Medical Use of Byproduct Material; Proposed Revision

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

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