 
output; source positioning accuracy within applicators; and the name of 
the individual or the source manufacturer who performed the 
calibration.


Sec. 35.2605  Records of installation, maintenance, and repair.

    A licensee shall retain a record of the installation, maintenance, 
and repair of therapeutic medical devices as required by Sec. 35.605 
for 3 years. For each installation, maintenance, and repair, the record 
must include the date, description of the service, and name(s) of the 
individual(s) who performed the work.


Sec. 35.2630  Records of dosimetry equipment.

    (a) A licensee shall retain a record of the calibration, 
intercomparison, and comparisons of its dosimetry equipment done in 
accordance with Sec. 35.630 for the duration of the license.
    (b) For each calibration, intercomparison, or comparison, the 
record must include--
    (1) The date;
    (2) The model numbers and serial numbers of the instruments that 
were calibrated, intercompared, or compared as required by paragraphs 
(a) and (b) of Sec. 35.630;
    (3) The correction factor that was determined from the calibration 
or comparison or the apparent correction factor that was determined 
from an intercomparison; and
    (4) The name(s) of the individual(s) who performed the calibration, 
intercomparison, or comparison.

[[Page 43576]]

Sec. 35.2632  Records of teletherapy full calibrations.

    (a) A licensee shall maintain a record of the teletherapy full 
calibrations required by Sec. 35.632 for 3 years.
    (b) The record must include--
    (1) The date of the calibration;
    (2) The manufacturer's name, model number, and serial number for 
the teletherapy unit, source, and instruments used to calibrate the 
teletherapy unit;
    (3) Tables that describe the output of the unit over the range of 
field sizes and for the range of distances used in radiation therapy;
    (4) A determination of the coincidence of the radiation field and 
the field indicated by the light beam localizing device;
    (5) An assessment of timer accuracy and linearity;
    (6) The calculated on-off error;
    (7) The estimated accuracy of each distance measuring and 
localization device; and
    (8) The signature of the authorized medical physicist who performed 
the full calibration.


Sec. 35.2633  Records of remote afterloader full calibrations.

    (a) A licensee shall maintain a record of the remote afterloader 
full calibrations required by Sec. 35.633 for 3 years.
    (b) The record must include--
    (1) The date of the calibration;
    (2) The manufacturer's name, model number, and serial number for 
the remote afterloader, source, and instruments used to calibrate the 
unit; the source output;
    (3) An assessment of timer accuracy and linearity, source 
positioning accuracy, source guide tube and connector lengths, and 
source retraction functionality; and
    (4) The signature of the authorized medical physicist who performed 
the full calibration.


Sec. 35.2635  Records of gamma stereotactic radiosurgery unit full 
calibrations.

    (a) A licensee shall maintain a record of the gamma stereotactic 
radiosurgery full calibrations required by Sec. 35.635 for 3 years.
    (b) The record must include--
    (1) The date of the calibration;
    (2) The manufacturer's name, model number, and serial number for 
the gamma stereotactic radiosurgery unit, source, and instruments used 
to calibrate the unit;
    (3) The unit output;
    (4) An assessment of the relative helmet factors, isocenter 
coincidence, timer accuracy and linearity, on-off error, and trunnion 
centricity; and
    (5) The signature of the authorized medical physicist who performed 
the full calibration.


Sec. 35.2642  Records of periodic spot-checks for teletherapy units.

    (a) A licensee shall retain a record of each periodic spot-check 
for teletherapy units required by Sec. 35.642 for 3 years.
    (b) The record must include --
    (1) The date of the spot-check;
    (2) The manufacturer's name, model number, and serial number for 
the teletherapy unit, source and instrument used to measure the output 
of the teletherapy unit;
    (3) An assessment of timer linearity and constancy;
    (4) The calculated on-off error;
    (5) A determination of the coincidence of the radiation field and 
the field indicated by the light beam localizing device;
    (6) The determined accuracy of each distance measuring and 
localization device;
    (7) The difference between the anticipated output and the measured 
output;
    (8) Notations indicating the operability of each entrance door 
electrical interlock, each electrical or mechanical stop, each source 
exposure indicator light, and the viewing and intercom system and 
doors; and
    (9) The name of the individual who performed the periodic spot-
check and the signature of the authorized medical physicist who 
reviewed the record of the spot-check.


Sec. 35.2643  Records of periodic spot-checks for remote afterloaders.

    (a) A licensee shall retain a record of each spot-check for remote 
afterloaders required by Secs. 35.643 and 35.644 for 3 years.
    (b) The record must include--
    (1) The date of the spot-check;
    (2) The manufacturer's name, model number, and serial number for 
the remote afterloader, source, and instrument used to measure the 
output of the remote afterloader;
    (3) The difference between the anticipated output and the measured 
output;
    (4) Notations indicating the operability of each entrance door 
electrical interlock, source retraction mechanism, radiation monitors, 
source exposure indicator lights, viewing and intercom systems if 
applicable, applicators and connectors, and source positioning 
accuracy; and
    (5) The name of the individual who performed the periodic spot-
check and the signature of the authorized medical physicist who 
reviewed the record of the spot-check.


Sec. 35.2645  Records of periodic spot-checks for gamma stereotactic 
radiosurgery units.

    (a) A licensee shall retain a record of each spot-check for gamma 
stereotactic radiosurgery units required by Sec. 35.645 for 3 years.
    (b) The record must include--
    (1) The date of the spot-check;
    (2) The manufacturer's name, model number, and serial number for 
the gamma stereotactic radiosurgery unit and the instrument used to 
measure the output of the unit;
    (3) The measured source output and source output against computer 
calculations;
    (4) Notations indicating the operability of radiation monitors, 
helmet microswitchs, emergency timing circuits, emergency off buttons, 
electrical interlocks, source exposure indicator lights, viewing and 
intercom systems, timer termination systems, hydraulic cutoff switch 
and stereotactic frames and localizing devices (trunnions); and
    (5) The name of the individual who performed the periodic spot-
check and the signature of the authorized medical physicist who 
reviewed the record of the spot-check.


Sec. 35.2647  Records of additional technical requirements for mobile 
remote afterloaders.

    (a) A licensee shall retain a record of each check for mobile 
remote afterloaders required by Sec. 35.647 for 3 years.
    (b) The record must include--
    (1) The date of the check;
    (2) The manufacturer's name, model number, and serial number of the 
remote afterloader;
    (3) Notations accounting for all sources before the licensee 
departs from a facility;
    (4) Notations indicating the operability of each entrance door 
electrical interlock, radiation monitors, source exposure indicator 
lights, viewing and intercom system, applicators and connectors, and 
source positioning accuracy; and
    (5) The signature of the individual who performed the check.


Sec. 35.2652  Records of surveys of therapeutic treatment units.

    (a) A licensee shall maintain a record of radiation surveys of 
treatment units made in accordance with Sec. 35.652 for the duration of 
use of the unit.
    (b) The record must include--
    (1) The date of the measurements;
    (2) The manufacturer's name, model number and serial number of the 
treatment unit, source, and instrument used to measure radiation 
levels;

[[Page 43577]]

    (3) Each dose rate measured around the source while the unit is in 
the off position and the average of all measurements; and
    (4) The signature of the individual who performed the test.


Sec. 35.2655  Records of 5-year inspection for teletherapy and gamma 
stereotactic surgery units.

    (a) A licensee shall maintain a record of the 5-year inspections 
for teletherapy and gamma stereotactic radiosurgery units required by 
Sec. 35.655 for the duration of use of the unit.
    (b) The record must contain--
    (1) The inspector's radioactive materials license number;
    (2) The date of inspection;
    (3) The manufacturer's name and model number and serial number of 
both the treatment unit and source;
    (4) A list of components inspected and serviced, and the type of 
service; and
    (5) The signature of the inspector.

Subpart M--Reports


Sec. 35.3045  Reports of medical events.

    (a) A licensee shall report any administration, except for 
administrations resulting from a direct intervention of a patient or 
human research subject that could not have been reasonably prevented by 
the licensee, that results in either--
    (1) A dose that differs from the prescribed dose by more than 0.05 
Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or 
tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and
    (i) The total dose or dosage delivered differs from the prescribed 
dose or dosage by 20 percent or more; or
    (ii) The fractionated dose delivered differs from the prescribed 
dose, for a single fraction, by 50 percent or more.
    (2) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 
0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose 
equivalent to the skin from any of the following--
    (i) An administration of a wrong pharmaceutical;
    (ii) An administration of a radiopharmaceutical by the wrong route 
of administration;
    (iii) An administration of a dose or dosage to the wrong individual 
or human research subject;
    (iv) An administration of a dose or dosage delivered by the wrong 
treatment mode; or
    (v) A leaking sealed source.
    (3) A dose to the skin or an organ or tissue other than the 
treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue 
and 20 percent the dose expected from the administration defined in the 
written directive.
    (b) The licensee shall notify by telephone the NRC Operations 
Center (301-951-0550) no later than the next calendar day after 
discovery of the medical event.
    (c) The licensee shall submit a written report to the appropriate 
NRC Regional Office listed in Sec. 30.6 of this chapter within 15 days 
after discovery of the medical event.
    (1) The written report must include--
    (i) The licensee's name;
    (ii) The name of the prescribing physician;
    (iii) A brief description of the event;
    (iv) Why the event occurred;
    (v) The effect on the individual(s) who received the 
administration;
    (vi) What improvements are needed to prevent recurrence;
    (vii) Actions taken to prevent recurrence;
    (viii) Whether the licensee notified the individual (or the 
individual's responsible relative or guardian), and if not, why not; 
and
    (ix) If there was notification, what information was provided.
    (2) The report must not contain the individual's name or any other 
information that could lead to identification of the individual.
    (d) The licensee shall notify the referring physician and also 
notify the individual affected by the medical event no later than 24 
hours after its discovery, unless the referring physician personally 
informs the licensee either that he or she will inform the individual 
or that, based on medical judgement, telling the individual would be 
harmful. The licensee is not required to notify the individual without 
first consulting the referring physician. If the referring physician or 
the affected individual cannot be reached within 24 hours, the licensee 
shall notify the individual as soon as possible thereafter. The 
licensee may not delay any appropriate medical care for the individual, 
including any necessary remedial care as a result of the medical event, 
because of any delay in notification. To meet the requirements of this 
section, the notification of the individual receiving the medical event 
may be made instead to that individual's responsible relative or 
guardian, when appropriate.
    (e) If the individual was notified pursuant to paragraph (d) of 
this section, the licensee shall also furnish, within 15 days after 
discovery of the medical event, a written report to the individual by 
sending either--
    (1) A copy of the report that was submitted to the NRC; or
    (2) A brief description of both the event and the consequences as 
they may affect the individual.
    (f) Aside from the notification requirement, nothing in this 
section affects any rights or duties of licensees and physicians in 
relation to each other, to individuals affected by the medical event, 
or to that individual's responsible relatives or guardians.


Sec. 35.3047  Report of a dose to an embryo/fetus or a nursing child.

    (a) A licensee shall report any dose to an embryo/fetus that is 
greater than 5 mSv (500 mrem) absorbed dose that is a result of an 
administration of byproduct material or radiation from byproduct 
material to a pregnant individual unless the dose to the embryo/fetus 
was specifically approved, in advance, by the authorized user.
    (b) A licensee shall report any dose to a nursing child that is 
greater than 5 mSv (500 mrem) total effective dose equivalent that is a 
result of an administration of byproduct material to a breast feeding 
individual.
    (c) The licensee shall notify by telephone the NRC Operations 
Center within 5 days after discovery of a dose to the embryo/fetus or 
nursing child that requires a report in paragraphs (a) or (b) in this 
section.
    (d) The licensee shall submit a written report to the appropriate 
NRC Regional Office listed in Sec. 30.6 no later than 15 days after 
discovery of a dose to the embryo/fetus or nursing child that requires 
a report in paragraphs (a) or (b) in this section.
    (1) The written report must include--
    (i) The licensee's name;
    (ii) The name of the prescribing physician;
    (iii) A brief description of the event;
    (iv) Why the event occurred;
    (v) The effect on the embryo/fetus or the nursing child;
    (vi) What improvements are needed to prevent recurrence; and
    (vii) Actions taken to prevent recurrence.
    (2) The report must not contain the individual's or child's name or 
any other information that could lead to identification of the 
individual or child.
    (e) The licensee shall notify the referring physician and also 
notify the pregnant individual or mother, hereafter referred to as the 
mother, within 5 days of discovery of an event that would require 
reporting under paragraph (a) or (b) of this section, unless the 
referring physician personally informs the licensee either that he or 
she will inform the mother or that, based on medical judgment, telling 
the mother would be harmful;

[[Page 43578]]

    (f) To meet the requirements of this section, the notification of 
the mother may be made instead to the mother's or child's responsible 
relative or guardian, when appropriate.
    (g) The licensee is not required to notify the mother without first 
consulting the referring physician. If the referring physician or 
mother cannot be reached within 5 days, the licensee shall make the 
appropriate notifications as soon as possible thereafter. The licensee 
may not delay any appropriate medical care for the embryo/fetus or for 
the nursing child, including any necessary remedial care as a result of 
the event, because of any delay in notification.
    (h) If notification was made pursuant to paragraphs (e) and (f) of 
this section, the licensee shall also furnish, within 15 days after 
discovery of the event, a written report to the mother or responsible 
relative or guardian, by sending either--
    (1) A copy of the report that was submitted to the NRC; or
    (2) A brief description of both the event and the consequences as 
they may affect the embryo/fetus or nursing child.


Sec. 35.3067  Reports of leaking sources.

    A licensee shall file a report within 5 days if a leakage test 
required by Sec. 35.67 reveals the presence of 185 Bq ( 0.005 
Ci) or more of removable contamination. The report must be 
filed with the appropriate NRC Regional Office listed in Sec. 30.6 of 
this chapter, with a copy to the Director, Office of Nuclear Material 
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001. The written report must include the model number and 
serial number if assigned, of the leaking source; the radionuclide and 
its estimated activity; the measured activity of each test sample 
expressed in microcuries; a description of the method used to measure 
each test sample; the date of the test; and the action taken.

Subpart N--Enforcement


Sec. 35.4001  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under Section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the 
sections specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
Section 186 of the Atomic Energy Act of 1954, as amended.


Sec. 35.4002  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For purposes of Section 223, 
all the regulations in 10 CFR part 35 are issued under one or more of 
sections 161b, 161i, or 161o, except for the sections listed in 
paragraph (b) of this section.
    (b) The regulations in 10 CFR part 35 that are not issued under 
subsections 161b, 161i, or 161o for the purposes of Section 223 are as 
follows: Secs. 35.1, 35.2, 35.7, 35.8, 35.12, 35.15, 35.18, 35.19, 
35.65, 35.100, 35.200, 35.300, 35.600, 35.4001, and 35.4002.

Appendix A to 10 CFR Part 35--Examining Organization or Entity

    I. Requirements for an examining organization or entity.
    An independent organization or entity that submits an 
application for approval of the Commission to examine individuals 
pursuant to Secs. 35.50(b)(3), 35.51(b)(3), 35.55(b)(3), 
35.290(b)(3), 35.292(b)(3), 35.390(b)(4), 35.490(b)(4), or 
35.690(b)(4) shall:
    1. Make its examination process available to the general public 
nationwide and ensure that it is not restricted because of race, 
color, religion, sex, age, national origin, or disability;
    2. Have an adequate staff, a viable system for financing its 
operations, and a policy-and decision-making review board;
    3. Have a set of written organizational by-laws and policies 
that provide adequate assurance of lack of conflict of interest and 
a system for monitoring and enforcing those by-laws and policies;
    4. Have a committee, whose members can carry out their 
responsibilities impartially, to review and approve the examination 
guidelines and procedures, and to advise the organization's staff in 
implementing the examination program;
    5. Have a committee, whose members can carry out their 
responsibilities impartially, to review complaints by examined 
individuals;
    6. Have written procedures describing all aspects of its 
examination program, maintain records of the current status of each 
individual's examination and the administration of its examination 
program;
    7. Have procedures to ensure that examinations are not given to 
individuals who have also been instructed by the examining 
organization in the same subject area;
    8. Have procedures to ensure that examined individuals are 
provided due process with respect to the administration of its 
examination program, including the process of being examined;
    9. Have procedures for proctoring examinations, including 
qualifications for proctors.
    10. Exchange information about examined individuals with the 
Commission and other independent examining organizations and/or 
Agreement States and allow periodic review of its examination 
program and related records;
    11. Provide a description to the Commission of its procedures 
for choosing examination sites and for providing an appropriate 
examination environment; and
    12. Submit its request to the Director, Office of Nuclear 
Materials Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001.
    II. Requirements for Examination Programs.
    All examination programs must--
    1. Require applicants for examination to receive training in the 
topics set forth in Secs. 35.50(b)(1), 35.51(b)(1), 35.55(b)(1), 
35.290(b)(1), 35.292(b)(1), 35.390(b)(1), 35.490(b)(1) or 
35.690(b)(1), or equivalent Agreement State regulations, and 
satisfactorily complete a written examination covering these topics; 
and
    2. Include procedures to ensure that all examination questions 
are protected from improper disclosure.
    III. Requirements for Written Examinations.
    1. All examinations must be designed to test an individual's 
knowledge and understanding of the topics listed in 
Secs. 35.50(b)(1), 35.51(b)(1), 35.55(b)(1), 35.290(b)(1), 
35.292(b)(1), 35.390(b)(1), 35.490(b)(1) or 35.690(b)(1), or 
equivalent Agreement State regulations;
    2. Test questions must be drawn from a question bank containing 
psychometrically valid questions based on the material in 
Secs. 35.50(b)(1), 35.51(b)(1), 35.55(b)(1), 35.290(b)(1), 
35.292(b)(1), 35.390(b)(1), 35.490(b)(1) or 35.690(b)(1), or 
equivalent Agreement State regulations; and
    3. Sample examinations must be submitted to the Commission for 
review initially and every 5 years.

    Dated at Rockville, Maryland, this 5th day of August, 1998.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.

    Note: This appendix will not appear in the Code of Federal 
Regulations.

Appendix A--Preliminary Regulatory Flexibility Analysis

    The NRC is required by the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) as

[[Page 43579]]

amended by the Small Business Regulatory Enforcement Fairness Act 
(SBREFA) to consider the impact of their rulemakings on small 
entities and evaluate alternatives that would accomplish regulatory 
objectives without unduly burdening small entities or erecting 
barriers to competition. This analysis describes the assessment of 
the small entity impacts expected to be incurred by 10 CFR Part 35 
licensees as a result of the comprehensive revisions to Part 35 
being proposed.
    An assessment of small entity impacts involves three major 
tasks: (1) defining ``small entities'' for the rule being analyzed, 
including ``small businesses,'' ``small governments,'' and ``small 
organizations;'' (2) determining what number constitutes a 
``substantial number'' of these entities; and (3) determining if 
``significant impacts'' will be incurred by licensees under the 
proposed rule.

1.1  Defining ``Small Entities'' Affected by the Rule

    The NRC has established size standards that it uses to determine 
which NRC licensees qualify as small entities (60 FR 18344; April 
11, 1995). These size standards are codified in 10 CFR 2.810. The 
size standards pertinent to Part 35 licensees include the following:
    Under 10 CFR 2.810(a)(1), a small business is a for-profit 
concern and is a concern that provides a service or a concern not 
engaged in manufacturing with average gross receipts of $5 million 
or less over its last 3 completed fiscal years. (The Small Business 
Administration size standards for the ``health services'' category, 
including ``offices and clinics of doctors of medicine'' and all 
other health services subcategories also establish $5 million as the 
cut off point for ``small entities.'')
    Under 10 CFR 2.810 (b) a small organization is a not-for-profit 
organization which is independently owned and operated and has 
annual gross receipts of $5 million or less.
    For purposes of this analysis, therefore, ``small entity'' 
refers to any specific licensee under 10 CFR Part 35 with annual 
gross receipts of $5 million or less.
    The proposed rule would affect 1902 NRC licensees. These 
licenses are issued principally to medical institutions, with at 
least 1216 of the Part 35 licensees classified as medical 
institutions (codes 2110, 2120, and 2121 in NRC's licensee tracking 
system). Review of available data indicates that at most 8 of these 
medical institutions had operating revenues of less than $5 million 
in 1996.
    First, all hospitals in States in which Part 35 licensees are 
regulated by NRC were screened for revenues, using data obtained 
from Profiles of U.S. Hospitals, 1996, HCIA Inc. HCIA collects, 
analyzes, and publishes data on hospitals, based on financial 
submissions to the Health Care Financing Administration (HCFA). 
Revenues were measured as operating revenue, which is the sum of net 
patient revenue and other operating revenue, such as revenue from 
sources such as cafeterias and parking facilities, but which does 
not include revenue from non-operating sources such as investment 
income or donations. Operating revenue therefore is a less inclusive 
measure of revenues than gross revenues. All hospitals identified as 
having operating revenues less than $5 million then were checked 
against the NRC License Tracking System to identify those medical 
institutions that both had revenues less than $5 million and were 
regulated by NRC under Part 35. Of the eight institutions that were 
identified as meeting both criteria, three had operating revenues 
above $4.4 million, and therefore may have gross revenues above $5 
million. They have, however, been included in the group of 
institutions with less than $5 million in revenues for this 
analysis.
    The balance of the licenses, approximately 686 licenses, are 
issued principally to physicians in private practice. Information on 
gross revenues for such physicians suggests that all may be ``small 
entities.''
    First, data from the AMA's Socioeconomic Monitoring System, 
provided in Physician Marketplace Statistics 1996: Profiles for 
Detailed Specialties, Selected States and Practice Arrangements, 
Center for Health Policy Research, American Medical Association, 
were reviewed for physicians' revenues or income. Table 89 of that 
source, which reports ``Total Practice Revenue per Self-Employed 
Nonfederal Physician (in thousands of dollars), 1995'' indicates 
that even at the 75th percentile no physician specialty, geographic 
area, or practice arrangement exceeded even $1 million in revenues. 
Similar data from the Physician Compensation and Production Survey: 
1996 Report Based on 1995 Data, Medical Group Management 
Association, indicate that the median for ``production,'' defined as 
gross charges, for all physicians was $422,937 in 1995 (p. 10). 
Although ``production'' generally is larger for specialists than all 
physicians, the difference is too small to place specialists above 
the $5 million criterion.
    In total, therefore, an upper bound estimate of 36 percent of 
Part 35 licensees, or approximately 686 licensees, may be ``small 
entities.''

1.2  Determining What Number Constitutes a Substantial Number

    This analysis applied a figure corresponding to 20 percent of 
small entities in determining whether a ``substantial number'' of 
small entities are likely to be impacted by the rule. Therefore, 
based on the analysis in section 1.1, the proposed rule would affect 
a substantial number of small entities.

1.3  Measuring ``Significant Impacts''

    To evaluate the impact that a small entity is expected to incur 
as a result of the rule, the analysis should calculate the entity's 
ratio of annualized compliance costs as a percentage of gross 
receipts. Entities are classified as facing potentially 
``significant'' impacts if this ratio exceeds one percent.
    Determining annual compliance costs for the revisions to Part 
35, however, is complicated by the fact that the proposed rule would 
comprehensively address a wide variety of uses of byproduct 
materials in medicine. The entities likely to be most affected by 
the rule are broad scope medical institutions with a large number of 
different modalities and conducting a large number of medical 
procedures involving byproduct material or radiation from byproduct 
material. However, the preceding analysis indicated that such broad 
scope licensees are not small entities. The costs attributable to 
Part 35 compliance for such broad scope licensees will be 
substantially greater than the annual compliance costs likely to be 
incurred by those licensees most likely to be small entities (i.e., 
single private practice physicians performing diagnostic 
procedures).
    The Part 35 rule addresses contingent actions as well as actions 
that must be carried out by all licensees. In particular, the lower 
risk posed by diagnostic procedures reduces the likelihood that 
private practice physicians performing diagnostic procedures will 
experience medical events involving costs of reporting and follow 
up.
    All licensees will incur annual compliance costs for general 
administrative and technical requirements established by Part 35, 
although the level of such compliance costs will vary significantly 
depending on certain contingencies and on the activities being 
performed by the licensee. Annual compliance costs for licensees are 
expected, in all cases, to involve compliance with requirements to 
establish and maintain a radiation protection program; possess, use, 
calibrate, and check survey instruments, and satisfy the 
requirements pertinent to the modality or modalities used by the 
licensee.
    NRC estimates that annual compliance costs for a licensee 
carrying out any level of activities under Part 35 will in all cases 
exceed 80 hours annually at $100 per hour, or $8,000. Assuming 
annual revenues of $244,000 for a single private practitioner 
subject to Part 35, as estimated in Socioeconomic Characteristics of 
Medical Practice, 1997, American Medical Association, Center for 
Health Policy Research, Table 43. ``Mean Physician Net Income (in 
thousands of dollars) after Expenses before Taxes, 1995,'' for the 
net income for ``all physicians-rad,'' a very conservative surrogate 
for gross revenues, these annual compliance costs exceed both the 
one percent cutoff level and the three percent cutoff level under 
SBREFA for ``significant impacts.'' Assuming an average 
``production'' of $423,000, (Section 1.1 of this analysis), however, 
the 1 percent but not the 3 percent cutoff is exceeded. Therefore, 
the proposed rule appears to have significant impacts on a 
significant number of licensees.
    NRC has taken a number of actions in this proposed rule to 
ensure that the proposed alternative is the least costly alternative 
that adequately protects workers and patients from radiation 
exposure. As the Regulatory Analysis prepared for the proposed rule 
demonstrates, the total annual cost to licensees of compliance with 
the proposed rule would be approximately $9.87 million less than the 
cost of compliance with the current rule (See XII. Regulatory 
Analysis of the Supplementary Information section of this document). 
This is equivalent to savings of approximately $1500 per licensee. 
Although savings to small licensees can be expected to be 
proportionately less than

[[Page 43580]]

savings to licensees with more extensive operations, smaller 
licensees also can be expected to incur smaller compliance costs.
    In order to assist small licensees, the NRC has sought in the 
proposed rule to eliminate prescriptive requirements wherever 
possible, and to allow for much greater flexibility in compliance. 
Such flexibility is particularly helpful to small licensees in 
reducing their cost of compliance, because it will enable them to 
avoid the costs of radiation safety measures, such as the detailed 
requirements for Radiation Safety Committees, that were especially 
oriented toward larger licensees with numerous modalities and 
activities in the same institution. NRC has reduced the training and 
experience requirements applicable to the diagnostic use of 
byproduct material by focusing those requirements on radiation 
safety and by reducing the number of hours of training required. NRC 
has also sought to reduce the prescriptive nature of requirements 
for testing and calibration, and to reduce reporting and 
recordkeeping burdens, which can have an especially strong impact on 
small entities.
    Finally, the program for revising Part 35 and the associated 
guidance documents has involved more interactions and consultations 
with potentially affected parties (the medical community and the 
public, including representatives of small licensees) than is 
provided by the typical notice and comment rulemaking process. Early 
public input was solicited through several different mechanisms: 
requesting public input through Federal Register notices; holding 
open meetings of the government groups developing the revised rule 
language; meeting with medical professional societies and boards; 
putting background documents, options for the more significant 
regulatory issues associated with the rulemaking, and a ``strawman'' 
draft proposed rule on the Internet; and convening public workshops. 
Participants from the broad spectrum of interests that may be 
affected by the rulemaking were invited to attend the public 
workshops in Philadelphia, PA., and Chicago, IL., held in October 
and November 1997. The public was also welcome to attend these 
workshops, as well as the Part 35 Workshop that was held in 
conjunction with the All Agreement States Meeting in October 1997, 
and the NRC's Advisory Committee on the Medical Uses of Isotopes 
meetings in September 1997 and March 1998.
    As indicated in the Regulatory Flexibility Analysis statement 
included in the proposed rule, the NRC requests comments from small 
medical licensees concerning the impacts of the proposed rule and 
any suggested modifications that may affect the economic impact of 
the proposed requirements.

[FR Doc. 98-21459 Filed 8-12-98; 8:45 am]
BILLING CODE 7590-01-P