[Federal Register Volume 67, Number 79 (Wednesday, April 24, 2002)]
[Rules and Regulations]
[Pages 20250-20397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9663]



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Part III





Nuclear Regulatory Commission





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10 CFR Parts 20, 32, and 35



Medical Use of Byproduct Material; Final Rule

  Federal Register / Vol. 67, No. 79 / Wednesday, April 24, 2002 / 
Rules and Regulations  

[[Page 20250]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 20, 32, and 35

RIN 3150-AF74


Medical Use of Byproduct Material

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations regarding the medical use of byproduct material. This final 
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 more risk-informed and more 
performance-based, consistent with the NRC's ``Strategic Plan for 
Fiscal Year 1997-Fiscal Year 2002.''

EFFECTIVE DATE: This regulation becomes effective on October 24, 2002.

ADDRESSES: Documents related to this rulemaking may be examined at the 
NRC Public Document Room, One White Flint North, 11555 Rockville Pike, 
Room O-1 F23, Rockville, MD 20852. Available documents include the 
final environmental assessment, regulatory analysis, regulatory 
flexibility analysis, and NUREG-1556, Vol. 9(draft), ``Consolidated 
Guidance About Materials Licenses: Program Specific Guidance About 
Medical Use Licenses.'' Documents created or received at the NRC after 
November 1, 1999, are also available electronically at the NRC's Public 
Electronic Reading Room on the Internet at http://www.nrc.gov/reading-rm.html. From this site, the public can gain entry into the NRC's 
Agencywide Document Access and Management System (ADAMS), which 
provides text and image files of NRC's public documents. For more 
information, contact the NRC Public Document Room (PDR) Reference staff 
at 1-800-397-4209, 301-415-4737 or by E-mail to [email protected].

FOR FURTHER INFORMATION CONTACT: Roger W. Broseus, Office of Nuclear 
Material Safety and Safeguards, Nuclear Regulatory Commission, 
Washington, DC 20555-0001, (301) 415-7608, E-mail [email protected].

SUPPLEMENTARY INFORMATION:

I. Background
II. Petition for Rulemaking
III. Summary of Public Comments and Responses to Comments
IV. Summary of Comments on Agreement State Compatibility and 
Responses to Comments
V. Summary of Changes Made Between the Current Part 35 and the 
Revised Part 35
VI. Coordination With the Advisory Committee on the Medical Uses of 
Isotopes
VII. Coordination With NRC Agreement States
VIII. Consistency With Medical Policy Statement
IX. Implementation
X. Issues of Compatibility for Agreement States
XI. Assessment of Federal Regulations and Policies on Families
XII. Finding of No Significant Environmental Impact: Availability
XIII. Paperwork Reduction Act Statement
XIV. Regulatory Analysis
XV. Regulatory Flexibility Analysis
XVI. Backfit Analysis
XVII. Small Business Regulatory Enforcement Fairness Act

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. Today, approximately eleven 
million patients undergo medical procedures involving byproduct 
material annually.
    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. In most cases, 
diagnostic nuclear medicine involves imaging agents used for the 
delineation and Iocalization 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 and radiation from byproduct material are 
regulated by either State or Federal laws and regulations. The 
principal statutory authority for NRC's regulation of the medical use 
of byproduct material rests in the Atomic Energy Act (AEA) of 1954, as 
amended, and the Energy Reorganization Act of 1974, as amended. NRC's 
medical use program includes regulation of the uses of byproduct 
material in medical diagnosis, therapy, and research. The NRC regulates 
the administration of byproduct material or radiation from byproduct 
material in 18 States, the District of Columbia, the Commonwealth of 
Puerto Rico, and various territories of the United States. There are 
approximately 1700 NRC licensees authorized for medical use of 
byproduct material under 10 CFR Part 35, ``Medical Uses of Byproduct 
Material.''
    Thirty-two States have each entered into an agreement with the NRC 
to regulate the use of byproduct material (as authorized by section 274 
of the Atomic Energy Act) within that State. These States issue 
licenses for certain diagnostic and therapeutic uses of radioactive 
materials, and currently regulate approximately 4200 institutions, 
e.g., hospitals, clinics, or physicians in private practice. For 
additional information on the

[[Page 20251]]

Agreement States' regulatory program refer to NRC's Management 
Directive (M.D.) 5.6, ``Integrated Materials Performance Evaluation 
Program (IMPEP),'' and M.D. 5.9, ``Adequacy and Compatibility of 
Agreement States Programs.''

Revision of NRC's Regulatory Program

    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 Project (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 (MPS) (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 NRC's Advisory 
Committee on the Medical Uses of Isotopes (ACMUI) and professional 
medical organizations and societies in the revision of Part 35 and the 
MPS.
    Based on the Commission's direction in this SRM, the process used 
by the NRC staff to develop the proposed rule and policy statement 
provided more opportunity for input from potentially affected parties 
than the normal notice and comment rulemaking process. The process 
included a number of public meetings and workshops with stakeholders 
and other affected parties, the ACMUI, Agreement States, and 
professional medical societies and organizations. See the proposed rule 
and policy statement published in the Federal Register (63 FR 43516; 63 
FR 43580; August 13, 1998).
    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. In a document published in 
the Federal Register, ``Medical Use of Byproduct Material: Issues and 
Request for Public Input'' (62 FR 42219-42220; August 6,1997), the 
Commission solicited early public input on the proposed rulemaking.
    The proposed revisions of Part 35 and the MPS that were developed 
in response to the Commission's SRMs were published for a 90-day public 
comment period on August 13, 1998 (63 FR 43516 and 63 FR 43580). The 
comment period was later extended by 30 days (63 FR 64829; November 23, 
1998) at the request of stakeholders. The document presenting the 
contemplated revision of Part 35 solicited public comment on the 
proposed rule; discussed the issues that were considered during the 
development of the proposed rule and associated guidance; and 
summarized the input that was received from the public, potentially 
affected parties, the ACMUI, and professional medical organizations. 
These issues included patient notification, precursor events, Radiation 
Safety Committee, quality management program, and training and 
experience for authorized users.
    In addition to publishing the proposed rule and MPS in the Federal 
Register for comment, the Commission also held facilitated public 
meetings during the comment period to discuss the Commission's 
resolution of the major issues. Publicly noticed workshops were held in 
San Francisco, CA, on August 19-20, 1998, in Kansas City, MO, on 
September 16-17, 1998, and in Rockville, MD, on October 21-22, 1998. 
The Commission also held a public workshop in February 1999 to solicit 
additional comments on implementation issues associated with the 
proposed revisions to the training and experience requirements. The 
Commission was specifically interested in information on the process 
and criteria for approving medical and other specialty boards and 
examining organizations and entities. The four public workshops are 
summarized in ``Summary of Public Meeting on Proposed Revisions to Part 
35 and the NRC's Medical Policy Statement,'' San Francisco, CA, August 
19-20, 1998 (September 11, 1998); ``Summary of Public Meeting on 
Proposed Revisions to 10 CFR Part 35, ``Medical Use of Byproduct 
Material'' and the NRC's Medical Policy Statement,'' Kansas City, MO, 
September 16-17, 1998 (October 12, 1998); ``Summary of Public Meeting 
on Proposed Revisions to 10 CFR Part 35, ``Medical Use of Byproduct 
Material'' and the NRC's Medical Policy Statement,'' Rockville, MD, 
October 21-22, 1998 (November 18, 1998); and ``Summary of Discussion; 
Facilitated Part 35 Public Meeting with Representatives of the Medical 
Boards Held in Rockville, Maryland, February 17-18, 1999'' (April 7, 
1999). The summary documents are available for inspection at the NRC 
Public Document Room, One White Flint North, 11555 Rockville Pike, Room 
O-1 F23, Rockville, MD 20852. Single copies of the summary documents 
are available from the persons indicated in the For Further Information 
Contact section of this document.
    The comments received at the workshops and the comments received in 
response to the proposed rule were all carefully considered by the Part 
35 Working and Steering Groups in developing the final rule. Section 
III, Summary of Public Comments and Responses to Comments, in the 
SUPPLEMENTARY INFORMATION in this document, includes a summary of the 
comments and the NRC staff's responses to them.
    In February 1999, the ACMUI diagnostic and therapeutic 
subcommittees held public meetings to review the public comments and 
the NRC staff's first draft of the final rule that addressed the 
comments. The full ACMUI held a public meeting in March 1999 to discuss 
specific issues that the Part 35 Working Group wanted the ACMUI to 
review and comment on before a draft final rule was forwarded for 
Commission consideration. The ACMUI presented its position on these and 
other issues at their annual briefing of the Commission in March 1999. 
In October 1999 and February 2002, the ACMUI briefed the Commission on 
specific issues that it wanted to bring to the Commission's attention. 
For additional information on the ACMUI's position on the rulemaking 
and associated issues refer to Section VI, Coordination with the 
Advisory Committee on the Medical Uses of Isotopes, in the 
SUPPLEMENTARY INFORMATION in this document.
    The Agreement States were involved throughout the rulemaking 
process. Both the Working Group and Steering Group that developed the 
revision of Part 35 included representatives of the Agreement States. A 
draft compatibility chart for Agreement States' regulations

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was published for comment with the proposed rule (63 FR 43516; August 
13, 1998). The NRC staff discussed the States' rulemaking issues with 
representatives of the Agreement States at the 1999 annual meeting of 
the Organization of Agreement States. For additional information refers 
to Section IV, Summary of Comments on Agreement State Compatibility and 
Responses to Comments; Section VI, Coordination with NRC Agreement 
States; and Section X, Issues of Compatibility for Agreement States, in 
the SUPPLEMENTARY INFORMATION in this document.
    As the Commission readied the final rule for publication in the 
Federal Register, Congress directed NRC not to implement or enforce 
certain parts of revised Part 35 relating to diagnostic nuclear 
medicine until after the NRC submitted a report to Congress explaining 
why the regulatory burden associated with the rule could not be reduced 
further without adversely affecting the public health and safety. 
``Energy and Water Development Appropriations Act, 2002,'' (Pub. L. 
107-66). The NRC transmitted the report to Congress on February 11, 
2002. That report concludes that further reduction of regulatory burden 
beyond that currently proposed in the revised rule has the potential to 
increase the risk to public health and safety. Although the Act 
permitted NRC to implement some aspects of the revised rule before 
submitting the report, NRC chose not to implement any portion of the 
revised rule until after its report was submitted.
    Nevertheless, the NRC acknowledges that stakeholders have 
identified substantial concerns related to the perceived burden of the 
implementing guidance and inspection programs. Therefore, the NRC is 
committed to a program, with public and stakeholder participation, to 
improve the licensing and inspection guidance to enhance the burden 
reduction offered by revised Part 35. The NRC noticed the availability 
of revised draft NUREG-1556, Volume 9, for public comment (67 FR 16467; 
April 5, 2002); the comment period ends on June 4, 2002. In addition, 
consideration of future rule changes will remain possible through the 
NRC's established rulemaking procedures as experience with the new rule 
is gained by both the NRC and our licensees.
    In addition to the revision of Part 35, the Commission published 
the revision of its policy statement on the Medical Use of Byproduct 
Material (MPS) (65 FR 47654; August 3, 2000). The revision of the MPS 
is another component of the Commission's overall program for revising 
its regulatory framework for medical use. The revision of Part 35 is 
consistent with the revision of the MPS. Section VIII, Consistency with 
the Medical Policy Statement, in the SUPPLEMENTARY INFORMATION in this 
document, addresses the consistency of the final rule with each 
statement in the revised MPS.
    The Commission is also concurrently publishing, in a separate 
document in this Federal Register, a modification of ``General 
Statement of Policy and Procedure for NRC Enforcement Actions,'' NUREG-
1600, to revise the examples of severity levels for Part 35 violations 
to reflect the revised medical use requirements in the final rule. 
These examples are used in the enforcement process to provide guidance 
for determining the significance of a particular violation.

Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act (NTTAA) of 
1995, Public Law 104-113, requires that Federal agencies use technical 
standards that are developed or adopted by voluntary consensus 
standards bodies unless the use of such a standard is inconsistent with 
applicable laws or otherwise impractical. In COMSECY-96-057, 
``Materials/Medical Oversight (DSI 7),'' the Commission specifically 
directed the NRC staff to examine 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. In addition, 
Statement 4 in the revised medical use policy statement provides that 
the NRC regulatory approach consider industry and professional 
standards that define acceptable approaches of achieving radiation 
safety.
    In developing this final rule, the NRC staff reviewed the technical 
literature to identify consensus standards and/or protocols that could 
be used or referenced either in the regulation or associated guidance 
document. This process included reviewing documents of the official 
standards consensus bodies that are identified on the National 
Institutes of Standards and Technology website, e.g., the American 
National Standards Institute (ANSI). In addition, the NRC staff 
reviewed protocols developed by technical professional societies that 
use a consensus process within their own organization, e.g., the 
American Association of Physicists in Medicine (AAPM). The NRC staff 
determined that voluntary consensus standards exist that met certain 
objectives in the final rule. Therefore, the NRC staff did not develop 
government-unique standards. The requirements in the final rule are, 
for the most part, performance-based and state the objectives to be 
achieved. This approach allows the licensee to select among various 
performance standards to meet the objectives of the regulation. This 
approach is consistent with the Commission's goal to develop more 
performance-based regulations. The Commission believes that this 
approach will provide medical use licensees with significant 
flexibility in designing their radiation protection programs.
    For additional information on how consensus standards were used in 
the development of the final rule refer to Section III, Summary of 
Public Comments and Responses to Comments in the SUPPLEMENTARY 
INFORMATION in this document.

II. Petitions for Rulemaking (PRM)

PRM-20-24

    The final rule completes action on 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. The petitioner basically 
requested that the NRC amend 10 CFR 20.1301, ``Dose limits for 
individual members of the public'' to:
    (1) Provide medical use 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);
    (3) Document compliance by issuing a radiation dose monitoring 
device (i.e., pocket dosimeter, film badge, TLD, or electronic 
dosimeter) to each specified visitor; and
    (4) Require licensees to instruct visitors about radiation safety.
    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 
comments received in response to that document were discussed in the 
August 13, 1998, proposed rule (63 FR 43516). Additional comments on 
the petition were received in response to the request for comments on 
the proposed rule and are discussed in Section III, Part III of the 
SUPPLEMENTARY INFORMATION of this document.
    The NRC reviewed the petitioner's request and comments received on 
the

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petition and believes there is merit in granting the petition in part. 
The final rule responds to the petition 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 hospitalized radiation 
patients, i.e., individuals who cannot be released under Sec. 35.75. We 
believe the emotional benefit to the patient or the visitor outweighs 
any increase in radiation risk to the visitor. In addition, we believe 
that the authorized user (AU) is the appropriate individual to 
evaluate, on a case-by-case basis, the merits of allowing a visitor to 
potentially receive this additional dose and would do so only when it 
is warranted by the situation. AUs have the primary responsibility for 
the health and safety of their patients. They are also responsible for 
determining, depending on the patient's condition, whether individuals 
can visit patients and with what limitations. Therefore, we believe the 
AU should determine whether a visitor is allowed to receive a dose up 
to 5 mSv (0.5 rem).
    The NRC did not grant request (2) of the petition that NRC exclude 
pregnant women and individuals younger than 18 years of age from 
receiving a dose in excess of 1 mSv (0.1 rem). Pregnant visitors are 
not excluded automatically from visiting individuals who cannot be 
released under 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 are two-fold. 
First, as noted in National Council on Radiation Protection and 
Measurements (NCRP) Commentary No. 11 (Dose Limits for Individuals Who 
Receive Exposure from Radionuclide Therapy Patients, 1995), 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 AU is not expected to demand confirmation of the 
visitor's nonpregnant status.
    The NRC also did not grant request (3) of the petition that 
compliance be documented by use of a radiation dose monitoring device 
(i.e., pocket dosimeter, film badge, TLD, or electronic dosimeter) by 
each specified visitor. The Commission does not intend to require 
monitoring and recording of individual doses to visitors of 
hospitalized radiation patients. The NRC evaluated the costs associated 
with monitoring doses to visitors 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 doses to visitors.
    The NRC also did not grant request (4) of the petition that 
licensees be required to instruct visitors about radiation safety. We 
believe that licensees should have flexibility in determining how they 
will effectively limit radiation exposure of the visitors to levels 
that are as low as is reasonably achievable.
    This completes action on PRM-20-24.

PRM-35-16

    On January 11, 2001, the NRC docketed a January 3, 2001, letter 
from Donald A. Podoloff, MD, of the American College of Nuclear 
Physicians, and Jonathan M. Links, PhD, of the Society of Nuclear 
Medicine, to the Office of the Secretary, as a petition for rulemaking 
under 10 CFR 2.802 (PRM-35-16). The petitioners requested that the 
Commission: rescind its approval of the NRC staff's proposed revision 
to 10 CFR Part 35, ``Medical Use of Byproduct Material''; revoke all of 
10 CFR Part 35, except for specifically identified requirements; and 
institute a new rulemaking proceeding to adopt a regulatory scheme for 
the use of byproduct material in diagnostic nuclear medicine that 
reflects the discipline's ``unparalleled and undisputed safety 
record.''
    The petitioners believe that the requested changes would benefit 
the public in two ways. First, substantial requirements for physicians' 
education, training, and experience, as well as appropriate evidence of 
mastery by testing would improve the knowledge and abilities of 
physicians offering diagnostic nuclear medicine. Second, costs to the 
health care system would decrease without any decrease in safety.
    The NRC denied the petition because:
    (1) The Commission approved the final rule addressing the issues 
raised in the petition after an extensive rulemaking process that 
provided an unprecedented level of enhanced stakeholder and public 
participation;
    (2) The Commission believed that the ACNP/SNM had many 
opportunities to present their concerns and suggestions as part of that 
process and did so; and
    (3) The petition did not appear to present any significant new 
information or recommendations that the Commission has not already 
considered.
    This completes action on PRM-35-16.

III. Summary of Public Comments and Responses to Comments

    This section summarizes the written and oral comments that we 
received on the proposed rule and provides responses to these comments. 
Part I contain a list of the acronyms used in this section. Part II 
discusses general issues that were considered during the rulemaking. 
Part III discusses specific comments on the proposed rule.

Part I--Acronyms

    The following acronyms are used in the discussion of both the 
general and specific comments.

AAPM  American Association of Physicists in Medicine
ABHP  American Board of Health Physics
ABR  American Board of Radiology
ABMS  American Board of Medical Specialities
ABNM  American Board of Nuclear Medicine
ACGME  Accreditation Council for Graduate Medical Education
ACMP  American College of Medical Physics
ACMUI  Advisory Committee on the Medical Uses of Isotopes
ACR  American College of Radiology
ALARA  As low as is reasonably achievable
AMP  Authorized medical physicist
ANP  Authorized nuclear pharmacist
ANSI  American National Standards Institute, Inc.
AO  Abnormal Occurrence
AU  Authorized user
FDA  Food and Drug Administration
Gy/h  Gray per hour
GBq  Gigabecquerel
HDR  High dose-rate remote afterloader
IDE  Investigational Device Exemption
IMPEP  Integrated Materials Performance Evaluation Program
IND  Investigational New Drug Exemption
INPO  Institute for Nuclear Power Operations
IRB  Institutional Review Board
JCAHO  Joint Commission on the Accreditation of Hospitals Organization
LDR  Low dose-rate remote afterloader
MBq  Megabecquerel
mCi  Millicuries
Ci  Microcuries
MDR  Medium dose-rate remote afterloader
mSv  Millisievert
NAS-IOM  National Academy of Sciences-Institute of Medicine
NCRP  National Council on Radiation Protection and Measurements
NIST  National Institute of Standards and Technology

[[Page 20254]]

PDR  Pulsed dose-rate remote afterloader
QMP  Quality Management Program
SSDR  Sealed Source and Device Registry
Sv  Sievert
RDRC  Radioactive Drug Research Committee
RSC  Radiation Safety Committee
RSO  Radiation Safety Officer

Part II--General Issues

A. Risk

Issue 1: What Is the Difference Between a Risk-Informed and a Risk-
Based Approach to Rulemaking?
    Comment. Commenters asked us to explain the difference between a 
``risk-based'' rule and a ``risk-informed'' rule.
    Response. A ``risk-based'' approach to regulatory decisionmaking is 
one in which a safety decision is solely based on the numerical results 
of a risk assessment. This places a heavier reliance on risk assessment 
results than currently may be practicable. A ``risk-informed'' approach 
to regulatory decisionmaking represents a philosophy that considers 
risk insights together with other factors to establish requirements 
that better focus licensee and regulatory attention on design and 
operational issues commensurate with their importance to health and 
safety.
    The Commission does not endorse risk-based regulation. In revising 
Part 35, the Commission used risk insights from available risk 
information. The Commission considered the completeness and reliability 
of the available risk information and balanced the insights drawn from 
this information against other factors, such as decades of licensing 
and inspection experience, the States' perspectives, statutory 
requirements, and public and stakeholder interests, in formulating 
policy.
Issue 2: How Was Risk Used in Revising Part 35?
    Comments. Commenters indicated that the NRC's approach to the Part 
35 rulemaking was flawed because a formal risk analysis had not been 
performed before initiating the rulemaking. Some commenters did not 
believe that the NRC has the expertise to perform or manage a rigorous 
risk analysis that is needed before publishing the final rule. Other 
commenters believed the proposed rule did not explain NRC's perception 
of the regulatory problem and how the rulemaking would solve that 
problem. Commenters asked that the NRC start the Part 35 rulemaking 
over by--
    (1) Identifying the problem (perform a formal risk-based analysis);
    (2) Revising the Medical Policy Statement;
    (3) Completing the rulemaking; and
    (4) Developing licensing, inspection, and enforcement policies and 
procedures to support the rule.
    Many of these commenters offered possible ways of evaluating risk 
and asked that stakeholders be allowed to participate in assessing 
risk. Some commenters indicated that the NRC should establish a risk-
benefit ``filter'' to evaluate this and future rulemakings. They 
believed that this approach would be useful in dealing with emerging 
technologies. They also believed that, if the NRC had a structured 
framework for risk analysis, appropriate regulations could be developed 
to deal with the real risk to the patient, public, and workers.
    Other commenters asked that we consider all types of risk before 
publishing the final rule, e.g., absolute, relative, comparable, 
perceived, cost, and ``pseudo risks.'' Commenters discussed these types 
of risks in the following terms and offered the following comments on 
each type of risk as they are viewed in the regulation of medicine. 
While most comments were directed at diagnostic nuclear medicine, many 
of the statements would also apply to therapeutic uses of byproduct 
material.
    Absolute risks are the risks of real health effects (deterministic, 
stochastic) that include harm to the patient, public, or worker. 
Commenters indicated that diagnostic nuclear medicine procedures do not 
present measurable health effects to the patient, public, or workers.
    Relative risks are the risks of diagnostic nuclear medicine 
relative to other diagnostic medical procedures that are currently 
unregulated for the end-user. The side-effects from many non-
radiological medical procedures involve higher risks of harm to the 
patients than microcurie and millicurie amounts of byproduct material 
that are used for tracer and localization and imaging studies, where 
there is no observable radiological or pharmaceutical effect.
    Comparable risks are the risks of diagnostic nuclear medicine as 
compared to other industrial risks (radiological and non-radiological) 
and other human activities that are acceptable to the general public.
    Perceived risks involve the public perception of safe and unsafe 
uses of radiation that eventually influence the licensee to comply with 
unnecessary NRC requirements in order to compete in the market place. 
One commenter noted that most cancer patients are willing to accept 
higher risks for the benefit of cure. This commenter believed that the 
large number and prescriptiveness of the current regulations add to the 
misconception that the public has of radiation. By reducing needless 
requirements on low risk nuclear medicine, the public perception will 
adjust accordingly, so that NRC regulatory oversight is less burdensome 
to licensees.
    Cost risks result in overspending on low risk activities. This 
economic imbalance creates a higher risk for other areas that do not 
receive the resources that would otherwise be available.
    Pseudo risks are unreal risks in which there is no harm associated 
with the activity or event, e.g., landfill alarms as a result of 
disposal of short-lived, low-activity radioactive waste from diagnostic 
nuclear medicine.
    Response. In March 1997, the Commission directed the revision and 
restructuring of Part 35 into a more risk-informed and, where 
appropriate, more performance-based regulation. This direction was part 
of the Commission's overall decision to decrease oversight of low-risk 
activities, such as diagnostic nuclear medicine, while retaining 
oversight of high-risk activities.
    Before initiating the rulemaking, the Commission thoroughly 
reviewed several extensive assessments, including the external review 
conducted by the National Academy of Sciences, Institute of Medicine 
(NAS-IOM), and the related report ``Radiation in Medicine, A Need for 
Regulatory Reform,'' a 1993 NRC internal senior management review and 
report, and the Commission's Strategic Assessment and Rebaselining 
initiative. During the development of the overall revision of Part 35, 
we considered information on risk provided by members of the public and 
professional societies, professional medical standards of practice, and 
event databases maintained by NRC to determine where oversight of 
lower-risk activities could be decreased and where continuation, or 
even broadening, of the regulations governing higher-risk activities 
was needed. In addition, throughout the development of the proposed 
rule and associated proposed guidance, public workshops were held and 
early opportunities for comment from the public and other potentially 
affected parties were provided. These interactions included significant 
discussions on the risk associated with medical uses of byproduct 
material. In addition, NRC sought and received comments on the draft 
guidance document published in August 1998.
    In further developing the licensing and inspection guidance, the 
NRC plans

[[Page 20255]]

to seek public comment and hold facilitated public workshops. The NRC 
expects that the development of the guidance will be completed before 
the effective date of the rule.
    While the NRC did not perform a formal risk assessment, we believe 
that we have adequately evaluated and considered the risks associated 
with use of byproduct material in medicine. We have eliminated 
requirements in the current Part 35 that are contained elsewhere in the 
Commission's regulations, such as the radiation protection requirements 
in Part 20. Part 35 licensees will continue to be required to comply 
with these requirements, such as the ALARA provisions in Part 20, but 
we do not believe that there is a need to duplicate the requirements in 
Part 35 unless there are specific, additional radiation protection 
requirements that are applicable to medical use licensees. We have 
maintained some prescriptive requirements in the rule that we believe 
are necessary to ensure adequate protection of the workers, patients, 
and public. The statements of considerations for the proposed rule and 
for this final rule and the accompanying Regulatory Analysis explain 
why we believe changes needed to be made in the regulations.
Issue 3: Is the Risk of Byproduct Material in Diagnostic Nuclear 
Medicine Low?
    Comment. Many commenters provided information indicating that risks 
associated with the use of byproduct material in diagnostic nuclear 
medicine is low. The commenters provided reasons for the deregulation 
of low risk nuclear medicine uses altogether. The commenters indicated 
that the average patient dose from administration of a single unit dose 
is comparable to the average annual radiation dose from natural 
background radiation in the United States. They believed that a zero 
risk tolerance is extremely impractical and the NRC should not attempt 
to regulate diagnostic nuclear medicine to account for errors that are 
harmless. Commenters indicated that the NRC should not substitute 
theoretical risk values for lack of measurable risk values, that ``real 
risk'' is based on real harms that are measurable, and that there are 
no measurable risks involved with diagnostic nuclear medicine.
    Commenters went on to state that diagnostic nuclear medicine has an 
outstanding performance history and that there have been zero 
consequences to the patients, workers, and public. Another commenter 
stated that in over 300 million applications of radiation for 
diagnostic purposes, there has been only one death, which occurred over 
30 years ago. Commenters believed that, by requiring compliance with 
regulations where there is no clear hazard or detrimental radiation 
dose, the NRC is diverting resources away from higher risk activities, 
e.g., non-radiological risks related to medical practice. This brand of 
economics for safety programs creates an unjustifiable imbalance of 
resource allocation for the licensee. They went on to say that an 
additional risk burden is placed on the higher, non-radiological risk 
activities because there is competition for finite resources that 
support NRC requirements for low risk nuclear medicine. In this sense, 
NRC requirements are overly burdensome for most licensees.
    Response. The NRC agrees that the risk associated with the use of 
byproduct material in diagnostic nuclear medicine is low. For this 
reason, the final rule is much different from the current rule. In 
consideration of the low radiation risks in the diagnostic area, we 
have reduced the unnecessary regulatory burden for diagnostic nuclear 
medicine licensees by either eliminating or decreasing the 
prescriptiveness of the regulations that apply to them. Instead, we are 
relying on a performance-based approach that emphasizes the training 
and experience of the authorized user (AU), authorized nuclear 
pharmacist (ANP), and Radiation Safety Officer (RSO).
Issue 4: Can Regulation of Diagnostic Nuclear Medicine Be Limited to 
Part 20 and Training and Experience Requirements?
    Comment. Commenters stated that the appropriate regulation of 
diagnostic nuclear medicine should involve only the radiation 
protection requirements in Part 20 and board certification requirements 
as an indication of medical competence. Another commenter identified 
the sections of the proposed rule asserted to perform no useful purpose 
and to have no risk-based justification. The identified provisions 
were: Secs. 35.6, 35.11(c), 35.13(d), 35.24, 35.27, 35.60, 35.61, 
35.62, 35.63, 35.69, 35.204, 35.2024, 35.2060, 35.2061, 35.2063, and 
35.2204.
    Response. The final rule includes requirements that are needed to 
protect occupationally exposed individuals, patients, and the public. 
Certain radiation protection-related requirements unique to medical use 
are needed in Part 35 because of their contribution to risk reduction. 
For example, the final rule retains requirements to calibrate 
instrumentation used to measure the radioactivity of patient dosages 
before they are administered (Sec. 35.60). For this reason and because 
the NRC believes that these requirements are essential to the safe 
handling of byproduct material, we believe the sections cited by the 
commenter should not be deleted from the rule. (Note, Secs. 35.60 and 
35.62 were combined in the final rule.)

B. Licensing

Issue 1: Should Diagnostic Nuclear Medicine Programs Be Given a General 
License Rather Than a Specific License?
    Comments. Many commenters recommended that the NRC issue a general 
rather than a specific license for diagnostic nuclear medicine 
programs. The NRC's role would be to establish training and experience 
requirements for physicians, pharmacists, and RSOs. They indicated that 
the applicant would provide the NRC with their name, location, and 
contact information and pay a licensing fee to NRC. Commenters 
emphasized that, after satisfying the minimum training and experience 
criteria for low risk nuclear medicine programs, the physician should 
be authorized to receive and use byproduct material with minimal or no 
regulatory oversight.
    Commenters compared the use of byproduct material in diagnostic 
nuclear medicine to medical uses of naturally-occurring or accelerator-
produced radioactive material (NARM), e.g., thallium-201, gallium-67, 
and indium-111. Commenters indicated that several states currently have 
no regulatory authority for NARM. In those states, any physician could 
receive and use NARM for nuclear medicine procedures without either a 
registration or a license. There were no training and experience 
criteria or other radiation safety regulations for medical use of 
NARM--the medical use of NARM was controlled by current standards for 
medical care. Commenters believed that the unregulated medical use of 
NARM products justifies a similar lack of regulations for medical use 
of byproduct materials that are currently regulated by NRC.
    Some commenters suggested that one of the state radiation control 
agencies should be allowed to establish a pilot program for general 
licensing of their nuclear medicine licensees. After a period of 
several years, the NRC could evaluate the pilot program. If the program 
were found to be successful, the NRC could revise its regulations to 
issue general licenses for diagnostic nuclear medicine facilities.

[[Page 20256]]

    Some commenters indicated that it should not be necessary to 
identify a physician for the medical use program because the focus of 
the revised Part 35 will be on radiation safety rather than on the 
physician's (AU's) clinical competence. These commenters recommended 
that the licensing process be simplified to identify the name and 
contact information for the management representative responsible for 
radiation safety and to describe any byproduct material that is 
normally used and that could become hazardous to public health and 
safety during a catastrophic event, e.g., an earthquake or a serious 
fire/explosion. This commenter believed that the NRC should authorize 
the applicant for broad scope use of byproduct material and should not 
review the licensee's standard operating procedures before the 
authorization.
    Some Agreement State commenters stated that they were opposed to 
the use of a general license in the medical use area. Commenters 
believed that, in the past, regulatory difficulties were created by 
general licenses for other non-medical uses, e.g., fixed gauges 
containing sealed sources. The Agreement State representatives believed 
that if this concept could not be supported for non-medical uses, then 
it was doubtful that it should be endorsed for medical uses. Many also 
believed a Radiation Safety Committee (RSC) should be retained to 
review all aspects of the radiation safety program before submitting an 
application to the regulatory agency and that the regulatory agency 
should continue to review procedures before the license or amendment 
was issued.
    Response. The NRC believes that diagnostic nuclear medicine 
programs should continue to be specifically licensed rather than 
generally licensed. A specific license is needed because the potential 
exists for individuals in the diagnostic nuclear medicine setting to be 
exposed to radiation levels in excess of the Part 20 dose limits, 
because of the possession of significant quantities of unsealed 
material, and because the training and experience of the ANP, AU, and 
RSO are necessary for the safe handling of byproduct material. However, 
we have reduced the amount of documentation that must be submitted by 
an individual or organization that is applying for a specific license 
to use byproduct material in diagnostic nuclear medicine. When applying 
for this type of license, the applicant only needs to provide us with 
information on its facility and the training and experience of the 
authorized medical physicist (AMP), AMP, ANP, AU, and/or RSO, as 
appropriate. The applicant no longer needs to provide us with detailed 
operating and emergency procedures, e.g., dose calibrator calibration 
procedures, survey meter calibration procedures, or safe handling 
procedures. In many cases, the final rule gives licensees the 
flexibility to use either the procedures that have been developed by 
nationally recognized organizations or the manufacturer's instructions. 
The final rule also reduces the unnecessary regulatory burden on 
diagnostic nuclear medicine licensees by eliminating or reducing the 
prescriptiveness of the regulations concerning diagnostic nuclear 
medicine.

C. Inspection

Issue 1: Could NRC Use an Outside Accrediting Organization for 
Inspections in Diagnostic Nuclear Medicine?
    Comment. Some commenters expressed a belief that the inspection 
program in diagnostic nuclear medicine was not necessary. They believed 
that the NRC could allow professional accreditation boards and 
organizations to conduct inspections on behalf of NRC. They state that 
these organizations are already involved with nationwide monitoring of 
the quality of nuclear medicine services in a peer review manner that 
encourages comprehensive improvement of quality and the safe use of 
radioactive materials. They compared this approach to NRC's recognition 
of the Institute of Nuclear Power Operations (INPO) for the reactor 
industry. These commenters went on to state that the low risks to 
patients, workers, and the public from the use of byproduct material 
for diagnostic nuclear medicine practices do not warrant the current 
level of NRC regulatory oversight.
    These commenters also provided two examples in which a similar 
approach has been used in the medical community. One example is where 
the medical community and the Food and Drug Administration (FDA) worked 
closely in implementing the ``Mammography Quality Standards 
Reauthorization Act of 1998'' (Pub. L. 105-248). The FDA partnered with 
the American College of Radiology (ACR) to establish the ACR 
accreditation standards as Federally mandated practice standards for 
personnel, equipment, quality assurance, and other activities involved 
in mammography. These national standards have led to broad improvements 
in mammography nationwide. A second example is where the State bureaus 
for hospital standards recognize the Joint Commission on the 
Accreditation of Hospitals Organization (JCAHO) accreditation as 
evidence that State laws have been met by the certified institutions. 
This approach allows State governments to focus their resources on 
those facilities that are not certifiable by the JCAHO. This reduces 
duplication of inspection effort and provides cost savings to the 
medical institutions.
    The commenters thought that the NRC should delegate the inspection 
program to an accrediting organization by rulemaking or by 
administrative action after the NRC has reviewed the accreditation 
organizations. They also indicated that this rulemaking or 
administrative action should result in a reduction in NRC fees assessed 
to licensees that voluntarily submit to the accreditation process.
    Commenters indicated that the NRC should review the accrediting 
program to assure that the content of the current monitoring 
(accrediting) program was adequate and equivalent to the NRC inspection 
program. Commenters indicated that the site review teams would identify 
deficiencies, recommend corrective actions, allow time for 
implementation of improvements, and offer an appeal process to the 
licensees. They believed that the NRC should then recognize the 
accreditation organization monitoring programs as adequate to evaluate 
radiation safety practices of nuclear medicine licensees.
    Along with the final rule, commenters recommended that the NRC post 
a list of approved accreditation boards and organizations. Licensees 
could voluntarily select the appropriate organization to evaluate their 
radiation safety programs. Accredited licensees would not be subject to 
direct inspection by NRC. Licensees that did not voluntarily select an 
NRC-approved accreditation organization would be subject to direct 
inspection by the NRC or an Agreement State. Commenters indicated that 
the NRC could audit the site review teams and randomly accompany them 
to observe the appropriateness of the evaluation process.
    Commenters cautioned that the accreditation organizations should 
not become the enforcement arm of the NRC and should not be required to 
report detailed, confidential findings to NRC. Commenters believed a 
pass/fail list of licensees that voluntarily submitted to the site 
review team could be made available to NRC. Alternatively, the NRC 
could condition the nuclear medicine licenses to require the licensees 
to notify NRC upon certification, re-certification, or change in 
certification

[[Page 20257]]

status (e.g., probation, suspension, termination).
    Some commenters did not agree with this approach to inspection. 
Commenters did not believe there would be a cost savings associated 
with this approach. They cited increased costs to utilities because of 
the INPO standards and to medical facilities because the cost of 
mammography operations were increased by the Mammography Quality 
Standards Act. These commenters believed that any cost savings 
associated with JCAHO certification were offset by increased fees from 
other organizations.
    Commenters that did not favor this approach indicated that site 
review team members would not have the authority of the Federal 
Government behind them as NRC inspectors do now. Some indicated that 
the proposed alternative was self-serving and did not account for 
independent clinics and institutions. These commenters indicated that 
NRC's endorsement of the accreditation process will set up an unfair 
advantage and will be used only to increase membership in accrediting 
organizations.
    Representatives from some Agreement States did not think it was 
likely that Agreement States would relinquish their inspection programs 
to accrediting organizations.
    Response. The NRC's inspection program is separate from this 
rulemaking and may be changed without changing the regulations. The NRC 
agrees that diagnostic nuclear medicine licensees, as a whole, have 
operated safely in the past and that the radiation risk to public, 
patients, and workers is low. The inspection and enforcement history 
indicates cooperation and successful implementation of radiation 
protection programs by most licensees.
    NRC licensees are encouraged to audit their own activities and 
discover and correct their own violations. A voluntary program of 
inspection by an accrediting organization is one method to accomplish 
this goal. For example, if accrediting organizations were noted to be 
successful in discovering violations and assuring that those violations 
are corrected, the frequency of inspections at accredited facilities 
could be decreased. Under this scenario, some NRC inspections could 
still be performed to verify the effectiveness of the voluntary program 
undertaken by the accrediting organization, but the overall number of 
inspections performed by the NRC would be reduced.
    In summary, we believe the proposal for involvement of professional 
accreditation boards and organizations in the inspection program should 
be further explored in an ongoing dialogue. In the interim, the NRC 
will continue to inspect nuclear medicine licensees but will also 
continue to make improvements to the inspection program, e.g., focusing 
the inspection program on risk and decreasing the inspection frequency 
for good performance.
Issue 2: What Changes Should Be Made in the Inspection Process as a 
Result of the Revised Part 35?
    Comment. Commenters expressed a concern that NRC inspections were 
too detailed and focused on records and use of checklists. Some 
commenters asked that NRC inspectors focus on radiation safety program 
management. They indicated that, if the program was managed properly, 
there would be no need to evaluate program records or the written 
procedures. Commenters believed that inspectors should be satisfied if 
the big picture does not indicate a violation because the final rule 
will be less prescriptive, more risk-informed, and performance-based. 
Other commenters asked that inspectors rely on conversations with 
licensee staff, and independent measurements to form a basis for 
inspection findings.
    Commenters asked that the NRC provide training on the new rule to 
inspectors before the final rule is published. They also asked that the 
period between inspections be increased. Commenters believe that the 
inspector should be able to recognize the differences between the 
current and final rule. Agreement State representatives also believe 
that there will be a critical need to provide training on the final 
rule to their inspectors. Some commenters also asked that inspectors be 
encouraged to describe the good practices. They believed this would 
foster a more positive relationship among NRC, workers, management, and 
the public.
    Response. In recent years, the NRC changed the focus of its medical 
inspections from a detail oriented inspection (check-list) to a more 
performance-oriented inspection. Under this approach, inspectors are 
directed to focus more on observations, interviews, and measurements 
than on record reviews to assess program adequacy. We have also revised 
our process for documenting inspection results. Before 1998, routine 
inspections were documented using a checklist format. In 1998 and 1999, 
we revised our procedures to allow findings to be documented in 
narrative form. This revision was designed to give the inspectors more 
flexibility and to promote a more performance-based inspection process.
    In recent years, we have also revised our inspection policy to 
focus on risk. The inspection policy now requires inspectors to extend 
the time between inspections for good performers, those licensees that 
have relatively few violations for several inspections in succession 
and no escalated enforcement actions. The time between inspections is 
also based on the radiation risks associated with the use of the 
byproduct material. For example, a licensee using byproduct material 
for imaging and localization studies in a hospital setting is scheduled 
to be inspected every 3 years. If this licensee is inspected and 
demonstrates good performance, the next inspection will be scheduled to 
be conducted after 5 years, rather than 3 years. A licensee using a 
high dose-rate remote afterloader (HDR) will be inspected every year. 
If this licensee is inspected and demonstrates good performance, the 
next inspection will be scheduled to be conducted after 2 years, rather 
than 1 year.
    The NRC is in the process of implementing the Medical Pilot 
Inspection Program that was approved by the Commission in SRM-SECY-00-
0001 (February 14, 2000), ``Pilot Program for NMSS Initiative on 
Streamlining Inspection and Enforcement.'' We are conducting 
inspections under the pilot program for licensees authorized to use 
unsealed byproduct material under Secs. 35.100, 35.200, and 35.300. 
This 1-year program is intended to streamline the inspection process 
and to focus inspections on radiation safety performance and more risk-
informed outcomes. The intent of the pilot program is to demonstrate 
that the streamlined approach can--
    (1) Maintain, and potentially enhance, safety;
    (2) Reduce unnecessary burdens on the licensee;
    (3) Increase NRC efficiency and effectiveness; and
    (4) Increase public confidence by explicitly addressing more risk-
informed outcomes. If successful, the program will be extended to other 
NRC material licensee inspection programs.
    Under this pilot program, inspectors are shifting primary focus 
away from detailed examination of the licensee's processes, policies, 
and procedures to an evaluation of the adequacy of outcomes for six 
radiation safety based and outcome oriented focus elements (FEs). These 
FEs are:
    (1) Adequate program surveillance and corrective actions;

[[Page 20258]]

    (2) Knowledgeable staff and management;
    (3) Occupational and public doses within regulatory limits;
    (4) Adequate security and control of licensed material;
    (5) Use of licensed material only as authorized; and
    (6) Radiopharmaceutical administrations conforming to the 
physicians written directives.
    The extent and depth of the inspection will be guided by the 
outcomes for the FEs and the potential risk associated with licensed 
activities. If the desired outcomes are not achieved by the licensee, 
then a detailed evaluation will follow. It will identify root causes 
and contributing factors for the licensee's apparent failure to conduct 
a satisfactory radiation protection program. The detailed evaluation 
will be similar to the approach that has been used during routine NRC 
inspections in the past, e.g., review of processes, policies, and 
procedures, additional observations, and interviews of licensee staff 
members.
    The experience gained from this program will be used to revise all 
medical inspection procedures. This will help to ensure that the 
medical inspection procedures incorporate the more risk-informed, more 
performance-based approach used in the rulemaking.
    We will continue to qualify inspectors using NRC Inspection Manual 
Chapter 1246, ``Formal Qualification Programs in the Nuclear Material 
Safety and Safeguards Program Area.'' During the inspector 
qualification program, the candidate completes self-study exams for the 
various parts of 10 CFR Chapter I and obtains classroom and practical 
laboratory experience for each type of medical use. The candidate 
accompanies other qualified inspectors and the inspection supervisor 
during inspections of various types of licenses for medical use 
programs to develop inspection skills necessary to evaluate radiation 
safety programs independently and to relate inspection findings to the 
NRC enforcement policy. Finally, individuals must pass an oral 
qualification board before they become certified to conduct inspections 
without direct supervision.
    The Agreement States also have formal training programs for their 
inspectors. Agreement State inspector qualification are reviewed during 
NRC's periodic review of the Agreement State program.
    NRC inspectors also participate in ongoing refresher training. This 
training includes new innovations in the health physics field as well 
as training in new initiatives underway at the NRC. Individuals 
performing medical inspections will receive training in the final Part 
35 as well as in any guidance documents associated with the rulemaking. 
Training will focus on the concepts associated with a more risk-
informed, more performance-based rule. In addition, inspectors received 
training on the pilot program for streamlining inspections before the 
pilot program was introduced.
Issue 3: Will the Agreement State Inspection Program Change as a Result 
of Changes in the NRC Inspection Program?
    Comment. Several commenters stated that Agreement States may 
experience problems with their inspection programs if they follow NRC's 
lead in moving from a prescriptive to a more performance-based approach 
to inspecting. Other commenters stated that, if the NRC adopted an 
approach in which inspections would be deferred or eliminated, States 
may not be able to, or choose not to, follow NRC's example.
    Response. Moving from prescriptive to more performance-based 
inspections will require a period of adjustment for both the NRC and 
Agreement States, as well as for the licensees. NRC and the Agreement 
States will address any needed adjustments via their internal training 
programs. In addition, Agreement States will be provided with copies of 
guidance documents currently under development by the NRC. Finally, 
Agreement States are afforded the flexibility to inspect more 
frequently based on local concerns.
Issue 4: What Changes Will Be Made in the Enforcement Program as a 
Result of the Revised Part 35?
    Comment. A commenter agreed with the principal of a performance-
based regulation, but questioned whether there would be any changes in 
the enforcement program.
    Response. The NRC's enforcement program is separate from this 
rulemaking and may be changed without changing the regulations. 
However, as a result of some changes in the rule, the Commission is 
also publishing, in a separate document in this Federal Register, a 
modification of ``General Statement of Policy and Procedure for NRC 
Enforcement Actions,'' NUREG-1600 (Enforcement Policy), to revise the 
examples of severity levels for violations associated with the 
requirements to: (1) Use written directives for certain medical uses of 
byproduct material; and (2) develop, implement, and maintain certain 
procedures for medical uses that require a written directive (10 CFR 
35.40 and 35.41). The revised examples reflect the revised requirements 
in Part 35.
    In a broader effort, the NRC is revising its enforcement policy to 
make that program more risk-informed and performance-based. For 
example, a number of lesser violations are no longer considered in the 
aggregate at a higher severity level. This change was introduced in the 
version of the Enforcement Policy published in the Federal Register on 
November 9, 1999 (64 FR 61142).
    Additionally, during the time that this rulemaking was being 
developed, guidance to the NRC staff was issued on non-escalated 
enforcement actions (EGM 98-007) in the materials enforcement area to 
assure that:
    (1) Non-cited violations are used for non-repetitive, non-willful 
Severity Level IV violations;
    (2) The use of enforcement discretion not to issue a citation is 
considered where warranted for Severity Level IV violations in 
accordance with Sections VII.B.2 through VII.B.6 of the Enforcement 
Policy;
    (3) Responses are not required for cited Severity Level IV 
violations if the licensee's corrective actions are already available 
in a docketed report or other correspondence;
    (4) RSC meeting minutes and other licensee program audit records 
are not used to identify violations that the licensee is already aware 
of unless the corrective action for the violation is not prompt or 
comprehensive; and
    (5) Multiple examples of the same violation are grouped into a 
single citation when appropriate.

D. Industry Standards

Issue 1: Can Standards of Practice Be Used as an Alternative to 
Regulation?
    Comment. Some commenters asked whether the NRC would consider 
replacement of regulations with standards of practice or industry 
standards that are well understood by medical professionals. For 
instance, one commenter points out that the American Association of 
Physicists in Medicine (AAPM) has recently published several excellent 
reports that relate to radiation safety, including the reports of Task 
Groups 59, 56, and 40.
    Some commenters believed that we could allow a licensee to commit 
to follow an established standard of practice and thereby limit our 
regulatory oversight. Commenters also pointed out that many current 
regulations have become the standard of care and, in instrumentation 
cases, the

[[Page 20259]]

manufacturer's guidance. Conversely, some commenters believed that we, 
as regulators, had the role of defining the minimum level of practice 
necessary to directly enhance safety. The commenters indicated that 
there are some limited cases where those practicing are not following 
``voluntary'' standards of practice; therefore regulations were needed. 
Finally, some commenters questioned our role in regulating an activity 
that is also regulated by another government agency or by the state.
    Response. The National Technology Transfer and Advancement Act 
(NTTAA) of 1995, Public Law 104-113, requires that Federal agencies use 
technical standards that are developed or adopted by voluntary 
consensus standards bodies unless the use of such a standard is 
inconsistent with applicable laws or is otherwise impractical. The 
Commission specifically directed the NRC staff to examine 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.
    In developing the final regulations for therapeutic uses of sealed 
sources, the NRC consulted several American Association of Physicists 
in Medicine (AAPM) reports, including AAPM Radiation Therapy Task Group 
No. 40--Comprehensive QA for Radiation Oncology, 1994 (AAPM TG-40); 
AAPM Radiation Therapy Committee Task Group No. 56--Code of Practice 
for Brachytherapy Physics, 1997 (AAPM TG-56); AAPM Radiation Therapy 
Committee Task Group No. 59--High Dose Rate Brachytherapy Treatment 
Delivery, 1998 (AAPM TG-59); and AAPM Report No. 54--Stereotactic 
Radiosurgery, 1995. In developing several other sections of the rule, 
we also consulted other nationally recognized bodies' reports, 
including the American National Standards Institute, Inc. (ANSI), ACR, 
and the American College of Medical Physics (ACMP). We understand that 
these and other standards of practice are often voluntary and, as such, 
medical professionals are not required to follow them. The final rule 
and guidance include statements of the objectives to be achieved and 
allow the licensee to select among the various performance standards to 
meet the objectives of the regulation. For example, in Sec. 35.60 we 
allow a licensee to calibrate instrumentation in accordance with 
nationally recognized standards or the manufacturer's instructions 
rather than to submit their specific calibration procedures for our 
review and approval. We believe that this provides the licensee 
significant flexibility in designing its radiation protection program.
    We agree that, in some cases, the licensed community must comply 
with several different Federal and state regulations for a single type 
of use. For instance, in the case of sealed radioactive sources for 
therapeutic medical uses, the licensed community must comply with FDA 
regulations for devices and must also comply with NRC regulations on 
the use of the radioactivity in or on humans. Whenever possible, we 
reviewed the various state and Federal regulations, including other NRC 
regulations, to limit duplication of requirements.
    For additional information on how consensus standards were used in 
the development of the final rule refer to Section I, Background in the 
SUPPLEMENTARY INFORMATION in this document.

E. Training and Experience

1. Training and Experience--General
Issue 1: Why Are There Two Sets of Training and Experience Requirements 
in the Final Part 35?
    Comment: One commenter noted that much of Subpart J is redundant 
with, but not identical to the training and experience requirements 
listed in the individual sections of the other subparts. The training 
and experience requirements should be identical if they are included in 
two subparts within the same part, or they should only be listed once 
in the part.
    Response. The NRC believes that Subpart J should be retained for a 
2-year transition period as stated in the proposed rule (63 FR 43516; 
August 13, 1998 ). The issue of recognition of medical and other 
specialty boards was discussed during an ACMUI briefing of the 
Commission on February 19, 2002. In that meeting, two committee members 
expressed concern that some boards did not qualify for recognition and 
may not be ready to apply for recognition within 6 months after 
publication of the final rule. Therefore, implementation of the new 
Part 35, without Subpart J, could disrupt the current license 
authorization process for new medical personnel because many license 
authorizations are granted based on recognition of board certification. 
The Commission has considered this matter and decided to retain the 
current training requirements in Subpart J for a 2-year period after 
the effective date of the final rule. As stated in Section IX, 
Implementation, during that 2-year period, licensees will have the 
option of complying with either the requirements of Subpart J or the 
requirements in Subparts B and D-H. During this transition period, the 
NRC will continue working with the ACMUI and the medical community to 
resolve any concerns with the training and experience requirements. The 
Commission will consider changes to the training and experience 
requirements, as appropriate.
    The training and experience requirements in Subparts B and D 
through H of the final rule provide alternative pathways for 
individuals who are not board certified, i.e., the rule specifies the 
total number of hours of training and experience needed to become an 
AMP, ANP, AU, or RSO. This was done because we do not believe that we 
should require that individuals be board certified, but we believe that 
we should require that they have adequate training to safely handle 
byproduct material. The primary difference between the ``board 
certification route'' and the ``alternative pathways'' concerns the 
regulatory process used for being approved as an AMP, ANP, or AU. For 
example, if an individual is certified by a board recognized by NRC, a 
licensee does not need to amend its license before it allows that 
individual to work as an AU, ANP, or AMP (reference Sec. 35.14(a) and 
Sec. 35.24(a)). However, if the individual is not board certified, the 
licensee must apply for and receive an amendment from NRC before it 
allows that individual to begin work (Sec. 35.13(b)). In the case of an 
RSO, a licensee must always amend its license before it allows an 
individual to work as an RSO unless the individual would be considered 
a temporary RSO under Sec. 35.24(c).
Issue 2: Would It Be Best for Regulations To Be Developed, 
Administered, and Monitored by Medical Speciality Organizations?
    Comment. A commenter believed that the training and experience 
requirements would be best developed, administered, and monitored by 
medical speciality organizations with expertise in clinical 
applications of radiation-related technologies. The commenter cited the 
Mammography Quality Standards Reauthorization Act as an example of a 
cooperative public/private partnership that uses the strengths of both 
established accreditation/certification programs and Federal Government 
enforcement authority.
    Response. The NRC acknowledges and values the expertise of medical 
and other speciality boards involved in

[[Page 20260]]

radiation-related technologies. We have met with many of these boards 
and received valuable information that was used to develop the final 
rule. However, we believe that the administration of this rule is best 
performed by the NRC.
Issue 3: Should Speciality Boards Be Listed by Name in the Regulations?
    Comment. Some commenters recommended that the regulations list the 
boards, by name, because the boards rarely change. Another set of 
commenters stated that the cardiology board should be listed by name in 
the rule. Other commenters expressed concern that NRC would recognize 
boards that were not recognized by the American Board of Medical 
Specialities (ABMS).
    Response. The NRC believes that any reference, by name, to boards 
should be deleted from the regulation because a rulemaking is needed to 
add new boards, to change the name of boards, or to delete existing 
boards. This has been a problem with the current Part 35 on several 
occasions when individuals requesting AU status have been certified by 
a board that is not listed in the regulations. In these cases, the NRC 
evaluated the training of these individuals, in consultation with the 
Advisory Committee on the Medical Uses of Isotopes (ACMUI), on a case-
by-case basis. In the future, without need for a rulemaking, NRC could 
recognize boards in a more timely manner. (Note: We have provisions in 
Secs. 35.50, 35.51, 35.55, 35.190, 35.290, 35.390, 35.392, 35.394, 
35.490, 35.491, 35.590, and 35.690 that allow individuals, who are 
certified by NRC-recognized boards, to function as an ANP, ANP, AU, or 
RSO.) Under the final rule, the boards must be recognized by the NRC or 
an Agreement State. The NRC will recognize a board if its certification 
process requires or will require an individual to meet all of the 
applicable requirements listed in the alternative pathway of the 
training and experience requirements in Subparts B and D through H. For 
example, the individual must complete the required number of hours of 
training and experience that covers specific topics; obtain a signed 
preceptor certification; and complete specifically identified patient 
casework, if required.
    We do not believe that the NRC's recognition of boards should be 
limited to those boards that are recognized by the ABMS. Our 
recognition is contingent on whether the certification process includes 
all the requirements listed in the alternative pathway. Before we 
recognize a board, we will review the board's submittal with ACMUI. We 
will maintain a list of recognized boards on our website.
    Boards that are listed in current Part 35, as well as any other 
boards that are not listed in the current rule, such as the cardiology 
boards, will need to apply for recognition under the revised Part 35. 
We believe it is necessary to obtain a commitment from all of the 
boards that their certifications meet the criteria in the alternative 
pathways in the final rule because it has been several years since NRC 
reviewed many of them.
Issue 4: Should the Board Certification Process Be ``Approved'' or 
``Recognized'' by the NRC?
    Comment. Commenters questioned the phrase ``whose certification 
process has been approved by the Commission'' because the board will 
continue to exist regardless of whether the Commission approves the 
board for Commission purposes.
    Response. Based on this comment, the NRC changed all training and 
experience requirements to state that the medical and other specialty 
board's certification process must be ``recognized'' by the Commission.
Issue 5: What Is the Preceptor's Role?
    Comment. A commenter stated the proposed regulations place an 
inappropriate burden on the preceptor to provide written certification 
that the applicant has satisfactorily completed the didactic 
instruction in a structured educational program, obtained the required 
hours of supervised practical experience, and achieved a level of 
competency to function independently as an AU. The commenter 
recommended that all didactic training be certified or approved by an 
independent organization not associated with any society, board, or 
medical speciality. The commenter stated that the preceptor should not 
make any judgment regarding competency and should simply attest that an 
individual completed the training program.
    Response. The regulations in the final rule do place a high degree 
of responsibility on the preceptor. Because the preceptor must be an 
AMP, ANP, AU, or RSO, the NRC believes that the preceptor is in the 
best position to certify that the individual has achieved a level of 
competency sufficient to function independently as an AMP, ANP, AU, or 
RSO. We do not believe this places an undue burden on a preceptor, but 
rather it demonstrates a high degree of confidence in the preceptor. 
Further, we believe that these types of judgments of competency in 
training and experience are consistent with the duties of individuals 
who direct training programs or provide training.
Issue 6: What Are the Training and Experience Requirements for 
Physicians Who Perform Research on Human Subjects?
    Comment. A commenter asked what the training and experience 
requirements are for physicians who perform research on human subjects.
    Response. There is no difference between the training and 
experience requirements for the administration of byproduct material or 
radiation from byproduct material to a human research subject and the 
training and experience requirements for an administration to a 
patient. For example, if the research involves using unsealed byproduct 
material for imaging and localization studies for which a written 
directive is required, the physician performing the research must meet 
the requirements in Sec. 35.390. If the research involves use of sealed 
byproduct material in a remote afterloader, the physician must meet the 
requirements in Sec. 35.690.
Issue 7: Should the Training and Experience Requirements Include an 
Examination?
    Comment. The NRC received comments both opposed to and in support 
of a requirement for individual who would like to become an AMP, ANP, 
AU, or RSO to pass an examination that would assess whether they had 
sufficient radiation safety knowledge.
    Some commenters supported the exam concept. One thought that it 
would provide an alternative to a requirement for a long training 
program. Those commenters who supported the examination believe that an 
examination is an important tool that should be used to assure that 
individuals have the necessary skill to handle byproduct material 
safely. Other commenters believed that the examination would be 
warranted if an individual had not taken an examination as part of a 
board certification.
    Several commenters stressed the practical problems of implementing 
the requirements for an examination. They noted that establishing an 
examination program was extremely time-intensive and expensive. 
According to several commenters, maintaining the confidentiality of 
questions was a concern. Some commenters said that the examination 
requirement was unnecessary and should be deleted unless the NRC had 
information that significant numbers of AMPs, ANPs,

[[Page 20261]]

AUs, and RSOs were being inadequately trained.
    Other commenters indicated that many training organizations already 
use testing as part of their educational programs. Therefore, the 
testing requirement would only increase training costs without adding 
benefit or value.
    Some commenters argued that neither should the NRC give the exam 
itself, nor should it determine the passing score. Other commenters 
suggested that examining organizations submit questions to the NRC and 
that the NRC should develop the exam. Some commenters recommended that 
the NRC collaborate with one or more boards to develop the radiation 
safety exam. Others suggested that several boards collaborate to 
develop a radiation safety examination independent of the NRC. 
Commenters also recommended that the NRC contract either directly or 
indirectly with a testing service to administer the exam.
    Several commenters stated that the proposed requirement in Appendix 
A for examining organizations to ensure that examinations are not given 
to individuals who have also been instructed by the examining 
organization was too prescriptive. One commenter explained that 
professional organizations must be trusted to both offer instruction 
and testing. Another commenter encouraged the NRC to keep the two 
functions separate.
    Response. The NRC believes that the training and experience 
requirements in the final rule for AMPs, ANPs, AUs, and RSOs are 
sufficient to assure that the radiation safety of the public, patients, 
human research subjects, and workers is maintained. Therefore, we 
deleted the requirement for an examination from all the training and 
experience sections. Instead of an examination, we will rely on the 
preceptor's certification that an individual has completed the required 
training and experience and has achieved a level of competency 
sufficient to function independently as an AMP, ANP, AU, or RSO.
Issue 8: Should Part 35 Contain Training and Experience Requirements 
for Technologists?
    Comment. Many commenters suggested that minimum training and 
experience requirements be established for nuclear medicine 
technologists. In addition, they suggested that technologists be 
required to pass an exam. Commenters stated that there is a need for 
training and experience requirements for those individuals who actually 
handle radioactive materials.
    One commenter felt that health care agencies, rather than the NRC, 
should mandate licensure requirements for technologists. Commenters 
opposed NRC requiring specific training and experience for nuclear 
medicine technologists, but supported mandated licensure requirements 
by health care agencies.
    Response. The NRC recognizes that technologists have an important 
and substantial role in the medical use of byproduct material. However, 
the licensee is responsible for ensuring that the training and 
experience of individuals working under the supervision of an AU or ANP 
are adequate. We will continue to rely on the regulations in 
Sec. 35.27, Supervision, to assure that individuals working under the 
supervision of an AU or ANP are provided adequate training. Therefore, 
we have not established training and experience requirements for 
technologists or other individuals using byproduct material under the 
supervision of an AU or ANP.
Issue 9: Will the Training and Experience Requirements for Physicians 
Affect Training Requirements for Technologists?
    Comment. Commenters were concerned that the reduction in the 
duration of some of the physicians' training programs would negatively 
affect the amount of training that licensees expect technologists to 
have completed. They were concerned that if NRC reduced the training 
requirements for AUs that licensees might reduce their training 
requirements for technologists. The commenters believed that as the 
technology becomes more sophisticated, a reduction in training could 
lead to poor quality studies and result in unnecessary radiation 
exposure to patients.
    Response. The NRC believes that under the final rule AUs will have 
sufficient training and experience to assure that byproduct material is 
handled safely. In addition, an AU is required to be a physician, 
dentist, or podiatrist. It is the licensee's responsibility to 
determine the level of training and experience, in addition to the 
instruction required in Sec. 35.27, needed for individuals working 
under the supervision of an AU.
2. Training and Experience--Unsealed Byproduct Material.
    For the most part, comments received on the following sections 
related to more than one section. Therefore, the NRC is summarizing 
comments received on these sections in this portion of the statement of 
considerations. Comments that pertain only to specific sections are 
discussed under that particular section heading.
    As discussed earlier, the training and experience requirements in 
proposed Sec. 35.290 were moved to final Sec. 35.190 and the training 
and experience requirements in proposed Sec. 35.292 were moved to final 
Sec. 35.290. For purpose of the following discussion, the summary of 
the comments refers to the sections in the proposed rule and the 
response refers to the sections in the final rule.
    Section 35.190, Training for uptake, dilution, and excretion 
studies.
    Section 35.290, Training for imaging and localization studies.
    Section 35.390, Training for use of unsealed byproduct material for 
which a written directive is required.
    Section 35.392, Training for the oral administration of sodium 
iodide iodine-131 (I-131) requiring a written directive in quantities 
less than or equal to 1.22 Gigabecquerels (33 millicuries).
    Section 35.394, Training for the oral administration of sodium 
iodide I-131 requiring a written directive in quantities greater than 
1.22 Gigabecquerels (33 millicuries).
Issue 1: Should NRC's Training and Experience Requirements Focus on 
Radiation Safety Rather Than Clinical Competency?
    Comment. Commenters generally supported the NRC focusing training 
and experience requirements on radiation safety rather than on clinical 
competency. Some commenters believed that the training and experience 
requirements for physicians who wish to use unsealed byproduct material 
should be based on demonstrated competence in nuclear science and 
radiation safety. These commenters did not believe that the NRC should 
define the criteria for clinical competence, but rather should allow 
clinical training to be defined by relevant medical specialty 
organizations such as the Accreditation Council for Graduate Medical 
Education (ACGME)-approved training programs or the ABMS-sanctioned 
certifying boards. However, commenters noted that ``AU status'' was 
frequently equated with clinical competency. As a result, these 
commenters encouraged the NRC to clearly state that a license granted 
under Part 35 only reflects the qualifications of a physician to safely 
handle radioactive material for medical use and not to practice nuclear 
medicine.
    Response. The current training and experience requirements for AUs 
under Secs. 35.100, 35.200, and 35.300 have been revised to focus on 
radiation safety. The NRC believes that the focus of these

[[Page 20262]]

training requirements should not be clinical competency. Clinical 
competency is best addressed by State Medical Boards, certifying 
organizations, and hospital credentialing committees. An individual's 
status as an AU means that the individual has met the requirements to 
handle byproduct material safely. It does not reflect an assessment of 
the individual's clinical or professional competency.
Issue 2: Should Training and Experience Be Limited to FDA-Approved Uses 
of Byproduct Material?
    Comment. A commenter recommended that training and experience be 
obtained in those activities that are related to FDA-approved uses of 
byproduct material, and that all research, drug testing, and related 
non-FDA approved procedures be excluded from training and experience 
activities.
    Response. The training and experience requirements in the final 
rule focus on radiation safety, not on clinical competency. Therefore, 
the NRC believes that individuals should have training and experience 
in the safe handling of all types of byproduct material. Thus, training 
and experience should not be limited to FDA-approved uses of byproduct 
material.
Issue 3: Where Should Training Be Obtained?
    Comment. A commenter recommended that the NRC not recognize 
training and experience that has been obtained at a facility that is 
supported by either commercial manufacturers or suppliers. Other 
commenters recommended that practical training should be in an ACGME-
accredited program in nuclear medicine or a graduate level course at an 
accredited university. Another commenter recommended that only those 
physicians completing an accredited residency program in an ABMS-
approved speciality be allowed to become AUs under Sec. 35.390.
    Response. The NRC does not believe that the rule should specify 
where the training should be obtained because this level of 
prescriptiveness is not warranted by the types and levels of byproduct 
material that are handled under Secs. 35.100, 35.200, and 35.300. We 
will investigate any allegations regarding inadequate training programs 
on a case-by-case basis. In addition, we do not believe that the rule 
should prohibit an individual from obtaining training at locations 
whose activities are supported by commercial manufacturers, suppliers, 
or the owners/investors. We will rely on the preceptor's written 
certification for final assurance that an individual has completed the 
required training and experience and is competent to function 
independently as an AU.
Issue 4: Should NRC Provide ``Deemed'' Status to Individuals?
    Comment: Commenters questioned whether NRC would provide ``deemed'' 
status to diplomates of the American Board of Nuclear Medicine (ABNM) 
and whether diplomates of the American Board of Radiology (ABR) or the 
ABNM should be licensed to use diagnostic radionuclides without 
additional education or examination requirements.
    Response. Any individual who is an AMP, teletherapy physicist, ANP, 
AU, or RSO on a license issued by the Commission or Agreement State, a 
permit issued by a Commission master material licensee, a permit issued 
by a Commission or Agreement State broad scope licensee, or a permit 
issued by a Commission master material license broad scope permittee 
before the effective date of the final rule will continue to be 
considered such by NRC. After the rule becomes effective, these 
individuals will have ``deemed'' status as an AMP, ANP, AU, or RSO on 
licenses that authorize similar type(s) of use(s) of byproduct 
material, i.e., there will be no change in what an individual is 
``authorized'' to do. For example, an individual currently recognized 
as a ``teletherapy physicist'' would be recognized as an AMP for 
teletherapy units under the final Part 35. However, the individual 
could not be listed as an AMP on a license only authorizing use of 
gamma stereotactic radiosurgery, unless he or she also satisfied the 
requirements in the new Sec. 35.51(b)(1) for experience with the tasks 
that are applicable to those units (Secs. 35.635, 35.645 and 35.652). 
The teletherapy physicist could not be listed as an AMP on a license 
that only included gamma stereotactic radiosurgery units and remote 
afterloaders, unless the individual obtained written certification, 
signed by a preceptor AMP, that he or she had satisfactorily completed 
the applicable requirements and had achieved a level of competency to 
function independently as an AMP for those types of uses.
    The same criteria would apply in determining if AUs have ``deemed 
status'' under the final rule. They would only continue to be 
recognized as AUs for the type(s) of use(s) of byproduct material for 
which they already have AU status. An AU under the current Sec. 35.932, 
Training for treatment of hyperthyroidism, would continue to be 
recognized as an AU for the use of I-131 for diagnosis of thyroid 
function under the new Sec. 35.390, Training for use of unsealed 
byproduct material for which a written directive is required. However, 
if the individual would also like AU status for parenteral 
administration of any beta emitter or a photon-emitting radionuclide 
with a photon energy less than 150 keV, the individual would have to 
satisfy the applicable training and experience requirements for this 
use in Sec. 35.390.
    Once the final rule becomes effective, diplomates of boards, such 
as the ABNM and ABR, will be considered to have met the training and 
experience requirements if the boards have been recognized by NRC. 
Recognition of a board will be contingent on whether the board's 
certification process includes all the requirements listed in the 
alternative pathways for satisfying the training and experience 
requirements. However, as stated previously, the Commission is 
retaining the current training requirements in Subpart J for a 2-year 
period after the effective date of the final rule. During that 2-year 
period, licensees will have the option of meeting either the 
requirements of Subpart J or the requirements in Subparts B and D-H.
Issue 5: Why Are There Different Requirements for Training of AUs Under 
Secs. 35.100, 35.200, and 35.300?
    Comment. Commenters questioned why the training and experience 
requirements for using byproduct material under Secs. 35.100, 35.200, 
and 35.300 are different. They indicated that the basic radiation 
safety practices and knowledge of radiation science should be the same 
regardless of the quantity of byproduct material and how it is used.
    Response. The NRC recognizes that there is a certain degree of 
basic radiation safety knowledge that is common among all the types of 
use, e.g., use of the decay formula and decontamination techniques. 
However, we also believe that there are some basic differences between 
the uses of byproduct material under Secs. 35.100, 35.200, and 35.300 
that warrant additional training and experience, e.g., increased 
potential for exposures in excess of Part 20 limits and the potential 
for adverse biological effects. For example, AUs handling byproduct 
material for imaging and localization studies, as compared to uptake, 
dilution, and excretion studies, are generally handling larger 
quantities and many different radionuclides. Also, AUs meeting the 
training and experience requirements in Sec. 35.190 are not authorized 
to prepare radioactive drugs

[[Page 20263]]

using generators and reagent kits, but AUs under Sec. 35.290 are 
authorized to prepare drugs using generators and reagent kits. Finally, 
AUs under Sec. 35.390 are handling material in quantities that can 
cause deterministic effects.
Issue 6: How Long Should the Training Programs Be for Individuals Who 
Would Like To Become AUs Under Secs. 35.190, 35.290, and 35.390?
    Comment. Numerous comments both supported and opposed the duration 
of the proposed training and experience requirements for individuals 
who would like to become an AU for unsealed byproduct material.
    Some commenters strongly supported the proposed reduction of the 
training and experience requirements for use of unsealed byproduct 
material in diagnostic nuclear cardiology because of the minimal risk 
to patients and public safety.
    Some commenters believed that NRC should not establish an 
``arbitrary'' number of training and experience hours. They indicated 
that it may take some individuals more time to master needed 
information. They believe that classroom training should focus on 
radiation safety and that there should be a requirement to show 
evidence of mastery in comprehensive nuclear and radiation science 
through an exam. In addition, they believe that the rule should clearly 
identify what knowledge and skills an individual should have.
    A commenter suggested that the proposed requirements for an 
individual who would like to use material under Sec. 35.100 be changed 
from 20 hours of classroom and laboratory experience to 40 hours of 
supervised practical experience.
    A commenter recommended that the proposed requirement for an 
individual who would like to use material under Sec. 35.200 should be a 
minimum of 240 hours of supervised practical experience. For the same 
type of use, another commenter suggested that an individual complete a 
6-month/1200 hour training program in an ACGME-accredited or equivalent 
training program. Finally, a commenter recommended that individuals 
certified by the ABR or ABNM should automatically qualify as AUs. These 
commenters also indicated that as an alternative pathway to board 
certification, an individual who would like to use material under 
Sec. 35.200 should be required to complete a dedicated 4-month nuclear 
medicine/radiology training program that integrates radiation safety 
training with clinical training and experience. This integrated 
experience should be obtained in an ACGME-approved residency program in 
diagnostic radiology or nuclear medicine.
    A commenter stated that the current training and experience 
requirements for physicians authorized for nuclear medicine therapy 
(Sec. 35.390) are minimal to a fault. The commenter cited the 1996 NAS-
IOM analysis of NRC's medical program that recommended increasing the 
requirements for a nuclear medicine therapy AU. Another commenter found 
it inconsistent that the use of unsealed byproduct material for therapy 
requires far less training than the use of sealed byproduct material. 
Another position is that therapeutic nuclear medicine represents a 
higher risk for patients. Therefore, the training and experience 
requirements to become an AU for therapy should be greater than those 
for diagnostic nuclear medicine.
    A commenter recommended that the current requirements for an 
individual who would like to use unsealed byproduct material under 
Sec. 35.300 should be revised to be at least equal to or greater than 
the requirements to use material under Sec. 35.200. Another commenter 
suggested that an individual have 100 hours, rather than 40 hours, of 
supervised practical experience under the supervision of an AU. The 
commenter went on to state that this additional time would be used to 
cover the requirements that pertain to dosages requiring a written 
directive.
    Another commenter stressed the importance of remembering that, 
under Sec. 35.300, byproduct material is used for therapeutic 
treatments and that the possibility of injury to the patient and others 
is very real. This commenter stated that he had personally seen both 
significant bone marrow suppression after using strontium for bone pain 
and life-threatening pulmonary edema after treatment of a patient with 
iodine-131 (I-131) for metastatic thyroid cancer of the lungs.
    Response. The NRC believes that the regulatory text should contain 
a list of the subject areas to be addressed in a training program. In 
the final rule, we have not included a requirement for an examination 
to demonstrate that an individual has sufficient knowledge in radiation 
safety. Instead, we will rely on the duration of the training program 
and the preceptor's written certification that a physician has 
completed the required training and experience and is competent to 
function independently as an AU.
    The following discussion summarizes the training and experience 
requirements for use of unsealed byproduct material under Secs. 35.100, 
35.200, and 35.300. We believe the specified training periods will 
provide individuals with sufficient knowledge to handle byproduct 
material safely. We also believe that it is sufficient to specify the 
overall period for training. We do not believe that any further 
breakdown is needed in terms of the hours devoted to classroom/
laboratory training and work experience. Note, this same approach is 
used in the current rule for the training and experience requirements 
for an ANP. In addition, this approach will provide needed flexibility 
in designing and implementing training programs.
    In Sec. 35.190, Training for uptake dilution and excretion studies, 
the total number of hours (i.e., 60 hours) in the final rule is the 
same as the total number of hours in the current rule and in the 
proposed rule. AUs, qualified under Sec. 35.290, Sec. 35.390, or 
equivalent Agreement State requirements, may use byproduct material 
under Sec. 35.100. AUs qualified under Sec. 35.190 are not authorized 
to prepare unsealed byproduct material using generators and reagent 
kits.
    In Sec. 35.290, Training for imaging and localization studies, we 
agree with the public comments that the proposed 120 hours is not 
sufficient. AUs in this category are authorized to prepare unsealed 
byproduct material for medical use using generators and reagent kits. 
Therefore, we have increased the period of training in Sec. 35.290 from 
120 hours in the proposed rule to 700 hours (essentially 4 months) in 
the final rule. This change was necessary to assure that physicians 
spend an adequate amount of time in an environment in which radioactive 
drugs are routinely being prepared and/or administered for medical use. 
Note that the 700 hours in the final rule is a reduction from the 
current 1200 hours of training required for imaging and localization 
studies.
    As stated earlier, we have not specified a breakdown between the 
number of hours of didactic (i.e., classroom and laboratory) and work 
experience to allow flexibility in designing and implementing training 
programs. Therefore, the number of hours of classroom and laboratory 
training needed to address the required subject areas in 
Sec. 35.290(c)(1)(i) may vary with individual training programs. The 
remainder of the required 700 hours would be devoted to supervised work 
experience to include, but not be limited to, the subject areas in 
Sec. 35.290(c)(1)(ii).
    We recognize that physicians in training will not dedicate all of 
their time specifically to the subject areas in Sec. 35.290(c)(1)(ii) 
and will be attending

[[Page 20264]]

to other clinical matters involving the diagnostic use of the material 
under the supervision of an AU (e.g., reviewing case histories or 
interpreting scans). Even though these clinical matters are not 
specifically required by the NRC, this type of supervised work 
experience may be counted toward the supervised work experience to 
obtain the required 700 hours.
    We agree that the training and experience requirements should be 
increased for individuals who would like to use byproduct material for 
which a written directive is required. The hours have been increased 
from 80 hours in the current rule to 700 hours in the revised 
Sec. 35.390, Training for use of unsealed byproduct material that 
requires a written directive. We believe this increase is needed 
because these physicians would be authorized to elute generators and 
prepare radioactive drugs, as well as to administer a wide variety of 
radionuclides requiring written directives. Thus, the associated 
radiation risks of the use could be greater. In addition, the work 
experience in the administration of such dosages to patients must 
specifically include at least three cases in each of the following 
categories for which the individual is requesting AU status:
    1. Oral administration of less than or equal to 1.22 Gigabecquerels 
(33 millicuries) of sodium iodide I-131;
    2. Oral administration of greater than 1.22 Gigabecquerels (33 
millicuries) of sodium iodide I-131;
    3. Parenteral administration of any beta-emitter or a photon-
emitting radionuclide with a photon energy less than 150 keV; and/or
    4. Parenteral administration of any other radionuclide.
    Physicians who are authorized under Sec. 35.390 for all of these 
types of administrations also meet the requirements in Secs. 35.190, 
35.290, 35.392, and 35.394.
Issue 7: What Are the Appropriate Training Requirements for an 
Individual Who Would Like To Use I-131 for Treatment of Hyperthyroidism 
and Thyroid Cancer?
    Comment. Commenters were strongly opposed to the proposed changes 
to the requirements for the administration of I-131 for treatment of 
hyperthyroidism and thyroid cancer. Commenters felt that there was no 
justification for revising the current Sec. 35.932, Training for 
treatment of hyperthyroidism, and to do so would conflict with NRC's 
guidelines of ``minimizing intrusion into medical judgments affecting 
patients and into other areas considered to be a part of the practice 
of medicine.'' These commenters indicated that the increased training 
was not warranted in light of endocrinologists' impeccable safety 
record with the use of I-131 and the fact that there have been no 
records of therapeutic misadministrations of any byproduct material by 
endocrinologists. In addition, commenters stated that, in reality, most 
of the practical aspects of handling I-131 that would be covered in the 
proposed 40 hours of additional training is already covered in the 80 
hours of didactic training and in the supervised clinical training that 
is currently required by Sec. 35.932, Training for treatment of 
hyperthyroidism, and Sec. 35.934, Training for treatment of thyroid 
carcinoma.
    Commenters stated that the clinical endocrinologist is the 
physician best qualified to take care of patients with thyroid disease 
and part of their responsibility is to protect their patients from 
unnecessary burdens. Commenters stated that the practical effect of 
increasing the basic radiation physics and safety training from 80 
hours to 120 hours would be to exclude endocrinologists from 
administering I-131 to patients with hyperthyroidism and thyroid 
cancer. Some commenters went on to state that increasing the 
requirement for licensure would actually result in fewer 
endocrinologists being able to take care of their own patients and 
would ultimately place increased and undue strain on the patients such 
as:
    1. Increased costs to the patient. The cost to patients receiving 
treatment in a hospital setting are double or triple the cost of an 
endocrinologist administering I-131 in his/her own office.
    2. Increased potential safety hazards for the patient. There is 
much more personal and focused attention given to the patient in the 
endocrinologist's office. In other settings, the patient is one of 
dozens of people waiting to be treated with a variety of doses for a 
variety of diseases. Thus, the possibility of error in communications 
and for the misadministration of I-131 is greatly increased.
    3. Increased emotional trauma during treatment. Patient anxiety and 
fear will be increased as a result of patients being required to go to 
nuclear medicine departments where other patients are being treated for 
all manner of disease, including cancer. This is an unnecessary 
exposure of the patient to psychological trauma and can be a deterrent 
to a patient seeking appropriate care.
    4. Increased need to visit additional specialists. With fewer 
endocrinologists administering I-131, patients will have to endure 
another layer of specialty consultation, resulting in delays in 
treatment, inconvenience and loss of time from work, significant 
increase in the cost of treatment, and exposure to unfamiliar settings 
and personnel.
    Commenters were also concerned that the proposed rule required that 
the 40 hours of supervised practical experience be obtained at a 
medical institution. They thought this is a prescriptive requirement 
which is not warranted because acceptable training could be provided in 
other clinical settings. Other commenters noted that this requirement 
would make it more difficult for endocrinologists to receive supervised 
practical experience from mentors or preceptors who practice and 
administer radioiodine in their offices, rather than in medical 
institutions.
    A commenter thought it paradoxical that the proposed rule would 
actually decrease the amount of clinical experience needed for 
licensure. The commenter indicated that currently, under Sec. 35.932, 
physicians are required to have supervised clinical experience with 10 
patients with hyperthyroidism and, under Sec. 35.934, they are required 
to have supervised clinical experience with 3 patients with thyroid 
cancer. The commenter indicated that, in the proposed rule, an 
individual must have experience with 5 cases. This commenter believed 
that this was a step backward from the current regulations because the 
clinical experience and practical aspects of the use of radioiodine are 
obtained during clinical experience, rather than obtained in a 
classroom setting. According to another commenter, the blanket 
requirement for 5 cases for each procedure may not always be 
appropriate. This commenter thought that it might be better to list the 
procedures and the number of required cases in the regulations.
    Response. In the final rule, Secs. 35.392 and 35.394 have been 
added to specifically address oral administrations of sodium iodide I-
131. These sections do not increase the duration of training for an 
endocrinologist over the current requirements in Secs. 35.932 and 
35.934.
    In the final rule, Sec. 35.392 was added to provide the training 
and experience requirements for physicians who only seek authorization 
for the oral administration of sodium iodide I-131 in dosages less than 
or equal to 1.22 gigabecquerels (GBq) (33 millicuries (mCi)) and do not 
seek authorization to prepare radioactive drugs using generators and 
reagent kits. To qualify as an AU under this limited authorization, an 
individual must have 80 hours of classroom and laboratory training and 
supervised work experience that includes 3 cases

[[Page 20265]]

involving the oral administration of sodium iodide I-131 in dosages 
less than or equal to 1.22 GBq (33 mCi). The NRC has not specified a 
breakdown between the number of hours of didactic (i.e., classroom and 
laboratory) and supervised work experience to allow licensees 
flexibility in designing and implementing training programs. Therefore, 
the number of hours of classroom and laboratory training and supervised 
work experience needed to adequately address the required subject areas 
can vary with individual training programs. These individuals may not 
prepare unsealed byproduct materials using generators and reagent kits.
    Also, Sec. 35.394 was added in the final rule to provide training 
and experience requirements for physicians who only seek authorization 
for the oral administration of sodium iodide I-131 in dosages greater 
than 1.22 GBq (33 mCi) and do not seek authorization to prepare 
radioactive drugs using generators and reagent kits. To qualify as an 
AU under this limited authorization, an individual must have 80 hours 
of classroom and laboratory training and work experience that includes 
3 cases involving the oral administration of sodium iodide I-131 in 
quantities greater than 1.22 GBq (33 mCi). Physicians authorized under 
Sec. 35.394 would also meet the training and experience criteria in 
Sec. 35.392. These individuals may not prepare unsealed byproduct 
materials using generators and reagent kits.
    We agree that it is not necessary for the supervised work 
experience required by Secs. 35.392 and 35.394 to be obtained at a 
medical institution. The essential element of this requirement is who 
is supervising the individual rather than where the experience is 
obtained. The final rule allows an individual to obtain work experience 
at any type of medical facility (e.g., medical institution, clinic, or 
private practice office), if the experience is under the supervision of 
an AU who meets the applicable requirements.
Issue 8: Should There Be a Difference Between the Training and 
Experience Requirements for Use of Sodium Iodide I-131 Liquid and 
Capsules?
    Comment. A commenter indicated that an individual who only planned 
on using iodine in a capsule should not be required to have as much 
training as someone who planned on using liquid iodine. The commenter 
recommended that only 40 hours of training was needed to learn how to 
handle I-131 capsules.
    Response. The final training and experience requirements do not 
differentiate between the different forms of I-131. The NRC believes 
that AUs should have the flexibility to prescribe whatever form of I-
131 they believe appropriate. Although there are differences between 
handling iodine in capsule form and liquid form (e.g., decontamination 
procedures), we do not believe that the differences are significant 
enough to warrant a separate category for training.
Issue 9: Should Diagnostic Use of I-131 Be Authorized Under Sec. 35.200 
or Sec. 35.300?
    Comment. A commenter noted that the proposed rule would move 
requirements for whole body imaging using sodium iodide I-131 from 
Sec. 35.200 to Sec. 35.300. The commenter argued that this would 
prevent physicians who are imaging specialists from performing the 
procedure and allow therapy specialists to do the procedure. This 
commenter suggested that the procedure not be included in either, but 
instead be listed as a line item authorization and that specified 
training and experience requirements be adopted for it.
    Response. The NRC does not believe that training and experience 
criteria for the use of sodium iodide I-131 for whole body imaging 
should be excluded from the regulations. The radiation safety 
considerations associated with the diagnostic use of millicurie 
quantities of sodium iodide I-131 more closely resemble the therapeutic 
use of sodium iodide I-131 than most diagnostic imaging and 
localization studies using technetium-99m. Therefore, the training and 
experience requirements for the use of sodium iodide I-131 in 
quantities greater than 1.11 Megabecquerels (MBq) (30 microcuries 
(Ci)), regardless of how it will be used, requires additional 
experience in the administration of these types of dosages.
    The final rule reduces the required number of cases, as stated in 
the proposed rule, from 5 to 3 for each type of use for which 
authorization is requested. We believe that a physician's involvement 
in 3 cases will provide him or her with adequate training and 
experience. In addition, we do not believe that requiring physicians to 
obtain administration experience or demonstrate they have such 
experience for three cases of sodium iodide I-131 represents an 
unwarranted burden, nor would it discourage such physicians from 
becoming authorized to use I-131.
Issue 10: Should Both Secs. 35.190 and 35.290 in the Final Rule Refer 
to Reagent Kits?
    Comment. A commenter stated that the proposed Sec. 35.292 (final 
Sec. 35.290) does not refer to ``reagent kits,'' although proposed 
Sec. 35.290 (final Sec. 35.190) does, and questioned whether this was 
an error.
    Response. The training and experience requirements to become an AU 
for imaging and localization require a physician to have experience 
with generators and reagent kits because physicians authorized under 
the final Sec. 35.290 (proposed Sec. 35.292) may prepare unsealed 
byproduct material using generator systems and reagent kits. Under the 
final Sec. 35.190 (proposed Sec. 35.290), physicians are not authorized 
to prepare byproduct material using generator systems and reagent kits. 
Therefore, it is appropriate that final Sec. 35.290, and not final 
Sec. 35.190, requires experience with eluting generator systems 
appropriate for preparing unsealed byproduct material for imaging and 
localization studies, measuring and testing the eluate for 
radiochemical purity, and processing the eluate with reagent kits.
Issue 11: Is It Necessary To Require Training in Calibrating Dose 
Calibrators and in Calculating and Measuring Dosages?
    Comment. A commenter stated that there was an inconsistency between 
the training and experience requirements in the proposed Secs. 35.292 
and 35.390 and the requirement to calibrate dose calibrators in 
Sec. 35.60 and the requirement to measure unit dosages in Sec. 35.63. 
The commenter recommended that we replace the phrase ``Calculating, 
measuring, and safely preparing patient or human research subject 
dosages,'' with the phrase ``Determining and safely preparing patient 
or human research subject dosages.''
    Response. The NRC believes that physicians who plan to use unsealed 
byproduct material must have training in calibrating instruments used 
to measure the activity of unsealed byproduct materials, in calculating 
and measuring dosages, and in eluting generators even though, in 
practice, an AU may choose to only use unit dosages. We believe that 
this training is important because AUs who meet the qualifications in 
the final Secs. 35.290 and 35.390 are not restricted to using unit 
dosages. The training requirements do not interfere with the practice 
of medicine or pharmacy because the rule provides sufficient 
flexibility for

[[Page 20266]]

procuring and preparing unsealed byproduct material.
    We have not replaced the words ``calculating and measuring'' with 
the word ``determining.'' Use of the words ``calculating and 
measuring'' clearly states our intent that an individual receive 
training in calculating (perform radioactive decay calculations) and 
measuring (use instrumentation to determine the activity) the activity 
of unsealed byproduct material.
Issue 12: Were There Any Other Changes Made to These Sections Between 
the Proposed and Final Rule?
    Response. Yes. The NRC revised the requirement for individuals to 
have experience administering dosages to patients or human research 
subjects to state: ``Administering dosages of radioactive drugs to 
patients or human research subjects.'' This was done to state clearly 
that experience administering radioactive drugs need not be limited to 
radioactive drugs containing byproduct material because there is no 
difference between the safety precautions that must be exercised when 
administering byproduct or nonbyproduct material.
    We revised the requirement for individuals to have experience using 
procedures to contain spilled byproduct material safely and using 
proper decontamination procedures to state: ``Using procedures to 
contain spilled radioactive material safely and using proper 
decontamination procedures.'' This was done to state clearly that 
experience with containing spilled radioactive material and 
decontaminating areas need not be limited to byproduct material because 
there is no difference between the safety precautions that must be 
exercised when handling byproduct or nonbyproduct material.
    We revised Secs. 35.290(c)(ii)(G) and 35.390(b)(ii)(F) to state: 
``* * * measuring and testing the eluate for radionuclidic purity* * 
*'' rather than ``* * * measuring and testing the eluate for 
radiochemical purity.'' This change has been made because it more 
accurately reflects the testing that licensees actually perform for 
quality control testing on generator eluates, e.g., determining the 
molybdenum-99 concentration in the eluate from a molybdenum-99/
technetium-99m generator.
    We added a reference to Sec. 35.390 in paragraph (b) of 
Secs. 35.100, 35.200, and 35.300. This was done to recognize that an 
individual who meets the requirements in Sec. 35.390 has sufficient 
training and experience to handle material safely under Secs. 35.100, 
35.200, and 35.300.
3. Training and Experience--Sealed Byproduct Material.
    For the most part, comments received on the following two sections 
related to more than one section. Therefore, the NRC is summarizing the 
comments received on these two sections in this discussion. Comments 
that pertain only to specific sections are discussed under that 
particular section heading.
    Section 35.490, Training for use of manual brachytherapy sources.
    Section 35.690, Training for use of remote afterloader units, 
teletherapy units, and gamma stereotactic radiosurgery units.
Issue 1: What Is the Appropriate Level of Training To Require?
    Comment. Some commenters felt that the current training 
requirements should be retained and that lessening of the current 
training requirements could have a tremendous detrimental effect on 
patient care. Many of these same commenters believed that the training 
for coronary artery therapy should be of the same level as for all 
other sealed source therapy. Conversely, some commenters supported 
lessening the training requirements to a level that considers only 
radiation safety and not clinical competence.
    Response. The NRC did not change the training levels required by 
these sections. We believe that individuals should complete a 
structured educational program that includes both classroom and 
laboratory training and work experience. We recognize that radiation 
safety training and clinical competency may be intertwined, especially 
for therapeutic uses of sealed sources. Therefore, we agree that 
significant changes should not be made in the current training 
requirements for AUs in this area.
Issue 2: Can This Section Be Revised To Refer to the Appropriate Review 
Committee and the Appropriate Time Division Reviewed by the Committee?
    Comment. A commenter suggested that Secs. 35.490(b)(2) and 
35.690(b)(2) should refer to the Residency Review Committee for 
Radiation Oncology (since 1993). The commenter also stated that the 
phrase ``that includes one year in a formal training program'' should 
be replaced with ``in radiation oncology as part of a formal training 
program.''
    Response. The NRC agrees with the suggested changes because the 
changes reflect the changes in the certification process since 1993. We 
have incorporated the requested changes in the rule.
Issue 3: Is Concurrent Training Allowed for Clinical and Work 
Experience?
    Comment. A commenter pointed out that, as written in the proposed 
rule, 6 years of training is required unless concurrent training is 
allowed. The commenter felt that the proposed rule would require 500 
hours of supervised practical experience plus 3 years of supervised 
clinical experience. The commenter also felt that the proposed rule 
would require 3 years of training with, for instance, iridium-192 
sources, and an additional 3 years of training in order to use gamma 
stereotactic radiosurgery sources.
    Response. The NRC agrees that concurrent training should be allowed 
for the clinical and work (practical) experience requirements in 
Secs. 35.490 and 35.690. Therefore, we revised the regulatory text in 
Secs. 35.490(b)(2) and 35.690(b)(2) to allow for concurrent work and 
clinical experience.
Issue 4: Were There Any Other Changes Made in These Sections Between 
the Proposed and Final Rule?
    Response. Yes. The NRC deleted the phrase ``or equivalent program 
approved by the NRC'' from Secs. 35.490(b)(2) and 35.690(b)(2) because 
a program equivalent to the ACGME program does not exist.

F. Global Changes in the Rule.

Issue 1: What Is the Sealed Source and Device Registry and How Do I 
Access the Registry?
    Comment. A commenter noted that the proposed revision would be 
strengthened if there were an indication as to the nature of the Sealed 
Source and Device Registry and how to obtain a copy.
    Response. The Sealed Source and Device Registry (SSDR), as defined 
in Sec. 35.2, is the national registry containing all the registration 
certificates, generated by both NRC and the Agreement States, that 
summarize the radiation safety information for sealed sources and 
devices and describe the licensing and use conditions approved for 
these products. The information contained in the registry is summarized 
from information provided during registration of the source or device 
in accordance with Sec. 32.210, Registration of product information. 
The Commission or Agreement State evaluates the information submitted 
to register a source (or device) and, if acceptable, issues a ``Safety 
Evaluation of Sealed Source (or Device).'' A

[[Page 20267]]

compilation of these evaluations can be found electronically at the 
following address: http://www.hsrd.ornl.gov/nrc/ssdr/ssdrindx.htm.
Issue 2: Should the Requirements in the Current Rule Related to 
Possession of Survey Instruments Be Deleted?
    Comment. A commenter stated that the requirements in the current 
Part 35 concerning possession of survey instruments are very useful and 
should not be deleted from the rule (Secs. 35.120, 35.220, 35.320, 
35.420, 35.520, and 35.620 in the current Part 35). This commenter 
believed that the Part 20 requirements are not specific enough on this 
point.
    Response. The NRC does not believe specific requirements relating 
to possession of survey instruments are needed in Part 35. Section 
20.1501 requires that the licensee make, or cause to be made, surveys 
to demonstrate compliance with 10 CFR Part 20. This provision requires, 
in part, 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 licensees to have adequate 
instrumentation. Information on the types of instruments is available 
in NUREG-1556, Vol. 9 (draft), ``Consolidated Guidance About Materials 
Licenses: Program-Specific Guidance about Medical Use Licenses.''
Issue 3: Should the Term ``Dose Calibrator'' Be Replaced With the Term 
``Radionuclide Calibrator'' in the Training and Experience Requirements 
for Unsealed Byproduct Material?
    Comment. Commenters suggested that we replace the term ``dose 
calibrator'' with the term ``radionuclide calibrator'' in proposed 
Secs. 35.50, 35.55, 35.290, 35.292, 35.390, 35.920 and 35.930.
    Response. The reference to ``dose calibrators'' in Secs. 35.50, 
35.55, 35.190, 35.290, and 35.390 has been deleted in the final rule 
and replaced with ``instruments used to determine the activity of 
dosages.'' (Secs. 35.920 and 35.930 will be retained 2 years after the 
effective date of the final rule.) As stated in the discussion of 
Sec. 35.60, this change recognizes that there are various types of 
instruments that can be used to measure the activity of unsealed 
byproduct material. Therefore, the NRC believes that individuals should 
have experience with the different types of instruments and not be 
limited only to experience with dose calibrators.
Issue 4: Were There Any Other Changes Made to the Rule Between the 
Proposed and Final Rule?
    Response. Yes. References in the proposed rule to Sec. 35.290 have 
been changed to Sec. 35.190 and references to Sec. 35.292 have been 
changed to Sec. 35.290. This was done because the training and 
experience requirements in proposed Secs. 35.290 and 35.292 were moved 
to Secs. 35.190 and 35.290, respectively. This change groups the 
sections that specify the requirements for an individual who would like 
to become an AU for a specific type of use with the section that 
provides information on that specific type of use. For example, 
Sec. 35.100 provides authorization for use of unsealed byproduct 
material for uptake, dilution, and excretion studies for which a 
written directive is not required and Sec. 35.190 contains the training 
and experience requirements for someone who would like to use material 
under Sec. 35.100.
    Throughout the final rule, the NRC has replaced the word 
``promptly'' with the phrase ``as-soon-as-possible.'' In the proposed 
rule, we used both ``promptly'' and ``as-soon-as-possible.'' For the 
purpose of this rule, both could be used interchangeably. Therefore, we 
have chosen to use the phrase ``as-soon-as-possible'' to maintain 
consistency within the rule. The phrase ``as-soon-as-possible'' is used 
to indicate that the required action should be taken immediately 
considering the circumstances. The term ``as soon as possible'' adds a 
degree of reasonableness to ``immediate.'' For example, a notification 
might be made the next morning rather than in the middle of the night.

G. Costs of the Revision

Issue 1: How Will Less Prescriptive Requirements in the Proposed Rule 
Affect Regulatory Compliance and Implementation Costs?
    Comment. Some commenters suggested that a shift from a more 
prescriptive to a less prescriptive and more performance-based 
regulatory system could lead to overall cost increases for regulatory 
compliance. For example, they said that if licensees are not required 
to submit procedures as part of their licensing application, and if NRC 
does not review their procedures at the time of licensing, the burden 
of reviewing the procedures may shift to inspections in the field. 
Therefore, these commenters believed that inspections might be more 
time-consuming and costly for both licensees and NRC. In addition, the 
frequency of review might increase because inspection cycles are 
shorter than licensing review cycles. Furthermore, the qualifications 
of inspectors might need to be increased, thus increasing the costs of 
implementing the rule. However, other commenters thought that less 
prescriptive regulatory requirements were desirable because, among 
other advantages, they would lower regulatory compliance costs.
    Response. The NRC estimates that licensees will incur lower 
compliance costs under less prescriptive regulatory requirements. 
Certain requirements have been eliminated and other requirements have 
been revised to allow licensees greater flexibility in compliance. For 
example, licensees will have greater flexibility in setting up 
Radiation Safety Committees and some licensees will not be required to 
form such committees. We plan to revise our licensing and inspection 
procedures and criteria to reflect the less prescriptive regulatory 
approach. Under the new performance-based approach, as long as 
licensees do not experience safety-related problems or medical events, 
they will be able to select the most efficient method of achieving 
regulatory compliance. It should not be necessary for NRC to incur 
implementation costs for inspections to review the approach licensees 
have selected, unless performance-related information suggests that a 
review is needed. For example, the NRC does not expect to review 
licensees' procedures unless a problem occurs that indicates the 
procedures may be inadequate and should be reviewed.
Issue 2: How Will the Cost and Availability of Health Care Involving 
Radionuclides Be Impacted by the Revised Regulations?
    Comment. Commenters argued that the costs of regulatory compliance 
could have the effect of reducing the availability of certain medical 
procedures by making them more expensive to the patient or by creating 
an incentive for physicians to substitute other procedures that have 
lower regulatory costs for diagnostic or therapeutic procedures 
involving radionuclides. Others stated that in their opinion the 
proposed rule was a positive step toward reducing compliance costs and 
creating concise and pertinent radiation safety standards.
    Response. The NRC believes that physicians act in the best interest 
of their patients. Therefore, the NRC expects that physicians will 
continue to select procedures that will result in the best diagnostic 
or therapeutic outcome for their patients.

[[Page 20268]]

Issue 3: How Will the Revised Regulations Affect Fees to Medical 
Licensees?
    Comment. Commenters suggested that if the revised Part 35 
regulations result in lower implementation costs to NRC and the 
Agreement States, there should be a reduction of licensing fees for 
medical use licensees.
    Response. Lower implementation costs that might result from this 
revision of Part 35 may not necessarily result in lower fees assessed 
to Part 35 licensees. Although budgeted costs are a major factor 
affecting the annual fees that individual NRC materials licensees are 
assessed, there are many other contributing factors. For example, a 
decrease in total costs to be assessed to materials licensees may not 
result in a decrease in the annual fee each licensee pays if there is 
also a significant decrease in the number of licensees available to pay 
the budgeted costs. Similarly, a decrease in costs associated with the 
implementation of Part 35 might be offset by increased costs for other 
activities.
    Most NRC materials licensees are subject to Part 171 annual fees 
only. The annual fees are established to recover NRC's budgeted costs 
allocated to this class of licensees, including the costs for 
inspections, license amendments, license renewals, and generic 
activities such as rulemaking and development of regulatory guides. The 
new license and inspection costs, which are indicative of the 
complexity of the various types of materials licenses, are used as a 
proxy for allocating the budgeted costs for the license fee categories 
within the materials license class.
    In FY 1999, the Commission determined that it would continue its 
policy to streamline and stabilize fees by adjusting the annual fees 
based on the percent change in the NRC's total budget each year, with 
additional adjustments for the number of licensees paying fees, changes 
in Part 170 collections, and other adjustments that may be required, 
unless there is a substantial change in the total NRC budget or the 
magnitude of the budget allocated to a specific class of licensees, in 
which case the annual fee base would be reestablished. The Commission 
established new baseline annual fees in FY 1999, and determined at that 
time that future annual fees should be rebaselined every three years, 
or earlier if warranted. After carefully considering all factors, 
including the changes to the amount of the budget allocated to classes 
of licensees, and weighing the complex issues related to both fairness 
and stability of fees, the Commission determined that it was 
appropriate to rebaseline the annual fees in FY 2001. A final rule 
revising the fee schedules was published on June 14, 2001 (66 FR 
32452).
Issue 4: Will Part 35 Create a Net Hazard by Imposing Costs for 
Regulatory Compliance That Could Be Better Spent Addressing Some Other 
Societal Risk?
    Comment. Commenters argued that for every approximately $9 to $12 
million spent on regulatory compliance and, therefore, not available 
for spending on some other aspect of safety, a life will be lost. They 
suggested that NRC has not demonstrated that the impact of the Part 35 
regulations in terms of patients saved from harm outweighs the costs 
imposed.
    Response. The NRC agrees that Part 35 should not impose costs that 
do not correspond to the risks being addressed. We have developed a 
rule that is intended to be more risk-informed, in which risk insights 
are considered together with other factors to establish requirements 
that better focus licensee and regulatory attention on design and 
operational issues commensurate with their importance to public health 
and safety. We have also made the final rule less prescriptive and more 
performance-based to help ensure that it does not create unnecessary 
compliance or implementation costs. Therefore, we believe that the 
final rule properly balances the risks and costs involved.
Issue 5: What Is the Total Cost of Regulating the Medical Uses of 
Radionuclides?
    Comment. Several commenters stated that it would be useful to know 
the total cost of regulating the medical uses of radionuclides. 
Knowledge of the full costs, in the view of some commenters, would 
allow the selection of the least costly and least restrictive 
regulations and would allow a more rational allocation of resources 
than the current system. Some commenters reported that their estimates 
indicated that the annual cost of regulatory compliance exceeded $100 
million; others reported that their estimate indicated the annual cost 
exceeded $130 million just for paperwork; still others reported that 
their estimate indicated the annual cost exceeded $500 million to $1 
billion the first year and hundreds of millions per year thereafter. In 
contrast, other commenters stated that developing an estimate of the 
total cost of compliance was probably very difficult or impossible.
    Response. In evaluating the costs of regulatory compliance and 
implementation, the NRC has used detailed information whenever it is 
available. We have sought data from a number of sources, including 
medical speciality groups, manufacturers, members of the ACMUI, the 
National Institutes of Health, and various published sources. However, 
certain necessary data are treated as proprietary. Other data are not 
collected or are available only in a disaggregated form. Many of the 
compliance costs will vary substantially from licensee to licensee, 
depending on the number and type of modalities and procedures that they 
use and perform. Other compliance costs will be dependent on numerous 
interrelated variables. We believe that an effort to collect the 
necessary data and/or develop necessary models to provide substitutes 
for missing or unavailable data would require very considerable time 
and expense. We are concerned that at the conclusion of such an effort, 
because of many remaining gaps and uncertainties in the underlying 
data, an estimate of the total cost of the regulations would still fall 
within such broad confidence bounds that it would be fundamentally 
flawed. In this regard, we note that commenters' estimates of the total 
costs of the regulations vary by at least one order of magnitude and 
provide little or no underlying basis for their conclusions. Therefore, 
we prepared an estimate of the regulatory costs for a typical single 
practitioner licensee in order to satisfy the requirements of the 
Regulatory Flexibility Act. We have not prepared an estimate of the 
kind called for by the commenters because of the reasons discussed 
above.
Issue 6: Is NRC Aware That Certain Costs Are Not Reimbursable by the 
Health Care Financing Agency (HCFA)?
    Comment. Several commenters noted that HCFA does not reimburse 
certain regulatory costs. Therefore, they asserted that either 
unnecessary regulations should be eliminated, or that NRC should 
intercede with HCFA to change the reimbursement policy. Estimates of 
the impact of HCFA's policy varied. A commenter suggested that at least 
35 percent of medicine is practiced in the public sector (Medicare, 
Medicaid, and State health care programs); that in nuclear medicine a 
larger percentage of costs are being paid by Federal agencies; and that 
absence of reimbursement can reduce a physician's revenues by 15 to 30 
percent. Another commenter estimated that regulatory compliance costs 
an estimated $30 to $40 per patient for a diagnostic procedure 
involving radionuclide materials. However, another commenter noted that 
for a procedure for which

[[Page 20269]]

reimbursement was $750 to $1,500, an estimated unpaid cost of 
compliance of $35 to $40 was not particularly significant.
    Response. The NRC believes that involvement by NRC in HCFA's 
development of policy on reimbursement is outside the scope of this 
rulemaking and NRC's jurisdiction.
Issue 7: Will Testing Requirements for New Authorized Users, Authorized 
Nuclear Pharmacists, etc., Cause an Unnecessary Increase in Cost 
Without Commensurate Benefit?
    Comment. Commenters argued that the testing requirements in the 
proposed rule were not necessary. Providers of didactic training 
already make use of testing as a validation system. In addition, 
testing would substantially increase the costs of implementing the 
rule. Development, administration, and maintenance of a separate 
testing system would not be cost effective. Unless testing were offered 
frequently, the requirement could create an obstacle to adequate 
staffing of medical institutions or nuclear pharmacies and actually 
negatively impact compliance and safety.
    Response. The NRC agrees with the commenters and have removed the 
testing requirement that was in the proposed rule.
Issue 8: Does the OMB Estimate Accurately Summarize the Paperwork 
Burden of the Proposed Rule?
    Comment. Commenters suggested that the OMB estimate of the Part 35 
recordkeeping and reporting requirements is too low, listing several 
items that in their opinion were not properly included. Some commenters 
argued that NRC's suggested procedures are ``useless'' and, therefore, 
licensees will need to write numerous procedures. In addition, 
increased legal costs, amendment costs, and costs from discarded doses 
needed to be included. Commenters also suggested that hundreds of 
millions of dollars in paperwork costs were missing from the estimate, 
or that such costs are ``staggering,'' without providing a more 
specific description of the sources of the missing costs.
    Response. The estimates for the information collection burden of 
many of the reporting and recordkeeping requirements in the proposed 
rule were based on previous estimates that were made available for 
public comment and submitted to the Office of Management and Budget 
(OMB). In a number of cases, the reporting and recordkeeping 
requirements in the final rule have been reduced from the requirements 
in the current rule. Therefore, the total information collection burden 
is lower than previously submitted to OMB for the current Part 35. In 
addition to information from previous burden estimates, we also 
obtained updated data from other sources such as NRC licensees, NRC 
regional licensing and inspection staff, NRC data bases, Agreement 
States, and stakeholders.
    We agree that the estimates for the information collection burden 
associated with the testing requirements in the proposed rule were 
uncertain and may have been too low. However, the testing requirements 
are not included in the final rule.
    Issue 9: Do the Potential Health and Safety Benefits of Requiring 
All Licensees to Possess Dose Calibrators Outweigh the Cost of the 
Calibrators?
    Comment. Commenters suggested that the NRC should not require all 
licensees to possess a dose calibrator. They noted that certain 
categories of licensees only use unit dosages, and, therefore, 
obtaining a dose calibrator would create an unnecessary expense for 
them.
    Response. The NRC has revised Sec. 35.63 to require a licensee to 
determine and record the activity of each dosage before medical use. 
For a unit dosage, this determination could be made by a decay 
correction, based on the activity or activity concentration determined 
by (1) a manufacturer or preparer licensed under Sec. 32.72 of this 
chapter or equivalent Agreement State requirements, or (2) an NRC or 
Agreement State licensee in accordance with a Radioactive Drug Research 
Committee-approved protocol or an Investigational New Drug (IND) 
protocol accepted by FDA for use in research. Therefore, a licensee who 
uses only unit dosages would not be required to incur the cost of a 
dose calibrator. However, the requirements also allow a licensee to use 
a dose calibrator to determine the activity of the unit dosage by 
direct measurement of radioactivity if he or she chooses to do so.
Issue 10: Do the Potential Health and Safety Benefits of Requiring 
Licensees To Conduct an Annual Retrospective Review of a Sample of 
Records of Administrations That Require a Written Directive Outweigh 
the Costs of the Reviews?
    Comment. Commenters on a ``strawman'' version of the rule stated 
that the review that would be required by Sec. 35.24(c) of the proposed 
rule, under which licensees would have been required to review a 
representative sample of records of administrations that require a 
written directive, would be an expensive requirement that would not 
reduce the rate of medical events. Furthermore, they said that a 
licensee would be forced to review 100 percent of the records to ensure 
that an inspection does not uncover a problem that was not reported.
    Response. The NRC agrees that the proposed requirement was too 
prescriptive and, therefore, we deleted it from the final rule.
    Issue 11: Do the Potential Health and Safety Benefits of Requiring 
Licensees To Establish Procedures To Provide Reasonable Assurance That 
a Radiopharmaceutical Will Not Be Unintentionally Administered to a 
Pregnant or Breast-Feeding Woman Outweigh the Costs of Compliance?
    Comment. Commenters argued that a requirement to provide reasonable 
assurance that a radiopharmaceutical will not be unintentionally 
administered to a pregnant or breast-feeding woman could result in the 
administration of pregnancy tests for nearly all patients of child-
bearing age, and this will increase costs.
    Response. The NRC recognizes that the standard of practice for 
authorized users is to assess the pregnancy or nursing status of their 
female patients (see ACR ``Standard for the Performance of Therapy with 
Unsealed Radionuclide Sources,'' 1996, and ``Society of Nuclear 
Medicine General Procedure Guidelines for Imaging with Radionuclides,'' 
1997). As a result, we do not believe that it is necessary for the NRC 
to require a licensee to assess the pregnancy or nursing status of 
patients before a medical treatment involving byproduct material.
Issue 12: Should Costs of Regulatory Implementation and Compliance by 
Licensees of Agreement States Be Included in the Regulatory Analysis?
    Comment. A commenter argued that the regulatory analysis should 
reflect the possibility that Agreement States may not adopt all of the 
regulatory provisions included in the proposed rule.
    Response. The NRC agrees with the commenter that, depending on the 
compatibility level assigned to particular regulatory requirements, 
Agreement States may not adopt all of the provisions in the proposed 
rule. However, in order to estimate the full impact of the regulatory 
changes in Part 35, we have assumed in developing the Regulatory 
Analysis that the Agreement States will adopt and implement all the 
provisions. However, we have provided sufficient details concerning 
estimated numbers of Agreement State licensees. Therefore, anyone who 
wishes to do so can estimate the effects of different

[[Page 20270]]

assumptions concerning Agreement State adoption and implementation of 
the requirements in the final rule.
Issue 13: Does the Regulatory Analysis Properly Estimate the Costs of 
Compliance With Particular Sections of the Proposed Rule?
    Comment. Commenters criticized the estimates in the Regulatory 
Analysis for particular sections of the proposed rule. In particular, 
they suggested that the time necessary to prepare a license amendment 
could be greater than estimated for Sec. 35.6, that the number of 
license amendments likely to be submitted under Sec. 35.13 could be 
estimated more precisely, and that the time required for a meeting of a 
Radiation Safety Committee could be greater than estimated. Commenters 
also suggested that the interaction of Secs. 35.400, 35.500, and 35.590 
with Sec. 35.12 was unclear, and additional license amendments might 
need to be costed under Sec. 35.12. Commenters questioned whether the 
intent of the rule was to require calibration of every brachytherapy 
source under Sec. 35.432, and, if so, said that additional costs should 
be estimated. Commenters also asked for substantiation for the $1000 
estimate for calibrating brachytherapy sources and asked for 
clarification regarding the number of affected licensees. When no 
incremental cost was indicated for a particular section of the proposed 
rule (e.g., Secs. 35.610, 35.3045, and 35.3067), a commenter requested 
that a cost estimate be provided.
    Response. The NRC reviewed the Regulatory Analysis and provided 
additional clarification when possible for the points raised by the 
commenters. We concluded that the estimated time for preparation of an 
application for a license amendment under Sec. 35.6 would not differ 
significantly from the time necessary to prepare any other license 
amendment application.
    We also concluded that because the changes to the requirements 
concerning when a license amendment is required reflect changes to 
other sections of the rule (e.g., revisions to the requirements 
concerning changes to the areas of use under Secs. 35.100 and 35.200) a 
count of former license amendment applications would not provide useful 
data. We agree that the time required for Radiation Safety Committee 
meetings can vary, but concluded that the elimination of prescriptive 
requirements for the Radiation Safety Committee, including the number 
of required attendees and procedural requirements concerning the 
meetings, would result in an average reduction in the duration of 
meetings. We concluded that the commenter had not correctly interpreted 
the interaction of Secs. 35.400, 35.500 and 35.590 with Sec. 35.12, 
particularly because the commenter appeared to be referring to the 
strawman proposed rule. Therefore, we did not provide the estimate 
called for. The estimate of $1000 per licensee for calibration of 
brachytherapy sources was based on information from NRC staff and 
members of the ACMUI concerning the number of calibrations that would 
be performed by an average licensee and the time necessary to perform 
each calibration. With respect to the commenter's request for a total 
cost estimate, see the response to Issue 5.

Part III--Specific Comments on the Proposed Rule

Part 20--Standards for Protection Against Radiation

Section 20.1002, Scope

Issue 1: Were Any Changes Made to This Section Between the Proposed and 
Final Rule?
    Response. Yes. The NRC amended this section to replace the phrase 
``to exposure from individuals administered radioactive material and 
released in accordance with Sec. 35.75'' with the phrase ``to exposure 
from individuals administered radioactive material and released under 
Sec. 35.75.'' This change clarifies that the dose to individual members 
of the public from a licensed operation does not include doses received 
by individuals exposed to patients who were released by the licensee 
under the provisions of Sec. 35.75.
    In 1997, we amended the regulations for the release of patients 
administered radioactive material to base the criteria for patient 
release on the potential dose to other individuals exposed to the 
patient (62 FR 4120; January 29, 1997). As part of that rulemaking, we 
also amended the regulatory text in Secs. 20.1002, 20.1003 and 21.1301 
to reflect the Commission's policy that patient release is governed by 
Sec. 35.75, not Sec. 20.1301 (62 FR 4120; January 29, 1997, see page 
4122).
    Current Secs. 20.1002, 20.1003, and 20.1301(a)(1) indicate that the 
dose limits for individual members of the public or for an 
occupationally exposed individual from a licensed operation do not 
include doses received by individuals exposed to patients who were 
released in accordance with Sec. 35.75. Upon further review, we believe 
that changes needed to be made to the current regulatory text in 
Secs. 20.1002, 20.1003, and 20.1301, to further clarify that the dose 
limits do not apply to the maximally exposed individual from a patient 
or human research subject who has been administered unsealed byproduct 
material or implant containing byproduct material (reference 
Sec. 35.75) and has been released from the licensee's control.
    Under Sec. 35.75, a licensee may release an individual from its 
control if the total effective dose equivalent to any other individual 
from exposure to the released individual is not likely to exceed 5 
millisievert (mSv)(0.5 rem). The licensee is required to comply with 
all the requirements in Sec. 35.75. Failure to comply with any of the 
provisions in Sec. 35.75 may result in enforcement action. This change 
in Sec. 20.1002 makes it clear that any violations will be cited 
against Sec. 35.75 and not Part 20.

Section 20.1003, Definitions

Issue 1: Were Any Changes Made to This Section Between the Proposed and 
Final Rule?
    Response. Yes. The NRC made corresponding changes to the 
definitions for occupational dose and public dose to clarify that these 
doses do not include doses received by individuals exposed to patients 
who were released by the licensee under the provisions of Sec. 35.75. 
Specifically, we amended these definitions to replace the phrase ``from 
exposure to individuals administered radioactive material and released 
in accordance with Sec. 35.75'' with the phrase ``from exposure to 
individuals administered radioactive material and released under 
Sec. 35.75.'' The rationale for these changes is discussed in depth 
under Sec. 20.1002, above.

Section 20.1301, Dose Limits for Individual Members of the Public

Issue 1: Who Should Approve Whether a Visitor Is Allowed To Receive a 
Dose Up to 5 mSv (0.5 rem)?
    Comment. A commenter suggested that the RSO, not the AU, should be 
the appropriate individual to approve the merits of allowing a visitor 
to receive up to 5 mSv (0.5 rem).
    Response. AUs have the primary responsibility for the health and 
safety of their patients. They are also responsible for determining, 
depending on the patient's condition, whether individuals can visit 
patients and with what limitations. Therefore, the NRC believes that 
the AU should approve whether a visitor is allowed to receive a dose up 
to 5 mSv (0.5 rem). However, the AU may consult with the RSO at any 
time regarding visitor control.

[[Page 20271]]

Issue 2: Should Visitors be Allowed To Receive a Dose Up to 5 mSv (0.5 
rem)?
    Comment. The commenter stated that the proposed rule did not meet 
any standard for justifying an increased exposure to someone visiting a 
hospitalized (confined) patient. The commenter indicated that one of 
the reasons for the increased dose limit in Sec. 35.75 was the economic 
benefit of allowing the patient or human research subject to be 
released from control earlier. He went on to state that in the case of 
the proposed revision to Sec. 20.1301, there was no economic benefit to 
the licensee and that NRC was basing this change on an emotional 
benefit to the patient rather than an economic benefit.
    Response. The justification for this change was discussed in detail 
in the Statements of Consideration for the proposed rule (63 FR 43516; 
August 13, 1998) and in the associated draft Regulatory Analysis. It is 
restated in Section III, Part III of the SUPPLEMENTARY INFORMATION in 
this document and in the final Regulatory Analysis. Overall, the NRC 
believes that the emotional benefit to the patient or the visitor 
outweighs the increase in radiation risk to the visitor. AUs should 
have the flexibility to make a determination, based on their judgment, 
as to whether a patient or human research subject would benefit from 
allowing a visitor to receive a dose up to 5 mSv (0.5 rem). The AU must 
consider the patient's condition when determining whether it is 
appropriate to allow a visitor to receive a dose up to 5 mSv (0.5 rem). 
We changed the regulatory text in Sec. 20.1301(c)(2) to clarify that 
the authorized user must make the determination whether the visit is 
appropriate before the visit occurs.
Issue 3: Were Any Changes Made to This Section Between the Proposed and 
Final Rule?
    Response. Yes. The NRC changed the regulatory text in 
Sec. 20.1301(a)(1) to indicate that the dose to individual members of 
the public from a licensed operation does not include doses received by 
individuals exposed to patients who were released by the licensed 
operation under the provisions of Sec. 35.75. Specifically, we replaced 
the phrase ``from exposure to individuals administered radioactive 
material and released in accordance with Sec. 35.75'' with the phrase 
``from exposure to individuals administered radioactive material and 
released under Sec. 35.75.'' The rationale for this change is discussed 
under Sec. 20.1002.

Part 32--Specific Domestic Licenses of Broad Scope for Byproduct 
Material

Section 32.72, Manufacture, Preparation, or Transfer for Commercial 
Distribution of Radioactive Drugs Containing Byproduct Material for 
Medical Use Under Part 35

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC corrected the reference to ``paragraph 
(b)(2) and (b)(3)'' in Sec. 32.72(b)(1) to read ``paragraphs (b)(2) and 
(b)(4).''

Part 35--Medical Use of ByProduct Material

Subpart A--General Information

Section 35.1, Purpose and scope.

Issue 1: How Does This Rule Provide for the Radiation Safety of 
Patients?
    Comment. Commenters did not believe that Part 35 should address the 
radiation safety of patients because it would necessitate NRC making 
medical judgments. Commenters noted that physicians are trained to make 
informed decisions on behalf of patients. They believed that the NRC 
should ensure that those practicing nuclear medicine are adequately 
trained in nuclear science, thus ensuring that the radiation safety of 
patients is provided for.
    Response. The NRC made no changes to the regulatory text in this 
section. We believe that the NRC should provide for the radiation 
safety of the public, workers, and patients. The Commission's goal in 
regulating nuclear material safety, as stated in its September 1997 
``Strategic Plan'' (NUREG-1614, Vol. 1), is to ``prevent radiation-
related deaths or illnesses due to civilian use of source, byproduct 
material, and special nuclear material.'' The radiation safety of the 
public, workers, and the patient is central to the fulfillment of the 
Commission's statutory mandate to ``protect health and minimize danger 
to life.''
    The Commission has decided to retain its long-standing medical use 
regulatory program. However, it is doing so with improvements, 
including decreased oversight of low-risk activities and continued 
emphasis on high-risk activities. The Commission has long recognized 
that physicians have the primary responsibility for the diagnosis and 
treatment of their patients. NRC regulations are predicated on the 
assumption that properly trained and adequately informed physicians 
will make decisions that are in the best interest of their patients. 
However, the NRC has a secondary, but necessary, role with respect to 
the radiation safety of patients. The NRC will, when justified by the 
risk to patients, regulate their radiation safety, primarily to ensure 
that the use of radionuclides is in accordance with the physician's 
directions.
Issue 2: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC replaced the word ``prescribes'' with the 
phrase ``contains the'' in the first sentence of the section because 
Part 35 contains the requirements and provisions for the medical use of 
byproduct material and for issuance of specific licenses authorizing 
medical use.

Section 35.2, Definitions

    The NRC received numerous comments on the definitions. Commenters 
asked us to revise, delete, or add definitions for terms used in the 
rule. We also added some new terms in this section because of changes 
made in other sections of the rule. Public comments and our response to 
the comments, as well as the reasons for other changes to this section, 
are presented below, in alphabetical order of the terms.
    Address of use.
Issue 1: Were There Any Changes Made in This Definition Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added the word ``preparing'' to the 
definition to recognize that licensees not only receive, use, and store 
byproduct material but, in the case of a medical licensee, they may 
also prepare the material for use.
    Area of use.
    Issue 1: Were There Any Changes Made in this Definition Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added the word ``preparing'' to the 
definition to recognize that licensees not only receive, use, and store 
byproduct material but, in the case of a medical licensee, they may 
also prepare the material for use.
    Authorized Medical Physicist.
Issue 1: Should the Term ``Medical Physicist'' Be Used in the Rule?
    Comment. Commenters believed that a ``medical physicist'' would 
better be defined by a unique term, similar to ``Authorized User,'' 
which has no meaning outside the regulations. They stated that use of 
the term ``authorized physicist'' would be consistent with ``authorized 
user.''

[[Page 20272]]

    Response. The NRC retained the term ``authorized medical 
physicist'' in the final rule. This was done to maintain consistency 
with other terms used in Part 35 (AU and ANP). We also believe the term 
``authorized physicist'' may be too broad, and we would like to make it 
clear that this individual has experience as a medical physicist.
Issue 2: Can an AMP Be an AU?
    Comment. Commenters questioned whether a medical physicist could be 
the AU and, if so, whether there would be a need to have a physician 
listed on a nuclear medicine license?
    Response. It is always necessary to name an AU on the Part 35 
license because only an AU can prescribe dosages or doses of byproduct 
material for medical use under Part 35. An AU for medical use under 
Secs. 35.100, 35.200, 35.300, 35.400, and 35.600 must be a physician. 
An AU for medical use under Sec. 35.500 may be a physician, dentist, or 
podiatrist. An AMP could only be an AU, named in the license, if the 
AMP meets the criteria in the definition of AU in Sec. 35.2, including 
the training and experience criteria cited in that section.
Issue 3: Were There Any Changes Made in This Definition Between the 
Proposed and Final Rule?
    Response. Yes. In addition to restructuring the definition, to make 
it more readable, the NRC substituted the word ``individual'' for the 
word ``physicist.'' This change has been made so that the definition of 
the term would be similar to the definition for an RSO.
    We also amended the definition for the AMP to include individuals 
identified as an AMP on a medical use permit issued by a Commission 
master material licensee, or a permit issued by a Commission master 
material license broad scope medical use permittee. This change, which 
was also made to the definitions of ``ANP,'' and ``AU,'' accounts for 
the fact that an AMP may be named on a permit issued by a master 
material licensee. For example, in the first case identified above, if 
a master material licensee has issued a permit that recognizes a 
particular individual as an AMP, under the revised definition the 
individual would continue to meet the requirements for an AMP under an 
NRC license. In the second case, if a master material licensee chooses 
to issue a broad scope permit to a hospital and that hospital has 
authorization to issue permits designating AMPs, under the revised 
definition an AMP on the permit would also meet the requirements for an 
AMP under an NRC license. For a definition and description of master 
materials licenses refer to NUREG-1556, Vol. 10, ``Consolidated 
Guidance About Materials Licenses: Program-Specific Guidance About 
Master Materials Licenses.''
    Authorized Nuclear Pharmacist.
Issue 1: What Are the Duties of an ANP?
    Comment. A commenter stated that the responsibilities and duties of 
the ANP were not codified.
    Response. The NRC did not change the regulatory text in response to 
this comment. We have used the definitions section to provide an 
understanding of what we mean by a term. We do not believe it is 
appropriate to list the responsibilities and duties of the ANP either 
in the definitions section or elsewhere in the rule. In most cases, we 
have not specified who must perform a particular duty. This was done to 
give the licensee flexibility in how it implements its radiation 
protection program. However, where justified by risk, we have specified 
who must perform specific duties in a limited number of cases. For 
example, the full calibration measurements on remote afterloader must 
be performed by an AMP (Sec. 35.633(h)).
Issue 2: Why Do Nuclear Pharmacies Have the Authority To Approve ANPs?
    Comment. A commenter did not believe that nuclear pharmacies should 
be authorized to approve ANPs.
    Response. This commenter objected to one way by which an individual 
may be qualified to be an ANP, i.e., approval by a nuclear pharmacy 
authorized to approve ANPs. This pathway to be a qualified ANP was 
added to the final rule for two reasons. One, the current definition 
needs to recognize that Sec. 32.72(b)(4) allows nuclear pharmacies to 
designate a pharmacist as an ANP if the individual meets certain 
requirements. Specifically, Sec. 32.72(b)(4) contains a 
``grandfathering'' provision permitting certain Part 32 nuclear 
pharmacy licensees to designate a pharmacist as an ANP, if the 
individual is identified, as of December 2, 1994, as an AU on a nuclear 
pharmacy license issued by the Commission. [If you would like 
additional information on Sec. 32.72, refer to the regulatory history 
of the radiopharmacy rule (58 FR 33396; December 2, 1994, see page 
33400).] Second, this change is needed because some nuclear pharmacies 
have a license amendment that allows them to approve ANPs if the 
individual meets the training and experience requirements in Part 35. 
Without this corresponding change in Part 35, the individual would not 
be allowed to function as an ANP regardless of the nuclear pharmacy's 
approval.
Issue 3: Were There Any Changes Made in This Definition Between the 
Proposed and Final Rule?
    Response. Yes. The definition was restructured to make it more 
readable. The NRC also amended the definition for the ANP to include 
pharmacists identified as ANPs on a permit issued by a Commission 
master material licensee that authorizes medical use or the practice of 
nuclear pharmacy or a permit issued by a Commission master material 
license broad scope medical use permittee that authorizes medical use 
or the practice of nuclear pharmacy, or designated as an ANP in 
accordance with Sec. 32.72(b)(4). This change, which parallels changes 
made to the definitions of ``AMP'' and ``AU,'' accounts for the fact 
that an ANP may be named on a permit issued by a master material 
licensee. In addition, the definition was amended to include ANPs that 
have been identified by a commercial nuclear pharmacy which has been 
given authorization to identify ANPs. In the first case identified 
above, if a master material licensee has issued a permit that 
recognizes a particular individual as an ANP, under the revised 
definition the individual would continue to meet the requirements for 
an ANP under an NRC license. In the second case, if a master material 
licensee chooses to issue a broad scope permit to a hospital and that 
hospital has authorization to issue permits designating ANPs, under the 
revised definition an ANP on the permit would also meet the 
requirements for an ANP under an NRC license.
    Authorized User.
Issue 1: What Does an AU Do?
    Comment. A commenter recommended that the definition of 
``Authorized user'' include the duties of an AU.
    Response. The NRC did not change the regulatory text to include the 
duties of the AU in the definition. We have used the definitions 
section to provide an understanding of what we mean by a term, as it is 
used in Part 35. Duties that must be performed by the AU are stated in 
regulatory text, where appropriate. The issue of whether the duties of 
a licensed individual belong in the definition section is discussed in 
more detail under the term ``authorized nuclear pharmacist.''
Issue 2: Does the Rule Distinguish Between Different Types of AUs?
    Comment. A commenter recommended we clarify each type of

[[Page 20273]]

AU, or distinguish between AUs involved in diagnostic versus 
therapeutic medical uses.
    Response. The NRC does not believe the definition of AU should be 
modified in this way. Other requirements in this part address the 
safety requirements for the different types of medical uses and the 
AU's actual duties. For example, the training and experience 
requirements for AUs, as well as other requirements in the regulations, 
differentiate between diagnostic and therapeutic medical uses of 
byproduct material. The training and experience requirements for an AU 
who would like to use unsealed byproduct material for uptake, dilution, 
and excretion studies (Sec. 35.290) differ from the training and 
experience requirements for an AU who would like to use unsealed 
byproduct material for therapy (Sec. 35.390). Also, radiation safety 
requirements are not the same for diagnostic medical uses as compared 
to therapeutic medical uses. Finally, the medical use license indicates 
what materials can be used by an AU.
Issue 3: Can Non-Physicians Be AUs?
    Comment. A commenter noted that although the definition of ``AU'' 
refers to ``any prescriber,'' (i.e., physician, dentist, or 
podiatrist),'' the proposed rule language (in Secs. 35.100, 35.200, and 
35.300) refers only to a physician. The commenter indicated that if 
dentists and podiatrists cannot be AUs, the regulations should state 
this.
    Response. Section 35.2 contains a general definition of an AU. 
Specific training and experience requirements for AUs are contained 
elsewhere within the regulatory text of Part 35. Where appropriate, the 
rule does specify when an AU must be a physician. An AU of materials 
authorized in Secs. 35.100, 35.200, 35.300, 35.400, and 35.600 must be 
a physician. An AU using materials authorized under Sec. 35.500 can be 
a physician, dentist, or podiatrist, if that individual meets all of 
the training and experience requirements for this type of use.
Issue 4: Were There Any Changes Made in This Definition Between the 
Proposed and Final Rule?
    Response. Yes. The NRC also amended the definition for the AU to 
include physicians, dentists, or podiatrists identified as AUs on a 
permit issued by a Commission master material licensee that is 
authorized to permit the medical use of byproduct material, or a permit 
issued by a Commission master material license broad scope medical use 
permittee that is authorized to permit the medical use of byproduct 
material. This change, which was also made to the definitions of 
``ANP,'' and ``AMP,'' accounts for the fact that an AU may be named on 
a permit issued by a master material licensee. For example, in the 
first case identified above, if a master material licensee has issued a 
permit that recognizes a particular individual as an AU, under the 
revised definition the individual would continue to meet the 
requirements for an AU under an NRC license. In the second case, if a 
master material licensee chooses to issue a broad scope permit to a 
hospital and that hospital has authorization to issue permits 
designating AUs, under the revised definition, an AU on the permit 
would also meet the requirements for an AU under an NRC license.
    We also added a reference to new sections in the final rule that 
list the training and experience requirements for individuals using 
only I-131 in quantities that would require a written directive 
(Secs. 35.392 and 35.394) and for individuals using strontium-90 for 
ophthalmic treatments (Sec. 35.491).
    Brachytherapy.
Issue 1: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added a definition for brachytherapy. We 
believe it is important to define such a term as it is used in Part 35 
so that the regulated community and regulatory agencies have a clear 
understanding of what we mean when we use the term in the rule.
    Brachytherapy source.
Issue 1: Were There Any Changes Made in This Definition Between the 
Proposed and Final Rule?
    Response. The NRC did not receive any public comment on this 
definition. However, we did delete the word ``sealed'' in the 
definition. This was done in order to include sources which do not meet 
the definition of ``sealed source'' (i.e., ``radioactive plated, 
embedded, and activated'' sources).
    Client's address.
Issue 1: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added a definition for client's address 
because we now use it in Sec. 35.80, ``Provision of mobile medical 
service.'' The term ``client's address'' encompasses an area of use, as 
well as a temporary job site. Use of this term in the rule is explained 
in greater depth under the discussion of Sec. 35.80.
    Diagnostic clinical procedures manual.
Issue 1: Is This Term Needed?
    Comment. Commenters recommended this term be deleted because it is 
too prescriptive and should be replaced with the term 
``radiopharmaceutical prescription/order.'' A radiopharmaceutical 
prescription/order can either be written for an individual patient 
(e.g., a written directive for therapeutic radiopharmaceuticals) or be 
in the form of specific standing orders. The commenter was concerned 
that use of the term ``clinical procedures manual'' may limit a 
licensee's ability to compound radioactive drugs. As such, according to 
the commenter, the term raises a clinical medical practice issue under 
state law regarding the practice of medicine and pharmacy. The 
commenter believed that it would be more appropriate for the NRC to 
require a general description of the radiation safety procedures used 
to protect workers, the public, and other patients from unintentional 
exposures. The commenter indicated the procedure manuals are written by 
physicians and should only be considered as informational or guidance 
documents for technologists.
    Response. In response to this comment, the NRC deleted ``diagnostic 
procedures manual'' both as a defined term in Sec. 35.2 and from the 
definition of ``prescribed dosage'' in Sec. 35.2. Also, because this 
term is not used in the regulatory text, we no longer need to define 
it.
    As modified, the rule is less prescriptive and does not limit a 
licensee's ability to compound certain radioactive drugs. Sections 
35.100, 35.200, and 35.300 permit certain uses of unsealed byproduct 
material which are prepared by an ANP, a physician who is an AU 
(meeting certain requirements), or an individual under their 
supervision.
    Health physicist.
    Comment. A commenter asked that we add a definition for ``health 
physicist.'' This individual would be defined as ``a person qualified 
in the art, science, and professional practice of radiation safety as 
evidenced by current certification by the American Board of Health 
Physics (ABHP) or an equivalent certifying body with substantially the 
same requirements.'' The commenter believed that NRC, when identifying 
physicists, was defining a specific position too narrowly, with 
delineated duties and responsibilities that represent only a portion of 
the duties and responsibilities of physicists who are involved in 
radiation safety.
    Response. The NRC has not defined the term in Part 35 because it is 
not used

[[Page 20274]]

in Part 35. Physicists meeting the requirements for an ``authorized 
medical physicist'' or ``Radiation Safety Officer'' would be recognized 
on the license as either an AMP or RSO, respectively.
    High dose-rate remote afterloader and low dose-rate remote 
afterloader.
Issue 1: Should There Be Another Category of ``Afterloader,'' Such as a 
``Non-Remote'' or ``Beta-Only'' Afterloader?
    Comment. A commenter stated that the proposed afterloader 
definitions don't distinguish between the beta device that delivers 
more than 2 Gray/hour (Gy/h) to a target tissue and less than 0.002 Gy/
h to the remainder of the body from the afterloader capable of 
delivering a lethal whole body dose. The proposed definitions will 
result in confusion for licensees and inspectors. The commenter 
recommended that another category of afterloaders, such as ``non-
remote'' or ``beta-only'' afterloaders, be developed.
    Response. The NRC has not distinguished between beta and photon-
emitting remote afterloaders in the definition. The purpose of the 
definition is to categorize afterloaders into different groups based on 
the dose rate (i.e. high, medium, or low) of the remote afterloader. 
Requirements for the devices are found in Subpart H. The final rule 
only addresses use of photon-emitting afterloaders. Use of beta-
emitting afterloaders is being addressed on a case-by-case basis at 
this time because use of these types of afterloaders is relatively new 
and both regulators and licensees continue to identify elements of safe 
operation.
Issue 2: Were There Any Other Changes Made in This Definition Between 
the Proposed and Final Rule?
    Response. Yes. The definition for a high dose-rate remote 
afterloader (HDR) was amended to state that it means a brachytherapy 
device that remotely delivers a dose rate in excess of 12 gray (1200 
rads) per hour at the point or surface where the dose is prescribed, 
rather than a dose rate in excess of 2 gray (200 rads) per hour. The 
definition for a low dose-rate remote afterloader (LDR) was also 
amended to state that it means a brachytherapy device that remotely 
delivers a dose rate of less than or equal to 2 gray (200 rads) per 
hour at the point or surface where the dose is prescribed, rather than 
a dose rate of less than 2 gray (200 rads) per hour. These changes were 
needed because the final rule includes a definition for medium dose-
rate remote afterloader (MDR).
    Licensee.
Issue 1: Should This Term Be Defined?
    Comment. A commenter asked that this term be defined.
    Response. The NRC did not define the term in Part 35 because 
``licensee'' is defined in 10 CFR 20.1003, ``Definitions,'' as the 
holder of a license. Wherever possible, we have tried to rely on the 
definitions in other parts of 10 CFR Chapter I that apply to medical 
licensees, rather than duplicate the definitions in Part 35.
    Management.
Issue 1: Who Is ``Management''?
    Comment. A commenter asked that we clarify what we mean when we use 
the term ``management.'' The commenter wanted to know whether 
management could be the chief executive officer or the head of one or 
all departments?
    Response. The NRC clarified the regulatory text to define 
management as the Chief Executive Officer (CEO) or other individual 
having the authority to manage, direct, or administer the licensee's 
activities, or those persons' delegate or delegates. If the head of one 
or all departments is a delegate(s) of the CEO or if the individual has 
the authority to manage, direct, or administer the licensee's 
activities, that person(s) would be considered to be part of 
``management.''
    Manual brachytherapy.
Issue 1: Should the Term ``Manual Brachytherapy'' Be Defined?
    Comment. A commenter asked that we define this term because it is 
not a common or standard term and it is used as a subpart title.
    Response. The NRC added a definition for manual brachytherapy. As 
used in this part, manual brachytherapy has been defined to be a type 
of brachytherapy in which the brachytherapy sources (e.g., seeds, 
ribbons) are manually placed topically on or inserted either into the 
body cavities that are in close proximity to a treatment site or 
directly into the tissue volume.
    Medical use.
Issue 1: Should the Definition of the Term ``Medical Use'' Include the 
Term ``Byproduct Material''?
    Comment. A commenter recommended that the term ``byproduct 
material'' be deleted from the definition of the term ``medical use'' 
because the regulations use the phrase ``byproduct material for medical 
use,'' which is redundant. The commenter did not believe it necessary 
to include the term ``byproduct material'' in the definition of 
``medical use'' and then to modify the term ``medical use'' with the 
phrase ``byproduct material'' in the regulations. The commenter stated 
that deleting the term ``byproduct material'' from the definition 
``requires the least amount of correction and simplifies compatibility 
by Agreement States.''
    Response. The NRC recognizes that there is some redundancy in using 
the phrase ``Medical use of byproduct material.'' However, we believe 
that this level of redundancy in some requirements is not 
objectionable, if it helps to clarify NRC's implementation of specific 
requirements of the AEA.
    Medium dose-rate remote afterloader.
Issue 1: Is There a Need for a Definition of the Term ``Medium Dose-
Rate Remote Afterloader''?
    Comment. Commenters were divided in response to our request for 
comment on whether the rule should define the term ``medium dose-rate 
remote afterloader.'' Some commenters recommended that the term be 
defined because, although the regulatory requirements for ``high'' and 
``medium'' dose-rate afterloaders are very similar, the radiation 
safety precautions are different and, thus, these terms require 
different definitions. Commenters who did not support a definition for 
an MDR cited various reasons for their position. Some commenters 
believed that the regulatory requirements for HDR and MDR should be 
identical, and, therefore, there was no need to define an MDR. This 
position is based on the opinion that the risks to patients from high, 
medium, pulsed and low dose-remote afterloaders, capable of whole body 
irradiation, are indistinguishable. Other commenters were concerned 
that the definition for an MDR could lead to confusion because the 
definition would overlap with the current definition of ``high dose-
rate remote afterloader.''
    Response. The NRC included a definition for an MDR in the final 
rule because the final rule contains requirements that apply to MDRs. 
The definitions of an HDR and an LDR were revised so there is no 
overlap between the definitions.
    Mobile medical service.
Issue 1: Were There Any Changes Made in This Definition Between the 
Proposed and Final Rule?
    Response. The NRC did not receive any public comment on this 
definition. However, we did change the term from ``mobile service'' to 
``mobile medical service.'' This was done because we wanted to state 
clearly that the mobile service provisions apply only to medical

[[Page 20275]]

use. The final rule defines ``mobile medical service'' as the 
transportation of byproduct material and its medical use at the 
``client's address,'' which includes the ``area of use'' or a 
``temporary job site.'' In addition, the definition of this term no 
longer contains the phrase ``by the same licensee'' because that phrase 
unduly limited the transportation and medical use of the byproduct 
material to one licensee.
    Output.
Issue 1. Were There Any Changes Made in This Definition Between the 
Proposed and Final Rule?
    Response. The definition for output was amended to also refer to 
the exposure rate or dose rate from a brachytherapy source, remote 
afterloader, or gamma stereotactic radiosurgery unit. The proposed rule 
only addressed the output from a teletherapy unit. This was done 
because various sections in Subpart H reference output from these other 
units.
    Patient intervention.
Issue 1: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added a definition for patient intervention. 
We believe this definition is needed to state clearly what we mean when 
we use the term in Sec. 35.3045. Discussion of patient intervention is 
found in the section of this document responding to comments on 
Sec. 35.3045.
    Preceptor.
Issue: Should the Term ``Preceptor'' Be Defined?
    Comment. Commenters recommended that the term be defined and that 
the definition distinguish between low-dose radiopharmaceuticals 
(diagnostic) and high-dose radiopharmaceuticals (therapeutic). The 
former would include ``persons designated as authorized physician users 
of low-dose radiopharmaceuticals.'' Preceptors of ``high-dose 
radiopharmaceuticals'' must be ``program directors of structured 
educational programs in medical teaching institutions that consist of 
didactic training and practical experience.'' Commenters believed that 
the ``preceptor'' should not be limited to someone in the medical, 
dental, or podiatry profession.
    Commenters believe the term ``preceptor'' should be defined as an 
individual who is listed on a license, such as an AU or RSO, or is 
appointed by licensee management to act in the capacity of a preceptor 
for the purpose of documenting that an individual has completed a 
structured educational program and/or practical experience. The 
preceptor must have demonstrated training and experience that is at 
least equal to the training and experience of the individuals being 
trained.
    Response. The NRC agrees the term ``preceptor'' should be defined 
because the term is used throughout the training and experience 
requirements in the revised Part 35. A preceptor is defined as someone 
who provides or directs the training and experience required for an 
individual to become an AU, AMP, ANP, or RSO. In addition, we agree 
that the preceptor must have training and experience that is at least 
equal to the training and experience required by the AU, AMP, ANP, or 
RSO, as appropriate. This is reflected in the paragraphs that require 
the preceptor certification in the training and experience requirements 
in Subparts B and D through H.
    Prescribed dosage.
Issue 1. Were There Any Changes Made in This Definition Between the 
Proposed and Final Rule?
    Response. Yes. The NRC amended the definition for ``prescribed 
dosage'' to allow the AU to direct the administration of a range of 
activity and to delete the reference to the ``diagnostic clinical 
procedures manual.''
    Prescribed dose.
Issue 1. Were There Any Changes Made in This Definition Between the 
Proposed and Final Rule?
    Response. Yes. The NRC amended the definition for ``prescribed 
dose'' to clarify that item (3) refers to manual brachytherapy and item 
(4) refers to remote brachytherapy afterloaders.
    Pulsed dose-rate remote afterloader.
Issue 1. Were There Any Changes Made in This Definition Between the 
Proposed and Final Rule?
    Response. Yes. The NRC restructured the definition of pulsed dose-
rate remote afterloader (PDR) to make it easier to read and clarified 
that it refers to a remote afterloading brachytherapy device. We also 
added a statement that the device uses a single source that is capable 
of delivering dose rates in the ``high dose-rate'' range, but is 
approximately one-tenth of the activity of typical HDR sources.
    Radiation Safety Officer.
Issue 1: Were There Any Changes Made in This Definition Between the 
Proposed and Final Rule?
    Response. Yes. The NRC restructured the definition to make it more 
readable. We also amended the definition for the RSO to include 
individuals identified as an RSO on a medical use permit issued by a 
Commission master material licensee. This change, which was also made 
to the definitions of ``ANP,'' ``AMP,'' and ``AU,'' accounts for the 
fact that an RSO may be named on a medical use permit issued by a 
master material licensee. If a master material licensee has issued a 
permit that recognizes a particular individual as an RSO, under the 
revised definition the individual would continue to meet the 
requirements for an RSO under an NRC license.
    Radionuclide or radiopharmaceutical.
    Comment. Commenters opposed the use of terms like ``radionuclide,'' 
or ``radiopharmaceutical'' in Part 35 because these terms are not 
defined as specifically containing byproduct material. They indicated 
that this was very important because NRC's statutory authority for 
regulating medical use under Part 35 is limited to byproduct material. 
They recommended that the regulation should use terms that have been 
defined to mean ``byproduct material radionuclide'' or ``byproduct 
material radiopharmaceutical.''
    Response. Section 35.1, Scope, specifies that ``this part contains 
the requirements and provisions for the medical use of byproduct 
material and for the issuance of specific licenses authorizing the 
medical use of this material.'' In addition, medical use is defined in 
Sec. 35.2, to mean the intentional internal or external administration 
of byproduct material or the radiation from byproduct material to 
patients or human research subjects under the supervision of an AU.
    The word ``radiopharmaceutical'' is only used in Secs. 35.204 and 
in 35.2063. In both cases, it is clear that the requirement applies to 
radiopharmaceuticals containing byproduct material. The word 
``radionuclide'' is used in Secs. 35.13, 35.40, 35.2067, and 35.3067 
and is also used in the training and experience sections in Subparts B 
and D through H. Again, it is clear that the requirements in 
Secs. 35.13, 35.40, 35.2067, and 35.3067 apply to radionuclides 
containing byproduct material, and it would be redundant for the rule 
text to restate the phrase ``containing byproduct material.'' In the 
case of the training and experience sections, we have chosen to allow 
an individual ``to take credit for'' experience obtained with handling 
nonbyproduct and byproduct material in meeting the training and 
experience requirements because there is very little difference between 
how byproduct and nonbyproduct materials are handled.
    Sealed source.

[[Page 20276]]

Issue 1: Are Epoxy Vials Used for Testing Dose Calibrators ``Sealed 
Sources''?
    Comment. A commenter asked that we clarify whether the epoxy vials 
used for testing dose calibrators are ``sealed sources.'' The commenter 
stated that epoxy vials are more correctly characterized as monoliths 
and should not be subject to leak testing.
    Response. A ``sealed source'' is defined in Sec. 35.2 as ``any 
byproduct material that is encased in a capsule designed to prevent 
leakage or escape of the byproduct material.'' Under this definition, 
epoxy vials used for testing dose calibrators are typically considered 
sealed sources. However, it is the licensee's responsibility to verify 
that a particular manufacturer's vial is considered by the relevant 
regulatory agencies to be a sealed source. This can be done by 
referencing the SSDR.
    Stereotactic radiosurgery.

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?

    Response. Yes. The definition was amended to clarify that 
stereotactic radiosurgery devices deliver therapeutic doses.
    Teletherapy.
Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. The NRC added a definition for teletherapy. This was done 
because we believed it is important to define this term as it is used 
in Part 35 so that the regulated community and the regulatory agencies 
have a clear understanding of how we have used a term within the rule.
    Therapeutic dosage and therapeutic dose.
Issue 1: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. The NRC added definitions for the terms ``therapeutic 
dosage'' and ``therapeutic dose'' because both terms are used in 
Sec. 35.40, ``Written directives.'' In addition, we believe these 
definitions are needed to eliminate any confusion about when a written 
directive is needed.
    Type of use.
Issue 1: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule.
    Response. Yes. The NRC added a definition for the term ``type of 
use.'' This term replaced the term ``clinical procedure'' in 
Sec. 35.13(a). We believe this term makes it clear that we are 
discussing ``uses'' in Part 35 (e.g., a use of byproduct material as 
specified in Secs. 35.100, 35.200, 35.300, 35.400, 35.500, 35.600, and 
35.1000), rather than ``clinical procedures'' (e.g., a bone scan, liver 
scan, or whole body scan).
    Unit dosage.
Issue 1: Is Manipulation of ``Unit Dosages'' Permitted Under the 
Definition of This Term?
    Comment. A commenter asked to what extent the ``end user'' would be 
allowed to manipulate a ``unit dosage.'' The commenter indicated that 
the greater the manipulation of the dosage, the greater the chance of 
an error being made in calculating the activity.
    Response. The NRC amended the definition of unit dosage to make it 
clear that unit dosages cannot be manipulated after being initially 
prepared because any manipulation could change the activity in the 
dosage.
Issue 2: Were There Any Other Changes Made in This Definition Between 
the Proposed and Final Rule?
    Response. Yes. The NRC amended the definition to stipulate that 
unit dosages must be prepared for medical use for administration as a 
single dosage to a patient or human research subject without any 
further manipulation of the dosage after it is initially prepared. This 
change acknowledges that preparation of a unit dosage is not limited to 
a manufacturer or preparer licensed under Sec. 32.72 or equivalent 
Agreement State requirement. It also highlights that a unit dosage is 
intended for administration to a patient or human research subject 
without any further manipulation.
    Written directive.
Issue 1: Does the Definition of ``Written Directive'' Recognize 
``Computerized Directives'?
    Comment. A commenter asked that the definition of written directive 
be revised to recognize that many facilities are using computerized 
systems and are not relying on written documents.
    Response. The NRC did not change the definition. The intent of the 
definition of ``written directive'' and the requirements in Sec. 35.40 
are to distinguish between an AU's written versus oral direction for 
the administration of byproduct material, rather than between written 
(hard copy) and electronic directions. As used in Part 35, ``written'' 
includes information recorded in a computerized system. If a written 
directive is generated or stored in a computerized system, the licensee 
must have a method of authenticating the AU's signature. Refer to the 
discussion of Sec. 35.5 for additional information on maintenance of 
records.

Section 35.5, Maintenance of records

Issue 1: Can Required Records, Other Than Originals, Be Authenticated?
    Comment. A commenter asked how a copy or microform is authenticated 
by authorized personnel. The commenter indicated there is no 
requirement to authenticate records stored in electronic media. The 
commenter believed that all records should be required to be 
authenticated in writing when provided for legal purposes, or verbally 
when being reviewed during an inspection.
    Response. Any record required by Part 35 must be maintained in 
accordance with Sec. 35.5. These records must be authenticated 
regardless of the storage media. The issue of authenticating records 
was addressed by the NRC under a separate rulemaking, published in the 
Federal Register on May 27, 1988 (53 FR 19240). The following 
explanation of ``authenticated,'' as stated in that final rule, applies 
to all records retained under NRC's regulatory authority: 
```Authenticated' denotes that the data has been verified for 
completeness and accuracy by an authorized individual and that it is a 
true representation of the original data'' (see page 19243).
Issue 2: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC made an editorial change in the second 
sentence to replace the phrase ``original, or a reproduced copy or a 
microform,'' with the phrase ``original, reproduced copy, or 
microform.''

Section 35.6, Provisions for Research Involving Human Subjects.

Issue 1: Should Sec. 35.6 Include a Requirement That Licensees Develop, 
Implement, and Maintain Procedures for Evaluating When a Medical 
Procedure Would be Considered To Be a Research Procedure?
    Comment. The NRC received a comment in support of the requirement, 
as well as comments opposed to the requirement. The commenter who wrote 
in favor of requiring such procedures stated there are occasions when a 
clear definition of what constitutes research would be useful in 
deciding which procedures must be approved by the Institutional Review 
Board (IRB) or RSC.
    Commenters opposed to a requirement for procedures indicated that 
FDA regulates research through IRBs. They believed that existing 
regulations and guidelines provided

[[Page 20277]]

adequate oversight of research and that decisions regarding research 
should be left to the individual licensee and the licensee's IRB. They 
noted that the IRB must follow the Federal Policy for the Protection of 
Human Research Subjects. As a result, they believed that research that 
is approved by an IRB and is within the scope of the authorized 
inventory should be permitted. Commenters also noted that similar 
procedures are not required in other areas of medicine. Finally, 
commenters indicated that a requirement for procedures would not 
increase public health and safety.
    Response. The NRC does not believe it is necessary to include a 
separate definition of the term ``research'' in Part 35 because Section 
102 of the Federal Policy for the Protection of Human Research Subjects 
defines the term ``research.'' (Further information on this can be 
found in the Federal Register (56 FR 28003; June 18, 1991, see page 
28013). In addition, we consider research conducted by NRC medical use 
licensees involving human subjects, which is also regulated by FDA, to 
be within the scope of Sec. 35.6(b). Therefore, it is not necessary for 
such a licensee, prior to conducting such research, to apply for and 
receive a specific amendment to its NRC license. However, under 
Secs. 35.6 and 35.7, the licensee is not relieved from complying with 
FDA or other requirements applicable to such research.
    We agree with the comment that the NRC should not add a requirement 
in Part 35 for licensees to develop, implement, and maintain procedures 
for evaluating when a medical procedure would be considered to be 
research. We believe that the issue of ensuring that all medical 
procedures and studies that should be subject to the policy are 
recognized as ``research'' and are reviewed by an IRB should be 
resolved as a matter of common policy, rather than in any separate 
effort by NRC. However, in reaching this conclusion, we do not believe 
that we must be guided by whether, for any given Commission 
requirement, there is a comparable requirement for other areas of 
medicine. The regulatory history of Part 35 shows that the Commission 
has operated under the assumption that Congress intended a 
disproportionate degree of Federal regulatory control be exercised over 
the medical use of nuclear materials, as compared to the medical use of 
other sources of radiation (e.g., x-rays or accelerator-produced 
isotopes) (44 FR 31701; May 14, 1980, see page 31702). The issue of why 
similar procedures are not required in other areas of medicine is 
outside the scope of this rulemaking.
Issue 2: Do Broad Scope Licensees Need a License Amendment Before 
Conducting Research?
    Comment. A commenter recommended that broad scope licensees be 
exempted from the requirement to amend their licenses before conducting 
research involving human subjects using byproduct material.
    Response. The NRC believes that broad scope medical use licensees 
should be required to comply with Sec. 35.6. This section is designed 
to protect the rights of human research subjects by requiring all 
licensees to obtain the informed consent of the subjects and by 
requiring an IRB to give prior review and approval of the research.
Issue 3: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC restructured the section to make it easier 
to read. We also added an introductory paragraph to make it clear that 
research permitted under Sec. 35.6 may only be performed using 
byproduct material that is already authorized for medical use by the 
license. For example, if a licensee is authorized to use byproduct 
material under Secs. 35.100, 35.200, and 35.300, it could not conduct 
research using a remote afterloader. However, the same licensee could 
conduct research using materials authorized in Secs. 35.100, 35.200, or 
35.300.
    We also added a new paragraph (d). This paragraph codifies the 
Commission's intent that Sec. 35.6 does not relieve licensees from 
complying with other provisions in Part 35. In other words, as stated 
in the regulatory history of Sec. 35.6, the relevant radiation safety 
provisions of Part 35 are applicable to research involving human 
subjects. For further information on this issue, you may want to refer 
to the December 2, 1994, Federal Register (59 FR 61767).

Section 35.8, Information Collection Requirements: OMB Approval

Issue 1: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. Paragraph (b) was amended to add references to 
Secs. 35.19, 35.190, 35.392, 35.394, 35.433, 35.491, 35.615, 35.1000, 
35.2041, 35.2433, and 35.2610 and to delete references to Secs. 35.62, 
35.292, 35.644, and Appendix A. These were conforming changes needed 
because of changes made in the regulatory text between the proposed and 
final rule.

Section 35.10, Implementation

Issue 1: Should the Time Period for Implementation of the Final Rule Be 
Extended?
    Comment. Commenters asked that the implementation period for the 
new rule be extended up to 1 year from its publication to allow 
licensees and applicants sufficient time to adjust their budgets for 
any increased expenditures needed to implement the rule.
    Response. The NRC has maintained a 6-month implementation period 
for all sections of the final rule. We believe that 6 months provides 
adequate time for licensees to develop and implement any changes in 
their radiation safety programs.
Issue 2: Should the Rule Provide Relief From Restrictive Requirements 
in the Rule or License?
    Comment. A commenter recommended that Sec. 35.10(e) be revised 
because otherwise it will maintain the most restrictive requirements of 
either the revisions of Part 35 or the licensee's current license 
conditions. The commenter was concerned if a license condition cites a 
deleted requirement in Part 35, the license condition remains in effect 
unless the license is amended in order to remove the needless 
requirements. The need for a license amendment would diminish the 
projected cost saving of the rule.
    Commenters also raised the issue of whether there is a ``duality'' 
of the new Part 35 and existing license conditions, thus raising a 
concern about inspection and enforcement. Licensees will have to make 
significant amendments comparable to submitting a license renewal. 
Commenters believed that, if feasible and upon written request, 
licensees should be permitted to comply with the ``new'' Part 35 
without regard to the restrictive nature of the license and without 
requiring a license amendment. If NRC believes that a regulation can be 
relaxed or eliminated without a reduction in radiation safety, the NRC 
should allow licensees to change their programs accordingly.
    Response. The NRC modified the text of Sec. 35.10 to allow for 
relief from the current rule and, in some cases, license conditions. 
The following discussion explains and summarizes the changes made in 
this section.
    Paragraph (a) requires licensees to implement the provisions in the 
rule 6 months after the final rule is published in the Federal 
Register, except as stated in paragraph (b) of this section.
    Paragraph (b) allows certain training and experience requirements 
to be

[[Page 20278]]

implemented on or before 2 years after the effective date of the final 
rule.
    Paragraph (c) allows, prior to the date 2 years after the effective 
date of the final rule, licensees to have the option of complying 
either with Subpart J or Subparts B and D-H.
    Paragraph (d) states if a license condition exempted a licensee 
from a provision in the current Part 35, that license condition 
continues to exempt the licensee from the requirements in the 
corresponding provision in Secs. 35.1-35.4002 of Part 35. As shown in 
the following example, a corresponding provision may not always have 
the same numerical section reference. For example, if a licensee is 
exempted from the requirements in current Sec. 35.57(c), Authorization 
for calibration and reference sources, the licensee will be exempted 
from the corresponding requirements in the final Sec. 35.65(c), 
Authorization for calibration, transmission, and reference sources.
    Paragraph (e) states that when a regulatory requirement in Part 35 
differs from the requirement in an existing license condition, the 
requirement in Part 35 governs. This paragraph primarily applies to 
those licensees that committed to follow the procedures in Regulatory 
Guide 10.8, ``Guide for the Preparation of Applications for Medical Use 
Programs.'' When the final rule becomes effective, licensees will 
follow the requirement in Part 35 if it differs from the requirement 
that the licensee committed to by referencing the Regulatory Guide. For 
example, most licensees have committed to calibrate their dose 
calibrators using the procedures in Regulatory Guide 10.8, Appendix C, 
``Model Procedure for Calibrating Dose Calibrator.'' These procedures 
are very prescriptive. The final Part 35 only requires licensees to 
calibrate instruments used to measure the activity of unsealed 
byproduct materials in accordance with nationally recognized standards 
or the manufacturer's instructions. Therefore, after the effective date 
of the final rule, a licensee must calibrate its dose calibrators in 
accordance with nationally recognized standards or the manufacturer's 
instructions, rather than being tied to using the procedures in 
Regulatory Guide 10.8.
    Paragraph (f) states that the licensee shall continue to comply 
with any license condition that requires it to implement procedures for 
spot-checks on teletherapy, photon-emitting remote afterloaders, or 
gamma stereotactic radiosurgery units and to implement emergency 
procedures for photon-emitting remote afterloaders, teletherapy units, 
or gamma stereotactic radiosurgery units until there is a license 
amendment or renewal that modifies or removes the condition. 
Specifically, licensees must continue to follow any emergency response 
and spot-check procedures for teletherapy, remote afterloaders, and 
gamma stereotactic radiosurgery units that were submitted to NRC in 
support of a licensing action because of the high radiation risk 
associated with this type of use of byproduct material.
Issue 3: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. Paragraph (b) was amended to add references to 
Secs. 35.190(a), 35.392(a), and 35.394(a), and to delete reference to 
Sec. 35.292(a). Paragraph (g) was deleted. Reference the General 
Training and Experience discussion in the beginning of this section of 
the SUPPLEMENTARY INFORMATION for more information.

Section 35.11, License Required

Issue 1: Should the Term ``Person'' Be Used in Lieu of ``Individual''?
    Comment. A commenter noted that the word ``person'' was used in 
paragraph (a), while in paragraphs (b) and (c), the word ``individual'' 
was used. They recommended that the word ``person'' in paragraph (a) be 
changed to ``individual.''
    Response. The NRC did not change the regulatory text of Sec. 35.11. 
The term ``person'' is used in Sec. 35.11(a) because licenses are 
issued to ``persons'' as defined in 10 CFR 30.4. Section 30.4 states 
that a person includes not only individuals (defined in 10 CFR 20.1003 
as ``any human being''), but also corporations, government agencies 
other than the Commission, and States. Paragraphs (b) and (c) of 
Sec. 35.11 use the term ``individual'' because the activities 
authorized by those sections are performed by ``individuals'' (under 
the supervision of an ``authorized user'' or ``authorized nuclear 
pharmacist''), but not necessarily by all of the entities which 
constitute ``persons.''
Issue 2: Can There Be Transfer of Sources Among Licensees?
    Comment. A commenter indicated that changes in the health care 
environment have created affiliations between hospital groups which may 
or may not be under a single NRC license. The commenter believed that 
this regulation could prohibit the cost savings created by these 
affiliations. The commenter believed that if sources are received from 
a licensed distributor and handled properly, there should be some 
flexibility in transferring the sources between licensees.
    Response. The NRC did not change the regulatory text in this 
section. However, we did change the regulatory text of Sec. 35.49 to 
address this comment. Section 35.11 references conditions of a specific 
license issued by the Commission or an Agreement State. This license 
would require the licensee to comply with all provisions of Part 35. 
Section 35.49 has been modified to state that a licensee may use sealed 
sources or devices for medical use which are non-commercially 
transferred from a Part 35 licensee, i.e., if two licensees are 
authorized to possess sealed sources for medical use, they may transfer 
the sources from one to the other.
Issue 3: Were There Any Other Changes Made in this Section Between the 
Proposed and Final Rule?
    Response. Yes. ``Prepare'' was added to paragraph (a) in 
recognition that medical licensees may also prepare byproduct material 
for medical use and need a license to do so. In addition, the section 
was restructured to make it easier to use. Paragraphs (b) and (c) were 
combined into one paragraph because they both provide information on 
when a specific license is not needed.

Section 35.12, Application for License, Amendment, or Renewal

Issue 1: Who May Apply for a License?
    Comment. The commenter believed that the requirements in the 
current Sec. 35.12(a) are inconsistent. According to the commenter, 
under the current rule, any person may apply for a license for medical 
use not sited in a medical institution, while only a medical 
institution's management may apply for a license for medical use sited 
in a ``medical institution.'' The commenter recommended that the NRC 
issue the license to a ``responsible person'' no matter what the 
license type. The commenter further recommended that the text of the 
rule be changed to reflect that the NRC will only accept a license 
application from a financially and/or legally responsible person.
    Response. The NRC did not make any changes between the proposed 
rule and the final rule in response to this comment. Section 35.12(a) 
of the final rule requires that the license application be signed by 
the applicant's or licensee's management, regardless of the types of 
use applied for or authorized. For a sole practitioner, the 
``management'' could be the same as the AU. This paragraph clarifies 
that ``management,'' by signing the

[[Page 20279]]

application, is responsible for the license, regardless of the size of 
the licensee.
Issue 2: Is There a Need for a Separate License for Medical Uses 
Covered by Sec. 35.600?
    Comment. Commenters stated that license applicants should be 
permitted to submit one license application covering several uses of 
radioactive material, as long as the activity is under both the same 
management and a qualified RSO. Commenters asked that we justify the 
inconsistent and separate licensing of a medical device such as a 
cobalt-60 machine because neither the administrative nor the technical 
requirements of the radiation safety program are going to be unique for 
the cobalt-60 unit. Commenters believed that a licensee should not be 
assessed a separate annual fee just for a medical device. The 
additional cost will only place a greater burden on the health care 
delivery system.
    Response. NRC agrees with the commenter that licensees should be 
permitted to submit one application covering all medical uses. We have 
amended the regulatory text to require only one application for a Part 
35 license, regardless of which medical use modalities the licensee 
will be performing. It will not be necessary for a licensee or 
applicant to file a separate application for each medical use of 
byproduct material, as described in Secs. 35.600 or 35.1000. Licensees 
who currently hold separate licenses may request that the licenses be 
combined.
    The commenter's suggestion that a single fee be assessed for all 
medical uses covered by a license would require a revision to Parts 170 
and 171. The NRC will address this issue in an annual fee rulemaking 
subsequent to the issuance of this revision to 10 CFR Part 35.
Issue 3: Can Licenses Be Combined at Facilities?
    Comment: Commenters believed that it would be advantageous for 
larger licensees that employ a full-time RSO and that have several 
existing licenses to unify all specific licenses into a single license. 
Commenters believed that the RSO should have the freedom and 
flexibility to manage resources to control all types of use without 
describing all the individual radiation safety procedures for the NRC. 
The RSO could appoint specialty RSOs, if needed, to manage the daily 
radiation safety program in specialty areas, e.g., nuclear medicine, 
cardiology, radiation therapy, or individual campuses. For example, 
universities or large hospitals with several campuses could issue sub-
licenses under a unified license. The RSO could authorize individual 
users who qualified under the training and experience criteria, without 
notifying NRC. This would be appropriate for authorizing physicians for 
emerging technologies, as well.
    Response. The NRC agrees that licensees should have the flexibility 
of combining several licenses into one license. This will help to 
foster a more unified radiation protection program at the licensee's 
facility. Section 35.12 has been amended to allow applicants to apply 
for one license for all types of medical uses. For example, it is no 
longer necessary to have separate licenses for medical uses such as 
teletherapy, gamma stereotactic radiosurgery, or diagnostic nuclear 
medicine. Licensees have flexibility in structuring their radiation 
protection program to include specialty RSOs but the Commission holds 
the RSO named on the license responsible for the radiation protection 
program. Licensees do not have authority to issue any type of license. 
Under Sec. 35.24, only licensee management can approve AUs.
Issue 4: Should Licensees Be Required To Submit Operating Procedures to 
NRC for Review and Approval as Part of the License Application?
    Comment. The NRC received comments recommending that we review 
operating procedures as part of the license application. We also 
received comments indicating that we did not need to review procedures 
and that licensees should have flexibility in program management.
    Some commenters recommended that we should not abandon our practice 
of reviewing a licensee's or applicant's procedures before issuing a 
license. These commenters believed it is important for NRC to review 
procedures as part of the licensing process. This is important because 
licensee management, AUs, workers, and NRC staff must have a common 
understanding of what is in the procedures. They believed that this 
would avoid enforcement problems during subsequent inspections.
    Commenters believed licensees should have the flexibility to change 
certain procedures, even if the procedures had been submitted to the 
NRC, as long as the spirit of the rule is met. Once the procedure is 
incorporated into the license, the regulatory agency and the licensee 
know what to expect. NRC review of procedures during the license 
application or renewal process is a good way to see if the licensee has 
established procedures in compliance with NRC requirements. Other 
commenters asked that this section be changed to include the 
requirement that applicants either (1) commit to adopting the model 
procedures contained in NUREG-1556, Volume 9(draft), or (2) submit with 
the application the procedures they wish to use for review and approval 
by the Commission. These commenters did not believe inspectors have the 
time or resources during an inspection to both conduct the inspection 
and determine the adequacy of the licensee's procedures.
    Other commenters suggested that the NRC review procedures only at 
the time of the initial application or when the license is periodically 
renewed. Procedures would not need to be submitted for license 
amendments. They believed that this approach would be helpful for 
smaller licensees that do not employ a full-time RSO and who usually 
rely on a consultant to write their standard operating procedures.
    We also received comments that did not support NRC review of 
procedures. These commenters indicated that the NRC must recognize that 
there are many acceptable procedures to accomplish a specified goal. A 
licensee should be able to use any one of a large number of procedures 
as long as the performance standard is met. No written procedures of 
any kind need to be submitted to the NRC for review or be required as 
license conditions. Commenters also indicated that because the level of 
radioactivity involved in diagnostic medical uses of byproduct material 
is so low, compliance with the requirement for licensees to develop, 
maintain, and implement procedures provides no additional safety. Such 
a requirement would only increase the cost to the patients without any 
corresponding increase in the safety of the patient, hospital worker, 
or physician. Finally, commenters stated that this licensing approach 
should be extended to other uses outside Part 35, such as radiography 
(Part 34) and irradiator (Part 36) licenses.
    Response. The NRC has amended the various provisions in the rule to 
delete, with one exception, the requirement for licensees to develop, 
implement, and maintain procedures (e.g., Sec. 35.24). We have also 
modified Sec. 35.12 to state that only procedures required under 
Secs. 35.610, 35.642, 35.643, and 35.645, as applicable, must be 
submitted to NRC for review as part of the license or amendment 
application. We agree that submittal of a licensee's operating 
procedures for NRC review and approval is necessary for certain higher 
risk medical uses such as those authorized in Subpart H, but is not

[[Page 20280]]

necessary for low risk uses, such as in diagnostic nuclear medicine. 
The lack of a procedure for the high risk modalities could result in 
situations where the public, workers, or patients could be exposed to 
unnecessary radiation. Overall, the final rule reduces the amount of 
documentation, including operating procedures, that an applicant must 
submit for either a license or amendment.
Issue 5: What Are the Information and Licensing Requirements for 
``Emerging Technology''?
    Comment. Commenters were concerned that significant resources may 
be expended by companies for clinical research for ``emerging 
technologies,'' without knowing what the actual regulatory requirements 
will be. Commenters asked that provisions be made for protection of 
confidential and proprietary information which licensees are required 
to submit in accordance with Sec. 35.12(d)(1). Commenters also asked 
whether NRC would be open to a petition for rulemaking proposing an 
appropriate way to license an ``emerging technology,'' such as 
brachytherapy.
    Response. The NRC clarified the regulatory text in Sec. 35.12(d) to 
make it clear that the information in paragraph (d)(1) must be 
submitted in addition to the information required by other paragraphs 
in this section. Paragraph (d) was added because the current rule does 
not provide for the efficient licensing of ``emerging technologies'' 
(i.e., those medical uses that are not specifically included in 
Subparts D through H). Paragraph (d)(1) provides a generic list of all 
the information needed by NRC to approve a medical use that is not 
specifically addressed in those Subparts. The specified information is 
needed because we must verify that the byproduct material will be 
handled safely. At this time, and because of the evolving nature of 
``emerging technologies,'' it is not possible to be more specific about 
the necessary information. Applicants for ``emerging technology'' 
licenses are encouraged to consult with the NRC staff about the 
required information during the application process. Of course, 
licensees for these technologies would also be required to comply with 
all the applicable sections in Part 35 and 10 CFR Chapter I (e.g., 
Parts 30 and 71).
    Provisions are already in place for the protection of trade secrets 
or privileged or confidential information. Section 2.790(b)(1) contains 
procedures under which any person who proposes to withhold a document 
(or a part of it) from public disclosure on the ground that it contains 
trade secrets or privileged or confidential information may file an 
application for withholding accompanied by an affidavit.
    Any ``interested person'' may file a petition for rulemaking under 
10 CFR 2.802. During the NRC review of the petition, the NRC staff will 
review the interested person's request and determine whether a 
rulemaking is needed to address the issue. In some cases, there may be 
existing regulatory requirements that adequately address the 
petitioner's request; in other areas, the petitioner's request may 
result in development of a new rule or revision of an existing rule.
    Although any ``interested person'' may file a petition for 
rulemaking in accordance with 10 CFR 2.802, such a petition should not 
be necessary for licensing ``brachytherapy.'' Licensing medical use 
involving brachytherapy is covered in the final rule in Subpart F, 
``Manual Brachytherapy,'' and Subpart H, ``Photon Emitting Remote 
Afterloader Units, Teletherapy Units, and Gamma Stereotactic 
Radiosurgery Units.'' If an applicant believes that the use is not 
covered in either Subparts F or H, the applicant may request use under 
Sec. 35.12(d) and Subpart K, ``Other Medical Uses of Byproduct Material 
or Radiation from Byproduct Material.'' Subpart K provides a means for 
licensing medical use of an ``emerging technology.''
Issue 6: Does a Broad Scope Licensee Need To Amend Its License for 
Medical Use of an Emerging Technology?
    Comment. A commenter stated that broad scope licensees should not 
be required to amend their licenses simply for medical use of emerging 
technologies. The commenter asked that this section be clarified or 
added to the list of exemptions for broad scope licenses in Sec. 35.15.
    Response. The NRC agrees with the commenter's recommendation. We 
amended Sec. 35.15 to relieve a broad scope licensee from the 
requirement to file a request for a license or amendment for medical 
use of byproduct material, as described in Sec. 35.1000. This 
regulatory relief only applies if the broad scope licensee is already 
authorized to possess the type and form of byproduct material used in 
the emerging technology.
Issue 7. Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. Section 35.12(a) was amended to delete the phrase 
``of the facility.'' The proposed rule required that the application be 
signed by the management of the facility. The final rule requires that 
the application be signed by the applicant's or licensee's management. 
The addition of the words ``applicant's or licensee's'' is discussed 
under Issue 1 of this section. The NRC deleted the phrase ``of the 
facility'' because the word ``management'' clearly ties the requirement 
to activities performed by the licensee. (Refer to the definition of 
``management'' in Sec. 35.2.)
    Paragraph (c) was amended to recognize that the application may be 
either in a letter format or on NRC Form 313, consistent with the 
current regulations.
    Paragraph (d) was amended to delete the requirement to submit 
information on the training and experience of proposed users of an 
emerging technology. This requirement was redundant of the requirement 
in paragraph (b) for applicants to submit the training and experience 
qualifications of AUs.

Section 35.13, License Amendments

Issue 1: Why Would a License Amendment Be Necessary for a Type of Use 
Not Authorized in the License?
    Comment. A commenter was concerned that this section implies the 
NRC will be regulating medical procedures through the licensing 
process, i.e., NRC will use license conditions to prevent the clinical 
use of certain isotopes. According to the commenters, physicians should 
not have to wait for the NRC to grant an amendment in order to practice 
medicine.
    Response. The NRC has not made any changes in the regulatory text 
as a result of these comments. Requiring a licensee to obtain a license 
amendment for a type of use permitted under Part 35, but not authorized 
on the licensee's current license, is not intended to prevent the 
medical use of certain radionuclides. A licensee must apply for and 
receive an amendment for such a type of use because it may change the 
licensee's byproduct material program and might increase the potential 
for radiation exposure to workers and the general public. For example, 
a licensee would need to amend its license if it is only authorized to 
use byproduct material for imaging and localization studies and it 
would like to use a remote afterloader. These types of changes in the 
byproduct material program are potentially significant and require a 
license amendment because:
    (1) The NRC must be assured that the licensee has adequate training 
and experience and facilities before authorizing a change in the type 
of

[[Page 20281]]

medical use or the amount of byproduct material used; and
    (2) Such a change might also indicate a need for increased 
inspection frequency.
Issue 2: Should There Be a Provision for a Temporary RSO?
    Comment. A commenter asked if we planned to add language to this 
section to codify the discussion in the Statements of Consideration for 
the proposed rule on Sec. 35.13(c) (53 FR 43516; August 13, 1998) 
regarding using an AU to fill the RSO position, if the RSO leaves with 
little or no warning. This commenter recommended that we add the 
following phrase to Sec. 35.13(c): ``changes permanent Radiation Safety 
Officer.'' Commenters recommended that we allow an ANP or AMP to 
function as the RSO because either of these individuals would meet the 
qualifications of an RSO in Sec. 35.50.
    Response. The NRC addressed these comments by adding a provision 
for a ``temporary RSO'' in Sec. 35.24(c). As stated in Sec. 35.24(c), 
and discussed in greater detail under the Statements of Consideration 
for Sec. 35.24, an AU or an individual qualified to be an RSO may 
function as the temporary RSO. The broader issue of who can be an RSO 
is discussed in greater detail in the response to comments on 
Sec. 35.50. A licensee would not need to amend its license for a 
temporary RSO.
Issue 3: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. Paragraph (a) was amended to clarify that a licensee 
must apply for a license amendment before it ``prepares'' byproduct 
material for a type of use that is not authorized on the licensee's 
current license.
    The NRC amended paragraph (b) to include ANPs identified on a 
permit issued by a Commission master material licensee that is 
authorized to permit the use of byproduct material in medical use or in 
the practice of nuclear pharmacy, or identified by a commercial nuclear 
pharmacy that has been given authorization to identify authorized 
nuclear pharmacists. This change has been made so that this section is 
consistent with the revised definition of ANPs in the final rule.
    We also made minor editorial changes to the regulatory text in 
paragraph (b) to make the rule easier to read. For example, we started 
each requirement by stating to whom the requirement applies, e.g., we 
replaced the phrase ``An authorized user who meets the requirements in 
* * * '' with ``For an authorized user, an individual who meets the 
requirements in * * * ''
    In addition, paragraph (b) was amended to add references to 
Secs. 35.190(a), 35.392(a), and 35.394(a); and to delete 
Sec. 35.292(a). These actions are considered conforming changes needed 
for other changes made to the regulatory text between the proposed and 
final rule. In addition, paragraphs (b)(4) and (5) were combined to 
make the rule easier to use.
    We also amended paragraph (d) requiring the licensee to apply for 
and receive a license amendment before it receives byproduct material 
in excess of the amount, in a different form, or a different 
radionuclide than is authorized in the license. This change makes the 
regulatory text clearer.
    A new paragraph (g) was added that requires a licensee to apply for 
a license amendment if it revises the procedures that must be submitted 
in accordance with Sec. 35.12(b)(2), where such revision reduces 
radiation safety. This applies to procedures required by Secs. 35.610, 
35.642, 35.643, and 35.645, as applicable.

Section 35.14, Notifications

Issue 1: Is the Purpose of Notification To Initiate a License 
Amendment?
    Comment. A commenter recommended the title of this section be 
changed to ``Thirty-day Notifications for Amendments.'' In addition, 
the commenter stated that an introductory sentence should be added to 
the section indicating that the notifications should be made to 
initiate license amendments. Without this sentence, it is not clear 
that the purpose of the notification is to initiate an amendment.
    Response. The NRC has not changed the regulatory text. The purpose 
of Sec. 35.14 is to identify when a licensee must notify NRC of changes 
in its program for which it does not need to apply for a license 
amendment. For example, if an AU, AMP, or ANP is certified by a 
specialty board recognized by NRC, the licensee may allow that 
individual to begin work immediately (without first seeking and 
obtaining a license amendment). All the licensee must do is notify the 
NRC, within 30 days, that the individual has begun working.
Issue 2: Is There a Conflict Between the Requirements in 
Secs. 35.13(b)(1) and 35.14(b)(1)?
    Comment. A commenter indicated that this section was confusing 
because it was not clear whether the board certifications mentioned in 
Sec. 35.14(a)(1) meant only those boards ``adopted by regulation'' or 
those certifying organizations listed in Appendix A. The commenter also 
believed the section conflicted with Sec. 35.13(b)(1), which permits 
persons to act as an AU if they meet the training and experience 
requirements in Secs. 35.290(a), 35.292(a), 35.390(a), 35.490(a), 
35.590(a), or 35.690(a) and Sec. 35.59 and Secs. 35.910, 35.920, 
35.930, 35.932, 35.934, 35.940, 35.941, 35.950, 35.960 and Sec. 35.49.
    Response. Section 35.13 provides information on when a licensee 
must apply for a license amendment. Section 35.14 provides information 
on when a licensee must notify NRC of a change in its program. In order 
to provide some regulatory relief to licensees and to allow individuals 
to begin work immediately, the NRC structured these provisions as two 
parts that address two different groups of people--those who are 
certified by a board recognized by NRC and those who are not certified 
by a board recognized by NRC. In the case of an AU, a licensee would 
not need to amend its license before allowing an individual to begin 
work if the individual is certified by a board whose certification 
process has been recognized by NRC. However, the licensee would need to 
notify us within 30 days of having allowed that individual to work as 
an AU. Conversely, a licensee would need to amend its license if the 
individual is NOT certified by a board that has been recognized by NRC.
    We have deleted any references to boards by name in the final rule. 
In addition, Appendix A to the proposed rule was not included in the 
final rule. More detailed information on these changes can be found 
under the discussion of ``General training and experience,'' in Part 
II, General Issues, at the beginning of this section.
Issue 3: Is It Necessary To Name an AMP on a License?
    Comment. A commenter recommended that NRC need only allow 
individuals who meet the training and experience requirements for an 
AMP to function as an AMP.
    Response. The NRC believes that the requirements for naming an AMP 
and AU in the license should be the same. In order to be considered an 
AMP, the individual must meet the training and experience 
qualifications in Sec. 35.51. If the individual is certified by a board 
whose certification process has been recognized by NRC, the licensee 
may allow that individual to begin work immediately and notify us 
within 30 days that the individual has begun work. If the individual is 
not certified by a board whose certification process

[[Page 20282]]

has been recognized by NRC, the licensee must apply for and obtain an 
amendment of its license before it allows that individual to begin work 
as an AMP.
Issue 4: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC revised paragraph (a) to include AUs, AMPs, 
and ANPs that are identified on a permit issued by a Commission master 
material licensee or a permit issued by a Commission master material 
license broad scope permittee. This change has been made so that this 
section is consistent with the revised definition of AUs, AMPs, and 
ANPs in the final rule. Paragraph (b)(4) was amended to state that the 
licensee must notify NRC when it adds to or otherwise changes the areas 
where byproduct material is used in accordance with Secs. 35.100 and 
35.200. This change has been made to clarify the regulatory text.

Section 35.15, Exemptions Regarding Type A Specific Licenses of Broad 
Scope

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. A new paragraph (f) was added that exempts broad 
scope licensees from the requirement to notify NRC when there are 
additions to or changes in the areas of use identified in the 
application or on the license where byproduct material is used in 
accordance with Secs. 35.100 and 35.200. This exemption is consistent 
with the current exemption that these licensees have from the 
requirement to apply for a license amendment when there are additions 
to or changes in the areas of use only at the addresses specified on 
the license. The exemption was inadvertently omitted from the proposed 
rule.

Section 35.19, Specific Exemptions

Issue: Shouldn't This Section Provide an Exemption for Diagnostic 
Nuclear Medicine?
    Comment Some commenters believed that essentially all diagnostic 
nuclear medicine procedures should be exempted from regulation because 
they would not endanger life or property or the common defense or 
security and are otherwise in the public interest.
    Response. The NRC did not make any changes in this section. Section 
35.19 recognizes that an applicant for a license or licensee filing an 
amendment request may seek to be exempted from a specific requirement 
in this part (50 FR 30616; July 26, 1985, see page 30624). However, 
this provision does not provide the basis for a ``blanket'' exemption 
of an entire category of medical use such as ``diagnostic nuclear 
medicine procedures'' from Part 35. Nevertheless, consistent with 
making Part 35 more risk-informed, we have decreased the regulatory 
burden on licensees administering or preparing byproduct material for 
most diagnostic uses by decreasing the requirements imposed on them in 
Part 35.

Subpart B--General Administrative Requirements

Section 35.20, ALARA Program

Issue 1: Should the Current Part 35 Requirements Related to ALARA 
Programs Be Deleted?
    Comment A commenter supported the deletion of the current Part 35 
requirements related to the ALARA program. However, another commenter 
believed that the requirements in Part 35 related to the ALARA program 
should be retained. This commenter stated that keeping this regulation 
in Part 35 is appropriate because Part 20 regulations are not specific 
enough.
    Response. The NRC deleted Sec. 35.20, which includes prescriptive 
requirements related to the ALARA program, in its entirety from the 
revised Part 35. Medical use licensees will continue to be required to 
comply with Sec. 20.1101 that includes a requirement to implement an 
ALARA program designed to keep doses as low as reasonably achievable. 
We believe that deletion of the prescriptive ALARA requirements that 
are in the current Sec. 35.20 will provide licensees flexibility in 
developing and implementing their ALARA programs.

Section 35.24, Authority and Responsibilities for the Radiation 
Protection Program

Issue 1: Can Licensee Management Delegate Its Responsibility To Approve 
Individuals Before Allowing Them To Work as an AU, ANP, or AMP?
    Comment Several commenters said that mandating that licensee 
management approve individuals before allowing them to work as AUs, 
ANPs, or AMPs is excessive. Normally, management does not approve other 
individuals to work in non-NRC licensed areas. The approval to work 
generally comes from the department chief or the hospital credentialing 
committee. Therefore, the commenters suggested inserting ``or 
management designee'' after ``management'' in paragraph (a)(2) of this 
section to allow management to delegate the responsibility for 
approving individuals to either a responsible individual in the 
department or the hospital credentialing committee.
    Response. In the current Part 35, the RSC has the responsibility to 
approve AUs, ANPs, and teletherapy physicists before allowing them to 
work. In the new Sec. 35.24(a)(2), licensee management is given this 
responsibility for several reasons. First, licensee management has the 
ultimate responsibility for the radiation protection program in the 
revised rule. Second, not all licensees are required to have an RSC. 
Therefore, giving licensee management the responsibility for approval 
of individuals makes the requirement uniform for all medical licensees, 
i.e., the authority for approving individuals is not dependent on 
whether or not a licensee has an RSC.
    As defined in Sec. 35.2, management means the chief executive 
officer or other individual having the authority to manage, direct, or 
administer the licensee's activities, or those persons' delegate or 
delegates. Thus, licensee management could delegate the task of 
approving individuals before allowing them to work.
Issue 2: Is There a Need for a Requirement for the RSO To Acknowledge 
Responsibility for Implementing the Radiation Protection Program in 
Writing?
    Comment The NRC received comments in response to the Commission's 
question as to whether a requirement for the RSO to acknowledge in 
writing responsibility for implementing the radiation protection 
program would impact the licensee's effectiveness in carrying out its 
radiation protection program. These comments both agreed and disagreed 
with the requirement in paragraph (b) of this section that an RSO agree 
in writing to be responsible for implementing the radiation protection 
program. One commenter supported this requirement, especially in cases 
where the RSO position is assigned to a junior medical staff member who 
has significantly more pressing obligations. Another commenter 
supported the requirement because it enhances the visibility of the RSO 
position. Several commenters noted that National Council on Radiation 
Protection and Measurements (NCRP) Report No. 127, Operational 
Radiation Safety Program (1998), Section 3 on Organization and 
Administration, includes recommendations for the RSO's responsibilities 
for the radiation safety program.

[[Page 20283]]

    Other commenters questioned why the RSO should be required to sign 
off on his or her duties when the AU, AMP, and ANP are not required to 
do so. One commenter said that a written agreement seems more 
appropriate between management and the AUs, or between the AUs and NRC. 
Increasing the responsibilities of the AUs would provide more incentive 
for them to become familiar with the details of the radiation safety 
aspects of the licensed activities. Another suggestion was that there 
be a requirement for the licensee and AUs to commit in writing to 
follow the radiation protection program, instructions, and procedures, 
as formalized/approved by the RSO.
    Other commenters questioned why there needs to be a paper trail of 
the RSO's agreement to be responsible for implementing the radiation 
safety program. They questioned whether there is a concern that 
management may assign the RSO duties to someone who is unaware of their 
responsibilities or there is a concern because unqualified, uncommitted 
RSOs have been named in the past. A commenter believes that if an 
individual agrees to assume the RSO's duties and his or her name is on 
the license as the RSO, a written statement from the RSO is redundant 
and unnecessary. Instead, the Commission should require that the 
individual appointed to be the RSO sign the license amendment naming 
him or her as RSO, which would not only provide documentation of their 
acceptance of the RSO duties, but would also provide the licensing 
staff with a copy of the RSO's signature for future reference.
    Another commenter was concerned that the written agreement seems to 
be more of a legal, contractual matter than it is a radiation safety 
matter, and it could be later used by management against the RSO.
    Response. After reviewing and evaluating the public comments, the 
NRC retained the requirement in paragraph (b) of this section for the 
RSO to acknowledge, in writing, responsibility for implementing the 
radiation protection program. We believe that future confusion over the 
responsibilities for the radiation protection program can be prevented 
by having a clear, written agreement between licensee management and 
the RSO. The final rule explicitly gives the RSO the responsibility for 
implementing the radiation protection program. Therefore, we believe it 
is more appropriate for that individual, rather than the AU, ANP, or 
AMP, to agree to that responsibility in writing.
Issue 3: Why Does the Rule Increase Management Oversight of, and 
Consequently Limit the RSO's Authority Over, the Radiation Safety 
Program?
    Comment. Commenters believe that the proposed rule is very 
prescriptive about the relationship between the RSO and licensee 
management. The rule implies that licensee management gives the 
responsibility for maintaining the radiation safety program to the RSO, 
but does not allow the RSO the authority needed to manage the program. 
No other radiation protection program in 10 CFR Chapter I has as much 
management oversight as the medical use program. The NRC should also 
stipulate that the RSO report directly to senior management.
    Response. The requirements in paragraphs (e) and (g) of Sec. 35.24 
that are associated with the RSO's authority are also in the current 
Sec. 35.23. The revised rule retains all of the RSO's current 
authority, plus provides the RSO with additional authority to stop 
unsafe operations. The NRC did not address whether there is the same 
level of management oversight of other NRC licensees' radiation 
protection programs because that issue is beyond the scope of this 
rulemaking. We believe that the requirements for both the RSO's 
authority and for management oversight are more risk-informed and, 
therefore, appropriate for the risk associated with the medical use of 
byproduct material.
Issue 4: Should There Be a Provision for a Temporary RSO?
    Comment. As noted in Issue 2 under Sec. 35.13, License amendments, 
a commenter asked if we planned to add regulatory text to allow a 
licensee to use an AU to fill the RSO position when the RSO leaves a 
facility with little or no advance warning. Commenters also recommended 
that we allow an ANP to function as the RSO if the individual meets the 
qualifications for an RSO in Sec. 35.50.
    Response. The NRC added a new provision in paragraph (c) of 
Sec. 35.24 that allows a licensee to have a temporary RSO for up to 60 
days a year if the licensee meets the requirements for RSOs in 
paragraphs (b), (e), (g), and (h) of this section and notifies the 
Commission in accordance with Sec. 35.14(b). The temporary RSO must 
meet the training and experience requirements in Secs. 35.50 and 35.59. 
This new provision was added so that licensees can appoint someone in a 
timely manner to fulfill the duties and responsibilities of the RSO 
following the sudden departure of the permanent RSO named on the 
license. We also added a new paragraph (d) that allows a licensee to 
simultaneously appoint more than one temporary RSO, if needed, to 
ensure that the licensee has an individual that is qualified to be an 
RSO for each of the different types and uses of byproduct material 
permitted by the license. Even though we have added a provision for a 
temporary RSO, a licensee is expected to fill the position of permanent 
RSO as soon as possible.
Issue 5: Would the Proposed Deletion of the Requirement for a Radiation 
Safety Committee (RSC) Impact the Licensee's Effectiveness in Carrying 
Out Its Radiation Protection Program?
    Comment. The NRC received a substantial number of comments on 
whether the proposed deletion of the RSC would impact the licensee's 
effectiveness in carrying out its radiation protection program. The 
majority of the comments supported retaining the current requirement 
for an RSC at medical institutions because the RSC is a valuable 
resource in this case. The decision to eliminate the RSC could be 
detrimental to the institution's radiation safety program, especially 
with the proposed reduction in the training and experience hours for 
some AUs. Commenters noted that, in a medical institution, the RSC 
provides a valuable forum with expertise from all aspects of the 
licensee's medical use operations. The RSC performs many functions, 
such as developing and mandating the implementation of radiation 
protection policies and procedures, peer reviewing the radiation safety 
aspects of research protocols, and responding to enforcement or 
infractions of radiation safety practices. In addition, it provides the 
RSO support, authority, and access to management. It is incorrect to 
assume that other hospital committees will encompass the area of 
radiation safety compliance. An accountable RSC, and documentation of 
its activities, will assure that decisions are made in the interest of 
radiation safety and regulatory compliance.
    Several commenters noted that NCRP Report No. 127, Operational 
Radiation Safety Program, clearly supports the RSC, especially in the 
formulation of policies, review and audit of program effectiveness, and 
guidance of the RSO.
    Other commenters supported retaining the requirement for an RSC, 
but not specifically tying the requirement to medical institution 
licensees. One recommendation was to retain the RSC for complex, 
multiple discipline, multi-department, and multi-use licensees. Another 
recommendation was for eliminating the requirement for

[[Page 20284]]

small operations authorized under Secs. 35.100 and 35.500, and possibly 
under Sec. 35.200, but making the requirement mandatory for activities 
under Secs. 35.300, 35.400, and 35.600 and for larger operations 
involving imaging. Other recommendations included modifying the 
definition of medical institution to only include those facilities that 
perform more than one radioactive material modality; and requiring an 
RSC for facilities with inpatients. Commenters also said that any 
requirement for facilities with multiple modalities should be qualified 
by ``within the same speciality'' because there is no benefit to having 
physicians who use completely separate modalities communicating 
regularly.
    Some commenters supported deletion of the RSC. According to one 
commenter, there is no evidence that the absence of an RSC jeopardizes 
public and occupational health and safety. Another commenter noted 
that, in some cases, other Federal agencies, such as the FDA, have 
committee requirements that meet radiation safety objectives. Also, 
facilities comply with Occupational Health and Safety Administration or 
Environmental Protection Agency regulations without a requirement for a 
committee. Therefore, deletion of the RSC would not reduce the 
effectiveness of the program, but would allow the licensee flexibility 
in meeting radiation safety objectives and in organizing its operations 
in the most efficient manner. However, another commenter said that 
removing the RSC may increase the burden on licensees, especially in 
conjunction with not requiring procedures to be submitted for review by 
licensing staff.
    Another commenter suggested that rather than eliminating the entire 
requirement for an RSC, it might be more appropriate to reduce the more 
prescriptive requirements, such as the meeting, quorum, recordkeeping, 
and membership requirements.
    Response. Based on public comments, the NRC retained the current 
requirement, with modifications, for certain medical licensees to have 
an RSC to oversee all the uses of byproduct material permitted by the 
license. In the final rule, only licensees that are authorized for two 
or more different types of uses of byproduct material under Subparts E, 
F, and H, or two or more types of therapy units under Subpart H, are 
required to establish an RSC. Examples of such licensees are those 
authorized to use therapeutic quantities of unsealed byproduct material 
(Sec. 35.300) and manual brachytherapy (Sec. 35.400), or manual 
brachytherapy (Sec. 35.400) and LDR units (Sec. 35.600), or teletherapy 
units (Sec. 35.600) and gamma stereotactic radiosurgery units 
(Sec. 35.600). An example where an RSC would not be required would be a 
licensee authorized for use of unsealed byproduct material for uptake, 
dilution, and excretion studies for which a written directive is not 
required (Sec. 35.100) and for use of unsealed byproduct material for 
imaging and localization studies for which a written directive is not 
required (Sec. 35.200). However, we believe that, based on public 
comments, many other medical use licensees will also continue to use an 
RSC to oversee the use of byproduct material, even if they are no 
longer required to do so. Licensees should note that the requirement 
for an RSC is no longer tied to medical institutions, which means that 
it now also applies to ``free-standing clinics.''
    We have deleted most of the prescriptive list of administrative 
requirements and committee tasks that are specified in the current 
rule. For example, the final rule does not include specific 
requirements for the frequency of meetings, the content of the meeting 
minutes, or the tasks that the RSC must perform to oversee the use of 
licensed material. However, based on public comment, we have specified 
the membership of the committee, as discussed in Issue 6.
Issue 6: If an RSC Is Required, Who Should Be Members of the Committee?
    Comment. The Commission asked whether the regulatory text should 
explicitly require that the RSO be a member of the RSC, if a 
requirement for a committee to oversee the radiation safety program was 
included in the final rule. Several commenters said that the membership 
of the RSC is best left to the licensee. While most licensees would 
make their RSO a member, there is no obvious reason to require this 
action. Some commenters said that the RSO should be allowed to decide 
the committee membership, and then submit the specialties of the 
membership to the NRC.
    Most commenters agreed that both the RSO and a representative of 
the licensee's upper management should be explicitly named as members. 
Commenters also recommended that representatives of the different users 
and the nursing staff be on the committee, if the facility is licensed 
for inpatient therapies. While the RSO is responsible for implementing 
the radiation safety program, a successful committee requires both 
management backing and resources, and user support.
    Response. As discussed in Issue 4, the final rule includes a 
requirement for certain medical licensees to have an RSC. We 
essentially agree with the commenters' recommendations for the 
membership of the RSC. We have included a requirement in the final rule 
that the membership of the RSC must include an AU for each type of use 
authorized by the license, the RSO, a representative of the nursing 
service, a representative of management, and other members the licensee 
considers appropriate.
Issue 7: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. Paragraph (b) was amended to delete the phrase ``in 
the daily operation of the licensee's radiation protection program.'' 
This phrase did not add anything to the requirement and was awkwardly 
worded.

Section 35.26, Radiation Protection Program Changes

Issue 1: What Is Meant by Changes in a Licensee's Radiation Protection 
Program That ``Do Not Reduce Radiation Safety?'
    Comment. Several commenters said that the provision in the proposed 
Sec. 35.26(a)(2), that radiation protection program changes can be made 
if the revisions ``do not reduce radiation safety,'' was ambiguous and 
subjective and would invite second-guessing by NRC inspectors. There 
should be objective measures for acceptable changes, such as changes 
that do not result in a licensee exceeding the limits in Part 20 or 
only changes that comply with all applicable regulations and license 
conditions.
    Response. The NRC intended for this provision to provide licensees 
with as much flexibility as possible in making changes in their 
radiation protection program, without seeking Commission approval. 
However, in response to comments that the proposed wording was not 
clear when applied to minor (ministerial) changes to the licensee's 
radiation protection program, we revised the rule to allow licensees to 
make revisions in their radiation protection program that are ``in 
compliance with the regulations and the license.''
Issue 2: Why Is There a Requirement To Instruct Individuals on Changes 
in the Radiation Protection Program?
    Comment. Commenters said that the requirement to instruct 
individuals on changes in the radiation protection program should be 
removed. This

[[Page 20285]]

requirement only adds work for licensees, with no resultant increase in 
safety, and is not consistent with the Commission's philosophy of more 
risk-informed regulations.
    Response. This requirement has been retained in the final rule 
because the NRC believes that it is important to instruct individuals 
on radiation protection program changes before they are implemented, so 
that individuals have a clear understanding of those changes in the 
radiation protection program that may affect them. This instruction may 
be provided in writing, or orally, and may be conducted on either an 
informal or formal basis. For example, the instruction could be 
provided at an informal staff meeting.

Section 35.27, Supervision

Issue 1: Why Does This Section Include Requirements for Supervising 
Individuals?
    Comment. Commenters had a number of concerns about the requirements 
for supervising individuals in this section. One concern was that there 
is no requirement for a licensee to notify the NRC that it operates in 
the manner permitted by this section, i.e., a licensee does not have to 
inform NRC when it allows supervised individuals to use byproduct 
material. Therefore, this section is not consistent with other sections 
in the regulations that only allow licensees to conduct activities that 
are permitted by their licenses. This section should be deleted or 
changed to require licensees to apply for a supervised user program 
within their license applications. In addition, commenters noted that 
if NRC is not made aware of this type of activity, it is not conducive 
to inspection activities.
    Another concern was that this section permits individuals, 
including physicians, to use byproduct material without completing the 
training and experience requirements for AU status. This also allows a 
physician who does not meet the training and experience requirements 
for an AU to perform the duties of the AU without the AU being present. 
If the training and experience required to become an AU is necessary, 
the supervising AU should be required to be present (e.g., during the 
administration and reading of films), and the supervised physician 
should be required to attain licensure in a specified period of time.
    Another commenter also said that this section should be deleted, 
but said that if the section is retained it should be revised to meet 
minimal ACGME teaching requirements for physicians. Recommended changes 
relate to whether: the supervising physician and the supervised 
physician must be within the same city (and preferably in the same 
building); the number of physicians supervised at one time should be 
limited; the duration of a physician working under the supervision of 
an AU should be limited; the NRC should verify the ability of the 
supervising individual to teach; the supervised program should have a 
curriculum, goals, objectives, handouts, and testing; and the NRC 
should be notified that a supervised physician program is in effect.
    Some commenters said that there was no need for this section 
because its provisions are covered in other sections of Part 35. For 
example, proposed Sec. 35.11 (b) and (c) state that a specific license 
is not needed for individuals receiving, possessing, using, 
transferring, and preparing byproduct material under the supervision of 
an AU or ANP, respectively. In addition, commenters said that 
paragraphs (a) and (b) of this section, that contain requirements for 
supervised individuals to follow the instructions of the supervising AU 
or ANP, should be deleted. If there is a failure to properly supervise, 
the licensee, not the supervisor, will ultimately be responsible 
because paragraph (d) of this section holds the licensee responsible 
for the acts and omissions of supervised individuals.
    In addition, one commenter said that the ANP should be added to 
paragraph (a) because, in order to prepare material, the material must 
first be received, possessed, and used.
    Response. Under part 35, only AUs and ANPs identified on a medical 
use license are allowed to use or prepare, respectively, byproduct 
material in the practice of medicine. It is frequently necessary for an 
AU or an ANP to delegate specific tasks associated with using or 
preparing byproduct material to other individuals who do not have the 
same training in the use or preparation of the byproduct material for 
medical use. This section allows for that delegation, if the 
individuals are properly supervised and instructed. The supervised 
individuals must also be required to follow the instructions of the 
supervisor for medical uses of radioactive material or for preparation 
of byproduct material for medical uses, the licensee's written 
radiation protection program procedures and written directive 
procedures, the license conditions, and the regulations of this 
chapter. These provisions do not require prior notification of the NRC 
that a licensee has delegated tasks associated with the medical use of 
byproduct material, e.g., tasks such as package receipt, 
administration, and disposal of the radioactive waste. Such a 
requirement would be an unnecessary burden and negate the flexibility 
afforded to licensees in conducting their medical use programs.
    The AUs and ANPs are best suited to determine what tasks supervised 
individuals are capable of performing and the degree of supervision 
that each needs. Consequently, this section does not include 
prescriptive requirements for training or list delegatable tasks. The 
NRC believes that the requirements in this section provide the best 
balance between NRC's responsibility to assure the public health and 
safety and the licensee's responsibility for the safe use of byproduct 
material.
    We have not added ANP to paragraph (a) of this section because this 
requirement is tied to Sec. 35.11(b)(1), which only allows individuals 
to receive, possess, use, or transfer material under the supervision of 
an AU. Section 35.11(b)(2) permits the preparation of byproduct 
material for medical use under the supervision of an AU or ANP, unless 
prohibited by license condition.
Issue 2: Is There a Need for Licensees To Have a Policy for Supervised 
Individuals To Request Clarification From AUs or ANPs About Procedures 
or Instructions (proposed Sec. 35.27(c))?
    Comment. Commenters said that the requirement for licensees to have 
a policy for supervised individuals to request clarification if they do 
not understand procedures or instructions should be deleted. This 
requirement will not stop a misadministration which may be caused by 
other factors, such as human error or poor management. One commenter 
said that there were no data demonstrating that the failure to ask 
clarifying questions had resulted in a misadministration associated 
with either nuclear medicine or radiation oncology. If 
misadministration data are being used to justify the requirement, then 
it should not apply to diagnostic nuclear medicine because there has 
probably never been an instance where a diagnostic misadministration 
was the result of someone not understanding procedures or instructions.
    Response. The NRC deleted the proposed paragraph (c) of this 
section that required licensees to have a policy for supervised 
individuals to request clarification if they do not understand 
procedures or instructions. Licensees should have flexibility in 
establishing communication programs that are tailored to their 
facilities. Appendix S, in NUREG-1556, Vol. 9 (draft),

[[Page 20286]]

discusses the importance of instructions being clearly communicated to 
professional team members, with constant attention devoted to detail 
during the treatment process. The guidance document states that 
licensees should instruct all workers to seek guidance if they do not 
understand how to carry out a written directive. Based upon actual case 
histories, the NRC believes that some types of medical events can be 
prevented if workers ask questions about what to do or how it should be 
done, before administering a dose or dosage, rather than continuing the 
procedure when there is any doubt.
Issue 3: What Is the Purpose and Intent of the Statement in the 
Proposed Sec. 35.27(d) That Licensees Are Responsible for the Acts and 
Omissions of Supervised Individuals?
    Comment. Commenters raised a number of concerns about the statement 
in paragraph (d) of the proposed rule that licensees that permit 
supervised activities are responsible for the acts and omissions of 
supervised individuals. By explicitly stating that the licensee is 
responsible for the acts and omissions of supervised individuals, the 
implication is that the licensee is not responsible for the acts and 
omissions of AUs, ANPs, AMPs, or the RSO. State laws hold the 
supervising physicians and pharmacists responsible for the actions of 
all health professionals working under their supervision. Another 
concern was that licensees would be held responsible for willful 
actions and omissions of supervised individuals against established 
policies and/or procedures. One commenter requested a definition of the 
term ``supervising AU.'' This term appears to imply that the ``AU'' is 
responsible for supervision, while other statements in Part 35 give the 
authority for supervision to management. In addition, some commenters 
suggested that this requirement be deleted because it states the 
obvious and is unnecessary.
    Response. This statement of the licensee's responsibility for the 
acts and omissions of supervised individuals is in the current 
Sec. 35.25(c). According to the Statements of Consideration for this 
provision, it was added to make it clear that a ``licensee can not 
delegate responsibility to supervised individuals. If a supervised 
individual, through misunderstanding, negligence, or commission, acts 
contrary to the requirements of the license, the regulations, or an 
order, the licensee remains responsible'' (51 FR 36932; October 16, 
1986). This is still an accurate statement of the Commission's intent 
in retaining this provision for supervision by an AU or ANP.
    As used in this section, a ``supervising AU'' is simply an AU who 
supervises an individual using byproduct material. Even though an 
individual may be supervised by an AU, the licensee is ultimately 
responsible for the acts and omissions of supervised individuals.
Issue 4: Should ``Telesupervision'' Be Allowed for Part 35 Licensees?
    Comment. One commenter said that the Part 35 rulemaking should 
address the issue of ``telesupervision.'' With present technology, AUs 
can stay in their offices and supervise medical procedures at 
facilities that are miles away. Due to all of the upcoming challenges 
of emerging technologies, the NRC should address this issue to ensure 
protection of public health and continued radiation safety.
    Response. The NRC has not addressed ``telesupervision'' during the 
revision of Part 35 because the need for the AU or a medical physicist 
to be present during the medical use of byproduct material is dependent 
on the risk associated with the particular modality. For example, the 
use of remote afterloader units requires onsite supervision by 
individuals who are knowledgeable of the radiological hazards 
associated with the use of that material.
Issue 5: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The phrase ``in addition to the requirements in 
Sec. 19.12'' was added to both paragraphs (a)(1) and (b)(1) of this 
section. This addition to Sec. 35.27 has been made as a reminder to 
licensees that they must also comply with the requirements for 
supervision in Sec. 19.12, Instructions to workers.
    The phrase ``written directive procedures'' was added to paragraph 
(a)(2) because it is important that supervised individuals follow the 
licensee's procedures for written directives.
    Paragraph (b)(1) of this section was amended to read ``individual's 
involvement with byproduct material,'' rather than ``use of byproduct 
material,'' because the requirement also applies to individuals who 
prepare byproduct material for medical use under the supervision of an 
ANP.

Section 35.40, Written directives

Issue 1: Why Does Part 35 Need To Include Requirements for Written 
Directives?
    Comment. Several commenters agreed that the NRC should require 
licensees to prepare written directives, especially for those 
procedures that create the greatest risk to the patient from errors and 
those procedures that are performed by supervised individuals. However, 
if the written directive is really meant to be a tool for communication 
between the AU and other health care staff, the proposed requirements 
for written directives should be revised to allow licensees more 
flexibility in defining what information must be included in written 
directives. For example, an AU should be allowed to determine what 
information is necessary for a supervised individual to administer the 
byproduct material. One commenter said that the NRC should only require 
that a written directive be prepared before a treatment to a patient is 
delivered and should not define even the essential elements of the 
directive.
    Another group of commenters opposed both the use of the term 
``written directive'' and the need for written directives for 
administrations of unsealed byproduct material in medicine. Written 
directives, as described in the proposed rule, are ``prescriptions,'' 
which are the standard of practice in medicine and pharmacy. 
Prescriptions are already controlled by the State Board of Medicine and 
Pharmacy and the Attorney General of each state. Licensees should be 
allowed to create records that are consistent with other requirements 
for medical practice and pharmacy, rather than duplicating a 
``prescription.'' The NRC should cite data demonstrating that the 
traditional method of prescribing medicine is not adequate. If the 
requirement for a written directive is retained, 
``radiopharmaceutical'' in Sec. 35.40(a) should be qualified by adding 
``containing byproduct material'' because no other radiopharmaceuticals 
fall under NRC's jurisdiction.
    Response. The NRC believes that the requirements for written 
directives in this section only include what is essential to provide 
high confidence that the byproduct material will be administered as 
directed by the AU. Licensees have the flexibility to include 
additional information that they feel is necessary for a supervised 
individual to perform a procedure according to the directions of the 
AU. Records that include the information specified in Sec. 35.40 and 
are used to demonstrate compliance with other requirements are 
acceptable.
    During the Quality Management and Misadministrations rulemaking (56 
FR 34104; July 25, 1991), several medical societies recommended that 
NRC use the term ``written directive'' to avoid confusion with the term 
``prescription''

[[Page 20287]]

in medical and pharmacy practices. We have retained the use of the term 
``written directive'' so that there continues to be a clear distinction 
between NRC's requirements and other requirements for a 
``prescription.''
    This section neither prevents licensees from keeping or creating 
other pharmacy or medical records, nor requires licensees to create 
records that duplicate prescriptions. Written directives are not 
duplicative of prescriptions. They must include information necessary 
to ensure that byproduct material is administered as directed by the 
AU. This may require different or more detailed information than is in 
a prescription.
    Most diagnostic procedures are low risk. Therefore, licensees are 
not required to prepare written directives for most administrations of 
unsealed byproduct material. This section only requires written 
directives for the higher-risk administrations, such as sodium iodide 
I-131 in quantities greater than 1.11 MBq (30 Ci). We also 
agree that the NRC's jurisdiction only covers radioactive drugs 
containing byproduct material, so we have replaced the word 
``radiopharmaceutical'' with ``radioactive drug containing byproduct 
material'' throughout Part 35.
Issue 2: Does a Written Directive Need To Be Prepared If the AU 
Physician Performs or Is Present During the Administration?
    Comment. Several commenters questioned the need for a written 
directive when the AU physician performs or is present during the 
medical use of the byproduct material. In particular, they questioned 
the benefit of a physician in such a situation having to prepare a 
written directive, if the primary purpose of written directives is to 
prevent misadministrations in carrying out the physician's directions. 
Commenters also questioned whether physicians were expected to prepare 
or revise written directives while simultaneously performing 
administrations.
    Response. Written directives must be prepared in accordance with 
Sec. 35.40 whether or not the AU physician performs or is present 
during the procedure that involves the medical use of byproduct 
material. The NRC does not expect physicians to either prepare or 
revise written directives while performing medical procedures. We agree 
with the commenter that the main reason for requiring written 
directives is to provide high confidence that the administration is 
according to the directions of the AU physician, i.e., that there is no 
misinterpretation of the physician's directions by another physician, 
pharmacist, or supervised individual.
    Licensees are required to retain copies of written directives for 3 
years. These copies provide documentation that the actual 
administrations were according to the written directives prepared 
before the administrations. Licensees are required to report medical 
events, in accordance with Sec. 35.3045, based on the differences 
between the information in the written directives and the actual 
administrations. Therefore, if written directives, or copies of them, 
are not available for all administrations for which they are required 
(e.g., if written directives were not prepared when physicians were 
present during the administrations) licensees will not be able to 
demonstrate compliance with either Sec. 35.40 or Sec. 35.3045.
Issue 3: What Are the Requirements for the AU's Signature on Written 
Directives?
    Comment. One commenter agreed that the requirement for the AU to 
sign the written directive should be retained. The AU checks the 
written directive for ``appropriateness of study'' before signing the 
document before treatment. This practice is part of the Quality 
Assurance Program developed by the Joint Review on Accreditation of 
Hospital Organizations.
    Several commenters requested clarification of the requirements and 
policies associated with signatures on written directives. One 
commenter said that the requirement for preparing, signing, and dating 
written directives has been interpreted differently by regulators in 
the past. The regulations should explicitly state whether a written 
directive must be signed by an AU, or whether a physician under the 
supervision of the AU may sign the written directive. Another commenter 
questioned whether ``electronic signatures'' or ``signatures on file'' 
would be accepted on written directives.
    Response. This section allows an individual under the supervision 
of an AU to prepare a written directive, but requires an AU to sign and 
date it. The NRC requires the signature of the AU on a written 
directive so that there is a record that the AU has reviewed and 
approved the information on the written directive.
    Section 35.5 allows records to be maintained electronically. 
Therefore, AUs may use their own electronic signatures if they are 
signing an electronic version of a written directive. However, 
licensees may not use the ``signature on file'' notation on written 
directives because another individual may add it to a written directive 
and, therefore, it may or may not mean that the AU has reviewed and 
approved the written directive.
Issue 4: How Soon Should Oral Directives or Oral Revisions to Written 
Directives Be Documented in Writing?
    Comment. One commenter recommended that written documentation of 
oral directives or oral revisions to written directives should be made 
the next working day. The current requirement for written documentation 
within 48 hours is unnecessarily restrictive in some cases (e.g., over 
a weekend) and too lenient in other cases (e.g., during the week).
    Response. In situations where a delay in order to revise a written 
directive or to prepare a written directive would jeopardize the 
patient's health, the current requirements in Sec. 35.32(a)(1) allow 
for revisions of written directives to be signed by the AU within 48 
hours of the oral revision and for written directives to be prepared 
within 24 hours of oral directives. In both the proposed and final 
requirements, NRC has decreased the regulatory burden on licensees by 
allowing licensees to document both oral directives and oral revisions 
to written directives within 48 hours. The 48-hour requirement provides 
more flexibility for AU physicians and also allows them to prepare any 
written documentation during the workweek, unless they choose to do 
otherwise.
    Written directives are essential to providing high confidence that 
the byproduct material is administered as directed by the AU. 
Therefore, we do not believe that the requirement should allow for 
written documentation of the administration ``the next working day.'' 
This could potentially result in a delay of over 80 hours before an 
error in the administration is identified, if the administration is 
made early Friday and the written directive is not prepared until late 
Monday.
Issue 5: Do the Requirements for Written Directives Allow for 
Prescribing Doses or Dosages in a Range?
    Comment. Several commenters said that the NRC should allow AU 
physicians to prescribe a range of doses and dosages in a written 
directive. At the time that written directives are prepared, physicians 
are not always aware of how much radioactive drug will be taken up or 
how many seeds will actually be implanted. One commenter suggested that 
an alternative to a dose range in manual brachytherapy is not to 
specify a dose. This allows the

[[Page 20288]]

physician to make a guess at the number of seeds of a certain strength 
to implant and when the implant is completed to document the number of 
seeds actually implanted. If this is acceptable, the dosimetry could be 
done later.
    Response. The regulations allow for AU physicians to prescribe a 
range of dosages, but not doses, in written directives. Section 35.2 
states that prescribed dosage means the specified activity or range of 
activity of unsealed byproduct material. The definition of prescribed 
dose in Sec. 35.2 is dependent on the modality.
    In addition, paragraph (b)(6)(ii) of this section allows the 
physician to change the written directive after the brachytherapy 
sources (other than HDR) are implanted, but before completion of the 
procedure, to more accurately reflect what actually took place (e.g., 
number of sources used, total source strength, exposure time, etc.).
Issue 6: What Is the Basis for Requiring Written Directives for 
Administrations of Greater Than 1.11 MBq (30 Ci) of Sodium 
Iodide I-131?
    Comment. One commenter questioned why the threshold for preparing a 
written directive for administrations of sodium iodide I-131 is set at 
greater than 1.11 MBq (30 Ci) when the patient release 
criteria in Sec. 35.75 indicates that hundreds of millicuries in a 
patient do not pose undue harm. Another commenter said that the 
threshold for I-131 should be increased.
    Response. The threshold for preparing a written directive for 
administrations of sodium iodide I-131 was set at 1.11 MBq (30 
Ci) because it results in a 0.5 sievert (Sv) (50 rem) dose to 
the thyroid. The Commission, with the recommendation of the ACMUI, 
adopted an organ dose of 0.5 Sv (50 rem) as one threshold for 
identifying medical events (previously ``misadministrations'') during 
the Quality Management Program and Misadministrations rulemaking (56 FR 
34104; July 25, 1991). We cited NCRP Commentary No. 7, 
Misadministrations of Radioactive Byproduct Material-Scientific 
Background (July 1991), as stating that this threshold was considered 
to be well below the onset of acute, clinically detectable adverse 
effects that may be caused by ionizing radiation. We believe that the 
current threshold for preparing a written directive for sodium iodide 
I-131 is appropriate. Therefore, we have retained it in the final rule.
    The criteria for licensees to authorize the release of patients in 
Sec. 35.75 are based on the potential dose to the maximally exposed 
individual, not on the quantity of byproduct material associated with 
the administration to the patient. Under Sec. 35.75, a licensee may 
authorize the release of any individual from its control who has been 
administered radioactive drugs or implants containing byproduct 
material, if the total effective dose equivalent to any other 
individual from exposure to the released individual is not likely to 
exceed 5 mSv (0.5 rem).
Issue 7: Should There Be Any Changes to the Proposed List of 
Information That Is Required To Be Included in Written Directives?
    Comment. For any administrations of quantities greater that 1.11 
MBq (30 Ci) of sodium iodide I-131, the name of the 
radiopharmaceutical and the route of administration should be provided 
so that the requirements for written directives for all unsealed 
byproduct material are consistent.
    Response. The requirements are not consistent because there is no 
need to specify either the name of radiopharmaceutical or the route of 
administration when sodium iodide is used. Sodium iodide is the name of 
the radioactive drug administered and it concentrates in the thyroid 
regardless of the route of administration.
    Comment. For gamma stereotactic radiosurgery, the total treatment 
volume should be deleted because there is no way of determining it 
numerically.
    Response. The NRC agrees with the comment and has deleted the 
requirement in paragraph (b)(3) of this section to include the total 
treatment volume in written directives for gamma stereotactic 
radiosurgery.
    Comment. For teletherapy, the inclusion of the overall treatment 
period is not necessary. Extending the treatment time for one or two 
missed fractions has no impact on the overall effectiveness of the 
treatment.
    Response. The NRC agrees that it is not necessary to include the 
overall treatment period in written directives for teletherapy. The 
requirement for overall treatment period has been deleted from 
paragraph (b)(4) of this section.
    Comment. For HDR brachytherapy, the number of fractions and dose 
per fraction can be used to calculate the total dose. The requirement 
for total dose should be deleted so that there is no confusion if two 
different doses (dose per fraction and total dose) are required on the 
written directive.
    Response. The NRC retained the requirement for the written 
directive for HDR brachytherapy to specify the total dose because the 
treatment time is very short compared to other types of brachytherapy.
    Comment. For all other brachytherapy, several commenters suggested 
revision of the requirements for written directives for brachytherapy. 
One commenter said there was no need to require the dose to be stated 
if the number and source strengths were included, while another 
commenter said the opposite. Another commenter suggested separate 
requirements for permanent and temporary brachytherapy implants.
    Response. Following discussion of the comments with the ACMUI, the 
NRC deleted the requirement in paragraph (b)(6)(i) of this section to 
provide the number of sources and source strengths before implantation. 
We do not believe that there needs to be different requirements for 
permanent and temporary brachytherapy because the rule allows the AU to 
document certain information after implantation, but before the 
procedure is completed.
Issue 8: Can the Footnote Be Incorporated Into the Regulatory Text of 
This Section?
    Comment. One commenter suggested that the footnote in this section 
be incorporated into the body of the rule text.
    Response. The NRC agrees and has incorporated the footnote, in its 
entirety, into the body of the text. That footnote contains important 
information about preparing written directives when a patient's health 
could be jeopardized by any delay in providing medical care. The 
requirements for written documentation of an oral directive and 
documentation of a revision to a written directive now appear in 
paragraphs (a)(1) and (c)(1) of this section, respectively.
Issue 9: Were Any Other Changes Made to This Section Between the 
Proposed and Final Rules?
    Response. Yes. Paragraph (a) was amended to delete the requirement 
for an AU to prepare a written directive. The change recognizes the 
fact that written directives are often prepared by supervised 
individuals.
    Paragraph (b)(2) was revised to make it clear that the requirements 
in this paragraph apply to an administration of a therapeutic dosage of 
unsealed byproduct material.
    The requirements for written directives for gamma stereotactic 
radiosurgery in paragraph (b)(3) were amended to delete ``the target 
coordinates (including gamma angle), collimator size, plug pattern, 
total dose for the treatment, and the total treatment

[[Page 20289]]

volume'' and to add ``the total dose, treatment site, and values for 
the target coordinate settings per treatment for each anatomically 
distinct treatment site.'' These changes were made to ensure that 
written directives for gamma stereotactic radiosurgery include the 
essential information.
    Paragraph (b)(5) was revised to make it clear that the requirements 
in this paragraph apply only to high dose-rate brachytherapy.
    Paragraph (b)(6) was revised to make it clear that the requirements 
in this paragraph apply to all other brachytherapy, including low, 
medium, and pulsed dose-rate remote afterloaders.
    Paragraph (b)(6)(i) was amended to delete the requirement for 
written directives for brachytherapy, before implantation, to include 
the number of sources and source strengths. The number of sources used 
is often not known until the procedure is performed.
    Paragraph (b)(6)(ii) was revised to include a requirement for 
written directives for brachytherapy, after implantation but before 
completion of the procedure, to document the number of sources. The 
number of sources used is determined during the procedure.
    Paragraph (d) was amended to include the words ``a copy of'' the 
written directive to conform with the text of Sec. 35.2040.

Section 35.41, Procedures for Administrations Requiring a Written 
Directive

Issue 1: Is There a Need for Medical Licensees to Have a Quality 
Management Program (QMP)?
    Comment. Most of the commenters favored deletion of the QMP, as it 
appears in the current Part 35. The commenters felt that the provisions 
of the QMP were redundant with requirements that are already in place 
because of State pharmacy laws or with regulations codifying the 
routine ``standard of care'' in medicine. They also noted that the data 
collected on misadministrations do not show that QMPs have any impact. 
In particular, there were no data that showed patient identification is 
a problem. Therefore, the issue of incorrect patients being 
administered dosages of byproduct material has been exaggerated. 
Several commenters noted that regulations cannot prevent 
misadministrations (medical events) that are due to human error, 
purposeful misconduct, or failure of a supervised individual to ask 
questions. In addition, commenters welcomed the paperwork relief 
provided by deletion of some of the QMP review and reporting 
requirements.
    Several commenters favored retention of the current QMP 
requirements. One commenter said that the requirement for a QMP 
reinforces the need for a quality improvement committee (QIC) in his 
institution. The QIC reviews patient records and plans, investigates, 
checks, and acts on issues of quality improvement. In addition, the QIC 
periodically reviews compliance with all aspects of the QMP, prepares a 
report that summarizes the findings of the review and identifies the 
corrective actions taken, and then submits it to the RSO. Therefore, 
the QMP can be important in assisting licensees to maintain good 
radiation protection programs. Another individual supported retention 
of the QMP for the following reasons: licensees have already developed 
QMPs that meet the regulations; the annual reviews of the QMPs evaluate 
the effectiveness of the therapy programs; QMP program reviews are 
documented and distributed to management; and they provide a mechanism 
to identify precursor events.
    Several commenters favored a more balanced approach. They would 
delete some of the prescriptive QMP requirements, such as submittal of 
the QMP plans to NRC for review, but retain some essential 
requirements, such as identifying the patient and ensuring that each 
administration is in accordance with the written directive.
    Response. The NRC has not retained the current Sec. 35.32, Quality 
management program, in the final rule. We have decided that only 
certain essential requirements are necessary to provide high confidence 
that byproduct material will be administered as directed by the AU. For 
any administration that requires a written directive to be prepared in 
accordance with Sec. 35.40, licensees must develop, implement, and 
maintain written procedures to assure that the patient's or human 
research subject's identity is verified before each administration and 
that each administration is in accordance with the written directive. 
These procedures must address certain items applicable to the 
licensee's use of byproduct material. Beyond these requirements, the 
final rule allows licensees the flexibility to develop procedures to 
meet their needs. In addition, there is no requirement for submission 
of these procedures to NRC for its approval, as was previously required 
by the quality management rule.
Issue 2: What Is the Commission's Intent in Requiring Procedures for 
Administrations Requiring a Written Directive in Sec. 35.41(a)?
    Comment. One commenter noted that the emphasis in Sec. 35.41 seems 
to be on development of the procedures, rather than on what the 
Commission is trying to accomplish with the procedures. Another 
commenter was in favor of the proposed requirements in paragraph (a) if 
the intent is to permit licensees to develop their own policies and 
procedures to prevent patient misadministration, rather than submitting 
QMP programs requiring prior approval by the NRC.
    Response. The NRC's intent in requiring procedures to provide high 
confidence that the administration will be as directed by an AU is to 
avoid burdening licensees with an absolute requirement that this 
objective be met. We do not intend to imply that all errors in the 
administration of byproduct material can be prevented. For additional 
information refer to the regulatory history of Part 35 (56 FR 34104; 
July 25, 1991, page 34115). Paragraph (a) provides licensees with some 
flexibility to develop procedures that are appropriate for their uses 
of byproduct material. We recognize that there is no ``absolute'' way 
to achieve the objectives of these procedures, e.g., verifying the 
patient's or human research subject's identity. However, NRC does 
require that these procedures be sufficient to provide high confidence 
that the patient's or human research subject's identity is verified. 
For example, just asking an individual his name may not provide high 
confidence that the administration was given to the correct individual. 
Although the procedures do not have to be submitted for NRC review and 
approval, licensees may be requested to make them available for review 
during an inspection or, following a medical event, to demonstrate that 
they provide the requisite high degree of confidence.
Issue 3: Does Sec. 35.41(b) Include the Appropriate Items That Should 
Be Addressed in Procedures for Written Directives?
    Comment. Commenters differed on whether the list of items that 
must, at a minimum, be addressed in the written procedures was too 
prescriptive or too vague. Commenters noted that if a licensee has 
procedures that provide high confidence that the patient's 
identification is verified and that the administration is in accordance 
with the written directive, the procedures will have to include the 
appropriate

[[Page 20290]]

information in paragraph (b). Another commenter said that not all of 
the items to be addressed in paragraph (b) are applicable to all of the 
uses of byproduct material that require a written directive.
    A commenter said that the requirement in paragraph (b) to have 
procedures for checking the manual and computer-generated dose 
calculations and verifying that any computer-generated dose 
calculations are correctly transferred into the consoles of therapeutic 
medical units is vague and does not state how these should be done. 
Another commenter recommended adding an ``/or'' after the word ``and'' 
in paragraph (b)(3) to acknowledge that there could be either manual or 
computer-generated dose calculations.
    Response. Paragraph (b) has been retained in the final rule because 
the Commission believes that these are the minimum items that should be 
addressed in procedures to provide high confidence that the patient's 
identification is verified and that the administration is in accordance 
with the written directive. The commenter correctly noted that not all 
of the items in paragraph (b) are applicable to all of the uses of 
byproduct material that require a written directive. Therefore, 
paragraph (b) of this section was revised to read that the procedures 
``must address the following items that are applicable to the 
licensee's use of byproduct material.'' Paragraph (b)(2) of this 
section was revised to read ``treatment plan, if applicable.'' Both of 
these changes were made because all of the items listed in paragraph 
(b) may not be applicable to the licensee's use of byproduct material. 
The NRC amended paragraph (b)(3) to state more correctly that ``both 
manual and/or computer-generated dose calculations'' should be checked. 
We have not been more specific in order to provide the licensee 
flexibility in determining how these items should be addressed in the 
procedures for his or her modality or unit.
Issue 4: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. Paragraph (b)(2) of this section was amended to read 
``verifying that the administration is in accordance with the treatment 
plan.'' The phrase ``the specific details'' was deleted because they 
are not provided in the regulations.
    Paragraph (b)(4) of this section was amended to read ``therapeutic 
medical units'' to correspond to the use of ``units'' in Subpart H.
    Paragraph (c) of this section was added to refer licensees to the 
record keeping requirements in Sec. 35.2041.

Section 35.49, Suppliers for Sealed Sources or Devices for Medical Use

Issue 1: Are the Sealed Sources and Devices Covered by This Section 
Only Supposed to Be for Medical Uses?
    Comment. As worded, one commenter said that the proposed regulation 
could be interpreted to mean that the sealed sources or devices 
manufactured, labeled, packaged, and distributed in accordance with a 
Part 30 and Sec. 32.74 license may be used only for medical use. If the 
latter interpretation is used, cesium-137 (Cs-137) brachytherapy 
sources could not be used for shielding evaluations because this is not 
a medical use.
    Response. The intent of the regulatory text is for licensees to use 
only the sealed sources and devices listed in paragraphs (a), (b), and 
(c) for medical use. Other sealed sources and devices may not be used 
for medical use. Therefore, the NRC revised the regulatory text to make 
it clearer that licensees shall use only the sealed sources and devices 
that are listed in paragraphs (a), (b), and (c) of this section for 
medical use. This paragraph does not address what sources may be used 
for non-medical uses. For example, Cs-137 brachytherapy sources may be 
used for shielding evaluations.
Issue 2: Are iridium-192 Seeds and Ribbons Considered to Be Sealed 
Sources Under Part 35?
    Comment. A commenter indicated that iridium-192 seeds and ribbons 
are not ``sealed'' sources. Are they included in the reference to 
sealed sources in this section?
    Response. The NRC considers iridium-192 seeds and ribbons to be 
sealed sources, as defined in Sec. 35.2.
Issue 3: Under What Circumstances Can Limited-Scope Licensees 
Participate in Medical Device Trials Conducted Under FDA-Approved 
Investigational Device Exemptions (IDE)?
    Comment. One commenter said that Sec. 35.49, under both the current 
and proposed regulations, has the effect of prohibiting medical 
facilities with specific licenses from participating in certain 
manufacturer-sponsored trials of medical devices conducted under FDA-
approved IDE. The commenter recommended that Sec. 35.49 be modified to 
permit the participation of limited-scope licensees in multi-site 
manufacturer-sponsored medical device trials conducted under FDA-
approved IDEs.
    Response. A specific licensee may have to amend its license before 
it participates in a trial with a source with an IDE in the following 
situations: (1) the sealed source/device design or use is changed from 
that documented in the SSDR; or (2) the sealed source or device was not 
initially distributed by a Sec. 32.74 supplier. There are other 
situations where a specific licensee may use a sealed source under an 
IDE and not have to amend its license. For example, when the sealed 
source is the same as the description in the SSDR and the sealed source 
was originally distributed by a Sec. 32.74 supplier, but the FDA 
requires an IDE because the description of the sealed source or device 
differs from that originally described to the FDA.
    There are additional regulatory requirements for broad scope 
medical licensees beyond the requirements for specific licensees. 
Because the broad scope licensees must comply with additional 
requirements to ensure the safe use of byproduct material, they have 
more flexibility than specific licensees in the activities that may be 
conducted under their licenses.
Issue 4: Should This Section Also Address Distribution by Sec. 32.72 
Licensees?
    Comment. One commenter questioned whether Sec. 35.49(a) should 
include Sec. 32.72 licensees as distributors of the sources.
    Response. Section 32.72 applies to unsealed byproduct material 
distributors. Therefore, these licensees should not be included in 
Sec. 35.49(a), which applies to sealed sources.
Issue 5: What Are the Regulations for the Use and Distribution of 
Sealed Sources and Devices From International Manufacturers?
    Comment. A commenter questioned whether the rules prohibit the use 
of sources and devices from international manufacturers that may not 
have an NRC or Agreement State license to manufacture, package, and 
distribute these sources and devices.
    Response. In order for an international manufacturer of sealed 
sources to distribute these sources in the United States, the 
manufacturer must have both a distribution license and a manufacturing 
license. The manufacturing license does not have to be from the US. The 
distribution license must be from NRC or an Agreement State and the 
sources to be distributed must go through the SSDR process.

[[Page 20291]]

Issue 6: What Other Comments Were Made on This Section in the Proposed 
Rule?
    Comment. One commenter said that ``assembled'' needed to be added 
to Sec. 35.49(a).
    Response. As used in Sec. 35.49(a), the word ``manufactured'' 
includes ``assembly'' of the sealed sources or devices.
Issue 7: Were There any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    The NRC added a new paragraph (b) to allow for medical use of 
sealed sources and devices that have been noncommercially transferred 
from a Part 35 licensee. ``Noncommercially transferred,'' as used in 
this part, means that the sources and devices are not being transferred 
for profit in the open market. Subsequent distribution of the sealed 
source or device is not subject to the requirements of this paragraph, 
if the source or device is distributed to licensees that have a license 
to possess the source or device. However, the source and device cannot 
be altered from the description and intended use documented in the 
SSDR. Currently, licensees must obtain an amendment exempting them from 
the requirements in this section following the initial distribution of 
the sealed source or device.

Section 35.50, Training for Radiation Safety Officer

Issue 1: Due to the Large Variation in Authorized Uses of Byproduct 
Material Under Medical Licenses, What Are Appropriate Training and 
Experience Requirements for RSOs Listed on Such Licenses?
    Comment. Commenters expressed concern that, due to the large 
variation in the authorized uses of byproduct material under medical 
licenses, it is difficult to have one set of requirements for RSOs. 
Other commenters believe that the qualifications of the RSO should be 
specified in competencies that are commensurate with the scope and 
complexity of the radiation safety program that the RSO must implement. 
For example, the required experience in paragraph (b) should be tied to 
the specific medical uses that are authorized on the license. It is 
neither necessary nor practical to require a certified health physicist 
to be the RSO at a small clinical program that only involves low risk 
modalities, such as routine nuclear medicine procedures. Alternatively, 
it is inappropriate for an AU to function as the RSO at a large complex 
program or one which may involve a broad scope license. A related 
comment was that certification by the ABHP does not mean that an 
individual is qualified to be an RSO for a medical licensee because he 
or she may have no experience in a medical environment.
    One commenter said that the issue of acceptable qualifications for 
an RSO should be dealt with both through the regulations and the 
licensing process. A license reviewer should be able to place 
additional qualifications on an RSO for a more complex byproduct 
material program.
    Another concern was the perceived inconsistencies in the 
requirements. For example, board certification in paragraph (a) 
requires many more hours of training and experience than is listed in 
paragraph (b). In addition, AUs, AMPs, and ANPs are not required to 
obtain written certification that they have achieved a level of 
radiation safety knowledge sufficient to independently function as an 
RSO.
    Response. The NRC agrees that it is very difficult to have a single 
set of training and experience requirements for RSOs named on medical 
licenses because of the wide variation in medical uses of byproduct 
material. Therefore, we made several changes to the current 
requirements for RSOs to ensure that the RSO has adequate training for 
the types of uses for which he or she has RSO responsibilities. The 
final rule requires that an RSO must have one year of full-time 
radiation safety experience involving similar types of uses of 
byproduct material and a signed preceptor statement that the individual 
can function as an RSO for a medical use licensee. If an AU, AMP, or 
ANP is named RSO, he or she must have the required experience with 
similar types of uses of byproduct material for which the individual 
has RSO responsibilities.
    The NRC reviews the training and experience of the RSO as part of 
the licensing process to determine if the individual has the 
qualifications to be named as RSO for the medical uses authorized on 
that license. A major focus during the rulemaking has been to 
incorporate all of the requirements for medical licensees in Part 35 so 
that there is no need for additional requirements (via license 
conditions) to be placed on licensees during the licensing review.
Issue 2: What Will Be the Status of an RSO Who Satisfies the Current 
Training and Experience Requirements, But Not the New Training and 
Experience Requirements, When the Rule Becomes Effective?
    Comment. One commenter said that the regulations need to 
accommodate older, valuable professionals with years of experience as 
health physicists and medical health physicists. The preceptor of such 
an individual may no longer be available (retired or deceased) to 
provide the written certification. In addition, it serves no purpose 
for these individuals to satisfy 200 hours of didactic training when 
they might well be the instructors for such programs.
    Response. An individual who is currently listed on a license as an 
RSO will be ``grandfathered'' under Sec. 35.57 when the rulemaking 
becomes final and will not have to satisfy the requirements in 
Sec. 35.50. The individual will be able to continue as an RSO, 
including being named as an RSO on a new license application at a 
future date.
Issue 3: Can a Technologist Be the RSO for a Medical Licensee?
    Comment. The NRC received comments that both supported and opposed 
technologists being RSOs for medical licensees. Some commenters think 
that nuclear medicine technologists are often the individuals who are 
most familiar with radiation safety requirements and are in the best 
position to carry them out. Other commenters think that technologists 
are more involved in clinical procedures. Therefore, technologists are 
not as totally oriented to radiation safety as either medical 
physicists or health physicists. One commenter said that certified or 
registered technologists would many times be better choices for RSOs 
than AUs. Another commenter said that one year of full-time experience 
as a radiation safety technologist does not provide enough opportunity 
to address all the issues that confront an RSO.
    Response. The current Part 35 allows a technologist to be an RSO if 
the requirements in Sec. 35.900, Radiation safety officer, are met. The 
NRC continues to believe that a technologist can be an RSO if he or she 
successfully completes all of the training and experience requirements 
in the new Sec. 35.50, Training for Radiation Safety Officer.
Issue 4: Is the Requirement in Sec. 35.50(b) for an RSO To Have 1 Year 
of Full-Time Supervised Radiation Safety Experience Involving Similar 
Types(s) of Use(s) of Byproduct Material Adequate?
    Comment. One commenter said that 1 year of full-time experience is 
not adequate for an RSO to cover both nuclear medicine and therapy or 
to cover all aspects of a broad scope licensee's radiation safety 
program.
    Response. The NRC has retained the requirement for 1 year of full-
time

[[Page 20292]]

supervised experience because that requirement is in the current 
Sec. 35.900(b)(2) for radiation safety technologists, and we have no 
evidence that the 1 year requirement has resulted in inadequate 
experience using byproduct material. This requirement is important 
because it must involve similar type(s) of use(s) of byproduct material 
for which the individual will have RSO responsibilities. In addition to 
the 1 year of full-time experience, the individual must also satisfy 
the other training and experience requirements in Sec. 35.50 in order 
to be named as an RSO on a license.
Issue 5: Why Is There a Requirement for an RSO To Obtain a Preceptor 
Statement?
    Comment. Several commenters questioned the need for a preceptor 
statement for RSOs and noted the difficulty of obtaining these 
statements. One commenter said that preceptors are not common in the 
health physics profession. RSOs often obtain their training and 
experience at multiple institutions. Therefore, no single individual 
would be able to attest to satisfactory completion of all of the 
training and experience requirements. Several commenters said that the 
requirement for a preceptor statement should allow for submission of 
documents such as resumes or college transcripts that are comparable to 
a preceptor statement. Another suggestion was that licensee management 
be able to sign the preceptor statement.
    Response. The NRC has retained the requirement for an RSO to obtain 
written certification that he or she has completed the training and 
experience requirements in paragraph (b)(1) of Sec. 35.50. We consider 
such a statement to be an important component of the overall training 
requirements. The requirement for a preceptor statement for an ANP is 
in the current Part 35. We are not aware of any difficulties an ANP may 
have experienced in getting the required written certification. We 
recognize that professionals very often get their training and 
experience at multiple locations and there may not be one individual 
who can attest to completion of all of the training and experience 
requirements. In that case, the preceptor would be expected to look at 
the transcripts or possibly check some references for the individual 
for whom they are preceptoring in order to certify that the individual 
has satisfied the requirements in paragraph (b)(1) of this section. We 
have required that the preceptors be RSOs because they are most 
qualified to judge whether the individual has achieved a level of 
radiation safety knowledge sufficient to independently function as an 
RSO for medical uses of byproduct material. Licensee management may not 
have the same knowledge. Therefore, the licensee may not be in the best 
position to judge another individual's level of radiation safety 
knowledge and experience. We discuss the training and experience 
requirements in the final rule, including the preceptor, in Section 
III, Part I, of the SUPPLEMENTARY INFORMATION of this document.
Issue 6: Should AUs, AMPs, and ANPs Be RSOs?
    Comment. The NRC received a number of comments that did not agree 
with the provision in paragraph (c) of this section that allows AUs, 
AMPs, or ANPs to be RSOs. Commenters felt that there was an 
inconsistency between the requirements for an RSO to complete 200 hours 
of didactic training, and allowing AUs, with as little as 40 hours of 
didactic training and 20 hours of supervised training, to be RSOs.
    There were no comments that recommended that the hours required for 
RSOs be reduced. Rather, commenters recommended that if AUs, AMPs, and 
ANPs are allowed to be RSOs, they should be required to satisfy the 
same requirements as RSOs, including 200 hours of didactic training and 
supervised experience in the activities listed in paragraph (b)(1)(ii). 
Another suggestion was to revise the training requirements for AUs to 
focus on requirements associated with being an RSO. One commenter said 
that paragraph (c) should be deleted because training and experience 
requirements for RSOs should be independent of AU, AMP, and ANP status.
    Another concern was that physicians typically have AU status for 
one type, or similar types, of medical use and may not be qualified to 
be the RSO for other types of medical uses. For example, a physician 
with AU status in nuclear medicine may be qualified to be an RSO for a 
licensee that only provides nuclear medicine services, but he or she 
should not be named as RSO for a brachytherapy device licensee or a 
broad scope licensee.
    Several commenters said that only AUs for Sec. 35.100 and 
Sec. 35.200 uses should be allowed to be RSOs, while another commenter 
suggested that an AU for Sec. 35.600 uses could be an RSO for all other 
uses. One commenter said that, in small practices, an AU should be 
allowed to serve as the RSO for the modality in which they have AU 
status, while in broad scope institutions a ``dedicated'' RSO is 
necessary. One commenter said that the regulations should allow 
licensees to have more than one RSO, or the regulations should 
emphasize that an RSO must have training and experience in all of the 
types of uses for which he or she has RSO responsibilities.
    Response. Following a review and evaluation of the public comments, 
the NRC retained the provision in paragraph (c) that allows AUs, AMPs, 
and ANPs to be RSOs. The current rule allows AUs that are identified on 
the licensee's license to be RSOs. Retention of this provision is 
important for a licensee that is a sole practitioner and must be both 
the AU and RSO. Not allowing such a licensee to be an RSO would result 
in unnecessary regulatory burden on that licensee.
    The final rule also allows for AMPs and ANPs to be RSOs. This 
provides medical licensees even more flexibility in whom they name as 
their RSO. We believe that AMPs are well aware of the radiation safety 
issues associated with therapeutic units. In addition, we believe that 
the 700 hours of training and experience required for ANPs provides 
them with extensive knowledge of the radiation safety issues associated 
with the medical use of unsealed byproduct material.
    Note that AUs, AMPs, and ANPs may be named as RSO only if they have 
experience with the radiation safety aspects of similar type(s) of 
use(s) of byproduct material for which the individual will have RSO 
responsibilities. For example, an AU of unsealed byproduct material 
cannot be named an RSO for therapeutic medical units, or vice versa, 
unless he or she has additional training and experience with these 
types of units.
    Part 35 does not allow licensees to have more than one permanent 
RSO. The RSO named on the license must have training and experience 
with the radiation safety aspects of all types of uses of byproduct 
material for which the individual will have RSO responsibilities. 
However, Sec. 35.24(c) in the final rule does allow licensees to name 
multiple temporary RSOs, if necessary. For additional information, 
refer to the discussion of the provision for temporary RSOs in 
Sec. 35.24.
Issue 7: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added a phrase, ``or permit issued by a 
Commission master material licensee,'' in paragraph (b)(1)(ii). This 
phrase was added to conform with the change in the definition of 
Radiation safety officer, in which the phrase ``a medical use permit 
issued by a Commission master material

[[Page 20293]]

licensee was added as one way to identify a Radiation Safety Officer.
    The NRC added a new paragraph (b)(1)(ii)(F) that states that the 
RSO's experience should include the use of emergency procedures to 
control byproduct material. The list of RSO duties in the current Part 
35 includes ``taking emergency action if control of byproduct material 
is lost,'' but this area was omitted in the proposed rule.
    We also reworded paragraph (b)(2) of this section to state more 
clearly that the preceptor must certify in writing that the individual 
has both completed the structured educational program in paragraph 
(b)(1) and achieved a level of radiation safety knowledge sufficient to 
function independently as an RSO for a medical use licensee.

Section 35.51, Training for an Authorized Medical Physicist

Issue 1: What Is the Distinction Between a Physicist, Health Physicist, 
and a Medical Physicist in Part 35?
    Comment. One commenter was concerned about the lack of 
differentiation between a physicist, a health physicist, and a medical 
physicist in the proposed rule. Health physics is radiation detection 
and radiation safety. Medical physics involves radiation detection and 
health physics, but with additional emphasis on treatment planning, 
therapy, and dosimetry. Under the new regulations, it appears that a 
solid state physicist with a masters degree, who had never had a course 
in medical physics or dosimetry, could work for 2 years on the 
radiation safety aspects of the tasks listed in Sec. 35.51(b)(1), learn 
to calibrate an HDR, take a test on radiation safety, and be an AMP.
    Response. The term ``authorized medical physicist,'' as used in 
Part 35, is defined in Sec. 35.2. The NRC uses the term AMP in the new 
Part 35, rather than ``teletherapy physicist'' as in the current Part 
35, because the regulations now include requirements for photon-
emitting remote afterloader units and gamma stereotactic radiosurgery 
units in addition to teletherapy units. The terms ``physicist'' and 
``health physicist'' are not defined in Sec. 35.2 because they are not 
used in Part 35. Physicists and health physicists that meet the 
requirements for an AMP or RSO would be recognized on the license as an 
AMP or RSO, respectively.
    The requirements for an AMP in this section are similar to the 
requirements for a teletherapy physicist in the current Sec. 35.961, 
Training for teletherapy physicist. As in the current Part 35, a 
physicist who wants to be an AMP would have to have a master's or 
doctor's degree in physics, biophysics, radiological physics, or health 
physics; and complete 1 year of full-time training in therapeutic 
radiological physics and an additional year of full-time work 
experience under the supervision of a medical physicist at a medical 
institution performing the tasks in the sections listed in 
Sec. 35.51(b)(1). The only new requirement is for an AMP to obtain a 
preceptor statement that he or she has obtained a level of competency 
sufficient to function independently as an AMP. We have deleted the 
proposed requirement for an AMP to demonstrate sufficient knowledge in 
radiation safety by passing an examination. We discuss the training and 
experience requirements in the final rule, including the deletion of 
the examination, in Section III, Part I, of this document.
Issue 2: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. In the lead-in sentence, a phrase ``Except as 
provided in Sec. 35.57'' was added. This phrase was inadvertently left 
out in the proposed rule.
    The phrase ``or an equivalent training program approved by the 
NRC'' was deleted from paragraph (b)(1) of this section because the NRC 
is not going to approve training programs under the revised training 
and experience requirements. For a more detailed discussion of the new 
training and experience requirements refer to Section III, Part I, of 
this document.
    Paragraph (b)(1) was amended to include a reference to the new 
Sec. 35.433, Decay of strontium-90 sources for ophthalmic use. Section 
Sec. 35.433 requires that only an AMP shall calculate the activity of 
each strontium-90 source that is used to determine the treatment times 
for ophthalmic treatments.
    In addition, we reworded paragraph (b)(2) to state more clearly 
that the preceptor must certify in writing that the individual both has 
completed the requirements in paragraph (b)(1) and has achieved a level 
of competency sufficient to function independently as an AMP. We also 
reworded paragraph (b)(2) to clarify that the preceptor has to be an 
AMP who meets the requirements in Sec. 35.51 or equivalent Agreement 
State requirements for an AMP for each type of therapeutic medical 
device for which the individual is requesting AMP status. For example, 
an individual who is an AMP for only remote afterloaders can not be a 
preceptor for an individual who wants to be an AMP for gamma 
stereotactic radiosurgery units.

Section 35.55, Training for an Authorized Nuclear Pharmacist.

Issue 1: Should the Current Requirement for ANPs To Complete 700 Hours 
in a Structured Educational Program Be Retained?
    Comment. Most commenters supported the proposal to maintain the 
current 700 hours of training and experience for ANPs because they 
believe that this training is necessary to assure the quality of 
nuclear pharmacy practitioners. One commenter recommended that the 700 
hours of training and experience should specifically include 200 hours 
of didactic training.
    Response. Throughout this rulemaking, the NRC reviewed and 
discussed the training and experience requirements in Part 35 at 
facilitated public meetings held both during the development of the 
proposed rule and during the public comment period on the proposed 
rule. Based on these discussions and on a review of the written 
comments received on the proposed rule, we made no changes to the 
current requirements for an ANP to complete 700 hours in a structured 
educational program. The current requirements are considered 
appropriate for the duties and responsibilities of an ANP, as defined 
in Sec. 35.2.
Issue 2: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. In the lead-in sentence, a phrase ``Except as 
provided in Sec. 35.57'' was added. This phrase was inadvertently left 
out in the proposed rule.
    The NRC reworded paragraph (b)(2) of this section to state more 
clearly that the preceptor must certify, in writing, that the 
individual both has completed the structured educational program in 
paragraph (b)(1) and has achieved a level of competency sufficient to 
function independently as an ANP. We also reworded this section to 
state more correctly that the preceptor is certifying that the 
individual has achieved a level of competency sufficient to function 
independently as an ANP, rather than to independently operate a nuclear 
pharmacy. The amended text is consistent with the text used in the 
other training and experience sections.

[[Page 20294]]

Section 35.57, Training for Experienced Radiation Safety Officer, 
Teletherapy or Medical Physicist, Authorized User, and Nuclear 
Pharmacist.

Issue 1: Why Doesn't Sec. 35.57 Include a Reference to Sec. 35.55, 
Training for an Authorized Nuclear Pharmacist?
    Comment. One commenter noted that Sec. 35.57(a) in the proposed 
rule referred to experienced RSOs, physicists, and nuclear pharmacists, 
but only referenced the training requirements for RSOs and physicists.
    Response. The NRC corrected Sec. 35.57(a) to include the reference 
to Sec. 35.55, Training for an authorized nuclear pharmacist.
Issue 2: Why Did Sec. 35.57(b) in the Proposed Rule Reference Training 
Requirements for AUs in Subparts C-H, When There Are No Training 
Requirements for AUs in Subpart C?
    Comment. One commenter noted that Sec. 35.57(b) in the proposed 
rule referenced training requirements for AUs in Subparts C-H, but 
there are no training requirements for AUs in Subpart C.
    Response. The NRC corrected Sec. 35.57(b) to delete the reference 
to Subpart C, which does not include training requirements for AUs.
Issue 3: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC revised paragraphs (a) and (b) to include 
AUs and other authorized persons that are identified on a permit issued 
by a Commission master material licensee, a permit issued by a 
Commission or Agreement State broad scope licensee, or a permit issued 
by a Commission master material license broad scope permittee. This 
change has been made so that this section is consistent with the 
revised definition of AUs and other authorized persons in the final 
rule.

Section 35.59, Recentness of Training

Issue 1: How Much Related Continuing Education and Experience Does an 
Individual Need To Have if Their Training and Experience Has Not Been 
Obtained Within 7 Years Preceding the Date of the Application?
    Comment. A commenter questioned that if the training and experience 
have not been obtained within the 7 years preceding the date of 
application, how much related continuing education and experience would 
the individual need to have, and would this be a case-by-case 
evaluation with input from the ACMUI.
    Response. If the training and experience was not obtained within 7 
years preceding the date of the application, the continuing education 
and experience requirements for an individual would be reviewed on a 
case-by-case basis, with input from the ACMUI, as necessary.

Subpart C--General Technical Requirements

Section 35.60, Possession, Use, and Calibration of Instruments To 
Measure the Activity of Unsealed Byproduct Materials

Issue 1: Can All Requirements for Calibration of Instruments Used To 
Measure the Activity of Unsealed Byproduct Material Be Combined? Is it 
Necessary to Have Prescriptive Calibration Requirements for these 
Instruments?
    Comment. Commenters proposed that Secs. 35.60 and 35.62 be combined 
into one section because both sections address calibration of 
instruments used to measure the activity of unsealed byproduct 
material. They also recommended that the prescriptive calibration 
requirements be deleted so that licensees have the flexibility to 
develop a calibration program that meets their needs.
    Response. The NRC agrees that Secs. 35.60 and 35.62 should be 
combined because both sections address instrument calibration. We also 
agree that the prescriptive requirements should be deleted from the 
section. Therefore, the regulatory text was amended to delete 
prescriptive calibration requirements. The section now requires that 
licensees calibrate instrumentation in accordance with nationally 
recognized standards (e.g., voluntary consensus standards, such as ANSI 
N42.13-1986 (R 1993), ``Calibration and Usage of Dose Calibrator 
Ionization Chambers for the Assay of Radionuclides.'') or with the 
manufacturer's instructions. This change makes the requirements for 
instrument calibration more flexible, more adaptable to new technology, 
and more performance-based.
Issue 2: Does This Section Apply To Licensees That Use Brachytherapy 
Sources?
    Comment. A commenter asked that we revise the section to state that 
the section does not apply to use of brachytherapy sources.
    Response. The title of this section has been amended to clarify 
that it only pertains to instruments used to measure the activity of 
unsealed byproduct material. The calibration of brachytherapy sources 
is addressed in Sec. 35.432.
Issue 3: Should Licensees That Only Use Unit Dosages Be Required To 
Possess, Use, and Calibrate Instruments To Measure the Activity of 
Unsealed Byproduct Material?
    Comment. Some commenters agreed that the NRC should not require 
unit dosages to be assayed. As a result, they did not believe that it 
was necessary to require licensees that only use unit dosages to 
possess, use or calibrate instruments to measure the activity of 
unsealed byproduct material. Other commenters disagreed with the 
proposed provision that did not require direct measurement of unit 
dosages prior to administration. They believed that all dosages should 
be assayed. Therefore, all licensees should be required to comply with 
this section.
    Response. The NRC amended the regulatory text to state clearly that 
this section only applies to direct measurements that are made in 
accordance with Sec. 35.63, which requires licensees to assay 
(measurement of radioactivity) nonunit dosages except when volumetric 
measurements and mathematical calculations are used.
    As stated in the Statements of Consideration for the proposed rule 
(63 FR 43533; August 13, 1998), if a licensee administers only unit 
dosages from manufacturers (or preparers) and uses decay methods to 
determine the dosages, the licensee is not required to have a 
measurement instrument and, thus, is exempt from the calibration 
requirements of this section. However, if a licensee administers unit 
dosages but chooses to reassay a unit dosage, the licensee must comply 
with this section. If an instrument is used to measure dosages, it is 
extremely important that it is calibrated.
Issue 4: Is It Necessary To Keep a Record of Instrument Calibrations?
    Comment. Some commenters did not believe that it was necessary to 
keep a record of the instrument calibrations.
    Response. The NRC retained the requirement to maintain calibration 
records because they are needed to document that the instruments have 
been calibrated. However, we have simplified the recordkeeping 
requirements in Sec. 35.2060 of the final rule by requiring that the 
licensee record the model and serial number of the instrument, the date 
of the calibration, the results of the calibration, and the name of the 
individual who performed the calibration. These changes are further 
discussed in Sec. 35.2060.

[[Page 20295]]

Section 35.61, Calibration of Survey Instruments

Issue 1: Is This Section Needed in Part 35?
    Comment. A commenter believed that this section should be deleted 
from Part 35 because survey instrument calibration is addressed in 10 
CFR 20.1501.
    Response. The NRC has not deleted this section. Section 20.1501 
requires that licensees calibrate survey instruments periodically, but 
it does not provide specific requirements for calibrations of survey 
instruments. Specific requirements are needed for Part 35 licensees to 
ensure that their radiation survey instruments are properly calibrated. 
An accurate survey instrument is important because individuals rely on 
the instrument output to assess radiation levels in areas in or 
adjacent to nuclear medicine or radiation therapy departments where 
patients or the public may have access.
Issue 2: Is It Necessary To Require That Survey Instrument Operability 
Be Determined With a Check Source?
    Comment. A commenter stated that the NRC should retain the 
requirement in the current rule that requires licensees to check survey 
instrument operability with a dedicated check source. Another commenter 
indicated that the word ``check'' should be deleted in the section 
title because the regulatory text did not include a requirement for an 
instrument ``check.''
    Response. The requirement to check survey instrument operability 
with a dedicated check source was not included in the proposed or final 
rule because the NRC believes that licensees should have flexibility in 
how they determine that instruments are operating properly. We deleted 
the word ``check'' from the title because the section does not include 
a requirement for an instrument ``check.''
Issue 3: How Often Should a Survey Instrument Be Calibrated?
    Comment. Commenters suggested various frequencies for instrument 
calibrations. Some commenters suggested that instruments be calibrated 
every 6 months. Others agreed with the 1-year interval in the proposed 
rule and still others suggested a 2-year interval.
    Response. The NRC believes that survey instruments should be 
calibrated before first use, annually, and following any repair that 
affects the calibration of the instrument. A 1-year calibration 
frequency is consistent with nationally recognized standards, such as 
ANSI (ANSI-N323A-1997).
Issue 4: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. In paragraph (a), the NRC added the phrase ``that 
affects the calibration.'' This was done to clarify that the licensee 
does not need to recalibrate an instrument if the repair did not affect 
the calibration. For example, if the licensee replaced the batteries in 
the instrument, the licensee would not need to calibrate it. In 
paragraph (a)(2), we added the word ``decade'' to account for 
instruments with digital readouts.
    Proposed paragraph (b) was deleted from the final rule. We believe 
the licensee should have flexibility in how it documents information on 
the status of survey instrument calibrations. Our primary concern is 
that the instrument is reading accurately. Proposed paragraph (c) 
stated that a licensee may not use a survey instrument if the 
difference between the indicated exposure rate and the calculated 
exposure rate exceeds 20 percent. Therefore, we do not believe the 
requirement in the proposed paragraph (b) for a licensee to attach a 
correction chart is needed. A statement regarding when a licensee shall 
consider a point calibrated is unnecessary. Because of the deletion of 
proposed paragraph (b), proposed paragraphs (c) and (d) have been 
redesignated as paragraphs (b) and (c) in the final rule.

Section 35.62, Possession, Use, Calibration, and Check of Instruments 
To Measure Dosages of Alpha- or Beta-Emitting Radionuclides

Issue 1: Can This Section Be Combined With Sec. 35.60?
    Comment. Commenters proposed that this section be combined with 
Sec. 35.60.
    Response. The NRC agreed that Secs. 35.60 and 35.62 could be 
combined because Part 35 requirements for instrument calibrations are 
the same for all types of instruments. (See the response to similar 
comments under Sec. 35.60.)

Section 35.63, Determination of Dosages of Unsealed Byproduct Material 
for Medical Use

Issue 1: Can This Section Be Combined With Sec. 35.60?
    Comment. A commenter proposed that this section be combined with 
Sec. 35.60.
    Response. The NRC did not combine Sec. 35.60 with Sec. 35.63 
because these sections have different purposes. Section 35.60 contains 
the requirements for calibrating instruments used to determine the 
activity of a dosage. Section 35.63 contains the requirements for 
determining the activity of a dosage.
Issue 2: Should Unit Dosages Be Reassayed Before Administration?
    Comment. Some commenters supported the lack of a proposed 
requirement for the licensee to reassay unit dosages. These commenters 
believed that the administered activity could be based on the activity 
reported by the nuclear pharmacy. Other commenters did not support the 
proposed rule. They believed that all dosages should be assayed by the 
licensee before administration.
    Response. The NRC believes that a licensee should determine and 
record the activity of each dosage before medical use. For unit 
dosages, this determination must be made by direct measurement of 
radioactivity or by a decay correction based on the activity or 
activity concentration. The provision for licensees to determine the 
activity of the unit dosage by direct measurement of radioactivity was 
added to the final rule. The activity or activity concentration must 
have been determined by a manufacturer or preparer licensed under 
Sec. 32.72 or equivalent Agreement State requirement or by an NRC or 
Agreement State licensee for use in research in accordance with an 
RDRC-approved protocol or an Investigational New Drug (IND) protocol 
accepted by FDA. Because the unit dosages have been assayed by the Part 
32 licensee or by a licensee for use in research in accordance with an 
RDRC-approved protocol or an IND protocol accepted by FDA, we do not 
believe the Part 35 licensee should be required to reassay the dosage. 
Licensees should note that, if a unit dosage has been changed or 
manipulated in any way, it is no longer considered to be a unit dosage 
and will need to be reassayed before it is administered.
Issue 3: Can Volumetric Measurements Be Used To Determine the Activity 
of a Dosage?
    Comment. Commenters asked that we clarify whether the phrase 
``combination of measurements and calculations'' would allow a licensee 
to base the administered activity on the radioactivity measurement made 
by a manufacturer (or a preparer), with volume measurement and 
calculation by a licensee. Commenters also asked that we clarify 
whether the term ``direct measurement'' means that the activity of the 
dosage must be based on a measurement of the radioactivity.
    Response. The NRC agrees that the terms ``direct measurement'' and

[[Page 20296]]

``combination of measurements and calculations'' in the proposed rule 
text needed to be clarified. In the final rule, we made two changes:
    1. We replaced the term ``direct measurement'' by ``direct 
measurement of radioactivity,'' and
    2. We added an alternate method for determining dosage by using the 
radioactivity measured by a manufacturer or a preparer, with volume 
measurement and calculation by a licensee.
Issue 4: Should the Administered Dosage Be Allowed To Deviate From the 
Prescribed Dosage?
    Comment. Commenters recommended that we delete the requirement in 
Sec. 35.63(d) that states: ``a licensee shall not use a dosage if the 
dosage differs from the prescribed dosage by more than 20 percent.'' 
Many commenters believed that this was an overly prescriptive 
requirement. They stated that it is the AU's responsibility to 
determine the proper dosage or dosage range for patients.
    Response. The NRC believes that the requirement should be 
maintained in the final rule with some modification to address 
prescribed dosage ranges. AUs are responsible for prescribing the 
dosage or dosage range. AUs may prescribe a dosage range greater than 
20 percent. This range can be case specific or can be a ``blanket'' 
range that would cover all administrations of unsealed byproduct 
material. For example, the AU could establish a policy where all 
administered dosages may deviate from the prescribed dosage by plus or 
minus ``xx'' percent.
    In cases where the AU has not prescribed a dosage range, we believe 
that the regulation should allow for some deviation from the prescribed 
dosage. Without this 20 percent ``default'' range, all administered 
dosages would need to exactly match the prescribed dosage at the time 
of administration. We believe that a 20 percent deviation is reasonable 
in consideration of current technology. We have not allowed a deviation 
outside of the prescribed range because the AU has the flexibility of 
establishing the acceptable range under this provision.
Issue 5: Is It Necessary To Perform a Decay Correction for Long-Lived 
Radionuclides?
    Comment. Commenters asked that the rule be modified so that 
licensees are not required to perform a decay correction for long-lived 
radionuclides.
    Response. The NRC does not believe that the rule should specify 
when, based on half life, a decay correction should be performed. We 
believe the rule addresses this issue by permitting a licensee to 
administer a dosage if the dosage activity is within 20 percent of the 
prescribed dosage or is within the prescribed dosage range. This 
requirement gives the licensee responsibility for determining when it 
is appropriate to perform a decay correction. In the case of a long-
lived radionuclide, the licensee may make a determination that a decay 
correction is not needed to verify that the dosage is within 20 percent 
of the prescribed dosage or is within the prescribed range because of 
the long half life of the byproduct material.

Section 35.65, Authorization for Calibration, Transmission, and 
Reference Sources

Issue 1: Are Medical Licensees Authorized To Receive Calibration 
Sources From Licensees That Are Licensed Under Secs. 32.72 and 32.74?
    Comment. A commenter asked that this section be revised to allow 
licensees to receive calibration and reference sources from licensees 
that are licensed under Sec. 32.72, Manufacture, preparation, or 
transfer for commercial distribution of radioactive drugs containing 
byproduct material for medical use under Part 35, and Sec. 32.74, 
Manufacture and distribution of sources or devices containing byproduct 
material for medical use.
    Response. NRC has added a new paragraph (b) to address the issue of 
whether medical use licensees can receive calibration, transmission, 
and reference sources from Sec. 35.72 and/or Sec. 32.74 licensees. 
Paragraph (a) of the current regulations has been reworded to state 
more clearly that licensees can receive sealed sources, not exceeding 
1.11 GBq (30 mCi) each, manufactured and distributed by a person 
licensed under Sec. 32.74 of this chapter or equivalent Agreement State 
regulations. A new paragraph (b) has been added to allow medical use 
licensees to receive sealed sources, not exceeding 1.11 GBq (30 mCi) 
each, redistributed by a licensee authorized to redistribute the sealed 
sources manufactured and distributed by a person licensed under 
Sec. 32.74 of this chapter, providing the redistributed sealed sources 
are in the original packaging and shielding and are accompanied by the 
manufacturer's approved instructions. This permits the sources to be 
received from any licensee with redistribution authorization, which 
codifies current practice.
Issue 2: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC inserted the word ``transmission'' in the 
section title. This was done to clarify that licensees may receive, 
possess and use transmission sources that do not exceed the quantity 
limits in this section.
    We corrected an error in paragraphs (a) and (b). Paragraph (a) 
should have referred to ``1.11 GBq (30 mCi)'' rather than ``1.11 
kilobecquerel (kBq) (30 mCi)'' and paragraph (b) (final rule paragraph 
(c)) should have referred to ``0.56 GBq (15 mCi)'' rather than ``0.56 
MBq (15 mCi).'' In addition, paragraph (c) (final rule paragraph (d)) 
was clarified. Our intent is to allow the licensee to receive, possess, 
and use byproduct material with a half-life longer than 120 days 
provided individual amounts do not exceed the smaller of 7.4 MBq (200 
Ci) or 1000 times the quantities in Appendix B of 10 CFR Part 
30.

Section 35.67, Requirements for Possession of Sealed Sources and 
Brachytherapy Sources

Issue 1: When Are Leak Tests Required?
    Comment. Some commenters believed that leak tests should only be 
required if a radioactive source has been abused, misused, or retrieved 
after being lost. Other commenters questioned whether the rule requires 
leak testing of small check sources. In addition, some commenters 
believed that sources should be leak tested annually. Others supported 
semiannual leak testing. Finally, some commenters believed the rule 
should not require a licensee to leak test certain sources, such as dry 
radionuclides embedded in acrylic.
    Response. Section 35.67(b) contains the leak test requirements for 
sealed sources. The NRC believes that sealed sources should be leak 
tested semiannually or in accordance with the interval approved by the 
Commission or an Agreement State in the SSDR. A semiannual leak testing 
requirement is consistent with recommendations in ANSI-N542. If 
licensees are unsure whether a source meets the definition of a sealed 
source, they should reference the SSDR. This registry may be accessed 
at http://www.hsrd.ornl.gov/nrc/ssdr/ssdrindx.htm.
    We have not included a requirement for a source to be leak tested 
if it has been ``abused, misused, or retrieved after being lost'' 
because the licensee is responsible for assuring that the dose limits 
in Part 20 are not exceeded. If the licensee suspects that a source may 
be leaking or could have been damaged, it

[[Page 20297]]

should evaluate whether a survey (leak test) should be performed.
    Paragraph (f) lists the sources that do not need to be leak tested. 
In particular Sec. 35.67(f)(3) states sources containing 3.7 MBq (100 
Ci) or less of beta or gamma-emitting material or 0.37 MBq (10 
Ci) or less of alpha-emitting material need not be leak 
tested. If a source contains less than this quantity of material, a 
leak test is not needed.
    We believe leak tests are needed for sources such as dry 
radionuclides embedded in acrylic because removable contamination could 
exist due to:
    1. Radioactivity contained at the surface of the acrylic;
    2. Interaction between any chemicals or solvents that may 
accidently come into contact with the acrylic;
    3. Aging of the acrylic; or
    4. Radiation damage to the acrylic. (Note: if the radioactivity of 
the acrylic source is less than the quantities in Sec. 35.67(f)(3), 
leak testing would not be necessary.)
    For example, a common dose calibrator source which is embedded in 
cast epoxy resin matrix, sometimes referred to as an ``E Vial,'' meets 
the definition of a sealed source and would have to be leak tested in 
accordance with the requirements in this section. However, E vials 
containing no more than 3.7 MBq (100 Ci) of a gamma-emitting 
material are exempt from leak testing under Sec. 35.67(f)(3).

Issue 2: When Should an Inventory of Sealed Sources and Brachytherapy 
Sources Be Performed?

    Comment. Commenters suggested that inventories of sealed sources 
should be performed quarterly, others suggested semiannually, as in the 
proposed rule. Other commenters believed that sealed sources that are 
exempt from leak testing should not be subject to inventory 
requirements. Another commenter questioned whether extra brachytherapy 
seeds should be subject to inventory requirements.
    Response. Sealed source inventories should be performed 
semiannually. A review of events where sources have been lost or stolen 
in the past 10 years indicated that quarterly inventories would not 
have had a significant impact on preventing the incidents. The change 
from a quarterly frequency to a semiannual frequency would reduce 
unnecessary regulatory burden and radiation exposure for individuals 
performing the inventories.
    The NRC believes sealed sources that are not required to be leak 
tested should be inventoried because handling sources listed in 
paragraph (f) would not necessarily be considered low risk. For the 
same reason, extra brachytherapy sources should be inventoried. If one 
of these sources were lost and were picked up by an individual, the 
radiation dose received by the individual may exceed the Part 20 
limits.
Issue 3: What Is the Appropriate Time Period for Reporting a Leaking 
Source?
    Comment. A commenter suggested that the time period for reporting a 
leaking source should be changed from ``within 5 days'' to ``within 15 
days.''
    Response. The NRC has not changed the time period for reporting a 
leaking source. We continue to believe that it is important to inform 
NRC promptly when a licensee discovers that a source is leaking.
Issue 4: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC amended paragraph (a) to delete the 
requirement to maintain a copy of the radiation safety and handling 
instructions supplied by the manufacturer for the duration of source 
use because it was overly prescriptive. We believe that this change 
makes the regulation more performance-based. However, deletion of the 
requirement does not prohibit the licensee from maintaining the 
instructions.
    Paragraphs (d) through (f) were amended by replacing the term 
``leakage test'' with the phrase ``leak test.'' This change reflects 
common use of the term ``leak test.''
    Paragraph (f) was revised to indicate clearly that a stored source 
is exempt from the leak testing requirements in this section, 
regardless of the length of time that it has been in storage. The 
current rule does not contain a requirement to leak test stored sources 
after 10 years. The provision for leak testing after 10 years was added 
to the proposed rule because, at that time, we believed that leak 
testing was appropriate given the time of storage and the potential for 
contamination. At this time, we do not think this prescriptive 
requirement is warranted because the licensee must test each stored 
source for leakage before any use or transfer unless it has been leak 
tested within 6 months before the date of use or transfer.

Section 35.69, Labeling of Vials and Syringes

Issue 1: Can This Section Be Deleted?
    Comment. Commenters suggested that this section should be deleted 
because appropriate labeling is the standard of medical and pharmacy 
practice and is adequately regulated by the FDA, the State Boards of 
medicine and pharmacy, and the US Pharmacopeia. Syringe shields can be 
used to maintain exposures ALARA. Under certain circumstances, syringe 
shields can be hazardous to patients because they could obscure subtle 
visualization of the syringe content.
    Response. The NRC does not think this section should be deleted in 
its entirety. In addition, we do not believe that this requirement 
duplicates the requirements of the FDA, State Boards of Medicine and 
Pharmacy, and the U.S. Pharmacopeia. The labeling requirements in Part 
35 are limited to two very specific purposes: to provide information to 
physicians or technologists that indicates the contents of the syringe 
to ensure that the administration is in accordance with the written 
directive; and to warn workers that the syringe contains byproduct 
material, i.e, radiation protection from the medical use of byproduct 
material. Labeling requirements of the other organizations have 
different purposes and, consequently, may result in different 
information on the labels. Any other labeling that contains the same 
information required by this section is acceptable. If another labeling 
requirement does not specify all of the information required by 
Sec. 35.69, the additional information may be included on that label.
    We deleted the requirement for the licensee to develop, implement, 
and maintain written procedures for labeling each syringe, syringe 
shield, or vial shield that contains a radiopharmaceutical and for 
shielding vials and syringes. We also deleted the requirement to 
provide individuals with instructions on these procedures. Both 
requirements have been deleted because we believe the rule should focus 
on labeling the vial or syringe, rather than on procedures.
    Syringe or vial shields can be used to maintain exposures ALARA. 
However, we believe licensees should have flexibility to determine 
whether syringe or vial shields should be used. Thus, we have deleted 
the requirements to shield the syringe or vial. However, deletion of 
the requirement does not prohibit the licensee from using syringe or 
vial shields. When syringe shields or vial shields are used by a 
licensee, the final rule requires the licensee to label the shields, if 
the label on the syringe or vial is not visible.

[[Page 20298]]

Section 35.70, Surveys for Ambient Radiation Exposure Rate

Issue 1: Is This Section Needed?
    Comment. Some commenters did not believe this section was needed 
because it was up to the licensee, through the RSO, to ensure radiation 
safety. Some commenters agreed that surveys should only be required 
when byproduct material requiring a written directive is used. Other 
commenters believed that the rule should require surveys of all areas 
where byproduct material is used.
    Response. This section is needed to ensure that a radiation survey 
is conducted in areas where unsealed byproduct material that requires a 
written directive was prepared or administered. The NRC believes that a 
radiation survey, at the end of each day, should be required in Part 35 
because patients and other individuals could be present near a nuclear 
medicine or radiation therapy department. Without surveying ambient 
radiation levels, it is possible for patients or other individuals to 
receive unnecessary or excessive radiation exposures.
    In order to make the rule more risk-informed, we do not believe all 
areas need to be surveyed. However, licensees must be prepared to show 
compliance with the public and occupational dose limits in Part 20.
Issue 2: When Should Surveys Be Performed?
    Comment. Some commenters believed that surveys should be performed 
after preparation or administration of byproduct material, rather than 
at the end of the day. Some opposed removing the existing requirements 
to survey areas where radiopharmaceuticals or waste is stored and to 
survey for removable contamination. Finally, one commenter asked that 
the NRC clarify whether the requirement for surveys in paragraph (b) 
applies only to patients' rooms or whether it also applies to the area 
where the patient's dosage was prepared.
    Response. The general survey requirements are in Part 20. In 
addition to these requirements, the NRC believes that medical use 
licensees should be required to perform radiation surveys at the end of 
the day in areas where unsealed byproduct material requiring a written 
directive was prepared for use or administered. A medical use licensee, 
such as a hospital, prepares and administers byproduct material to 
multiple patients or human research subjects throughout the day. If a 
survey were required after each preparation or administration of 
byproduct material, there would be a significant increase in the 
licensee's burden to comply with this requirement without an associated 
safety benefit. We believe that a survey at the end of each day of use 
is sufficient to detect elevated radiation levels. If elevated levels 
are detected, corrective action, if warranted, could be taken. However, 
licensees always have the flexibility of performing more frequent 
surveys.
    We do not believe a requirement for weekly surveys for removable 
contamination is needed because licensees are required to show 
compliance with public and occupational dose limits in Part 20 of this 
chapter. In addition, the licensee will need to be able to show 
compliance with Part 20, Subpart F, Surveys and Monitoring.
    We have clarified paragraph (b) to indicate that the licensee does 
not need to perform the surveys required by paragraph (a) of this 
section in areas where patients or human research subjects are confined 
when they cannot be released under Sec. 35.75. In this case, the 
licensee must be prepared to show compliance with the Part 20 
requirements.

Section 35.75, Release of Individuals Containing Radiopharmaceuticals 
or Implants

Issue 1: Should Any Changes Be Made to the Criteria for Release of 
Individuals Containing Pharmaceuticals or Implants?
    Comment. Some commenters supported the dose-based release criteria 
in the proposed rule, while others asked that the criteria be revised. 
Those commenters that supported the 5 mSv (0.5 rem) release limit 
believed that Sec. 35.75 provided regulatory relief to the medical 
profession without an associated increase in radiation risk to the 
public. These commenters recognized that one of the major obstacles to 
allowing the release of individuals in accordance with Sec. 35.75 is a 
possible increase in radiation alarms at landfills. However, they 
believed the issue of landfill alarms should be addressed in other 
ways, such as raising the threshold for the alarms to a ``more 
practical'' level, rather than revising the release criteria in 
Sec. 35.75. Commenters also indicated that several studies had been 
conducted that indicated that radiation exposures to family members 
from released patients were less than the 5 mSv (0.5 rem) limit. As a 
result, they asked that NRC reevaluate information provided in the 
guidance associated with this requirement.
    Other commenters asked that the release criteria be revised because 
they believed that the criteria were based solely on economics and not 
on radiation risk. They were also concerned that household waste from 
an individual who had been released from the hospital could be 
contaminated and could trigger radiation alarms at landfills. This 
situation would affect State radiation protection programs because the 
States would have to investigate incidents in which the alarms had been 
activated.
    Response. The NRC does not believe that any changes are needed to 
this section as a result of the public comments. We acknowledge that 
some States have reported an increase in the number of alarms at 
landfills. However, we have no documentation indicating that the 
exposure rates to the maximally exposed individuals have exceeded the 
dose limit in Sec. 35.75. The NRC does not have regulatory jurisdiction 
over the landfill operators, nor over the alarm set points for 
radiation detectors at landfills. However, we do encourage continued 
communication between regulatory bodies and landfill operators to 
resolve this issue.
    We believe that the release criteria provide licensees with needed 
flexibility in program management. A dose limit of 5 mSv (0.5 rem) to 
individuals knowingly exposed while voluntarily helping in the care, 
support, and comfort of patients provides adequate protection of these 
individuals. In addition, licensees are required to provide 
instructions to the released individual, or the individual's parent or 
guardian, on actions recommended to maintain doses to other individuals 
as low as reasonably achievable (ALARA) if the total effective dose 
equivalent to any other individual is likely to exceed 1mSv (0.1 rem). 
Licensees should consider this latter provision regarding instructions 
on maintaining exposures ALARA in situations where the individual has 
been released under Sec. 35.75 but remains hospitalized for other 
reasons. In this case, the maximally exposed individual may be a member 
of the licensee's staff. The dose limit of 5 mSv (0.5 rem) to 
individuals comforting patients is consistent with the recommendations 
of the NCRP and the International Commission on Radiological Protection 
(ICRP). For additional information on the background of this section, 
refer to 62 FR 4120 (January 29, 1997).
    Finally, we recognize that the values presented in NUREG-1556, 
Volume 9, for release of patients are based on some conservative 
values. The licensee may use case-specific information in place of the 
values used in the guidance document.

[[Page 20299]]

Issue 2: What Other Changes Were Made in This Section Between the 
Proposed and Final Rule?
    Response. In paragraph (b), the term ``breast feeding infant'' was 
replaced with the term ``nursing infant.'' This was done to maintain 
consistency within Part 35. Paragraph (d) was revised to state that 
records of the instructions provided to breast-feeding females should 
be made in accordance with Sec. 35.2075(b) rather and Sec. 35.2075(c). 
This change was needed because of a change in the codified text of 
Sec. 35.2075. For additional information refer to the discussion of 
Sec. 35.2075.

Section 35.80, Provision of Mobile Medical Service

Issue 1: Should Mobile Medical Service Licensees Be Allowed To Operate 
Under Reciprocity in Other Regulatory Jurisdictions?
    Comment. Commenters indicated that mobile medical services are 
currently operating under reciprocity in some States. Some Agreement 
States indicated they do not allow medical licensees to operate under 
reciprocity, while other Agreement States said they permit mobile 
medical services to come to their State under reciprocity.
    Response. Agreement States have the flexibility of determining 
whether they will issue mobile medical licenses and whether they will 
allow NRC or other State licensees to operate in their State under 
reciprocity. Under reciprocity, an Agreement State may allow a specific 
licensee from another Agreement State (or the NRC) to work within the 
Agreement State without requiring the licensee to obtain a license in 
that State. Similarly, under reciprocity, a specific licensee from an 
Agreement State may work in NRC jurisdictions, provided the 
requirements in 10 CFR 150.20, Recognition of Agreement State 
Licensees, are met. Specifically, NRC allows Agreement State mobile 
medical service licensees to operate in areas under NRC jurisdiction 
provided they comply with all the requirements in Sec. 150.20, 
including submittal of the information required in that section.
Issue 2: Should NRC Allow Byproduct Material To Be Delivered to a 
Client's Address of Use?
    Comment. A commenter recommended that the NRC permit byproduct 
material to be delivered to the client's address.
    Response. Byproduct material may only be transferred to an NRC or 
Agreement State licensee because the licensee is responsible for the 
safe handling of the material. In almost all cases, the client is 
neither an NRC nor an Agreement State licensee. Therefore, the material 
must only be transferred to the licensed mobile medical service. 
Byproduct material may be delivered to the mobile medical service 
licensee at the mobile site (i.e., mobile van) if the byproduct 
material is secured against unauthorized removal (Secs. 20.1801 and 
20.1802).
Issue 3: What Checks Should Be Performed on Instruments Used To Measure 
the Activity of Unsealed Byproduct Material at a Client's Address?
    Comment. A commenter recommended that the check for instrument 
operation at the client's address be limited to a constancy check.
    Response. Licensees must check the operation of instruments used to 
measure the activity of unsealed byproduct material to ensure that the 
instrument is functioning properly. This section was revised to require 
that licensees check instruments used to measure the activity of 
unsealed byproduct material for constancy before medical use at each 
client's address or on each day of use, whichever is more frequent. In 
the case of a mobile medical service, we believe that a constancy check 
must be performed to ensure that the instrument is functioning 
properly. The need for additional testing on the instruments is 
determined by how the licensee addresses compliance with Sec. 35.60.
Issue 4: Is it Necessary To Check a Survey Instrument With a Dedicated 
Check Source?
    Comment. A commenter recommended that the requirement to check the 
survey instrument with a dedicated check source be deleted because this 
check was no longer included in Sec. 35.61.
    Response. The NRC does not believe that the requirement to check 
survey instruments with a dedicated check source should be deleted from 
Sec. 35.80. While we have deleted the requirement from Sec. 35.61, we 
believe it is needed in Sec. 35.80 because there is a greater 
likelihood that a survey instrument in a mobile unit may become damaged 
or uncalibrated as a result of extensive movement.
Issue 5: Do Mobile Medical Service Licensees Need To Collect 
Contaminated Waste Generated by Patients After Administration of the 
Byproduct Material?
    Comment. A commenter asked that NRC clarify whether mobile medical 
service licensees need to return to the client's address to collect 
contaminated waste generated by patients after the administration of 
the byproduct material.
    Response. The mobile medical service licensee does not need to 
return to the client's address to collect contaminated waste generated 
by the patient after the administration. The waste is no longer 
considered under the licensee's control because the patient would have 
been released from licensee control under Sec. 35.75.
Issue 6: What Other Changes Were Made Between the Proposed and Final 
Rule?
    Response. The NRC amended this section to use the term ``mobile 
medical service'' rather than ``mobile service'' to indicate clearly 
that the provisions in this section only apply to medical use. In 
addition, in paragraphs (a)(1) through (a)(4), ``client's address of 
use'' was replaced by ``client's address,'' which is defined in 
Sec. 35.2. This was done to recognize that mobile medical service may 
be provided at an area of use or a temporary job site. (Area of use is 
defined as a portion of an address of use that has been set aside for 
the purpose of receiving, preparing, using, or storing byproduct 
material.)
    Paragraph (a)(1) was also amended by replacing the term ``each 
entity'' with the phrase ``the licensee and the client.'' We believe 
this more clearly states our intent that the mobile medical service 
obtain a letter from each client that delineates the authority and 
responsibility of the licensee and the client.
    Paragraph (a)(2) was amended to clarify that the instruments 
referred to in this paragraph refer to those instruments used to 
measure the activity of unsealed byproduct material.
    In paragraph (b), ``the client's address of use'' was replaced by 
``the client.'' This was done to clarify that byproduct material cannot 
be delivered to the client unless the client has a license allowing 
possession of the byproduct material.

Section 35.92, Decay-In-Storage

    Issue 1: Should This Section Be Moved to Part 20?
    Comment. Commenters believed that decay-in-storage should be 
addressed in Part 20 rather than in Part 35.
    Response. Part 20 provides the general requirements for various 
waste disposal methods, including the decay-in-storage method. 
Currently, detailed procedures for decay-in-storage are in license 
conditions. The NRC believes the specific provisions for decay-in-
storage that apply to a medical licensee should be codified in Part 35.

[[Page 20300]]

Issue 2: Should the Rule Continue To Require That Byproduct Material Be 
Held for 10 Half-Lives Before Disposal As Nonradioactive Material?
    Comment. Commenters were divided in response to the NRC's request 
for specific comment on whether byproduct material should be held for a 
minimum of 10 half-lives. Commenters in favor of retaining the 
requirement believed that it would help ensure that the waste is not 
prematurely disposed of as nonradioactive material due to human error 
or instrumentation malfunction. They also believed that licensees may 
not have adequate survey instruments to survey low-energy beta 
emitters, such as sulfur-35 (S-35).
    Commenters supporting the deletion of the requirement indicated 
that holding the byproduct material for 10 half-lives was in no way a 
guarantee that the waste could be disposed of as nonradioactive 
material. They believed that deletion of the requirement to hold the 
material for 10 half-lives would improve sanitary conditions and 
provide for more efficient use of storage space. Finally, they 
indicated that although S-35 is difficult to detect with a survey 
instrument, S-35 is not a component in any FDA-approved 
radiopharmaceutical for routine use.
    Response. The NRC has not included a requirement in the final rule 
to hold byproduct material for 10 half-lives before disposing of the 
material as nonradioactive material. We do not believe this requirement 
is needed in light of the requirement in paragraph (a)(1) that 
precludes disposal of byproduct material without regard to its 
radioactivity until radiation levels adjacent to the material do not 
exceed background levels.
Issue 3: Does the Requirement To Obliterate Radiation Labels Only Apply 
to the Outermost Container, Especially if the Material Will Be Handled 
as Biohazardous Material?
    Comment. A commenter questioned whether the obliteration of 
radiation labels is only required on the outermost container. 
Specifically, the commenter asked whether labels needed to be defaced 
on inner containers if the label on the outer container had been 
defaced and the inner label was not visible.
    Response. NRC revised the text in paragraph (a)(2) to require that 
all radiation labels be removed or obliterated, except for radiation 
labels on materials that are within containers and that will be managed 
as biomedical waste after they have been released from the licensee. 
All radiation labels must be removed or obliterated from outer 
containers once the radioactivity can not be distinguished from the 
background level. Radiation labels on biomedical waste (e.g., sharps 
containers or individual needles and syringes) do not have to be 
removed or obliterated due to the associated biohazard of retrieving 
such material from the outer container. Also, in many cases, the waste 
barrels containing biomedical waste will be incinerated.
Issue 4: What Type of Byproduct Material May Be Held for Decay-In-
Storage?
    Comment. A commenter asked whether radioactive ``seeds'' can be 
held for decay-in storage.
    Response. The final rule allows a licensee to hold byproduct 
material with a physical half-life of less than 120 days for decay-in-
storage before disposal without regard to its radioactivity. If a 
``seed'' contains byproduct material with a half-life of less than 120 
days, this provision applies.
Issue 5: Were There Any Other Changes Made Between the Proposed and 
Final Rule?
    Response. Yes. Paragraph (a) was revised to indicate clearly that 
the provisions in this section pertain only to disposal of the material 
without regard to its radioactivity. Licensees must continue to comply 
with any other regulations that pertain to disposal of the material 
(e.g., Environmental Protection Agency and State biomedical waste 
regulations).

Subpart D--Unsealed Byproduct Material--Written Directive Not Required

General Comments
Issue 1: What Are the Correct Titles for Subparts D and E?
    Comments. Commenters recommended renaming Subparts D and E to avoid 
use of the terms ``low dose'' and ``high dose.'' A commenter 
recommended renaming these sections: Subpart D--Unsealed Byproduct 
Material--Written Directive Not Required and Subpart E--Unsealed 
Byproduct Material--Written Directive Required.
    Response. The NRC agrees that the titles of Subparts D and E should 
be renamed to avoid use of the terms ``low dose'' and ``high dose.'' 
Subparts D and E in the final rule have been renamed to use the 
requirement for a ``written directive'' as the basis for associating 
the use of the material to radiation risk. The new titles are Subpart 
D--Unsealed Byproduct Material--Written Directive Not Required and 
Subpart E--Unsealed Byproduct Material--Written Directive Required.
Issue 2: Are the Regulations in Part 35 (except the training and 
experience requirements) Needed?
    Comment. Commenters proposed removing the regulations for 
diagnostic nuclear medicine, except for the training and experience 
requirements, from Part 35. The commenters believed that properly 
trained physicians, with the assistance of other associated nuclear 
medicine health care providers and the standards of radiation 
protection in Part 20, are all that are necessary to protect the public 
health and safety adequately.
    Response. During the development of the proposed rule, the NRC 
eliminated requirements in the current Part 35 that are contained 
elsewhere in the Commission's regulations, such as the radiation 
protection requirements in Part 20. Part 35 licensees will need to 
comply with these requirements, such as the ALARA provisions in Part 
20, but we believe there is no need to duplicate requirements.
    Part 20 contains general radiation protection requirements 
applicable to all licensees; Part 35 contains requirements specific to 
medical use licensees. While some commenters believe that Part 35 
should not contain any requirements associated with low risk 
procedures, certain radiation protection-related requirements specific 
to medical use are needed in Part 35 because of their contribution to 
risk reduction. For example, the final rule retains requirements to 
perform quality control tests on instrumentation used to measure the 
radioactivity of patient dosages before administration. These 
regulations are necessary to provide high confidence that the 
instrumentation used to measure dosages is operating properly.
    In other cases, more specific requirements were kept in Part 35 
where justified by risk. The majority of those requirements deal with 
the therapeutic uses of sealed radioactive material. We believe that 
the requirements in the final rule are necessary, in addition to the 
requirements in Part 20, to ensure that the dosage administered to a 
patient is as prescribed by the AU and to ensure protection of workers 
and the public.
Issue 3: Should the Requirements for Diagnostic and Therapeutic Uses of 
Unsealed Byproduct Materials for Medical Use Be Combined?
    Comment. A commenter believed that the proposed rule intermingled 
requirements for diagnostic and therapeutic nuclear medicine and failed

[[Page 20301]]

to provide a regulatory scheme appropriate to each.
    Response. Early in the rulemaking process, the NRC considered 
structuring the rule to have completely ``stand-alone'' subparts for 
each type of medical use. However, under this approach, there would 
have been significant duplication of the requirements which would make 
the entire rule unnecessarily voluminous. For example, if we took this 
approach, each subpart would have had a section that addressed when a 
license was needed, criteria for amending a license, or RSO 
qualifications.
    We have structured the rule so that Subparts A, B, C, L, M, and N 
contain the requirements that apply to all licensees. Subparts D, E, F, 
G, H, and K contain the requirements that apply to a particular 
modality, e.g., Subpart D provides specific requirements for the use of 
unsealed byproduct material which does not require a written directive, 
and Subpart E contains the requirements for the use of unsealed 
byproduct material which requires a written directive. The subparts for 
each type of use also contain the specific training and experience 
requirements for the AU.

Section 35.100, Use of Unsealed Byproduct Material for Uptake, 
Dilution, and Excretion Studies for Which a Written Directive Is Not 
Required

Issue 1: Why Doesn't the NRC Eliminate or Reduce the Regulation of 
Certain Sec. 35.100 Materials?
    Comment. A commenter recommended eliminating or reducing regulation 
of materials in Sec. 35.100 with extremely low doses (e.g., 35 
Ci of I-125 iothalamate, 10 Ci of iodine-125 (I-125) 
albumin and 1 Ci of cobalt-57 (Co-57) cyanocobalamin) because 
medical use of these materials involves minimal risk.
    Response. The NRC does not believe that the requirements for the 
medical use of byproduct material described in Sec. 35.100 should be 
eliminated. If this material is not handled safely, the public or 
occupationally exposed individuals could receive an exposure in excess 
of the Part 20 dose limits. However, we have reduced some regulatory 
requirements that apply to this type of use, e.g., the requirements in 
Secs. 35.24, 35.61, 35.92, and 35.290 of the final rule. Explanations 
for these changes can be found in the discussions of the respective 
sections.
Issue 2: Should Secs. 35.100 and 35.200 Be Combined Because the 
Procedures Performed in Both Modalities Do Not Require a Written 
Directive?
    Comment. A commenter suggested that the two types of studies listed 
under Subpart D in the proposed rule in Secs. 35.100 and 35.200 should 
be combined into one category, ``unsealed byproduct material for which 
a written directive is not required.''
    Response. Early in the development of the proposed rule, the NRC 
considered combining these two categories into one section. We did not 
do so because we believe that the training and experience requirements 
for individuals using byproduct material for imaging and localization 
should be more rigorous than such requirements for individuals who only 
use unsealed byproduct material for uptake, dilution, and excretion 
studies. This is because AUs using unsealed material under Sec. 35.200 
are allowed to compound radiopharmaceuticals and, in general, are 
handling multiple types of radionuclides at higher activity levels than 
users performing uptake, dilution, and excretion studies.
Issue 3: Is the Reference in Sec. 35.100(b) Referring to Sec. 35.292 
Correct?
    Comment. A Commenter Suggested the Cross Reference in 
Sec. 35.100(b) to Sec. 35.292 Should Be Sec. 35.290.
    Response. The cross reference in Sec. 35.100(b) of the proposed 
rule to an individual who meets the criteria to become an AU for use of 
unsealed byproduct material for imaging and localization is correct. 
The requirements in the proposed Sec. 35.292 were moved to Sec. 35.290 
in the final rule, so Sec. 35.100(b) now references Sec. 35.290. The 
NRC also added a reference to Sec. 35.390. Sections 35.292 and 35.390 
in the final rule give physicians authorization to prepare radioactive 
drugs using generators and reagent kits. AUs qualified under the final 
Sec. 35.190 (proposed Sec. 35.290) do not have this type of 
authorization.
Issue 4: Why Aren't FDA-Approved IND Pharmacokinetic Studies Addressed 
in the Proposed Rule?
    Comment. A commenter stated that the proposed rule did not 
recognize pharmaceutical companies that do not have a 10 CFR Part 35 
license but label compounds with byproduct material and transfer them 
to specific licensees for use in FDA-approved IND pharmacokinetic 
studies. This commenter proposed addition of a new Sec. 35.100(c) to 
address this issue.
    Response: The final rule addresses this comment and other omissions 
in the proposed rule. The proposed rule did not recognize 
pharmaceutical companies who do not have a Part 32 license but who 
label compounds with byproduct materials and transfer them to a 
specific licensee for use in FDA-approved IND studies. The proposed 
rule also did not recognize the use of unsealed byproduct material 
obtained from an NRC or Agreement State licensee in accordance with an 
RDRC protocol. Finally, Sec. 35.100 in the proposed rule did not allow 
specific medical use licensees, who do not have individuals qualified 
under Secs. 35.292, 35.55, 35.920, or 35.980, to prepare unsealed 
byproduct material in accordance with an RDRC or IND protocol accepted 
by FDA for use in research. These omissions in the proposed rule unduly 
restricted labeling and transfer of unsealed byproduct material to Part 
35 licensees. New paragraphs (c) and (d) have been added to 
Secs. 35.100 and 35.200 of the final rule to address all of these 
situations.

Section 35.190, Training for Uptake, Dilution, and Excretion.

Issue 1: Is It Necessary for Physicians Using Byproduct Materials Under 
Sec. 35.100 To Be Board Certified in Nuclear Medicine?
    Comment. A commenter believed that there should be an alternative 
training and experience pathway for individuals who are not full board 
certified nuclear medicine physicians, but would like to become an AU 
for materials authorized under Sec. 35.100.
    Response. The final rule contains three pathways for individuals to 
become AUs for material under Sec. 35.100. The first pathway, 
Sec. 35.190(a), requires a physician to be certified by a board 
recognized by NRC. The second pathway, Sec. 35.190(b), allows AUs, 
qualified under Secs. 35.290, 35.390, or equivalent Agreement State 
requirements, to use byproduct material under Sec. 35.100. The third 
pathway, Sec. 35.190(c), requires that the physician complete 60 hours 
of training and experience in basic radionuclide handling techniques 
applicable to the medical use of unsealed byproduct material for 
uptake, dilution, and excretion studies. The 60 hours includes 
classroom and laboratory training and work experience.
Issue 2: Were There Any Other Changes Made Between the Proposed and 
Final Rule?
    Response: Yes. The training and experience requirements that were 
in the proposed Sec. 35.290 were moved to Sec. 35.190 in the final 
rule. This is

[[Page 20302]]

discussed in greater detail under the general discussion on training 
and experience located at the beginning of this section of the 
SUPPLEMENTARY INFORMATION.

Section 35.200, Use of Unsealed Byproduct Material for Imaging and 
Localization Studies for Which a Written Directive Is Not Required

Issue 1: Were There Any Changes Made in This Section Between The 
Proposed and Final Rule?
    Response. Yes. Paragraphs (c) and (d) were added to this section in 
the final rule. These changes are identical to the changes made to 
Sec. 35.100. The reasons for these additions are in the discussion of 
Sec. 35.100, Issue 4.

Section 35.204, Permissible molybdenum-99 Concentration

Issue 1: Why Is It Necessary for NRC Regulations To Address molybdenum-
99 (Mo-99) Concentrations?
    Comments. Commenters argued for eliminating this section because 
U.S. Pharmacopeia (USP) and FDA standards already address this area. 
Another commenter believed that the proposed requirements were 
excessive and unnecessary. Some commenters supported the change in the 
requirement from evaluating the Mo-99 concentration for every elution, 
to evaluating it for only the first elution.
    Response. The NRC believes that this requirement is necessary as a 
means to check generator eluate before medical use to ensure that the 
generator was not damaged in shipment. This requirement does not 
preclude more frequent evaluations of the Mo-99 concentrations. We 
revised paragraph (a) to express the permissible concentration level in 
SI units: ``0.15 kilobecquerel of molybdenum-99 per megabecquerel of 
technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of 
technetium-99m).'' This level is identical to that used in the U.S. 
Pharmacopeia (USP) 23 U.S. Pharmacopeial Convention, Inc., 1995, pages 
1486-1487.
Issue 2: Were There Any Changes Made in This Section Between the 
Proposed and final Rule?
    Response. Yes. The NRC amended paragraph (c) to be more precise. We 
replaced the phrase ``measure molybdenum concentration'' with the 
phrase ``measure the molybdenum-99 concentration.''

Section 35.205, Control of Aerosols and Gases (current rule)

Issue 1: Should the Current Requirements Related to Aerosols and Gases 
Be Deleted?
    Comment. The NRC received comments supporting and opposing the 
deletion of this section in the current rule. A commenter supported the 
deletion of the requirement because the current requirement is too 
prescriptive. Another commenter believed that the requirement to 
control radioactive aerosols and gases should be retained. This 
commenter stated that the requirement of having a negative pressure 
environment ensures that there is control over ``escaping radioactive 
gas.''
    Response. The NRC does not believe this requirement is needed in 
Part 35. Part 35 licensees must comply with the occupational and public 
dose limits of Part 20. Additional prescriptive requirements for 
limiting airborne concentrations of radioactive material are not 
warranted in Part 35.

Section 35.290, Training for Imaging and Localization Studies

Issue 1: Should All Individuals Be Required To Have Experience With 
Eluting Generators?
    Comment. A commenter recommended that the NRC revise the training 
and experience requirements in the proposed Sec. 35.292 to state: ``To 
be authorized for possession and use of technetium from a generator 
system, the applicant must obtain supervised practical experience 
eluting technetium-99m from generator systems.'' The commenter is 
drawing a distinction between AUs that plan to limit their use to unit 
dosages, rather than preparing the dosages themselves. The commenter 
believed the requirement, as proposed, would be consistent with actual 
practice and good radiation safety practices. In addition, the 
commenter recommended that the preceptor not be required to certify 
that an individual has achieved a level of competency with regards to 
use of generators. Another commenter believed that we should delete 
requirements for individuals to receive training in eluting generators, 
measuring and testing the eluate for radiochemical purity and 
processing the eluate with reagent kits because unit dosages are 
obtained from a Part 32 licensee.
    Response. The NRC has not modified the regulatory text to establish 
separate training and experience requirements for AUs only using unit 
dosages. We have also not deleted the requirement for ``eluting 
generator systems appropriate for preparation of radioactive drugs for 
imaging and localization studies, measuring and testing the eluate for 
radionuclidic purity, and processing the eluate with reagent kits to 
prepare labeled radioactive drugs.'' Physicians who meet all the 
qualifications in the final Sec. 35.290 are authorized to use generator 
systems and reagent kits in the preparation of radioactive drugs and 
must be trained accordingly, even though they may elect to use only 
unit dosages. If a physician does not have experience in eluting 
generators he or she will be authorized for unit dosages only. For the 
same reason, we believe that the preceptor should certify that the 
individual has achieved a level of competency with regards to use of 
generators. We would unduly limit where a licensee may obtain unsealed 
byproduct material if we made any further revisions to the regulatory 
text.
Issue 2: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response: Yes. The requirements in the proposed Sec. 35.290 were 
moved to the final Sec. 35.190. The requirements in the proposed 
Sec. 35.292 were moved to the final Sec. 35.290. This is discussed in 
greater detail under the general discussion on training and experience 
located at the beginning of this section of the SUPPLEMENTARY 
INFORMATION.

Subpart E--Unsealed Byproduct Material--Written Directive Required

Section 35.300, Use of Unsealed Byproduct Material for Which a Written 
Directive Is Required

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. Paragraph (b) was amended by changing the reference 
to Sec. 35.292 in the proposed rule to Sec. 35.290 in the final rule 
and adding a reference to Sec. 35.390. The proposed rule would have 
allowed licensees to use any unsealed byproduct material prepared for 
medical use by an ANP, a physician who is an AU and who meets the 
requirements specified in the proposed Sec. 35.292 (Sec. 35.290 of the 
final rule), or an individual under the supervision of either as 
specified in Sec. 35.27. The NRC added the reference to Sec. 35.390 in 
paragraph (b) of the final rule because a physician who meets the 
training requirements in Sec. 35.390 also meets the training 
requirements in Sec. 35.290.
    Paragraphs (c) and (d) were added to this section. This was done 
because the proposed rule did not recognize pharmaceutical companies 
who do not

[[Page 20303]]

have a 10 CFR Part 32 license, but label compounds with byproduct 
materials and transfer them to a specific licensee for use in FDA-
approved IND studies. Also, the proposed rule did not allow specific 
medical use licensees to prepare unsealed byproduct material in 
accordance with an IND protocol accepted by FDA for use in research. 
These omissions in the proposed rule unduly restricted labeling and 
transfer of unsealed byproduct material to Part 35 licensees. The final 
rule addresses these situations.
    Sections 35.100 and 35.200 have been revised to address both the 
RDRC and IND approved material. Note: Sec. 35.300, in contrast to 
Secs. 35.100 and 35.200, does not include reference to RDRC 
authorizations because FDA's RDRC regulations restrict RDRC approvals 
to pharmacokinetic and physiological studies. Further, the dose limits 
for a study that can be approved by an RDRC under 21 CFR 361.1 are as 
follows:
    (1) For a single administration of radioactive drug--whole body, 
gonads, blood forming organs, and lens--3 rem; all other organs--5 rem; 
and
    (2) For multiple administrations (or annual dose commitment)--whole 
body, gonads, blood forming organs, and lens--5 rem; all other organs--
15 rem.

Section 35.310, Safety Instruction

Issue 1: Who Must Participate in Annual Retraining on Radiation Safety?
    Comments. Many commenters questioned the need for the radiation 
safety instruction required in Sec. 35.310. Some commenters found this 
requirement to be very burdensome. A commenter suggested that posting 
radiation safety precautions on a patient's door or in the patient's 
chart could replace the training requirement. Another commenter 
believed that annual retraining was not needed for certified radiation 
therapy technologists and, therefore, recommended that the section 
specify annual retraining only for ``persons without specialized 
training in handling radioactive materials.'' Other commenters thought 
the requirement was too prescriptive, and that licensees should be 
given the freedom to decide how to assure compliance with the dose 
limits in Sec. 35.75 on a case-by-case basis. According to another 
commenter, annual retraining should be required only for health care 
personnel who were not directly supervised by trained radiation safety 
staff. Some commenters argued against placing the radiation safety 
instruction requirement in Part 35, while other commenters suggested 
that we make the requirement only applicable to allied health workers 
who are not nurses. The commenter believed that the need for training 
should be dependent on whether the licensees needed to provide the 
individual with dosimetry. These commenters suggested that we revise 
Sec. 35.310(a) to state: ``A licensee shall provide radiation safety 
instruction, initially and at least annually, to personnel, whose 
exposure rates may approach the limits in Part 20, caring for patient 
or human research subjects that have received therapy * * *''
    Response. The NRC believes that it is important that personnel 
caring for patients or human research subjects, who cannot be released 
in accordance with Sec. 35.75, receive instruction in limiting 
radiation exposure to the public and workers and in the radiation 
safety actions to be taken in the case of a medical emergency or death. 
We believe this provision is needed because exposure in excess of the 
public dose limits could result unless proper precautions are taken. We 
also believe this requirement is consistent with ALARA principles. We 
do not believe that only posting doors or a chart provides adequate 
information to the licensee's staff, without corresponding instruction.
    The rule does not require the licensee to instruct all hospital 
staff. Instruction must only be provided to personnel caring for 
patients or human research subjects who cannot be released in 
accordance with Sec. 35.75. We considered the comments regarding who 
should receive the training and whether the requirement should be 
linked to a dose limit. We decided that it is more appropriate to 
specify that instruction must be provided to personnel caring for 
patients or human research subjects, rather than tie the instruction to 
the dose limits in Part 20. This was done because it is possible for a 
licensee's staff member to receive a dose that is less than the 
occupational dose limits in Part 20, but take an action that could 
result in a dose to a member of the public that exceeds the public dose 
limit.
    We have given the licensee flexibility on the level and detail of 
instruction that must be provided. The instruction need only be 
commensurate with the duties of the personnel. In other words, the 
licensee can determine the appropriate level of radiation safety 
instruction to be provided, depending on the level of care provided by 
the personnel. For example, a primary care nurse may receive detailed 
instructions on patient and visitor control, but the ward clerk may 
only need to be instructed to observe the caution signs on the 
patient's door.
    We recognize that certified radiation therapy technologists or 
other individuals who have received specialized training in handling 
radioactive materials would have received training in the areas 
required by this section as part of a training program. However, we 
believe that refresher training is warranted because of the potential 
for unnecessary exposure to workers and the public if needed safety 
precautions are not observed.
Issue 2: Can the AU Have a Designee?
    Comment: A commenter recommended that paragraph (a)(5) be revised 
to require that personnel be instructed to notify the RSO (or his or 
her designee) and the AU (or his or her designee) if the patient or the 
human research subject has a medical emergency or dies.
    Response: The final rule provides the RSO flexibility in 
designating who should be notified to address radiation protection 
issues. However, the rule does not provide for the AU to have a 
designee. The AU is the individual who is responsible for the medical 
use and supervision of other persons using the byproduct material. 
Therefore, because of the type of dosages that are administered under 
Sec. 35.300, we believe it is important that an AU be available to be 
contacted in case of a medical emergency or death.
Issue 3: Should the Current Requirements in Sec. 35.315(a)(4) Related 
to Surveys Be Deleted?
    Comment. A commenter indicated that removal of the current 
requirements in Sec. 35.315(a)(4) to perform a radiation survey 
following a therapeutic administration of I-131 would be ill-advised. 
This commenter also believed that the requirement to perform a careful 
contamination room survey should not be removed.
    Response. The NRC does not believe these survey requirements should 
be in Part 35. We believe Part 20 contains adequate information 
regarding radiation surveys. As required in Sec. 20.1501, the licensee 
must make or cause to be made surveys that are needed to comply with 
the regulations in Part 20. Part 35 licensees are responsible for 
ensuring that the occupational and public dose limits in Part 20 are 
not exceeded.

[[Page 20304]]

Issue 4: Were There Any Other Changes Made to This Section Between the 
Proposed and Final Rule?
    Response. Yes. In paragraph (a), the term ``radiopharmaceutical 
therapy'' was replaced with the phrase ``therapy with unsealed 
byproduct material.'' This change clarifies that this section addresses 
both drugs and biologics containing byproduct material. The term 
radiopharmaceutical does not cover both radioactive drugs and 
radiobiologics containing byproduct material.
    Paragraph (b) of the proposed rule (paragraph (a)(5) of the final 
rule) was restructured to clarify our intent that, for the purpose of 
this section, only the RSO may have a designee.

Section 35.315, Safety Precautions

Issue 1: Does the Rule Allow the Licensee to Quarter Patients or Human 
Research Subjects Receiving Therapy With Unsealed Byproduct Material 
Together?
    Comment. Commenters did not believe that the requirement to quarter 
a patient or human research subject, who cannot be released in 
accordance with Sec. 35.75, in a private room with a private bathroom 
is justifiable. They believed that the requirement should be deleted, 
citing calculations suggesting that two patients undergoing identical 
radiation treatments (unsealed byproduct material) and occupying the 
same room would each have their total radiation dose increased by less 
than 1 percent due to the presence of the other patient. Others 
believed that allowing two patients undergoing treatment in the same 
room would be helpful as a means of controlling contamination and 
would, therefore, support ALARA principles.
    Commenters also argued that allowing a nontherapy patient to share 
a room with a patient undergoing radiation therapy (unsealed byproduct 
material) was unacceptable. They said this would result in unnecessary 
exposure to a member of the public and would not be ALARA.
    Other commenters opposed allowing the sharing of a posted 
restricted room with a patient who was not undergoing radiation 
therapy. These commenters were concerned about the radiation exposure 
to hospital housecleaning staff. Other commenters supported the 
requirement for a private room because they were concerned that medical 
institution management and health care insurance companies would not 
allow patients or human research subjects to be quartered in private 
rooms or in a double room (with single occupancy) because it was too 
expensive.
    Response. The NRC revised this provision to allow the licensee to 
quarter a patient or human research subject in either (1) a private 
room with a private sanitary facility; or (2) a room, with a private 
sanitary facility, with another individual who also has received 
therapy with unsealed byproduct material and who also cannot be 
released under Sec. 35.75. This requirement does not preclude the 
licensee from quartering the patient in a private room. This change 
recognizes that the exposure patients could receive from each other is 
insignificant in light of the exposure the patient is receiving from 
their administered dosages. Conversely, we do not believe that it is 
appropriate to allow a therapy and nontherapy patient to share a room 
because the nontherapy patient would not receive a radiation exposure 
under normal conditions.
    We believe that contamination control is essential and that two 
patients could share the same room without negatively affecting the 
licensee's ability to control contamination. However, licensees should 
be mindful of the radiation hazards associated with different 
radionuclides, especially when quartering in the same room individuals 
who have received different radionuclides. We do not agree that sharing 
rooms will increase the exposure to housecleaning staff. Assuming that 
two patients require treatment, the exposure to the housekeeping staff 
should not be significantly different whether the patients are 
quartered in the same room or different rooms. In either situation, 
licensees have the responsibility to maintain the exposures below the 
Part 20 limits.
Issue 2: Should a Patient or Human Research Subject Be Allowed To Take 
Contaminated Articles Home?
    Comment. A commenter asked that this section be revised to permit 
the licensee to package items contaminated with short-lived material so 
that the items could be released at the same time as the patient or 
human research subject. The commenter went on to state that the section 
should also include a requirement for the licensee to instruct the 
individual not to unpack the package and use anything in the package 
until a predetermined date. Finally, the commenter recommended that the 
date be calculated to ensure the activity remaining in the package is 
small.
    Response. The NRC has not changed the rule because of the potential 
for unnecessary radiation exposure to the public if the material were 
not handled properly once it is released from licensee control. Any 
items contaminated as a result of medical use are the responsibility of 
the licensee.
Issue 3: Should Additional Requirements Be Added To Sec. 35.315 To 
Address Hospitalization of Patients Who Can Be Released Under 
Sec. 35.75, But Are Still Hospitalized Because of Medical Reasons?
    Comment. A commenter questioned how a patient, who had been 
released under Sec. 35.75, but was still hospitalized for another 
medical condition, should be managed. The commenter was concerned that 
the nursing staff could be confused by the instructions provided to the 
patient under Sec. 35.75, because Sec. 35.315 does not address the 
management of this type of patient. The commenter suggested that 
Sec. 35.315 be revised to require licensees to implement radiation 
safety precautions, to include posting warning signs, whenever patients 
receiving therapy quantities of radiopharmaceuticals are hospitalized.
    Response. It is the licensee's responsibility, under Sec. 35.75, to 
control any individual who has been administered unsealed byproduct 
material or implants containing byproduct material if the total 
effective dose equivalent to any other individual from exposure to the 
released individual is likely to exceed 5 mSv (0.5 rem).
    We do not believe that Sec. 35.315 should be revised to 
specifically address patients who are released in accordance with 
Sec. 35.75 but remain hospitalized for other reasons because compliance 
with Sec. 35.75 ensures that the maximally exposed individual does not 
receive a dose in excess of 5 mSv (0.5 rem).
Issue 4: Are the Limits in Sec. 35.315 for the Release of Material and 
Items Removed From the Patient's or Human Research Subject's Room 
Appropriate?
    Comment. A commenter was strongly in favor of the revised survey 
requirements because the previous rules were too prescriptive and not 
warranted for reasons of health and safety. Another commenter believed 
that the release limits in Sec. 35.315(a)(3) of the proposed rule are 
unnecessarily low and are not logical when compared to the annual limit 
of intake for I-131 and I-125.
    Response. Under Sec. 35.315 (a)(4) in the final rule, material and 
items from the patient's or the human research subject's room cannot be 
removed until the radiation levels adjacent to the items are not 
distinguishable from natural background, unless the material and

[[Page 20305]]

items are managed as radioactive waste. Because this requirement is 
consistent with the release requirements in Sec. 35.92 for radioactive 
waste, the NRC does not believe additional modification is needed.
Issue 5: Should the Bioassay Requirements in the Current 
Sec. 35.325(a)(8) Be Included in the Final Rule?
    Comment. A commenter asked that the current Sec. 35.315(a)(8) be 
revised and incorporated in the final rule. The commenter recommended 
that the following provision be added: A licensee shall measure the 
thyroid burden of each individual who helped prepare or administer a 
dosage of I-131 within 3 days after administering the dosage if there 
is a likelihood that the individual would receive more than 10 percent 
of the Annual Limit of Intake in Appendix B of Part 20.
    Response. The NRC has not included bioassay requirements in the 
final rule. Licensees are required to comply with Part 20. As such, 
they must limit occupational exposure to the limits in Part 20. In 
addition, they must develop, document, and implement a radiation 
protection program commensurate with the scope and extent of licensed 
activities (Sec. 20.1101). This would include assessing whether 
individuals preparing or administering I-131 need bioassays.
Issue 6: Were There Any Other Changes Made to This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC restructured paragraph (b) to clarify our 
intent in the proposed rule that, for the purpose of this section, only 
the RSO may have a designee. This same change has been made in 
Sec. 35.310. The reasons for this change are under the discussion of 
Sec. 35.310, Issue 2.

Section 35.390, Training for Use of Unsealed Byproduct Material for 
Which a Written Directive Is Required

Issue 1: Should the Training and Experience Requirements in Sec. 35.390 
Include Instruction in Giving Radiation Safety Directions in the Event 
the Patient or Human Research Subject Dies?
    Comment. A commenter recommended that the NRC add a requirement to 
Sec. 35.390(b)(1) to require that an individual receive instruction on 
issuing radiation safety directions in the event the patient or human 
research subject dies.
    Response. The NRC does not believe this change is necessary because 
this issue should be addressed as part of the licensee's overall 
radiation safety program. Licensees should have flexibility in how they 
address radiation safety issues associated with the death of a patient 
or human research subject.

Section 35.392, Training for the Oral Administration of Sodium Iodide 
I-131 Requiring a Written Directive in Quantities Less Than or Equal to 
1.22 Gigabecquerels (33 millicuries)

Issue 1: Were There Any Changes Made in This Subpart Between the 
Proposed and Final Rule?
    Response: Yes. The NRC added specific training and experience 
requirements for the oral administration of sodium iodide I-131 
requiring a written directive in quantities less than or equal to 1.22 
GBq (33 mCi). This addition is discussed in greater detail under the 
general discussion on training and experience located at the beginning 
of this section of the SUPPLEMENTARY INFORMATION.

Section 35.394, Training for the Oral Administration of Sodium Iodide 
I-131 Requiring a Written Directive in Quantities Greater Than 1.22 
Gigabecquerels (33 millicuries)

Issue 1: Were There Any Changes Made in This Subpart Between the 
Proposed and Final Rule?
    Response: Yes. The NRC added specific training and experience 
requirements for the oral administration of sodium iodide I-131 
requiring a written directive in quantities greater than 1.22 GBq (33 
mCi). This addition is discussed in greater detail under the general 
discussion on training and experience located at the beginning of this 
section of the SUPPLEMENTARY INFORMATION.

Subpart F--Manual Brachytherapy

Section 35.400, Use of Sources for Manual Brachytherapy

Issue 1: Should All Therapy Sealed Sources Be Required To Have National 
Institute of Standards and Technology (NIST) Traceability?
    Comment. Some commenters felt that all sources used for therapeutic 
applications should be required by regulation to have a NIST traceable 
national standard. Conversely, some commenters felt that it is 
inconsistent to require licensees to calibrate in the absence of 
national standards for all clinically used sources.
    Response. This comment pertains to all sources used for manual 
brachytherapy under Section 35.400. Section 35.432 requires that source 
output be measured with a dosimetry system that has been calibrated 
using a system or source traceable to NIST. The NRC agrees with the 
AAPM position that all therapy sealed sources should be calibrated 
using a system or sources traceable to NIST and published protocols 
accepted by nationally recognized bodies or by a calibration laboratory 
accredited by AAPM. In limited cases, a traceable standard identical to 
the therapy sealed source is not available. In these cases, the 
requirement allows the licensee the flexibility to use protocols 
accepted by nationally recognized bodies to meet the calibration 
requirement. As an example, AAPM Report No. 21--Specification of 
Brachytherapy Source Strength, 1987, recommends that sources used in 
radiation therapy have calibrations with direct or secondary 
traceability to national standards. AAPM defines direct traceability as 
``when a source or calibrator has been calibrated either at NIST or an 
AAPM-Accredited Dosimetry Calibration Laboratory.'' AAPM defines 
secondary traceability as ``when the source is calibrated in comparison 
with a source of the same design and comparable strength which has 
direct traceability or when the source is calibrated using an 
instrument with direct traceability.'' In addition, AAPM TG-56 
recommends that, for ``sources that do not have a national standard 
yet, users should develop a constancy check calibrated against the 
vendor's standard and use this constancy check to verify the source 
strength. Another option is to develop one's own secondary standard.'' 
This allows the licensee flexibility in the event that a direct NIST 
traceable standard does not exist.
Issue 2. Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added a new paragraph (b) to this section 
that allows a licensee to use therapy sources in medical research as 
long as the research is conducted in accordance with an active IDE 
application accepted by the FDA if the requirements in Sec. 35.49(a) 
are met. This was done to clarify how research with sealed sources 
could be conducted if the medical use of the sources differed from the 
statements found in the SSDR for the sources. With this change, we 
allow the use of previously registered sources for uses other than 
those described in the original registration process, as long as the 
requirements in paragraph (b) are met.

[[Page 20306]]

Section 35.404, Surveys After Source Implant and Removal

Issue 1: Is the Requirement for Radiation Surveys After Brachytherapy 
Source Implant Necessary?
    Comment. Commenters felt that a survey of the patient after 
brachytherapy sources have been implanted for the purpose of looking 
for misplaced sources would be difficult. The commenters stated that 
with the sources in the patient, the background around the patient is 
too high to detect an errant source. Additionally, some commenters 
believed that radiation surveys should be deleted from Part 35 because 
this is a Part 20 issue.
    Response. The NRC agrees that Part 20 requires surveys and control 
of licensed material. However, in order to clarify that surveys must be 
conducted to locate and account for all sources that have not been 
implanted, the requirements for surveys have been retained in 
Sec. 35.404(a). Section 20.1501 requires, in part, that each licensee 
shall make, or cause to be made, surveys that may be necessary for the 
licensee to comply with the regulations in this part and are reasonable 
to evaluate: the magnitude and extent of radiation levels; the 
concentration or quantities of radioactive material; and the potential 
radiological hazards that could be present. In addition, Subpart I of 
Part 20 requires that the licensee secure from unauthorized removal or 
control and maintain constant surveillance of licensed material. 
Because surveys under Sec. 35.404(a) are not necessarily radiation 
surveys, the term ``radiation'' has been removed from the title and the 
text of paragraph (a) of this section. Depending on the area being 
surveyed and the ability to distinguish from the radiation background 
around the patient implanted with brachytherapy sources, these surveys 
may include radiation surveys of a facility room (e.g., operating room 
suite) after the patient with implanted sources has been removed from 
the room, radiation surveys in and around the patient's room after the 
implant, and visual surveys of the patient's bed after the implant.
Issue 2: Does Adjacent Area Include Contiguous Restricted and 
Unrestricted Areas?
    Comment. A commenter requested that we explicitly indicate that 
``adjacent area'' does not categorically include ``contiguous 
restricted and unrestricted areas.'' The commenter stated that the 
latter wording appears in the current Sec. 35.415(a)(4). The commenter 
indicated there was little rationale for the current requirement and 
that it has been deservedly removed in the proposed rule.
    Response. The NRC deleted the requirement in the current rule 
(Sec. 35.415(a)(4)) that required radiation surveys in contiguous 
restricted and unrestricted areas to demonstrate compliance with the 
requirements of Part 20. We agree that this requirement is covered by 
Part 20. Deleting this requirement and relying on Part 20 to ensure 
that adequate surveys are performed provides the licensee flexibility 
in performing adequate surveys. For instance, an adequate survey 
following a brachytherapy implant may include a radiation survey of 
restricted and unrestricted areas with a maximally loaded patient in a 
representative patient room. If the circumstances of subsequent 
brachytherapy patient treatments are equivalent to the initial survey 
conditions, we believe that the licensee may rely upon the initial 
survey to show compliance with Part 20.

Section 35.406, Brachytherapy Source Accountability

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC changed the title of the section from 
``Brachytherapy source inventory,'' to ``Brachytherapy source 
accountability.'' This title more accurately reflects the regulations 
in this section. The inventory requirements for sealed sources or 
brachytherapy sources are in Sec. 35.67 of the final rule.

Section 35.410, Safety Instruction

Issue 1: Who Must Participate in Annual Retraining?
    Comment. Many commenters questioned the need for the training 
required in Sec. 35.410. Some commenters found this requirement to be 
very burdensome. Another commenter believed that annual retraining was 
not needed for certified radiation therapy technologists and, 
therefore, recommended that the section only require annual retraining 
for ``persons without specialized training in handling radioactive 
materials.'' Additionally, one commenter stated that initial and annual 
training of all nurses and all hospital staff was not cost effective.
    Response. The NRC believes that it is important that personnel 
caring for patients or human research subjects, who have received a 
brachytherapy implant and cannot be released in accordance with 
Sec. 35.75, receive instruction. This instruction should include 
information on how to minimize radiation exposures to the public and 
workers and the radiation safety actions to be taken in the case of a 
medical emergency or a death. We believe this provision is needed 
because exposures in excess of public dose limits could result if 
proper precautions are not taken. We also believe this requirement is 
consistent with ALARA principles.
    We do not require training of all hospital staff. We allow the 
licensee flexibility in determining the appropriate level of radiation 
safety instruction to be provided, depending on the level of 
involvement by various personnel caring for the patient or human 
research subject. The instruction need only be commensurate with the 
duties of the personnel. For example, a primary care nurse may receive 
detailed instructions on patient and visitor control but the ward clerk 
may only need to be instructed to observe the caution signs on the 
patient's door.
    We recognize that certified radiation therapy technologists, or 
other individuals who have received specialized training in handling 
radioactive materials, may have received training in the areas required 
by this section as part of their training program. However, we believe 
that refresher training is warranted because of the potential for 
unnecessary exposure to workers and the public if needed safety 
precautions are not observed.
Issue 2: When Notifying an AU Following a Patient Emergency, Can a 
Physician Designee Be Notified if the AU Is Not Available?
    Comment. A commenter recommended that for notifications of patient 
or human research subject medical emergencies, the AU, like the RSO, 
may not always be readily available and should also have the option to 
specify a designee, such as another physician.
    Response. Sections 35.11 and 35.27 permit an individual to use 
byproduct material under the supervision of an AU. Nevertheless, an AU, 
and not a designee, is responsible for the medical use and supervision 
of the byproduct material. In the event of a medical emergency 
involving a patient or human research subject implanted with 
brachytherapy source(s), the NRC believes that, because of the doses 
administered under Sec. 35.400, an AU must be notified, and this 
notification cannot be delegated to a designee.

[[Page 20307]]

Issue 3. Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC restructured paragraph (a)(5) to clarify our 
intent that, for the purpose of this section, only the RSO may have a 
designee.

Section 35.415, Safety Precautions

Issue 1: Is It Necessary To List the Type and Location of Emergency 
Response Equipment in the Regulations?
    Comment. Commenters believed that the requirement to list the 
contents of an emergency pack was too prescriptive and confusing. 
Additionally, commenters felt that the emergency equipment did not need 
to be specifically located in the patient's room but could be somewhere 
accessible in the hospital. Commenters felt that the licensee should 
have the freedom to adequately stock and locate an emergency pack. One 
commenter also felt that the phrase ``supplies necessary to surgically 
remove applicators'' kept in the patient's room implied that surgery 
should be conducted in a nonsterile environment.
    Response. The NRC agrees with these comments because, in a 
performance-based rule, the essential objectives should be stated in 
the regulatory text. Therefore, we revised the regulatory text to 
identify the essential objective of having emergency response equipment 
available near each treatment room. The list of specific items that are 
needed for emergency responses has been deleted from this section. The 
licensee has the flexibility to determine the type of emergency 
response equipment needed to respond to a source that is either 
dislodged from the patient or lodged within the patient following 
removal of the source applicators.
    We agree that the emergency equipment does not need to be 
maintained in the treatment room. However, it should be maintained near 
each treatment room in order to expeditiously respond to an emergency. 
The rule allows the licensee some flexibility in locating the emergency 
response equipment. The issue of whether to conduct surgical removals 
of applicators or sources within a treatment room that may not be a 
sterile environment is left to the licensee's discretion.
Issue 2: Can Brachytherapy Patients Be Quartered in the Same Room With 
a Patient Not Receiving Radiation Therapy?
    Comment. The NRC solicited specific comment on the current 
requirement that the licensee not quarter a brachytherapy patient in 
the same room as an individual who is not receiving radiation therapy. 
The majority of commenters agreed with the requirement that would allow 
more than one brachytherapy patient in a room although a few commenters 
questioned this requirement. Some commenters believed that the final 
rule should retain the requirement that the licensee not quarter a 
patient in the same room as an individual who is not receiving 
radiation therapy. One commenter pointed out that a posted restricted 
room should not be shared with a patient not involved in the therapy. 
Another commenter believed that the requirement to prohibit placing a 
therapy patient in the same room as a nontherapy patient should apply 
not only to patients confined under Sec. 35.75, but also to any patient 
where another individual in the room could receive over 1 mSv (0.1 
rem). This commenter believed that limiting the requirement to only 
patients confined under Sec. 35.75 was not ``as low as is reasonably 
achievable.'' Conversely, other commenters suggested that the provision 
for a private room be deleted.
    Response. In the current Part 35, the NRC permits the sharing of a 
brachytherapy patient room with another ``individual undergoing 
radiation therapy.'' In the final rule, we clarified that the other 
``individual undergoing radiation therapy'' refers to another 
brachytherapy patient. This is consistent with changes made to 
Sec. 35.315 to allow therapy patients treated with unsealed material to 
share a room if they cannot be released under Sec. 35.75.
    We did not change the final rule in response to comments on the 
allowable exposure to the patient sharing the room or to individual 
members of the public. Section 20.1301 requires the licensee to conduct 
operations so that, in part, the total effective dose equivalent to 
individual members of the public from the licensed operation does not 
exceed 1 mSv (0.1 rem) in a year, exclusive of the dose contributions, 
in part, from exposure to individuals administered radioactive material 
and released under Sec. 35.75. Section 35.75 allows release of patients 
administered byproduct material if the total effective dose equivalent 
to any other individual from exposure to the released individual is not 
likely to exceed 5 mSv (0.5 rem). Therefore, if the licensee confines a 
patient receiving brachytherapy and has not authorized the release of 
the patient under Sec. 35.75, the licensee must limit the total 
effective dose equivalent to individual members of the public to less 
than 1m Sv (0.1 rem) in a year. Concurrent with this Part 35 rulemaking 
is a new provision in 10 CFR 20.1301(c) that allows a licensee to 
permit visitors to individuals who cannot be released under Sec. 35.75 
to receive a radiation dose not to exceed 5 mSv (0.5 rem), provided the 
authorized user has determined that it is appropriate. Alternatively, 
if the licensee authorizes the release of the patient receiving 
brachytherapy under Sec. 35.75, the licensee must make the 
determination that the total effective dose equivalent to any other 
individual is not likely to exceed 5 mSv (0.5 rem). The licensee must 
also provide the released individual, or the individual's parent or 
guardian, with instructions on actions recommended to maintain doses to 
other individuals as low as is reasonably achievable, if the total 
effective dose equivalent to any other individual is likely to exceed 1 
mSv (0.1 rem). In all cases, the licensee is required, under 
Sec. 20.1101, to conduct operations to achieve doses that are as low as 
is reasonably achievable.
Issue 3: Where Should ``Radioactive Materials'' Signs Be Posted?
    Comment. A commenter suggested that having the option to put 
``Radioactive Materials'' signs in the chart instead of on the door was 
not a good idea. This commenter felt that signs should be posted on the 
door and in the chart.
    Response. Section 35.415(a) in the current rule specifically states 
that the patient's door has to be posted. The NRC revised this section 
to require that the licensee visibly post the patient's or human 
research subject's room with a ``Radioactive Materials'' sign. We also 
revised this section to allow the licensee flexibility in determining 
where to place the posting so that it is visible. Notations as to where 
and how long visitors may stay may be placed in the patient's chart or 
posted on the door.
Issue 4: Why Is There a Difference in the Time Periods To Notify the AU 
and the RSO, or his or her Designee, if the Patient or Human Research 
Subject Dies or has a Medical Emergency?
    Comment. A commenter suggested that the time periods for 
notification of a medical emergency and death should be the same.
    Response. The NRC agrees with the comment. In the final rule, the 
notification time periods are the same whether the patient or human 
research subject has a medical emergency or dies. We also modified this 
section to require that, in the event of a medical emergency, the 
notification should be as soon as possible, rather than immediately, 
because the licensee's

[[Page 20308]]

primary responsibility during a patient's medical emergency is the care 
of the patient.
Issue 5: Following a Patient Emergency, When Should an AU Versus an RSO 
Be Notified and Can A Physician Designee Be Notified if the AU is not 
Available?
    Comment. A commenter felt that the AU should be notified and the 
notification of the RSO should be left to the AU's discretion. Another 
commenter recommended that for notifications of medical emergencies, 
the AU, like the RSO, may not always be readily available and should 
also have the option to specify a designee, such as another physician.
    Response. Sections 35.11 and 35.27 permit an individual to use 
byproduct material under the supervision of an AU. Nevertheless, an AU, 
and not a designee, is responsible for the medical use and supervision 
of the byproduct material. Therefore, under Sec. 35.415(c) an AU and 
not a designee, must be notified in the event that a patient or human 
research subject has a medical emergency or dies. Under Sec. 35.24, the 
RSO is responsible for implementing the radiation protection program. 
Therefore, we believe that notification of the RSO, or his or her 
designee, provides additional assurance that appropriate corrective 
actions to respond to any radiation safety hazard associated with the 
emergency or death are taken.
Issue 6. Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. Paragraph (a) was reworded to make it clear that the 
requirements in Sec. 35.75 apply to the release of individuals, not to 
the confinement of individuals. In addition, paragraph (c) was 
restructured to clarify our intent that, for the purpose of this 
section, only the RSO may have a designee.

Section 35.432, Calibration of Brachytherapy Sources

Issue 1: What Does the Term ``Nationally Recognized Body'' Mean and 
What Is the Policy for Taking Recommendations From These Bodies and 
Making Them Regulations?
    Comment. Commenters questioned what was intended by the term 
``nationally recognized body'' and stated that professional protocols 
may contain items that are recommended, but that were never intended to 
be adopted as regulations.
    Response. Examples of nationally recognized bodies include ANSI, 
AAPM, ACR, ACMP, and NIST. Documents issued by nationally recognized 
bodies include multiple peer-reviews of the reports, protocols, or 
standards. The requirements in this subpart are based on 
recommendations found in AAPM TG-40 and TG-56 and are consistent with 
the calibration requirements for sealed sources and devices for 
therapy, including those found in ANSI documents. However, the NRC did 
not include all the recommendations made in these reports because we 
recognize the prescriptiveness of various reports. Instead, the 
regulation contains only the essential objectives for the test being 
required. For additional information on the use of consensus standards 
in developing the revision of Part 35 refer to Section I, Background.
Issue 2: What Is the Meaning of the Term ``Intervals Consistent With 1 
Percent Physical Decay?''
    Comment. One commenter requested that we clarify whether the 
requirement meant 1.0000 percent or allowed rounding down to 1 percent. 
Some commenters felt that 1 percent was too prescriptive because the 
calibration requirements are higher. Additionally, a commenter stated 
that correcting the output/activity at ``'intervals consistent with 1 
percent physical decay'' was not feasible for short half-life sources.
    Response. This section requires that outputs or activities be 
corrected for physical decay at intervals consistent with 1 percent 
physical decay. ``Rounding'' is a mathematical term. ``Consistent with 
1 percent'' includes from 0.51 percent to 1.49 percent. The 1 percent 
correction is separate from the calibration. The accuracy of the 
calibration must be within a given percentage provided by the published 
protocol used to perform the calibration. This calibration is then used 
to determine the dose delivered to the patient.
Issue 3: Should the Rule Contain a Requirement To Perform Calibration 
Measurements of Brachytherapy Sources and, if so, Can the Licensee Rely 
on the Manufacturer's or Distributor's Calibration?
    Comment. In the proposed rule, the NRC solicited specific comment 
on requirements for brachytherapy source calibrations. Some commenters 
felt that the vendor's calibration should be verified by the licensee 
because use of unverified vendor calibrations poses serious hazards for 
the patient. Other commenters believed that the calibration of 
brachytherapy sources should be the manufacturer's responsibility. They 
also suggested that we could easily verify procedures at a few 
manufacturers, rather than at multiple hospitals. Some commenters also 
requested that we require the manufacturer to guarantee the source 
activity or output within 3 percent.
    Response. The NRC believes that it is good practice to verify the 
calibration provided by the manufacturer because of the high risk 
associated with therapy doses to patients. Therefore, Sec. 35.432 
requires a licensee to perform calibration measurements before the 
first medical use of a brachytherapy source. The licensee shall 
determine the source output or activity using a dosimetry system that 
meets the requirements of Sec. 35.630(a); determine source positioning 
accuracy within applicators; and use published protocols accepted by 
nationally recognized bodies to meet the previous two requirements.
    However, we also believe that licensees should be able to use 
calibration measurements provided by the source manufacturer or by a 
calibration laboratory accredited by the AAPM as long as it was done in 
accordance with a published protocol accepted by a nationally 
recognized body using appropriately calibrated equipment. In order to 
ensure the reliability of the outputs or activities reported by the 
manufacturer, the manufacturer must perform the calibrations in 
accordance with the same requirements placed on the licensee. This also 
addresses the issue that the manufacturer guarantee the activity or 
output because the manufacturer must use at least the same performance 
standard as the licensee.
Issue 4: What is the Meaning of the Term ``Full'' in ``Full 
Calibration?'
    Comment. A commenter suggested that the title be changed to 
``Verification of calibration measurements of brachytherapy sources.'' 
Another commenter requested clarification of the term ``full'' in 
``full calibration.'' Another commenter suggested that the term ``full 
calibration'' be replaced with ``spot check'' and the phrase ``spot 
check assay'' should be added to be consistent with terminology used in 
AAPM TG-40 and TG-56.
    Response. The NRC agrees that the term ``full'' is confusing in the 
title because we do not define ``full.'' Therefore, the title of this 
section has been changed to ``Calibration measurements of brachytherapy 
sources.'' Also, the term ``full'' has been deleted from the regulatory 
text in this section. The terminology, including ``calibration,'' was 
selected to be consistent with terminology used in

[[Page 20309]]

Subpart H of Part 35 and in AAPM and ANSI reports.
Issue 5: When Should the Brachytherapy Sources Be Calibrated?
    Comment. A commenter requested clarification on whether 
brachytherapy sources should be calibrated before the first medical use 
period or before the first medical use at a given facility.
    Response. As written, the requirement is that each licensee must 
calibrate its brachytherapy sources before the first medical use at the 
licensee's facility. If the licensee is licensed for medical use at 
more than one facility in a single license, this calibration must only 
be performed once, before medical use, at any of the facilities listed 
in the license.
Issue 6: Does the Rule Allow Calibration of a Sampling of Sources When 
a Batch of Sources is Received?
    Comment. Some commenters suggested that for short half-life sources 
and pure beta-emitting sources [e.g., I-125 and palladium-103 (Pd-
103)], a sampling of the sources should be allowed.
    Response. The NRC does not preclude a sampling of short half-life 
sources when received in a large batch. The rule requires that the 
calibration be performed using published protocols accepted by 
nationally recognized bodies, such as AAPM. The AAPM, in the report 
from TG-40, recommends for short half-life sources that ``for groupings 
with a large number of loose seeds, a random sample containing at least 
10 percent of the seeds be calibrated'' and ``for a large number of 
seeds in ribbons, a minimum of 10 percent or 2 ribbons (whichever is 
larger) should be calibrated.'' However, this recommendation is made to 
the end user and as a verification of the source strength measurement 
performed by the manufacturer. The licensee must ensure that the 
published protocol allows for sampling of sources that have not been 
previously calibrated.
Issue 7: Are Sources Currently in the Possession of the Licensee Exempt 
From the Calibration Requirement?
    Comment. A commenter suggested that we include an exemption for 
sources in inventory before the requirement becomes effective.
    Response. Because calibration standards and methods have varied 
over the years, the NRC believes that to ensure that the correct dose 
is given to the patient, in accordance with Sec. 35.41, the 
brachytherapy source output or activity must be calibrated in 
accordance with published protocols currently accepted by nationally 
recognized bodies. Therefore, we did not revise this section to include 
the requested exemption for sources in inventory before the effective 
date of the rule. Instead, we revised this section to clarify that all 
brachytherapy sources must be appropriately calibrated before the first 
medical use after the effective date of this rule. By including this 
date, the rule now clearly indicates that sources currently possessed 
by the licensee must be calibrated before the first medical use after 
the effective date of this rule and in accordance with a published 
protocol accepted by a nationally recognized body. If the source was 
previously calibrated in accordance with a currently accepted published 
protocol and using a dosimetry system that meets the requirements of 
Sec. 35.630(a), the calibration would not need to be repeated after the 
final rule becomes effective.
Issue 8: Are the Calibration Requirements for High-Dose Versus Low-Dose 
Sources the Same?
    Comment. A commenter requested that the calibration requirements 
make a distinction between high-dose and low-dose brachytherapy 
sources.
    Response. The NRC does not believe that such a distinction is 
needed. We believe that when a therapeutic dose is delivered to a 
patient or human research subject, the licensee is responsible for 
ensuring that the correct dose is administered, regardless of the 
source strength.
Issue 9: Do the Manufacturer's Measurements Need To Be Performed 
Consistent With Those Required by the Licensee?
    Comment. A commenter suggested that for the manufacturer's accepted 
measurements, the phrase ``that are made in accordance with the 
requirements of this section'' be deleted.
    Response. This phrase has been retained in the final rule. To 
ensure the same level of calibration, the NRC believes that unverified 
calibrations performed by the manufacturer must meet the same 
calibration standard as the calibrations required of the licensee.
Issue 10: Is the Requirement for Source Positioning Accuracy Necessary?
    Comment. Some commenters felt that the requirement for source 
positioning accuracy within applicators was vague and may be irrelevant 
or impossible to comply with.
    Response. The NRC believes that, in order for the licensee to 
ensure further that the correct dose is delivered, the applicators used 
to help deliver the dose must be appropriately tested. We reviewed 
several standards currently available for calibration of brachytherapy 
sources. For example, AAPM TG-40 recommends, at a minimum, that initial 
tests be performed on brachytherapy applicators. TG-40 states that ``of 
major concern is that the applicators position the source where they 
are intended to be localized, and that any part of the structures which 
are used to attenuate the radiation (e.g., rectal and bladder shields) 
have not shifted.''
Issue 11: Should the Accuracy of Source Activity or Output 
Determination Be Stated in the Rule?
    Comment. A commenter suggested that the accuracy for I-125 be 
changed to 10 percent because a 5 percent accuracy is not possible.
    Response. The NRC deleted the reference to +/-5 percent from 
Sec. 35.432(c)(1) of the proposed rule. We do not believe that the 
accuracy of the source activity or output measurement needs to be 
stated in the rule because the published protocol addresses the 
accuracy requirement.
Issue 12: Is New Equipment Required by Licensees To Perform 
Calibrations?
    Comment. Several commenters indicated that the new requirement to 
calibrate brachytherapy sources would require licensees not currently 
involved in teletherapy or remote afterloader therapy to procure 
equipment. Additionally, a commenter requested clarification on whether 
a well ionization chamber (e.g., dose calibrator) was adequate for 
calibrating low dose rate brachytherapy sources because farmer chambers 
have historically been associated with Sec. 35.630.
    Response. As represented in the Regulatory Analysis accompanying 
this final rule, the NRC recognizes that licensees may need to procure 
additional equipment to meet this requirement. We believe that the 
additional expenditure is warranted for the licensee administering 
brachytherapy doses to ensure that the correct dose is administered to 
patients. We agree that a well ionization chamber could meet the 
requirement if the chamber, or source used to calibrate the chamber, is 
traceable to NIST or an AAPM-accredited calibration laboratory, and a 
published protocol accepted by a nationally recognized body is used.

[[Page 20310]]

Section 35.433, Decay of strontium-90 sources for ophthalmic uses

Issue 1: Were There Any Other Changes Made to This Subpart Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added this new section that requires an AMP 
to calculate the activity of a strontium-90 (Sr-90) source that will be 
used in determining the treatment time for ophthalmic uses. It also 
requires that the activity be calculated using the source activity 
determined under Sec. 35.432.
    We added this section because we are aware of numerous 
misadministrations involving Sr-90 for opthalmic use that were caused 
by individuals improperly calculating the decay of sealed sources. 
Given the risks associated with use of Sr-90 and the numerous 
misadministrations in this area, a more prescriptive requirement is 
warranted.

Section 35.457, Therapy-Related Computer Systems

Issue: Were There Any Other Changes Made to This Subpart Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added this new section that is consistent 
with the requirement found in Sec. 35.657 for therapy-related computer 
systems. The new section requires brachytherapy licensees who use 
treatment planning systems to perform acceptance testing on the system 
in accordance with published protocols accepted by nationally 
recognized bodies.

Section 35.490, Training for Use of Manual Brachytherapy Sources

    General comments on this section are summarized under the General 
Training topic found at the beginning of this section of the Federal 
Register notice.
Issue 1: Should Training Include Ordering and Inventory of Byproduct 
Material?
    Comment. A commenter requested that we delete the following from 
work experience requirements: ``ordering'' material safely and 
``maintaining running inventories of material on hand.'' The commenter 
believed that there was no risk associated with these procedures.
    Response. Because the AU is responsible for use of byproduct 
material under the license, the NRC believes that experience in 
ordering and maintaining inventories of radioactive materials is an 
important component of a training program for an AU.

Section 35.491, Training for ophthalmic use of strontium-90

Issue 1: Were There Any Other Changes Made in This Subpart Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added this new section. The proposed rule 
had deleted specific training and experience requirements for 
individuals who wanted to use Sr-90 for ophthalmic use. Under the 
proposed rule, these individuals would need to meet the training and 
experience requirements in the proposed Sec. 35.490 or Sec. 35.940. 
This change was proposed because, at that time, we believed it was 
warranted in view of the similarities between the use of Sr-90 eye 
applicators and the use of sealed byproduct material in medical 
devices, and recent misadministrations involving Sr-90 eye applicators. 
Upon further review of the misadministrations, we believe that the 
majority of the misadministration events could have been prevented if 
an AMP had calculated the decay of the sources, rather than if NRC 
required additional training and experience for AUs who want to use Sr-
90 for ophthalmic use. Therefore, we added a requirement for an AMP to 
calculate the activity of the source (Sec. 35.433) and have included a 
specific section that provides the training and experience requirements 
for an individual who would like to use Sr-90 sources for ophthalmic 
treatments.
    This section is identical to Sec. 35.941, Training for ophthalmic 
use of Sr-90 in the current rule with minor exceptions. We have deleted 
the phrase ``who is in the active practice of therapeutic radiology or 
ophthalmology.'' We believe it is important that the individual is a 
physician and therefore this additional level of prescriptive 
regulation is not warranted. We have also added a requirement for a 
written statement, signed by a preceptor AU, stating that the 
individual has satisfactorily completed the training requirements and 
has achieved a level of competency sufficient to function independently 
as an AU for use of Sr-90 for ophthalmic treatments. This change is 
consistent with the other training and experience sections within the 
revised rule. The preceptor statement is discussed in more detail under 
the General Training topic found at the beginning of this section. 
Additionally, we have added a provision that a physician who meets the 
requirements in Sec. 35.490 or equivalent Agreement State requirements 
would automatically meet the requirements to become an AU under 
Sec. 35.491.

Subpart G--Sealed Sources for Diagnosis

    The NRC received comments on only three areas in Subpart G. They 
are: (1) SSDR; (2) availability of survey instruments; and (3) training 
and experience requirements. The first two topics are summarized under 
the ``Global Changes'' topic in the beginning of this section because 
the same comments pertain to multiple sections in the rule. Comments on 
the training and experience requirements are summarized under the 
``General Training'' topic found at the beginning of this section.

Subpart H--Photon Emitting Remote Afterloader Units, Teletherapy Units, 
and Gamma Stereotactic Units

General Comments
Issue 1: Can This Subpart Be Revised To Eliminate Redundant and Overly 
Prescriptive Requirements?
    Comment. A commenter suggested that Subpart H should be rewritten 
to eliminate redundancy and overprescriptive procedures that the NRC 
expects licensees to follow. The commenter felt that the licensees 
should have the ability to develop their own procedures instead of the 
NRC dictating each step.
    Response. The NRC agrees that the rule should not be redundant and 
we have combined sections whenever possible. For example, in the final 
rule, we combined Sec. 35.644, Periodic spot-checks for low dose-rate 
remote afterloaders, with Sec. 35.643, Periodic spot-checks for high 
dose-rate and pulse dose-rate remote afterloader units. However, the 
full calibration requirements for all therapy units have been retained 
in separate sections for each type of unit to avoid confusion on the 
applicability of certain tests for a given therapy unit.
    Subpart H contains requirements for emergency response and 
operating procedures, including full calibration and spot-check tests. 
Where warranted by risk, we maintained the prescriptive requirements in 
the rule. We identified the performance objectives for full 
calibrations and spot-checks in the rule. This decision was based on 
various AAPM and ANSI reports. However, the exact content of these 
procedures has not been specified. These procedures are required to be 
developed by the licensee and the AMP. Where applicable, the procedures 
must use published protocols accepted by a nationally recognized body. 
We believe that this provides the licensee more flexibility in 
developing its procedures.

[[Page 20311]]

Issue 2: How Have National Standards Been Incorporated Into the Rule?
    Comment. Commenters were concerned that we are transforming 
recommended ``practice standards'' into excessively prescriptive and 
unnecessarily burdensome regulatory requirements.
    Response. In many sections, the rule allows licensees to develop 
their own procedures in accordance with multiple peer-reviewed reports, 
protocols, or standards. Examples include following recommendations 
published by the AAPM, ACR, ANSI, and ACMP. The NRC believes this 
provides licensees with the flexibility needed to develop their own 
procedures as long as they meet the minimum regulatory requirements in 
this subpart.
    For additional information on the use of consensus standards in the 
final rule refer to I, Background, in the SUPPLEMENTARY INFORMATION.
Issue 3: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC changed the title of this subpart and the 
language in Sec. 35.600 to make it clear that the requirements in this 
section refer to only photon-emitting remote afterloader units, 
teletherapy units, and gamma stereotactic radiosurgery units.

Section 35.600, Use of a Sealed Source in a Remote Afterloader Unit, 
Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit

Issue 1: Should All Therapy Sealed Wources Be Required to Have NIST 
Traceability?
    Comment. Some commenters said that all sources used for therapeutic 
applications should be required by regulation to have a NIST traceable 
national standard. Conversely, some commenters said that it is 
inconsistent to require licensees to calibrate such sources in the 
absence of national standards for all clinically used sources.
    Response. Sections 35.632, 35.633, and 35.635 require that sealed 
source output be measured with a dosimetry system that has been 
calibrated using a system or source traceable to NIST and published 
protocols accepted by nationally recognized bodies or by calibration 
laboratory accredited by AAPM. The NRC agrees with the AAPM position 
that all therapy sealed sources should be calibrated in accordance with 
a traceable standard. In limited cases, a traceable standard identical 
to the therapy sealed source is not available. In these cases, 
Secs. 35.632, 35.633, and 35.635 allow the licensee the flexibility to 
use protocols accepted by nationally recognized bodies to meet the 
calibration requirement. As an example, AAPM Report Number 21 
recommends that sources used in radiation therapy have calibrations 
with direct or secondary traceability to national standards. AAPM 
defines direct traceability as ``when a source or calibrator has been 
calibrated either at NIST or an AAPM-Accredited Dosimetry Calibration 
Laboratory.'' AAPM defines secondary traceability as ``when the source 
is calibrated in comparison with a source of the same design and 
comparable strength which has direct traceability or when the source is 
calibrated using an instrument with direct traceability.'' In addition, 
AAPM TG-56 recommends that for ``sources that do not have a national 
standard yet, users should develop a constancy check calibrated against 
the vendor's standard and use this constancy check to verify the source 
strength. Another option is to develop one's own secondary standard.'' 
This allows the licensee flexibility in the event that a direct NIST 
traceable standard does not exist.
Issue 2: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added a new paragraph (b) to this section 
that allows a licensee to use therapy sources in medical research if 
the research is conducted in accordance with an active IDE application 
accepted by the FDA and if the requirements in Sec. 35.49(a) are met. 
This was done to clarify how research with sealed sources could be 
conducted if the medical use of the sources differed from the 
statements found in the SSDR for the sources. With this change, we 
allow previously registered sources to be used for uses other than 
those described in the original registration process as long as the 
requirements in paragraph (b) are met.

Section 35.604, Surveys of Patients and Human Research Subjects Treated 
With a Remote Afterloader Unit

Issue 1: What Is the Purpose of the Survey Required by This Section?
    Comment. A commenter requested clarification of the requirement to 
survey the patient or human research subject and the remote afterloader 
with a portable radiation detection survey instrument to confirm that 
the source(s) have been removed from the patient or human research 
subject and returned to the safe shielded position.
    Response. The radiation surveys are needed to ensure that a source 
does not remain within the patient or outside of the source shield 
following completion of each treatment with the unit.
Issue 2: Who May Perform the Survey?
    Comment. A commenter requested that the rule be revised to allow 
the medical physicist to train an assistant to do the radiation 
surveys, required by Sec. 35.604, when the physicist is not available.
    Response. The rule does not specify who must perform the surveys 
required by Sec. 35.604. The NRC believes that the licensee should have 
the flexibility to decide who should perform the surveys. However, the 
record of the survey must include the name of the individual who 
performed the survey, in accordance with Sec. 35.2404.

Section 35.605, Installation, Maintenance, Adjustment, and Repair

Issue 1: Who May Repair a LDR Unit?
    Comment. The NRC solicited comments on whether the restrictions in 
this section on who may work on a device containing a sealed source 
should apply to LDR units. Some commenters said that the restrictions 
should apply to LDR units. Other commenters believed that the 
restrictions should only apply to LDR units if the device manufacturer 
recommends the restriction for the particular device. Conversely, some 
commenters said that the restrictions should not apply to LDR units 
because the risk from these low dose-rate units is minimal enough that 
a trained individual knowledgeable of the unit's operation could 
install, perform maintenance, adjust, or repair the device. They 
believed that we should not ``over-regulate'' these units. Some 
commenters also believed that users of nonmedical devices who perform 
these types of services must submit procedures that show they have had 
appropriate training in performing these services on the specific 
devices. They stated that persons who perform installation, 
maintenance, and repair of other NRC-regulated devices (that do not 
apply radiation to humans) are routinely limited to services on the 
specific devices for which they have training and experience, e.g., 
fixed gauges, radiography cameras, etc. In addition, repairs of therapy 
devices are not just an issue of source or cable replacement, but could 
also include electronics and software modifications. Consequently, they 
believed that none of the training and experience requirements 
identified in the proposed

[[Page 20312]]

regulations provide for this kind of training. Therefore, the service 
provider's specific training must be evaluated by the NRC.
    Response. Because of the risk associated with therapy devices, the 
final rule only allows an NRC or Agreement State licensed entity to 
install, maintain, adjust, or repair a therapy device that involves 
work on the source(s) shielding, the source(s) driving unit, or other 
electronic or mechanical component that could expose the source(s), 
reduce the shielding around the source(s), or compromise the radiation 
safety of the therapy unit or the source(s). Additionally, these 
regulations limit the installation, replacement, relocation, or removal 
of the sealed source(s) or source(s) in a teletherapy unit, gamma 
stereotactic radiosurgery unit, HDR, MDR, and PDR, to an entity 
specifically licensed by the NRC or an Agreement State for these 
activities. For LDR source(s), the NRC allows an AMP or a specifically 
licensed entity to perform these functions. This provides relief for 
licensees possessing LDRs when replacing decayed sources or removing 
and installing sources to render each individualized treatment plan. 
However, for work on the LDR source(s) safe, the source(s) driving 
unit, or other electronic or mechanical components that may expose the 
source(s) or compromise the radiation safety of the unit, we believe 
that specialized training, in addition to the training required to meet 
AMP status, is necessary to perform these activities. Therefore, only 
personnel specifically licensed by the NRC or an Agreement State may 
perform these activities.
Issue 2: Does Install, Maintain, Adjust, or Repair Include Assembly?
    Comment. A commenter suggested that the word ``assembly'' be added 
to the list of activities that must be performed by a specifically 
licensed person.
    Response. The NRC believes that ``assembly'' is included within the 
meaning of installation and repair. Therefore, we made no change in the 
regulatory text.

Section 35.610, Safety Procedures and Instructions for Remote 
Afterloader Units, Teletherapy Units, and Gamma Stereotactic 
Radiosurgery Units

Issue 1: Does the Rule Allow Individuals Other Than the Patient To Be 
Present in the Treatment Room?
    Comment. Commenters indicated that therapy administrations in 
cardiac catheterization suites require the presence of other persons 
for the safety of the patient during the treatment, and may require 
that individuals have access to the patient through the treatment room 
doors without interruption of the treatment. In such cases, the 
commenters believed that the exposures to personnel were already 
limited by Part 20 requirements. A commenter also questioned the term 
``contraindicated'' in the phrase ``ensuring that only the patient * * 
* is in the treatment room before initiating treatment with the 
source(s), unless contraindicated * * *''
    Response. The NRC agrees that, in limited cases, the licensee may 
need to allow other individuals in the treatment room during treatment. 
We also agree that the scope of ``unless contraindicated'' needs to be 
defined. Therefore, we modified the final rule to permit individuals 
approved by the AU, AMP, or RSO to be present in the treatment room, 
during treatment with the source(s). These individuals are in the best 
position to determine if an individual may be present in the treatment 
room during a treatment. However, licensees are still required to 
control the exposures of workers and members of the public in 
accordance with Part 20.
Issue 2: Must the Console and the Console Keys Be Secured?
    Comment. A commenter suggested that securing both the console and 
the console keys was redundant. The commenter went on to state that 
securing a teletherapy or a gamma stereotactic radiosurgery treatment 
room is unnecessary if the console or console keys are secured because 
it would be highly unlikely that unauthorized individuals would remove 
the devices given their bulk and weight. The commenter felt that, in 
keeping with a performance-based rule, this section should be revised 
to read ``prevention of unauthorized use or removal of the device when 
not in use or unattended.''
    Response. Paragraph (a)(1) of this section specifies the mechanism 
for ensuring that the licensed material in therapy treatment devices is 
controlled when the devices are not attended or are not in use. In 
keeping with a performance-based rule, the NRC removed the proposed 
requirement for written security procedures. This allows the licensee 
flexibility in determining the appropriate method for meeting this 
requirement. General requirements for security of byproduct material 
are addressed in Part 20, Subpart I. However, because of the high risk 
posed by these sources, we believe that a more prescriptive requirement 
is warranted.
Issue 3: Where Should Emergency Procedures and Instructions Be Posted?
    Comment. Some commenters said that requiring a copy of instructions 
and procedures to be posted only at the device console was too 
prescriptive. They suggested that the language should be revised to 
read ``in the immediate vicinity of the device console.'' A commenter 
also suggested that paragraph (c) of this section was unnecessary 
because it requires posting the location of the procedures, and 
paragraph (b) requires the procedures be posted. Another commenter 
suggested that, in some cases, a console may not exist.
    Response. The NRC has not changed either paragraph (b) or (c) in 
the final rule. Paragraph (b) requires that a copy of the emergency 
procedures required by paragraph (a)(4) be physically located at the 
unit console. Paragraph (c) requires posting the location of emergency 
procedures and the names and telephone numbers of the emergency 
contacts. Because the emergency procedures for some devices (e.g., HDR 
units) may consist of several volumes of error codes and their meaning, 
we do not require that these procedures be posted. However, the actual 
location (e.g., specific drawer in the console) where these procedures 
are stored must be posted at the unit console to alert individuals 
about where to find the detailed emergency procedures in the event of 
an emergency. We agree that this does not specifically require posting 
the procedures on the console, but may allow, for instance, posting 
them on the wall in front of the console. We also believe that a 
console exists for ``remotely'' delivered sources because the sources 
must be removed from the source shielding from outside of the treatment 
room. For cardiac units, this may be an infusion console.
Issue 4: Should Device Operators Be Listed in the License?
    Comment. A commenter felt that operator knowledge was vital to 
prevent a medical event, but the requirements do not address operator 
education, training, or experience. The commenter suggested that the 
operator be named in the license.
    Response. It is the licensee's responsibility to ensure that 
operators are trained. In accordance with Sec. 35.27, operators use 
licensed material and operate licensed devices, depending on the 
activity being conducted, under the supervision of the AU. Therefore, 
the NRC does not believe that NRC's prior

[[Page 20313]]

review of a specific operator's training is necessary.
Issue 5: What Is the Appropriate Frequency and Scope of Instruction?
    Comment. Some commenters suggested that we clarify that persons not 
receiving annual refresher training are simply prohibited from 
operating the unit until the training is provided and that the 
individuals need not be removed from authorization in the institutional 
license. A commenter also felt that the instruction requirements were 
too prescriptive for the variety of devices. In addition, while it may 
be possible to perform a drill simulating the removal of a patient from 
a teletherapy unit, such a drill is not practical for an HDR unit. The 
commenter requested that the regulatory text be revised to read ``a 
licensee shall provide instruction and practice drills or 
demonstrations, initially and at least annually * * *'' Conversely, 
some commenters suggested that retraining was not necessary at all 
because the AMP and the operator routinely perform the procedures.
    Response. The NRC amended the regulatory text to clarify the 
requirements for instruction. We believe that initial instruction and 
annual retraining are needed to ensure that the correct dose is 
administered to the patient or human research subject and to ensure 
that responsible individuals appropriately respond to emergencies. We 
also believe that emergency drills are appropriate for all devices. The 
requirement for training on emergency and operating procedures has been 
revised to clarify that the training provided is ``as appropriate to 
the individual's assigned duties.'' We believe that the revised rule 
allows the licensee flexibility in determining the appropriate level of 
instruction to be provided depending on the level of involvement of 
personnel in the operation of and emergency response for the therapy 
unit.
Issue 6: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. In keeping with a more performance-based rule, the 
NRC removed the requirement for a written procedure for preventing dual 
operation of radiation producing devices. This allows the licensee 
flexibility in determining the appropriate method for meeting this 
requirement.
    Paragraph (g) of this section was added to refer licensees to the 
record keeping requirements in Sec. 35.2610.

Section 35.615, Safety Precautions for Remote Afterloader Units, 
Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Issue 1: Is It Necessary To List the Type and Location of Emergency 
Response Equipment in the Regulations?
    Comment. Commenters believed that the requirement to list the 
contents of an emergency pack was too prescriptive and confusing. 
Additionally, commenters believed that the emergency equipment did not 
need to be specifically located in the patient's room but could be 
somewhere accessible in the hospital. Commenters felt that the licensee 
should have the freedom to adequately stock and locate an emergency 
pack. One commenter also felt that the phrase ``supplies necessary to 
surgically remove applicators'' kept in the patient's room implied that 
surgery should be conducted in a nonsterile environment.
    Response. The NRC agrees with these comments because, in a 
performance-based rule, the essential objectives should be stated in 
the regulation. Therefore, we revised the regulatory text to identify 
the essential objective of having emergency response equipment 
available near each treatment room. The list of specific items that are 
needed for emergency responses has been deleted from this section. The 
licensee has the flexibility to determine the type of emergency 
response equipment needed to respond to a source that remains in the 
unshielded position or is lodged within the patient following 
completion of the treatment.
    We agree that the emergency equipment does not need to be 
maintained in the treatment room. However, it should be maintained near 
each treatment room in order to expeditiously respond to an emergency. 
The final rule allows the licensee some flexibility in locating the 
emergency response equipment but does not preclude the licensee from 
placing the equipment in the room. This is especially important in the 
situation where heavy source shields are needed. The issue of whether 
to conduct surgical removals of applicators or sources within a 
treatment room that may not be a sterile environment is left to the 
licensee's discretion.
Issue 2: Is This Section Applicable to Remote Afterloader Units With 
Beta-Emitting Sources?
    Comment. The NRC solicited specific response on whether the safety 
precautions in this section should apply to beta-emitting sources. Some 
commenters felt that the requirements in this section should not apply 
to remote afterloader beta-emitting sources, since the lower doses from 
the beta-emitting sources present a very low risk. For example, some 
commenters felt that paragraphs (b), (c), (d), and (g) could be waived. 
Other commenters did not believe that we should waive the requirements 
in this section for remote afterloader beta-emitting sources in keeping 
with ALARA.
    Response. The NRC amended the title of this subpart to make it 
clear that it only applies to photon-emitting units. We agree that when 
requirements for beta-emitting remote afterloader units are 
subsequently added to the regulations, many of the types of 
requirements described in this section may be appropriate. However, 
until the use and safety issues of beta-emitting remote afterloader 
units are fully understood, specific requirements for these units have 
not been incorporated into this subpart.
Issue 3: Who May Generate a Treatment Plan?
    Comment. A commenter suggested adding a requirement that only an 
AMP may generate an HDR treatment plan. The commenter believed that the 
level of complexity and the chance for error in this area certainly 
warranted a requirement in this area.
    Response. The NRC has not changed the final rule to state who 
should generate a treatment plan. We believe that licensees should 
determine who will generate the treatment plan. Additionally, we remind 
licensees that under Sec. 35.41, Procedures for administrations 
requiring a written directive, the licensee must develop, implement, 
and maintain written procedures to provide high confidence that each 
administration is in accordance with the written directives, including 
providing the correct dose to the patient.
Issue 4: Is an Intercom System Necessary?
    Comment. A commenter requested that the requirement for an intercom 
system be deleted because voice communication with the patient is not 
necessary during treatment. The commenter also suggested that the 
requirement to have an intercom system restricts treatments given by a 
deaf employee.
    Response. Based on ANSI and AAPM recommendations and to help ensure 
patient and worker safety, the NRC retained the requirement for an 
intercom system in the final rule. This does not preclude additional 
use of

[[Page 20314]]

another voice activated system that can be used by a deaf operator.
Issue 5: Should the Word ``Expeditious'' Be Used in the Rule?
    Comment. A commenter suggested that the term ``expeditious'' in 
paragraph (e) implies that, if the source is difficult to remove, the 
licensee will be cited. The commenter also felt that this requirement 
could interfere with what the physician considers to be in the best 
interest of the patient.
    Response. The potential dose to the patient from a decoupled or 
jammed therapy source remaining within the patient is significant. 
Therefore, the NRC has retained the requirement for a licensee to only 
conduct treatments which allow for expeditious removal of a decoupled 
or jammed source.
Issue 6: Who Needs To Be Present During LDR Treatments?
    Comment. A commenter felt that treatments with an LDR unit should 
allow for trained individuals, working under the supervision of an AU, 
who have been trained in the operation of the device to be physically 
present during treatment initiation and an AU and AMP immediately 
available. Another commenter felt that the AU and the AMP should be 
physically present during the initiation of patient treatments 
involving LDR devices. This commenter also asked whether the reference 
to a radiation oncology physician includes a resident in training. 
Still another commenter requested that the NRC delete the requirement 
for an AU and AMP to be present for continuation of LDR treatments 
because the treatment may last 48-72 hours and it is not possible to 
have someone continually available.
    Response. In response to public comments, the requirements for the 
presence of trained personnel during LDR, MDR, and PDR treatments were 
amended. The final rule does not contain any requirements for the 
presence of trained personnel for LDR treatments. The risk associated 
with use of byproduct material in an LDR and manual brachytherapy are 
similar. Therefore, the NRC does not believe that regulatory text is 
needed in this area.
    For MDR and PDR units, an AMP must be physically present during the 
initiation of patient treatments and must be immediately available 
during continuation of the treatments. The final rule allows an AU to 
permit a physician, working under his/her supervision and with training 
specific to operation and emergency response for the unit, to be 
physically present in place of the AU during initiation of patient 
treatment involving an MDR or PDR unit. The final rule also allows the 
AU to permit an individual, working under his/her supervision and with 
training in removing source applicator(s), to be ``immediately 
available'' in place of the AU during continuation of patient treatment 
involving an MDR or PDR unit. Because the treatment times for pulsed 
dose-rate treatments are significantly longer than those for high dose-
rate treatments and the activities of pulsed dose-rate sources are 
approximately one-tenth of the activities of high dose-rate sources, 
the change in physician attendance during pulsed dose-rate treatments 
is warranted. Additionally, for normal resumption of treatment 
controlled by the pulsed dose-rate device during the normal 
continuation of the treatment, the presence of a medical professional 
is not required. This revision allows the licensee flexibility in 
determining the appropriate personnel to have physically present or 
``immediately available'' for medical response to patients treated with 
these units.
Issue 7: Who Needs To Be Present During HDR Treatments?
    Comment. Some commenters believed that a physician and a properly 
trained radiation therapy technologist should be present for HDR 
treatments. The commenters believed that the responsibility for the 
device is the AU's, since this is an FDA-approved device. Another 
commenter believed that the physical presence of an AMP is sufficient 
if an AU, or a physician trained to respond to an emergency, could be 
summoned to the HDR unit console within 2 minutes. Some commenters also 
requested that all remote afterloader requirements be combined because 
the present requirements are repetitive.
    Response. The NRC believes that the requirements for HDR units 
should differ from the requirements for LDR, MDR, and PDR treatments 
because the treatment times and the source activities differ 
significantly. We believe that the requirements appropriately address 
emergency situations.
    An AMP is required to be physically present during the initiation 
and continuation of all patient treatments involving the unit. The 
final rule allows an AU to permit a physician, working under his or her 
supervision, to be physically present in place of the AU during 
continuation of patient treatment as long as the physician has received 
operating and emergency response training for the device and as long as 
the AU is physically present during initiation of the patient 
treatment. We believe that this revision is appropriate because it 
allows the licensee flexibility in determining who should be physically 
present during treatments involving HDR units.
Issue 8: Who Needs To Be Present During Gamma Stereotactic Radiosurgery 
Treatments?
    Comment. A commenter requested that for gamma stereotactic 
radiosurgery treatments, an AU or anyone trained in the setting of the 
coordinates and emergency procedures should be present. Another 
commenter suggested that emergency response could be limited to 
requiring the presence of a physician capable of dealing with the 
patient's medical needs and two individuals trained in emergency 
procedures particular to the unit. Still another commenter suggested 
that we require continuous monitoring by one trained individual and 
monitoring by an AU during the start and the end of the treatment.
    Response. The NRC requires the physical presence of an AU and an 
AMP throughout all patient gamma stereotactic radiosurgery treatments 
to ensure appropriate response to an emergency and to ensure that the 
correct dose is delivered to the patient.
Issue 9: Were There Aany Other Changes Made in This Section Bbetween 
the Proposed and Final Rule?
    Response. Yes. The NRC amended paragraph (b)(2) to delete the word 
``immediately.'' We did not believe the word was needed because the 
text clearly indicates that the interlock system must cause the sources 
to be shielded when an entrance door is opened.
    We also added a requirement to Sec. 35.615 (f) that an AU and an 
RSO, or his or her designee, must be notified in the event the patient 
or human research subject has a medical emergency or dies. This 
notification requirement is similar to Sec. 35.415(c) and provides 
consistency in the requirements for therapy devices and manual 
brachytherapy. In cases where an AU is physically present during the 
patient treatment, the notification need only be made to the RSO.

Section 35.630, Dosimetry equipment

Issue: Is Calibrated Dosimetry Equipment Needed for Low Dose-Rate 
Therapy?
    Comment. A commenter suggested that licensees routinely do not have 
or have available, other than through a source provider, calibrated 
dosimetry equipment that is applicable to the

[[Page 20315]]

lower dose-rates used in standard brachytherapy. Therefore, the 
commenter requested that dosimetry equipment only be required for 
higher dose-rate procedures.
    Response. As noted in the Regulatory Analysis accompanying this 
final rule, the NRC recognizes that licensees may need to procure 
additional equipment to meet this requirement. We believe that the 
additional expenditure is warranted for the licensee administering 
therapeutic doses to ensure that the correct dose is administered to 
patients. However, we added regulatory text on the use of the source 
output or activity determined by the manufacturer so that this section 
is consistent with the requirements in Subpart F, Manual Brachytherapy. 
In the final rule, a licensee using an LDR source(s) may rely on the 
manufacturer's calibration, and hence the manufacturer's calibration 
equipment, as long as the equipment and source calibration is performed 
in accordance with protocols accepted by nationally recognized bodies.

Section 35.632, Full Calibration Measurements on Teletherapy Uunits

Issue 1: What Does the Term ``Nationally Recognized Body'' Mean and 
What Is the Policy for Making Recommendations From These Bodies Into 
Regulations?
    Comment. Commenters questioned what was intended by the term 
``nationally recognized body'' and stated that professional protocols 
may contain items that are recommended but that were never intended to 
be adopted as regulations.
    Response. ``Nationally recognized bodies,'' as used in Part 35, 
refers both to official standards consensus bodies that are identified 
on the NIST website and to those professional organizations that 
develop their reports, protocols, or standards using a consensus 
process and multiple peer-reviews. Examples of nationally recognized 
bodies include ANSI, AAPM, ACR, and ACMP. The requirements in this 
subpart are based on recommendations found in ANSI and AAPM reports and 
are consistent with the calibration requirements for other sealed 
sources and devices for therapy. However, the NRC did not include all 
the recommendations made in the ANSI and AAPM reports nor did we adopt 
them as regulations because we recognize the prescriptiveness of 
various reports. Instead, the regulation only contains the essential 
objectives for the test being required are listed in the rule.
    For additional information on the use of consensus standards from 
nationally recognized bodies, refer to Section I, Background, and the 
discussion of industry standards in the beginning of this section.
Issue 2: What Is the Meaning of the Term ``Intervals Consistent With 1 
Percent Physical Decay''?
    Comment. One commenter requested that we clarify whether the 
requirement meant 1.0000 percent or allowed rounding down to 1 percent. 
Some commenters felt that 1 percent was too prescriptive because the 
calibration requirements are higher. Additionally, a commenter 
requested that the posted values be within 1 percent of the 
mathematically corrected values.
    Response. This section in the final rule requires that outputs be 
corrected for physical decay at intervals not exceeding 1 month for 
cobalt-60, 6 months for cesium-137, or at intervals consistent with 1 
percent decay for all other nuclides. ``Rounding'' is a mathematical 
term. ``Consistent with 1 percent'' includes from 0.51 percent to 1.49 
percent. The 1 percent correction is separate from the output full 
calibration. The accuracy of the output full calibration must be within 
+/-3 percent in accordance with paragraph (b)(1) of this section. This 
calibration is then used to determine the dose delivered to the 
patient.
Issue 3: What Is the Meaning of the Term ``Calibrate'' When Referring 
to Timer Accuracy and Linearity?
    Comment. Commenters requested the meaning of ``calibrate'' when 
referencing timer accuracy and linearity. The commenters suggested 
that, if the purpose is to measure these items to assure they are 
within some tolerance, this purpose should be stated in the regulation.
    Response. Procedures for calibrating the timer are provided in 
various protocols, which include tolerances. Examples include ANSI N449 
and N449-1, ``Procedures for Periodic Inspection of Cobalt-60 and 
Cesium-137 Teletherapy Equipment'; and AAPM TG-40. As stated in this 
regulation, the calibration must be performed in accordance with 
published protocols accepted by nationally recognized bodies. The term 
calibrate, as used in this context, means to perform measurements to 
assure that the timer is operating appropriately within a given 
tolerance. The tolerances may be found in reports such as AAPM TG-40. 
Therefore, the licensee is given flexibility in developing its 
calibration methods.
Issue 4: Why are repetitive output measurements necessary?
    Comment. A commenter agreed with the requirement for full 
calibration of sources. However, the commenter suggested that 
repetitive output checks of long-lived sources, such as cesium, was 
unnecessary because the output is not going to change as long as the 
source is not leaking.
    Response. When delivering a therapeutic dose to a patient or human 
research subject, the NRC believes that the licensee is responsible for 
ensuring that the correct dose is administered. Additionally, in 
accordance with Sec. 35.41, the licensee must implement procedures to 
ensure that the dose is administered in accordance with the written 
directive. As part of ensuring that the correct dose is administered, 
we believe that the source output for all sources used to administer a 
therapeutic dose must be calibrated and verified. We also agree with 
published protocols, such as ANSI and AAPM recommendations, that 
include periodic recalibration of source activity when delivering 
therapeutic doses. Therefore, we retained the proposed calibration 
requirements in the final rule.

Section 35.633, Full Calibration Measurements on Remote Afterloader 
Units

Issue 1: Why Are Repetitive Output Measurements Necessary and Shouldn't 
the Output Test Requirements Reference the Equipment Calibration 
Requirements?
    Comment. A commenter agreed with the requirement for full 
calibration of sources. However, the commenter suggested that 
repetitive output checks of long-lived sources, such as cesium, was 
unnecessary, because the output is not going to change as long as the 
source(s) is not leaking. Another commenter suggested that the output 
calibration requirement should reference the requirement for dosimetry 
equipment in Sec. 35.630.
    Response. When delivering a therapeutic dose to a patient or human 
research subject, the NRC believes that the licensee is responsible for 
ensuring that the correct dose is administered. Additionally, in 
accordance with Sec. 35.41, the licensee must implement procedures to 
ensure that the dose is administered in accordance with the written 
directive. As part of ensuring that the correct dose is administered, 
we believe that the source output for all sources used to administer a 
therapeutic dose must be calibrated and verified. We also agree with 
published protocols, such as AAPM recommendations, that

[[Page 20316]]

include periodic recalibration of source activity when delivering 
therapeutic doses. Therefore, we retained the proposed calibration 
requirements in the final rule. However, for consistency with manual 
brachytherapy, which is traditionally low dose-rate, we included an 
allowance for LDR sources in the final rule. Paragraph (f) allows 
licensees using LDRs to accept the manufacturer's calibration of the 
unit and source as long as the manufacturer conducted the calibration 
in accordance with this section and with a published protocol accepted 
by a nationally recognized body and used a dosimetry system as 
described in Sec. 35.630(a) to measure the output.
Issue 2: What System Tests and Tolerances Should Be Included in 
Calibration Requirements?
    Comment. Commenters requested the meaning of ``calibrate'' when 
referencing source guide tubes, connectors, and timer accuracy and 
linearity. If the purpose is to measure these items to assure they are 
within some tolerance, the commenters suggested that this purpose be 
stated in the regulation. Another commenter suggested that timer 
accuracy is irrelevant to dosimetry as long as the timer functions the 
same at the time of treatment as at the time of calibration (i.e., 
consistency), and responds linearly. Some commenters requested deletion 
of: (1) Timer accuracy and linearity for LDR and PDR units; (2) guide 
tube calibrations; (3) connector length calibrations; (4) 
autoradiograph of LDR sources to verify inventory (because sources are 
difficult to remove from the unit); and (5) battery backup checks 
(should only be performed at preventative maintenance inspection 
conducted by the manufacturer). Additionally, a commenter suggested 
that a reasonable positioning accuracy was 2 millimeters for an HDR 
stepping source and 5 millimeters for an LDR source (reference AAPM TG-
59). A commenter also requested that the NRC clarify that tests for 
tubes and connectors apply to tubes and connectors in use, and that no 
tests are required if the unit is not in use.
    Response. Various professional reports provide suggested protocols 
for quality assurance tests on remote afterloaders. The NRC based the 
performance objectives for various tests in this section on 
recommendations made by AAPM TG-56. For instance, AAPM TG-56 suggests 1 
millimeter positional accuracy for HDR, LDR, and PDR units; initial, 
annual, and quarterly battery backup checks; timer accuracy tests for 
LDR units; and autoradiograph of LDR sources. We agree with the 
recommendations made in AAPM reports and believe that the calibration 
requirements in this section are warranted to ensure that the correct 
dose is administered to the patient.
    The terminology used in this section was chosen to reflect the 
current language used in practice. AAPM reports use ``timer accuracy 
and linearity, applicators, transfer tubes, and transfer tube-
applicator interfaces.'' We noted small discrepancies in the 
terminology used in the proposed requirements versus in AAPM reports. 
Therefore, we revised the term ``source guide tube'' to ``source 
transfer tube'' and the term ``connector'' to ``transfer tube-
applicator interface'' in the final rule. The tests apply only to units 
and accessories in use.
Issue 3: How Frequently Should Recalibrations Be Performed?
    Comment. A commenter stated that a full calibration is always 
performed immediately after the source exchange. However, it is 
probable that the source exchange for an iridium-192 HDR source may 
take more than 120 days. The commenter suggested that a full 
calibration on the source after 120 days was not necessary if the 
source was not yet exchanged for a new source. Another commenter agreed 
with the proposed requirement that HDR units should be calibrated 
within 120 days and that LDR units should be calibrated annually, 
within 1 year. A commenter also requested clarification of the phrase 
``not exceeding one quarter.''
    Response. The NRC believes that, for iridium-192 (Ir-192) HDR 
sources, the source calibration frequency can be changed to ``at source 
exchange'' to allow for source exchanges that slightly exceed the 120-
day period. Therefore, the frequency for full recalibration of HDR, 
MDR, and PDR units has been revised to quarterly for sources whose 
half-lives exceed 75 days. We believe that this revision will 
facilitate the use of sources with short half-lives. We also believe 
that this revision will not reduce safe use of sources whose half-lives 
are less than 75 days (e.g., Ir-192), because these sources are 
exchanged at the end of their useful life, which is approximately 
quarterly for Ir-192. The requirement to perform a full calibration at 
source exchange has been retained. The phrase ``not exceeding one 
quarter'' can be equated to a 3-month period.
Issue 4: Who Is Required To Perform the Decay Corrections for Source 
Output?
    Comment. A commenter requested that dosimetrists be allowed to 
perform decay corrections.
    Response. The AMP remains responsible for performing decay 
corrections because of the high consequence associated with errors in 
these corrections.
Issue 5: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC deleted the requirement to repeat the full 
calibration of the remote afterloader unit and source, whenever spot-
check measurements indicate that the output differs by more than 5 
percent from the output obtained at the last full calibration. We 
deleted this requirement because the requirement to perform output 
spot-checks on remote afterloader units was deleted from Sec. 35.643.
    We also revised Sec. 35.633(b) to include patient dose delivery 
components for LDR units that are detailed in AAPM TG-56. Specifically, 
the requirements in paragraphs (b)(4), (b)(5), (b)(6), and (b)(7) were 
moved in the final rule so that they apply to all remote afterloaders, 
including LDRs. The items in these paragraphs are measurement of the 
length of the source transfer tubes and applicators; measurement of the 
timer accuracy and linearity over the typical range of use; and 
function tests of the source transfer tubes, applicators, and transfer 
tube-applicator interfaces. We believe that these changes are necessary 
to ensure that, during acceptance testing of the units, including LDR 
units, and after source replacement, these additional tests that 
increase patient radiation safety are performed.

Section 35.635, Full Calibration Measurements on Gamma Stereotactic 
Radiosurgery Units

Issue 1: What Is the Meaning of the Term ``Calibrate'' When Referring 
to Timer Accuracy and Linearity?
    Comment. Commenters requested the meaning of ``calibrate'' when 
referencing timer accuracy and linearity. The commenters suggested 
that, if the purpose is to measure these items to assure they are 
within some tolerance, this purpose should be stated in the regulation.
    Response. The terminology used in this section reflects the current 
language used in practice. AAPM reports use ``timer accuracy and 
linearity.'' As

[[Page 20317]]

stated in this regulation, calibrations must be performed in accordance 
with published protocols accepted by nationally recognized bodies. The 
term calibrate, as used in this context, means to perform measurements 
to assure that the timer is operating appropriately within a given 
tolerance. The tolerances may be found in reports such as AAPM TG-40. 
Therefore, the licensee is given flexibility in developing its 
calibration methods.
Issue 2: Can the Licensee Adopt the Manufacturer's Measurements for 
Relative Helmet Factors?
    Comment. A commenter suggested that many users currently adopt the 
manufacturer's recommended relative helmet factors rather than measure 
them directly. The commenter stated that this was preferable because: 
(1) There are inherent difficulties in measuring these factors; (2) 
requiring users to measure their own factors could result in large 
errors in some situations; and (3) using the manufacturer's factors 
aids in sharing information among facilities conducting research 
protocols.
    Response. The NRC believes that measurement of helmet factors is 
inherent in patient dosimetry. Various professional reports provide 
suggested protocols for quality assurance tests on gamma stereotactic 
radiosurgery units. The performance objectives for various tests in 
this section are based on recommendations in AAPM Report No. 54. For 
example, AAPM Report No. 54 recommends that helmet factors be measured 
by the end user. However, in the final rule we changed the proposed 
requirement for annual measurements of relative helmet factors to 
require only measurements before the first medical use of the helmet 
and following any damage to the helmet.
Issue 3: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC added the components related to the delivery 
of the dose to the patient that are in Sec. 35.645, Periodic spot-
checks for gamma stereotactic radiosurgery, because all patient dose 
delivery components detailed in the periodic spot-check section, 
Sec. 35.645, were not included in the proposed full calibration 
requirements, and, therefore, were not required during initial quality 
assurance testing on the unit or after source replacement. The new 
paragraphs (b)(7) through (b)(10) in the final rule include tests of 
the treatment table retraction mechanism, helmet microswitches, 
emergency timing circuits, and stereotactic frames and localizing 
devices (trunnions). We believe that these changes are necessary to 
ensure that these additional tests involving patient radiation safety 
are performed during acceptance testing of the unit and after source 
replacement. These additions are consistent with the approach used in 
the teletherapy unit requirements for full calibration and spot-checks.

Section 35.642, Periodic Spot-Checks for Teletherapy Units

Issue 1: What Is the Meaning of the Term ``Calibrate'' When Referring 
to Timer Accuracy and Linearity?
    Comment. Commenters requested the meaning of ``calibrate'' when 
referencing timer accuracy and linearity. The commenters suggested 
that, if the purpose is to measure these items to assure they are 
within some tolerance, this purpose should be stated in the regulation.
    Response. Procedures for calibrating the timer are provided in 
various protocols, which include tolerances. Examples include ANSI N449 
and N449-1, and AAPM TG-40. The term calibrate, as used in this 
context, means to perform measurements to assure that the timer is 
operating appropriately within a given tolerance. The tolerances may be 
found in reports such as AAPM TG-40. As stated in this regulation, the 
measurements must be performed in accordance with procedures 
established by the AMP. The licensee is therefore given flexibility in 
developing its spot-check methods.
Issue 2: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. Paragraph (f) was revised to add a reference to the 
procedures required by paragraph (b).

Section 35.643, Periodic Spot-Checks for Remote Afterloader Units

Issue 1: Is an Output Spot-Check Necessary?
    Comment. Commenters requested deletion of the output spot-check 
because output is calibrated at installation and by the manufacturer, 
thereby satisfying all the requirements for assuring correct dosimetry 
and administration. A commenter also suggested that a requirement to 
determine the output with a dosimetry system described in 
Sec. 35.630(b) be included.
    Response. The NRC agrees that the full calibration output 
measurements are adequate. Therefore, we have deleted the proposed 
output spot-check requirement. We believe that a quarterly test for 
HDR, MDR, and PDR source output and an annual test of LDR source output 
are sufficient to ensure that the correct dose is delivered to the 
patient. In the place of the output check, we have included a 
requirement to check the computer decayed source activity against a 
precalculated decay chart to confirm that the unit has decayed the 
source activity properly. The output checks done in accordance with 
Sec. 35.633 continue to require the use of an appropriate dosimetry 
system, described in Sec. 35.630, when performing the output 
calibration.
Issue 2: How Frequently Should Spot-Checks Be Performed?
    Comment. Some commenters suggested that the spot-checks be done 
each day of use, thereby insuring patient safety and not duplicating 
weekly checks. A commenter requested that the term ``beginning of each 
day of use'' be revised to ``prior to the use of the device on a given 
day.'' Another commenter suggested that the frequencies provided in 
NUREG/CR-6276, ``Quality Management in Remote Afterloading 
Brachytherapy'', should be used. With regard to timer constancy, a 
commenter felt that a monthly check was adequate for LDR units.
    Response. The regulation has been amended to state ``before the 
first use of an HDR, MDR, or PDR unit on a given day.'' The NRC 
developed the frequency of the spot-checks from recommendations of AAPM 
TG-40 and TG-56, meetings with medical physicists, input from the 
Therapy Subcommittee of the ACMUI, and NUREG/CR-6276. Therefore, we 
believe that the frequencies of the spot-checks are appropriate.
Issue 3: What Is the Meaning of the Term ``Calibrate'' When Referring 
to Timer Constancy/Accuracy and Linearity?
    Comment. A commenter requested that timer constancy be deleted 
because it is not a credible source of risk to the patient with the 
current timer technology. The commenter stated that this is verified at 
installation and needs no further monitoring. Commenters also requested 
the meaning of ``calibrate'' when referencing timer accuracy and 
linearity. The commenters suggested that, if the purpose is to measure 
these items to assure they are within some tolerance, this purpose 
should be stated in the regulation.
    Response. The terminology used in this section was chosen to 
reflect the current language used in practice. AAPM reports use the 
terminology ``timer accuracy and linearity.'' The

[[Page 20318]]

term calibrate, as used in this context, means to perform measurements 
to assure that the timer is operating appropriately within a given 
tolerance. The tolerances may be found in reports such as AAPM TG-40. 
As stated in this regulation, the measurements must be performed in 
accordance with procedures established by the AMP. The licensee is 
given flexibility in developing its spot-check methods. The NRC has 
also retained timer checks because they are recommended by the AAPM and 
are similar to ANSI requirements for teletherapy units. Spot-checks of 
timer linearity are not required by this section because we believe 
that timer linearity for remote afterloaders needs only to be measured 
during full calibration measurements.
Issue 4: Why Must Nonexistent Source Exposure Indicator Lights Be 
Checked?
    Comment. A commenter suggested that checks of source exposure 
indicator lights be deleted because these lights do not exist on a 
remote afterloader unit.
    Response. The NRC is unaware of any remote afterloader units that 
do not have source exposure indicator lights. Source position indicator 
light checks are recommended by the AAPM and are similar to ANSI 
requirements for teletherapy units. Therefore, these requirements have 
been retained in the final rule.
Issue 5: Is It Necessary To Perform a Simulated Cycle of Treatment?
    Comment. A commenter suggested that the requirement to conduct a 
simulated cycle of treatment should be deleted because it is vague and 
will not necessarily provide any higher level of assurance that the 
remote afterloader unit is working properly than the daily and monthly 
checks already performed.
    Response. The NRC agrees with this comment and has deleted this 
requirement.
Issue 6: Does a Treatment System Have To Be Locked-Out if the System 
Fails Safety Tests, But a Backup System Is Available?
    Comment. A commenter suggested that the NRC change the wording in 
this section to be more flexible. The commenter stated that, in some 
instances, a backup device may be available that will allow patient 
treatments to continue without compromising patient safety.
    Response. This section does not prohibit the use of the unit if the 
licensee replaces the malfunctioning system before using the unit for 
treatment. Additionally, the requirement to arrange for prompt repair 
of a system has been deleted from this section. The NRC believes that 
the requirement to lock the control console in the off position and not 
use the unit until repaired is sufficient.
Issue 7: Should Door Interlocks and Audiovisual Systems Apply to LDR 
Units?
    Comment. The NRC solicited specific comment as to whether the 
requirements for electrical interlocks and audiovisual systems should 
apply to low dose-rate remote afterloader units. Some commenters felt 
that LDR units may not require interlocks or audiovisual systems, 
depending on the dose rate and whether sources are gamma-emitters only. 
One commenter suggested that we always require interlocks, but require 
an audiovisual system only when direct visual contact is not available. 
Another commenter felt that we should always require interlocks and an 
audiovisual system for LDR units.
    Response. The NRC amended the title of this subpart to clarify that 
it only applies to photon-emitting units. We have retained the 
requirements for interlocks for LDR units because they are consistent 
with recommendations in AAPM reports. We have not included a 
requirement for an audiovisual system for an LDR.
Issue 8: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. Paragraph (f) was revised to add a reference to the 
procedures required by paragraph (b).

Section 35.645, Periodic Spot-checks for Gamma Stereotactic 
Radiosurgery Units

Issue 1: How Frequently Should Spot-Checks Be Performed?
    Comment. A commenter suggested that the requirement for monthly 
checks be deleted if spot-checks are performed daily. A commenter 
specified that the term ``beginning of each day of use'' be revised to 
``prior to the use of the device on a given day.'' Another commenter 
suggested that the frequencies provided in NUREG/CR-6324 should be 
used. Other commenters said that: (1) A daily output measurement was 
not necessary as long as the user checks the mechanical integrity of 
the system through a standard run; and (2) the manufacturer recommends 
that the battery backup system only be tested on a monthly basis.
    Response. The regulation has been amended to state ``before first 
use of the unit on a given day.'' The NRC developed the frequency of 
the spot-checks from recommendations of AAPM Report No. 54, meetings 
with medical physicists, input from the Therapy Subcommittee of the 
ACMUI, and NUREG/CR-6324, ``Quality Assurance for Gamma Knives.'' We 
believe that the final rule distinguishes between the checks that must 
be done daily or monthly. Additionally, the final rule only requires 
output checks and battery backup checks monthly. Therefore, we believe 
that the frequencies of the spot-checks are appropriate.
Issue 2: Define ``Assure Proper Operation of Stereotactic Frames and 
Localizing Devices?''
    Comment. A commenter requested that we clarify what is meant by 
``assure proper operation of stereotactic frames and localizing 
devices.''
    Response. Various professional reports provide suggested protocols 
for quality assurance tests on gamma stereotactic radiosurgery units. 
For instance, reports from AAPM, ACR, ACMP, and ANSI may be used by the 
licensee in performance of these tests. The phrase ``assure proper 
operation of stereotactic frames and localizing devices'' means to 
perform quality assurance tests on these devices to assure that they 
operate appropriately when used to deliver a dose to a patient. The 
measurements must be performed in accordance with procedures 
established by the AMP. The licensee is, therefore, given flexibility 
in developing its spot-check methods.
Issue 3: What Is the Meaning of the Term ``Calibrate'' When Referring 
to Timer Accuracy and Linearity?
    Comment. Commenters requested the meaning of ``calibrate'' when 
referencing timer accuracy and linearity. The commenters suggested 
that, if the purpose is to measure these items to assure they are 
within some tolerance, this purpose should be stated in the regulation.
    Response. The terminology used in this section reflects the current 
language used in practice. AAPM reports use ``timer accuracy and 
linearity.'' The term calibrate, as used in this context, means to 
perform measurements to assure that the timer is operating 
appropriately within a given tolerance. The tolerances may be found in 
reports such as AAPM TG-40 The measurements must be performed in 
accordance with procedures established by the AMP. Therefore, the 
licensee is given flexibility in developing its spot-check methods.

[[Page 20319]]

Issue 4: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC deleted the requirement to check the 
hydraulic cutoff mechanism because we believe that checking the 
hydraulic backup system monthly is sufficient.
    We revised the regulatory text to make the spot-checks, and 
associated corrective actions, consistent with the requirements in 
Secs. 35.642 and 35.643. Paragraph (b)(1) requires that licensees 
perform spot-checks in accordance with written procedures established 
by the AMP. Paragraph (b)(2) requires that the AMP review the results 
of the spot-checks within 15 days and notify the licensee as soon as 
possible in writing of the results of the spot-checks.
    Paragraph (g) was revised to add a reference to the procedures 
required by paragraph (b).

Section 35.647, Additional Technical Requirements for Mobile Remote 
Afterloader Units

Issue 1: What Are the Requirements for Discontinuing Use of a 
Malfunctioning Unit?
    Comment. A commenter noted that this section did not contain a 
requirement for discontinuation of use of a malfunctioning unit and 
questioned whether this was an oversight.
    Response. The NRC agrees with this comment. We believe that a 
licensee using a mobile unit must also meet the requirements described 
in other sections of this subpart applicable to the particular device 
in use. However, for clarification, we added language that prohibits 
the use of the unit if a safety check is failed. Paragraph (d) now 
reads: ``If the results of the checks required in paragraph (b) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning 
system.''
Issue 2: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. Consistent with the terminology used in Sec. 35.633, 
``connectors'' was revised to ``source transfer tubes, and transfer 
tube-applicator interfaces.''

Section 35.652, Radiation Surveys

Issue 1: Are These Surveys Limited to Therapy Units?
    Comment. A commenter questioned whether the surveys required by 
this section were only for therapy devices or if they included other 
instruments or devices used at medical facilities.
    Response. The requirements of Part 35 apply only to medical uses of 
byproduct material. The requirements in this section apply to licenses 
issued for uses in this subpart. Therefore, these requirements do not 
include sealed sources covered by other subparts (e.g., Subparts F and 
G). The NRC added the phrase ``licensed under this subpart'' to this 
section to clarify this issue.
Issue 2: Why Do Radiation Levels Around Devices Differ?
    Comment. Commenters suggested that the maximum radiation levels and 
average radiation levels around devices could be made a generic number, 
as with radiography cameras and source changers. They also suggested 
that it may make sense to put in the average acceptable reading for 
each type of afterloader unit (i.e., high dose-rate, low dose-rate, and 
pulsed dose-rate units).
    Response. The radiation levels referenced in the SSDR differ 
greatly by device manufacturer. Therefore, the NRC retained the 
requirement in paragraph (a) of this section ``to ensure that the 
maximum radiation levels and average radiation levels from the surface 
of the main source safe with the source(s) in the shielded position do 
not exceed the levels stated in the Sealed Source and Device 
Registry.''

Section 35.657, Therapy-Related Computer Systems

Issue 1: What Is the Purpose of Acceptance Testing on Computer 
Operating Systems?
    Comment. Commenters felt that acceptance testing of computer 
operating systems should be deleted because no method could guarantee 
that software would always operate appropriately. A commenter also said 
that this requirement should be deleted because it appears to be a year 
2000 concern with operating systems.
    Response. The NRC agrees with these concerns and has deleted the 
requirement to verify operability of computerized operating systems. 
This concern is addressed by the FDA's regulations of medical devices, 
which require reliability testing on computerized operating systems.
Issue 2: Should Acceptance Testing of Treatment Planning Systems Be a 
Requirement?
    Comment. Commenters believed that the requirement for treatment 
planning system acceptance testing was warranted. However, they 
suggested that the methodology for acceptance testing should be left to 
the licensee. The commenters also questioned the ability to guarantee 
that the systems are operating appropriately and questioned our 
interest in the device operating system that is reviewed by the FDA.
    Response. Paragraph (a) of this section in the proposed rule would 
have required the licensee to verify that the computerized operating 
system and treatment planning system are operating appropriately. Based 
on these comments, FDA's review of reliability testing on medical 
devices, and the device's associated computer operating systems, the 
NRC deleted these requirements from the final rule.
    We agree with commenters that treatment planning system acceptance 
testing is warranted. Therefore, the requirement to perform acceptance 
testing on treatment planning systems has been retained. We believe 
that this requirement is appropriate and still provides the licensee 
flexibility in designing its acceptance testing program. We amended the 
regulation to incorporate the components of acceptance testing 
addressed in AAPM TG-56. The licensee is provided flexibility in 
performing acceptance testing of treatment planning systems as long as 
a published protocol accepted by a nationally recognized body is used 
and as long as the minimum testing requirements are met.

Section 35.690, Training for use of Remote Afterloader Units, 
Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rules?
    Response.Yes. The NRC revised paragraph (b)(3) to read ``an 
authorized user of each type of therapeutic unit for which the 
individual is requesting authorized user status.'' This change 
clarifies that the preceptor authorized user must certify that the 
individual has achieved a level of competency sufficient to function 
independently as an authorized user for each type of unit for which the 
individual would like authorized user status. However, this does not 
mean that the individual has to satisfy paragraphs (b)(1) and (b)(2) in 
their entirety for each type of unit, e.g., an individual does not need 
1400 hours in a structured educational program if he or she wants to be 
an AU for two types of units under Sec. 35.690.
    In paragraph (b)(3) we also clarified that the preceptor AU must be 
an AU for each type of unit for which he or she is a preceptor.

[[Page 20320]]

    General comments on this section are summarized under the General 
Training topic found at the beginning of this section.

Subpart J--Training and Experience Requirements

Issue 1: Why are There Two Sets of Training and Experience Requirements 
in the Revised Part 35?
    Comment. One commenter noted that much of Subpart J is redundant 
with, but not identical to, the training and experience requirements 
listed in the individual sections of the other subparts. The training 
and experience requirements should be identical if they are included in 
2 subparts within the same part, or they should only be listed once in 
the part.
    Response. The NRC believes that Subpart J should be retained for a 
2-year transition period as stated in the proposed rule (63 FR 43516; 
August 13, 1998). The issue of recognition of medical and other 
specialty boards was discussed during an ACMUI briefing of the 
Commission on February 19, 2002. In that meeting, two committee members 
expressed concern that some boards did not qualify for recognition and 
may not be ready to apply for recognition within 6 months after 
publication of the final rule. Therefore, implementation of the new 
Part 35, without Subpart J, could disrupt the current license 
authorization process for new medical personnel because many license 
authorizations are granted based on recognition of board certification. 
The Commission has considered this matter, and decided to retain the 
current training requirements in Subpart J for a 2-year period after 
the effective date of the final rule. As stated in Section IX, 
Implementation, during that 2-year period, licensees will have the 
option of complying with either the requirements of Subpart J or the 
requirements in Subparts B and D-H. During this transition period, the 
NRC will continue working with the ACMUI and the medical community to 
resolve any concerns with the training and experience requirements.
    The Commission will consider changes to the training and experience 
requirements, as appropriate.
    Individuals who have status as AUs, AMPs, ANPs, and RSOs at the 
time the rule becomes effective will be ``grandfathered'' under 
Sec. 35.57, and will not have to satisfy the new training and 
experience requirements. For additional information on the ``deemed 
status'' of individuals when the final rule becomes effective refer to 
the general discussion of the training and experience requirements at 
the beginning of this section.
Issue 2: Why Were the Lists of Certifying Medical Boards in Subpart J 
of the Current Part 35 Not Updated During the Rulemaking to Include 
Other Medical Specialty Boards and Other Subspecialties?
    Comment. Several commenters noted that there are other medical 
specialty boards and other subspecialties that should be added to the 
lists of certifying boards in Subpart J.
    Response. The suggested updates were not made in the final rule 
because Subpart J will be retained for 2 years after the effective date 
of the final rule and there are no lists of certifying specialty boards 
in the new training and experience requirements in Subparts B and D 
through H of Part 35. Under the new regulations, the NRC will continue 
to review the appropriate training and experience requirements of the 
boards and recognize the boards that satisfy these requirements. 
However, we will provide the lists of recognized boards in a public 
document (e.g., on NRC's Internet site www.nrc.gov>), rather than in 
the regulations. Before the effective date of the final rule, we 
encourage the certifying boards to submit their applications for 
recognition under the new regulations. However, the licensees will have 
2 years after the effective date of the final rule to comply with the 
new requirements. For additional information on the recognition of 
specialty boards refer to the general discussion of the training and 
experience requirements at the beginning of this section.
Issue 3: Why Have the References to ACGME programs been retained in 
Subpart J?
    Comment. Several commenters said that all references to ACGME 
programs of less than 2 years should be deleted.
    Response. The NRC deleted the references to ACGME programs of less 
than 2 years.
Issue 4: Why Are There No Training Requirements for Endovascular 
Brachytherapy in Subpart J?
    Comment. One commenter noted that Subpart J includes no training 
requirements for endovascular brachytherapy.
    Response. The NRC will delete Subpart J 2 years after the effective 
date of the final rule. When the research on endovascular brachytherapy 
is completed, the standard protocol for this technology will be 
evaluated to determine if it is similar to the modalities currently 
licensed under Part 35 or if it should be licensed as an emerging 
technology under Sec. 35.1000. Following this determination, the 
training and experience requirements for this modality will be 
evaluated to see if new requirements are needed for this use or if it 
should continue to be regulated as a sealed source therapy.

Section 35.981, Training for Experienced Nuclear Pharmacists

Issue 1: What is the Impact of Deleting This Section?
    Comment. All of the commenters that responded to this question, 
which the NRC asked in the proposed rule, said that this section could 
be deleted because the requirements in Sec. 35.57 for an experienced 
nuclear pharmacist are adequate.
    Response. This section will be deleted, along with the other 
sections of Subpart J, 2 years after the effective date of the final 
rule.

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

Section 35.1000, Other Medical Uses of Byproduct Material or Radiation 
From Byproduct Material

Issue 1: What Is the Purpose and Scope of This Section?
    Comment. There were a number of general comments on this section. 
Comments ranged from an endorsement of the need for this section to 
concerns that NRC's regulations for emerging technologies will limit 
the use of new technologies and radiopharmaceuticals and, consequently, 
affect the delivery of high quality health care.
    Some commenters believed that the purpose of this section is vague, 
undefined, and confusing, and that there needs to be a clearer 
definition of an emerging technology. One suggestion was that the 
definition be tied to whether an IND/IRB approval is required. Another 
commenter said that this section should specifically exempt 
radiopharmaceuticals because they are regulated by the FDA under RDRC, 
new drug applications (NDA), biologic product license applications 
(PLA), and INDs. Thus, all radiopharmaceuticals should fit under 
Subpart D or E.
    One commenter said that emerging technology uses should be reviewed 
on a case-by-case basis to determine their proper location in the 
regulations. The commenter proposed a process to determine how an 
emerging technology should be regulated: propose performance-based 
regulations for a 90-day comment period; locate the regulations in a 
separate subpart; and

[[Page 20321]]

establish that any technology placed in this subpart would have a 5-7 
year sunset period at which time the regulations for this technology 
would be relocated in another appropriate subpart. This process would 
provide the opportunity for the technology to establish itself and 
allow the regulations to be amended, based on observed risk.
    Response. The NRC added Subpart K to Part 35 so that there would be 
codified regulatory requirements and a more clearly defined process to 
obtain a license, or a license amendment, for a new medical use of 
byproduct material or radiation from byproduct material, i.e., an 
emerging technology. By adding requirements for emerging technologies 
to the regulations in Secs. 35.12(d) and 35.1000, an applicant for a 
medical use that does not fit the regulatory requirements for another 
subpart knows the type of information to submit to NRC.
    The scope of this subpart includes all new medical uses of 
byproduct material or radiation from byproduct material. We have not 
attempted to define what is included in this subpart or what is 
excluded from this subpart more clearly because there is no way to 
predict what types of medical technologies will be developed in the 
future. The Commission, with input from the ACMUI, as requested, will 
determine if the emerging technology is truly a new technology and is 
covered by Subpart K, or if the ``new'' technology is actually a type 
of use regulated under Subparts D through H.
Issue 2: What Process Will Be Used to Establish Regulatory Requirements 
and Evaluate Applications for Emerging Technologies?
    Comment. Commenters stated that it is important to have a 
reasonable regulatory scheme and time frame for approving applications 
for new technologies. Some commenters expressed concerns about placing 
so much regulatory burden (e.g., too many safety constraints) on new 
technologies that there is an impact on the development of new 
products.
    Emerging technologies have an undefined risk. Once the risk becomes 
clear, the degree of regulation that is needed to minimize the risks to 
the public can be defined. The NRC might be interested in the design of 
trials involving emerging technologies, and what kind of data are 
collected, in order to define the risks from emerging technologies.
    A model was suggested for establishing the requirements for 
emerging technologies. Under the suggested model, appropriate 
professional societies would establish task forces to examine the 
issues (e.g., the training requirements) associated with the emerging 
technology. This model was successful in defining the standards for 
gamma stereotactic radiosurgery in the late 1980's when it was 
considered an emerging technology.
    Response. The NRC agrees with these comments and will take them 
into consideration in setting up the process for establishing 
regulatory requirements and for approving applications for emerging 
technologies. We intend to evaluate each technology on a case-by-case 
basis and to work with the ACMUI, the medical community, the public, 
and the developers of the new technology, as appropriate, to determine 
the specific risks associated with the technology and any additional 
regulatory requirements for the medical use of the technology.
Issue 3. Will the NRC Coordinate its Regulations for Emerging 
Technologies With the FDA's Regulations?
    Comment. One commenter has observed that the FDA process works well 
in addressing patient safety for investigational new drugs and devices. 
This commenter suggested that the NRC communicate its concerns to the 
FDA to assure that any radiation safety issues will be included and 
documented in the investigational research process.
    Response. The NRC does not intend to develop requirements that are 
redundant with those of the FDA. FDA and NRC have different authorities 
and responsibilities for protection of public health and safety; FDA 
has the authority to approve investigational new drugs and devices; and 
NRC has the authority to protect the public, workers, and patients from 
the medical use of byproduct material. However, we have a ``Memorandum 
of Understanding'' with FDA under which we coordinate certain agency 
functions and share information (58 FR 47300; September 8, 1993 and 62 
FR 15740; April 2, 1997, renewal).
Issue 4: Why Does This Section Not Include Training and Experience 
Requirements for AUs of Emerging Technologies?
    Comment. Several commenters said that this section should provide 
the minimum criteria and training requirements for AUs of these new 
medical uses. The qualifications of individuals to use emerging 
technologies are pretty well established by the developers of the 
emerging technology, and they are aware of the radiation safety 
problems associated with the new technology. Whether it is an emerging 
technology or not, there is a need to understand the properties and 
hazards of the radioactive material being used, the radiobiological 
issues, and the measures to be taken in the event of a spill, and to 
demonstrate the ability to safely handle the radioactive material.
    Response. Section 35.1000 does not include any training and 
experience requirements for AUs of emerging technologies because there 
is no way of knowing what training requirements will be necessary for 
the safe use of byproduct material in new technologies. Applicants are 
required by Sec. 35.12(b) to provide the training and experience for 
the AU, ANP, or AMP, as appropriate, to the NRC. The training and 
experience will be evaluated on a case-by-case basis with input from 
the ACMUI and individuals who have been involved with development of 
the technology, as needed, and other input, as appropriate.
Issue 5: Will Cost Issues Be Considered During the Development of 
Requirements for Emerging Technologies?
    Comment. Comments were provided on several different cost issues. 
One commenter said that it is very difficult to spend millions of 
dollars on clinical research on new technologies and have no idea what 
the regulatory requirements are going to be. Another commenter said 
that cost effectiveness needs to be considered during the development 
of requirements for new technologies. For example, a requirement to 
have multiple professionals present during a procedure would not only 
increase the cost of the procedure, but would also limit its 
availability to patients.
    Response. Licensing requirements for emerging technologies will be 
based on the risk posed by the specific modality and when possible 
licensing requirements will be modeled on other medical uses with 
similar risk. In order for new or revised requirements to be codified 
in Part 35, a public rulemaking process under the Administrative 
Procedure Act must be followed including the development of a cost-
benefit analysis made available for public comment.
Issue 6: Will Intravascular Brachytherapy Be Considered an Emerging 
Technology in the Revised Part 35?
    Comment. Some commenters believe that intravascular brachytherapy 
is still experimental and covered by Sec. 35.6 and need not be 
considered in Sec. 35.1000. Other commenters believe that intravascular 
brachytherapy should be categorized, or specifically mentioned, as an 
emerging technology under the provisions described in Sec. 35.1000.

[[Page 20322]]

    One commenter stated that in the proposed rule the standard use of 
radioisotopes in patients in the field of cardiology was reclassified 
as experimental and cardiologists had become radiation oncologists.
    Response. Section 35.6 contains some specific provisions for 
protection of human research subjects and does not permit the use of 
byproduct material for medical uses that are not authorized on the 
licensee's medical use license. Intravascular brachytherapy is a very 
complex field with a number of methodologies and radionuclides being 
evaluated for use. Currently, the NRC is regulating intravascular 
brachytherapy as a sealed source therapy. Because no single standard 
protocol for intravascular brachytherapy has been established, the 
Commission, with input from the ACMUI, the medical community, and the 
public, will review the technology in light of that protocol to 
determine if new regulatory requirements are needed for this use. 
Pending development of those regulatory requirements, an applicant will 
be able to submit a license application or amendment request, under the 
provisions of Secs. 35.12 and 35.1000, to incorporate the new modality 
into their licensed program.
Issue 7. What Are the Training and Experience and Radiation Safety 
Requirements for Intravascular Brachytherapy?
    Comment. Some commenters felt that intravascular brachytherapy 
should have the same training and radiation safety requirements as the 
rest of radiation oncology. Other commenters felt that the training and 
radiation safety requirements for nuclear cardiology should be reserved 
until the technology advances enough to develop standard protocols with 
the assistance of a group of experts. Still other commenters stated 
that the NRC should develop the training and safety requirements for 
intravascular brachytherapy.
    Response. As we noted in Issue 6, intravascular brachytherapy is 
currently an evolving medical treatment composed of diverse 
technologies. Currently, the NRC is regulating intravascular 
brachytherapy as a sealed source therapy with the associated training 
and experience requirements for that therapy. The types of sources used 
vary widely in terms of the type of radiation emitted, the activity, 
and the level of encapsulation. In fact, intravascular brachytherapy 
may not evolve into either a standard protocol or a single modality. 
Pending receipt of additional information, we believe that it is too 
early to make changes in the level of training and experience for the 
use of intravascular brachytherapy.
Issue 8: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response: Yes. The NRC corrected the wording in paragraph (a) to 
state that the information that is required to be submitted by an 
applicant for use of byproduct material under Sec. 35.1000 is in 
Sec. 35.12(b) through (d), not only in paragraphs (b) and (c).
    We amended the wording in paragraph (b) to reflect a change in 
Sec. 35.12(d) that allows licensees to submit an application for a 
license amendment, rather than an application for a separate license, 
for use of byproduct material under Sec. 35.1000. This change is 
discussed under Sec. 35.12.

Subpart L--Records

Issue 1: Should All the Recordkeeping Requirements Be Grouped Into One 
Subpart or Should They be Incorporated Into the Section Requiring the 
Record?
    Comment. Commenters provided a wide range of responses to the 
Commission's question on whether all of the recordkeeping requirements 
should be grouped into one subpart, or whether they should be 
incorporated into the individual sections requiring the records. Some 
commenters favored having all of the recordkeeping requirements in one 
subpart because this format provides for easy reference, simplifies 
licensing, assists licensees in meeting their obligations for the 
radiation safety program, and simplifies compliance. Other commenters 
favored having the recordkeeping requirements in the individual 
sections because this format would place all of the requirements 
pertaining to a particular area of interest in one section. Therefore, 
licensees would know exactly what was expected of them in a particular 
area. They also find the similar separation in 10 CFR Part 20 to be 
confusing. Several commenters preferred a ``balanced approach'' in 
which the recordkeeping requirements would be in the individual 
sections and then all of the requirements would be summarized in a 
separate subpart.
    Response. After reviewing all of the responses to this question, 
the NRC concluded that having all of the recordkeeping requirements in 
one subpart makes it easier for licensees to reference these 
requirements. However, the final rule is consistent with the ``balanced 
approach'' because each section in the final rule that is associated 
with a recordkeeping requirement includes a cross-reference to the 
specific recordkeeping requirements in Subpart L.
Issue 2: Are All of the Recordkeeping Requirements in Part 35 Needed?
    Comment. Comments on the need for the recordkeeping requirements in 
Part 35 ranged from all of the records are needed; to the only records 
that are needed are those that document overexposures, exceeding 
environmental limits, and leaking sources; to the only records that 
should be required are those that have a documented history of 
improving radiation safety; to none of the records are needed.
    Response. During preparation of the final rule, each specific 
recordkeeping requirement was reviewed in light of these comments and 
changes were made, where appropriate. These changes are noted in the 
discussions of the individual recordkeeping sections.
Issue 3: Are the Recordkeeping Requirements too Prescriptive?
    Comment. The recordkeeping requirements in the proposed revision 
maintain the detailed, prescriptive elements that are in the current 
Part 35.
    Response. All of the elements in the recordkeeping requirements in 
the proposed rule were considered important for documenting radiation 
safety issues associated with a more risk-informed regulation. During 
preparation of the final rule, the NRC reviewed each recordkeeping 
requirement in light of this comment and made appropriate changes.
Issue 4: Why Are There Different Retention Periods for the Records 
Required by This Subpart?
    Comment. One commenter said that compliance with NRC's 
recordkeeping requirements would be simplified if all of the record 
retention periods were the same. Another commenter suggested that 
because most of the records have a retention period of 3 years, it 
would make more sense to include a separate section that states that 
all of the records in this subpart are to be maintained for 3 years, 
unless otherwise stated, than to restate the retention period in each 
section.
    Response. The record retention periods in Part 35 were set 
according to either the safety significance of the action being 
recorded or the inspection frequency. As a result, there are several 
different retention periods for records in Subpart L. Because record 
retention periods are tied to safety considerations, the NRC believes 
that the regulations should specifically state the retention period for 
each recordkeeping

[[Page 20323]]

requirement even if it means repeating regulatory text.
Issue 5: How Can a Patient's Privacy and Confidentiality be Protected 
in Records Required by NRC?
    Comment. A comment received stated that the patient's privacy and 
confidentiality are ``ignored'' with NRC recordkeeping requirements for 
records of the patient's name, social security number, and other 
personal information.
    Response. Any records that must include the patient's name or 
personal information relating to the patient are to be retained by the 
licensee. Reports relating to medical events, which licensees provide 
to the NRC, explicitly must not contain the individual's name or any 
other information that could lead to identification of the individual.
Issue 6: Can Initials Be Used on a Record To Identify the Individual 
Who Performs an Activity or an Operation?
    Comment. The requirement to record the ``name of the individual'' 
that performed a certain activity appears throughout this subpart. 
Several commenters said that because it is common practice to utilize 
initials as identifiers of individuals, the words ``name of the 
individual'' should be replaced with ``identification of the 
individual.''
    Response. The NRC requires that the full name of an individual 
appear on a record to better ensure future identification of the 
individual who performed the activity or operation. It is not uncommon 
for several individuals to have different names, but the same initials. 
Also, initials are more likely to be illegibly scribbled.
Issue 7: Why Do Some Records Require a Signature, Rather Than the Name 
of the Individual?
    Comment. Several commenters said that requiring a signature on a 
record is prescriptive, not performance based, and does not necessarily 
mean that an individual has actually read or reviewed a record.
    Response. The NRC has required signatures only on those records 
where we feel it is important to the radiation safety program to 
document who approved the action, reviewed the report, performed the 
calibration, etc. If an individual signs a record saying, for example, 
that he or she performed an action, we assume that the individual 
actually did perform whatever action was required and is in compliance 
with the recordkeeping requirements in this part. Note that most of the 
recordkeeping requirements in Subpart L require the name of the 
individual, rather than a signature.
Issue 8: Do the Recordkeeping Requirements in Part 35 Allow for the Use 
of Electronic Signatures?
    Comment. Some commenters were concerned that the requirements for 
signatures preclude maintaining records electronically.
    Response. Section 35.5, Maintenance of records, allows records to 
be maintained electronically. Therefore, electronic signatures are 
permitted.

Section 35.2024, Records of Authority and Responsibilities for 
Radiation Protection Programs

Issue 1: Can the Requirements in This Section Be Made Less Prescriptive 
and Therefore Less Burdensome on Licensees?
    Comment. Several commenters felt that the requirements in this 
section are too prescriptive and burdensome, especially for private 
practices with one physician who is also the owner/president and RSO.
    Response. The NRC has retained the requirements in this section 
because we believe that records associated with the authority and 
responsibilities of the radiation protection program are fundamental to 
the safe use of byproduct material by all medical licensees, regardless 
of their size. Even single practice physicians, who may also serve as 
RSOs, need to be well aware of and to document their authority, duties, 
and responsibilities associated with being the RSO named on either an 
NRC or Agreement State license.
Issue 2: Why is It Necessary for Licensees to Retain Records of the 
Licensee's Management's Written Approval of Actions Associated With the 
Radiation Protection Program for 5 Years?
    Comment. One commenter said that the requirement in paragraph (a) 
of this section to retain records for 5 years is excessive.
    Response. The NRC considers the records required by paragraph (a) 
of this section to be important in documenting actions taken by the 
licensee's management that affect its radiation protection program. 
These records include requests for a license application, renewal, or 
amendment; approval of AUs, AMPs, and ANPs; and radiation protection 
program changes that do not require a license amendment. The 5-year 
retention period will ensure that the records that are key to a 
licensee's radiation protection program are available for review during 
inspection of medical use licensees. During the development of the 
proposed rule, we evaluated the retention period for this requirement 
and changed the retention period from the duration of the license to 5 
years. Therefore, the recordkeeping burden for licensees to comply with 
the requirements in this paragraph is less than the burden to comply 
with the current rule.
Issue 3: Why is it Necessary for Both Licensee Management and the RSO 
to Sign the Authorities, Duties, and Responsibilities of the RSO?
    Comment. Several commenters said that the requirement in paragraph 
(b) of this section for both licensee management and the RSO to sign 
the authorities, duties, and responsibilities of the RSO was too 
prescriptive. They felt that it was unnecessary to require the 
signature of both of them because other sections only require one 
signature or name. One commenter was also concerned that, if a problem 
occurred, the written agreement could be used by licensee management 
against the RSO.
    Response. The NRC retained the requirement for signatures of both 
licensee management and the RSO because we believe it is important that 
there is a signed record of what the licensee management and the RSO 
agree are the authorities, duties, and responsibilities of the RSO. If 
both the licensee management and the RSO have a clear understanding of 
the responsibilities of the RSO for the licensee's radiation protection 
program, problems such as that referred to in the comment could be 
avoided. We explicitly state in this section that the signed document, 
as required by Sec. 35.24 (b), and the responsibilities of the 
Radiation Safety Officer, as required by Sec. 35.24 (e), must be 
retained for the duration of the license. This retention period is 
identical to the retention period specified in Sec. 30.51(b), which 
would otherwise apply. However, without this explicit statement in Part 
35, the licensee would have to reference the general recordkeeping 
provisions in Sec. 30.51 for the record retention period.

Section 35.2026, Records of Radiation Protection Program Changes

Issue 1: Why is There a Requirement for Retaining Records of Changes to 
a Licensee's Radiation Protection Program that ``Do Not Reduce 
Safety,'' and Why Must These Records Be Signed by Licensee Management?
    Comment. Commenters said that it is excessive and unnecessary to 
retain

[[Page 20324]]

records of radiation protection program changes that do not reduce 
safety. In addition, the commenters believed that it is unnecessary to 
have licensee management sign the records of radiation protection 
program changes that had already been reviewed and signed by the RSO, 
the licensee's radiation safety expert.
    Response. Licensees are required to obtain Commission approval for 
changes in their radiation protection program, except for the revisions 
authorized by Sec. 35.26. Because licensees are not required to submit 
these latter changes to NRC for approval, the records of the changes 
made in accordance with Sec. 35.26 provide the Commission an 
opportunity to evaluate these changes during the inspection process. 
The NRC believes that this approach is warranted in light of the 
importance of changes in a licensee's radiation protection program.
    The reference in proposed Sec. 35.26(a)(2) to changes that ``do not 
reduce radiation safety'' resulted in many comments that this phrase 
was ``ambiguous'' and ``subjective.'' The proposed wording was intended 
to provide the licensee with as much flexibility as possible in making 
changes in its radiation protection program, without seeking Commission 
approval. However, because commenters felt that the proposed wording 
was not clear, we revised the text of paragraph (a)(2) to state the 
more objective parameter of changes that are ``in compliance with the 
regulations and the license.''
    We have deleted the requirement in Sec. 35.2026 for the RSO to sign 
the records of radiation protection program changes because licensee 
management is ultimately responsible for the radiation protection 
program. Therefore, the final rule includes a requirement for licensee 
management to sign these records.
Issue 2: Can the Requirements in This Section Be Made Less Prescriptive 
and Therefore Less Burdensome on Licensees?
    Comment. Several commenters noted that the recordkeeping 
requirements in this section are quite prescriptive and suggested that 
the sentence with the list of items that must be included in the 
records be deleted or revised to be less prescriptive.
    Response. The NRC believes that the recordkeeping requirements in 
this section are needed to document what changes have been made in the 
licensee's radiation protection program. We considered the burden on 
licensees during development of the final requirements for this section 
and believe that the requirements for radiation protection changes, and 
the associated records, provide the licensee more flexibility to manage 
its radiation protection program than in the current rule and reduce 
the recordkeeping burden on licensees. For example, licensees must 
currently retain a record of each radiation protection change until the 
license has been renewed or terminated. Under the final rule, licensees 
are only required to retain these records for 5 years.
Issue 3: Why Are Licensees Required To Retain a Copy of the Old 
Radiation Protection Procedures?
    Comment. One commenter questioned the need to retain a copy of the 
old radiation protection procedures because they are immaterial to the 
current procedures and could be confusing to workers.
    Response. The NRC believes that licensees should retain a copy of 
their old radiation protection procedures for 5 years so that they are 
available during the licensee's next inspection after the procedures 
were changed. If a ``problem'' or ``event'' is discovered during an 
inspection, the radiation protection procedures that were in place at 
the time of the event may be very useful in determining the cause of 
the event.
    We suggest retaining the copy of the old radiation protection 
procedures in the licensee's filing system so that they are not readily 
available for workers to refer to by mistake.
Issue 4. Were There Any Other Changes Made In This Section Between the 
Proposed and Final Rules?
    Response. Yes. The word ``safety'' was removed from the title of 
this section. This change has been made to correct an inconsistency 
between the regulatory text in this recordkeeping section and the 
corresponding Sec. 35.26, Radiation protection program changes.

Section 35.2040, Records of Written Directives

Issue 1: Is There a Need for an NRC Requirement to Retain a Copy of 
Written Directives for Therapeutic Administrations of Unsealed 
Byproduct Material?
    Comment. One commenter said that the requirement for retaining a 
copy of written directives should exempt radiopharmaceuticals because 
state laws already require retention of prescription records.
    Response. Section 35.40, Written directives, contains a list of 
items that must be included in a written directive and requires that an 
AU sign and date the written directive before administration of sodium 
iodide I-131 greater than 1.11 MBq (30 Ci) or any therapeutic 
dosage of unsealed byproduct material. In other words, this section 
includes specific requirements for preparing written directives before 
administering higher dosages of unsealed byproduct material. 
Prescriptions for radiopharmaceuticals may or may not be signed by AUs 
and may or may not include all of the items that are required by 
Sec. 35.40 for written directives for administrations of therapeutic 
dosages of unsealed byproduct material. The NRC believes that retaining 
copies of written directives will help ensure that administrations of 
therapeutic dosages of unsealed byproduct material are in accordance 
with the written directives. In addition, a copy of the written 
directive may be useful in evaluating whether a medical event was a 
result of a generic problem that may also affect other licensees.

Section 35.2041, Records for Procedures for Administrations Requiring a 
Written Directive

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. This section was added to the final rule. We 
explicitly state in this section that the procedures required in 
Sec. 35.41 (a) must be retained for the duration of the license. This 
retention period is identical to the retention period specified in 
Sec. 30.51(b), which would otherwise apply. However, without this 
explicit statement in Part 35, the licensee would have to reference the 
general recordkeeping provisions in Sec. 30.51 for the record retention 
period.

Section 35.2045, Records of Medical Events

Issue 1: Can the Requirements in This Recordkeeping Section Be Made 
Less Prescriptive and Therefore Less Burdensome on Licensees?
    Comment. One commenter noted that the recordkeeping requirements in 
this section are quite prescriptive and suggested that the list of 
items that must be included in the records be deleted.
    Response. Section 35.2045 has been deleted in the final rule. Since 
licensees are required to report information about medical events to 
the NRC under Sec. 35.3045, we believe that it is not necessary to 
require licensees to retain a record of this information under 
Sec. 35.2045.

[[Page 20325]]

Issue 2: Should There Be a Requirement for Maintaining Records of 
Significant Precursor Events?
    Comment. One commenter opposed the recordkeeping requirement for 
significant precursor events.
    Response. There are no recordkeeping requirements for significant 
precursor events in the final rule because there are no requirements 
for reporting precursor events.

Section 35.2060, Records of Calibrations of Instruments Used To Measure 
the Activity of Unsealed Byproduct Material

Issue 1: Does This Section Address ``Calibrations'' or ``Performance 
Checks''?
    Comment. A commenter recommended that the word ``calibrations'' be 
replaced with the term ``performance checks'' because the commenter 
believes that the tests required by the section are more accurately 
defined as performance checks.
    Response. The NRC did not adopt this comment because this section 
addresses calibration of all instruments used to measure the activity 
of unsealed byproduct material, including dose calibrators. We believe 
this is the appropriate term because the term ``calibration'' is 
commonly used within the radiation protection profession.
Issue 2: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The NRC changed the title of this section to state 
more accurately that it addresses the calibration of instruments used 
to measure the activity of unsealed byproduct material. In addition, we 
deleted prescriptive requirements from Sec. 35.2060. This change is 
consistent with the revisions made to Sec. 35.60. The licensee is only 
required to record the model and serial number of the instrument; the 
date of the calibration; the results of the calibration; and the name 
of the individual who performed the calibration. We believe that this 
information will provide adequate documentation of calibrations of 
instruments used to measure the activity of unsealed byproduct 
material.

Section 35.2061, Records of Radiation Survey Instrument Calibrations

Issue 1: Is it Necessary to Keep Instrument Calibration Records?
    Comment. Commenters suggested that the requirement to retain 
records of radiation survey instruments be deleted. Some commenters 
stated that because the current calibration status and expiration date 
must be displayed on the instrument, they did not see a benefit to 
radiation safety by maintaining certificates of calibration. Other 
commenters stated that this section is already covered in 10 CFR 
20.2103.
    Response. The NRC believes records of calibration should be kept 
because they can be used to document that the instrument has been 
calibrated. This is particularly important when the calibration sticker 
is unreadable, missing, or in error or when an instrument that was used 
in a required survey cannot be located. Section 20.2103 requires that 
licensees maintain records of calibrations but it does not provide 
specific recordkeeping requirements. Therefore, this section is needed 
to provide medical use licensees with specific information on what 
items must be maintained in this record.
Issue 2: Were There Any Other Changes Made In This Section Between the 
Proposed and Final Rules?
    Response. Yes. The NRC amended Sec. 35.2061 to delete the 
requirements to include the description of the calibration procedure 
and the source used in calibrating the meter; the certified exposure 
rates from the source; the rates indicated by the instrument being 
calibrated; and the correction factors deduced from the calibration 
data. These changes are consistent with the revisions made to 
Sec. 35.61. In the final rule, the licensee is required to record the 
model and serial number of the instrument; the date of the calibration; 
the results of the calibration; and the name of the individual who 
performed the calibration. We believe this information will provide 
adequate documentation of calibrations of radiation survey instruments.

Section 35.2063, Records of Dosages of Unsealed Byproduct Material for 
Medical Use

Issue 1: Are Records of Administered Dosages of Unsealed Byproduct 
Material Needed?
    Comment. Commenters did not believe this recordkeeping section was 
needed because prescribing and dispensing records are required by state 
medical and pharmacy laws. Other commenters did not believe that the 
recordkeeping requirements should apply to byproduct material 
administered under Secs. 35.100 and 35.200.
    Response. The NRC believes that it is important to keep records of 
the dosages administered. These records are needed to document that the 
byproduct material was administered to a patient or human research 
subject in accordance with the written directive and to document the 
amount of byproduct material that was administered. However, if a 
licensee keeps the same records to comply with other requirements, the 
licensee need not retain duplicate records.
Issue 2: Should the Expiration Date of a Radioactive Drug Be Deleted 
From the Regulations?
    Comment. A commenter indicated that the current requirement in 
Sec. 35.53 to record the expiration date of a radioactive drug should 
not be deleted from the regulations. The commenter believed the 
expiration date is important because it can be used, for example, to 
establish time limits on sterility, dosage, and effectiveness of 
tagging. The commenter also believed the paperwork burden for including 
the expiration date is minimal.
    Response. The NRC agrees that the expiration date of a radioactive 
drug is important. However, we believe that licensees have to comply 
with other regulations governing the use of drugs that include noting 
the expiration date because it is related to stability and sterility. 
Therefore, we do not believe that it is necessary to have a requirement 
in Part 35 for licensees to record the expiration date of a radioactive 
drug.
Issue 3: Should the Terms ``Prescribed Dosage'' Be Removed From the 
Requirement?
    Comment. A commenter asked that the term ``prescribed dosage'' be 
deleted from Sec. 35.2063 because there is no requirement for the AU to 
prescribe the dosage and, in the case of therapeutic administrations, 
only a written directive is needed.
    Response. The NRC has not deleted the term ``prescribed dosage.'' 
The term is defined in Sec. 35.2. In Part 35, only an AU may direct the 
administration of sealed or unsealed byproduct material for medical 
use.
Issue 4: Were There Any Other Changes Made In This Section Between the 
Proposed and Final Rules?
    Response. Yes. The NRC restructured Sec. 35.2063 to match the 
format used in other recordkeeping sections. We also deleted the 
requirements for the record to include the radionuclide, generic name, 
trade name, or abbreviation of the radiopharmaceutical and its lot 
number. These items were deleted to make the rule less prescriptive. 
The final rule requires that the licensee record the 
radiopharmaceutical; patient or human research subject's name, or

[[Page 20326]]

identification number, if one has been assigned; the prescribed dosage, 
the determined dosage, or a notation that the total activity is less 
than 1.1 MBq (30 Ci); the date and time of the dosage 
determination; and the name of the individual who determined the 
dosage. This information will provide adequate documentation of dosage 
administrations.

Section 35.2067, Records of Leak Tests and Inventory of Sealed Sources 
and Brachytherapy Sources

Issue 1: Why Should Licensees Maintain Records of Negative Leak Tests?
    Comment. A commenter agreed with retention of positive leak test 
records, but not with the requirement to maintain records of negative 
tests.
    Response. The rule requires records of all leak tests required by 
Sec. 35.67(b) to show that leak tests were performed. The NRC changed 
the final rule to require records of the test results, but a licensee 
has flexibility in how it records the test results. For negative leak 
tests, a licensee may simply document that the measured activity is 
``negative.''
Issue 2: Should This Section Make a Reference to Sec. 35.2406, Records 
of Brachytherapy Source Inventory?
    Comment. A commenter asked that we add a reference which states 
that additional brachytherapy records may be required by Sec. 35.2406.
    Response. The NRC does not believe this reference is needed. We 
have tried to eliminate redundancy and cross referencing in the rule 
unless it is needed to make the rule more understandable.
Issue 3: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The NRC amended the title of this section to state 
more clearly what type of records are required by this section.
    We also deleted the requirements to record the measured activity of 
each test sample and a description of the method used to measure each 
test sample in the record. These items were deleted to make the rule 
less prescriptive.

Section 35.2070, Records of Surveys for Ambient Radiation Exposure Rate

Issue 1: Are Contamination Surveys Included in This Section?
    Comment. A commenter indicated that the requirement for records of 
removable contamination should be deleted because Sec. 35.70 does not 
require removable contamination surveys.
    Response. The commenter is correct. The NRC deleted the requirement 
for the licensee to record removable contamination in each area 
(expressed in disintegrations per minute per 100 square centimeters) 
and the instrument used to analyze the samples. However, the licensee 
must maintain records to show compliance with ALARA.
Issue 2: Are the Requirements in This Section Already Covered by 
Sec. 20.2103, Records of Surveys?
    Comment. Commenters did not believe this section was needed because 
radiation surveys are addressed in Sec. 20.2103.
    Response. 10 CFR Part 20 contains general provisions on records. 
Section 20.2103 requires that licensees maintain records of surveys, 
but it does not provide specific recordkeeping requirements. This 
section is needed to specify what Part 35 licensees must document in 
the record required by this section.
Issue 3: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The NRC deleted the requirements to record a plan of 
each area surveyed; the trigger level established for each area; and 
the detected dose rate at several points in each area expressed in 
millirem per hour or the removable contamination in each area expressed 
in disintegrations per minute per 100 square centimeters. These items 
were deleted to make the rule less prescriptive. The final rule 
requires the licensee to record the date of the survey; the results of 
the survey; the instrument used to make the survey; and the name of the 
individual who performed the survey.

Section 35.2075, Records of the Release of Individuals Containing 
Unsealed Byproduct Material or Implants Containing Byproduct Material

Issue 1: Should Paragraph (b) of This Section That Requires That a 
Record Be Kept That Instructions Were Provided to a Breast-Feeding 
Woman Be Deleted?
    Comment. A commenter stated that the requirements in paragraph (b) 
[proposed paragraph (c)] are intrusive into medical practice. The 
commenter believed that instructions should be left to the physician's 
judgment.
    Response. The NRC did not make any changes in paragraph (b) of the 
proposed rule which requires licensees to keep a record that 
instructions, including written instructions, were provided to a 
breast-feeding female if the radiation dose to the infant or child from 
continued breast-feeding could result in a total effective dose 
equivalent exceeding 5 mSv (0.5 rem). This requirement is also in the 
current Part 35. We believe that providing written instructions to 
patients or human research subjects is necessary because they may not 
remember all the oral instructions. In addition, written instructions 
provide needed information to other family members or individuals who 
are caring for the patient or human research subject.
    The requirement for a licensee to retain a record to demonstrate 
that instructions were provided to a breast-feeding female is more 
risk-informed. These records are associated with higher risk 
administrations of radiopharmaceuticals, e.g., therapeutic 
administrations of iodine-131.
Issue 2: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The NRC corrected paragraph (a) of this section 
because it inadvertently required that licensees maintain records of 
all releases. This recordkeeping requirement was more restrictive than 
the current rule. We modified the rule to require records of the 
release of individuals only when the total effective dose equivalent is 
calculated by using the retained activity rather than the administered 
activity; using an occupancy factor less than 0.25 at 1 meter (3.3 
feet); using the biological or effective half-life; or considering the 
shielding by tissue. We also amended paragraph (c) to specify that the 
records required by both paragraphs (a) and (b) of this section must be 
maintained for 3 years.

Section 35.2080, Records of Mobile Medical Services

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The NRC amended the title of this section to state 
more clearly what type of records are required by this section.
    We also deleted the requirement to record a plan of each area 
surveyed and the measured dose rate at several points in each area of 
use expressed in millirem per hour. These items were deleted to make 
the rule less prescriptive. The final rule requires the licensee to 
record the date of the survey; the results of the survey; the 
instrument used to make the survey; and the name of the individual who 
performed the survey. In addition, we clarified that the letter that 
permits the use of byproduct material must delineate the authority and 
responsibility of the licensee and the client.

[[Page 20327]]

Section 35.2092, Records of Decay-in-Storage

Issue 1: Are the Requirements in This Section Already Covered by 
Sec. 20.2103, Records of Surveys?
    Comment. Commenters did not believe this section was needed because 
radiation surveys are addressed in Sec. 20.2103.
    Response. 10 CFR Part 20 contains general provisions on records. It 
does not provide specific recordkeeping requirements for disposal of 
waste through decay-in-storage. Section 35.2092 is needed to specify 
what Part 35 licensees must document in the records required by 
Sec. 35.92.
Issue 2: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The NRC amended the first sentence to replace the 
term ``made in accordance with'' with the phrase ``as required by.'' We 
believe this makes the sentence more readable. We also deleted the 
requirement to document the name of the radionuclide that was disposed. 
We do not believe it is necessary for the licensee to document what 
material was disposed of because Sec. 35.92 no longer requires that the 
material be held for 10 half-lives. However, this does not preclude the 
licensee from including this information in the record.
    We also amended the requirement so that the record includes the 
name of the individual who performed the survey, rather than the name 
of the individual who performed the disposal. We believe that it is 
important to have a record of the individual who actually surveyed the 
material and determined that it could be disposed of without regard to 
its radioactivity.

Section 35.2204, Records of Molybdenum-99 Concentration

Issue 1: Can This Record Be Deleted?
    Comment. Commenters suggested that this section, as well as 
Sec. 35.204, be deleted. They did not believe the rule should require 
licensees to measure molybdenum-99 concentrations. (See comments on 
Sec. 35.204.)
    Response. The NRC did not delete the requirement for licensees to 
measure molybdenum-99 concentrations, nor have we deleted the 
requirement for licensees to maintain a record of the molybdenum-99 
concentration tests required by Sec. 35.204. We believe the record is 
needed to document that the test has been performed and that the 
results of the test do not exceed the levels specified in Sec. 35.204.

Section 35.2310, Records of Safety Instruction

Issue 1: Is It Necessary To Maintain Records of Safety Instruction 
Given to Non-Film Badged Workers?
    Comment. According to commenters, it is excessive to require 
licensees to maintain records of training given to non-film badged 
allied health care workers, who receive instruction in accordance with 
Secs. 35.310, 35.410 or 35.610.
    Response. Records of all individuals receiving safety instruction 
in accordance with Secs. 35.310, 35.410 or 35.610 are needed to 
document that the instruction was provided by the licensee. The NRC 
believes it is important that the personnel caring for patients or 
human research subjects who have received radiopharmaceutical therapy 
(and cannot be released in accordance with Sec. 35.75) receive 
instruction in limiting radiation exposure to the public or workers and 
what actions should be taken in the case of a medical emergency or 
death.
Issue 4: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The title of this section was changed to correspond 
to the title of Sec. 35.310, Safety instruction. That section includes 
the requirement for licensees to retain a record of individuals 
receiving safety instruction.

Section 35.2404, Records of Surveys After Source Implant and Removal

Issue 1: Is It Necessary To Maintain Records of Negative Surveys? Also, 
Can the Record Retention Requirement Be Changed from 3 Years to 1 Year?
    Comment. Some commenters felt that maintenance of negative surveys 
for 3 years was excessive and suggested that the survey record include 
only an indication of the survey being performed and the results of any 
positive surveys. These same commenters also suggested that the record 
need only be kept for 1 year.
    Response. The NRC simplified the recordkeeping requirements in this 
section by deleting the requirement to record the location of the 
survey and the patient identifier. These items were deleted to make the 
rule less prescriptive. We added a requirement to record ``the results 
of the survey'' because we do not believe that a requirement to record 
the results of the survey is excessive, even if the results are that 
all sources are accounted for. We have also retained the 3-year 
recordkeeping period to be consistent with the 3-year inspection period 
for most medical use licensees.
Issue 2: Could the Recordkeeping Requirements of This Section Be Less 
Prescriptive, Consistent With Providing More Flexibility in Running a 
Radiation Protection Program?
    Comment. A commenter suggested that the contents of the record for 
radiation surveys be deleted, consistent with providing the licensee 
flexibility in developing, maintaining, and implementing its radiation 
protection program. If this cannot be done, the commenter suggested 
that the ``name of the individual'' be changed to ``the identity of the 
individual.''
    Response. The NRC simplified the recordkeeping requirements in this 
section by deleting the requirement to record the location of the 
survey and the patient identifier. As discussed in Issue 6 of the 
general comments on this subpart, we believe that the full name of an 
individual must appear on a record to better ensure future 
identification of the individual who performed the survey.
Issue 3: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The NRC changed both the title and regulatory text 
of this section to accommodate changes made in Sec. 35.404, Surveys 
after source implant and removal. For example, the term ``radiation'' 
was struck from the section, recognizing that the survey may not 
necessarily be a radiation survey. The licensee may also perform a 
visual survey to locate and account for all sources. Other changes are 
discussed in the comments on Sec. 35.404.

Section 35.2406, Records of Brachytherapy Source Accountability

Issue 1: Is It Necessary To Retain a Record of Permanent Implant 
Sources Returned to Storage If All Sources Were Used During the 
Implant?
    Comment. A commenter suggested that, in some permanent implant 
cases, all of the sources will be utilized. The commenter proposed that 
the word ``unused'' be added to item (c)(2) immediately before 
``sources.''
    Response. The NRC changed the regulatory text in this section to 
require that the record include ``the number and activity of sources 
not implanted.'' Therefore, if all of the sources were used, the 
licensee would have to note that all of the sources were implanted and, 
consequently, none were returned to storage.

[[Page 20328]]

Issue 2: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The title of this section was changed to correspond 
to the revised title of Sec. 35.406, Brachytherapy source 
accountability. That section requires licensees to maintain 
accountability at all times for all brachytherapy sources in storage or 
use.

Section 35.2432, Records of Calibration Measurements of Brachytherapy 
Sources

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The title of this section was changed to correspond 
to the title of Sec. 35.432, Calibration measurements of brachytherapy 
sources. That section requires licensees to retain records of 
calibrations performed before the first medical use of brachytherapy 
sealed sources. Several changes were also made in this section to 
accommodate changes made in Sec. 35.432. For example, the proposed rule 
said that the full calibration measurements must include determination 
of the output or activity within +/-5 percent, and the final rule says 
that a licensee must determine the source output or activity using a 
dosimetry system that meets the requirements in Sec. 35.630(a). Other 
changes are discussed in the comments on Sec. 35.432.

Section 35.2433, Records of Decay of Strontium-90 Sources for 
Ophthalmic Treatments

Issue 1: Were There any Other Changes Made in This Subpart Between the 
Proposed and Final Rules?
    Response. Yes. The NRC added this section to correspond with the 
new Sec. 35.433, Decay of strontium-90 sources for ophthalmic 
treatments. That section includes a requirement that a record be made 
of the activity of each strontium-90 source that is used to determine 
the treatment times for ophthalmic treatments. For additional 
information, see the discussion for Sec. 35.433.

Section 35.2605, Records of Installation, Maintenance, Adjustment, and 
Repair of Remote Afterloader Units, Teletherapy Units, and Gamma 
Stereotactic Radiosurgery Units

Issue 1: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The NRC amended the title of this section to state 
more clearly what type of records are required by this section.
    We also added the word ``adjustment'' to the title and text of this 
section to conform them with the regulatory text. In addition, the 
phrase ``remote afterloader unit, teletherapy unit, or gamma 
stereotactic unit'' was added. This list of units was added because 
Subpart H in the final rule includes requirements for these types of 
devices, in addition to the requirements for teletherapy units which 
are in the current Part 35.

Section 35.2610, Records of Safety Procedures

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. This section was added to the final rule. We 
explicitly state in this section that the procedures required in 
Secs. 35.610 (a)(4) and (d)(2) must be retained until the licensee no 
longer possesses the remote afterloader, teletherapy unit, or gamma 
stereotactic radiosurgery unit. Without this explicit statement, the 
licensees would have to reference the general recordkeeping provisions 
in Sec. 30.51 for the record retention period and therefore, would have 
had to retain the procedures for the duration of the license.

Section 35.2630, Records of Dosimetry Equipment Used With Remote 
Afterloader Units, Teletherapy Units, and Gamma Stereotactic 
Radiosurgery Units

Issue 1: Can the Record Retention Period for This Section Be Changed 
From ``for the Duration of the License'' to 3 Years?
    Comment. A commenter suggested that the record retention period 
could be changed to ``3 years after the last calibration.''
    Response. The NRC has not changed the record retention period in 
this section. The dosimetry equipment calibrations, intercomparisons, 
and comparisons performed to show compliance with Sec. 35.630 are 
necessary to document that the correct radiation dose is delivered to 
the patient or human research subject. If there is a future question 
about whether the correct radiation dose was delivered to a patient or 
human research subject, we believe that these records should be 
available to document that calibration of the therapy unit has been 
made with properly calibrated instruments.
Issue 2: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. The NRC amended the title of this section to state 
more clearly what type of records are required by this section.
    We also amended paragraph (b)(2) to require that licensees include 
the manufacturer's name for the instruments that are calibrated, 
intercompared, or compared in accordance with Sec. 35.630. This change 
is consistent with requirements in other sections to include the 
manufacturer's name of other types of equipment.

Section 35.2632, Records of Teletherapy, Remote Afterloader, and Gamma 
Stereotactic Radiosurgery Full Calibrations

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. Changes were made in this section to incorporate the 
requirements that were in the proposed Secs. 35.2633 and 35.2635, which 
were deleted. Section 35.2632 in the final rule includes the 
recordkeeping requirements for full calibrations of teletherapy, remote 
afterloader, and gamma stereotactic radiosurgery units. Licensees can 
refer to this section for all of the recordkeeping requirements for 
full calibrations of the therapy units covered by Subpart H.

Section 35.2633, Records of Remote Afterloader Full Calibrations

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. This section was deleted in the final rule because 
the requirements were moved to Sec. 35.2632, Records of teletherapy, 
remote afterloader, and gamma stereotactic radiosurgery full 
calibrations. This change has been made so that all of the 
recordkeeping requirements for full calibrations of therapy units in 
Subpart H would be in one place for easier reference for licensees.

Section 35.2635, Records of Gamma Stereotactic Radiosurgery Unit Full 
Calibrations

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. This section was deleted in the final rule because 
the requirements were moved to Sec. 35.2632, Records of teletherapy, 
remote afterloader, and gamma stereotactic radiosurgery full 
calibrations. This

[[Page 20329]]

change has been made so that all of the recordkeeping requirements for 
full calibrations of the therapy units covered by Subpart H would be in 
one place for easier reference for licensees.

Section 35.2642, Records of Periodic Spot-Checks for Teletherapy Units

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. Paragraph (c) was added to the final rule. We 
explicitly state in this section that the procedures required in 
Sec. 35.642 (b) must be retained until the licensee no longer possesses 
the teletherapy unit. Without this explicit statement, the licensees 
would have to reference the general recordkeeping provisions in 
Sec. 30.51(b) for the record retention period and therefore, would have 
had to retain the procedures for the duration of the license.

Section 35.2643, Records of Periodic Spot-Checks for Remote Afterloader 
Units

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. Several changes were made to accommodate changes 
made in Sec. 35.643.
    Paragraph (c) was added to the final rule. We explicitly state in 
this section that the procedures required in Sec. 35.643 (b) must be 
retained until the licensee no longer possesses the remote afterloader 
unit. Without this explicit statement, the licensees would have to 
reference the general recordkeeping provisions in Sec. 30.51(b) for the 
record retention period and therefore, would have had to retain the 
procedures for the duration of the license.

Section 35.2645, Records of Periodic Spot-Checks for Gamma Stereotactic 
Radiosurgery Units

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. Several changes were made to accommodate changes 
made in Sec. 35.645. These changes are discussed in the comments on 
Sec. 35.645.
    Paragraph (c) was added to the final rule. We explicitly state in 
this section that the procedures required in Sec. 35.645 (b) must be 
retained until the licensee no longer possesses the gamma stereotactic 
radiosurgery unit. Without this explicit statement, the licensees would 
have to reference the general recordkeeping provisions in Sec. 30.51(b) 
for the record retention period and therefore, would have had to retain 
the procedures for the duration of the license.

Section 35.2647, Records of Additional Technical Requirements for 
Mobile Remote Afterloader Units

Issue 1: Were There Any Changes Made in This Section Between the 
Proposed and Final Rules?
    Response. Yes. Other changes are discussed in the comments on 
Sec. 35.647.

Section 35.2652, Records of Surveys of Therapeutic Treatment Units

Issue: Can the Record Retention Period Be Changed to 3 Years, Instead 
of ``for the Duration of Use of the Unit?
    Comment. A commenter suggested that the record retention period 
could be changed to 3 years.
    Response. The NRC has not changed the record retention period in 
this section. The surveys performed to show compliance with Sec. 35.652 
are necessary to ensure that the source/device radiation level limits 
stated in the SSDR are not exceeded. We believe that these surveys 
should be retained for the duration of use of the device because of the 
potential radiation risks associated with these devices.

Subpart M--Reports

Issue 1: Should All the Reporting Requirements Be Grouped Into One 
Subpart or Should They Be Incorporated Into the Section Requiring the 
Report?
    Comment. Commenters provided diverse responses to the Commission's 
question on whether all of the reporting requirements should be grouped 
into one subpart, or whether they should be incorporated into the 
individual sections requiring the reports. Commenters favored having 
all of the reporting requirements in one subpart because this format 
provides for easy reference, simplifies licensing, and assists 
licensees in determining their reporting requirements, which makes it 
easier to maintain compliance. Other commenters favored having the 
reporting requirements in the individual sections because this format 
is more orderly and informative. They find the similar separation of 
the actual reporting requirements and the requirements for what needs 
to be in the reports in Part 20 to be confusing. A number of 
individuals have misinterpreted sections of Part 20 simply because of 
the separation. Several commenters preferred a balanced approach where 
the reporting requirements would be in the individual sections and all 
of the requirements summarized in a separate subpart.
    Response. After reviewing all of the comments responding to this 
question, the NRC concluded that having all of the reporting 
requirements in one subpart makes it easier for licensees to reference 
those requirements. However, the final rule is consistent with the 
``balanced approach'' because each section in the final rule that is 
associated with a reporting requirement includes a cross-reference to 
the specific reporting requirements in Subpart M.

Section 35.3045, Report and Notification of a Medical Event

Issue 1: Do Stakeholders Think That the Term ``Medical Event'' is an 
Improvement Over the Use of the Term ``Misadministration'' in the 
Current Part 35?
    Comment. Commenters supported the use of the term ``medical 
event.'' One commenter agreed with the change, but could see no reason 
for ``candy coating'' the term ``misadministration.''
    Response. The NRC used the term ``medical event'' in the final rule 
because some believe the term ``misadministration'' has a negative 
connotation that implies negligence on the part of the physician or 
other hospital workers. The term ``medical event'' more correctly and 
simply conveys that the byproduct material or radiation from byproduct 
material was not administered as directed by the AU.
Issue 2: Are the Reporting Requirements for Medical Events Necessary?
    Comment. Several commenters said that there was no need for the 
requirements in this section. Events that result from poor radiation 
protection practices are covered in the primary regulations for the use 
of radioactive material, e.g., inadequate survey of a patient following 
an HDR treatment. If such problem areas in licensees' programs are 
brought to their attention, licensees can correct the problems before 
they result in medical events.
    Other commenters expressed concern that the overall wording in this 
section is subject to a great deal of interpretation and debate over 
whether specific actions are appropriate for a particular patient and 
whether an event is a reportable medical event. Therefore, the NRC 
should develop more specific language describing a medical event in 
order to avoid intrusion into medical judgments. It should be made 
clear that medical events are major deviations from a planned treatment 
that have or could have significant effects on the patient. These 
effects include either a

[[Page 20330]]

reduction in the possibility of tumor control or an increase in the 
possibility of complications. In addition, licensees should be able to 
appeal to medical experts if NRC staff determines that an incident is a 
reportable medical event.
    Response. The NRC believes that the reporting and notification 
requirements in this section are necessary so that the NRC is aware of 
events that trigger the thresholds for medical events to determine what 
actions, if any, need to be taken to prevent recurrence; so that other 
licensees can be made aware of generic problems that result in medical 
events; and so that patients can make timely decisions regarding 
remedial and prospective health care. The requirements throughout Part 
35 are more specific for medical use than the general requirements for 
the use of radioactive material in the other parts, e.g., Part 20 
requirements.
    During the development of the final rule, we revisited the proposed 
wording of all sections, including Sec. 35.3045, to see if we could 
clarify the regulatory text to avoid future misinterpretations and 
debates about the meaning of the regulatory text. This type of 
clarifying change has been made to exclude reporting medical events 
that are due to ``patient intervention.''
Issue 3: Are the Threshold Dose Levels for Reporting Medical Events Set 
at Appropriate Levels?
    Comment. Some commenters said that the reporting levels for medical 
events in the proposed Sec. 35.3045(a)(1) cannot be justified on the 
basis of any real risk to either patients or the public. Reporting at 
these levels implies that these events result in harm to the patient, 
when they often result in no effect on the patient. Therefore, this is 
an example of a low risk requirement that the 1997 NAS-IOM Report 
(Radiation in Medicine: A Need for Regulatory Reform, Institute of 
Medicine, National Academy Press, Washington, DC, 1997) recommended be 
deleted. In addition, inherent risks do not justify intrusion by NRC 
into professional activities and the doctor-patient relationship.
    Commenters said that the action level criteria for the total dose 
delivered from brachytherapy procedures or gamma stereotactic 
radiosurgery procedures should be revised from the prescribed dose to a 
level at which harm to patients has been demonstrated. Another 
commenter questioned why the threshold was not similar to FDA's 
requirements for reporting morbidity and mortality.
    One commenter said that the reporting thresholds of 0.05 Sv (5 rem) 
effective dose equivalent or 0.5 Sv (50 rem) to an organ or tissue were 
reasonable levels because they are ``reasonably significant radiation 
exposures.'' Five rem is the annual limit for a radiation worker, and 
50 rem to an organ is the level when one might start seeing organ 
effects. For example, 50 rem to the testicles will result in a 
decreased sperm count.
    Response. The NRC made no change in the proposed threshold 
reporting levels for medical events. These reporting levels correspond 
to the annual occupational dose limits in Part 20 and the level for 
reporting overexposures of workers to NRC. We believe that applying 
these same thresholds to reporting exposures to patients is reasonable.
    The NRC uses the information from the reports of medical events 
that exceed the dose thresholds to reduce the likelihood of other 
medical events. For example, information from a report may indicate a 
breakdown in the licensee's program for ensuring that byproduct 
material or radiation from byproduct material is administered as 
directed by the AU or may indicate a generic issue that should be 
reported to other licensees.
Issue 4: Should Licensees Be Required to Report Events In Which the 
Administration of Byproduct Material or Radiation From Byproduct 
Material Results in a Total Dose That Differs From the Prescribed Dose 
by 20 Percent or More?
    Comment. Commenters said that the 20 percent difference is 
arbitrary, and that exceeding this limit presents little or no risk to 
the patient. The limit should be examined and justified. 
Recommendations ranged from the limit should be 100 percent, to maybe 
there should not be a limit and the physician can decide when to report 
harm to a patient, to it is inappropriate to have a single criterion 
for all procedures.
    Commenters believe that the 20 percent limit is reasonable for 
external beam therapy and unsealed therapeutic radiopharmaceuticals, 
but that it is too restrictive for brachytherapy, gamma stereotactic 
radiosurgery, and unsealed diagnostic dosages. Commenters said that 
they were aware of clinical data that supported the 20 percent level 
for external beam therapy. However, they were unaware of any 
brachytherapy or gamma stereotactic radiosurgery data demonstrating 
that a 20 percent difference between the prescribed dose and delivered 
dose would result in harm to the patient. In addition, a few 
millimeters in brachytherapy can make a tremendous difference in the 
dose. Some provision should be made to exempt brachytherapy, or to 
change the 20 percent limit up to 100-120 percent.
    Several commenters questioned the applicability of the 20 percent 
limit to uses of unsealed byproduct material. Exceeding a radiotherapy 
dosage by 20 percent may be significant, but reporting an 
administration of a diagnostic dosage that exceeds the prescribed 
dosage by 20 percent is overregulation.
    Response. The NRC has retained the 20 percent difference that is in 
the current rule. According to the Statements of Consideration for the 
Quality Management Program and Misadministrations rulemaking (56 FR 
34104; July 25, 1991), a 20 percent difference between the prescribed 
dose and the total dose delivered is required to be reported because it 
could possibly indicate a deficiency in the licensee's program, not 
because it necessarily indicates a significant risk to the patient. We 
agree with this rationale and see no reason to change the threshold.
    Licensees should note that they do not have to report an event in 
which the total dose or dosage delivered differs from the prescribed 
dose or dosage by 20 percent or more unless the dose also differs from 
the prescribed dose or from the dose that would have resulted from the 
prescribed dosage by more than 0.05 Sv (5 rem) effective dose 
equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) 
shallow dose equivalent to the skin.
    The NRC uses the information from the reports of medical events 
where the administration of byproduct material or radiation from 
byproduct material results in a total dose that differs from the 
prescribed dose by 20 percent or more to reduce the likelihood of other 
medical events. For example, the difference between the prescribed and 
administered doses may indicate a breakdown in the licensee's program 
for ensuring that byproduct material or radiation from byproduct 
material is administered as directed by the AU.
Issue 5: Does the Proposed Rule Adequately Address Wrong Treatment 
Site?
    Comment. Commenters both agreed and disagreed on whether the 
proposed rule adequately addressed wrong treatment site. Two commenters 
said that it was unclear how wrong treatment site will be handled for 
therapy, especially for brachytherapy where a medical event can occur 
if the patient moves even a small distance. In addition, commenters 
questioned how the wrong treatment site criteria will be applied to 
permanent seed implants that migrate from the prescribed site.

[[Page 20331]]

    Another comment was that the criteria for a medical event involving 
the wrong treatment site must be justified. The criteria of a 0.5 Sv 
(50 rem) tissue/organ dose and difference of 20 percent from the 
expected dose defined in the written directive are excessively 
restrictive. Justification can be provided that the percentage 
deviation could be 100 percent. At a minimum, radiobiological 
justification can be made for 1 Sv (100 rem) as a significant 
threshold. The FDA uses this threshold criteria for evaluating lengthy 
fluoroscopy studies that could result in skin injury.
    Response. In Sec. 35.3045(a)(3) of the proposed rule, the NRC 
attempted to define more clearly when exposure of a wrong treatment 
site is considered a medical event by including both a 0.5 Sv (50 rem) 
tissue/organ dose limit and a 20 percent deviation from the expected 
dose defined in the written directive. We believe that the proposed 0.5 
Sv (50 rem) tissue/organ dose limit should be retained, but the 
allowable deviation from the dose in the written directive should be 
increased to 50 percent. Therefore, we amended paragraph (a)(3) of this 
section in the final rule to read ``50 percent of the dose expected * * 
*'' We believe that this change allows for some variation in doses to 
the wrong treatment site during administrations of radiation from 
byproduct material, and requires licensees to only report significant 
doses to the wrong treatment site due to the movement of the patient or 
source, e.g., during brachytherapy treatments. In addition, we added a 
statement that is in the current rule, which was inadvertently not 
included in the proposed rule, that excludes permanent implants of 
seeds that were implanted in the correct site but migrated outside the 
treatment site.
Issue 6: Does the Proposed Rule Adequately Address Patient 
Intervention?
    Comments. The NRC received a range of responses to the Commission's 
question on whether the proposed rule adequately addressed patient 
intervention, i.e., actions by the patient such as dislodging or 
removing treatment devices or prematurely terminating treatment. 
Several commenters said that this issue was adequately addressed in the 
rule. Other commenters said that any patient intervention should not 
result in a medical event. One commenter said that an exemption should 
be provided to the licensee when the cause of a medical event is 
patient intervention.
    A number of commenters said that the phrase in the proposed rule 
``that could have been prevented by the licensee'' was ambiguous and 
subjective, and should be deleted because it would result in varying 
interpretations between NRC and licensees. In addition, decisions on 
what are considered ``reasonable medical practices'' for patient 
control infringe on the practice of medicine and should be left to the 
physician's professional judgment. Therefore, this requirement is in 
violation of Statement 2 of the proposed revision of the Medical Policy 
Statement: NRC will not intrude into medical judgments affecting 
patients, except as necessary to provide for the radiation safety of 
workers and the general public.
    Response. As part of the medical use rulemaking, the Commission is 
codifying a common-sense approach to the reporting requirements for 
medical events that excludes incidents involving patient intervention. 
In the proposed rule, the phrase ``that could not have been reasonably 
prevented by the licensee'' was added to Sec. 35.3045(a) in an attempt 
to avoid further expenditure of resources by licensees and NRC in 
trying to determine what constitutes patient intervention, which is not 
specifically addressed in the current rule. The issue has involved 
whether or not a licensee did everything it should to prevent patient 
intervention during a treatment that resulted in a medical event. 
Following our evaluation of the comments on patient intervention, the 
NRC deleted the proposed phrase from Sec. 35.3045(a) because it did not 
seem to clarify when an event caused by patient intervention must be 
reported to NRC as a medical event.
    In the final Sec. 35.3045(b), we addressed the issue of when an 
event caused by patient intervention must be reported to NRC as a 
medical event. In addition, we added a definition of patient 
intervention to Sec. 35.2. As defined, patient intervention means 
``actions by the patient or human research subject, whether intentional 
or unintentional, such as dislodging or removing treatment devices or 
prematurely terminating the administration.'' We believe licensees 
should only be required to report serious medical events due to patient 
intervention. Paragraph (b) of this section in the final rule requires 
licensees to report any event resulting from intervention of a patient 
or human research subject in which the administration of byproduct 
material or radiation from byproduct material results or will result in 
unintended permanent functional damage to an organ or a physiological 
system, as determined by a physician. As a result of the significantly 
higher threshold, the NRC will only receive reports involving patient 
intervention for events with serious consequences, e.g., unintentional 
permanent functional damage.
    This reporting requirement should result in decreased regulatory 
burden on licensees because in most situations where patients intervene 
in their treatment, either voluntarily or involuntarily, there is no 
permanent functional damage. Therefore, the revised reporting 
requirement should significantly reduce the resources expended by the 
NRC and licensees in debating what are considered reasonable medical 
practices for patient control because the NRC will no longer require 
most of the reports it currently receives involving patient 
intervention. In addition, it should avoid intrusion into medical 
judgments by the NRC because the decision on whether the administration 
resulted in permanent functional damage to an organ or a physiological 
system is to be determined by a physician.
Issue 7: Why Do Licensees Need To Notify the NRC By Telephone No Later 
Than the Next Calendar Day After Discovery of a Medical Event?
    Comment. Two commenters questioned the need for licensees to notify 
the NRC no later than the next calendar day after discovery of a 
medical event because this requirement implies that these events are 
harmful or hazardous. There are some medical events with serious 
consequences that should be reported right away but there is no benefit 
in reporting events with no medical significance so promptly.
    Response. According to the Statements of Consideration for the 
Quality Management Program and Misadministration final rule [56 FR 
34104; July 25, 1991], misadministrations (medical events) warrant 
telephone notification of the NRC no later than the next calendar day 
because these events require that a threshold of either 0.05 Sv (5 rem) 
effective dose equivalent or 0.5 Sv (50 rem) dose equivalent be 
exceeded. The early telephone notification allows the NRC to promptly 
take any necessary actions based on the circumstances, e.g., dispatch 
an inspector or medical consultant or notify other licensees of 
potential generic problems. The NRC continues to believe that licensees 
should promptly notify the NRC of medical events that trigger these 
thresholds because the circumstances of the medical events need to be 
evaluated as soon as possible to determine if any

[[Page 20332]]

immediate follow-up or corrective actions are necessary.
    All medical events may not be associated with serious consequences. 
However, we believe that a requirement that allows for different 
reporting periods, depending on the initial assessment of the event, 
would lead to differing interpretations and confusion as to whether the 
magnitude of the event requires notification of the NRC no later than 
the next calendar day. In addition, there may be a medical event where 
the seriousness of the consequences would not be immediately apparent 
and which, therefore, would not be reported.
Issue 8: Should Licensees Be Required To Notify the Individual 
(Affected By the Medical Event) About a Medical Event?
    Comment. The NRC received a range of comments on the requirement in 
Sec. 35.3045(e) to notify the individual affected by the medical event. 
These ranged from the licensee should always notify the patient or 
guardian to this requirement should be deleted.
    Some commenters suggested modification of the requirement. For 
example, a licensee should be allowed not to notify an individual if 
the rationale for withholding the information is noted in the written 
report to the NRC. Other suggestions were that notification of the 
patient should not be required unless the medical event results in a 
detrimental effect to the patient, or it is necessary to ensure patient 
safety.
    Other commenters said that the requirement should depend on the 
risk of the procedure. In cases of diagnostic and low-risk therapeutic 
procedures, notification should not be mandatory. For high-risk 
therapeutic applications, a patient should only be notified if an 
adverse outcome is probable and only if the patient's mental state 
would not be adversely affected.
    Commenters provided a number of reasons why they felt that this 
requirement should be deleted: it overlaps with existing medical 
practice standards; it intrudes into the practice of medicine; it 
interferes with the physician-patient relationship; there are no data 
that patients are not being notified; it presents the appearance of 
much greater harm than there may actually be; there is no precedent in 
other areas of medicine; and it is in contradiction to NRC's Medical 
Policy Statement.
    Response. The NRC retained the proposed requirements for notifying 
individuals following a medical event in the final rule. As stated in 
the proposed rule (63 FR 43516; August 13, 1998), this position 
reaffirms statements made by the Commission during the 
misadministration rulemaking, 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)]. We continue to 
believe that patient notification enables patients, in consultation 
with their personal physicians, to make timely decisions regarding any 
remedial and prospective medical care. This approach also codifies 
existing medical ethical standards obligating physicians to provide 
complete and accurate information to their patients.
    This approach is consistent with aspects of another Federal patient 
notification requirement specifically in ``The Mammography Quality 
Standards Reauthorization Act of 1998,'' Pub. L. 105-248, under which 
notification of a patient may be required for certain events (e.g., 
when a patient has received mammography from a facility whose quality 
is found to be ``so inconsistent with quality standards as to present a 
risk to individual or public health''). [42 U.S.C. 263b(h)(2)(1999)]. 
By statute, as well as FDA regulations, a summary of the written report 
of the patient's mammography results must be sent directly to the 
patient if the patient's physician is not available or if there is no 
such physician. [42 U.S.C. 263b(f)(1)(G)(ii)(III); 21 CFR 
900.12(e)(1)(2)(ii)(a) and (iii) (1999).]
Issue 9: Should Licensees Be Required To Notify the Referring Physician 
About a Medical Event?
    Comment. Several commenters disagreed with the need for a 
regulation requiring licensees to notify referring physicians about a 
medical event. Nuclear medicine physicians and referring physicians 
have a professional relationship that would be negatively impacted if 
the nuclear medicine physician provided inaccurate information or 
withheld information from the referring physician. Therefore, the NRC 
does not need to mandate notification of the referring physician.
    Response. It is important that a referring physician is aware of 
medical events involving individuals. The referring physician knows the 
individual and his or her medical history and is likely to be in the 
best position to make a decision about whether informing the individual 
about the medical event would be harmful. That physician may also need 
to evaluate any follow-up actions relative to the individual's overall 
health history. Although notification of referring physicians may 
represent the ``standard of care,'' that practice may not be uniformly 
followed. Therefore, the NRC retained the current requirement for a 
licensee to notify the referring physician about a medical event. The 
final rule includes a requirement that licensees annotate a copy of 
their report to the NRC about the medical event and provide it to the 
referring physician, if other than the licensee, within 15 days after 
discovery of the medical event. We believe that it is important for the 
referring physician to have all the available documentation about the 
medical event to support any decision about remedial or prospective 
health care. The 15-day time period to provide the referring physician 
with a copy of the record is based on paragraph (d) which requires a 
licensee to submit a report to the NRC within 15 days. Consistency, 
where possible, between the requirements in Subparts L and M will 
simplify compliance with the recordkeeping and reporting requirements.
    The issue of notifying the referring physician was addressed in the 
Statements of Consideration for the 1995 rulemaking that amended the 
medical misadministration requirements (``Medical Misadministration of 
Radiation and Radioactive Material,'' 60 FR 48623; September 20, 1995). 
The Commission noted that ``If a misadministration occurs because the 
material was administered to the wrong individual, there may be no 
referring physician. If there is no referring physician, the licensee 
is relieved of the responsibility of notifying the referring physician, 
but must comply with all other requirements of Sec. 35.33.''
Issue 10: Why Is There a Requirement for a Licensee To Provide a 
Written Report to the Individual Affected by a Medical Event?
    Comment. The NRC received several comments on the need for a 
licensee to provide a written report to the individual affected by a 
medical event. Commenters were concerned that providing a written 
report to the individual may lead to a misunderstanding of the 
consequences for the patient (i.e., the individual may be unduly 
alarmed that a report had to be submitted to NRC) and jeopardize the 
individual's confidence in the ability of the physician providing 
medical care. Another commenter noted that there is no precedent for 
providing a written

[[Page 20333]]

report to a patient about a misadministration of other diagnostic 
agents.
    Response. The NRC deleted the current requirement to furnish an 
individual affected by a medical event with a written report. Instead, 
in the final rule licensees are required to inform the individual, or 
responsible relative or guardian, that a written description of the 
event can be obtained from the licensee upon request. Licensees are 
required to provide such a written description to the individual, if 
requested. We believe that a written report would be especially useful 
to an individual who needs to make decisions about any follow-up 
medical care, and provides the individual a permanent record to refer 
to for information about the event.
Issue 11: What Other Changes Were Made as a Result of Comments?
    Comment. It is not clear whether the thresholds in paragraph (a)(1) 
and either (a)(1)(i) or (ii) need to occur simultaneously for the event 
to be reported.
    Response. The NRC made editorial changes in the text of paragraph 
(a) to make it clearer that an event is only classified as a reportable 
medical event if both the threshold in paragraph (a)(1) and the 
threshold for the difference between the total dose and prescribed dose 
in paragraph (a)(1)(i) or the difference between the total dosage and 
prescribed dosage in paragraph (a)(1)(ii) or the difference between the 
fractionated dose delivered and the prescribed dose in paragraph 
(a)(1)(iii) have been exceeded.
    Comment. The word ``of'' is missing between ``20 percent'' (50 
percent in the final rule) and ``the dose expected'' in paragraph 
(a)(3) of this section that addresses the threshold for determining 
when a dose to a ``wrong treatment site'' is a reportable medical 
event.
    Response. The text of paragraph (a)(3) of this section has been 
corrected to read ``50 percent of the dose expected from the 
administration defined in a written directive.''
    Comment. Paragraphs (c)(1)(vi) and (vii) could be combined into one 
paragraph because they both address actions or improvements that have 
been taken, or are planned, to prevent recurrence of a medical event.
    Response. We combined the requirements in the proposed paragraphs 
into paragraph (d)(1)(vi) in the final rule.
Issue 12: Were There Any Other Changes Made in This Section Between the 
Proposed and Final Rule?
    Response. Yes. The NRC amended the title of this section to state 
more correctly that this section includes both reporting and 
notification requirements for medical events.
    The phrase ``results from intervention by a patient or human 
research subject'' in paragraph (a) of the proposed rule was deleted 
and replaced by ``an event that results from patient intervention'' in 
the final rule. We made this change because the definition of patient 
intervention in Sec. 35.2 includes actions by either a patient or human 
research subject, so paragraph (a) of the proposed rule contained 
duplicative language.
    We added the phrase ``administration of byproduct material or 
radiation from byproduct material'' in paragraph (a) of the final rule 
because the requirements in Part 35 are limited to the medical use of 
byproduct material.
    Paragraph (a)(1) was clarified to add the phrase ``dose that would 
have resulted from the prescribed dosage.'' This change was needed to 
clarify that this provision applies to the medical use of sealed and 
unsealed byproduct material as evidenced by the reference to ``total 
dosage'' in paragraph (a)(1)(ii).
    Paragraph (a)(1)(i) of the proposed rule that contained the 
threshold for the difference between the delivered dose or dosage and 
the prescribed dose or dosage was split into paragraphs (a)(1)(i) and 
(ii) in the final rule. We made this change to reflect the fact that 
physicians can prescribe a range of dosages, but not doses, in written 
directives.
    We replaced the word ``pharmaceutical'' in paragraph (a)(2)(i) with 
``radioactive drug containing byproduct material'' because the 
requirements in Part 35 are limited to the medical use of byproduct 
material.
    We amended paragraph (a)(3) to read ``50 percent or more'' (20 
percent in the proposed rule) to make it clearer that the dose to a 
wrong treatment site has to exceed 50 percent or more of the dose 
expected from the administration defined in the written directive 
before a licensee is required to report the event to NRC as a medical 
event.
    Paragraphs (d)(1)(v)and (vi) [paragraphs (c)(1)(v) and (vii) of the 
proposed rule] require that information on the effects of the medical 
event on the individual who received the administration and on the 
actions to prevent recurrence be included in the written report to the 
NRC. We reworded these paragraphs in the final rule to read ``the 
effect, if any, on the individual;'' and ``what actions, if any, have 
been taken, or are planned, to prevent recurrence.'' The words ``if 
any'' and ``are planned'' were added because there might not be any 
effect or any actions taken at the time the event is reported.
    We revised paragraph (d)(1)(vii) [paragraph (c)(1)(viii) in the 
proposed rule] to require that the written report include a 
certification that the licensee notified the individual (or the 
individual's responsible relative or guardian), and if not, why not. We 
made this revision because notifying these individuals is important 
enough to warrant documentation that the individual(s) was notified. In 
addition, we believe that it is important that the licensee notify the 
patient so that he or she can be actively involved in any decision 
about remedial or prospective health care following the event.
    We deleted paragraph (c)(1)(ix) in the proposed rule because the 
referring physician, and not the licensee, may have notified the 
individual. Therefore, the licensee may not know what information the 
referring physician provided to the individual.
    We amended paragraph (e) [paragraph (d) of the proposed rule] in 
the final rule. The words ``when appropriate'' were deleted from the 
last sentence in paragraph (d) of the proposed rule because the intent 
was covered by the phrase ``may be made'' in the same sentence.
    We added paragraph (g) to the final rule to require that licensees 
annotate a copy of their report to the NRC about the medical event and 
provide it to the referring physician, if other than the licensee, 
within 15 days after discovery of the medical event. We believe that it 
is important for the referring physician to have all the available 
documentation about the medical event to support any decision about 
remedial or prospective health care.

Section 35.3047, Report and Notification of a Dose To An Embryo/Fetus 
or a Nursing Child

Issue 1: Should the Abnormal Occurrence Policy Statement Criteria for 
Reporting of Unintended Exposures to an Embryo/Fetus or Nursing Child 
Be Modified?
    Comment. Numerous commenters recommended that Sec. 35.3047 be 
deleted and the Abnormal Occurrence (AO) Criteria be revised to reflect 
the deletion of this section.
    Response. The information required by this section is needed so 
that NRC can comply with Section 208 of the Energy Reorganization Act 
of 1974 (Pub. L. 93-438, 5848, 42 U.S.C.), as amended, to submit an 
annual report to

[[Page 20334]]

Congress of unscheduled incidents or events which the Commission 
considers significant from the standpoint of public health and safety, 
e.g., abnormal occurrences. (The ``Reports Elimination Act,'' Pub. L. 
104-66, changed the Abnormal Occurrence (AO) report to a yearly 
publication.)
    The NRC identifies an abnormal occurrence using the revised 
abnormal occurrence criteria that were published in the Federal 
Register (62 FR 18820; April 17, 1997). Section II of that policy 
statement defines unintended radiation exposure as ``any occupational 
exposure, exposure to the general public, or exposure as a result of a 
medical misadministration (as defined in Sec. 35.2) involving the wrong 
individual that exceeds the reporting values established in the 
regulations.'' This section also states that ``All other reported 
medical misadministrations will be considered for reporting as an 
Abnormal Occurrence under the criteria for medical licensees. In 
addition, unintended radiation exposures include any exposure to a 
nursing child, fetus, or embryo as a result of an exposure (other than 
an occupational exposure to an undeclared pregnant woman) to a nursing 
mother or pregnant woman above specified values.'' Appendix A, Section 
I.A.2., ``Abnormal Occurrence Criteria,'' of the policy statement, 
states that NRC will provide information on ``any unintended radiation 
exposure to any minor (an individual less than 18 years of age) 
resulting in an annual total effective dose equivalent of 50 mSv (5 
rem) or more, or to an embryo/fetus resulting in a dose equivalent of 
50 mSv (5 rem) or more.''
    At the present time, the NRC has no regulatory requirements that 
require licensees to report those types of events. Therefore, the 
Commission considered two alternatives: revise the current Abnormal 
Occurrence Criteria to delete the requirement to report this type of 
event to Congress; or develop a reporting requirement for licensees 
that would provide the information needed by the Commission to comply 
with Section 208.
    After extensive discussion and consideration of the public 
comments, we have decided to pursue the second option. We are not 
convinced that it is inappropriate for the NRC to report this type of 
event to Congress and that the reporting requirement in Sec. 35.3047 
will be overly burdensome or unwarranted. We are also not inclined to 
further revise the AO criteria because they have recently been revised 
and limited comments were received on the proposed criteria.
    The thresholds for reporting an unintended dose to an embryo/fetus 
or a nursing child have been raised in the final rule to the reporting 
levels in Appendix A, Section I.A.2, of the AO policy statement. 
Licensees are now required to report any unintended dose to an embryo/
fetus that is greater than 50 mSv (5 rem) dose equivalent and any dose 
to a nursing child that is either greater than 50 mSv (5 rem) effective 
dose equivalent or results in unintended permanent functional damage to 
an organ or a physiological system, as determined by a physician. We 
believe that Sec. 35.3047, as revised in the final rule, provides a 
balanced resolution of this issue. The regulatory burden on licensees 
will be substantially less than it would have been under the proposed 
Sec. 35.3047 because of the higher reporting thresholds in the final 
rule; and the NRC will receive the information it needs to report to 
Congress. In addition, because of the more serious consequences 
associated with these higher thresholds, we believe that the NRC should 
receive reports of these unintended doses to an embryo/fetus or nursing 
child.
Issue 2: What Is the Impact of the Proposed Reporting Requirement on 
Licensee Procedures, Activities, or Medical Practices?
    Comment. According to the comments, the biggest impact of the 
proposed reporting requirement on licensees is associated with the need 
to determine the pregnancy status of individuals. Commenters had many 
concerns about NRC's expectations of pregnancy testing, such as delays 
in emergency scans pending the completion of pregnancy tests; the 
sensitivity of pregnancy tests; false negative tests in early 
pregnancy; the age range for pregnancy testing; privacy of minors; 
patients refusing to pay for pregnancy tests; and the method for 
calculating conception dates.
    Commenters were also concerned about the licensees' 
responsibilities when they find out later that there was an unintended 
exposure to a pregnant individual. This can happen if, for example, the 
patient may not be aware of, or opts to conceal, the fact that she is 
pregnant. Licensees should not be held responsible for what patients do 
against medical advice and reporting such incidents will not prevent a 
recurrence. Unintended exposures may also occur in cases where the AU 
is not required to examine the patient, consult with the referring 
physician, or see the patient's chart, e.g., non-iodine diagnostic 
studies.
    Commenters said that the overwhelming majority of nuclear medicine 
procedures are safe to perform on pregnant women. In fact, they are 
often the tests of choice for pregnant women because other radiologic 
procedures frequently involve higher radiation doses. For the few cases 
in which administration of a pharmaceutical is not recommended (e.g., 
sodium iodide I-131), pregnancy information is ascertained. They 
believe that, by default, the proposed requirement will require 
pregnancy testing on every female of childbearing age. The inaccuracy, 
costs, etc. of the tests will lead patients to seek alternative, and 
often less effective, treatments.
    Response. The Commission recognizes that the standard of practice 
for AUs is to assess the pregnancy or nursing status of their patients 
(reference ACR ``Standard for the Performance of Therapy with Unsealed 
Radionuclide Sources,'' 1996, and ``Society of Nuclear Medicine General 
Procedure Guidelines for Imaging with Radionuclides,'' 1997). As a 
result, we do not believe that it is necessary for the NRC to require a 
licensee to assess the pregnancy or nursing status of patients before a 
medical treatment involving byproduct material.
    We do believe that it is appropriate to require the licensee to 
inform the NRC when the licensee learns of an unintended dose to an 
embryo/fetus or a nursing child that exceeds the thresholds in 
Sec. 35.3047. The occurrence of such an unintended dose does not 
necessarily mean that the licensee is in violation of the requirements 
in Part 35 as long as the licensee reports it and it is not otherwise 
in violation of NRC regulatory requirements.
    However, the NRC acknowledges that, in some cases, the licensee 
might not be able to prevent the dose to an embryo/fetus or nursing 
child. For example, there is no way for an AU to prevent administration 
of an unintended dose to an embryo/fetus if the pregnancy test was 
negative because it was given very early in the pregnancy.
Issue 3: What Should Be the Reporting Threshold for a Dose to an 
Embryo/Fetus or a Nursing Child?
    Comment. Commenters said that the proposed reporting level of 5 mSv 
(500 millirem) to an embryo/fetus or a nursing child is not consistent 
with the Commission's intent of making Part 35 more risk-informed and 
performance based because it cannot be justified on the basis of risk. 
This reporting level is also not consistent with the NRC's need to 
submit an annual report to Congress

[[Page 20335]]

on unscheduled incidents or events which the Commission considers 
significant from the standpoint of public health and safety, i.e., 
abnormal occurrences. One commenter noted that significant biological 
effects would not be observable at this reporting level in either an 
embryo/fetus or a nursing child, as demonstrated by the healthy births 
of children who were exposed to radiopharmaceuticals in utero for the 
purpose of diagnosing the mothers of these children. The only radiation 
doses that truly present a significant health and safety issue are 
those which result in actual non-stochastic effects. Therefore, another 
commenter suggested that the NRC consider only those medical events 
which result in actual non-stochastic effects as abnormal occurrences. 
In addition, one commenter said that there is no similar requirement by 
agencies regulating diagnostic x-ray machines. Furthermore, the 
proposed reporting level is going to result in NRC receiving a number 
of reports of questionable accuracy and utility.
    Commenters suggested a range of reporting levels from 1-25 rem dose 
equivalent. One commenter suggested that the reporting level should be 
the same as for medical events: 5 rem total effective dose equivalent 
or 50 rem to an organ or tissue. Another commenter noted that at his 
institution, genetic counselors do not consider radiation to be a risk 
until about 15-20 rem to the embryo/fetus. One commenter suggested that 
licensees report only radiation-induced injuries and deaths from 
radiopharmaceuticals and radiologic devices that were due to accidents 
and that were not reportable to the FDA.
    A commenter noted that NCRP Report No. 54, ``Medical Radiation 
Exposure of Pregnant and Potentially Pregnant Women'' (1977), states 
that the risk to the embryo/fetus is negligible below 5 rad and is only 
significant when compared to other risks of pregnancy above 15 rad. 
This is consistent with the recommendations in AAPM Radiation Therapy 
Task Group No. 36--Fetal Dose from Radiotherapy with Photon Beams, 1995 
(AAPM TG-36).
    Commenters also noted that the lack of adequate data makes it 
virtually impossible to accurately calculate radiation doses to an 
embryo/fetus at various gestational periods from radiopharmaceuticals. 
They also questioned how the NRC suggests that patients be monitored to 
ensure that they are complying with instructions about breast feeding 
if the nursing child could receive a dose in excess of 100 millirem.
    Response. Following an evaluation of the comments and further 
review of published recommendations and literature, the NRC changed the 
reporting thresholds in Sec. 35.3047 in the final rule. Paragraph (a) 
requires that a licensee report to the NRC any administration of 
byproduct material or radiation from byproduct material to a pregnant 
woman that results in a dose to an embryo/fetus that is greater than 50 
mSv (5 rem) dose equivalent unless the administration was specifically 
approved, in advance, by the AU. We emphasize that only unintended 
exposures must be reported to the NRC. If a licensee knows that an 
individual is pregnant and makes the decision that it is necessary to 
proceed with a test involving the administration of byproduct material 
or radiation from byproduct material, the licensee would not have to 
report the dose to the pregnant individual as a medical event. 
Paragraph (b) requires that a licensee report to NRC any administration 
of byproduct material to a breast-feeding woman that results in a dose 
to the nursing child that is greater than 50 mSv (5 rem) total 
effective dose equivalent or a dose that has resulted in unintended 
permanent functional damage to an organ or a physiological system, as 
determined by a physician. These reporting levels are consistent with 
the recommendations in NCRP Commentary No. 9, ``Considerations 
Regarding the Unintended Radiation Exposure of the Embryo, Fetus or 
Nursing Child'' (1994). At a reporting threshold of 50 mSv (5 rem), 
there are no detectable deterministic effects, and the risk of 
stochastic effects (e.g., cancer) is less than 1 percent. This report 
concluded that ``setting requirements for action after radiation 
exposure of the embryo, fetus, or nursing child at some level below an 
effective dose of 100 mSv (10 rem) to allow for a margin of safety 
should enable all such incidents with the potential for harm to be 
dealt with appropriately.''
    We believe that the reporting threshold on the final rule is not 
overly burdensome on licensees. Unintended doses to an embryo/fetus or 
nursing child exceeding 50 mSv (5 rem) are rarely encountered in the 
practice of nuclear medicine (refer, for example, to Russell, J.R., et. 
al, Radiation Absorbed Dose to the Embryo/Fetus from 
Radiopharmaceuticals, Health Physics 73:756-769;1997).
Issue 4: Should Sec. 35.3047 Include a Requirement for a Licensee To 
Notify a Pregnant Individual or Mother About an Event That Must Be 
Reported to the NRC in Accordance With This Section?
    Comment. The physician should be able to determine whom to notify. 
The method and extent of notifying a pregnant individual or mother are 
solely a matter of the physician's judgment, within the context of the 
physician-patient relationship. In some cases, the best individual to 
notify may be the pediatrician (or future pediatrician), which is not 
an option in the rule. The pediatrician, not the mother's referring 
physician, will be caring for the infant. The notification requirements 
in this section are an intrusion into the practice of medicine.
    Response. The NRC retained the requirement for notification of the 
pregnant individual or mother in the final rule. Although notification 
of the pregnant individual or mother may represent the ``standard of 
care,'' that practice may not be uniformly followed. We believe that 
the pregnant individual or mother should be notified so that she can 
participate in any decisions on follow-up medical care, if necessary.
Issue 5: Is there a Better Term Than ``Responsible Relative or 
Guardian'' That Could be Applied to Those Situations Where the Mother 
is Not Notified, e.g., in the Referring Physician's Medical Judgment 
Telling the Mother Would Be Harmful; the Mother Is a Minor; or the 
Mother Is Not Competent To Make Decisions Regarding Medical Care?
    Comment. Several comments were received in response to this 
question, which was published in the proposed rule. Some commenters 
said that the term ``responsible relative or guardian'' itself was 
sufficient, and recommended no alternative wording. The term 
``guardian'' appears to be very clear because the only comment on 
guardian said that it does not need to be fixed.
    The NRC also received several comments on the interpretation of 
``responsible relative.'' Several commenters hoped that ``responsible'' 
is not used as a substitute for ``legal.'' The term ``responsible'' 
should allow for notification of someone who cares for the minor but 
who is neither a blood relative nor a legal guardian. Not telling the 
mother only because she is a minor is not a responsible rule and is 
inappropriate. The medical community and the laws of each state 
determine if a mother is allowed information that may affect her child 
if she is a minor. The other two situations, it would be

[[Page 20336]]

harmful to the mother or the mother is not competent, should cover when 
notification of the responsible relative or guardian is necessary. 
Another commenter said that for an adult, what is really meant by 
notifying the ``responsible relative'' is notifying the relative or 
individual who has medical power of attorney.
    Response. The final rule retains the current phrase ``responsible 
relative or guardian'' because the NRC did not receive any suggested 
term that better captures the intent of this requirement, which is that 
someone be told in those situations where the mother is not notified. 
We believe this terminology could include an individual who has medical 
power of attorney. However, it would be unduly restrictive to limit the 
individual to be notified, in lieu of the patient, to an individual 
with medical power of attorney. A physician's decision on whom to 
notify is based on many factors, including the Code of Medical Ethics 
of the American Medical Association and state laws that govern the 
release of a patient's medical information to another individual.
    To assist with the interpretation of the current notification 
requirements in the misadministration rule, the Commission had 
previously provided the examples used in the question of when it 
expects that a ``responsible relative or guardian,'' rather than the 
patient, would be notified about a misadministration. These were 
provided only as examples, and are not part of the actual regulatory 
text, e.g., we did not intend by the examples that a mother should not 
necessarily be notified if she is a minor. We believe that the 
referring physician should have the discretion to either inform the 
mother or to determine that, based on medical judgment, telling her 
would be harmful, in which case the mother's or child's responsible 
relative should be notified.
Issue 6: Why Do Licensees Need To Notify the NRC, by Telephone, Within 
5 Days and in Writing no Later Than 15 Days After Discovery of a Dose 
to an Embryo/Fetus or Nursing Child that Requires a Report Under This 
Section?
    Comment. Commenters questioned the need to notify NRC by telephone 
within 5 days and in writing no later than 15 days after discovery of a 
dose to an embryo/fetus or nursing child that requires a report under 
this section. These reporting requirements give the perception that 
there is much greater harm than there actually is. One commenter said 
that the licensee should only have to report in writing to the Regional 
Office within 30 days after discovery of the dose. The other commenter 
said that notification of the NRC should be changed from 5 days to 15 
days after discovery of the event, or at least changed to 5 working 
days so there is ample time over a holiday period. The additional time 
is needed for the licensee to assure the validity of the information in 
the report.
    Response. The final rule contains a significantly higher reporting 
threshold than the proposed rule for reporting an unintended dose to a 
nursing child or an embryo/fetus as a result of the unintentional 
administration of byproduct material or radiation from byproduct 
material. Licensees are now required to report any dose to an embryo/
fetus that is greater than 50 mSv (5 rem) dose equivalent and any dose 
to a nursing child that is either greater than 50 mSv (5 rem) effective 
dose equivalent or results in unintended permanent functional damage to 
an organ or a physiological system, as determined by a physician. More 
serious consequences are associated with these higher thresholds. 
Therefore, the reporting requirement in the proposed rule to notify the 
NRC within 5 days after discovery of the unintended dose has been 
revised to require notification of the NRC no later than the next 
calendar day. Early telephone notification will allow the NRC to 
promptly take any necessary actions based on the circumstances, e.g., 
dispatch a medical consultant. Prompt notification of events that 
trigger these thresholds is important because the circumstances of the 
medical event may need to be reviewed as soon as possible to determine 
if any follow-up actions are necessary.
    The reporting requirement in the proposed rule to submit a written 
report to the NRC Regional Office no later than 15 days after discovery 
of the dose has also been retained in the final rule. We believe that 
the 15 day reporting period is justified by the more serious 
consequences associated with the higher reporting thresholds. It is 
important that the NRC has all of the information in the written report 
as soon as possible to evaluate the event and to determine if any 
follow-up actions are available. The rule language recognizes that the 
licensee may not have all of the final information on the event at the 
time the report is submitted to NRC.
Issue 7: Were There any Other Changes Made in This Section Between The 
Proposed and Final Rules?
    Response. Yes. The NRC amended the title of this section to state 
more correctly that this section includes both reporting and 
notification requirements following a dose to an embryo/fetus or 
nursing child that exceeds the thresholds in Sec. 35.3047.
    We amended paragraph (b)(2) to read `` * * * permanent functional 
damage to an organ or a physiological system of the child * * *'' to 
make it clear that this reporting criterion applies to the nursing 
child.
    We combined paragraphs (d)(1)(vi) and (vii) in the proposed rule 
into one paragraph [(d)(1)(vi)] in the final rule because they both 
address actions or improvements that have been taken, or are planned, 
to prevent recurrence of a medical event.
    We reworded paragraphs (d)(1)(v)and (vi) in the final rule to read 
``the effect, if any, on the embryo/fetus or the nursing child;'' and 
``what actions, if any, have been taken, or are planned, to prevent 
recurrence.'' We added the words ``if any'' and ``are planned'' because 
there might not be any effect or any actions taken at the time the 
event is reported. We deleted paragraph (d)(1)(vi) in the proposed rule 
because it was duplicative of paragraph (d)(1)(vii).
    We added a new paragraph (d)(1)(vii) to require that the written 
report include a certification that the licensee notified the pregnant 
individual or mother (or the mother's or child's responsible relative 
or guardian), and if not, why not. This provides NRC with documentation 
that the pregnant individual or mother was notified. We made this 
revision because notifying these individuals is important enough to 
warrant documentation that the individual(s) was notified. In addition, 
we believe that it is important that the licensee notify the pregnant 
individual or mother so that she can be actively involved in any 
decision about remedial or prospective health care following the event.
    We amended paragraph (e) [paragraph (d) of the proposed rule] in 
the final rule. The words ``when appropriate'' were deleted from the 
last sentence in paragraph (d) of the proposed rule because the intent 
was covered by the phrase ``may be made'' in the same sentence.
    We combined proposed paragraphs (e), (f), and (g) into one 
paragraph so the format of this section is similar to the section on 
reporting medical events.
    Paragraph (h) of the proposed rule that required the licensee to 
furnish the mother, or responsible relative or guardian, with a written 
report was deleted in the final rule. Instead, paragraph (e) in the 
final rule requires licensees to inform the mother, or the mother's or 
child's responsible relative or guardian, that a written description of 
the event can be obtained from the licensee upon request. Licensees are

[[Page 20337]]

required to provide such a written description to the individual, if 
requested. We believe that a written description would be especially 
useful to an individual who needs to make decisions about any follow-up 
medical care, and provides the individual a permanent record to refer 
to for information about the event.
    We added paragraph (f) to the final rule to require that licensees 
annotate a copy of their report to the NRC about the event and provide 
it to the referring physician, if other than the licensee, within 15 
days after discovery of the event. We believe that it is important for 
the referring physician to have all the available documentation about 
the event to support any decision about remedial or prospective health 
care. The 15-day time period to provide the referring physician with a 
copy of the record was based on paragraph (d) which requires a licensee 
to submit a report to the NRC within 15 days. We have attempted to have 
consistency in the requirements in Subparts L and M, where possible, to 
simplify compliance with the recordkeeping and reporting requirements.

Section 35.3067, Report of a leaking source

Issue: Where There any Changes Made in This Section Between the 
Proposed and Final Rules?

    Response. Yes. The NRC changed the title of this section so that it 
refers to a single report. This change makes the title of this section 
consistent with the titles of the other sections in Subpart M.
    We made this section more performance based by using ``the results 
of the test'' instead of the more detailed requirements of ``the 
measured activity of each test sample expressed in microcuries'' and 
``a description of the method used to measure each test sample.'' These 
changes are consistent with changes made in response to comments on 
Sec. 35.2067, Records of leaking sources.

IV. Summary of Comments on Agreement State Compatibility and 
Responses to Comments

Part 1: General Questions

Issue 1: How does NRC Determine if a Requirement Should Be Given a 
Health and Safety (H&S) Classification?
    Comment. Several commenters expressed a concern regarding the 
compatibility categories, especially those designated as ``D (H&S)''. 
Commenters stated that the (H&S) classification has nothing to do with 
compatibility but does apply to adequacy of a State's radiation control 
program. They further stated that, if the NRC finds it necessary to use 
this classification, then it should define the ``significant safety 
issues'' that led to the (H&S) designation. Other commenters stated 
that H&S designations for Agreement State requirements is a ``back 
door'' to compatibility requirements and may be unevenly and/or 
inappropriately enforced. Commenters recommended that if a requirement 
must be adopted by an Agreement State in order for that State's program 
to be found ``adequate,'' the requirement should be assigned a 
``compatibility'' designation. H&S designations should be assigned only 
when a requirement has a direct Part 20 connection.
    Response. On September 3, 1997, the Commission approved an Adequacy 
and Compatibility Policy for Agreement State Programs. This policy was 
developed in an open environment, with early and substantive 
involvement by Agreement State representatives. Management Directive 
5.9, ``Adequacy and Compatibility of Agreement State Programs'' 
(Adequacy and Compatibility Policy) provides guidance on applying the 
Adequacy and Compatibility Policy to Agreement State program elements 
including regulations.
    The assignment of compatibility categories to each requirement in 
the revised rule has been made in accordance with the Adequacy and 
Compatibility Policy. The compatibility category assignments are needed 
to assure that byproduct material is used with a minimum level of 
safety nationwide. Those program elements (including regulations) which 
are not required for compatibility, as noted in the Adequacy and 
Compatibility Policy, may be required because of their health and 
safety (H&S) significance. The NRC has reviewed and revised, where 
appropriate, the chart detailing the compatibility categories for each 
requirement in the final rule. Each requirement in the rule, identified 
for compatibility or adequacy, has an accompanying rationale explaining 
its health and safety significance or its need based on consistency 
between NRC and Agreement State programs.
    NRC conducts performance based reviews of Agreement State programs 
in accordance with the Integrated Materials Performance Evaluation 
Program (IMPEP). Findings of Adequacy and Compatibility for each 
Agreement State program are made by a management review board (MRB) 
consisting of senior NRC managers along with a manager from an 
Agreement State. These findings are made based on a number of factors, 
including regulations.
    Under the Adequacy and Compatibility Policy, and the review of 
Agreement State programs under IMPEP, the Agreement States are provided 
flexibility in administering their programs. Regulations and other 
program elements identified as having adequacy or health and safety 
significance may be addressed through the promulgation of compatible 
regulations or the adoption of other legally binding documents. Final 
findings of Agreement State program adequacy and compatibility are made 
by the MRB based on their assessment of the entire program, not just 
its regulations. This process assures a level of consistency in the 
review of Agreement State programs. Each Agreement State program 
director is afforded an opportunity to appear before the board to 
explain his or her State's performance and answer questions from the 
MRB.
Issue 2: What Flexibility Should Be Given to Agreement States?
    Comment. A commenter stated that Part 35 should not be a matter of 
compatibility for the Agreement States beyond requiring that states 
have a system for authorizing the medical use of byproduct material. 
Another commenter stated that the Agreement States should be allowed to 
regulate medical users as appropriate and as needed. They believed that 
the rule should be a low compatibility issue. Another commenter stated 
that the proposed Part 35 will deal a death blow to the Agreement State 
Program by demanding that every Agreement State adopt the essential 
portions of NRC's new Part 35 under threat of being incompatible and 
inadequate. The commenter stated that the Agreement States want 
flexibility. A commenter also expressed that this may cause Agreement 
States to give back their programs.
    On this same topic, a commenter stated that nearly all of NRC's 
policy on Agreement State adequacy and compatibility should be 
rejected. The practices of medicine and pharmacy have no 
``transboundary implications'' and should be changed from compatibility 
Category ``B'' to ``D'' because they are State functions. All 
compatibility category ``C'' items should be changed to ``D'' because 
they are too restrictive. All ``Health and Safety'' (H&S) requirements 
for adequacy should be removed because they are not necessary for 
``Health and Safety.'' The commenter further stated that, ``Health and 
Safety'' is accomplished by starting

[[Page 20338]]

with qualified professionals who follow professional standards.
    In contrast, commenters stated that a uniform or relatively uniform 
approach nationwide between Agreement State regulations and NRC 
regulations can be worked out and can be adopted. In particular, the 
American Association for Nuclear Cardiology requested that the NRC 
require the new Part 35 requirements to be at least a level C 
compatibility for the Agreement States.
    Response. The Adequacy and Compatibility Policy for Agreement 
States Programs is explained in response to Issue 1. The assignment of 
the specific compatibility categories to the requirements in the 
revised rule is necessary to assure that byproduct material is used 
with a uniform level of radiation safety nationwide. This is different 
from the State regulation of medicine and pharmacy, which addresses 
global safety and competency issues.
Issue 3: Was the Comment Period on the Proposed Rule and on 
Compatibility Assignments Extended?
    Comment. Agreement State representatives commented that the comment 
period was too brief to allow a comprehensive review of the rule, the 
licensing guide, and the compatibility listing. They also asked that we 
provide a listing of essential objectives for each section and why 
particular designations were assigned. In addition, Agreement State 
representatives asked that the comment period for the rationale for 
compatibility assignments should be extended up to 90-days after 
publication of the listing. They further stated that the degree of 
flexibility allowed the Agreement States is an important issue and 
should not be omitted from the discussion because information was not 
available in a timely manner.
    Response. Supplement III of this document contains more detailed 
discussion of the comments that we received on the length of the 
comment period. As a result of public comment, we extended the comment 
period on the proposed rule from November 12, 1999 to December 16, 
1999.
    The proposed rule contained a brief explanation of the 
compatibility assignments that were made for the proposed rule. 
Subsequent to that publication, we received requests from Agreement 
State representatives to provide supporting documentation for how the 
assignments were made and to provide the essential objectives for each 
section. This information has been made available to the Agreement 
States in an All Agreement States letter, dated January 4, 1999. We 
asked that the States provide comments and suggestions on the 
compatibility designations by February 12, 1999.
    The NRC considered all comments received on the compatibility 
designations and, where appropriate, made changes to either the 
assignment or to the rationale for the assignment. Section X of this 
document contains a summary of the compatibility designations. A more 
detailed compatibility chart which provides the essential objectives 
for each section and why particular designations were assigned is 
posted on the NRC Website at http://www.hsrd.ornl.gov/nrc/home.html. 
Click on [NRC-State Letters] and then select Part 35 Compatibility 
Chart.
Issue 4: How has NRC Incorporated Comments From the Agreement States on 
Agreement State issues?
    Comment. A commenter questioned how the Agreement States comments 
were considered during the rulemaking.
    Response. In the early stages of the rulemaking process, the NRC 
established a working group and a steering committee comprised of State 
personnel and NRC staff. One member of the NRC working group was also a 
member of the Conference of Radiation Control Program Director's, Inc., 
SR-6 Committee. This Committee is responsible for revising Part G, 
``Medical Use of Radionuclides,'' of the Suggested State Regulations. 
As such, there was a considerable amount of information exchanged 
between the States and the NRC staff during the development of the 
proposed and final rule. We also discussed the revision of Part 35 with 
representatives of the Agreement States at the 1997, 1998, and 1999 
annual meetings of the Organization of Agreement States. In addition, 
we received numerous comment letters from the States, all of which were 
considered in developing the final rule.
    Technical comments and our response to the comments are discussed 
under the specific section headings. More general comments or comments 
that pertain exclusively to the compatibility level assigned to the 
requirement are discussed in this section.

Part 2--Comments on Compatibility Designations

    The NRC received numerous comments on the compatibility 
designations assigned to specific sections. The following part provides 
the comments and our response to the comments. In many cases, but not 
all, we made changes to the compatibility designation based on the 
comment.

Part 20--Standards for Protection Against Radiation

Section 20.1301, Dose Limits for Individual Members of the Public

    Comment. A commenter stated that this requirement should not be a 
compatibility category A. The compatibility category for this 
requirement should be D.
    Response. This section meets the criteria for compatibility 
category A because it is an NRC program element which is generally 
applicable and is a dose limit. No change is required.

Part 35--Medical Use of Byproduct Material

Section 35.6, Provision for Research Involving Human Subjects

    Comment. A commenter stated that compelling Agreement States to 
adopt this requirement does not reflect that there may be other 
criteria affecting human research subjects.
    Response. A further review of this section indicates that Agreement 
States should adopt this requirement in order to avoid a gap in the 
consistent nationwide application of this Federal policy. The 
compatibility category was changed from ``D'' to ``C.'' The NRC also 
added a requirement to the section indicating that nothing in this 
section relieved licensees from complying with the other requirements 
in Part 35.

Section 35.24, Authority and Responsibilities for the Radiation 
Protection Program

    Comment. A commenter stated that this requirement should be 
classified compatibility category D, not D Health and Safety (H&S). The 
commenter indicated that, while management should be responsible for 
the areas identified here, there may be other ways to ensure radiation 
safety. Further, in the opinion of the commenter, the intent of this 
requirement will be defeated for small facilities where the AU/RSO is 
management's designee.
    Response. Section 35.24 in the final rule is assigned a 
compatibility category D, with the exception of paragraphs (b) and (f). 
These two paragraphs are assigned to compatibility category H&S. The 
H&S compatibility category provides the Agreement States with the 
flexibility needed to use other methods such as legally binding 
requirements to achieve the essential objective of this rule. In 
addition, Sec. 35.24(b) and (f) meet the two failure test criteria for 
the assignment of compatibility category H&S. This designation provides 
a

[[Page 20339]]

minimum level of safety in the implementation of a radiation protection 
program.

Section 35.40, Written Directives

    Comment. A commenter stated that the requirement for a written 
directive may not be contained in the State's radiation regulations. 
Another commenter stated that written directives do not meet the 
definition for a compatibility category C in Subpart A, because it does 
not create a gap or a duplication. It was also noted that written 
directives are a compatibility category ``D (H&S)'' in Subpart B. 
Another commenter stated that written directives should not be 
designated compatibility category H&S and that there are other methods 
to ensure the right dose is delivered to the right patient (e.g., 
requiring the physician to be present during a therapy treatment).
    Response. In the final rule, paragraphs (a) and (b) of Sec. 35.40, 
``Written Directives,'' are assigned a compatibility category H&S. The 
NRC believes that it may be possible to ensure the right dose is 
delivered to the right patient if a legally binding requirement is in 
effect and there is some documentation by the physician in the routine 
radionuclide use log. In accordance with the Policy on Adequacy and 
Compatibility for Agreement State Programs, legally binding 
requirements may be acceptable in lieu of a specific regulation on 
written directives if the essential objectives of this rule are 
achieved. Section 35.40 meets the two failure test criteria for the 
assignment of compatibility category H&S. This designation provides a 
minimum level of safety for the medical use of agreement materials by 
reducing the likelihood of a medical event.

Section 35.61, Calibration of Survey Instruments

    Comment. A commenter stated that the requirement in Sec. 35.61 to 
note the date of the calibration on an instrument should not be a 
compatibility category H&S. The length of time for record retention is 
not a compatibility category H&S and should be designated a 
compatibility category C in all areas of the regulations.
    Response. The NRC agrees with the commenter that the requirement to 
note the calibration date on a survey instrument and the record 
retention requirement should not be a compatibility category H&S. 
Therefore, these requirements have been revised from H&S to a 
compatibility category D. All of the other requirements in Sec. 35.61 
remain compatibility category H&S.

Section 35.63, Determination of Dosages of Unsealed Byproduct Material 
for Medical Use

    Comment. A commenter stated that there may be some confusion 
regarding the compatibility category assigned to the requirement 
covering radiopharmaceutical dosages prepared by the medical use 
licensee under 10 CFR 35.63 versus those prepared by a commercial 
pharmacy/manufacturer under 10 CFR 32.72.
    Response. Both medical licensees and the commercial preparer of 
radiopharmaceuticals must determine and record the activity of each 
dosage intended for medical use. Therefore, this requirement is a 
compatibility category H&S.

Section 35.67, Requirements for Possession of Sealed Sources and 
Brachytherapy Sources

    Comment. A commenter stated that paragraph (a) should be a 
compatibility category C. The commenter believed that licensees can 
develop better procedures and should have the opportunity to submit 
them for review and approval by the licensing agency.
    Response. Section 35.67(a) meets the two failure test criteria for 
the assignment of compatibility category H&S. This designation assists 
in establishing a minimum level of safety for the medical use of 
agreement materials by reducing the likelihood of a medical event and 
worker overexposure.
    Comment. A commenter stated that paragraph (f) rather than (e) 
should be a compatibility category D and paragraph (e) should be a 
compatibility category ``D (H&S)''. Another commenter stated that 
paragraph (f) which provides a waiver of leak test requirements does 
not meet the criteria for compatibility category H&S.
    Response. Paragraph (e) is a compatibility category H&S because the 
technical requirements are already addressed in Part 20 and Part 30 and 
the actual reporting requirement for leaking sources is contained in 
Sec. 35.3067 which is a compatibility category C. We agree with the 
commenters. The compatibility category for paragraph (f) was revised 
from H&S to D.

Section 35.70, Surveys of Ambient Radiation Exposure Rate

    Comment. A commenter questioned the need for a compatibility 
category H&S for paragraph (b).
    Response. The NRC agrees with the commenters and have revised this 
section to indicate that Sec. 35.70(b) is assigned a compatibility 
category D.

Section 35.75, Release of Individuals Containing Radioactive Drugs or 
Implants Containing Byproduct Material

    Comment. A commenter stated that 10 CFR 35.75, which has been 
assigned a compatibility category C, should be changed to category B 
due to significant transboundary implications.
    Response. The assignment of a compatibility category C to this 
requirement is appropriate because the term transboundary applies to 
the use of byproduct material by licensees which operate in multiple 
locations. The compatibility category C designation provides a minimum 
level of safety, while providing some flexibility to Agreement States 
to be more restrictive.

Section 35.80, Provisions of Mobile Medical Service

    Comment. A commenter did not agree with the original basis for 
designating this section as D compatibility. They disagreed with the 
following statement: ``since there is no potential for medical use of 
byproduct material in other regulatory jurisdictions under 
reciprocity'' the section is designated a D compatibility.''
    Other commenters commented on specific paragraph designations. A 
commenter stated that paragraph (a)(1) should not be a compatibility 
category H&S issue. Another commenter stated that paragraph (a)(4) 
should be a compatibility category H&S issue, but that the designation 
is inconsistent with the requirements for fixed facilities. (Note: 
Fixed facilities have to conduct surveys only for procedures requiring 
a written directive (Sec. 35.70)).
    Response. The Agreement State representatives informed the NRC 
staff that not all Agreement States authorize mobile services and that 
there are a number of additional State professional and technical 
licensing issues which complicate this activity. The medical use of 
byproduct material (diagnostic or therapeutic) as a mobile service has 
been designated a compatibility category D for all Agreement States 
(not required for compatibility) and category H&S for those Agreement 
States which authorize mobile services. This designation H&S assists in 
establishing a minimum level of safety for the medical use of agreement 
materials by reducing the likelihood of a medical event and worker 
overexposure.
    The NRC agrees with the specific comments on paragraphs (a)(1) and 
(a)(4). The compatibility categories were revised from H&S to D in 
these sections.

Section 35.92, Decay-In-Storage

    Comment. A commenter stated that this section should not be a

[[Page 20340]]

compatibility category H&S issue. The failure scenario is in error in 
that it assumes waste would be placed in ordinary trash if storage of 
isotopes with longer or shorter half-lives were permitted. Permitting 
decay-in-storage does not mean material that has not decayed would be 
placed in ordinary trash.
    Response. This section is a compatibility category D for those 
States that choose not to allow the decay-in-storage option. For States 
allowing this option, the compatibility category is H&S. The two or 
fewer failure test scenario was reworded to better reflect the 
importance of the H&S assignment for this requirement.

Sections 35.100, Use of Unsealed Byproduct Material for Uptake, 
Dilution, and Excretion Studies for Which a Written Directive Is Not 
Required and 35.200, Use of Unsealed Byproduct Material for Imaging and 
Localization Studies for Which a Written Directive Is Not Required

    Comment. A commenter questioned the assignment of a compatibility 
category H&S to Secs. 35.100 and 35.200 because they are very low risk 
procedures.
    Response. Both requirements meet the two or fewer failure test 
scenario detailed in Management Directive 5.9 for the assignment of 
compatibility category H&S. These provisions assist in establishing a 
minimum level of safety in the medical use of agreement materials by 
reducing the likelihood of a medical event.

Section 35.390, Training for Use of Unsealed Byproduct Material for 
Which a Written Directive Is Required

    Comment. A commenter believed that Agreement States should have the 
option of adopting higher standards for training even if it means the 
state would become ``incompatible.''
    Response. A compatibility category B was assigned to this 
requirement, as well as all of the other training and experience 
requirements in Part 35. This ensures that the training and experience 
requirements for the medical use of byproduct material are consistent 
between NRC and the Agreement States.

Section 35.432, Calibration Measurements of Brachytherapy Sealed 
Sources

    Comment. A commenter stated that this requirement should not be a 
compatibility category C.
    Response. This requirement was assigned a compatibility category 
H&S which provides a minimum level of safety for the medical use of 
agreement materials by reducing the likelihood of a medical event.

Section 35.604, Surveys of Patients and Human Research Subjects Treated 
With a Remote Afterloader Unit

    Comment. A commenter stated that the requirement for after implant 
surveys is not appropriate for a compatibility category C, since it is 
a Part 20 requirement.
    Response. The NRC agrees with this comment and has changed the 
requirement to a compatibility category H&S.

Sections 35.610, Safety Procedures and Instructions for Remote 
Afterloader Units, Teletherapy Units, and Gamma Stereotactic 
Radiosurgery Units

    Comment.A commenter stated that Sec. 35.610 should be compatibility 
category C, as there can be other ways of meeting the essential 
objectives.
    Response. Section 35.610 meets the two or fewer failure test 
criteria for the assignment of compatibility category H&S. This 
designation assists in establishing a minimum level of safety for the 
medical use of agreement materials by reducing the likelihood of a 
medical event and worker overexposure.

Section 35.615, Safety Precautions for Remote Afterloader Units, 
Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

    Comment. A commenter stated that Sec. 35.615 should be 
compatibility category C, as there can be other ways of meeting the 
essential objectives.
    Response. Section 35.615 meets the two or fewer failure test 
criteria for the assignment of compatibility category H&S. This 
designation assists in establishing a minimum level of safety for the 
medical use of agreement materials by reducing the likelihood of a 
medical event and worker overexposure.
General Comments on Training
    Comment. A commenter stated that when the Part 35 rulemaking 
becomes effective, Agreement States that have more strict training and 
experience requirements for non-board certified physicians will not be 
able to accept individuals who have met the less restrictive 
requirements needed to become AUs on NRC licenses as authorized.
    Response. When the final Part 35 becomes effective, the Agreement 
States will have up to 3 years to adopt compatible regulations. The 
training and experience criteria for physicians is a compatibility 
category B which means that the requirement has significant direct 
transboundary implications. Agreement States' requirements should be 
essentially identical to those of the NRC so that there are consistent 
training and experience requirements for the medical use of byproduct 
material. Non-board certified physicians will continue to be afforded 
the opportunity to present alternate credentials on a case-by-case 
basis.

V. Summary of Changes Made Between the Current Part 35 and the 
Revised Part 35

    Subpart A, General Information, contains general information 
regarding medical use of byproduct material.
    Section 35.1, Purpose and scope, was amended to specify that Part 
35 provides for the radiation safety of workers, the general public, 
patients, and human research subjects. The NRC included the phrase 
``patients, and human research subjects'' to make it clear that the 
provisions of this rule apply to the radiation safety of those 
individuals. This addition is consistent with the revision of the 
Medical Use Policy Statement that was published in the Federal Register 
on August 3, 2000 (65 FR 47654). We also added a reference to Part 171, 
``Annual Fees for Reactor Operating Licenses, and Fuel Cycle Licenses 
and Materials Licenses, Including Holders of Certificates of 
Compliance, Registrations, and Quality Assurance Program Approvals and 
Government Agencies Licensed By NRC.'' This change makes it clear that 
the provisions in Part 171 apply to medical licensees.
    Section 35.2, Definitions, was amended. The NRC either deleted, 
revised, or added specific definitions based on the use of the terms 
within Part 35. Each category of action is discussed separately.

Deleted Definitions

    The NRC deleted the following terms because they do not appear in 
the final rule: as low as is reasonably achievable (ALARA), dental use, 
diagnostic clinical procedures manual, ministerial change, 
misadministration, podiatric use, recordable event, and teletherapy 
physicist.

Revised Definitions

    The NRC revised the definitions of address of use and area of use 
to clarify that they also include the building where byproduct material 
is prepared for use. This recognizes that licensees not only receive, 
use, and store byproduct material, but, in the case of medical 
licensees, they may also prepare the material for use.

[[Page 20341]]

    The NRC revised the definition for authorized nuclear pharmacist 
(ANP) to eliminate the specific board certifications by name and to 
refer to the specific section(s) in Part 35 containing the requirements 
the individual must meet to be considered an ANP. We deleted the 
reference to the specific board certifications because the regulatory 
text in Part 35 no longer incorporates a listing of specialty boards 
whose diplomates automatically fulfill the training and experience 
requirements. In place of listing the boards, the final rule provides 
for NRC recognition of the boards. We revised the definition of ANP to 
include individuals identified as ANPs on a specific license issued by 
the Commission or Agreement State that authorizes medical use or the 
practice of nuclear pharmacy; a permit issued by a Commission master 
material licensee that authorizes medical use or the practice of 
nuclear pharmacy; a permit issued by a Commission or Agreement State 
broad scope medical use licensee that authorizes medical use or the 
practice of nuclear pharmacy; or a permit issued by a Commission master 
material license broad scope medical use permittee that authorizes 
medical use or the practice of nuclear pharmacy. In addition, an ANP 
can be an individual identified as an authorized nuclear pharmacist by 
a commercial nuclear pharmacy which has been given authorization to 
identify authorized nuclear pharmacists or an individual designated as 
an authorized nuclear pharmacist in accordance with Sec. 32.72(b)(4).
    The NRC revised the definition for an authorized user (AU) to 
eliminate the specific board certifications by name and to refer to the 
specific section(s) in Part 35 containing the requirements the 
individual must meet to be considered or an AU. We deleted the 
reference to the specific board certifications because the regulatory 
text in Part 35 no longer incorporates a listing of specialty boards 
whose diplomates automatically fulfill the training and experience 
requirements. In place of listing the boards, the final rule provides 
for NRC recognition of the boards. We revised the definition of AU to 
include individuals identified as AUs on a Commission or Agreement 
State license that authorizes the medical use of byproduct material; a 
permit issued by a Commission master material licensee that is 
authorized to permit the medical use of byproduct material; a permit 
issued by a Commission or Agreement State specific licensee of broad 
scope that is authorized to permit the medical use of byproduct 
material; or a permit issued by a Commission master material license 
broad scope permittee that is authorized to permit the medical use of 
byproduct material.
    The NRC revised the definition for a brachytherapy source to 
acknowledge current practices within the radiation oncology field. In 
addition, we deleted the word ``sealed'' from the definition to include 
sources that do not meet the definition of ``sealed source,'' i.e., 
radioactive plated, embedded, and activated sources.
    The NRC revised the definition of management to recognize an 
individual having the authority to manage, direct, or administer the 
licensee's activities who may not have the title of Chief Executive 
Officer.
    The NRC amended the definition of medical use to replace the word 
``therefrom'' with the phrase ``from byproduct material'' because the 
regulations in Part 35 apply only to the medical use of byproduct 
material.
    The NRC replaced the definition of mobile nuclear medicine service 
with a definition for mobile medical service because it is a broader 
term that encompasses all modalities that could be performed by a 
mobile medical service.
    The NRC revised the definition of output to refer to the exposure 
rate or dose rate coming from a brachytherapy source, remote 
afterloader, or gamma stereotactic radiosurgery unit. The current rule 
only addresses the output from a teletherapy unit.
    The NRC revised the definitions of prescribed dosage and prescribed 
dose. As modified, the definition of prescribed dosage allows the AU to 
prescribe a range of activity, without reference to the diagnostic 
clinical procedures manual. The term unsealed byproduct material in 
this definition replaces the term radiopharmaceutical. We added a 
reference to remote afterloaders to the definition of prescribed dose.
    The NRC revised the definition of Radiation Safety Officer (RSO) to 
include a reference to the specific requirements an individual must 
meet in order to be authorized as an RSO. This change makes the 
definition of RSO consistent with the definitions of ANP, AU, and 
authorized medical physicist (AMP). We also amended the definition to 
state that an RSO could also be an individual identified on a specific 
medical use license issued by the Commission or Agreement State license 
or a permit issued by a Commission master material licensee.
    The NRC revised the definition of written directive to delete the 
provisions for the date the directive was signed, the signature of the 
AU before administration of any byproduct material or radiation from 
byproduct material to a specific patient or human research subject, and 
the specific information that must be included in written directives. 
These provisions were considered to be substantive requirements and 
were moved to Sec. 35.40, Written directives.

New Definitions

    The NRC added the following definitions either because they are 
used in the final Part 35 or the stakeholders asked that definitions of 
the terms be added to help clarify regulatory text. Definitions were 
added for the following terms: authorized medical physicist, 
brachytherapy, client's address, high dose-rate remote afterloader, low 
dose-rate remote afterloader, manual brachytherapy, medical event, 
medium dose-rate remote afterloader, patient intervention, preceptor, 
pulsed dose-rate remote afterloader, Sealed Source and Device Registry, 
stereotactic radiosurgery, structured educational program, teletherapy, 
temporary job site, therapeutic dosage, therapeutic dose, treatment 
site, type of use, and unit dosage.
    The NRC amended Sec. 35.5, Maintenance of records, to insert 
``and'' in the current phrase ``drawings and specifications.''
    The NRC amended the title of Sec. 35.6 to read Provisions for the 
protection of human research subjects. We also restructured this 
section to make it easier to read. We added an introductory paragraph 
to make it clear that research permitted under Sec. 35.6 may only be 
performed using byproduct material that is already authorized for 
medical use by the license. For example, if a licensee is authorized to 
use byproduct material for medical use under Secs. 35.100, 35.200, and 
35.300 and Cs-137 for calibration of survey instruments, it cannot 
conduct medical research using the Cs-137 source. However, the same 
licensee can conduct research using materials authorized under 
Secs. 35.100, 35.200, or 35.300.
    We added paragraph (d) to codify the Commission's intent that 
Sec. 35.6 does not relieve licensees from complying with other 
provisions in Part 35 and that all relevant radiation safety provisions 
of Part 35 are applicable to research involving human subjects. This 
position is further discussed in the regulatory history of Sec. 35.6. 
For further information on this issue, see the Federal Register of 
December 2, 1994 (59 FR 61767).

[[Page 20342]]

    The NRC made no changes in Sec. 35.7, FDA, other Federal, and State 
requirements.
    The NRC amended Sec. 35.8, Information collection requirements; OMB 
approval, to reflect the renumbering of some sections within the rule 
and the additional recordkeeping and reporting sections which are in 
separate subparts in the new rule.
    Section 35.10, Implementation, is a new section that discusses the 
provisions for implementing the final rule. A detailed discussion of 
the implementation provisions can be found in Section IX of the 
SUPPLEMENTARY INFORMATION. This section replaces the current 
Sec. 35.999, Resolution of conflicting requirements during transition 
period.
    The NRC revised Sec. 35.11, License required. Paragraph (a) was 
revised to state more clearly that a person may manufacture, produce, 
acquire, receive, possess, prepare, use, or transfer byproduct material 
for medical use only in accordance with a specific license issued by 
the Commission or an Agreement State or as allowed in paragraphs (b)(1) 
and (b)(2) of this section. We added ``prepare'' to recognize that 
medical use licensees may also prepare the byproduct material for use 
and need a license to do so. We amended paragraphs (b)(1) and (b)(2) to 
reflect that the requirements for supervision in the current Sec. 35.25 
were replaced by the requirements in the final Sec. 35.27.
    The NRC revised Sec. 35.12, Application for license, amendment, or 
renewal.
    We revised paragraph (a) to state that any application for a 
license, amendment, or renewal must be signed by the applicant's or 
licensee's management. 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. We believe it is 
important that management apply for a license, regardless of where the 
byproduct material is used, because NRC holds the licensee responsible 
for any actions of its employees.
    We revised paragraph (b) to address license applications for uses 
authorized under Secs. 35.600 and 35.1000. Therefore, the current 
paragraph (c) was no longer needed and was deleted. We no longer 
require licensees to have separate licenses for teletherapy or gamma 
stereotactic radiosurgery units. In addition, paragraph (b) lists the 
items that must be submitted to NRC in support of a license 
application. The new paragraph (c) provides a list of the items that 
must be submitted to NRC in support of a license amendment. The lists 
in paragraphs (b) and (c) codify existing licensing practices. Finally, 
we amended paragraphs (b) and (c) to delete the reference to the 
regulatory guides. Guidance for completing an application is in NUREG-
1556, Vol. 9 (draft), ``Consolidated Guidance About Materials Licenses: 
Program-Specific Guidance About Medical Use Licenses.'' NUREG-1556, Vol 
9 (draft), is available for inspection at the NRC Public Document Room, 
2120 L Street NW. (Lower Level), Washington, DC.
    We deleted the statement in the current paragraph (d) that 
referenced where to find copies of regulatory guides, application 
forms, or where to submit an application or an amendment request. This 
information is not needed in the regulation. The new paragraph (d) 
addresses applications for medical use of byproduct material as 
described in Sec. 35.1000, i.e. applications that are not specifically 
included in Subparts D through H of the final rule and are referred to 
as ``emerging technologies.'' The current rule does not address 
emerging technologies. Therefore, it does not provide for efficient 
licensing of emerging technologies. Paragraph (d)(1) provides a list of 
the additional information needed by NRC to approve a license or 
license amendment for a use not specifically addressed in Subparts D 
through H of the new rule. This additional submittal will provide NRC 
with information on the radiation safety aspects of the specific 
medical use of the material. Applicants for uses under Sec. 35.1000 
must also submit the information required by paragraph (b) and (c) of 
this section.
    The NRC revised Sec. 35.13, License amendments. We revised 
paragraph (a) to clarify that a licensee must apply for a license 
amendment before it ``prepares'' byproduct material for a type of use 
that is not authorized on the licensee's current license. Paragraph (a) 
was also changed to reference ``type of use'' rather than ``clinical 
procedure.'' In addition, paragraph (a) was expanded to include AUs, 
AMPs, and ANPs identified on a permit issued by a Commission master 
material licensee that is authorized to permit the use of byproduct 
material in medical use or in the practice of nuclear pharmacy or by a 
commercial nuclear pharmacy that has been given authorization to 
identify authorized nuclear pharmacists. The term ``type of use'' is 
defined in Part 35 and is more appropriate for use in this requirement. 
We added the reference to an AMP to paragraph (b). A medical use 
licensee is no longer required to amend its license before allowing 
anyone to work as an AMP if that individual meets the training and 
experience requirements in Sec. 35.51(a), and the training and 
experience requirements were met within the 7 years preceding the date 
of the application in accordance with Sec. 35.59. In addition, 
paragraphs (a) and (b) were reworded to indicate clearly the subject of 
each paragraph.
    In paragraph (c), we deleted the requirement for a licensee to 
apply for a license amendment if the teletherapy physicist changes, 
provided the individual meets the requirements in Secs. 35.51(a) and 
35.59. This change is consistent with licensing requirements for AUs 
and ANPs. Additionally, in the revised Sec. 35.24(c), the Commission 
recognizes that unusual conditions may arise when the RSO leaves a 
licensee with little to no advance warning. In this event, the licensee 
may want to consider using an AU or other individual qualified to be an 
RSO to fill the position, pending appointment of a new RSO. Under these 
conditions, the licensee must move expeditiously to permanently fill 
the position of RSO and should contact the appropriate NRC regional 
office and explain the situation.
    We revised paragraph (d) to require the licensee to apply for and 
receive a license amendment before it receives byproduct material in 
excess of the amount or in a different form or it receives a different 
radionuclide than is authorized on the license. This change clarifies 
that the requirement is tied to a licensee's authorization to possess, 
not order, byproduct material and to clarify when an amendment is 
needed. For example, if a license authorizes possession of any 
byproduct material identified in Secs. 35.100, 35.200, and 35.300, in 
any chemical and/or physical form, a licensee would be required to 
obtain a license amendment if it wanted to possess sealed sources for 
manual brachytherapy (Sec. 35.400). This same licensee would not need 
to amend its license if it wanted to use sodium iodide I-131 for 
thyroid carcinoma because that use is authorized by Sec. 35.300. 
Further, an amendment would not be required if the licensee wanted to 
use Tc-99m labeled methylene diphosphonate (MDP) rather than Tc-99m 
labeled sestamibi because the use is authorized by Sec. 35.200.
    To reduce regulatory burden, we deleted the requirement in 
paragraph (e) for a licensee to apply for a license amendment if there 
is a change in the areas where byproduct material is used under either 
Sec. 35.100 or Sec. 35.200. In addition, the requirement in the current 
paragraph (e) for a licensee to apply for an amendment before it 
changes the

[[Page 20343]]

address(es) of use identified in the application or on the license was 
moved to the final paragraph (f).
    We added a new paragraph (g) that requires a licensee to apply for 
a license amendment if it revises the procedures that must be submitted 
in accordance with Sec. 35.12(b)(2), where the revision reduces 
radiation safety. This applies to procedures required by Secs. 35.610, 
35.642, 35.643, and 35.645, as applicable.
    The NRC revised Sec. 35.14, Notifications. Paragraph (a) was 
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 AMP under Sec. 35.13(b), which is comparable to the 
notification requirements for AUs or ANPs. This change was needed 
because we would like to be notified when an AMP who has been approved 
by the licensee begins work. (Reference change made to Sec. 35.13(b)). 
We revised paragraph (b) to require that the licensee notify NRC when 
an AMP permanently discontinues performance of duties under the license 
and 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. If there is a change in 
ownership, the licensee must take appropriate action to have its 
license amended before the transfer occurs. We also added a requirement 
to paragraph (b) for a licensee to notify NRC of any changes in areas 
where byproduct material is used in accordance with either Sec. 35.100 
or Sec. 35.200. These revisions to the requirements for notifications 
were warranted because of the associated revisions to the requirements 
for license amendments in Sec. 35.13.
    The NRC amended Sec. 35.15, Exemptions regarding Type A specific 
licenses of broad scope, to add the term ``authorized medical 
physicist'' to paragraph (e). This change is needed because, under the 
revised requirements in Sec. 35.13, broad scope licensees have the 
authority to appoint AUs, ANPs, or AMPs without applying for a license 
amendment if the individuals meet the approved criteria in Subparts B 
and D through H.
    We added a new paragraph (f) to exempt broad scope licensees from 
Sec. 35.14(b)(4), which requires licensees to notify NRC if there have 
been any changes in the areas where byproduct material is used in 
accordance with either Sec. 35.100 or Sec. 35.200. This provision for 
exemptions is consistent with the current exemption these licensees 
have from applying for a license amendment before they add to or change 
the areas of use identified in the application or on the license.
    We added a new paragraph (g) to also exempt these broad scope 
licensees from Sec. 35.49(a). This change codifies an exemption 
currently provided to these licensees through a standard license 
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 only receiving sealed sources or devices 
manufactured from licensees with medical distribution licenses issued 
in accordance with Sec. 32.74. This change replaces the license 
condition.
    The NRC revised Sec. 35.18, License issuance. Paragraph (a) lists 
the conditions that must be met in order for the Commission to issue a 
license. We added requirements for a mobile medical service license as 
paragraph (b). The NRC will issue a license for mobile medical 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 provision is necessary because mobile medical 
service licensees do not have the capability of controlling individuals 
who cannot be released under Sec. 35.75.
    The NRC amended Sec. 35.19, Specific exemptions, to delete the 
statement that the Commission will review requests for exemptions from 
training and experience requirements with the assistance of its 
Advisory Committee on the Medical Uses of Isotopes (ACMUI). This 
statement is a matter of Commission policy rather than a regulatory 
requirement.
    Subpart B, General Administrative Requirements, contains the 
general administrative requirements regarding medical use of byproduct 
material.
    The NRC deleted the current Sec. 35.20, ALARA program. ALARA is 
discussed in Sec. 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. Therefore, 
we do not believe that the current Sec. 35.20 is needed in light of the 
requirements in Sec. 20.1101. A medical use licensee should have 
flexibility in developing, maintaining, and implementing a radiation 
protection program that meets the requirements of Part 20.
    The NRC deleted the current Sec. 35.21, Radiation Safety Officer. 
The requirements in paragraph (a) were moved to Sec. 35.24. The list of 
the RSO's duties in paragraph (b) was deleted because it is overly 
prescriptive and in some cases overlaps with the requirements in 
Sec. 20.1101. We believe that the licensee should have flexibility in 
developing, maintaining, and implementing its radiation protection 
program, including establishing the RSO's duties.
    The NRC deleted the current Sec. 35.22, Radiation Safety Committee. 
The issue of whether the NRC should require a Radiation Safety 
Committee (RSC) was identified as a cross-cutting issue. Therefore, 
this issue was discussed at public meetings throughout the rulemaking 
process. Comments received on this topic are discussed in Section III 
of the SUPPLEMENTARY INFORMATION. The basic requirement for certain 
medical licensees to have an RSC to oversee all uses of byproduct 
material permitted by the license was moved to Sec. 35.24. However, the 
requirement was modified so that only licensees that are authorized for 
two or more different types of uses of byproduct material under 
Subparts E, F and H, or two or more types of units under Subpart H, are 
required to establish an RSC. Several other requirements that are 
currently in Sec. 35.22 were also moved to Sec. 35.24 and are discussed 
under that section. However, most of the requirements that are 
currently in Sec. 35.22 have been deleted to provide licensees with 
more flexibility in how they use the Committee to oversee the radiation 
safety aspects of the medical use of byproduct material.
    The NRC deleted the current Sec. 35.23, Statements of authority and 
responsibilities. The requirements in this section, with some 
modifications, were moved to Sec. 35.24.
    The NRC added a new Sec. 35.24, Authority and responsibilities for 
the radiation protection program. A number of the current, prescriptive 
requirements associated with the radiation protection program have been 
deleted to provide licensees more flexibility in achieving the 
objective of radiation safety.
    Paragraph (a) requires licensee management to approve, in writing, 
licensing actions; individuals before allowing them to work as an AU, 
ANP, or AMP; and radiation protection program changes that do not 
require a license amendment and are permitted under Sec. 35.26. We 
believe that licensee

[[Page 20344]]

management should be responsible for these approvals as part of their 
overall responsibility for the radiation protection program. This is a 
change from the current Sec. 35.22, which gives the RSC the 
responsibility for two of these approvals: approval of individuals 
before allowing them to work as an RSO, AU, ANP, or AMP; and approval 
of radiation protection program changes that do not require a license 
amendment.
    The requirement in paragraph (b) to appoint an RSO is currently in 
Sec. 35.21. Paragraph (b) also includes a new requirement that the RSO 
agree, in writing, to be responsible for implementing the radiation 
protection program. The requirements in paragraphs (e) and (g), 
associated with the authorities, duties, and responsibilities of the 
RSO, are similar to the requirements in the current Sec. 35.23.
    Paragraph (c) includes a new provision that allows a licensee to 
have a temporary RSO for up to 60 days a year if the individual is 
qualified to be an RSO under Secs. 35.50 and 35.59 and if the licensee 
meets the requirements for RSOs in paragraphs (b), (e), (g), and (h) of 
this section. We added this new provision so that licensees can appoint 
someone to fulfill the duties and responsibilities of the RSO in a 
timely manner, following the sudden departure of the permanent RSO 
named on the license. Licensees are required by Sec. 35.14(b) to notify 
the Commission in writing no later than 30 days after an RSO 
permanently discontinues performance of duties under the license.
    Paragraph (d) allows a licensee to simultaneously appoint more than 
one temporary RSO, if needed, to ensure that the licensee has an 
individual that is qualified to be an RSO for each of the different 
types and uses of byproduct material permitted by the license.
    Paragraph (f) contains a requirement for certain medical licensees 
to have an RSC to oversee all the uses of byproduct material permitted 
by the license. We modified the current requirement in Sec. 35.22 so 
that only licensees that are authorized for two or more different types 
of uses of byproduct material under Subparts E, F, and H, or two or 
more types of units under Subpart H, are required to establish an RSC. 
For example, licensees that are permitted on their license to use 
therapeutic quantities of unsealed byproduct material (Sec. 35.300) and 
manual brachytherapy (Sec. 35.400), or manual brachytherapy 
(Sec. 35.400) and low dose-rate remote afterloaders (Sec. 35.600), or 
teletherapy (Sec. 34.600) and gamma stereotactic radiosurgery 
(Sec. 35.600) would be required to have an RSC. However, we believe 
that many other medical licensees will also continue to use an RSC to 
oversee the use of byproduct material. Licensees should note that the 
requirement for an RSC is no longer limited to medical institutions, 
which means that it now also applies to free-standing clinics.
    The new requirement for an RSC is much less prescriptive than the 
requirements in the current Sec. 35.22. For example, paragraph (f) does 
not include the list of administrative requirements and committee tasks 
that are specified in the current rule. However, based on public 
comment, we have specified that the membership of the committee should 
include an AU of each type of use permitted by the license, the RSO, a 
representative of the nursing service, a representative of management 
who is neither an AU nor an RSO, and other members the licensee 
considers appropriate.
    Paragraph (h) requires that the licensee retain a record of 
management's approval of actions in paragraph (a); written acceptance 
of RSO duties as specified in paragraph (b); and the duties, 
responsibilities, and authority of the RSO specified in paragraph (e) 
in accordance with Sec. 35.2024, Records of authority and 
responsibilities for radiation protection programs.
    The NRC deleted the current Sec. 35.25, Supervision. The 
requirements in this section, with some modifications, were moved to 
Sec. 35.27. The requirements in paragraphs (a)(3) and (b)(3) for 
periodic reviews of the work of supervised individuals were deleted 
because we believe that these requirements are too prescriptive. 
Licensees should have flexibility in how they evaluate supervised 
individuals because they are held responsible for their acts and 
omissions.
    Section 35.26, Radiation protection program changes, is a new 
section. The requirements in this section are similar to the 
requirements in the current Sec. 35.31, which was deleted. This section 
allows licensees to revise their radiation protection programs without 
Commission approval if the revision does not require an amendment in 
accordance with Sec. 35.13; if the revision is in compliance with the 
regulations and license; if the change has been reviewed and approved 
by the RSO, and reviewed and approved in writing by licensee 
management; and if the affected individuals have been instructed on the 
revised program before the changes are implemented. This requirement 
provides licensees with flexibility to manage their radiation 
protection programs and clearly defines the situations that will not 
require Commission approval of an amendment to their license. The NRC 
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 
subject to misinterpretation. This change is intended to provide clear 
guidance to licensees on when they can revise their radiation 
protection programs without obtaining Commission approval.
    We believe that it is important to instruct individuals in program 
changes, including those permitted under Sec. 35.26, before they are 
implemented. This instruction may be provided in writing or orally and 
may be conducted on an informal or formal basis. It is not necessary to 
document that this instruction 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 instruction was 
provided.
    Section 35.27, Supervision, is a new section. The requirements in 
this section are similar to the requirements in the current Sec. 35.25, 
which was deleted. The NRC deleted the requirement to instruct 
individuals in the principles of radiation safety from paragraphs 
(a)(1) and (b)(1). This type of instruction is adequately addressed by 
Sec. 19.12, Instructions to workers, of this chapter. We also amended 
paragraphs (a)(1) and (b)(1) to require that, in addition to the 
requirements in Sec. 19.12, the licensee shall instruct supervised 
individuals in the written radiation protection procedures, written 
directive procedures, regulations of this chapter, and license 
conditions. We revised paragraph (a)(2) to clarify that the 
instructions, procedures, regulations, and license conditions that 
supervised individuals are required to follow are limited in this part 
to those involving the medical use of byproduct material. We deleted 
paragraphs (a)(3) and (b)(3) of the current Sec. 35.25 because the 
licensee should have flexibility in evaluating employee performance. We 
amended paragraph (b)(2) to require supervised individuals to follow 
the instructions of the supervising AU or ANP regarding the preparation 
of byproduct material for medical use, written radiation protection 
procedures, regulations of this chapter, and license conditions. The 
statement in paragraph (c) that licensees are responsible for the acts 
and omissions of supervised individuals is similar to the statement in 
the current Sec. 35.25(c).
    The NRC deleted the current Sec. 35.29, Administrative requirements 
that apply

[[Page 20345]]

to the provision of mobile service. The conditions for the Commission 
to issue a mobile medical service license were moved to Sec. 35.18. The 
requirements in paragraphs (b) and (d) were moved to Sec. 35.80. We 
deleted paragraph (c) because this requirement, which addressed the 
client's responsibilities, was viewed as being overly prescriptive. 
Mobile medical service licensees are required to comply with all the 
provisions of the license that authorize the use, possession, and 
transfer of material.
    The NRC deleted the current Sec. 35.31, Radiation safety program 
changes. The requirements, with some modifications, were moved to 
Sec. 35.26 so that all the requirements pertaining to management of the 
licensee's radiation protection program appear in one area of Subpart 
B.
    The NRC deleted the current Sec. 35.32, Quality management program. 
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 public 
meetings throughout the rulemaking. Comments received on this topic are 
discussed in Section III of the SUPPLEMENTARY INFORMATION. Based on 
these comments, the Commission deleted the requirements for a quality 
management program. However, the Commission believes there are three 
elements of the current quality management program that should continue 
to be addressed in the rule for certain procedures: confirming patient 
identity, requiring written directives, and verifying dose. The 
requirements for these three elements are in Secs. 35.40 and 35.41. 
However, we believe that licensees will continue to implement other 
elements of the current quality management program 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 specified in 
the current rule.
    The NRC deleted the current Sec. 35.33, Notifications, reports, and 
records of misadministrations. The recordkeeping and reporting 
requirements were moved to Subparts L and M, respectively.
    Section 35.40, Written directives, is a new section. This section 
contains requirements for the preparation of written directives that 
are similar to the requirements in the current Secs. 35.2 and 35.32. 
Written directives are no longer required for administrations of sodium 
iodide I-125 because sodium iodide I-131 is primarily used now. Based 
on public comments and discussions with the ACMUI, changes were made in 
the information that must be included in written directives. For gamma 
stereotactic radiosurgery, the requirements for target coordinates, 
collimator size, plug pattern, and total dose have been deleted, and 
requirements for total dose, treatment site, and values for the target 
coordinate settings per treatment for each anatomically distinct 
treatment site have been added. For teletherapy, the requirement for 
overall treatment period has been deleted and a requirement for number 
of fractions has been added. For high dose-rate remote afterloading 
brachytherapy, requirements have been added for the dose per fraction 
and the number of fractions. For all other brachytherapy, before 
implantation, the requirements for number of sources and source 
strengths have been deleted and requirements for treatment site and 
dose have been added; and after implantation, but before completion of 
the procedure, a requirement for the number of sources has been added. 
Licensees should refer to Sec. 35.41 for the requirements for 
procedures for administrations requiring written directives.
    Section 35.41, Procedures for administrations requiring a written 
directive, is a new section. Paragraph (a) of this section requires 
licensees to develop, implement, and maintain written procedures to 
provide high confidence 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. The 
specific details to be included in the written directives are in 
Sec. 35.40. Paragraph (b) of this section specifies the items that 
must, at a minimum, be addressed in the procedures. The items 
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 AU. However, the regulations 
are not prescriptive about how these objectives are met, allowing 
licensees the flexibility to develop procedures to meet their needs. 
This section includes no requirement for submittal or approval of the 
procedures, as was previously required by the quality management rule. 
The recordkeeping requirements for this section are in Sec. 35.2041, 
Records for procedures for administrations requiring a written 
directive.
    The NRC retained Sec. 35.49, Suppliers for sealed sources or 
devices for medical use with one modification. We added a new paragraph 
(b) to this section to permit noncommercial transfer of sealed sources 
or devices for medical use between Part 35 licensees that have a 
license to possess the source or device. Currently, licensees must 
obtain an amendment exempting them from the requirements in this 
section following initial distribution of the sealed source or device.
    Section 35.50, Training for Radiation Safety Officer, is a new 
section. The training and experience requirements for an RSO were 
moved, with some modifications, from the current Sec. 35.900, Radiation 
Safety Officer. Two changes made in the new section should be noted. 
First, the listing of specialty boards by name was deleted because the 
regulatory text in Part 35 will no longer incorporate a listing of 
specialty boards whose diplomates automatically fulfill the training 
and experience requirements for RSOs. In place of listing the boards, 
the final rule provides for NRC recognition of the boards. Second, an 
individual must obtain written certification from a preceptor 
indicating that the individual has satisfactorily completed the 
requirements in this section and has achieved a level of competency 
sufficient to function independently as an RSO. Section III of the 
SUPPLEMENTARY INFORMATION contains a detailed discussion of the 
Commission's changes to the training and experience requirements in 
Part 35. Note, 2 years after the effective date of the final rule, 
Sec. 35.50 will replace the current requirements in Sec. 35.900, 
Radiation Safety Officer.
    The NRC deleted the current Sec. 35.50, Possession, use, 
calibration and check of dose calibrators. The requirements in this 
section, with some modifications, were moved to Sec. 35.60.
    Section 35.51, Training for an authorized medical physicist, is a 
new section. The training and experience requirements for an AMP were 
moved, with some modifications, from the current Sec. 35.961, Training 
for teletherapy physicist. Three changes made in the new section should 
be noted. First, the title of this section was revised because the 
training and experience requirements in this section now apply to AMPs, 
rather than just teletherapy physicists, because requirements for gamma 
stereotactic radiosurgery units and remote afterloader units have been 
codified in the revised Part 35. Second, the listing of specialty 
boards by name was deleted because the regulatory text in Part 35 will 
no longer incorporate a listing of specialty boards whose diplomates 
automatically fulfill the training and experience requirements for 
AMPs. In

[[Page 20346]]

place of listing the boards, the final rule provides for NRC 
recognition of the boards. Third, an individual must obtain written 
certification from a preceptor indicating that the individual has 
satisfactorily completed the requirements in this section and has 
achieved a level of competency sufficient to function independently as 
an AMP. Section III of the SUPPLEMENTARY INFORMATION contains a 
detailed discussion of the Commission's changes to the training and 
experience requirements in Part 35. Note, 2 years after the effective 
date of the final rule, Sec. 35.51 will replace the requirements in 
Sec. 35.961, Training for authorized medical physicist.
    The NRC deleted the current Sec. 35.51, Calibration and check of 
survey instruments. The requirements in this section, with some 
modifications, were moved to Sec. 35.61.
    The NRC deleted the current Sec. 35.52, Possession, use, 
calibration, and check of instruments to measure dosages of alpha- or 
beta-emitting radionuclides. The requirements in this section, with 
some modifications, were moved to Sec. 35.60.
    The NRC deleted the current Sec. 35.53, Measurements of dosages of 
unsealed byproduct material for medical use. The requirements in this 
section, with some modifications, were moved to Sec. 35.63.
    Section 35.55, Training for an authorized nuclear pharmacist, is a 
new section. The training and experience requirements for an ANP were 
moved, with some modifications, from the current Sec. 35.980, Training 
for an authorized nuclear pharmacist. One change made in the new 
section should be noted. The listing of specialty boards by name was 
deleted because the regulatory text in Part 35 will no longer 
incorporate a listing of specialty boards whose diplomates 
automatically fulfill the training and experience requirements for 
ANPs. In place of listing the boards, the final rule provides for NRC 
recognition of the boards. Section III of the SUPPLEMENTARY INFORMATION 
contains a detailed discussion of the new training and experience 
requirements in Part 35. Note, 2 years after the effective date of the 
final rule, Sec. 35.55 will replace the current requirements in 
Sec. 35.980, Training for an authorized nuclear pharmacist.
    Section 35.57, Training for an experienced Radiation Safety 
Officer, teletherapy or medical physicist, authorized user, and nuclear 
pharmacist, is a new section that replaces the current requirements in 
Secs. 35.901, 35.970, and 35.981, which will be retained for 2 years 
after the effective date of the final rule. All individuals who are 
identified as RSOs, teletherapy or medical physicists, AUs, and nuclear 
pharmacists on an NRC or Agreement State license or an equivalent 
permit issued before the effective date of the final rule will have 
``deemed'' status after the rule becomes effective. These individuals 
do not need to comply with the new training and experience requirements 
unless they want to be named on a license for other types of uses.
    The NRC deleted the current Sec. 35.57, Authorization for 
calibration and reference sources. The requirements in this section, 
with some modifications, were moved to Sec. 35.65.
    Section 35.59, Recentness of training, is a new section that 
replaces 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. The NRC expects that (1) 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 that (2) the individual has had related continuing 
education and experience since completing the required training and 
experience requirements. Continuing education and experience 
requirements are reviewed on a case-by-case basis, with input from the 
ACMUI, as necessary. We amended the text in the current Sec. 35.972 to 
reference Subparts B, D, E, F, G, and H because the revised training 
and experience requirements appear in the subparts with their 
associated modality.
    The NRC deleted the current Sec. 35.59, Requirements for possession 
of sealed sources and brachytherapy sources. The requirements in this 
section, with some modifications, were moved to Sec. 35.67.
    Subpart C, General Technical Requirements, contains general 
technical requirements regarding medical use of byproduct material.
    Section 35.60, Possession, use, and calibration of instruments used 
to measure the activity of unsealed byproduct material, is a new 
section that replaces the current Secs. 35.50 and 35.52. This section 
addresses calibration of all instruments used to measure the activity 
of all unsealed byproduct materials, rather than only dose calibrators 
used to measure the activity of dosages of photon-emitting 
radionuclides (Sec. 35.50) or instruments used to measure dosages of 
alpha- or beta-emitting radionuclides (Sec. 35.52). The change 
recognizes that there are various types of instruments that can be used 
to measure the activity of unsealed byproduct materials. This change 
also gives licensees flexibility in developing a calibration program 
which meets their program needs.
    The NRC deleted prescriptive calibration requirements in the 
current Secs. 35.50 and 35.52. Paragraph (b) in the final rule requires 
that licensees calibrate the instrumentation in accordance with 
nationally recognized standards (e.g., voluntary consensus standards, 
such as ANSI N42.13-1986 (R 1993), ``Calibration and Usage of Dose 
Calibrator Ionization Chambers for the Assay of Radionuclides'') or 
with the manufacturer's instructions. This change makes the regulation 
more flexible, more adaptable to new technology, and more performance-
based.
    Licensees should note that they are required by Sec. 35.63 to 
determine the activity of each dosage before medical use. If they use 
only unit dosages of radioactive drugs that meet the definition in 
Sec. 35.2, then Sec. 35.63 allows the licensee to determine the dosage 
by direct measurement of radioactivity; or by a decay correction based 
on the activity or activity concentration determined by either a 
manufacturer or preparer licensed under Sec. 32.72 or equivalent 
Agreement State requirements or an NRC or Agreement State licensee for 
use in research in accordance with a Radioactive Drug Research 
Committee (RDRC)-approved protocol or an Investigational New Drug (IND) 
protocol accepted by the Food and Drug Administration (FDA). If a 
licensee chooses to determine the dosage using this method, a licensee 
would not be required to possess instrumentation to measure the 
activity of the dosage, i.e., the licensee would not be required to 
comply with Sec. 35.60. However, if a licensee chooses to reassay a 
unit dosage for the purpose of adjusting the activity, it would no 
longer be considered a unit dosage once it was altered, and the 
licensee must comply with Sec. 35.60. This requirement is appropriate 
because confirmation of a dosage, or adjustment of dosages, must be 
based on properly-calibrated equipment.
    The recordkeeping requirements for this section are in 
Sec. 35.2060, Records of calibrations of instruments used to measure 
the activity of unsealed byproduct material.
    The requirements in the current Sec. 35.60, with minor 
modifications, were moved to the final Sec. 35.69.
    Section 35.61, Calibration of survey instruments, is a new section 
that replaces the current Sec. 35.51. The requirements in the current 
Sec. 35.51 to

[[Page 20347]]

note the apparent exposure rate from a dedicated check source, as 
determined at the time of calibration; to attach a correction chart or 
graph to the instrument; and to check each survey instrument for proper 
operation with a dedicated check source each day of use were deleted. 
These changes give the licensee greater flexibility in calibrating 
instruments.
    Paragraph (a) in the new Sec. 35.61 now requires the licensee to 
calibrate survey instruments used to show compliance with this part and 
with Part 20 before first use, annually, and following a repair that 
affects the calibration. Paragraph (b) requires 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 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 are in 
Sec. 35.2061, Records of radiation survey instrument calibrations.
    The requirements in the current Sec. 35.61, with minor 
modifications, were moved to the final Sec. 35.69.
    Section 35.63, Determination of dosages of unsealed byproduct 
material for medical use, is a new section that replaces the current 
Sec. 35.53. This section requires licensees to determine and record the 
activity of each dosage before medical use. For unit dosages as defined 
in Sec. 35.2, paragraph (b) allows the licensee to determine the dosage 
by direct measurement of radioactivity; or by a decay correction based 
on the activity or activity concentration determined by either a 
manufacturer or preparer licensed under Sec. 32.72 or equivalent 
Agreement State requirements or an NRC or Agreement State licensee for 
use in research in accordance with a RDRC-approved protocol or an IND 
protocol accepted by the FDA. Because the unit dosages have been 
assayed by the Part 32 licensee or by a licensee for use in research in 
accordance with an RDRC-approved protocol or an IND protocol accepted 
by FDA, the NRC does not believe the Part 35 licensee should be 
required to reassay the dosage. Licensees should note that if a unit 
dosage is changed or manipulated in any way it is no longer considered 
to be a unit dosage and will need to be reassayed before it is 
administered.
    For other than unit doses, paragraph (c) allows the licensee to 
determine the dosage by direct measurement of radioactivity; by 
combination of direct measurement of radioactivity and mathematical 
calculations; or by combination of volumetric measurements and 
mathematical calculations based on the measurement made by a 
manufacturer or preparer licensed under Sec. 32.72 or an equivalent 
Agreement State requirement. The current rule limits the licensee to 
using direct measurement for determining the activity of a photon-
emitting radionuclide, but allows alpha-or beta-emitting radionuclides 
to be measured either by direct measurement or by combination of 
measurements and calculations. This change 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) permits a licensee to use a dosage if the dosage does 
not differ from the prescribed dosage by more than 20 percent or if the 
dosage falls within the prescribed dosage range. We believe that the 
rule should allow for some deviation from the prescribed dosage if the 
licensee chooses to prescribe a dosage rather than a dosage range. 
Without this allowed deviation, the administered dosage would need to 
match the prescribed dosage. We have not allowed a deviation outside of 
the prescribed range because we believe that allowing the AU to 
establish a dosage range provides the AU with the needed flexibility. 
The final paragraph (d) codifies requirements that are currently 
imposed on licensees by license conditions and provides guidance 
regarding allowed deviations for a dosage range. This does not prevent 
an AU 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 dosages of unsealed byproduct material for 
medical use.
    Section 35.65, Authorization for calibration, transmission, and 
reference sources, is a new section that replaces the current 
Sec. 35.57. Paragraph (a) was revised to allow the receipt, possession, 
and use of sealed sources for the purposes of this section if they do 
not exceed 1.11 GBq (30 mCi) each and they are manufactured and 
distributed by a person licensed under Sec. 32.74 or equivalent 
Agreement State regulations. Paragraph (b) was revised to allow the 
receipt, possession, and use of sealed sources for the purposes of this 
section if they do not exceed 1.11 GBq (30 mCi) each and they are 
redistributed by a licensee authorized to redistribute the sealed 
sources manufactured and distributed by a person licensed under 
Sec. 32.74 of this chapter, providing the redistributed sealed sources 
are in the original packaging and shielding and are accompanied by the 
manufacturer's approved instructions. In paragraphs (b) and (c) of the 
final rule, the references in the current Sec. 35.57 to Secs. 35.100 
and 35.200 were deleted because specific radionuclides were not listed 
in these sections. Paragraph (c) was revised to allow possession of 
calibration and reference sources with half-lives not longer than 120 
days. The current section only allows possession of sources with half-
lives not longer than 100 days. This change has been made so that the 
section would be consistent with the financial assurance regulations in 
Part 30. Paragraph (d) was revised to allow possession of any byproduct 
material with a half-life longer than 120 days in individual amounts 
that do not exceed the smaller of the following two values: 7.4 
Megabecquerels (MBq) (200 Ci) or 1000 times the quantities in 
Appendix B of Part 30. This change has been made to limit the 
possession activity below the level where financial assurance is 
required. In paragraph (e), the possession limit for Tc-99m was 
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 the use of 
Tc-99m under Sec. 35.100 or Sec. 35.200.
    Section 35.67, Requirements for possession of sealed sources and 
brachytherapy sources, is a new section that replaces the current 
Sec. 35.59. Paragraph (a) continues to require that the licensee follow 
the radiation safety and handling instructions supplied by the 
manufacturer, but the requirement to maintain the instructions for the 
duration of source use has been deleted. Paragraph (b) requires 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

[[Page 20348]]

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.
---------------------------------------------------------------------------

    Paragraph (c) retains the detection level for leakage at 185 
Becquerels (Bq) (0.005 microcuries (Ci). The NRC deleted the 
prescriptive requirements on how to satisfy the leak test requirements 
in the current Sec. 35.59(c) to reflect the more risk-informed, 
performance-based nature of this final rule. Paragraph (d) requires 
that leak test records be maintained in accordance with Sec. 35.2067, 
Records of leak tests and inventory of sealed sources and brachytherapy 
sources. We revised paragraph (e) to give the licensee two additional 
alternatives for action after a leaking source has been identified. The 
final rule gives the licensee the added flexibility of repairing or 
disposing of the source in accordance with Parts 20 and 30 if the 
leakage test reveals the presence of 185 Bq (0.005 Ci) 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 Parts 20 and 30. The licensee is still required to 
report to the NRC if a leakage test reveals the presence of 185 Bq 
(0.005 Ci) or more of removable contamination. Reporting 
requirements for this section are in Sec. 35.3067, Report of a leaking 
source.
    We amended paragraph (g) to change the frequency for source 
inventories from quarterly to semi-annually to reduce the regulatory 
burden on licensees and to exempt gamma stereotactic radiosurgery 
sources from the requirement for physical inventories. However, the 
final rule does not preclude the licensee from conducting an inventory 
on a more frequent basis. The recordkeeping requirements for this 
section were moved to Sec. 35.2067, Records of leak tests and inventory 
of sealed sources and brachytherapy sources.
    We deleted paragraphs (h) and (i) in the current Sec. 35.59 because 
radiation surveys are addressed under Part 20.
    Section 35.69, Labeling of vials and syringes, is a new section 
that replaces the current Secs. 35.60 and 35.61. It requires that 
syringes and vials containing unsealed byproduct material be labeled to 
identify the radioactive drug. It also requires that syringe shields 
and vial shields be labeled unless the label on the syringe or vial is 
visible when shielded. These requirements are needed because the 
Commission does not believe that the labeling requirements in Part 20 
are sufficient to ensure that syringes, vials, syringe shields, or vial 
shields are properly labeled to identify the radioactive drug. In 
addition, the Commission believes that labeling helps to reduce 
administration errors.
    The NRC does not address shielding of vials and syringes in this 
section. Licensees are required to show compliance with the public and 
occupational dose limits specified in Part 20 of this chapter. We 
believe that the licensee should have flexibility in complying with 
these limits.
    The NRC revised Sec. 35.70, Surveys of ambient radiation exposure 
rate, was revised. The term ``contamination'' was deleted from the 
title because this section no longer addresses contamination surveys. 
The final rule requires that licensees survey, at the end of each day 
of use, all areas where unsealed byproduct material requiring written 
directives were prepared for use or administered, except areas where 
patients or human research subjects are confined when they cannot be 
released under Sec. 35.75. Maintaining the requirement for surveys in 
areas where unsealed byproduct material requiring a written directive 
is used is consistent with the Commission's direction for a more risk-
informed rule.
    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 
(Sec. 20.1101). In situations where radioactive material is used at 
levels that would not require a survey under this section, the licensee 
should be aware that a survey may be required by Sec. 20.1501. The 
Commission believes that licensees will continue to perform radiation 
surveys as dictated by ``good health physics'' practices.
    The recordkeeping requirements for this section are in 
Sec. 35.2070, Records of surveys for ambient radiation exposure rate. 
All other requirements in the current Sec. 35.70 were deleted.
    The NRC revised Sec. 35.75, Release of individuals containing 
unsealed byproduct material or implants containing byproduct material. 
We amended the title of the section and paragraph (a) to delete the 
term ``permanent.'' This clarifies that this section applies to all 
individuals released from licensee control. Paragraph (b) was 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 change has been made to 
clarify what is meant by ``dose'' in this section.
    We modified paragraph (b)(2) 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.
    We amended the footnote to reference NUREG-1556, Volume 9 (draft), 
``Consolidated Guidance About Materials Licenses, Program-Specific 
Guidance About Medical Licenses,'' that superseded Regulatory Guide 
8.39.
    We revised paragraphs (c) and (d) to indicate that the 
recordkeeping requirements for this section are in Sec. 35.2075, 
Records of the release of individuals containing radioactive drugs or 
implants containing byproduct material.
    The NRC revised Sec. 35.80, Provision of mobile medical service. We 
changed the title to make it clear that the provisions in this part 
apply to all mobile medical services and not just to mobile nuclear 
medicine services. We deleted the current paragraphs (a), (b), and (c) 
because the use of unsealed byproduct material is limited by the 
requirements in Secs. 35.100 and 35.200, and control and security of 
material are addressed in Part 20. The remainder of the current 
requirements were incorporated into paragraphs (a) or (c) of the final 
rule.
    Paragraph (a) requires the mobile medical service provider to 
obtain a letter from its client that permits the use of byproduct 
material at the client's address. This letter should clearly delineate 
the authority and responsibility of the licensee and the client. This 
paragraph also requires that the mobile medical service provider checks 
the instruments used to measure the activity of unsealed byproduct 
materials for constancy before medical use at each address of use or on 
each day of use, whichever is more frequent. For example, if a mobile 
medical service licensee provides service to more than one client in a 
day, the instruments would need to be checked at each client's address. 
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 final rule.

[[Page 20349]]

    Paragraph (a) also requires that the licensee check survey 
instruments for proper operation with a dedicated check source, before 
use, at each client's address. We believe this is appropriate because 
extensive movement in a transport vehicle may cause the instruments to 
become damaged or uncalibrated. Finally, paragraph (a) requires the 
licensee to survey all areas of use to ensure compliance with the dose 
limits in Part 20 before leaving each client's address. This is 
necessary to ensure that all radioactive material is removed from a 
client's facility.
    Paragraph (b) addresses the delivery of byproduct material. It does 
not allow byproduct material to be delivered from the manufacturer or 
the distributor to the client's address, unless the client has a 
license allowing possession of the byproduct material. This requirement 
is similar to the requirement in the current Sec. 35.29 (which was 
deleted by this rulemaking).
    The recordkeeping requirements for this section are in 
Sec. 35.2080, Records of mobile medical services.
    The NRC deleted the current Sec. 35.90, Storage of volatiles and 
gases. Licensees are required to comply with the public and 
occupational dose limits in Part 20 and to maintain exposures ALARA. We 
believe that licensees should have flexibility in complying with Part 
20, and, therefore, a prescriptive requirement in Part 35 is not 
needed.
    We revised Sec. 35.92, Decay-in-storage, to allow decay-in-storage 
for byproduct material with a physical half-life of less than 120 days. 
Under the current rule, decay-in-storage was only authorized for 
material with a half-life of less than 65 days. This change provides 
licensees with greater flexibility in handling radioactive waste and 
codifies current licensing practice. Licensees that would like to decay 
material with a physical half life greater than 120 days would have to 
apply for and receive an amendment that would permit the decay-in-
storage.
    Paragraph (a) was revised to indicate clearly that the provisions 
in this section pertain only to disposal of material without regard to 
its radioactivity. The requirement in the current paragraph (a)(1) to 
hold byproduct material for 10 half-lives was deleted. This requirement 
was not needed in light of the requirement in paragraph (a) of the 
final rule that precludes disposal of radioactive material until 
radiation levels adjacent to the material do not exceed background 
levels. Paragraph (a)(2) requires the licensee to remove or obliterate 
all radiation labels, except for radiation labels on materials that are 
within containers and that will be managed as biomedical waste after 
they have been released from the licensee.
    The requirement in the current paragraph (a)(4) to separate and 
monitor each generator column was deleted. This change recognized that 
the current level of prescriptiveness is not needed because of the 
requirements in paragraph (a)(1).
    The recordkeeping requirements for this section are in 
Sec. 35.2092, Records of decay-in-storage.
    The NRC retitled Subpart D Unsealed Byproduct Material--Written 
Directive Not Required. This subpart combines the requirements in the 
current Subpart D, Uptake, dilution, and excretion and Subpart E, 
Imaging and localization. This change has been made to consolidate 
specific requirements for the use of unsealed byproduct material where 
a written directive is not required into one subpart. These changes are 
consistent with the Commission's intent to make Part 35 modality 
specific where appropriate. We believe that administrations of unsealed 
byproduct material not requiring a written directive are in a lower 
risk category than those administrations requiring a written directive. 
Therefore, we are using the requirement for a written directive as the 
threshold to distinguish between the two levels of risk associated with 
administrations of unsealed byproduct material.
    The NRC revised Sec. 35.100, Use of unsealed byproduct material for 
uptake, dilution, and excretion studies for which a written directive 
is not required. The title and introductory paragraph were changed to 
state clearly that the provisions in this subpart do not apply to the 
medical use of byproduct material that would require a written 
directive.
    Paragraph (a) was amended to change the format for citing Title 10 
of the Code of Federal Regulations (CFR). The reference to Title 10 is 
now stated as ``of this chapter'' instead of using the format ``10 
CFR.''
    We amended paragraph (b) to reflect changes to the section numbers 
in the final rule (i.e., requirements in Secs. 35.25 and 35.920 were 
moved, with some modification, to Secs. 35.27 and 35.290, 
respectively). We also added a reference to Sec. 35.390 because 
physicians meeting these training and experience criteria can now elute 
generators and prepare radioactive drugs. This paragraph permits 
medical use licensees to prepare radioactive drugs from any unsealed 
byproduct material (e.g., radiochemicals), provided the drug is 
prepared by an ANP or AU.
    We added paragraph (c) to allow specific licensees to obtain 
unsealed byproduct material prepared by an NRC or Agreement State 
licensee for use in research in accordance with a RDRC-approved 
protocol or an IND protocol accepted by the FDA. This change has been 
made because the current rule did not allow a licensee to use material 
from a supplier, who was not a Sec. 32.72 licensee, unless the supplier 
had obtained a license exemption from the NRC. The final rule allows a 
medical use licensee to receive radioactive drugs that are for use in 
an RDRC-approved protocol or an IND protocol and are prepared and 
distributed by NRC or Agreement State licensees who are not Sec. 32.72 
licensees.
    We added paragraph (d) to allow any individual to prepare a 
radioactive drug from any unsealed byproduct material (e.g., 
radiochemicals) for use in research in accordance with either an RDRC-
approved protocol or an IND protocol accepted by FDA. This change has 
been made because an AU meeting the qualifications in Sec. 35.910 of 
the current rule could not prepare radioactive drugs under an RDRC-
approved protocol or an IND protocol. Therefore, if a licensee was only 
authorized to use byproduct material under Sec. 35.100, it could not 
prepare byproduct material for use under an RDRC-approved protocol or 
an IND protocol unless the material had been prepared by an ANP or AU 
who was qualified to prepare radioactive drugs. The final rule resolves 
the issue by allowing any individual to prepare a radioactive drug in 
accordance with either an RDRC-approved protocol or an IND protocol.
    The NRC deleted the current Sec. 35.120, Possession of survey 
instruments, 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 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 the licensee to have adequate 
instrumentation. Guidance on the types of instruments medical licensees 
could consider using is in NUREG-1556, Vol. 9 (draft), ``Program-
Specific Guidance about Medical Use Licenses.''
    Section 35.190, Training for uptake, dilution, and excretion 
studies, is a new section. The training and experience requirements for 
an AU for unsealed byproduct material for uptake, dilution, and 
excretion studies for which a written directive is not required were 
moved, with some modifications, from

[[Page 20350]]

the current Sec. 35.910, Training for uptake, dilution, and excretion 
studies. Three changes made in the new section should be noted. First, 
the listing of specialty boards by name was deleted because the 
regulatory text in Part 35 will no longer incorporate a listing of 
specialty boards whose diplomates automatically fulfill the training 
and experience requirements for AUs. In place of listing the boards, 
the final rule provides for NRC recognition of the boards. Second, the 
new requirements require a total of 60 hours of training and experience 
that must include classroom, laboratory, and supervised work 
experience. Third, an individual must obtain written certification from 
a preceptor indicating that the individual has satisfactorily completed 
the requirements in this section and has achieved a level of competency 
sufficient to function independently as an AU. Section III of the 
SUPPLEMENTARY INFORMATION a detailed discussion of the Commission's 
changes to the training and experience requirements in Part 35. Note, 2 
years after the effective date of the final rule, Sec. 35.190 will 
replace the current requirements in Sec. 35.910, Training for uptake, 
dilution, and excretion studies.
    The NRC revised Sec. 35.200, Use of unsealed byproduct material for 
imaging and localization studies for which a written directive is not 
required. The title and introductory paragraph were changed to state 
clearly that the provisions in this subpart do not apply to the medical 
use of byproduct material that would require a written directive.
    We amended paragraph (a) to change the format for citing Title 10 
of the Code of Federal Regulations (CFR). The reference to Title 10 is 
now stated as ``of this chapter'' instead of using the format ``10 
CFR.''
    We amended paragraph (b) to reflect changes to the section numbers 
in the final rule (i.e., requirements in Secs. 35.25 and 35.920 were 
moved, with some modification, to Secs. 35.27 and 35.290, 
respectively). We also added a reference to Sec. 35.390 because 
physicians meeting these training and experience criteria can now elute 
generators and prepare radioactive drugs. This paragraph permits 
medical use licensees to prepare radioactive drugs from any unsealed 
byproduct material (e.g., radiochemicals), provided the drug is 
prepared by an ANP or AU.
    We added paragraph (c) to allow specific licensees to obtain 
unsealed byproduct material prepared by an NRC or Agreement State 
licensee for use in research in accordance with an RDRC-approved 
protocol or an IND protocol accepted by the FDA. This change has been 
made because the current rule did not allow a licensee to use material 
from a supplier, who was not a Sec. 32.72 licensee, unless the supplier 
had obtained a license exemption from the NRC. The final rule allows a 
medical use licensee to receive radioactive drugs that are for use in 
an RDRC-approved protocol or an IND research protocol and are prepared 
and distributed by NRC or Agreement State licensees who are not 
Sec. 32.72 licensees.
    We added paragraph (d) to allow any individual to prepare a 
radioactive drug from any unsealed byproduct material (e.g., 
radiochemicals) for use in research in accordance with either an RDRC-
approved protocol or an IND protocol accepted by FDA. This change has 
been made because an AU meeting the qualifications in Sec. 35.920 of 
the current rule could not prepare radioactive drugs under an RDRC-
approved protocol or an IND protocol. Therefore, if a licensee was only 
authorized to use byproduct material under Sec. 35.200, it could not 
prepare byproduct material for use under an RDRC-approved protocol or 
an IND protocol unless the material had been prepared by an ANP or AU 
who was qualified to prepare radioactive drugs. The final rule resolves 
the issue by allowing any individual to prepare a radioactive drug in 
accordance with either an RDRC-approved protocol or an IND protocol.
    The NRC revised Sec. 35.204, Permissible molybdenum-99 
concentration. Paragraph (a) was revised to express the permissible 
concentration level as 0.15 kilobecquerel of molybdenum-99 per 
megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per 
millicurie of technetium-99m). This level is identical to that used in 
the U.S. Pharmacopea (USP) 24 U.S. Pharmacopial Convention, Inc., 2000, 
pages 1598-1599. Paragraph (b) was revised to require that a licensee 
measure the molybdenum-99 concentration of the first eluate from a 
generator. We believe 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 were moved to 
Sec. 35.2204, Records of molybdenum-99 concentration.
    The NRC deleted the current Sec. 35.205, Control of aerosols and 
gases. Part 35 licensees must comply with the occupational and public 
dose limits of Part 20. Additional prescriptive requirements for 
limiting airborne concentrations of radioactive material are not needed 
in Part 35.
    The NRC deleted the current Sec. 35.220, Possession of survey 
instruments 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 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 licensees to have adequate 
equipment. Guidance on the types of instruments medical licensees could 
consider using is in NUREG-1556, Vol. 9 (draft).
    Section 35.290, Training for imaging and localization studies, is a 
new section. The training and experience requirements for an AU for 
unsealed byproduct material for imaging and localization studies for 
which a written directive is not required were moved, with some 
modifications, from the current Sec. 35.920, Training for imaging and 
localization studies. Three changes made in the new section should be 
noted. First, the listing of specialty boards by name was deleted 
because the regulatory text in Part 35 will no longer incorporate a 
listing of specialty boards whose diplomates automatically fulfill the 
training and experience requirements for AUs. In place of listing the 
boards, the final rule provides for NRC recognition of the boards. 
Second, the new requirements require a total of 700 hours of training 
and experience that must include classroom, laboratory, and supervised 
work experience. Third, an individual must obtain written certification 
from a preceptor indicating that the individual has satisfactorily 
completed the requirements in this section and has achieved a level of 
competency sufficient to function independently as an AU. Section III 
of the SUPPLEMENTARY INFORMATION contains a detailed discussion of the 
Commission's changes to the training and experience requirements in 
Part 35. Note, 2 years after the effective date of the final rule, 
Sec. 35.290 will replace the current requirements in Sec. 35.920, 
Training for imaging and localization studies.
    Subpart E was retitled, Unsealed byproduct material--written 
directive required. The subpart contains the

[[Page 20351]]

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.
    The NRC revised Sec. 35.300, Use of unsealed byproduct material for 
which a written directive is required. The title and introductory 
paragraph were 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. The first paragraph in this section 
was revised to state clearly that medical uses under this section 
require a written direction. Also, the phrase ``therapeutic 
administration'', used in the current rule, was deleted because some 
medical uses in this modality will require a written directive, but 
they are not ``therapeutic administrations'' (e.g., diagnostic whole 
body imaging with sodium iodide I-131).
    We amended paragraph (a) to change the format for citing Title 10 
of the Code of Federal Regulations (CFR). The reference to Title 10 is 
now stated as ``of this chapter'' instead of using the format ``10 
CFR.''
    We amended paragraph (b) to reflect changes to the section numbers 
in the final rule (i.e., requirements in Secs. 35.25 and 35.920 were 
moved, with some modification, to Secs. 35.27 and 35.290, 
respectively). We also added a reference to Sec. 35.390 because 
physicians meeting these training and experience criteria can now elute 
generators and prepare radioactive drugs. This paragraph permits 
medical use licensees to prepare radioactive drugs from any unsealed 
byproduct material (e.g., radiochemicals), provided the drug is 
prepared by an ANP or AU.
    We added paragraph (c) to allow specific licensees to obtain 
unsealed byproduct material prepared by other NRC or Agreement State 
licensees for use in medical research in accordance with an IND 
protocol accepted by the FDA. This change has been made because the 
current rule did not allow a licensee to use material from a supplier, 
who was not a Sec. 32.72 licensee, unless the supplier had obtained a 
license exemption from the NRC. The final rule allows a medical use 
licensee to receive radioactive drugs, for use in IND research 
protocols, that are prepared and distributed by NRC or Agreement State 
licensees who are not Sec. 32.72 licensees. This paragraph is similar 
to the regulatory text added to Secs. 35.100 and 35.200. However, we 
have not included a reference to RDRC-approved protocols because RDRCs 
are authorized to approve radioactive drugs for certain types of 
research uses intended to obtain basic information regarding the 
metabolism of a radioactive drug, or regarding human physiology, 
pathophysiology, or biochemistry, but they are not intended for 
immediate diagnostic, therapeutic, or similar purposes. Additionally, 
the maximum radiation dose from a single administration of a 
radioactive drug in an RDRC-approved protocol must be less than 3 rem 
to the whole body, active blood forming organs, lens of the eye, and 
gonads, and less than 5 rem to other organs. We expect that doses from 
materials requiring a written directive would exceed these limits. 
Thus, research with such materials could not be conducted under the 
aegis of RDRC approval.
    We added paragraph (d) to allow any individual to prepare a 
radioactive drug from any unsealed byproduct material (e.g., 
radiochemicals) for use in research in accordance with an IND protocol 
accepted by FDA. This change has been made because an AU meeting the 
qualifications in Secs. 35.930, 35.932, or 35.934 of the current rule 
could not prepare radioactive drugs under an IND protocol. Therefore, 
if a licensee was only authorized to use byproduct material under 
Sec. 35.300, it could not prepare byproduct material for use under an 
IND protocol unless the material had been prepared by an ANP or AU who 
was qualified to prepare radioactive drugs. The final rule resolves the 
issue by allowing any individual to prepare a radioactive drug in 
accordance with an IND protocol.
    The NRC revised Sec. 35.310, Safety instruction to state explicitly 
that the instruction requirements of this section are in addition to, 
and not in lieu of, the training requirements in Sec. 19.12. We believe 
it is important that personnel caring for patients or human research 
subjects that have received a dosage requiring a written directive, 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.
    Paragraph (a) in the final rule requires that safety instruction be 
provided initially and at least annually. The current rule does not 
specify when instructions must be given. Typically, the frequency of 
training has been handled during the licensing process. We do not 
expect that the same level of training be provided to all individuals 
caring for the patient. The level of training should be commensurate 
with the potential radiation exposure the caregiver may receive, based 
on the level of contact the individual is expected to have with 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. We have deleted the 
reference to ``procedures'' in paragraph (a) because we have chosen to 
focus this section on instruction rather than on procedures. The 
licensee should have flexibility in program management and recognize 
that licensees may develop alternative ways of addressing the issues in 
paragraphs (a)(1) through (a)(5). Paragraph (a)(2) was also 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 
final provisions of Sec. 20.1301(c). Paragraph (a)(5) was revised to 
state that personnel should notify the RSO, or his or her designee, and 
the AU if the patient or the human research subject has a medical 
emergency or dies. This change has been made to allow the RSO to 
designate an individual to act in his or her behalf, in such cases, to 
address radiation protection issues and to ensure that the AU is 
notified. The recordkeeping requirements for this section are in 
Sec. 35.2310, Records of safety instruction.
    We revised Sec. 35.315, Safety precautions. Paragraph (a) was 
revised to clarify that the requirements in this section only apply if 
a patient or research subject cannot be released under Sec. 35.75. 
Paragraph (a)(1) was revised to give the licensee flexibility in 
quartering patients. Option 1 is identical to the current rule, i.e., 
it allows the licensee to quarter the patient or human research subject 
in a private room with a private sanitary facility. Option 2 allows the 
licensee to quarter the individual in a room, with a private sanitary 
facility, with another individual who also has received therapy with a 
radioactive drug containing byproduct material and who also cannot be 
released under Sec. 35.75. We included option 2 in the final rule 
because we believe that the dose that patients would receive from each 
other would be inconsequential in light of the dose that they receive 
from the medical treatment that they have undergone.
    We revised paragraph (a)(2) 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 so it is visible. 
These requirements are in addition to the posting requirements in Part 
20. We believe that the posting requirements in Part 20 are not 
adequate

[[Page 20352]]

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) were deleted because they 
are radiation protection requirements that are covered under Part 20. 
We revised paragraph (b) to state that the licensee shall notify the 
RSO, or his or her designee, and the AU as soon as possible if the 
patient or human research subject has a medical emergency or dies. This 
change allows the RSO to designate an individual to act in his or her 
behalf, in such cases, to address radiation protection issues and to 
ensure that the AU is notified.
    The NRC deleted the current Sec. 35.320, Possession of survey 
instruments 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 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 a licensee to have adequate 
equipment. Guidance on the types of instruments medical licensees could 
consider using is in NUREG-1556, Vol. 9 (draft).
    Section 35.390, Training for use of unsealed byproduct material for 
which a written directive is required, is a new section. The training 
and experience requirements for an AU for unsealed byproduct material 
for which a written directive is required were moved, with some 
modifications, from the current Sec. 35.930, Training for therapeutic 
use of unsealed byproduct material. Three changes made in the new 
section should be noted. First, the listing of specialty boards by name 
was deleted because the regulatory text in Part 35 will no longer 
incorporate a listing of specialty boards whose diplomates 
automatically fulfill the training and experience requirements for AUs. 
In place of listing the boards, the final rule provides for NRC 
recognition of the boards. Second, the new requirements require a total 
of 700 hours of training and experience that must include classroom, 
laboratory, and supervised work experience. Third, an individual must 
obtain written certification from a preceptor indicating that the 
individual has satisfactorily completed the requirements in this 
section and has achieved a level of competency sufficient to function 
independently as an AU. Section III of the SUPPLEMENTARY INFORMATION 
contains a detailed discussion of the Commission's changes to the 
training and experience requirements in Part 35. Note, 2 years after 
the effective date of the final rule, Sec. 35.390 will replace the 
current requirements in Sec. 35.930, Training for therapeutic use of 
unsealed byproduct material.
    Section 35.392, Training for the oral administration of sodium 
iodide I-131 requiring a written directive in quantities less than or 
equal to 1.22 Gigabecquerels (33 millicuries), is a new section. The 
training and experience requirements for an AU for iodine-131 treatment 
of hyperthyroidism were moved, with some modifications, from the 
current 35.932, Training for treatment of hyperthyroidism. Three 
changes made in the new section should be noted. First, the section is 
no longer limited to use of iodine-131 for treatment of 
hyperthyroidism. Second, the final rule provides for NRC recognition of 
the boards. Third, an individual must obtain written certification from 
a preceptor indicating that the individual has satisfactorily completed 
the requirements in this section and has achieved a level of competency 
sufficient to function independently as an AU. Section III of the 
SUPPLEMENTARY INFORMATION contains a detailed discussion of the 
Commission's changes to the training and experience requirements in 
Part 35. Note, 2 years after the effective date of the final rule, 
Sec. 35.392 will replace the current requirements in Sec. 35.932, 
Training for treatment of hyperthyroidism.
    Section 35.394, Training for the oral administration of sodium 
iodide I-131 requiring a written directive in quantities greater than 
1.22 Gigabecquerels (33 millicuries), is a new section. The training 
and experience requirements for an AU for iodine-131 for treatment of 
thyroid carcinoma were moved, with some modifications, from the current 
35.934, Training for treatment of thyroid carcinoma. Three changes made 
in the new section should be noted. First, the section is no longer 
limited to use of iodine-131 for treatment of thyroid carcinoma. 
Second, the final rule provides for NRC recognition of the boards. 
Third, an individual must obtain written certification from a preceptor 
indicating that the individual has satisfactorily completed the 
requirements in this section and has achieved a level of competency 
sufficient to function independently as an AU. Section III of the 
SUPPLEMENTARY INFORMATION contains a detailed discussion of the 
Commission's changes to the training and experience requirements in 
Part 35. Note, 2 years after the effective date of the final rule, 
Sec. 35.394 will replace the current requirements in Sec. 35.934, 
Training for treatment of thyroid carcinoma.
    Subpart F was 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.
    The NRC retitled Sec. 35.400, Use of sources for manual 
brachytherapy, and deleted the specific sources and uses listed in the 
current paragraphs (a) through (g). This conforms with the more risk-
informed, performance-based nature of this final rule. The licensee has 
the flexibility to use brachytherapy sources for therapeutic medical 
uses as approved in the SSDR. In addition, we added a new paragraph (b) 
to allow the use of brachytherapy sources in medical research as long 
as the research is conducted in accordance with an active 
Investigational Device Exemption (IDE) application accepted by the FDA. 
With this revision, we allow previously registered sources to be used 
for uses other than those described in the original sealed source 
registration process if the research is conducted under an active IDE 
application accepted by the FDA.
    The NRC retitled and revised Sec. 35.404, Surveys after source 
implant and removal. The current paragraph (a) was redesignated 
paragraph (b) and was amended to delete the requirement that a licensee 
may not release a patient or a human research subject treated by 
temporary implant until all sources have been removed. The release of 
patients or human research subjects is addressed in Sec. 35.75. The 
reference to radiation when referring to the survey was also removed 
because this was repetitive of the requirement to perform the survey 
with a radiation detection survey instrument. The new paragraph (a) 
contains the requirements, with minor modifications, that were 
previously required by Sec. 35.406(c). The survey required by paragraph 
(a) is performed to locate and account for all sources that have not 
been implanted. However, this survey does not necessarily have to be a 
radiation survey. Depending on the area being surveyed and the ability 
to distinguish from the radiation background around the patient 
implanted with brachytherapy sources, the survey may be a visual or a 
radiation survey. Therefore, this section includes all of the survey 
requirements for this subpart. The recordkeeping requirements for this 
section are in Sec. 35.2404, Records of surveys after source implant 
and removal.

[[Page 20353]]

    The NRC retitled and revised Sec. 35.406, Brachytherapy sources 
accountability. Paragraph (a) requires that the licensee maintain 
accountability for all brachytherapy sources in storage or use. We 
deleted the majority of the prescriptive requirements and associated 
recordkeeping requirements in the final section to give the licensee 
flexibility in program management. The requirements in the current 
paragraph (c) were moved to Sec. 35.404. We believe that the 
requirements that were retained in this section are essential to the 
radiation safety program. The recordkeeping requirements for this 
section are in Sec. 35.2406, Records of brachytherapy source 
accountability.
    The NRC revised Sec. 35.410, Safety instruction to state explicitly 
that the instruction requirements in this section are in addition to, 
and not in lieu of, the training requirements of Sec. 19.12. We believe 
that it is important that personnel caring for patients or human 
research subjects that have received brachytherapy (and cannot be 
released under Sec. 35.75), receive instruction in limiting radiation 
exposure to the public and workers and the actions to be taken in the 
case of a medical emergency or death.
    Paragraph (a) in the final rule requires that safety instruction be 
provided initially and at least annually. The current rule does not 
specify when instructions must be given. Typically, the frequency of 
training has been handled during the licensing process. We do not 
expect 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. We have deleted the reference to ``procedures'' 
in paragraph (a) because we have chosen to focus this section on 
instruction rather than on procedures. We believe the licensee should 
have flexibility in program management and recognize that licensees may 
develop alternative ways of addressing the issues in paragraphs (a)(1) 
through (a)(5). We revised paragraph (a)(4) 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 final provisions of Sec. 20.1301(c). We revised 
paragraph (a)(5) to state that personnel should notify the RSO, or his 
or her designee, and an AU, if the patient or human research subject 
has a medical emergency or dies. This change provides the RSO 
flexibility in designating who should be notified to address radiation 
protection issues and ensures that an AU is notified. The recordkeeping 
requirements for this section are in Sec. 35.2310, Records of safety 
instruction.
    The NRC revised Sec. 35.415, Safety precautions. Paragraph (a) was 
amended to clarify that the requirements in this section only apply if 
a patient or human research subject is receiving brachytherapy and 
cannot be released in accordance with Sec. 35.75. Paragraph (a)(1) was 
amended to clarify that a patient or human research subject who is 
receiving brachytherapy can only share a room with another 
brachytherapy patient.
    We revised paragraph (a)(2) to require that the patient's room, 
rather than the door, be visibly posted to give the licensee 
flexibility in determining where to place the posting so it is visible. 
These posting requirements are in addition to the posting requirements 
in Part 20. We believe that the posting requirements in 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 requirement to 
put a note on the door or in the patient's or human research subject's 
chart where and how long visitors may stay in the patient's or human 
research subject's room was moved from the current paragraph (a)(2) to 
the new paragraph (a)(3). We deleted the current requirements in 
paragraphs (a)(3) and (4) because they are radiation protection 
requirements that are covered under Part 20. We added a new requirement 
(paragraph b) that requires the licensee to have emergency response 
equipment available near each treatment room. This addition codifies 
requirements that are currently imposed on licensees by license 
conditions. The current paragraph (b) was redesignated as paragraph (c) 
and was revised to state that the licensee shall notify the RSO, or his 
or her designee, and an AU as soon as possible if the patient or human 
research subject has a medical emergency or dies. This change has been 
made: (1) To recognize that in a medical emergency, the licensee's 
primary responsibility is the care of the patient; (2) to provide the 
RSO flexibility in whom should be notified to address radiation 
protection issues; and (3) to ensure that the AU is notified.
    The NRC deleted the current Sec. 35.420, Possession of survey 
instruments 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 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 the licensee to have adequate 
equipment. Guidance on the types of instruments medical licensees could 
consider using is in NUREG-1556, Vol. 9.
    Section 35.432, Calibration measurements of brachytherapy sources, 
is a new section that requires a licensee authorized to use 
brachytherapy sources for medical use to perform calibration 
measurements on brachytherapy sources before the first medical use of 
the source(s) after the effective date of this rule. The requirements 
in this section are based on recommendations found in AAPM TG-40 and 
TG-56, and are consistent with the calibration requirements for sealed 
sources and devices for therapy. The final rule allows the licensee to 
rely on the output measurement provided by the source manufacturer or 
by a calibration laboratory accredited by the American Association of 
Physicists in Medicine, as long as the calibration was conducted in 
accordance with a published protocol accepted by a nationally 
recognized body and appropriately calibrated equipment was used. As 
discussed in the Regulatory Impact Statement, the NRC recognizes that 
licensees may need to procure additional equipment to meet this 
requirement. We believe that the additional expenditure is warranted in 
order for the licensee administering brachytherapy doses to ensure that 
the correct dose is delivered to patients. The recordkeeping 
requirements for this section are in Sec. 35.2432, Records of 
calibration measurements of brachytherapy sources.
    Section 35.433, Decay of strontium-90 sources for ophthalmic 
treatment, is a new section. This section requires that only an AMP may 
calculate the activity of a strontium-90 source that is used to 
determine the treatment times for ophthalmic treatments. It also 
requires that the decay must be based on the activity determined under 
Sec. 35.432. This section was added because the NRC is aware of 
numerous misadministrations involving strontium-90 for ophthalmic use 
that were caused by individuals improperly decaying the sources. Given 
the risks associated with the use of strontium-90 and the numerous 
misadministrations in this area, more prescriptive requirements are 
warranted to ensure that the activities of strontium-90 sources are 
correctly determined. The recordkeeping requirements for this section 
are in Sec. 35.2433, Records of decay of strontium-90 sources for 
ophthalmic treatments.

[[Page 20354]]

    Section 35.457, Therapy-related computer systems, is a new section 
that requires acceptance testing on the treatment planning system of 
therapy-related computer systems in accordance with published protocols 
accepted by nationally recognized bodies. The requirements in this 
section are based on recommendations found in AAPM TG-56. The 
components of the acceptance testing are provided in this section. 
However, the licensee retains the flexibility in developing the 
acceptance testing program. The NRC believes that these new 
requirements are warranted in order for the licensee administering 
brachytherapy doses to ensure that the correct dose is delivered to 
patients.
    Section 35.490, Training for use of manual brachytherapy sources, 
is a new section. The training and experience requirements for an AU of 
manual brachytherapy sources were moved, with some modifications, from 
the current Sec. 35.940, Training for use of brachytherapy sources. Two 
changes made in the new section should be noted. First, the listing of 
specialty boards by name was deleted because the regulatory text in 
Part 35 will no longer incorporate a listing of specialty boards whose 
diplomates automatically fulfill the training and experience 
requirements for AUs. In place of listing the boards, the final rule 
provides for NRC recognition of the boards. Second, an individual must 
obtain written certification from a preceptor indicating that the 
individual has satisfactorily completed the requirements in this 
section and has achieved a level of competency sufficient to function 
independently as an AU. Section III of the SUPPLEMENTARY INFORMATION 
contains a detailed discussion of the Commission's changes to the 
training and experience requirements in Part 35. Note, 2 years after 
the effective date of the final rule, Sec. 35.490 will replace the 
current requirements in Sec. 35.940, Training for use of brachytherapy 
sources.
    Section 35.491, Training for ophthalmic use of strontium-90, is a 
new section. The training and experience requirements for an AU of 
strontium-90 sources for ophthalmic treatment were moved, with some 
modifications, from the current Sec. 35.941, Training for ophthalmic 
use of strontium-90. Two provisions in the new section should be noted. 
First, an individual must obtain written certification from a preceptor 
indicating that the individual has satisfactorily completed the 
requirements in this section and has achieved a level of competency 
sufficient to function independently as an AU. Second, the NRC added a 
provision that a physician who meets the requirements in Sec. 35.490 
would automatically meet the requirements to become an AU under 
Sec. 35.491. Section III of the SUPPLEMENTARY INFORMATION contains a 
detailed discussion of the Commission's changes to the training and 
experience requirements in Part 35. Note, 2 years after the effective 
date of the final rule, Sec. 35.491 will replace the current 
requirements in Sec. 35.941, Training for ophthalmic use of strontium-
90.
    Subpart G was retitled Sealed Sources for Diagnosis. This subpart 
contains the requirements for diagnostic medical use of sealed sources 
and replaces the requirements in the current Subpart H, Sealed Sources 
for Diagnosis.
    In Sec. 35.500, Use of sealed sources for diagnosis, the NRC 
deleted the specific sources and uses listed in paragraphs (a) and (b). 
This conforms with the more risk-informed, performance-based nature of 
this final rule. The licensee has the flexibility to use sealed sources 
for diagnostic medical uses as approved in the SSDR.
    The NRC deleted the current Sec. 35.520, Availability of survey 
instrument 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 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 the licensee to have adequate 
equipment. Guidance on the types of instruments medical licensees could 
consider using is in NUREG-1556, Vol. 9 (draft).
    Section 35.590, Training for use of sealed sources for diagnosis, 
is a new section. The training and experience requirements for an AU of 
a diagnostic sealed source in a device were moved, with some 
modifications, from the current Sec. 35.950, Training for use of sealed 
sources for diagnosis. One change made in the new section should be 
noted. The listing of specialty boards by name was deleted because the 
regulatory text in Part 35 will no longer incorporate a listing of 
specialty boards whose diplomates automatically fulfill the training 
and experience requirements for AUs. In place of listing the boards, 
the final rule provides for NRC recognition of the boards. Section III 
of the SUPPLEMENTARY INFORMATION contains a detailed discussion of the 
Commission's changes to the training and experience requirements in 
Part 35. Note, 2 years after the effective date of the final rule, 
Sec. 35.590 will replace the current requirements in Sec. 35.950, 
Training for use of sealed sources for diagnosis.
    The NRC retitled Subpart H, Photon Emitting Remote Afterloader 
Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units, 
and amended its provisions to address all medical uses of photon 
emitting sealed sources in devices for therapy. Devices such as 
teletherapy, remote afterloaders, and gamma stereotactic radiosurgery 
units are addressed in this subpart. This subpart does not contain 
requirements for manual brachytherapy, which are in Subpart F, nor does 
it include requirements for beta emitting devices, such as beta 
emitting intravascular brachytherapy devices. This subpart replaces the 
requirements in the current Subpart I, Teletherapy.
    The NRC retitled Sec. 35.600, Use of a sealed source in a remote 
afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery 
unit, and deleted any references to specific radionuclides and devices 
in the codified text. The licensee has the flexibility to use sealed 
sources in photon emitting devices for therapeutic medical uses as 
approved in the SSDR. In addition, we added paragraph (b) to allow the 
use of therapy sealed sources in medical research as long as the 
research is conducted in accordance with an active IDE application 
accepted by the FDA. This change allows previously registered sources 
to be used for uses other than those described in the original sealed 
source registration process, if the research is conducted under an 
active IDE application accepted by the FDA.
    Section 35.604, Surveys of patients and human research subjects 
treated with a remote afterloader unit, is a new section. This section 
requires that a licensee make a radiation survey of a patient or human 
research subject to confirm that the sources have been removed from the 
individual and returned to a shielded position before releasing the 
individual from licensee control. For fractionated low dose-rate or 
pulsed dose-rate treatments where the patient is not releasable under 
Sec. 35.75, surveys need only be performed after the last time the 
source is returned to the shielded position. For example, a survey of 
the patient is not required every time that the source is retracted 
into the shielded safe when nursing personnel enter the patient 
treatment room to provide care to patients undergoing fractionated 
treatments using a low or pulsed dose-rate remote afterloader unit. 
This new requirement was previously imposed on remote afterloader 
licensees by license

[[Page 20355]]

condition. The recordkeeping requirements for this section are in 
Sec. 35.2404, Records of radiation surveys of patients and human 
research subjects.
    The NRC retitled Sec. 35.605, Installation, maintenance, 
adjustment, and repair, and amended the codified text to clarify that 
only a person specifically licensed by the Commission or an Agreement 
State can install, maintain, adjust, or repair a unit that involves 
work on the source shielding, source driving unit, or other electronic 
or mechanical mechanism that could expose the source, reduce the 
shielding around the source, or compromise the radiation safety of the 
unit or the sources. The types of units referred to in this section 
were revised to include remote afterloader units and gamma stereotactic 
radiosurgery units, rather than just teletherapy units.
    Paragraph (b) also specifies that, except for low dose-rate remote 
afterloader units, only a person specifically licensed by the 
Commission or an Agreement State shall install, replace, relocate, or 
remove a sealed source or source contained in a device. For low dose-
rate remote afterloader units, installation, replacement, relocation, 
or removal of a sealed source must be done by a person specifically 
licensed by the Commission or an Agreement State or by an AMP. The 
exception to allow an AMP to perform these activities for low dose-rate 
remote afterloader units was included in the final rule because we 
believe that the radiation hazards associated with installation, 
replacement, relocation, or removal of a sealed source in these devices 
are similar to that of manipulation of manual brachytherapy sources. 
The recordkeeping requirements for this section are in Sec. 35.2605, 
Records of installation, maintenance, adjustment, and repair.
    The NRC deleted the current Sec. 35.606, License amendments. The 
requirements in the current paragraphs (a), (b), and (d) are addressed 
in the final Sec. 35.13(e). Paragraph (c) was deleted because the 
licensees must comply with the dose limit requirements in Part 20, and 
no further limitations are warranted. Paragraph (e) was deleted because 
the requirement to file an amendment before allowing an individual to 
perform the duties of the AMP is addressed in the final Sec. 35.13(b). 
Paragraph (e) was deleted because the requirements in Subpart H require 
that the AMP perform specific duties. Any deviations from these 
requirements would necessitate an exemption from Part 35.
    The NRC retitled Sec. 35.610, Safety procedures and instructions 
for remote afterloader units, teletherapy units, and gamma stereotactic 
radiosurgery units, and amended the codified text to include remote 
afterloader units and gamma stereotactic radiosurgery units.
    Paragraph (a) requires that a licensee secure the unit, console, 
console keys, and treatment room when not in use or unattended; permit 
only approved individuals into the treatment room during treatment; 
prevent dual operation of radiation producing devices; and develop, 
implement, and maintain written emergency response procedures.
    Paragraphs (a)(1) and (a)(3) codify requirements that are currently 
imposed on licensees by license conditions related to use of remote 
afterloaders. Because of the applicability of the requirements to all 
therapy units, they were added to the rule with the intent of having 
the requirements apply to all such units. We expanded paragraph (a)(2) 
to recognize that there are certain design conditions that will 
necessitate an individual, other than the patient, being in the 
treatment room during the treatment. An example of this condition is 
use of a low energy gamma source in a therapeutic medical device where 
the AU may need to be in the room with the patient. This exception does 
not relieve the licensees from complying with the dose limits for 
occupationally-exposed individuals or the general public in Part 20. In 
paragraph (a)(4), we codified requirements that are currently imposed 
on licensees by license conditions related to emergency procedures.
    We revised paragraph (b) to require that a copy of the licensee's 
procedures be physically located at the unit console. We revised 
paragraph (c) to require that the location of the procedures and 
emergency response telephone numbers be posted. Previously, all of 
these procedures were required to be posted. This was impractical with 
the addition of remote afterloaders because error conditions and 
responses are often several pages in length.
    Paragraphs (d) and (e), previously paragraph (b), were revised to 
require that the licensee provide initial and at least annual 
instruction in specifically identified procedures to all individuals 
who operate the unit, and initial and at least annual practice drills 
in emergency procedures to unit operators, AMPs, and AUs. The level of 
instruction should be commensurate with the individual's assigned 
duties. For example, an individual need not be instructed in equipment 
inspection, unless it is expected that during the normal course of the 
day, the individual will be required to inspect the unit. We believe 
that due to the complexity of therapeutic treatment units, refresher 
training and practice drills on emergency response are warranted. The 
recordkeeping requirements for this section are in Sec. 35.2310, 
Records of instruction and training.
    Paragraph (g) was added to refer to the recordkeeping requirements 
in Sec. 35.2610 for the procedures required by paragraphs (a)(4) and 
(d)(2).
    The NRC retitled Sec. 35.615, Safety precautions for remote 
afterloader units, teletherapy units, and gamma stereotactic 
radiosurgery units, and amended the codified text to include remote 
afterloader units and gamma stereotactic radiosurgery units. The 
current requirements in paragraphs (a) and (b) remain essentially the 
same, with minor changes to the language to support requirements for 
remote afterloader units and gamma stereotactic radiosurgery units. We 
deleted many of the prescriptive requirements [e.g., beam condition 
indicator light] [current paragraph (c)] and radiation monitor [current 
paragraph (d)] because they are addressed in Part 20.
    We added new requirements in paragraph (d) for intercom systems, 
and in paragraphs (e), (f), and (g) to codify requirements that are 
currently imposed by license conditions. Current license conditions 
were modified when they were incorporated into the final rule. For 
example, the presence of an AU and an AMP during patient treatments was 
clarified for each type of unit. As used in this provision, physically 
present means to be within hearing distance of normal voice. 
Immediately available means that the individual is available on an on-
call basis to respond to an emergency. At a minimum, this person must 
be available by telephone.
    We believe that the inherent risk of these procedures justifies the 
prescriptiveness of this regulation and that it is important for a 
properly trained physician to be available at all times to respond to 
an emergency requiring source removal.
    We deleted the current Sec. 35.620, Possession of survey 
instruments, 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 Part 20, and 
that the licensee 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 licensees to have adequate 
equipment. Guidance on the types of instruments medical licensees could 
consider using is in NUREG-1556, Vol. 9 (draft).

[[Page 20356]]

    The NRC amended Sec. 35.630, Dosimetry equipment, to provide 
calibration requirements for instruments used in this subpart and 
Subpart F. Paragraph (a)(1) requires that dosimetry systems be 
calibrated using a source or system traceable to the National Institute 
of Standards and Technology (NIST) and in accordance with published 
protocols accepted by a nationally recognized body; or by a calibration 
laboratory accredited by AAPM. This change gives licensees two 
alternatives for direct traceability of dosimetry equipment 
calibration, i.e., either a source or the measurement instrument (e.g., 
well chamber) can be calibrated against a national standard. We 
acknowledge that the industry standards for instrument calibration 
provide adequate assurance that equipment is properly calibrated. We 
amended paragraph (a)(2) to delete the reference to intercomparison 
meetings sanctioned by a calibration laboratory or radiologic physics 
centers accredited by the AAPM. This provision is no longer necessary 
because the AAPM does not sanction intercomparison meetings. References 
to cobalt-60 and cesium-137 contained within teletherapy units were 
deleted to make the section applicable to dosimetry equipment for all 
radionuclides and therapy units. In addition, licensees using only low 
dose-rate remote afterloader units are not required to possess 
dosimetry equipment if they rely on the source output or activity 
determined by the manufacturer, as long as the manufacturer uses 
appropriately calibrated equipment and performs the calibration in 
accordance with published protocols accepted by a nationally recognized 
body. This allowance has been made to be consistent with the 
requirements for manual brachytherapy sources. The recordkeeping 
requirements for this section are in Sec. 35.2630, Records of dosimetry 
equipment.
    The NRC retitled Sec. 35.632, Full calibration measurements on 
teletherapy units, and amended the codified text to clarify that the 
requirements in this section apply to teletherapy units. In paragraph 
(d), we deleted the reference to the AAPM Task Group Reports and 
replaced it with a requirement that full calibration measurements be 
done in accordance with published protocols accepted by nationally 
recognized bodies. This allows the licensee more flexibility in 
choosing appropriate protocols. We acknowledge that the industry 
standards for teletherapy unit calibration provide adequate assurance 
that equipment is properly calibrated. Paragraph (e) was revised to 
include mathematical correction of output for sources other than 
cobalt-60 and cesium-137. In paragraph (f), we replaced the term 
``teletherapy physicist'' with the term ``authorized medical 
physicist.'' The recordkeeping requirements for this section are in 
Sec. 35.2632, Records of teletherapy, remote afterloader, and gamma 
stereotactic radiosurgery full calibrations.
    Section 35.633, Full calibration measurements on remote afterloader 
units, is a new section that contains the requirements for the 
calibration of remote afterloader units. This section is similar in 
content to Sec. 35.632. Requirements in this section were based on 
recommendations found in AAPM Task Group Report No. 56--Code of 
Practice for Brachytherapy Physics (1997) and AAPM Task Group Report 
No. 59. The recordkeeping requirements for this section are in 
Sec. 35.2632, Records of teletherapy, remote afterloader, and gamma 
stereotactic radiosurgery full calibrations.
    The NRC deleted the current Sec. 35.634, Periodic spot-checks, and 
moved the requirements of this section, with minor modifications, to 
Sec. 35.642.
    Section 35.635, Full calibration measurements on gamma stereotactic 
radiosurgery units, is a new section that contains the requirements for 
the calibration of gamma stereotactic radiosurgery units. This section 
is similar in content to Sec. 35.632. Requirements in this section are 
based on recommendations found in AAPM Report No. 54. The recordkeeping 
requirements for this section are in Sec. 35.2632, Records of 
teletherapy, remote afterloader, and gamma stereotactic radiosurgery 
full calibrations.
    The NRC deleted the current Sec. 35.636, Safety checks for 
teletherapy facilities. The requirements in this section were extended 
to all therapy units and incorporated into the final Secs. 35.642, 
35.643, 35.645, and 35.647.
    The NRC deleted the current Sec. 35.641, Radiation surveys for 
teletherapy facilities. Radiation surveys at the surface of the main 
source safe of therapy units were addressed in the final Sec. 35.652. 
The remaining requirements in the current Sec. 35.641 were deleted to 
allow the licensee more flexibility in managing its radiation 
protection program.
    Section 35.642, Periodic spot-checks for teletherapy units, is a 
new section that contains the requirements that were previously found 
in Sec. 35.634, Periodic spot-checks. The NRC replaced the phrase 
``teletherapy physicist'' with the term ``authorized medical 
physicist'' throughout the section. We deleted the requirement in 
paragraph (c) to maintain a copy of the physicist's notification of the 
results of spot-checks to the licensee to reduce the recordkeeping 
requirements for licensees. We modified paragraph (d) to require that 
the safety spot-checks be performed once in each calendar month and 
after each source installation. This change replaces the safety check 
requirements after each source replacement in the current Sec. 35.636, 
which is deleted in the final rule. We modified paragraph (d)(3) to 
replace the term ``beam condition indicator'' with ``source exposure 
indicator'' to clarify that indicators were needed to note whether the 
source was exposed and note to what degree the source was exposed. We 
revised paragraph (d)(4) to include a requirement for an intercom 
system that was previously imposed by license condition. An intercom is 
needed to assure that the licensee's staff and the patients have the 
ability to communicate verbally in addition to the ability to 
communicate visually. We revised paragraph (e) to require that if a 
malfunction is identified during a safety spot-check the licensee lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning 
system. This change makes Sec. 35.642 consistent with the requirement 
in the current Sec. 35.636 regarding immediate actions to be taken when 
a malfunctioning system is identified. The recordkeeping requirements 
for this section are in Sec. 35.2642, Records of periodic spot-checks 
for teletherapy units.
    Section 35.643, Periodic spot-checks for remote afterloader units, 
is a new section that replaces the current Sec. 35.643, Modification of 
teletherapy unit or room before beginning a treatment program. The NRC 
deleted requirements in the current Sec. 35.643 because they were 
considered overly prescriptive. This allows the licensee more 
flexibility in designing a radiation protection program that is 
specific to its facility and which assures that the dose limits in Part 
20 are not exceeded.
    The new Sec. 35.643 contains the requirements for periodic spot-
checks of remote afterloader units, and is similar in content to 
Sec. 35.642. Requirements in this section are based on recommendations 
in AAPM TG-40 and TG-56. The recordkeeping requirements for this 
section are in Sec. 35.2643, Records of periodic spot-checks for remote 
afterloader units.
    Section 35.645, Periodic spot-checks for gamma stereotactic 
radiosurgery

[[Page 20357]]

units, is a new section that replaces the current Sec. 35.645, Reports 
of teletherapy surveys, checks, tests, and measurements. The 
requirements in the current Sec. 35.645 were deleted to reduce the 
reporting burden on medical use licensees. The NRC believes that there 
is no need to submit survey results to the appropriate Regional Office 
because the survey results are maintained by a licensee to show 
compliance with Part 20 and, therefore, are available for review.
    The new Sec. 35.645 contains requirements for periodic spot-checks 
of gamma stereotactic radiosurgery units, and is similar in content to 
Sec. 35.642. Requirements in this section are based on recommendations 
found in AAPM Report No. 54. The recordkeeping requirements for this 
section are in Sec. 35.2645, Records of periodic spot-checks for gamma 
stereotactic radiosurgery units.
    Section 35.647, Additional technical requirements for mobile remote 
afterloader units, replaces the current Sec. 35.647, 5-year inspection. 
Requirements in the current Sec. 35.647 were moved to Sec. 35.655. This 
section now contains the requirements for mobile remote afterloader 
units which were previously listed in an internal NRC document 
entitled, ``Supplement 1 to Policy and Guidance Directive FC 86-4; 
Revision 1, Mobile Remote Afterloading Brachytherapy Licensing 
Module.'' The recordkeeping requirements for this section are in 
Sec. 35.2647, Records of additional technical requirements for mobile 
remote afterloader units.
    Section 35.652, Radiation surveys, is a new section. This section 
replaces the current requirements in Sec. 35.641. This section requires 
that, in addition to the surveys required by Sec. 20.1501, the licensee 
make surveys to ensure that the maximum radiation levels and average 
radiation levels from the surface of the main source safe do not exceed 
the levels stated in the SSDR. These surveys provide added assurance 
that a device has been manufactured and that source(s) have been 
installed properly. The recordkeeping requirements for this section are 
in Sec. 35.2652, Records of surveys of therapeutic treatment units.
    Section 35.655, 5-year inspection for teletherapy and gamma 
stereotactic radiosurgery units, is a new Section and contains the 
requirements for inspections that were in the current Sec. 35.647. 
Section 35.655 requires that teletherapy units and gamma stereotactic 
radiosurgery units be inspected and serviced during source replacement, 
or at intervals not to exceed 5 years, to assure proper functioning of 
the source exposure mechanism. Most gamma stereotactic radiosurgery 
licensees are required, by license condition, to inspect the units 
every 7 years. However, professionals in the medical community have 
indicated that the units are inspected on a more frequent basis. The 
NRC believes that the risk associated with using gamma stereotactic 
radiosurgery units justifies a change in the inspection frequency to a 
frequency consistent with teletherapy units, i.e., 5 years. The 
recordkeeping requirements for this section are in Sec. 35.2655, 
Records of 5-year inspection for teletherapy and gamma stereotactic 
radiosurgery units.
    Section 35.657, Therapy-related computer systems, is a new section 
that requires licensees to perform acceptance testing on the treatment 
planning system of therapy-related computer systems in accordance with 
published protocols accepted by nationally recognized bodies. These 
changes are consistent with recommendations found in AAPM TG-56. The 
components of the testing are provided in this section. However, the 
licensee retains flexibility in developing the acceptance testing 
program. The NRC believes that these new requirements are warranted for 
the licensee administering therapy doses to ensure that the correct 
dose is delivered to patients.
    Section 35.690, Training for use of remote afterloader units, 
teletherapy units, and gamma stereotactic radiosurgery units, is a new 
section. This section contains the training and experience requirements 
for an AU of teletherapy, remote afterloader, and gamma stereotactic 
radiosurgery units. The current section, Sec. 35.960, Training for 
teletherapy, was expanded to include the training for AUs of remote 
afterloaders and gamma stereotactic radiosurgery units because 
requirements for gamma stereotactic radiosurgery units and remote 
afterloader units have been codified in the revised Part 35. Two 
changes made in the new section should be noted. First, the listing of 
specialty boards by name was deleted because the regulatory text in 
Part 35 will no longer incorporate a listing of specialty boards whose 
diplomates automatically fulfill the training and experience 
requirements for AUs. In place of listing the boards, the final rule 
provides for NRC recognition of the boards. Second, an individual must 
obtain written certification from a preceptor indicating that the 
individual has satisfactorily completed the requirements in this 
section and has achieved a level of competency sufficient to function 
independently as an AU. Section III of the SUPPLEMENTARY INFORMATION 
contains a detailed discussion of the Commission's changes to the 
training and experience requirements in Part 35. Note, 2 years after 
the effective date of the final rule, Sec. 35.690 will replace the 
current requirements in Sec. 35.960, Training for use of therapeutic 
medical devices.
    Subpart J, Training and Experience Requirements, is in the current 
Part 35 and will be retained for 2 years after the effective date of 
the final rule. Licensees will have the option to comply with the 
training and experience requirements in Subpart J or in Subparts B and 
D-H until 2 years after the effective date of the final rule. During 
this transition period, the NRC will continue working with the ACMUI 
and the medical community to resolve any concerns with the training and 
experience requirements. The Commission will consider changes to the 
training and experience requirements, as appropriate. A more detailed 
discussion of the Commission's changes to the training and experience 
requirements is in Section III of the SUPPLEMENTARY INFORMATION of this 
document. The schedule for implementation of the training and 
experience requirements is in Section IX of the SUPPLEMENTARY 
INFORMATION of this document.
    Section 35.900, Radiation Safety Officer, is in the current Part 
35. Two changes have been made in this section to correspond to the 
revised numbering system: Sec. 35.57, Training for experienced 
Radiation Safety Officer, teletherapy or medical physicist, authorized 
user, and nuclear pharmacist; and Sec. 35.24, Authority and 
responsibilities for the radiation protection program. This section 
will be retained for 2 years after the effective date of the final 
rule, at which time licensees will be required to comply with the 
training and experience requirements in the new Sec. 35.50, Training 
for Radiation Safety Officer. Section IX of the SUPPLEMENTARY 
INFORMATION of this document contains a detailed discussion of the 
Commission's implementation of the training and experience 
requirements.
    Section 35.901, Training for experienced Radiation Safety Officer, 
was deleted in its entirety, and the requirements of this section have 
been moved to the Sec. 35.57.
    Section 35.910, Training for uptake, dilution, and excretion 
studies, is in the current Part 35. One change has been made in this 
section to correspond to the revised numbering system: Sec. 35.57, 
Training for experienced Radiation Safety Officer, teletherapy or 
medical physicist, authorized user, and nuclear pharmacist. This 
section will be

[[Page 20358]]

retained for 2 years after the effective date of the final rule, at 
which time licensees will be required to comply with the training and 
experience requirements in the new Sec. 35.190, Training for uptake, 
dilution, and excretion studies. Section IX of the SUPPLEMENTARY 
INFORMATION of this document contains a detailed discussion of the 
Commission's implementation of the training and experience 
requirements.
    Section 35.920, Training for imaging and localization studies, is 
in the current Part 35. One change has been made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section will be retained 
for 2 years after the effective date of the final rule, at which time 
licensees will be required to comply with the training and experience 
requirements in the new Sec. 35.290, Training for imaging and 
localization studies. Section IX of the SUPPLEMENTARY INFORMATION of 
this document contains a detailed discussion of the Commission's 
implementation of the training and experience requirements.
    Section 35.930, Training for therapeutic use of unsealed byproduct 
material, is in the current Part 35. One change has been made in this 
section to correspond to the revised numbering system: Sec. 35.57, 
Training for experienced Radiation Safety Officer, teletherapy or 
medical physicist, authorized user, and nuclear pharmacist. This 
section will be retained for 2 years after the effective date of the 
final rule, at which time licensees will be required to comply with the 
training and experience requirements in the new Sec. 35.390, Training 
for use of unsealed byproduct material for which a written directive is 
required. Section IX of the SUPPLEMENTARY INFORMATION of this document 
contains a detailed discussion of the Commission's implementation of 
the training and experience requirements.
    Section 35.932, Training for treatment of hyperthyroidism, is in 
the current Part 35. One change has been made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section will be retained 
for 2 years after the effective date of the final rule, at which time 
licensees will be required to comply with the training and experience 
requirements in the new Sec. 35.392, Training for the oral 
administration of sodium iodide I-131 requiring a written directive in 
quantities less than or equal to 1.22 Gigabecquerels (33 millicuries). 
Section IX of the SUPPLEMENTARY INFORMATION of this document contains a 
detailed discussion of the Commission's implementation of the training 
and experience requirements.
    Section 35.934, Training for treatment of thyroid carcinoma, is in 
the current Part 35. One change has been made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section will be retained 
for 2 years after the effective date of the final rule, at which time 
licensees will be required to comply with the training and experience 
requirements in the new Sec. 35.394, Training for the oral 
administration of sodium iodide I-131 requiring a written directive in 
quantities greater than 1.22 Gigabecquerels (33 millicuries). Section 
IX of the SUPPLEMENTARY INFORMATION of this document contains a 
detailed discussion of the Commission's implementation of the training 
and experience requirements.
    Section 35.940, Training for use of brachytherapy sources, is in 
the current Part 35. One change has been made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section will be retained 
for 2 years after the effective date of the final rule, at which time 
licensees will be required to comply with the training and experience 
requirements in the new Sec. 35.490, Training for use of manual 
brachytherapy sources. Section IX of the SUPPLEMENTARY INFORMATION of 
this document contains a detailed discussion of the Commission's 
implementation of the training and experience requirements.
    Section 35.941, Training for ophthalmic use of strontium-90, is in 
the current Part 35. One change has been made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section will be retained 
for 2 years after the effective date of the final rule, at which time 
licensees will be required to comply with the training and experience 
requirements in the new Sec. 35.491, Training for ophthalmic use of 
strontium-90. Section IX of the SUPPLEMENTARY INFORMATION of this 
document contains a detailed discussion of the Commission's 
implementation of the training and experience requirements.
    Section 35.950, Training for use of sealed sources for diagnosis, 
is in the current Part 35. One change has been made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section will be retained 
for 2 years after the effective date of the final rule, at which time 
licensees will be required to comply with the training and experience 
requirements in the new Sec. 35.590, Training for use of sealed sources 
for diagnosis. Section IX of the SUPPLEMENTARY INFORMATION of this 
document contains a detailed discussion of the Commission's 
implementation of the training and experience requirements.
    Section 35.960, Training for use of therapeutic medical devices, is 
in the current Part 35. One change has been made in this section to 
correspond to the revised numbering system: Sec. 35.57, Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized user, and nuclear pharmacist. This section will be retained 
for 2 years after the effective date of the final rule, at which time 
licensees will be required to comply with the training and experience 
requirements in the new Sec. 35.690, Training for use of remote 
afterloader units, teletherapy units, and gamma stereotactic 
radiosurgery units. Section IX of the SUPPLEMENTARY INFORMATION of this 
document contains a detailed discussion of the Commission's 
implementation of the training and experience requirements.
    Section 35.961 has been retitled, Training for an authorized 
medical physicist, to reflect that the training and experience 
requirements in this section apply to authorized medical physicists 
rather than just teletherapy physicists. In addition, the list of tasks 
in paragraph (c) has been changed to reflect the new numbering system. 
This section will be retained for 2 years after the effective date of 
the final rule, at which time licensees will be required to comply with 
the training and experience requirements in the new Sec. 35.51, 
Training for an authorized medical physicist. Section IX of the 
SUPPLEMENTARY INFORMATION of this document contains a detailed 
discussion of the Commission's

[[Page 20359]]

implementation of the training and experience requirements.
    Section 35.970, Training for experienced authorized users, was 
deleted in its entirety and the requirements are moved to Sec. 35.57.
    Section 35.971, Physicians training in a three month program, was 
deleted in its entirety. Three-month nuclear medicine programs are no 
longer available. Criteria for authorized users are now specified in 
other areas of the rule.
    Section 35.972, Recentness of training, was deleted in its entirety 
and the requirements are moved to Sec. 35.59.
    Section 35.980, Training for an authorized nuclear pharmacist, was 
not changed. This section will be retained for 2 years after the 
effective date of the final rule, at which time licensees will be 
required to comply with the training and experience requirements in the 
new Sec. 35.55, Training for an authorized nuclear pharmacist. Section 
IX of the SUPPLEMENTARY INFORMATION of this document contains a 
detailed discussion of the Commission's implementation of the training 
and experience requirements.
    Section 35.981, Training for experienced nuclear pharmacists, has 
not been changed. This section will be retained for 2 years after the 
effective date of the final rule, at which time licensees will be 
required to comply with the training and experience requirements in the 
new Sec. 35.57, Training for experienced Radiation Safety Officer, 
teletherapy or medical physicist, authorized user, and nuclear 
pharmacist.
    The NRC deleted the current Sec. 35.990, Violations, and moved the 
requirements of this section, with minor modifications, to the new 
Sec. 35.4001, Violations.
    The NRC deleted the current Sec. 35.991, Criminal penalties, and 
moved the requirements of this section, with minor modifications, to 
the new Sec. 35.4002, Criminal penalties.
    The NRC deleted the current Sec. 35.999, Resolution of conflicting 
requirements during transition period, and moved the requirements of 
this section, with modifications, to the new Sec. 35.10, 
Implementation.
    Subpart K, Other Medical Uses of Byproduct Material or Radiation 
from Byproduct Material, is a new subpart. This subpart includes all 
new medical uses of byproduct material or radiation from byproduct 
material, i.e., types of uses that are not regulated under Subparts D 
through H.
    Section 35.1000, Other medical uses of byproduct material or 
radiation from byproduct material, is a new section. It has been added 
so that there are codified regulatory requirements and a more clearly 
defined process to obtain a license, or an amendment to a license, for 
a new medical use of byproduct material or radiation from byproduct 
material, i.e., an emerging technology. The specific information that 
must be provided to the Commission in support of an application for use 
under Sec. 35.1000 is provided in Sec. 35.12(d). The Commission intends 
to evaluate each application on a case-by-case basis and to work with 
the ACMUI, the medical community, and the developers of the new 
technology, as appropriate, to determine the risks associated with the 
technology and the appropriate regulatory requirements, including the 
training and experience requirements, for use of the technology.
    Subpart L, Records, is a new subpart. This subpart contains all the 
specific recordkeeping requirements necessary to implement the 
requirements in Part 35. The general requirements for record 
maintenance, such as electronic storage, are provided in Sec. 35.5. The 
records are grouped in one subpart to facilitate use by the licensees. 
A licensee may refer to this subpart to determine whether something 
must be recorded, instead of having to review the entire regulation to 
find out if there is a particular recordkeeping requirement. Many of 
the recordkeeping requirements remain unchanged from the current Part 
35. However, some new sections have been added as a result of new 
requirements, especially in Subpart H, that codify requirements for 
remote afterloaders and gamma stereotactic radiosurgery units that are 
currently imposed by license conditions.
    Section 35.2024, Records of authority and responsibilities for 
radiation protection programs, requires the licensee to retain a record 
of actions taken by the licensee's management in accordance with 
Sec. 35.24(a) for 5 years. The Commission believes that it is important 
to document the licensee's management review and approval of licensing 
actions and changes to the radiation protection program. The record of 
licensing actions and radiation protection program changes must include 
a summary of the actions taken and a signature of licensee management. 
The 5-year retention period is a reduction from the current 
requirements to maintain records of the approval of licensing actions, 
individuals, and radiation protection program changes. Similar records 
in the current Secs. 35.23 and 35.31 are required to be maintained for 
the duration of the license. The 5-year retention period will decrease 
the recordkeeping burden on licensees and will also allow sufficient 
time for NRC to review records of licensee actions.
    Paragraph (b) of this section requires the licensee to retain a 
copy of both the authorities, duties, and responsibilities of the RSO 
in accordance with Sec. 35.24(e) and a signed copy of each RSO's 
agreement to be responsible for implementing the radiation safety 
program, in accordance with Sec. 35.24(b), for the duration of the 
license. These records must include the signatures of both the RSO and 
licensee management. The current Part 35 requires that the signed copy 
of the authorities, duties, and responsibilities of the RSO be retained 
until the Commission terminates the license.
    Section 35.2026, Records of radiation protection program changes, 
requires the licensee to retain a record of each radiation protection 
program change made in accordance with Sec. 35.26(a) for 5 years. The 
record must include a copy of the old and new procedures, the effective 
date of the change, and the signature of the licensee management that 
reviewed and approved the change. The requirements in the current 
Sec. 35.31 to include the reasons for the change, and a summary of 
radiation safety matters that were considered before making the change, 
have been deleted. The Commission recognizes that the requirement for 
management's signature is redundant with the requirement in 
Sec. 35.2024. However, it believes this approach is warranted in light 
of the importance of these actions. This record is needed to document 
what radiation changes were made in the program to facilitate the 
Commission's evaluation of minor radiation safety program changes, and 
provides licensees with a record of the changes. Currently, licensees 
must retain a record of each ``radiation safety program'' change until 
the license has been renewed or terminated. Therefore, the 5-year 
retention period in the final rule represents a reduction in the 
licensee's recordkeeping burden.
    Section 35.2040, Records of written directives, requires the 
licensee to retain a copy of written directives required by Sec. 35.40 
for 3 years. The final rule includes only minor changes to the specific 
items that must currently be recorded in written directives in 
accordance with Sec. 35.32. These records will help to ensure that 
administrations are in accordance with the written directives. The 3-
year recordkeeping retention period corresponds with the current 
retention period for written directives in Sec. 35.32(d). These changes 
are discussed under Sec. 35.40.
    Section 35.2041, Records for procedures for administrations 
requiring

[[Page 20360]]

a written directive, is a new section. This section requires licensees 
to retain a copy of the procedures required by Sec. 35.41(a) for the 
duration of the license.
    Section 35.2060, Records of calibrations of instruments used to 
measure the activity of unsealed byproduct material, requires the 
licensee to maintain a record of instrument calibrations performed in 
accordance with Sec. 35.60 for 3 years. These records are required to 
document that the instruments are calibrated properly. This section 
replaces the requirements in the current Sec. 35.50 (e) and adds 
recordkeeping requirements for instruments used to measure the activity 
of dosages of nonphoton-emitting radionuclides. The prescriptive 
requirements for the record were deleted because licensees should have 
flexibility in determining how the results of the calibration are 
recorded. The final rule requires that the name of the individual who 
performed the calibration be documented in the record, rather than the 
initials of the individual who performed the constancy check and the 
identity of the individual for all other required tests. The NRC 
believes that this change is needed because recording the name of the 
individual will better ensure future identification of the individual 
who performed the calibration. The change is also needed because it 
gives the licensee the flexibility of using paper records or computer-
generated records. This requirement does not prohibit licensees from 
continuing to have the individual who performed the calibration sign 
the record. The 3-year recordkeeping retention period is consistent 
with the current retention period for instrument calibrations.
    The final rule requires that the record contain the model and 
serial number of the instrument; the date of the calibration, the 
results of the calibration; and the name of the individual who 
performed the calibration.
    Section 35.2061, Records of radiation survey instrument 
calibrations, requires the licensee to maintain a record of radiation 
survey instrument calibrations required by Sec. 35.61 for 3 years. This 
record is needed to provide adequate documentation of instrument 
calibration. This section replaces the requirements in the current 
Sec. 35.51(d). The NRC deleted the requirement to include the 
descriptions of the calibration procedure and the source used; the 
certified exposure rates from the source and the rates indicated by the 
instrument being calibrated; and the correction factors deduced from 
the calibration data. This revision is consistent with the revisions 
made to Sec. 35.61. The 3-year recordkeeping retention period is 
consistent with the current retention period for instrument 
calibrations.
    The final rule requires that the licensee record the model and 
serial number of the instrument; the date of the calibration; the 
results of the calibration; and the name of the individual who 
performed the calibration.
    Section 35.2063, Records of dosage of unsealed byproduct material 
for medical use, requires the licensee to maintain a record of dosage 
determinations required by Sec. 35.63 for 3 years. This record is 
needed to show that material has been administered to a patient or 
human research subject. This section replaces the requirements in the 
current Sec. 35.53(c). Changes have been made from the current 
recordkeeping requirements for dosage measurement. The NRC deleted the 
requirement to include the generic name, trade name, or abbreviation of 
the radiopharmaceutical; its lot number and expiration date; and the 
activity of the dosage at the time of measurement. With the exception 
of the expiration date, the requirements were deleted to make the rule 
less prescriptive. We deleted the expiration date because it is 
primarily related to drug stability and sterility. The term ``dosage 
measurement'' was replaced by the term ``dosage determination'' to be 
consistent with the changes made in Sec. 35.63. Finally, a change has 
been made to require that the name of the individual who determined the 
dosage be documented rather than the initial of the individual who made 
the record. We believe that this change is needed because recording the 
name of the individual will better ensure future identification of the 
individual who determined the dosage. The 3-year recordkeeping 
retention period corresponds with the current retention period for 
dosage records.
    The final rule requires that licensees record the 
radiopharmaceutical; the patient's or human research subject's name, or 
identification number if one has been assigned; the prescribed dosage, 
the determined dosage, or a notation that the total activity is less 
than 1.1 MBq (30 Ci); the date and time of the dosage 
determination; and the name of the individual who determined the 
dosage.
    Section 35.2067, Records of leak tests and inventory of sealed 
sources and brachytherapy sources, requires the licensee to retain 
records of the leak tests and inventory required by Sec. 35.67(b) and 
(g), respectively, for 3 years. Leak test records are required to show 
that the leak test was done at the appropriate time interval and that 
sealed sources are not leaking. Inventory records are necessary to show 
that the possession of sealed sources did not exceed the amount 
authorized by the license. This section replaces the requirements in 
the current Sec. 35.59(d) and (g). The NRC deleted the requirement to 
record the measured activity of each leak test sample and a description 
of the method used to measure each test sample. These changes were done 
to make the rule less prescriptive. We also revised the rule to require 
that the name of the individual performing the leak test and inventory 
be recorded rather than the signature of the RSO. We believe this 
change is needed because recording the name of the individual will 
ensure future identification of the individual who performed the leak 
test or inventory. The record retention period was reduced from 5 years 
to 3 years to reduce regulatory burden. The Commission does not believe 
the longer record retention period is warranted.
    The final rule requires that leak test records must contain the 
model number, and serial number if one has been assigned, of each 
source tested; the identity of each source radionuclide and its 
estimated activity; the results of the test; the date of the test; and 
the name of the individual who performed the test. Inventory records 
must contain the model number of each source, and serial number if one 
has been assigned; the identity of each source radionuclide and its 
nominal activity; the location of each source; and the name of the 
individual who performed the inventory.
    Section 35.2070, Records of surveys for ambient radiation exposure 
rate, requires the licensee to maintain records of radiation surveys 
for 3 years. These records are needed to document that surveys were 
performed. This section replaces the requirements in the current 
Sec. 35.70(h). The NRC revised the current requirements to delete the 
need to record a plan of each area surveyed; the trigger level 
established for each area; and the detected dose rate at several points 
in each area expressed in millirem per hour or the removable 
contamination in each area expressed in disintegrations per minute per 
100 square centimeters. These deletions were done to make the rule less 
prescriptive and to delete reference to surveys for removable 
contamination. The final rule requires that the name of the individual 
performing the survey be recorded rather than the initials of the 
individual. We believe this change is needed because recording the name 
of the individual will ensure easier

[[Page 20361]]

identification of the individual who performed the survey. The 3-year 
recordkeeping retention period is consistent with the current retention 
period for radiation surveys.
    The final rule requires that the record include the date of the 
survey; the results of the survey; the instrument used to make the 
survey; and the name of the individual who performed the survey.
    Section 35.2075, Records of the release of individuals containing 
unsealed byproduct material or implants containing byproduct material, 
requires the licensee to maintain records of patient release required 
by Sec. 35.75 for 3 years. This record is needed to show compliance 
with the requirements in Sec. 35.75. No changes have been made from the 
recordkeeping requirements in the current Sec. 35.75 (c) and (d).
    Section 35.2080, Records of mobile medical services, requires the 
licensees to maintain a copy of each letter that permits the use of 
byproduct material at a client's address of use for 3 years after the 
last provision of service; and to retain the records of the surveys for 
3 years. The records are needed to show compliance with the 
requirements in Sec. 35.80. The NRC deleted the requirements to record 
a plan of each area that was surveyed and the measured dose rate at 
several points in each area of use expressed in millirem per hour. This 
change was done to make the rule less prescriptive. The final rule 
requires that the name of the individual performing the survey rather 
than the initials of the individual be recorded. We believe this change 
is needed because recording the name of the individual will ensure 
easier identification of the individual who performed the survey.
    Paragraph (a) of the final rule requires that the record include a 
copy of each letter that permits the use of byproduct material at a 
client's address. Paragraph (b) requires that the record of each survey 
include the date of survey, the result of the survey, the instrument 
used to make the survey, and the name of the individual who performed 
the survey.
    Section 35.2092, Records of decay-in-storage, requires the licensee 
to maintain records of the disposal of licensed materials made in 
accordance with Sec. 35.92 for 3 years. This record is needed to 
document that radioactive material is not disposed of as ordinary 
waste. This section replaces the requirements in the current Sec. 35.92 
(b). The NRC deleted the requirement to record the date that the 
material was placed in storage and the radionuclides because the 
requirement to store material for 10 half-lives was deleted. We also 
revised the requirement so that the record includes the name of the 
individual who performed the survey, rather than the name of the 
individual who performed the disposal. We believe that it is important 
to have a record of the individual who actually surveyed the material 
and determined that it could be disposed without regard to its 
radioactivity. The 3-year recordkeeping retention period is consistent 
with the current retention period for waste disposal records.
    The final rule requires that the record include the date of the 
disposal; the survey instrument used; the background radiation level; 
the radiation level measured at the surface of each waste container; 
and the name of the individual who performed the survey.
    Section 35.2204, Records of molybdenum-99 concentrations, requires 
the licensee to maintain a record of the molybdenum-99 concentration 
tests required by Sec. 35.204(b) for 3 years. This record is needed to 
document that the concentration measurement has been made and that the 
maximum molybdenum-99 concentration level was not exceeded. This 
section replaces the requirements in the current Sec. 35.204 (c). The 
NRC deleted the requirements to record the measured activity of the 
technetium expressed in millicuries and the measured activity of the 
molybdenum expressed in microcuries. The 3-year recordkeeping retention 
period is consistent with the current retention period for records of 
molybdenum-99 concentration.
    The final rule requires that the record include, for each measured 
elution of technetium-99m, the ratio for the measures expressed as 
kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m 
(microcuries of molybdenum per millicurie of technetium); the time and 
date of the measure; and the name of the individual who made the 
measurement.
    Section 35.2310, Records of safety instruction, requires the 
licensee to maintain a record of radiation safety instructions required 
by Secs. 35.310, 35.410, and 35.610 for 3 years. This record is needed 
to document that the instruction was given. This section replaces the 
requirements in Secs. 35.310, 35.410, and 35.610. The rule has been 
revised to require that the licensee record the topics covered rather 
than a description of the instruction. The NRC believes the term 
``description of the instruction'' was too vague and could have been 
interpreted too broadly. For example, the licensee could question 
whether the rule required a listing of the topics or a general 
description, e.g., such as laboratory or classroom training. The change 
makes it clear that the record should contain the topics, e.g., 
patient, visitor, waste, or contamination control. The 3-year 
recordkeeping retention period is consistent with the current retention 
period for training records.
    The final rule requires that the record include a list of the 
topics covered, the date of the instruction, the name(s) of the 
attendee(s), and the name(s) of the individual(s) who provided the 
instruction.
    Section 35.2404, Records of surveys after source implant or 
removal, requires the licensee to maintain a record of the surveys 
required by Secs. 35.404 and 35.604 for 3 years. The licensee is no 
longer specifically required to record the dose rate from the patient 
or the human research subject expressed as millirem per hour and 
measured at 1 meter from the patient or human research subject. Each 
record must include the date and results of the survey, the survey 
instrument used, and the name of the individual who made the survey. 
These records are used to show that sources have not been misplaced and 
that all sources have been removed from the patient. The 3-year 
recordkeeping retention period is consistent with the current retention 
period for surveys found in Part 20.
    Section 35.2406, Records of brachytherapy source accountability, 
requires the licensee to maintain a record of brachytherapy source 
accountability required by Sec. 35.406 for 3 years. Changes have been 
made in the recordkeeping requirements found in the current rule. The 
licensee is no longer required to record the following items because 
they were deleted from Sec. 35.406: the names of the individuals 
permitted to handle the sources; name and room number of the patient or 
the human research subject receiving the implant; number and activity 
of the sources in storage after the removal; and the number and 
activity of sources in storage after the return.
    The final rule requires that, for temporary implants, the record 
must include the number and activity of sources removed from and 
returned to storage; the time and date they were removed from and 
returned to storage; the name(s) of the individual(s) who removed them 
from and returned them to storage; and the location of use. For 
permanent implants, the record must include the number and activity of 
sources removed from storage; the number and activity of sources 
permanently implanted in the patient or human research subject; the 
number and activity of sources not implanted; the

[[Page 20362]]

date they were removed from and returned to storage; and the name(s) of 
the individual(s) who removed them from and returned them to storage. 
This record is required so that if a brachytherapy source is misplaced 
or missing the licensee is immediately alerted and can take appropriate 
action. The 3-year recordkeeping retention period is consistent with 
the current retention period for inventory records.
    Section 35.2432, Records of calibration measurements of 
brachytherapy sources, requires the licensee to retain a record of the 
results of brachytherapy source calibrations required by Sec. 35.432 
for 3 years after the last use of the source. This is a new 
recordkeeping section. The record must contain the date of the 
calibration; the manufacturer's name, model number, and serial number 
for the source and instruments used to calibrate the source; the source 
output or activity; the source positioning accuracy within the 
applicators; and the signature of the AMP. These records are needed to 
document that the brachytherapy sources have been calibrated.
    Section 35.2433, Records of decay of strontium-90 sources for 
ophthalmic treatments, requires the licensee to maintain a record of 
the activity of a strontium-90 source, as required by Sec. 35.433, for 
the life of the source. This is a new recordkeeping section. The 
records for each strontium-90 source must include the date and initial 
activity of the source as determined under Sec. 35.432; and, for each 
decay calculation, the date and the source activity as determined under 
Sec. 35.433. These records are needed to document that the treatment 
times for ophthalmic uses of strontium-90 are based on properly decayed 
sources.
    Section 35.2605, Records of installation, maintenance, adjustment, 
and repair of remote afterloader units, teletherapy units, and gamma 
stereotactic radiosurgery units, requires the licensee to retain a 
record of the installation, maintenance, adjustment, and repair of 
these units as required by Sec. 35.605, for 3 years. This is a new 
recordkeeping section. Previously, licensees were not required to keep 
records of installation, maintenance, adjustment, and repair. For each 
installation, maintenance, adjustment, and repair, the record must 
include the date, description of the service, and name(s) of the 
individual(s) who performed the work. This record is necessary to 
document that the units are properly installed, maintained, adjusted, 
and repaired; to establish trends in unit performance; and to establish 
a service history that may be used in evaluation of generic equipment 
problems.
    Section 35.2610, Records of safety procedures, is a new section. 
This section requires licensees to retain a copy of the procedures 
required by Secs. 35.610(a)(4) and (d)(2) until the licensee no longer 
possesses the remote afterloader, teletherapy unit, or gamma 
stereotactic radiosurgery unit.
    Section 35.2630, Records of dosimetry equipment used with remote 
afterloader units, teletherapy units, and gamma stereotactic 
radiosurgery units, requires the licensee to retain a record of the 
calibration, intercomparison, and comparisons of its dosimetry 
equipment done in accordance with Sec. 35.630 for the duration of the 
license. Some changes have been made in the recordkeeping requirements 
from the current rule. For example, a requirement, similar to 
requirements for other instruments, has been added to record the 
manufacturer's name of the instruments that were calibrated. These 
records are needed to show that calibrations of medical units were made 
with properly calibrated instruments.
    Section 35.2632, Records of teletherapy, remote afterloader, and 
gamma stereotactic radiosurgery full calibrations, requires the 
licensee to maintain a record of the full calibrations required by 
Secs. 35.632, 35.633, and 35.635 for 3 years. The record retention 
period was decreased from the duration of the use of the unit's source 
to 3 years to reduce regulatory burden. The term ``teletherapy 
physicist'' was replaced with the term ``authorized medical 
physicist.'' In addition, the current recordkeeping requirements for 
this section were reduced to recording the date of the calibration; 
manufacturer's name, model number, and serial number for the unit, 
source and instruments used to calibrate the unit; the results and 
assessment of the calibration; the results of the autoradiograph 
required for low dose-rate remote afterloader units; and the signature 
of the AMP who performed the full calibration. These records are needed 
to document that calibrations were performed in accordance with 
Secs. 35.632, 35.633, and 35.635.
    Section 35.2642, Records of periodic spot-checks for teletherapy 
units, requires the licensee to retain a record of each periodic spot-
check for teletherapy units required by Sec. 35.642 for 3 years. Minor 
changes have been made in the recordkeeping requirements from the 
current rule. For instance, the licensee is no longer required to 
record the operability of the beam condition indicator light, but is 
required to record the operability of the source exposure indicator 
light. This change reflects corresponding changes made in Sec. 35.642. 
These records are needed to document that spot-checks were performed in 
accordance with Sec. 35.642. The 3-year recordkeeping retention period 
is consistent with the current retention period for periodic spot-
checks.
    Paragraph (c) requires that the licensee retain a copy of the 
procedures required by Sec. 35.642(b) until the licensee no longer 
possesses the teletherapy unit.
    Section 35.2643, Records of periodic spot-checks for remote 
afterloader units, requires the licensee to retain a record of each 
spot-check for remote afterloader units required by Sec. 35.643 for 3 
years. This is a new recordkeeping section. The record must include the 
date of the spot-check; the manufacturer's name, model number, and 
serial number for both the remote afterloader unit and source; an 
assessment of timer accuracy; notations indicating the operability of 
each entrance door electrical interlock, radiation monitors, source 
exposure indicator lights, viewing and intercom systems, clock and 
decayed source activity in the unit's computer; the name of the 
individual who performed the periodic spot-check; and the signature of 
the AMP who reviewed the record of the spot-check. These records are 
needed to document that spot-checks were performed in accordance with 
Sec. 35.643.
    Paragraph (c) requires that the licensee retain a copy of the 
procedures required by Sec. 35.643(b) until the licensee no longer 
possesses the remote afterloader.
    Section 35.2645, Records of periodic spot-checks for gamma 
stereotactic radiosurgery units, requires the licensee to retain a 
record of each spot-check for gamma stereotactic radiosurgery units 
required by Sec. 35.645 for 3 years. This is a new recordkeeping 
section. The record must include the date of the spot-check; the 
manufacturer's name, model number, and serial number for the gamma 
stereotactic radiosurgery unit and the instrument used to measure the 
output of the unit; an assessment of timer linearity and accuracy; the 
calculated on-off error; a determination of trunnion centricity; the 
difference between the anticipated output and the measured output; an 
assessment of source output against computer calculations; notations 
indicating the operability of radiation monitors, helmet microswitches, 
emergency timing circuits, emergency off buttons, electrical 
interlocks, source exposure indicator lights, viewing and intercom

[[Page 20363]]

systems, timer termination, treatment table retraction mechanism, 
stereotactic frames and localizing devices (trunnions); the name of the 
individual who performed the periodic spot-check; and the signature of 
the AMP who reviewed the periodic spot-check. This record is needed to 
show that spot-checks were performed in accordance with Sec. 35.645.
    Paragraph (c) requires that the licensee retain a copy of the 
procedures required by Sec. 35.645 (b) until the licensee no longer 
possesses the gamma stereotactic radiosurgery unit.
    Section 35.2647, Records of additional technical requirements for 
mobile remote afterloader units, requires the licensee to retain a 
record of each check for mobile remote afterloader units required by 
Sec. 35.647 for 3 years. This is a new recordkeeping section. The 
record must include the date of the check; the manufacturer's name, 
model number, and serial number for the remote afterloader unit; 
notations accounting for all sources before departing from a facility; 
notations indicating the operability of each entrance door electrical 
interlock, radiation monitors, source exposure indicator lights, 
viewing and intercom system, applicators, source transfer tubes, and 
transfer tube applicator interfaces, and source positioning accuracy; 
and the signature of the individual who performed the check. This 
record is needed to show that required spot-checks were performed in 
accordance with Sec. 35.647 and that the unit is operable.
    Section 35.2652, Records of surveys of therapeutic treatment units, 
requires the licensee to maintain a record of radiation surveys made in 
accordance with Sec. 35.652 for the duration of use of the unit. This 
recordkeeping requirement has been changed to require that the records 
of radiation surveys of the treatment unit must be maintained for the 
duration of use of the unit, rather than for the duration of the 
license, to reduce regulatory burden. In addition, the licensee is no 
longer required by this section to maintain a plan of the areas 
surrounding the treatment room that were surveyed, the measured dose 
rate at several points in each area expressed in millirem per hour, and 
the calculated maximum quantity of radiation over a period of 1 week 
for each restricted and unrestricted area. This change reflects 
corresponding changes made in Sec. 35.652. The record must include the 
date of the measurements; the manufacturer's name, model number and 
serial number of the treatment unit, source, and instrument used to 
measure radiation levels; each dose rate measured around the source 
while the unit is in the off position and the average of all 
measurements; and the signature of the individual who performed the 
surveys. This record is needed to document radiation levels in areas 
surrounding therapeutic devices in accordance with Sec. 35.652.
    Section 35.2655, Records of 5-year inspection for teletherapy and 
gamma stereotactic radiosurgery units, requires the licensee to 
maintain a record of the 5-year inspection for teletherapy and gamma 
stereotactic radiosurgery units required by Sec. 35.655 for the 
duration of the unit. This recordkeeping requirement has been changed 
to require that the records of inspections of the treatment units must 
be maintained for the duration of use of the unit, rather than for the 
duration of the license, to reduce the regulatory burden. A minor 
change has been made to delete the requirement to maintain a record of 
the components replaced to also reduce the regulatory burden. The 
record must contain the inspector's radioactive materials license 
number; the date of inspection; the manufacturer's name, model number 
and serial number for both the treatment unit and source; a list of 
components inspected and serviced; the type of service; and the 
signature of the inspector. This record is needed to document the type 
of service that was performed in accordance with Sec. 35.655.
    Subpart M, Reports, is a new subpart in Part 35. This subpart 
contains all the reporting requirements necessary to implement the 
requirements in Part 35. Grouping of reporting requirements into one 
subpart was done to facilitate use by licensees. A licensee may refer 
to this section when determining whether something must be reported, 
rather than having to review the entire regulation to find out if there 
is a particular reporting requirement. Two of the reporting 
requirements appear in the current Secs. 35.33 and 35.59. A third 
reporting requirement was added so that the NRC can comply with the 
requirement to submit an annual report to Congress of unscheduled 
incidents or events which the Commission considers significant from the 
standpoint of public health and safety.
    Section 35.3045, Report and notification of a medical event, 
provides criteria for reporting and notifying individuals about a 
medical event. The requirements in the final rule are based on the 
current requirements in Sec. 35.33, Notifications, reports, and records 
of misadministrations. Changes were made to make the reporting 
threshold dose-based where possible; to add a dose threshold of 0.5 
Sievert (Sv) (50 rem) shallow dose equivalent to the skin; and to 
address two areas that have caused problems in implementing the current 
requirements for reporting misadministrations--patient intervention and 
wrong treatment site. In addition, several changes were made to the 
requirements associated with the report and record of the event.
    Patient intervention is not specifically addressed in the current 
rule. However, a licensee is expected to act reasonably, in accordance 
with prevailing standards of care, to prevent patient intervention from 
causing a misadministration. This situation has resulted in numerous 
debates over whether or not a licensee had done everything it should to 
prevent patient intervention during treatment. In order to correct the 
current situation, the NRC defined patient intervention to mean 
intentional or unintentional actions taken by a patient or human 
research subject such as dislodging or removing treatment devices or 
prematurely terminating the administration. We have also added a 
specific requirement for reporting medical events that occur as a 
result of patient intervention. Licensees are required to report any 
event resulting from intervention of a patient or human research 
subject in which the administration of byproduct material or radiation 
from byproduct material results or will result in unintended permanent 
functional damage to an organ or a physiological system, as determined 
by a physician. This reporting requirement should result in minimal 
regulatory burden on licensees because in most situations where 
patients or human research subjects intervene, either voluntarily or 
involuntarily, in their treatment there is no resultant permanent 
medical damage. Even though there is a high threshold for reporting in 
the final rule, licensees are expected to continue to act reasonably, 
as required under the current rule, to prevent medical events caused by 
patient intervention.
    The final rule includes specific criteria for determining when a 
dose to a wrong treatment site is a reportable medical event: a dose to 
the skin or an organ or tissue other than the treatment site that 
exceeds by 0.5 Sv (50 rem) to an organ or tissue and 50 percent or more 
of the dose expected from the administration defined in the written 
directive (excluding, for permanent implants, seeds that were implanted 
in the correct site but migrated outside the treatment site).
    The final rule retains the current requirement in Sec. 35.33 that 
licensees notify the NRC Operations Center, by telephone, no later than 
the next

[[Page 20364]]

calendar day after discovery of the medical event. The final rule also 
retains the current requirement for licensees to submit a written 
report to the appropriate NRC Regional Office listed in 10 CFR 30.6 
within 15 days after discovery of the medical event. This reporting 
requirement is needed to ensure that NRC is aware of medical events. In 
addition, the licensee is required to notify the referring physician 
and the individual affected by the medical event, or the responsible 
relative or guardian, no later than 24 hours after its discovery, 
unless the referring physician personally informs the licensee either 
that he will inform the individual or that, based on medical judgment, 
telling the individual would be harmful. The written report to the NRC 
must include certification that the licensee notified the individual 
(or the individual's responsible relative or guardian), and, if not, 
why not. Since licensees are required to report information about the 
medical event to the NRC and to the referring physician, we believe 
that it is not necessary to require licensees to retain a record of the 
medical event.
    A change was also made in the current requirement for a written 
report to be provided to the affected individual within 15 days of 
discovery of the medical event. In the current rule, licensees can 
provide the individual with a brief description of both the event and 
the consequences as they may affect the individual if they include a 
statement that the individual can also obtain a copy of the report that 
was submitted to the NRC from the licensee. In the final rule, the 
licensee is not required to include this statement because knowledge 
that a report had to be submitted to the NRC might unduly alarm an 
individual involved in a medical event with no added benefit. However, 
licensees are required to inform the individual, or a responsible 
relative or guardian, that a written description of the event can be 
obtained from the licensee upon request. Licensees are required to 
provide this written description to the individual, if requested. In 
addition, licensees are required to annotate a copy of their report to 
the NRC about the medical event and provide it to the referring 
physician, if other than the licensee, within 15 days after discovery 
of the medical event. The NRC believes that this is important so that 
the individual's referring physician has all the available 
documentation about the medical event to support any decisions about 
remedial or prospective health care. The 15-day time period to provide 
the referring physician with a copy of the record was based on 
paragraph (d), which requires a licensee to submit a report to the NRC 
within 15 days. We have attempted to have consistency in the 
requirements in Subparts L and M, where possible, to simplify 
compliance with the recordkeeping and reporting requirements. Refer to 
Section III of the SUPPLEMENTARY INFORMATION for additional information 
on the reporting and notification requirements in Sec. 35.3045.
    Section 35.3047, Report and notification of a dose to an embryo/
fetus or a nursing child, is a new section. Paragraph (a) requires that 
a licensee report to NRC any administration of byproduct material, or 
radiation from byproduct material, to a pregnant female that results in 
a dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose 
equivalent unless the administration was specifically approved, in 
advance, by the AU. It should be emphasized that only unintended 
exposures are required to be reported to NRC.
    Paragraph (b) requires that a licensee report to NRC any 
administration of byproduct material to a breast feeding woman that 
results in a dose to a nursing child that is greater than 50 mSv (5 
rem) total effective dose equivalent or a dose that has resulted in 
unintended permanent functional damage to an organ or a physiological 
system of the child, as determined by a physician.
    The reporting requirements in this section are similar to the 
reporting requirements for medical events. Paragraph (c) in the final 
rule requires that licensees notify the NRC Operations Center, by 
telephone, no later than the next calendar day after discovery of a 
dose to an embryo/fetus or a nursing child that requires a report. In 
paragraph (d), the licensee is required to submit a written report to 
the appropriate NRC Regional Office listed in 10 CFR 30.6 no later than 
15 days after discovery of a dose to an embryo/fetus or a nursing 
child.
    Paragraph (e) requires the licensee to notify the referring 
physician and the pregnant individual or mother no later than 24 hours 
after discovery of the event, unless the referring physician personally 
informs the licensee either that he/she will inform the mother or that, 
based on medical judgment, telling the mother would be harmful. If 
verbal notification is made, licensees are required to inform the 
mother, or the mother's or child's responsible relative or guardian, 
that a written description of the event can be obtained from the 
licensee upon request. Licensees are required to provide such a written 
description, if requested.
    Licensees are required in paragraph (f) annotate a copy of their 
report to the NRC about the event and provide it to the referring 
physician, if other than the licensee, within 15 days after discovery 
of the event. The NRC believes that this is important so that the 
referring physician has all the available documentation about the event 
to support any decisions about remedial or prospective health care. The 
15-day time period to provide the referring physician with a copy of 
the record was based on paragraph (d) which requires a licensee to 
submit a report to the NRC within 15 days. We have attempted to have 
consistency in the requirements in Subparts L and M, where possible, to 
simplify compliance with the recordkeeping and reporting requirements. 
Refer to Section III of the SUPPLEMENTARY INFORMATION for additional 
information on the notification requirements in Sec. 35.3047.
    Information required by this section is needed so that the NRC can 
comply with Section 208 of the Energy Reorganization Act of 1974 (Pub. 
L. 93-438), as amended, to submit an annual report to Congress of 
unscheduled incidents or events which the Commission considers 
significant from the standpoint of public health and safety, e.g., 
abnormal occurrences.
    The NRC identifies an abnormal occurrence using the revised 
abnormal occurrence criteria that were published in the Federal 
Register on April 17, 1997 (62 FR 18820). Section II of the policy 
statement defines unintended radiation exposure as ``any occupational 
exposure, exposure to the general public or exposure as a result of a 
medical misadministration (as defined in Sec. 35.2) involving the wrong 
individual that exceeds the reporting values established in the 
regulations.'' This section also states that ``All other reported 
medical misadministrations will be considered for reporting as an 
Abnormal Occurrence under the criteria for medical licensees. In 
addition, unintended radiation exposures include any exposure to a 
nursing child, fetus, or embryo as a result of an exposure (other than 
an occupational exposure to an undeclared pregnant woman) to a nursing 
mother or pregnant woman above specified values.'' Appendix A, Section 
I. A, of the policy statement, states that NRC will provide information 
on ``any unintended radiation exposure to any minor (an individual less 
than 18 years of age) resulting in an annual total effective dose 
equivalent of 50 mSv (5 rem) or more, or to an embryo/fetus

[[Page 20365]]

resulting in a dose equivalent of 50 mSv (5 rem) or more.''
    At the present time, the NRC has no regulatory requirements that 
require reporting of those types of events. The Commission considered 
two alternatives that could be pursued: revise the current Abnormal 
Occurrence Criteria to delete the requirement to inform Congress of 
this type of event; or develop a reporting requirement that would 
provide the information needed by the Commission to comply with Section 
208. The Commission did not pursue the first option because the 
Abnormal Occurrence reporting criteria were recently reviewed and 
revised.
    The Commission recognizes that the standard of practice for AUs is 
to assess the pregnancy or nursing status of their patients (reference 
American College of Radiology ``Standard for the Performance of Therapy 
with Unsealed Radionuclide Sources,'' 1996, and ``Society of Nuclear 
Medicine General Procedure Guidelines for Imaging with Radionuclides,'' 
1997). As a result, the NRC does not believe that it is appropriate to 
have a rule that requires a licensee to assess the pregnancy or nursing 
status of patients prior to a medical treatment involving byproduct 
material. However, we do believe it is appropriate to require the 
licensee to inform the NRC when the licensee learns of an unintended 
dose to an embryo/fetus or a nursing child that exceeds the thresholds 
in Sec. 35.3047. For example, a licensee must report an unintended dose 
resulting from an individual not disclosing her pregnancy or nursing 
status at the time of administration of the byproduct material or 
radiation from byproduct material. In this situation, the unintended 
dose could have been prevented if the AU had followed the standard of 
practice, noted above, to assess the pregnancy status of the patient. 
The occurrence of such an incident does not necessarily mean that the 
licensee is in violation of the requirements in Part 35, as long as the 
licensee reports it and it is not otherwise in violation of NRC 
regulatory requirements. For example, a reportable dose to a nursing 
child under Sec. 35.3047 is not necessarily subject to enforcement 
action if the licensee has complied with Sec. 35.75.
    However, the NRC acknowledges that, in some cases, the licensee 
might not be able to prevent the dose to an embryo/fetus or nursing 
child. This type of case is not reportable under Sec. 35.3047. For 
example, there is no way for an AU to prevent administration of an 
unintended dose to an embryo/fetus if the pregnancy test was negative 
because it was given very early in the pregnancy.
    Section 35.3067, Report of a leaking source, requires the licensee 
to file a report with the appropriate NRC Office listed in Sec. 30.6 of 
this chapter, with a copy to the Director, Office of Nuclear Material 
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001, within 5 days if a leak test required by Sec. 35.67 
reveals the presence of 185 Bq (0.005 microcurie) or more of removable 
contamination. This reporting requirement is similar to the reporting 
requirements for leaking sources in the current Sec. 35.59, but the 
final rule does not require that as much prescriptive information be 
included in the report. The report must contain the model number and 
serial number, if assigned, of the leaking source; the radionuclide and 
its estimated activity; the results of the test; the date of the test; 
and the action taken.
    Subpart N, Enforcement, contains statements regarding enforcement. 
This subpart contains the statements in the current Subpart K, 
Enforcement.
    Section 35.4001, Violations, is a new section that replaces the 
current Sec. 35.990 which was deleted. Other than changing the number 
of this section to reflect the new numbering system, no changes were 
made in the current statements regarding violations.
    Section 35.4002, Criminal penalties, is a new section that replaces 
the current Sec. 35.991 which was deleted. Other than changing the 
numbers of this section and the sections referenced under paragraph (b) 
to reflect the new numbering system, no changes were made in the 
current statements regarding criminal penalties.

VI. Coordination With the Advisory Committee on the Medical Uses of 
Isotopes

    The Advisory Committee on the Medical Uses of Isotopes (ACMUI) is 
an advisory body established to advise the NRC staff on matters that 
involve the administration of radioactive material and radiation from 
radioactive material. The proposed rule (63 FR 43516; August 13, 1998) 
for Part 35 summarized the ACMUI positions on the major crosscutting 
issues that were considered during development of the proposed rule.
    During the development of the final rule, the NRC held public 
meetings of the ACMUI subcommittees for diagnostic and therapeutic 
medical uses on February 23-24, 1999, and February 25-26, 1999, 
respectively. The subcommittees reviewed the comments received by NRC 
during the public comment period and during the three facilitated 
public meetings held during that period. They also reviewed a first 
draft of the final rule that addressed the public comments. The 
subcommittees' comments are summarized in ``Summary of Discussion: 
Public Meeting of the Advisory Committee on the Medical Uses of 
Isotopes (ACMUI) Diagnostic Subcommittee Held in Rockville, Maryland on 
February 23-24, 1999'' (April 22, 1999) and ``Summary of Discussion: 
Public Meeting of the Advisory Committee on the Medical Uses of 
Isotopes (ACMUI) Therapeutic Subcommittee Held in Rockville, Maryland 
on February 25-26, 1999'' (April 22, 1999). 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.
    The full ACMUI held a public meeting on March 24-25, 1999, to 
discuss specific issues that the Part 35 Working Group wanted the ACMUI 
to review and comment on before it forwarded a draft final rule for 
Commission consideration. The issues included training and experience; 
Radiation Safety Committee; temporary Radiation Safety Officer; 
information that must be included in a written directive; determination 
of dosages of unsealed byproduct material; reports of medical events; 
and report of an unintended dose to an embryo/fetus or nursing child. 
The ACMUI presented their position on these and other issues at their 
annual briefing of the Commission on March 25, 1999. The ACMUI meeting 
was transcribed and the minutes are available for inspection at the NRC 
Public Document Room. Single copies of the minutes are available as 
indicated in the For Further Information Contact section of this 
document. The Commission briefing was also transcribed, and the 
transcript is available for inspection at the NRC Public Document Room.
    On October 20, 1999, the ACMUI met to prepare for a Commission 
briefing, the next day, on the draft final rule for Part 35. Because 
the briefings are public opportunities for the Commission to hear from 
ACMUI, the Committee identified specific issues that they wanted to 
bring to the Commission's attention. The ACMUI meeting was transcribed 
and the minutes are available for inspection at the NRC Public Document 
Room. Single copies of the minutes are available as indicated in the 
For Further Information Contact section of this document.

[[Page 20366]]

    At the October 21, 1999, briefing of the Commission, the ACMUI 
reaffirmed that stakeholders were involved throughout the rulemaking 
process, including extensive involvement of the ACMUI and its 
subcommittees and the regulated community. In addition, the Committee 
believed that the draft final rule forwarded to the Commission in 
August 1999 (SECY-99-201) was more risk-informed and more performance-
based, while maintaining occupational, public, and patient safety. 
ACMUI endorsed the provisions in the draft final rule for the Radiation 
Safety Committee, the dose thresholds for reporting medical events, and 
the reporting threshold for unintended exposure of an embryo/fetus or 
nursing child. In addition, the ACMUI endorsed the training and 
experience requirements for authorized users, authorized medical 
physicists, authorized nuclear pharmacists, and radiation safety 
officers, and, in particular, encouraged uniform national standards for 
training and experience. The ACMUI noted that it does not support any 
regulation requiring notification of physicians and patients, as this 
is redundant of existing standards of care. However, if notification 
requirements for medical events continue to be in Part 35, the ACMUI 
said that it would prefer the alternative rule language provided by the 
NRC staff over the existing requirements (refer to SECY-99-201, 
Attachment 4, for further discussion of the alternative text). (Note: A 
modification of the alternative rule language was approved by the 
Commission and is in Sec. 35.3045 of the final rule.) In addition, the 
Committee encouraged early recognition of the medical specialty boards 
and use of the guidance document, as well as focusing NRC license 
reviewers and inspectors on licensee performance and high risk 
procedures. The Commission briefing was transcribed and is available 
for inspection at the NRC Public Document Room or via the Commission's 
web site at http://www.nrc.gov/NRC/COMMISSION/TRANSCRIPTS/19991021b.html.
    The issue of recognition of medical and other specialty boards was 
again discussed during an ACMUI briefing of the Commission on February 
19, 2002. The ACMUI meeting was transcribed and the transcript is 
available for inspection at the NRC Public Document Room. Single copies 
of the transcript are available as indicated in the For Further 
Information Contact section of this document. In that meeting, two 
committee members expressed concern that some boards did not qualify 
for recognition and might not be ready to apply for recognition within 
6 months after publication of the final rule. Therefore, implementation 
of the new Part 35, without Subpart J, could disrupt the current 
license authorization process for new medical personnel because many 
license authorizations are granted based on recognition of board 
certification. The Commission has considered this matter, and decided 
to retain the current training requirements in Subpart J for a 2-year 
period after the effective date of the final rule. As discussed, under 
Section IX, Implementation, licensees will have the option of complying 
with either Subpart J or Subparts B and D-H for 2 years. During this 
transition period, the NRC will continue working with the ACMUI and the 
medical community to resolve any concerns with the training and 
experience requirements. The Commission will consider changes to the 
training and experience requirements, as appropriate.

VII. Coordination With NRC Agreement States

    The NRC staff discussed the revision of Part 35 with 
representatives of the Agreement States at the 1997, 1998, and 1999 
annual meetings of the Organization of Agreement States. In addition, a 
draft compatibility chart for the proposed revision was developed in 
accordance with the compatibility categorization criteria detailed in 
NRC Management Directive 5.9, ``Adequacy and Compatibility of Agreement 
State Programs'' (dated February 27, 1998), and was published for 
comment with the proposed rule (63 FR 43516; August 13, 1998). The 
compatibility chart was later updated and provided to the Agreement 
States for comment on January 4, 1999. A summary of the comments 
received on the Agreement State compatibility designations and NRC's 
responses to the comments, and the compatibility designations for the 
final rule are found in Sections IV and X, respectively, of the 
SUPPLEMENTARY INFORMATION.
    Both the Working Group and Steering Group that developed the 
revision of Part 35 included Agreement State representatives. The 
Agreement State representative on the Working Group is also a member of 
the Conference of Radiation Control Directors' Suggested State 
Regulation Committee on Medical Regulation, which has been working 
toward parallel development of suggested state medical regulations. 
State participation in the process provided an early and continuous 
opportunity for State input and enhanced the development of 
corresponding rules in State regulations.

VIII. Consistency With Medical Policy Statement

    The Commission has revised its General Policy on the Regulation of 
the Medical Uses of Radioisotopes that was issued on February 9, 1979 
(44 FR 8424), as part of the Commission's overall program for revising 
its regulatory framework for medical use. The proposed revision and 
detailed discussion on the need for the revision was published for 
comment in the Federal Register (63 FR 43580; August 13, 1998), 
concurrently with publication of the proposed revision to Part 35 (63 
FR 43516; August 13, 1998). The revised MPS was published on August 3, 
2000; 65 FR 47654. That document addressed the comments received on the 
proposed revision to the MPS.
    The revision of Part 35 is consistent with the Commission's 
revision of the Medical Use Policy Statement. The consistency of the 
final rule with each policy statement is discussed below.
    The first statement of the revised policy reads ``NRC will continue 
to regulate the uses of radionuclides in medicine as necessary to 
provide for the radiation safety of workers and the general public.'' 
The final rule is consistent with the statement because one of its 
purposes is to provide for the radiation safety of workers and 
individual members of the public, which is central to fulfillment of 
the Commission's statutory mandate in the Atomic Energy Act of 1954, as 
amended, to ``protect health and minimize danger to life.''
    The second statement of the revised policy reads ``NRC will not 
intrude into medical judgments affecting patients, except as necessary 
to provide for the radiation safety of workers and the general 
public.'' The final rule is consistent with this statement because its 
focus is on protecting the public and workers from patients who have 
been administered byproduct material or radiation from byproduct 
material for medical use.
    The third statement of the revised policy reads ``NRC will, when 
justified by the risk to patients, regulate the radiation safety of 
patients primarily to assure the use of radionuclides is in accordance 
with the physician's directions.'' The final rule is consistent with 
this statement because it includes provisions, where warranted by the 
risk, to provide high confidence that the authorized user's directions 
for the administration of byproduct material are followed.

[[Page 20367]]

    The fourth statement of the revised policy reads ``NRC, in 
developing a specific regulatory approach, will consider industry and 
professional standards that define acceptable approaches of achieving 
radiation safety.'' The final rule is consistent with this statement 
because the rulemaking process included NRC examining relevant industry 
and professional standards to determine if specific areas of concern to 
NRC were included in the standards, or whether regulatory requirements 
needed to be included in Part 35.

IX. Implementation

    Except as discussed below, the revised regulations in 10 CFR Parts 
20, 32, and 35 become effective October 24, 2002, 6 months after 
publication of this final rule. Because the draft consolidated guidance 
document for medical use licensees has been developed in parallel with 
the revised regulatory requirements in Part 35, the Commission believes 
that a longer implementation period is not necessary. The 6-month 
implementation period allows the NRC time to train licensing and 
inspection staff so that the revised Part 35 will be uniformly 
implemented; and provides licensees the time to understand the specific 
features of the revised Part 35, and to develop and implement any 
changes in their radiation safety programs or procedures that are 
required to comply with the revised requirements. The NRC is evaluating 
what type of workshops might need to be offered for the benefit of 
licensees, Regional Offices, States, and others who are affected by the 
revision.
    The Commission provides that licensees will have up to 2 years 
after the effective date of the final rule to comply with the training 
requirements for authorized users, authorized medical physicists, 
authorized nuclear pharmacists, and Radiation Safety Officers. During 
this 2-year period, licensees will have the option of complying with 
either requirements of Subpart J or the requirements in Subparts B and 
D-H.
    The 2-year transition period will allow additional time for medical 
and other specialty boards to seek NRC recognition as a ``specialty 
board'' in accordance with Secs. 35.50(a), 35.51(a), 35.55(a), 
35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 
35.590(a), and 35.690(a). The 2-year time period will also allow 
individuals from Agreement States time to satisfy the training 
requirements in order to work in NRC jurisdictions.
    Section 35.10 of the rule addresses how a licensee can determine if 
it must comply with the requirements of the revised Part 35 when it 
becomes effective or if it must continue to comply with the 
requirements of its license conditions. If a license condition exempts 
a licensee from a provision of the current Part 35 on the effective 
date of the final rule, paragraph (d) of this section states that the 
license condition will continue to exempt the licensee from the 
requirements in the corresponding provision in the revised Part 35. 
Paragraph (e) states that if a requirement in the revised Part 35 
differs from the requirements in an existing license requirement that 
addresses the same issue, the requirement in Part 35 governs. Under 
most circumstances, medical use licensees will not be required to have 
their licenses amended in this situation, even if the revised 
requirement is less restrictive than their current license condition. 
The exceptions to paragraph (e) are listed in paragraph (f), which 
requires a licensee to continue to comply with any licensee condition 
to have procedures for responding to emergency situations (Sec. 35.610) 
and spot checks involving teletherapy units (Sec. 35.642), photon 
emitting remote afterloader units (Sec. 35.643), or gamma stereotactic 
radiosurgery units (Sec. 35.645).

X. Issues of Compatibility for Agreement States

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' approved by the Commission on June 30, 1997 
(62 FR 46517), specific requirements within this rule should be adopted 
by Agreement States for purposes of compatibility or because of their 
health and safety significance. Implementing procedures for the Policy 
Statement establish specific categories which have been applied to 
categorize the requirements in Parts 20, 32, and 35. A Compatibility 
Category ``A'' designation means the requirement is a basic radiation 
protection standard or deals with related definitions, signs, labels, 
or terms necessary for a common understanding of radiation protection 
principles. Compatibility Category ``A'' designated Agreement State 
requirements should be essentially identical to those of the NRC. A 
Compatibility Category ``B'' designation means the requirement has 
significant direct transboundary implications. Compatibility Category 
``B'' designated Agreement State requirements should be essentially 
identical to those of the NRC. A Compatibility Category ``C'' 
designation means the essential objectives of the requirement should be 
adopted by the State to avoid conflicts, duplications, or gaps. The 
manner in which the essential objectives are addressed in the Agreement 
State requirement need not be the same as NRC provided the essential 
objectives are met. A Compatibility Category ``D'' designation means 
the requirement does not need to be adopted by an Agreement State for 
purposes of compatibility. The Compatibility Category Health and Safety 
(H&S) identifies requirements that are not required for compatibility, 
but which have particular health and safety significance. Agreement 
States should adopt the essential objectives of such requirements in 
order to maintain an adequate program.

Summary of NRC Rules With Compatibility or Health and Safety 
Designations Under the Revision of 10 CFR Parts 20, 32 & 35

    All Sections not listed here are Compatibility Category D

----------------------------------------------------------------------------------------------------------------
            Section and paragraph                                        Section title
----------------------------------------------------------------------------------------------------------------
                                                   CATEGORY A
 
20.1003, Occupational dose. Public Dose......  Definitions.
20.1301(a) & (c).............................  Dose limits to individual members of the public.
----------------------------------------------------------------------------------------------------------------
                                                   CATEGORY B
 
32.72(b)(1) & (b)(2)(ii).....................  Manufacture, preparation, or transfer for commercial distribution
                                                of radioactive drugs containing byproduct material for medical
                                                use under Part 35.
32.74(a) & (a)(3)............................  Manufacture and distribution of sources or devices containing
                                                byproduct material for medical use.
35.2, Agreement State. Authorized medical      Definitions.
 physicist. Authorized nuclear pharmacist.
 Authorized user. Radiation safety officer.
 Sealed source.
35.50........................................  Training for Radiation Safety Officer.

[[Page 20368]]

 
35.51........................................  Training for an authorized medical physicist.
35.55........................................  Training for an authorized nuclear pharmacist.
35.57........................................  Training for experienced Radiation Safety Officer, teletherapy or
                                                medical physicist, authorized user, and nuclear pharmacist.
35.59........................................  Recentness of training.
35.190.......................................  Training for uptake, dilution and excretion studies.
35.290.......................................  Training for imaging and localization studies.
35.390.......................................  Training for use of unsealed byproduct material for which a
                                                written directive is required.
35.392.......................................  Training for the oral administration of sodium iodide I-131
                                                requiring a written directive in quantities less than or equal
                                                to 1.22 Gigabecquerels (33 millicuries).
35.394.......................................  Training for the oral administration of sodium iodide I-131
                                                requiring a written directive in quantities greater than 1.22
                                                Gigabecquerels (33 millicuries).
35.490.......................................  Training for use of manual brachytherapy sources.
35.491.......................................  Training for ophthalmic use of strontium-90.
35.590.......................................  Training for use of sealed sources for diagnosis.
35.690.......................................  Training for use of remote afterloader units, teletherapy units,
                                                and gamma stereotactic radiosurgery units.
----------------------------------------------------------------------------------------------------------------
                                                   CATEGORY C
 
35.2, Medical use. Prescribed dosage.          Definitions.
 Prescribed dose. Treatment site.
35.6.........................................  Provisions for the protection of human research subjects.
35.11........................................  License required.
35.49........................................  Suppliers for sealed sources or devices for medical use.
35.75(a) & (b)...............................  Release of individuals containing unsealed byproduct material or
                                                implants containing byproduct material.
35.400.......................................  Use of sealed sources for manual brachytherapy.
35.500.......................................  Use of sealed sources for diagnosis.
35.600.......................................  Use of a sealed source in a remote afterloader unit, teletherapy
                                                unit, or gamma stereotactic radiosurgery unit.
35.3045......................................  Report and notification of a medical event.
35.3047......................................  Report and notification of a dose to an embryo/fetus or a nursing
                                                child.
35.3067......................................  Report of a leaking source.
----------------------------------------------------------------------------------------------------------------
                                                  CATEGORY H&S
 
35.24(b) & (f)...............................  Authority and responsibilities for the radiation protection
                                                program.
35.27........................................  Supervision.
35.40(a) & (b)...............................  Written directives.
35.41(a).....................................  Procedures for administrations requiring a written directive.
35.60(a) & (b)...............................  Possession, use and calibration of instruments used to measure
                                                the activity of unsealed byproduct material.
35.61(a)(1), (a)(2), (b), & (c)..............  Calibration of survey instruments.
35.63(a)-(d).................................  Determination of dosages of unsealed byproduct material for
                                                medical use.
35.67(a)-(e) & (g)...........................  Requirements for possession of sealed sources and brachytherapy
                                                sources.
35.69........................................  Labeling of vials and syringes.
35.70(a).....................................  Surveys of ambient radiation exposure rate
35.80(a)(2), (a)(3), & (b)...................  Provision of mobile medical service.
35.92........................................  Decay-in-storage.
35.100.......................................  Use of unsealed byproduct material for uptake, dilution, and
                                                excretion studies for which a written directive is not required.
35.200.......................................  Use of unsealed byproduct material for imaging and localization
                                                studies for which a written directive is not required.
35.204(a) & (b)..............................  Permissible molybdenum-99 concentration.
35.300.......................................  Use of unsealed byproduct material for which a written directive
                                                is required.
35.310(a)....................................  Safety instruction.
35.315.......................................  Safety precautions.
35.404(a) & (b)..............................  Surveys after source implant and removal.
35.406(a) & (b)..............................  Brachytherapy sources accountability.
35.410(a)....................................  Safety instruction
35.415 Safety precautions....................
35.432(a)-(c)................................  Calibration measurements of brachytherapy sealed sources.
35.433(a)....................................  Decay of strontium-90 sources for ophthalmic treatments.
35.457.......................................  Therapy-related computer systems.
35.604(a)....................................  Surveys of patients and human research subjects treated with a
                                                remote afterloader unit.
35.605(a)-(c)................................  Installation, maintenance, adjustment and repair.
35.610(a)-(e)................................  Safety procedures and instructions for remote afterloader units,
                                                teletherapy units, and gamma stereotactic radiosurgery units.
35.615.......................................  Safety precautions for remote afterloader units, teletherapy
                                                units, and gamma stereotactic radiosurgery units.
35.630(a) & (b)..............................  Dosimetry equipment.
35.632(a)-(f)................................  Full calibration measurements on teletherapy units.
35.633(a)-(h)................................  Full calibration measurements on remote afterloader units.
35.635(a)-(f)................................  Full calibration measurements on gamma stereotactic radiosurgery
                                                units.
35.642(a)-(e)................................  Periodic spot-checks for teletherapy units.
35.643(a)-(e)................................  Periodic spot-checks for remote afterloader units.
35.645(a)-(f)................................  Periodic spot-checks for gamma stereotactic radiosurgery units.

[[Page 20369]]

 
35.647(a)-(d)................................  Additional technical requirements for mobile remote afterloader
                                                units.
35.652(a) & (b)..............................  Radiation surveys.
35.655(a) & (b)..............................  Five-year inspection for teletherapy and gamma stereotactic
                                                radiosurgery units.
35.657.......................................  Therapy-related computer systems.
----------------------------------------------------------------------------------------------------------------

XI. Assessment of Federal Regulations and Policies on Families

    In accordance with Section 654 of the Treasury and General 
Government Appropriation Act of 1999, Public Law No. 105-277, 112 Stat. 
2681, 528-29 (1998), to be codified at 5 USC 601 note, the NRC has 
assessed this action against the seven factors set forth in the Act. 
The NRC has determined that this action will not negatively affect 
family well-being.

XII. Finding of No Significant Environmental Impact Availability

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the Commission's regulations in 
Subpart A of 10 CFR Part 51, that this rule is a major Federal action 
but will not significantly affect the quality of the human environment, 
and, therefore, an environmental impact statement is not required. The 
amendments relax some requirements, eliminate certain procedural 
restrictions, focus on those requirements that are essential for 
patient safety, reduce or eliminate duplications or overlaps between 
Part 35 and the other parts of 10 CFR, and provide greater flexibility 
for licensees in how they meet the objectives in the requirements. The 
Commission believes that the more risk-informed, performance-based 
amendments will provide greater flexibility in the medical use of 
byproduct material while continuing to adequately protect public health 
and safety. With the exception of the amendment to 10 CFR 20.1301, the 
rulemaking action will not lead to an increase in radiation exposure to 
the public or health care workers, or radiation releases to the 
environment beyond the exposures or releases currently resulting from 
the medical use of byproduct material or radiation from byproduct 
material. The amendment to 10 CFR 20.1301 is expected to result in an 
increase in radiation exposure to the public. However, this alternative 
is consistent with generally accepted radiation protection principles, 
such as those expressed by the International Commission on Radiation 
Protection (ICRP), the National Council on Radiation Protection and 
Measurements (NCRP), and the International Atomic Energy Agency (IAEA).
    The NRC requested public comments on any environmental justice 
considerations that may be related to this rule. Because there were no 
comments specific to those considerations, the environmental assessment 
has not changed in this regard as a result of public comment.
    The NRC requested the views of the States on the environmental 
assessment for this rule. Because there were no comments specific to 
the environmental assessment, the environmental assessment has not 
changed as a result of the views of the States.
    The environmental assessment is available for inspection as 
indicated in the ADDRESSES section of this document. Single copies of 
the environmental assessment are available as indicated in the FOR 
INFORMATION CONTACT section of this document.

XIII. Paperwork Reduction Act Statement

    This final rule amends information collection requirements that are 
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). These requirements were approved by the Office of Management and 
Budget, approval numbers 3150-0010 and 3150-0120.
    Because the rule will reduce existing information collection 
requirements, the annual burden to the public for these information 
collections is expected to be decreased by 65 hours per licensee. This 
reduction includes the time required for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing the information collection. The 
final rule has been revised to allow licensees, as an alternative to 
the revised training and experience requirements in Subparts B and D-H, 
to continue to use the current Subpart J training and experience 
requirements for a period of 2 years after the effective date of the 
final rule. This will allow NRC licensees and individuals in Agreement 
States sufficient time to meet the revised training requirements. This 
final rule adds an information collection burden for individuals to 
request certification for training and experience. The burden for this 
information collection is estimated to average .5 hours per request. 
Because the burden for this information collection is insignificant, 
Office of Management and Budget (OMB) clearance is not required.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information or an information collection 
requirement unless the requesting document displays a currently valid 
OMB control number.

XIV. Regulatory Analysis

    The Commission has prepared a regulatory analysis on this final 
regulation. The analysis examines the costs and benefits of the 
alternatives considered by the Commission. The analysis is available 
for inspection as indicated in the ADDRESSES section of this document. 
Single copies of the analysis are available as indicated in the FOR 
INFORMATION CONTACT section of this document.

XV. Regulatory Flexibility Analysis

    The NRC has prepared a final regulatory flexibility analysis of the 
impact of this rule on small entities as required by Section 604 of the 
Regulatory Flexibility Act. The analysis indicates that 40 percent of 
the medical licensees are small entities. Although the final rule has 
an economic impact of an estimated $8,000 annually on the smallest of 
these licensees, the selected alternative is the least costly 
alternative that provides adequate protection from radiation exposure 
to the public, patients and workers. The analysis is available for 
inspection as indicated in the ADDRESSES section of this document. 
Single copies of the analysis are available as indicated in the FOR 
INFORMATION CONTACT section of this document.

XVI. Backfit Analysis

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

XVII. Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement

[[Page 20370]]

Fairness Act of 1996, the NRC has determined that this action is not a 
major rulemaking and has verified this determination with the Office of 
Information and Regulatory Affairs of OMB.

List of Subjects

10 CFR Part 20

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

10 CFR Part 32

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

10 CFR Part 35

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


    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended, the Energy Reorganization 
Act of 1974, as amended, and 5 U.S.C. 552 and 553, the NRC is adopting 
the following amendments to 10 CFR parts 20, 32 and 35.

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

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

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


    2. Section 20.1002 is revised to read as follows:


Sec. 20.1002  Scope.

    The regulations in this part apply to persons licensed by the 
Commission to receive, possess, use, transfer, or dispose of byproduct, 
source, or special nuclear material or to operate a production or 
utilization facility under Parts 30 through 36, 39, 40, 50, 60, 61, 70, 
or 72 of this chapter, and in accordance with 10 CFR 76.60 to persons 
required to obtain a certificate of compliance or an approved 
compliance plan under part 76 of this chapter. The limits in this part 
do not apply to doses due to background radiation, to exposure of 
patients to radiation for the purpose of medical diagnosis or therapy, 
to exposure from individuals administered radioactive material and 
released, under Sec. 35.75, or to exposure from voluntary participation 
in medical research programs.

    3. In Sec. 20.1003, the definitions for occupational dose and 
public dose are revised to read as follows:


Sec. 20.1003  Definitions

* * * * *
    Occupational dose means the dose received by an individual in the 
course of employment in which the individual's assigned duties involve 
exposure to radiation or to radioactive material from licensed and 
unlicensed sources of radiation, whether in the possession of the 
licensee or other person. Occupational dose does not include doses 
received from background radiation, from any medical administration the 
individual has received, from exposure to individuals administered 
radioactive material and released, under Sec. 35.75, from voluntary 
participation in medical research programs, or as a member of the 
public.
* * * * *
    Public dose means the dose received by a member of the public from 
exposure to radiation or to radioactive material released by a 
licensee, or to any other source of radiation under the control of a 
licensee. Public dose does not include occupational dose or doses 
received from background radiation, from any medical administration the 
individual has received, from exposure to individuals administered 
radioactive material and released, under Sec. 35.75, or from voluntary 
participation in medical research programs.
* * * * *

    4. In Sec. 20.1301, the introductory text of paragraph (a) and 
paragraph (a)(1) are revised, paragraphs (c), (d), and (e) are 
redesignated as paragraphs (d), (e), and (f), and a new paragraph (c) 
is added to read as follows:


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

    (a) Each licensee shall conduct operations so that --
    (1) The total effective dose equivalent to individual members of 
the public from the licensed operation does not exceed 0.1 rem (1 mSv) 
in a year, exclusive of the dose contributions from background 
radiation, from any medical administration the individual has received, 
from exposure to individuals administered radioactive material and 
released, under Sec. 35.75, from voluntary participation in medical 
research programs, and from the licensee's disposal of radioactive 
material into sanitary sewerage in accordance with Sec. 20.2003, and
* * * * *
    (c) Notwithstanding paragraph (a)(1) of this section, a licensee 
may permit visitors to an individual who cannot be released, under 
Sec. 35.75, to receive a radiation dose greater than 0.1 rem (1 mSv) 
if--
    (1) The radiation dose received does not exceed 0.5 rem (5 mSv); 
and
    (2) The authorized user, as defined in 10 CFR Part 35, has 
determined before the visit that it is appropriate.
* * * * *

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

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

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


Sec. 32.72  [Amended]

    6. In Sec. 32.72, in paragraph (b)(1), the reference to ``paragraph 
(b)(2) and (b)(3)'' is revised to read ``paragraphs (b)(2) and (b)(4)'' 
and the reference to ``10 CFR 35.25'' is revised to read ``10 CFR 
35.27'' and in paragraph (b)(2)(ii), the reference to ``10 CFR 
35.980(b) and 35.972'' is revised to read ``10 CFR 35.55(b) and 
35.59.''


Sec. 32.74  [Amended]

    7. In Sec. 32.74, in the introductory text of paragraph (a), the 
reference to ``Secs. 35.400 and 35.500'' is revised to read 
``Secs. 35.400, 35.500, and 35.600'' and in paragraph (a)(3), the 
reference to ``Secs. 35.57, 35.400, or 35.500'' is revised to read 
``Secs. 35.65, 35.400, 35.500, and 35.600.''

    8. 10 CFR Part 35 is revised to read as follows:

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

Subpart A-- General Information

Sec.
35.1   Purpose and scope.
35.2   Definitions.
35.5   Maintenance of records.
35.6   Provisions for the protection of human research subjects.

[[Page 20371]]

35.7   FDA, other Federal, and State requirements.
35.8   Information collection requirements: OMB approval.
35.10   Implementation.
35.11   License required.
35.12   Application for license, amendment, or renewal.
35.13   License amendments.
35.14   Notifications.
35.15   Exemptions regarding Type A specific licenses of broad 
scope.
35.18   License issuance.
35.19   Specific exemptions.
Subpart B--General Administrative Requirements
35.24   Authority and responsibilities for the radiation protection 
program.
35.26   Radiation protection program changes.
35.27   Supervision.
35.40   Written directives.
35.41   Procedures for administrations requiring a written 
directive.
35.49   Suppliers for sealed sources or devices for medical use.
35.50   Training for Radiation Safety Officer.
35.51   Training for an authorized medical physicist.
35.55   Training for an authorized nuclear pharmacist.
35.57   Training for experienced Radiation Safety Officer, 
teletherapy or medical physicist, authorized user, and nuclear 
pharmacist.
35.59   Recentness of training.
Subpart C--General Technical Requirements
35.60   Possession, use, and calibration of instruments used to 
measure the activity of unsealed byproduct material.
35.61   Calibration of survey instruments.
35.63   Determination of dosages of unsealed byproduct material for 
medical use.
35.65   Authorization for calibration, transmission, and reference 
sources.
35.67   Requirements for possession of sealed sources and 
brachytherapy sources.
35.69   Labeling of vials and syringes.
35.70   Surveys of ambient radiation exposure rate.
35.75   Release of individuals containing unsealed byproduct 
material or implants containing byproduct material.
35.80   Provision of mobile medical service.
35.92   Decay-in-storage.
Subpart D--Unsealed Byproduct Material--Written Directive Not Required
35.100   Use of unsealed byproduct material for uptake, dilution, 
and excretion studies for which a written directive is not required.
35.190   Training for uptake, dilution, and excretion studies.
35.200   Use of unsealed byproduct material for imaging and 
localization studies for which a written directive is not required.
35.204   Permissible molybdenum-99 concentration.
35.290   Training for imaging and localization studies.
Subpart E--Unsealed Byproduct Material--Written Directive Required
35.300   Use of unsealed byproduct material for which a written 
directive is required.
35.310   Safety instruction.
35.315   Safety precautions.
35.390   Training for use of unsealed byproduct material for which a 
written directive is required.
35.392   Training for the oral administration of sodium iodide I-131 
requiring a written directive in quantities less than or equal to 
1.22 Gigabecquerels (33 millicuries).
35.394   Training for the oral administration of sodium iodide I-131 
requiring a written directive in quantities greater than 1.22 
Gigabecquerels (33 millicuries).
Subpart F--Manual Brachytherapy
35.400   Use of sources for manual brachytherapy.
35.404   Surveys after source implant and removal.
35.406   Brachytherapy sources accountability.
35.410   Safety instruction.
35.415   Safety precautions.
35.432   Calibration measurements of brachytherapy sources.
35.433   Decay of strontium-90 sources for ophthalmic treatments.
35.457   Therapy-related computer systems.
35.490   Training for use of manual brachytherapy sources.
35.491   Training for ophthalmic use of strontium-90.
Subpart G--Sealed Sources for Diagnosis
35.500   Use of sealed sources for diagnosis.
35.590   Training for use of sealed sources for diagnosis.
Subpart H--Photon Emitting Remote Afterloader Units, Teletherapy Units, 
and Gamma Stereotactic Radiosurgery Units
35.600   Use of a sealed source in a remote afterloader unit, 
teletherapy unit, or gamma stereotactic radiosurgery unit.
35.604   Surveys of patients and human research subjects treated 
with a remote afterloader unit.
35.605   Installation, maintenance, adjustment, and repair.
35.610   Safety procedures and instructions for remote afterloader 
units, teletherapy units, and gamma stereotactic radiosurgery units.
35.615   Safety precautions for remote afterloader units, 
teletherapy units, and gamma stereotactic radiosurgery units.
35.630   Dosimetry equipment.
35.632   Full calibration measurements on teletherapy units.
35.633   Full calibration measurements on remote afterloader units.
35.635   Full calibration measurements on gamma stereotactic 
radiosurgery units.
35.642   Periodic spot-checks for teletherapy units.
35.643   Periodic spot-checks for remote afterloader units.
35.645   Periodic spot-checks for gamma stereotactic radiosurgery 
units.
35.647   Additional technical requirements for mobile remote 
afterloader units.
35.652   Radiation surveys.
35.655   Five-year inspection for teletherapy and gamma stereotactic 
radiosurgery units.
35.657   Therapy-related computer systems.
35.690   Training for use of remote afterloader units, teletherapy 
units, and gamma stereotactic radiosurgery units.
Subpart I--Reserved
Subpart J--Training and Experience Requirements
35.900   Radiation Safety Officer.
35.910   Training for uptake, dilution, and excretion studies.
35.920   Training for imaging and localization studies.
35.930   Training for therapeutic use of unsealed byproduct 
material.
35.932   Training for treatment of hyperthyroidism.
35.934   Training for treatment of thyroid carcinoma.
35.940   Training for use of brachytherapy sources.
35.941   Training for ophthalmic use of strontium-90.
35.950   Training for use of sealed sources for diagnosis.
35.960   Training for use of therapeutic medical devices.
35.961   Training for an authorized medical physicist.
35.980   Training for an authorized nuclear pharmacist.
35.981   Training for experienced nuclear pharmacists.
Subpart K--Other Medical Uses of Byproduct Material or Radiation From 
Byproduct Material
35.1000   Other medical uses of byproduct material or radiation from 
byproduct material.
Subpart L--Records
35.2024   Records of authority and responsibilities for radiation 
protection programs.
35.2026   Records of radiation protection program changes.
35.2040   Records of written directives.
35.2041   Records for procedures for administrations requiring a 
written directive.
35.2060   Records of calibrations of instruments used to measure the 
activity of unsealed byproduct materials.
35.2061   Records of radiation survey instrument calibrations.
35.2063   Records of dosages of unsealed byproduct material for 
medical use.
35.2067   Records of leaks tests and inventory of sealed sources and 
brachytherapy sources.
35.2070   Records of surveys for ambient radiation exposure rate.
35.2075   Records of the release of individuals containing unsealed 
byproduct material or implants containing byproduct material.
35.2080   Records of mobile medical services.
35.2092   Records of decay-in-storage.
35.2204   Records of molybdenum-99 concentrations.

[[Page 20372]]

35.2310   Records of safety instruction.
35.2404   Records of surveys after source implant and removal.
35.2406   Records of brachytherapy source accountability.
35.2432   Records of calibration measurements of brachytherapy 
sources.
35.2433   Records of decay of strontium-90 sources for ophthalmic 
treatments.
35.2605   Records of installation, maintenance, adjustment, and 
repair of remote afterloader units, teletherapy units, and gamma 
stereotactic radiosurgery units.
35.2610   Records of safety procedures.
35.2630   Records of dosimetry equipment used with remote 
afterloader units, teletherapy units, and gamma stereotactic 
radiosurgery units.
35.2632   Records of teletherapy, remote afterloader, and gamma 
stereotactic radiosurgery full calibrations.
35.2642   Records of periodic spot-checks for teletherapy units.
35.2643   Records of periodic spot-checks for remote afterloader 
units.
35.2645   Records of periodic spot-checks for gamma stereotactic 
radiosurgery units.
35.2647   Records of additional technical requirements for mobile 
remote afterloader units.
35.2652   Records of surveys of therapeutic treatment units.
35.2655   Records of 5-year inspection for teletherapy and gamma 
stereotactic radiosurgery units.
Subpart M-- Reports
35.3045   Report and notification of a medical event.
35.3047   Report and notification of a dose to an embryo/fetus or a 
nursing child.
35.3067   Report of a leaking source.
Subpart N-- Enforcement
35.4001   Violations.
35.4002   Criminal penalties.

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

Subpart A--General Information


Sec. 35.1  Purpose and scope.

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


Sec. 35.2  Definitions.

    Address of use means the building or buildings that are identified 
on the license and where byproduct material may be received, prepared, 
used, or stored.
    Agreement State means any State with which the Commission or the 
Atomic Energy Commission has entered into an effective agreement under 
subsection 274b of the Atomic Energy Act of 1954, as amended.
    Area of use means a portion of an address of use that has been set 
aside for the purpose of receiving, preparing, using, or storing 
byproduct material.
    Authorized medical physicist means an individual who--
    (1) Meets the requirements in Secs. 35.51(a) and 35.59; or
    (2) Is identified as an authorized medical physicist or teletherapy 
physicist on--
    (i) A specific medical use license issued by the Commission or 
Agreement State;
    (ii) A medical use permit issued by a Commission master material 
licensee;
    (iii) A permit issued by a Commission or Agreement State broad 
scope medical use licensee; or
    (iv) A permit issued by a Commission master material license broad 
scope medical use permittee.
    Authorized nuclear pharmacist means a pharmacist who--
    (1) Meets the requirements in Secs. 35.55(a) and 35.59; or
    (2) Is identified as an authorized nuclear pharmacist on--
    (i) A specific license issued by the Commission or Agreement State 
that authorizes medical use or the practice of nuclear pharmacy;
    (ii) A permit issued by a Commission master material licensee that 
authorizes medical use or the practice of nuclear pharmacy;
    (iii) A permit issued by a Commission or Agreement State broad 
scope medical use licensee that authorizes medical use or the practice 
of nuclear pharmacy; or
    (iv) A permit issued by a Commission master material license broad 
scope medical use permittee that authorizes medical use or the practice 
of nuclear pharmacy; or
    (3) Is identified as an authorized nuclear pharmacist by a 
commercial nuclear pharmacy that has been authorized to identify 
authorized nuclear pharmacists; or
    (4) Is designated as an authorized nuclear pharmacist in accordance 
with Sec. 32.72(b)(4).
    Authorized user means a physician, dentist, or podiatrist who--
    (1) Meets the requirements in Secs. 35.59 and 35.190(a), 35.290(a), 
35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), or 35.690(a); or
    (2) Is identified as an authorized user on--
    (i) A Commission or Agreement State license that authorizes the 
medical use of byproduct material;
    (ii) A permit issued by a Commission master material licensee that 
is authorized to permit the medical use of byproduct material;
    (iii) A permit issued by a Commission or Agreement State specific 
licensee of broad scope that is authorized to permit the medical use of 
byproduct material; or
    (iv) A permit issued by a Commission master material license broad 
scope permittee that is authorized to permit the medical use of 
byproduct material.
    Brachytherapy means a method of radiation therapy in which sources 
are used to deliver a radiation dose at a distance of up to a few 
centimeters by surface, intracavitary, intraluminal, or interstitial 
application.
    Brachytherapy source means a radioactive source or a manufacturer-
assembled source train or a combination of these sources that is 
designed to deliver a therapeutic dose within a distance of a few 
centimeters.
    Client's address means the area of use or a temporary job site for 
the purpose of providing mobile medical service in accordance with 
Sec. 35.80.
    Dedicated check source means a radioactive source that is used to 
assure the constant operation of a radiation detection or measurement 
device over several months or years.
    Dentist means an individual licensed by a State or Territory of the 
United States, the District of Columbia, or the Commonwealth of Puerto 
Rico to practice dentistry.
    High dose-rate remote afterloader, as used in this part, means a 
brachytherapy device that remotely delivers a dose rate in excess of 12 
gray (1200 rads) per hour at the point or surface where the dose is 
prescribed.
    Low dose-rate remote afterloader, as used in this part, means a 
brachytherapy device that remotely delivers a dose rate of less than or 
equal to 2 gray (200 rads) per hour at the point or surface where the 
dose is prescribed.
    Management means the chief executive officer or other individual 
having the authority to manage, direct, or administer the licensee's 
activities, or those persons' delegate or delegates.
    Manual brachytherapy, as used in this part, means a type of 
brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) 
are manually placed topically on or inserted either into the body 
cavities that are in close proximity to a treatment site or directly 
into the tissue volume.
    Medical event means an event that meets the criteria in 
Sec. 35.3045(a).

[[Page 20373]]

    Medical institution means an organization in which more than one 
medical discipline is practiced.
    Medical use means the intentional internal or external 
administration of byproduct material or the radiation from byproduct 
material to patients or human research subjects under the supervision 
of an authorized user.
    Medium dose-rate remote afterloader, as used in this part, means a 
brachytherapy device that remotely delivers a dose rate of greater than 
2 gray (200 rads), but less than 12 gray (1200 rads) per hour at the 
point or surface where the dose is prescribed.
    Mobile medical service means the transportation of byproduct 
material to and its medical use at the client's address.
    Output means the exposure rate, dose rate, or a quantity related in 
a known manner to these rates from a brachytherapy source or a 
teletherapy, remote afterloader, or gamma stereotactic radiosurgery 
unit for a specified set of exposure conditions.
    Patient intervention means actions by the patient or human research 
subject, whether intentional or unintentional, such as dislodging or 
removing treatment devices or prematurely terminating the 
administration.
    Pharmacist means an individual licensed by a State or Territory of 
the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico to practice pharmacy.
    Physician means a medical doctor or doctor of osteopathy licensed 
by a State or Territory of the United States, the District of Columbia, 
or the Commonwealth of Puerto Rico to prescribe drugs in the practice 
of medicine.
    Podiatrist means an individual licensed by a State or Territory of 
the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico to practice podiatry.
    Preceptor means an individual who provides or directs the training 
and experience required for an individual to become an authorized user, 
an authorized medical physicist, an authorized nuclear pharmacist, or a 
Radiation Safety Officer.
    Prescribed dosage means the specified activity or range of activity 
of unsealed byproduct material as documented--
    (1) In a written directive; or
    (2) In accordance with the directions of the authorized user for 
procedures performed pursuant to Secs. 35.100 and 35.200.
    Prescribed dose means--
    (1) For gamma stereotactic radiosurgery, the total dose as 
documented in the written directive;
    (2) For teletherapy, the total dose and dose per fraction as 
documented in the written directive;
    (3) For manual brachytherapy, either the total source strength and 
exposure time or the total dose, as documented in the written 
directive; or
    (4) For remote brachytherapy afterloaders, the total dose and dose 
per fraction as documented in the written directive.
    Pulsed dose-rate remote afterloader, as used in this part, means a 
special type of remote afterloading brachytherapy device that uses a 
single source capable of delivering dose rates in the ``high dose-
rate'' range, but--
    (1) Is approximately one-tenth of the activity of typical high 
dose-rate remote afterloader sources; and
    (2) Is used to simulate the radiobiology of a low dose-rate 
treatment by inserting the source for a given fraction of each hour.
    Radiation Safety Officer means an individual who--
    (1) Meets the requirements in Secs. 35.50(a) and 35.59; or
    (2) Is identified as a Radiation Safety Officer on--
    (i) A specific medical use license issued by the Commission or 
Agreement State; or
    (ii) A medical use permit issued by a Commission master material 
licensee.
    Sealed source means any byproduct material that is encased in a 
capsule designed to prevent leakage or escape of the byproduct 
material.
    Sealed Source and Device Registry means the national registry that 
contains all the registration certificates, generated by both NRC and 
the Agreement States, that summarize the radiation safety information 
for the sealed sources and devices and describe the licensing and use 
conditions approved for the product.
    Stereotactic radiosurgery means the use of external radiation in 
conjunction with a stereotactic guidance device to very precisely 
deliver a therapeutic dose to a tissue volume.
    Structured educational program means an educational program 
designed to impart particular knowledge and practical education through 
interrelated studies and supervised training.
    Teletherapy, as used in this part, means a method of radiation 
therapy in which collimated gamma rays are delivered at a distance from 
the patient or human research subject.
    Temporary job site means a location where mobile medical services 
are conducted other than those location(s) of use authorized on the 
license.
    Therapeutic dosage means a dosage of unsealed byproduct material 
that is intended to deliver a radiation dose to a patient or human 
research subject for palliative or curative treatment.
    Therapeutic dose means a radiation dose delivered from a source 
containing byproduct material to a patient or human research subject 
for palliative or curative treatment.
    Treatment site means the anatomical description of the tissue 
intended to receive a radiation dose, as described in a written 
directive.
    Type of use means use of byproduct material under Secs. 35.100, 
35.200, 35.300, 35.400, 35.500, 35.600, or 35.1000.
    Unit dosage means a dosage prepared for medical use for 
administration as a single dosage to a patient or human research 
subject without any further manipulation of the dosage after it is 
initially prepared.
    Written directive means an authorized user's written order for the 
administration of byproduct material or radiation from byproduct 
material to a specific patient or human research subject, as specified 
in Sec. 35.40.


Sec. 35.5  Maintenance of records.

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


Sec. 35.6  Provisions for the protection of human research subjects.

    (a) A licensee may conduct research involving human research 
subjects only if it uses the byproduct materials specified on its 
license for the uses authorized on its license.
    (b) If the research is conducted, funded, supported, or regulated 
by another Federal agency that has implemented the Federal Policy for 
the Protection of Human Subjects (Federal Policy), the licensee shall, 
before conducting research--
    (1) Obtain review and approval of the research from an 
``Institutional Review Board,'' as defined and described in the Federal 
Policy; and
    (2) Obtain ``informed consent,'' as defined and described in the 
Federal

[[Page 20374]]

Policy, from the human research subject.
    (c) If the research will not be conducted, funded, supported, or 
regulated by another Federal agency that has implemented the Federal 
Policy, the license shall, before conducting research, apply for and 
receive a specific amendment to its NRC medical use license. The 
amendment request must include a written commitment that the licensee 
will, before conducting research--
    (1) Obtain review and approval of the research from an 
``Institutional Review Board,'' as defined and described in the Federal 
Policy; and
    (2) Obtain ``informed consent'', as defined and described in the 
Federal Policy, from the human research subject.
    (d) Nothing in this section relieves licensees from complying with 
the other requirements in this part.


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

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


Sec. 35.8  Information collection requirements: OMB approval.

    (a) The Commission has submitted the information collection 
requirements contained in this part to the Office of Management and 
Budget (OMB) for approval as required by the Paperwork Reduction Act 
(44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a 
person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. OMB has 
approved the information collection requirements in this part under 
control number 3150-0010.
    (b) The approved information collection requirements contained in 
this part appear in Secs. 35.6, 35.12, 35.13, 35.14, 35.19, 35.24, 
35.26, 35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 35.63, 
35.67, 35.69, 35.70, 35.75, 35.80, 35.92, 35.190, 35.204, 35.290, 
35.310, 35.315, 35.390, 35.392, 35.394, 35.404, 35.406, 35.410, 35.415, 
35.432, 35.433, 35.490, 35.491, 35.590, 35.604, 35.605, 35.610, 35.615, 
35.630, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, 35.647, 35.652, 
35.655, 35.690, 35.900, 35.910, 35.920, 35.930, 35.940, 35.950, 35.960, 
35.961, 35.980, 35.981, 35.1000, 35.2024, 35.2026, 35.2040, 35.2041, 
35.2060, 35.2061, 35.2063, 35.2067, 35.2070, 35.2075, 35.2080, 35.2092, 
35.2204, 35.2310, 35.2404, 35.2406, 35.2432, 35.2433, 35.2605, 35.2610, 
35.2630, 35.2632, 35.2642, 35.2643, 35.2645, 35.2647, 35.2652, 35.2655, 
35.3045, 35.3047, and 35.3067.
    (c) This part contains information collection requirements in 
addition to those approved under the control number specified in 
paragraph (a) of this section. These information collection 
requirements and the control numbers under which they are approved are 
as follows:
    (1) In Sec. 35.12, NRC Form 313, including NRC Form 313A, which 
licensees may use to provide supplemental information, is approved 
under control number 3150-0120.
    (2) [Reserved]


Sec. 35.10  Implementation.

    (a) A licensee shall implement the provisions in this part on or 
before October 24, 2002, with the exception of the requirements listed 
in paragraph (b) of this section.
    (b) A licensee shall implement the training requirements in 
Secs. 35.50(a), 35.51(a), 35.55(a), 35.59, 35.190(a), 35.290(a), 
35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a) on 
or before October 25, 2004.
    (c) Prior to October 25, 2004, a licensee shall satisfy the 
training requirements of this part for a Radiation Safety Officer, an 
authorized medical physicist, an authorized nuclear pharmacist, or an 
authorized user by complying with either:
    (1) The appropriate training requirements in subpart J; or
    (2) The appropriate training requirements in subpart B or subparts 
D through H.
    (d) If a license condition exempted a licensee from a provision of 
Part 35 on October 24, 2002, then the license condition continues to 
exempt the licensee from the requirements in the corresponding 
provision of Secs. 35.1-35.4002.
    (e) When a requirement in this part differs from the requirement in 
an existing license condition, the requirement in this part shall 
govern.
    (f) A licensee shall continue to comply with any license condition 
that requires it to implement procedures required by Secs. 35.610, 
35.642, 35.643, and 35.645 until there is a license amendment or 
renewal that modifies the license condition.


Sec. 35.11  License required.

    (a) A person may manufacture, produce, acquire, receive, possess, 
prepare, use, or transfer byproduct material for medical use only in 
accordance with a specific license issued by the Commission or an 
Agreement State, or as allowed in paragraphs (b)(1) or (b)(2) of this 
section.
    (b) A specific license is not needed for an individual who--
    (1) Receives, possesses, uses, or transfers byproduct material in 
accordance with the regulations in this chapter under the supervision 
of an authorized user as provided in Sec. 35.27, unless prohibited by 
license condition; or
    (2) Prepares unsealed byproduct material for medical use in 
accordance with the regulations in this chapter under the supervision 
of an authorized nuclear pharmacist or authorized user as provided in 
Sec. 35.27, unless prohibited by license condition.


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

    (a) An application must be signed by the applicant's or licensee's 
management.
    (b) An application for a license for medical use of byproduct 
material as described in Secs. 35.100, 35.200, 35.300, 35.400, 35.500, 
35.600, and 35.1000 must be made by--
    (1) Filing an original and one copy of NRC Form 313, ``Application 
for Material License,'' that includes the facility diagram, equipment, 
and training and experience qualifications of the Radiation Safety 
Officer, authorized user(s), authorized medical physicist(s), and 
authorized nuclear pharmacist(s); and
    (2) Submitting procedures required by Secs. 35.610, 35.642, 35.643, 
and 35.645, as applicable.
    (c) A request for a license amendment or renewal must be made by--
    (1) Submitting an original and one copy of either--
    (i) NRC Form 313, ``Application for Material Licens''; or
    (ii) A letter requesting the amendment or renewal; and
    (2) Submitting procedures required by Secs. 35.610, 35.642, 35.643, 
and 35.645, as applicable.
    (d) In addition to the requirements in paragraphs (b) and (c) of 
this section, an application for a license or amendment for medical use 
of byproduct material as described in Sec. 35.1000 must also include 
information regarding any radiation safety aspects of the medical use 
of the material that is not addressed in Subparts A through C of this 
part.
    (1) The applicant shall also provide specific information on--
    (i) Radiation safety precautions and instructions;
    (ii) Methodology for measurement of dosages or doses to be 
administered to patients or human research subjects; and

[[Page 20375]]

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


Sec. 35.13  License amendments.

    A licensee shall apply for and must receive a license amendment--
    (a) Before it receives, prepares, or uses byproduct material for a 
type of use that is permitted under this part, but that is not 
authorized on the licensee's current license issued under this part;
    (b) Before it permits anyone to work as an authorized user, 
authorized nuclear pharmacist, or authorized medical physicist under 
the license, except--
    (1) For an authorized user, an individual who meets the 
requirements in Secs. 35.190(a), 35.290(a), 35.390(a), 35.392(a), 
35.394(a), 35.490(a), 35.590(a), 35.690(a), 35.910, 35.920, 35.930, 
35.932, 35.934, 35.940, 35.941, 35.950, or 35.960 and 35.59;
    (2) For an authorized nuclear pharmacist, an individual who meets 
the requirements in Secs. 35.55(a) or 35.980 and 35.59;
    (3) For an authorized medical physicist, an individual who meets 
the requirements in Secs. 35.51(a) or 35.961 and 35.59;
    (4) An individual who is identified as an authorized user, an 
authorized nuclear pharmacist, or authorized medical physicist--
    (i) On a Commission or Agreement State license or other equivalent 
permit or license recognized by NRC that authorizes the use of 
byproduct material in medical use or in the practice of nuclear 
pharmacy;
    (ii) On a permit issued by a Commission or Agreement State specific 
license of broad scope that is authorized to permit the use of 
byproduct material in medical use or in the practice of nuclear 
pharmacy;
    (iii) On a permit issued by a Commission master material licensee 
that is authorized to permit the use of byproduct material in medical 
use or in the practice of nuclear pharmacy; or
    (iv) By a commercial nuclear pharmacy that has been authorized to 
identify authorized nuclear pharmacists.
    (c) Before it changes Radiation Safety Officers, except as provided 
in Sec. 35.24(c);
    (d) Before it receives byproduct material in excess of the amount 
or in a different form, or receives a different radionuclide than is 
authorized on the license;
    (e) Before it adds to or changes the areas of use identified in the 
application or on the license, except for areas of use where byproduct 
material is used only in accordance with either Sec. 35.100 or 
Sec. 35.200;
    (f) Before it changes the address(es) of use identified in the 
application or on the license; and
    (g) Before it revises procedures required by Secs. 35.610, 35.642, 
35.643, and 35.645, as applicable, where such revision reduces 
radiation safety.


Sec. 35.14  Notifications.

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


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

    A licensee possessing a Type A specific license of broad scope for 
medical use, issued under Part 33 of this chapter, is exempt from--
    (a) The provisions of Sec. 35.12(d) regarding the need to file an 
amendment to the license for medical use of byproduct material, as 
described in Sec. 35.1000;
    (b) The provisions of Sec. 35.13(b);
    (c) The provisions of Sec. 35.13(e) regarding additions to or 
changes in the areas of use at the addresses identified in the 
application or on the license;
    (d) The provisions of Sec. 35.14(a);
    (e) The provisions of Sec. 35.14(b)(1) for an authorized user, an 
authorized nuclear pharmacist, or an authorized medical physicist;
    (f) The provisions of Sec. 35.14(b)(4) regarding additions to or 
changes in the areas of use identified in the application or on the 
license where byproduct material is used in accordance with either 
Sec. 35.100 or Sec. 35.200.
    (g) The provisions of Sec. 35.49(a).


Sec. 35.18  License issuance.

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


Sec. 35.19  Specific exemptions.

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

[[Page 20376]]

Subpart B--General Administrative Requirements


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

    (a) In addition to the radiation protection program requirements of 
Sec. 20.1101 of this chapter, a licensee's management shall approve in 
writing--
    (1) Requests for a license application, renewal, or amendment 
before submittal to the Commission;
    (2) Any individual before allowing that individual to work as an 
authorized user, authorized nuclear pharmacist, or authorized medical 
physicist; and
    (3) Radiation protection program changes that do not require a 
license amendment and are permitted under Sec. 35.26;
    (b) A licensee's management shall appoint a Radiation Safety 
Officer, who agrees, in writing, to be responsible for implementing the 
radiation protection program. The licensee, through the Radiation 
Safety Officer, shall ensure that radiation safety activities are being 
performed in accordance with licensee-approved procedures and 
regulatory requirements.
    (c) For up to 60 days each year, a licensee may permit an 
authorized user or an individual qualified to be a Radiation Safety 
Officer, under Secs. 35.50 and 35.59, to function as a temporary 
Radiation Safety Officer and to perform the functions of a Radiation 
Safety Officer, as provided in paragraph (g) of this section, if the 
licensee takes the actions required in paragraphs (b), (e), (g), and 
(h) of this section and notifies the Commission in accordance with 
Sec. 35.14(b).
    (d) A licensee may simultaneously appoint more than one temporary 
Radiation Safety Officer in accordance with paragraph (c) of this 
section, if needed to ensure that the licensee has a temporary 
Radiation Safety Officer that satisfies the requirements to be a 
Radiation Safety Officer for each of the different types of uses of 
byproduct material permitted by the license.
    (e) A licensee shall establish the authority, duties, and 
responsibilities of the Radiation Safety Officer in writing.
    (f) Licensees that are authorized for two or more different types 
of uses of byproduct material under Subparts E, F, and H of this part, 
or two or more types of units under Subpart H of this part, shall 
establish a Radiation Safety Committee to oversee all uses of byproduct 
material permitted by the license. The Committee must include an 
authorized user of each type of use permitted by the license, the 
Radiation Safety Officer, a representative of the nursing service, and 
a representative of management who is neither an authorized user nor a 
Radiation Safety Officer. The Committee may include other members the 
licensee considers appropriate.
    (g) A licensee shall provide the Radiation Safety Officer 
sufficient authority, organizational freedom, time, resources, and 
management prerogative, to--
    (1) Identify radiation safety problems;
    (2) Initiate, recommend, or provide corrective actions;
    (3) Stop unsafe operations; and,
    (4) Verify implementation of corrective actions.
    (h) A licensee shall retain a record of actions taken under 
paragraphs (a), (b), and (e) of this section in accordance with 
Sec. 35.2024.


Sec. 35.26  Radiation protection program changes.

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


Sec. 35.27  Supervision.

    (a) A licensee that permits the receipt, possession, use, or 
transfer of byproduct material by an individual under the supervision 
of an authorized user, as allowed by Sec. 35.11(b)(1), shall--
    (1) In addition to the requirements in Sec. 19.12 of this chapter, 
instruct the supervised individual in the licensee's written radiation 
protection procedures, written directive procedures, regulations of 
this chapter, and license conditions with respect to the use of 
byproduct material; and
    (2) Require the supervised individual to follow the instructions of 
the supervising authorized user for medical uses of byproduct material, 
written radiation protection procedures established by the licensee, 
written directive procedures, regulations of this chapter, and license 
conditions with respect to the medical use of byproduct material.
    (b) A licensee that permits the preparation of byproduct material 
for medical use by an individual under the supervision of an authorized 
nuclear pharmacist or physician who is an authorized user, as allowed 
by Sec. 35.11(b)(2), shall--
    (1) In addition to the requirements in Sec. 19.12 of this chapter, 
instruct the supervised individual in the preparation of byproduct 
material for medical use, as appropriate to that individual's 
involvement with byproduct material; and
    (2) Require the supervised individual to follow the instructions of 
the supervising authorized user or authorized nuclear pharmacist 
regarding the preparation of byproduct material for medical use, 
written radiation protection procedures established by the licensee, 
the regulations of this chapter, and license conditions.
    (c) A licensee that permits supervised activities under paragraphs 
(a) and (b) of this section is responsible for the acts and omissions 
of the supervised individual.


Sec. 35.40  Written directives.

    (a) A written directive must be dated and signed by an authorized 
user before the administration of I-131 sodium iodide greater than 1.11 
Megabequerels (MBq) (30 microcuries (Ci)), any therapeutic 
dosage of unsealed byproduct material or any therapeutic dose of 
radiation from byproduct material.
    (1) If, because of the emergent nature of the patient's condition, 
a delay in order to provide a written directive would jeopardize the 
patient's health, an oral directive is acceptable. The information 
contained in the oral directive must be documented as soon as possible 
in writing in the patient's record. A written directive must be 
prepared within 48 hours of the oral directive.
    (b) The written directive must contain the patient or human 
research subject's name and the following information--
    (1) For any administration of quantities greater than 1.11 MBq (30 
Ci) of sodium iodide I-131: the dosage;
    (2) For an administration of a therapeutic dosage of unsealed 
byproduct material other than sodium iodide I-131: the radioactive 
drug, dosage, and route of administration;
    (3) For gamma stereotactic radiosurgery: the total dose, treatment 
site, and values for the target coordinate settings per treatment for 
each anatomically distinct treatment site;
    (4) For teletherapy: the total dose, dose per fraction, number of 
fractions, and treatment site;
    (5) For high dose-rate remote afterloading brachytherapy: the 
radionuclide, treatment site, dose per fraction, number of fractions, 
and total dose; or

[[Page 20377]]

    (6) For all other brachytherapy, including low, medium, and pulsed 
dose rate remote afterloaders:
    (i) Before implantation: treatment site, the radionuclide, and 
dose; and
    (ii) After implantation but before completion of the procedure: the 
radionuclide, treatment site, number of sources, and total source 
strength and exposure time (or the total dose).
    (c) A written revision to an existing written directive may be made 
if the revision is dated and signed by an authorized user before the 
administration of the dosage of unsealed byproduct material, the 
brachytherapy dose, the gamma stereotactic radiosurgery dose, the 
teletherapy dose, or the next fractional dose.
    (1) If, because of the patient's condition, a delay in order to 
provide a written revision to an existing written directive would 
jeopardize the patient's health, an oral revision to an existing 
written directive is acceptable. The oral revision must be documented 
as soon as possible in the patient's record. A revised written 
directive must be signed by the authorized user within 48 hours of the 
oral revision.
    (d) The licensee shall retain a copy of the written directive in 
accordance with Sec. 35.2040.


Sec. 35.41  Procedures for administrations requiring a written 
directive.

    (a) For any administration requiring a written directive, the 
licensee shall develop, implement, and maintain written procedures to 
provide high confidence that:
    (1) The patient's or human research subject's identity is verified 
before each administration; and
    (2) Each administration is in accordance with the written 
directive.
    (b) At a minimum, the procedures required by paragraph (a) of this 
section must address the following items that are applicable to the 
licensee's use of byproduct material--
    (1) Verifying the identity of the patient or human research 
subject;
    (2) Verifying that the administration is in accordance with the 
treatment plan, if applicable, and the written directive;
    (3) Checking both manual and computer-generated dose calculations; 
and
    (4) Verifying that any computer-generated dose calculations are 
correctly transferred into the consoles of therapeutic medical units 
authorized by Sec. 35.600.
    (c) A licensee shall retain a copy of the procedures required under 
paragraph (a) in accordance with Sec. 35.2041.


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

    For medical use, a licensee may only use--
    (a) Sealed sources or devices manufactured, labeled, packaged, and 
distributed in accordance with a license issued under 10 CFR Part 30 
and 10 CFR 32.74 of this chapter or equivalent requirements of an 
Agreement State;
    (b) Sealed sources or devices noncommercially transferred from a 
Part 35 licensee; or
    (c) Teletherapy sources manufactured and distributed in accordance 
with a license issued under 10 CFR Part 30 or the equivalent 
requirements of an Agreement State.


Sec. 35.50  Training for Radiation Safety Officer.

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


Sec. 35.51  Training for an authorized medical physicist.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized medical physicist to be an individual who--
    (a) Is certified by a specialty board whose certification process 
includes all of the training and experience requirements in paragraph 
(b) of this section and whose certification has been recognized by the 
Commission or an Agreement State; or
    (b)(1) Holds a master's or doctor's degree in physics, biophysics, 
radiological physics, medical physics, or health physics and has 
completed 1 year of full-time training in therapeutic radiological 
physics and an additional year of full-time work experience under the 
supervision of an individual who meets the requirements for an 
authorized medical physicist at a medical institution that includes the 
tasks listed in Secs. 35.67, 35.433, 35.632, 35.633, 35.635, 35.642, 
35.643, 35.645, and 35.652, as applicable; and
    (2) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraph (b)(1) of this 
section and has achieved a level of competency sufficient to function 
independently as an authorized medical physicist for each type of 
therapeutic medical unit for which the individual is requesting 
authorized medical physicist status. The written certification must be 
signed by a preceptor authorized medical physicist who meets the 
requirements in Sec. 35.51 or equivalent Agreement State requirements 
for an authorized medical physicist for each type of therapeutic 
medical unit for which the individual is requesting authorized medical 
physicist status.

[[Page 20378]]

Sec. 35.55  Training for an authorized nuclear pharmacist.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized nuclear pharmacist to be a pharmacist who--
    (a) Is certified as a nuclear pharmacist by a specialty board whose 
certification process includes all of the requirements in paragraph (b) 
of this section and whose certification has been recognized by the 
Commission or an Agreement State; or
    (b)(1) Has completed 700 hours in a structured educational program 
consisting of both:
    (i) Didactic training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use; and
    (E) Radiation biology; and
    (ii) Supervised practical experience in a nuclear pharmacy 
involving--
    (A) Shipping, receiving, and performing related radiation surveys;
    (B) Using and performing checks for proper operation of instruments 
used to determine the activity of dosages, survey meters, and, if 
appropriate, instruments used to measure alpha- or beta-emitting 
radionuclides;
    (C) Calculating, assaying, and safely preparing dosages for 
patients or human research subjects;
    (D) Using administrative controls to avoid medical events in the 
administration of byproduct material; and
    (E) Using procedures to prevent or minimize radioactive 
contamination and using proper decontamination procedures; and
    (2) Has obtained written certification, signed by a preceptor 
authorized nuclear pharmacist, that the individual has satisfactorily 
completed the requirements in paragraph (b)(1) of this section and has 
achieved a level of competency sufficient to function independently as 
an authorized nuclear pharmacist.


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

    (a) An individual identified as a Radiation Safety Officer, a 
teletherapy or medical physicist, or a nuclear pharmacist on a 
Commission or Agreement State license or a permit issued by a 
Commission or Agreement State broad scope licensee or master material 
license permit or by a master material license permittee of broad scope 
before October 24, 2002 need not comply with the training requirements 
of Secs. 35.50, 35.51, or 35.55, respectively.
    (b) Physicians, dentists, or podiatrists identified as authorized 
users for the medical use of byproduct material on a license issued by 
the Commission or Agreement State, a permit issued by a Commission 
master material licensee, a permit issued by a Commission or Agreement 
State broad scope licensee, or a permit issued by a Commission master 
material license broad scope permittee before October 24, 2002 who 
perform only those medical uses for which they were authorized on that 
date need not comply with the training requirements of Subparts D-H of 
this part.


Sec. 35.59  Recentness of training.

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

Subpart C--General Technical Requirements


Sec. 35.60  Possession, use, and calibration of instruments used to 
measure the activity of unsealed byproduct material.

    (a) For direct measurements performed in accordance with 
Sec. 35.63, a licensee shall possess and use instrumentation to measure 
the activity of unsealed byproduct material before it is administered 
to each patient or human research subject.
    (b) A licensee shall calibrate the instrumentation required in 
paragraph (a) of this section in accordance with nationally recognized 
standards or the manufacturer's instructions.
    (c) A licensee shall retain a record of each instrument calibration 
required by this section in accordance with Sec. 35.2060.


Sec. 35.61  Calibration of survey instruments.

    (a) A licensee shall calibrate the survey instruments used to show 
compliance with this part and 10 CFR Part 20 before first use, 
annually, and following a repair that affects the calibration. A 
licensee shall--
    (1) Calibrate all scales with readings up to 10 mSv (1000 mrem) per 
hour with a radiation source;
    (2) Calibrate two separated readings on each scale or decade that 
will be used to show compliance; and
    (3) Conspicuously note on the instrument the date of calibration.
    (b) A licensee may not use survey instruments if the difference 
between the indicated exposure rate and the calculated exposure rate is 
more than 20 percent.
    (c) A licensee shall retain a record of each survey instrument 
calibration in accordance with Sec. 35.2061.


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

    (a) A licensee shall determine and record the activity of each 
dosage before medical use.
    (b) For a unit dosage, this determination must be made by--
    (1) Direct measurement of radioactivity; or
    (2) A decay correction, based on the activity or activity 
concentration determined by--
    (i) A manufacturer or preparer licensed under Sec. 32.72 of this 
chapter or equivalent Agreement State requirements; or
    (ii) An NRC or Agreement State licensee for use in research in 
accordance with a Radioactive Drug Research Committee-approved protocol 
or an Investigational New Drug (IND) protocol accepted by FDA.
    (c) For other than unit dosages, this determination must be made 
by--
    (1) Direct measurement of radioactivity;
    (2) Combination of measurement of radioactivity and mathematical 
calculations; or
    (3) Combination of volumetric measurements and mathematical 
calculations, based on the measurement made by a manufacturer or 
preparer licensed under Sec. 32.72 of this chapter or equivalent 
Agreement State requirements.
    (d) Unless otherwise directed by the authorized user, a licensee 
may not use a dosage if the dosage does not fall within the prescribed 
dosage range or if the dosage differs from the prescribed dosage by 
more than 20 percent.
    (e) A licensee shall retain a record of the dosage determination 
required by this section in accordance with Sec. 35.2063.


Sec. 35.65  Authorization for calibration, transmission, and reference 
sources.

    Any person authorized by Sec. 35.11 for medical use of byproduct 
material may receive, possess, and use any of the following byproduct 
material for check, calibration, transmission, and reference use.
    (a) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, 
manufactured and distributed by a person licensed under Sec. 32.74 of 
this chapter or equivalent Agreement State regulations.

[[Page 20379]]

    (b) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, 
redistributed by a licensee authorized to redistribute the sealed 
sources manufactured and distributed by a person licensed under 
Sec. 32.74 of this chapter, providing the redistributed sealed sources 
are in the original packaging and shielding and are accompanied by the 
manufacturer's approved instructions.
    (c) Any byproduct material with a half-life not longer than 120 
days in individual amounts not to exceed 0.56 GBq (15 mCi).
    (d) Any byproduct material with a half-life longer than 120 days in 
individual amounts not to exceed the smaller of 7.4 MBq (200 
Ci) or 1000 times the quantities in Appendix B of Part 30 of 
this chapter.
    (e) Technetium-99m in amounts as needed.


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

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


Sec. 35.69  Labeling of vials and syringes.

    Each syringe and vial that contains unsealed byproduct material 
must be labeled to identify the radioactive drug. Each syringe shield 
and vial shield must also be labeled unless the label on the syringe or 
vial is visible when shielded.


Sec. 35.70  Surveys of ambient radiation exposure rate.

    (a) In addition to the surveys required by Part 20 of this chapter, 
a licensee shall survey with a radiation detection survey instrument at 
the end of each day of use. A licensee shall survey all areas where 
unsealed byproduct material requiring a written directive was prepared 
for use or administered.
    (b) A licensee does not need to perform the surveys required by 
paragraph (a) of this section in an area(s) where patients or human 
research subjects are confined when they cannot be released under 
Sec. 35.75.
    (c) A licensee shall retain a record of each survey in accordance 
with Sec. 35.2070.


Sec. 35.75  Release of individuals containing unsealed byproduct 
material or implants containing byproduct material.

    (a) A licensee may authorize the release from its control of any 
individual who has been administered unsealed byproduct material or 
implants containing byproduct material if the total effective dose 
equivalent to any other individual from exposure to the released 
individual is not likely to exceed 5 mSv (0.5 rem). \1\
---------------------------------------------------------------------------

    \1\ NUREG-1556, Vol. 9 (draft), ``Consolidated Guidance About 
Materials Licenses: Program-Specific Guidance About Medical 
Licenses,'' describes methods for calculating doses to other 
individuals and contains tables of activities not likely to cause 
doses exceeding 5 mSv (0.5 rem).
---------------------------------------------------------------------------

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


Sec. 35.80  Provision of mobile medical service.

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

[[Page 20380]]

accordance with Sec. 35.2080(a) and (b), respectively.


Sec. 35.92  Decay-in-storage.

    (a) A licensee may hold byproduct material with a physical half-
life of less than 120 days for decay-in-storage before disposal without 
regard to its radioactivity if it--
    (1) Monitors byproduct material at the surface before disposal and 
determines that its radioactivity cannot be distinguished from the 
background radiation level with an appropriate radiation detection 
survey meter set on its most sensitive scale and with no interposed 
shielding; and
    (2) Removes or obliterates all radiation labels, except for 
radiation labels on materials that are within containers and that will 
be managed as biomedical waste after they have been released from the 
licensee.
    (b) A licensee shall retain a record of each disposal permitted 
under paragraph (a) of this section in accordance with Sec. 35.2092.

Subpart D--Unsealed Byproduct Material--Written Directive Not 
Required


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

    Except for quantities that require a written directive under 
Sec. 35.40(b), a licensee may use any unsealed byproduct material 
prepared for medical use for uptake, dilution, or excretion studies 
that is--
    (a) Obtained from a manufacturer or preparer licensed under 
Sec. 32.72 of this chapter or equivalent Agreement State requirements; 
or
    (b) Prepared by an authorized nuclear pharmacist, a physician who 
is an authorized user and who meets the requirements specified in 
Secs. 35.290 or 35.390, or an individual under the supervision of 
either as specified in Sec. 35.27; or
    (c) Obtained from and prepared by an NRC or Agreement State 
licensee for use in research in accordance with a Radioactive Drug 
Research Committee-approved protocol or an Investigational New Drug 
(IND) protocol accepted by FDA; or
    (d) Prepared by the licensee for use in research in accordance with 
a Radioactive Drug Research Committee-approved application or an 
Investigational New Drug (IND) protocol accepted by FDA.


Sec. 35.190  Training for uptake, dilution, and excretion studies.

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user of unsealed byproduct material for the uses authorized 
under Sec. 35.100 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (c) of this 
section and whose certification has been recognized by the Commission 
or an Agreement State; or
    (b) Is an authorized user under Secs. 35.290 or 35.390 or 
equivalent Agreement State requirements; or
    (c)(1) Has completed 60 hours of training and experience in basic 
radionuclide handling techniques applicable to the medical use of 
unsealed byproduct material for uptake, dilution, and excretion 
studies. The training and experience must include--
    (i) Classroom and laboratory training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use; and
    (E) Radiation biology; and
    (ii) Work experience, under the supervision of an authorized user 
who meets the requirements in Sec. 35.190, Sec. 35.290, or Sec. 35.390 
or equivalent Agreement State requirements, involving--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Calibrating instruments used to determine the activity of 
dosages and performing checks for proper operation of survey meters;
    (C) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (D) Using administrative controls to prevent a medical event 
involving the use of unsealed byproduct material;
    (E) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (F) Administering dosages of radioactive drugs to patients or human 
research subjects; and
    (2) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Secs. 35.190, 35.290, or 
35.390 or equivalent Agreement State requirements, that the individual 
has satisfactorily completed the requirements in paragraph (c)(1) of 
this section and has achieved a level of competency sufficient to 
function independently as an authorized user for the medical uses 
authorized under Sec. 35.100.


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

    Except for quantities that require a written directive under 
Sec. 35.40(b), a licensee may use any unsealed byproduct material 
prepared for medical use for imaging and localization studies that is--
    (a) Obtained from a manufacturer or preparer licensed under 
Sec. 32.72 of this chapter or equivalent Agreement State requirements; 
or
    (b) Prepared by an authorized nuclear pharmacist, a physician who 
is an authorized user and who meets the requirements specified in 
Secs. 35.290 or 35.390, or an individual under the supervision of 
either as specified in Sec. 35.27;
    (c) Obtained from and prepared by an NRC or Agreement State 
licensee for use in research in accordance with a Radioactive Drug 
Research Committee-approved protocol or an Investigational New Drug 
(IND) protocol accepted by FDA; or
    (d) Prepared by the licensee for use in research in accordance with 
a Radioactive Drug Research Committee-approved application or an 
Investigational New Drug (IND) protocol accepted by FDA.


Sec. 35.204  Permissible molybdenum-99 concentration.

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


Sec. 35.290  Training for imaging and localization studies.

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user of unsealed byproduct material for the uses authorized 
under Sec. 35.200 to be a physician who--

[[Page 20381]]

    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (c) of this 
section and whose certification has been recognized by the Commission 
or an Agreement State; or
    (b) Is an authorized user under Sec. 35.390 or equivalent Agreement 
State requirements; or
    (c)(1) Has completed 700 hours of training and experience in basic 
radionuclide handling techniques applicable to the medical use of 
unsealed byproduct material for imaging and localization studies. The 
training and experience must include, at a minimum,--
    (i) Classroom and laboratory training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use;
    (E) Radiation biology; and
    (ii) Work experience, under the supervision of an authorized user, 
who meets the requirements in Secs. 35.290 or 35.390 or equivalent 
Agreement State requirements, involving--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Calibrating instruments used to determine the activity of 
dosages and performing checks for proper operation of survey meters;
    (C) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (D) Using administrative controls to prevent a medical event 
involving the use of unsealed byproduct material;
    (E) Using procedures to safely contain spilled radioactive material 
and using proper decontamination procedures;
    (F) Administering dosages of radioactive drugs to patients or human 
research subjects; and
    (G) Eluting generator systems appropriate for preparation of 
radioactive drugs for imaging and localization studies, measuring and 
testing the eluate for radionuclidic purity, and processing the eluate 
with reagent kits to prepare labeled radioactive drugs; and
    (2) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Secs. 35.290 or 35.390 or 
equivalent Agreement State requirements, that the individual has 
satisfactorily completed the requirements in paragraph (c)(1) of this 
section and has achieved a level of competency sufficient to function 
independently as an authorized user for the medical uses authorized 
under Secs. 35.100 and 35.200.

Subpart E--Unsealed Byproduct Material--Written Directive Required


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

    A licensee may use any unsealed byproduct material prepared for 
medical use and for which a written directive is required that is--
    (a) Obtained from a manufacturer or preparer licensed under 
Sec. 32.72 of this chapter or equivalent Agreement State requirements; 
or
    (b) Prepared by an authorized nuclear pharmacist, a physician who 
is an authorized user and who meets the requirements specified in 
Secs. 35.290 or 35.390, or an individual under the supervision of 
either as specified in Sec. 35.27; or
    (c) Obtained from and prepared by an NRC or Agreement State 
licensee for use in research in accordance with an Investigational New 
Drug (IND) protocol accepted by FDA; or
    (d) Prepared by the licensee for use in research in accordance with 
an Investigational New Drug (IND) protocol accepted by FDA.


Sec. 35.310  Safety instruction.

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


Sec. 35.315  Safety precautions.

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


Sec. 35.390  Training for use of unsealed byproduct material for which 
a written directive is required.

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user of unsealed byproduct material for the uses authorized 
under Sec. 35.300 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (b) of this 
section and whose certification has been recognized by the Commission 
or an Agreement State; or (b)(1) Has completed 700 hours of training 
and experience in basic radionuclide handling techniques applicable to 
the medical use of unsealed byproduct material requiring a written 
directive. The training and experience must include--
    (i) Classroom and laboratory training in the following areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity;
    (D) Chemistry of byproduct material for medical use; and
    (E) Radiation biology; and

[[Page 20382]]

    (ii) Work experience, under the supervision of an authorized user 
who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), or 
equivalent Agreement State requirements. A supervising authorized user, 
who meets the requirements in Sec. 35.390(b), must have experience in 
administering dosages in the same dosage category or categories (i.e., 
Sec. 35.390(b)(1)(ii)(G)(1), (2), (3), or (4)) as the individual 
requesting authorized user status. The work experience must involve--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Calibrating instruments used to determine the activity of 
dosages, and performing checks for proper operation of survey meters;
    (C) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (D) Using administrative controls to prevent a medical event 
involving the use of unsealed byproduct material;
    (E) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures;
    (F) Eluting generator systems, measuring and testing the eluate for 
radionuclidic purity, and processing the eluate with reagent kits to 
prepare labeled radioactive drugs; and
    (G) Administering dosages of radioactive drugs to patients or human 
research subjects involving a minimum of three cases in each of the 
following categories for which the individual is requesting authorized 
user status--
    (1) Oral administration of less than or equal to 1.22 
Gigabecquerels (33 millicuries) of sodium iodide I-131;
    (2) Oral administration of greater than 1.22 Gigabecquerels (33 
millicuries) of sodium iodide I-131 \2\;
---------------------------------------------------------------------------

    \2\ Experience with at least 3 cases in Category (G)(2) also 
satisfies the requirement in Category (G)(1).
---------------------------------------------------------------------------

    (3) Parenteral administration of any beta emitter or a photon-
emitting radionuclide with a photon energy less than 150 keV; and/or
    (4) Parenteral administration of any other radionuclide; and
    (2) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraph (b)(1) of this 
section and has achieved a level of competency sufficient to function 
independently as an authorized user for the medical uses authorized 
under Sec. 35.300. The written certification must be signed by a 
preceptor authorized user who meets the requirements in Sec. 35.390(a), 
Sec. 35.390(b), or equivalent Agreement State requirements. The 
preceptor authorized user, who meets the requirements in 
Sec. 35.390(b), must have experience in administering dosages in the 
same dosage category or categories (i.e., Sec. 35.390(b)(1)(ii)(G)(1), 
(2), (3), or (4)) as the individual requesting authorized user status.


Sec. 35.392  Training for the oral administration of sodium iodide I-
131 requiring a written directive in quantities less than or equal to 
1.22 Gigabecquerels (33 millicuries).

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user for the oral administration of sodium iodide I-131 
requiring a written directive in quantities less than or equal to 1.22 
Gigabecquerels (33 millicuries), to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (c) of this 
section and whose certification has been recognized by the Commission 
or an Agreement State; or
    (b) Is an authorized user under Sec. 35.390(a), Sec. 35.390(b), for 
uses listed in Sec. 35.390(b)(1)(ii)(G)(1) or (2), Sec. 35.394, or 
equivalent Agreement State requirements; or
    (c)(1) Has successfully completed 80 hours of classroom and 
laboratory training, applicable to the medical use of sodium iodide I-
131 for procedures requiring a written directive. The training must 
include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Chemistry of byproduct material for medical use; and
    (v) Radiation biology; and
    (2) Has work experience, under the supervision of an authorized 
user who meets the requirements in Sec. 35.390(a), Sec. 35.390(b), 
Sec. 35.392, Sec. 35.394, or equivalent Agreement State requirements. A 
supervising authorized user who meets the requirements in 
Sec. 35.390(b), must have experience in administering dosages as 
specified in Sec. 35.390(b)(1)(ii)(G)(1) or (2). The work experience 
must involve--
    (i) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (ii) Calibrating instruments used to determine the activity of 
dosages and performing checks for proper operation for survey meters;
    (iii) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (iv) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (v) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (vi) Administering dosages to patients or human research subjects, 
that includes at least 3 cases involving the oral administration of 
less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium 
iodide I-131; and
    (3) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and 
(c)(2) of this section and has achieved a level of competency 
sufficient to function independently as an authorized user for medical 
uses authorized under Sec. 35.300. The written certification must be 
signed by a preceptor authorized user who meets the requirements in 
Sec. 35.390(a), Sec. 35.390(b), Sec. 35.392, Sec. 35.394, or equivalent 
Agreement State requirements. A preceptor authorized user, who meets 
the requirement in Sec. 35.390(b), must have experience in 
administering dosages as specified in Sec. 35.390(b)(1)(ii)(G)(1) or 
(2).


Sec. 35.394  Training for the oral administration of sodium iodide I-
131 requiring a written directive in quantities greater than 1.22 
Gigabecquerels (33 millicuries).

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user for the oral administration of sodium iodide I-131 
requiring a written directive in quantities greater than 1.22 
Gigabecquerels (33 millicuries), to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (c) of this 
section and whose certification has been recognized by the Commission 
or an Agreement State; or
    (b) Is an authorized user under Sec. 35.390(a), Sec. 35.390(b) for 
uses listed in Sec. 35.390(b)(1)(ii)(G)(2), or equivalent Agreement 
State requirements; or
    (c)(1) Has successfully completed 80 hours of classroom and 
laboratory training, applicable to the medical use of sodium iodide I-
131 for procedures requiring a written directive. The training must 
include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Chemistry of byproduct material for medical use; and
    (v) Radiation biology; and
    (2) Has work experience, under the supervision of an authorized 
user who

[[Page 20383]]

meets the requirements in Sec. 35.390(a), Sec. 35.390(b), Sec. 35.394, 
or equivalent Agreement State requirements. A supervising authorized 
user, who meets the requirements in Sec. 35.390(b), must have 
experience in administering dosages as specified in 
Sec. 35.390(b)(1)(ii)(G)(2). The work experience must involve--
    (i) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (ii) Calibrating instruments used to determine the activity of 
dosages and performing checks for proper operation for survey meters;
    (iii) Calculating, measuring, and safely preparing patient or human 
research subject dosages;
    (iv) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (v) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (vi) Administering dosages to patients or human research subjects, 
that includes at least 3 cases involving the oral administration of 
greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-
131; and
    (3) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and 
(c)(2) of this section and has achieved a level of competency 
sufficient to function independently as an authorized user for medical 
uses authorized under Sec. 35.300. The written certification must be 
signed by a preceptor authorized user who meets the requirements in 
Sec. 35.390(a), Sec. 35.390(b), Sec. 35.394, or equivalent Agreement 
State requirements. A preceptor authorized user, who meets the 
requirements in Sec. 35.390(b), must have experience in administering 
dosages as specified in Sec. 35.390(b)(1)(ii)(G)(2).

Subpart F-- Manual Brachytherapy


Sec. 35.400  Use of sources for manual brachytherapy.

    A licensee shall use only brachytherapy sources for therapeutic 
medical uses:
    (a) As approved in the Sealed Source and Device Registry; or
    (b) In research in accordance with an active Investigational Device 
Exemption (IDE) application accepted by the FDA provided the 
requirements of Sec. 35.49(a) are met.


Sec. 35.404  Surveys after source implant and removal.

    (a) Immediately after implanting sources in a patient or a human 
research subject, the licensee shall make a survey to locate and 
account for all sources that have not been implanted.
    (b) Immediately after removing the last temporary implant source 
from a patient or a human research subject, the licensee shall make a 
survey of the patient or the human research subject with a radiation 
detection survey instrument to confirm that all sources have been 
removed.
    (c) A licensee shall retain a record of the surveys required by 
paragraphs (a) and (b) of this section in accordance with Sec. 35.2404.


Sec. 35.406  Brachytherapy sources accountability.

    (a) A licensee shall maintain accountability at all times for all 
brachytherapy sources in storage or use.
    (b) As soon as possible after removing sources from a patient or a 
human research subject, a licensee shall return brachytherapy sources 
to a secure storage area.
    (c) A licensee shall maintain a record of the brachytherapy source 
accountability in accordance with Sec. 35.2406.


Sec. 35.410  Safety instruction.

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


Sec. 35.415  Safety precautions.

    (a) For each patient or human research subject who is receiving 
brachytherapy and cannot be released under Sec. 35.75, a licensee 
shall--
    (1) Not quarter the patient or the human research subject in the 
same room as an individual who is not receiving brachytherapy;
    (2) Visibly post the patient's or human research subject's room 
with a ``Radioactive Materials'' sign; and
    (3) Note on the door or in the patient's or human research 
subject's chart where and how long visitors may stay in the patient's 
or human research subject's room.
    (b) A licensee shall have applicable emergency response equipment 
available near each treatment room to respond to a source--
    (1) Dislodged from the patient; and
    (2) Lodged within the patient following removal of the source 
applicators.
    (c) A licensee shall notify the Radiation Safety Officer, or his or 
her designee, and an authorized user as soon as possible if the patient 
or human research subject has a medical emergency or dies.


Sec. 35.432  Calibration measurements of brachytherapy sources.

    (a) Before the first medical use of a brachytherapy source on or 
after October 24, 2002, a licensee shall have--
    (1) Determined the source output or activity using a dosimetry 
system that meets the requirements of Sec. 35.630(a);
    (2) Determined source positioning accuracy within applicators; and
    (3) Used published protocols currently accepted by nationally 
recognized bodies to meet the requirements of paragraphs (a)(1) and 
(a)(2) of this section.
    (b) A licensee may use measurements provided by the source 
manufacturer or by a calibration laboratory accredited by the American 
Association of Physicists in Medicine that are made in accordance with 
paragraph (a) of this section.
    (c) A licensee shall mathematically correct the outputs or 
activities determined in paragraph (a) of this section for physical 
decay at intervals consistent with 1 percent physical decay.
    (d) A licensee shall retain a record of each calibration in 
accordance with Sec. 35.2432.


Sec. 35.433  Decay of strontium-90 sources for ophthalmic treatments.

    (a) Only an authorized medical physicist shall calculate the 
activity of

[[Page 20384]]

each strontium-90 source that is used to determine the treatment times 
for ophthalmic treatments. The decay must be based on the activity 
determined under Sec. 35.432.
    (b) A licensee shall retain a record of the activity of each 
strontium-90 source in accordance with Sec. 35.2433.


Sec. 35.457  Therapy-related computer systems.

    The licensee shall perform acceptance testing on the treatment 
planning system of therapy-related computer systems in accordance with 
published protocols accepted by nationally recognized bodies. At a 
minimum, the acceptance testing must include, as applicable, 
verification of:
    (a) The source-specific input parameters required by the dose 
calculation algorithm;
    (b) The accuracy of dose, dwell time, and treatment time 
calculations at representative points;
    (c) The accuracy of isodose plots and graphic displays; and
    (d) The accuracy of the software used to determine sealed source 
positions from radiographic images.


Sec. 35.490  Training for use of manual brachytherapy sources.

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user of a manual brachytherapy source for the uses 
authorized under Sec. 35.400 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (b) of this 
section and whose certification has been recognized by the Commission 
or an Agreement State; or
    (b)(1) Has completed a structured educational program in basic 
radionuclide handling techniques applicable to the use of manual 
brachytherapy sources that includes--
    (i) 200 hours of classroom and laboratory training in the following 
areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (D) Radiation biology; and
    (ii) 500 hours of work experience, under the supervision of an 
authorized user who meets the requirements in Sec. 35.490 or equivalent 
Agreement State requirements at a medical institution, involving--
    (A) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (B) Checking survey meters for proper operation;
    (C) Preparing, implanting, and removing brachytherapy sources;
    (D) Maintaining running inventories of material on hand;
    (E) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (F) Using emergency procedures to control byproduct material; and
    (2) Has obtained 3 years of supervised clinical experience in 
radiation oncology, under an authorized user who meets the requirements 
in Sec. 35.490 or equivalent Agreement State requirements, as part of a 
formal training program approved by the Residency Review Committee for 
Radiation Oncology of the Accreditation Council for Graduate Medical 
Education or the Committee on Postdoctoral Training of the American 
Osteopathic Association. This experience may be obtained concurrently 
with the supervised work experience required by paragraph (b)(1)(ii) of 
this section; and
    (3) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Sec. 35.490 or equivalent 
Agreement State requirements, that the individual has satisfactorily 
completed the requirements in paragraphs (b)(1) and (b)(2) of this 
section and has achieved a level of competency sufficient to function 
independently as an authorized user of manual brachytherapy sources for 
the medical uses authorized under Sec. 35.400.


Sec. 35.491  Training for ophthalmic use of strontium-90.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of strontium-90 for ophthalmic radiotherapy to be a 
physician who--
    (a) Is an authorized user under Sec. 35.490 or equivalent Agreement 
State requirements; or
    (b)(1) Has completed 24 hours of classroom and laboratory training 
applicable to the medical use of strontium-90 for ophthalmic 
radiotherapy. The training must include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (iv) Radiation biology; and
    (2) Supervised clinical training in ophthalmic radiotherapy under 
the supervision of an authorized user at a medical institution that 
includes the use of strontium-90 for the ophthalmic treatment of five 
individuals. This supervised clinical training must involve--
    (i) Examination of each individual to be treated;
    (ii) Calculation of the dose to be administered;
    (iii) Administration of the dose; and
    (iv) Follow up and review of each individual's case history; and
    (3) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Sec. 35.490, Sec. 35.491, 
or equivalent Agreement State requirements, that the individual has 
satisfactorily completed the requirements in paragraphs (a) and (b) of 
this section and has achieved a level of competency sufficient to 
function independently as an authorized user of strontium-90 for 
ophthalmic use.

Subpart G--Sealed Sources for Diagnosis


Sec. 35.500  Use of sealed sources for diagnosis.

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


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

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

Subpart H--Photon Emitting Remote Afterloader Units, Teletherapy 
Units, and Gamma Stereotactic Radiosurgery Units


Sec. 35.600  Use of a sealed source in a remote afterloader unit, 
teletherapy unit, or gamma stereotactic radiosurgery unit.

    A licensee shall use sealed sources in photon emitting remote 
afterloader units, teletherapy units, or gamma stereotactic 
radiosurgery units for therapeutic medical uses:
    (a) As approved in the Sealed Source and Device Registry; or

[[Page 20385]]

    (b) In research in accordance with an active Investigational Device 
Exemption (IDE) application accepted by the FDA provided the 
requirements of Sec. 35.49(a) are met.


Sec. 35.604  Surveys of patients and human research subjects treated 
with a remote afterloader unit.

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


Sec. 35.605  Installation, maintenance, adjustment, and repair.

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


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

    (a) A licensee shall--
    (1) Secure the unit, the console, the console keys, and the 
treatment room when not in use or unattended;
    (2) Permit only individuals approved by the authorized user, 
Radiation Safety Officer, or authorized medical physicist to be present 
in the treatment room during treatment with the source(s);
    (3) Prevent dual operation of more than one radiation producing 
device in a treatment room if applicable; and
    (4) Develop, implement, and maintain written procedures for 
responding to an abnormal situation when the operator is unable to 
place the source(s) in the shielded position, or remove the patient or 
human research subject from the radiation field with controls from 
outside the treatment room. These procedures must include--
    (i) Instructions for responding to equipment failures and the names 
of the individuals responsible for implementing corrective actions;
    (ii) The process for restricting access to and posting of the 
treatment area to minimize the risk of inadvertent exposure; and
    (iii) The names and telephone numbers of the authorized users, the 
authorized medical physicist, and the Radiation Safety Officer to be 
contacted if the unit or console operates abnormally.
    (b) A copy of the procedures required by paragraph (a)(4) of this 
section must be physically located at the unit console.
    (c) A licensee shall post instructions at the unit console to 
inform the operator of--
    (1) The location of the procedures required by paragraph (a)(4) of 
this section; and
    (2) The names and telephone numbers of the authorized users, the 
authorized medical physicist, and the Radiation Safety Officer to be 
contacted if the unit or console operates abnormally.
    (d) A licensee shall provide instruction, initially and at least 
annually, to all individuals who operate the unit, as appropriate to 
the individual's assigned duties, in--
    (1) The procedures identified in paragraph (a)(4) of this section; 
and
    (2) The operating procedures for the unit.
    (e) A licensee shall ensure that operators, authorized medical 
physicists, and authorized users participate in drills of the emergency 
procedures, initially and at least annually.
    (f) A licensee shall retain a record of individuals receiving 
instruction required by paragraph (d) of this section, in accordance 
with Sec. 35.2310.
    (g) A licensee shall retain a copy of the procedures required by 
Secs. 35.610(a)(4) and (d)(2) in accordance with Sec. 35.2610.


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

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

[[Page 20386]]

of all patient treatments involving the unit; and
    (ii) An authorized medical physicist and either an authorized user 
or a physician, under the supervision of an authorized user, who has 
been trained in the operation and emergency response for the unit, to 
be physically present during continuation of all patient treatments 
involving the unit.
    (3) For gamma stereotactic radiosurgery units, require an 
authorized user and an authorized medical physicist to be physically 
present throughout all patient treatments involving the unit.
    (4) Notify the Radiation Safety Officer, or his/her designee, and 
an authorized user as soon as possible if the patient or human research 
subject has a medical emergency or dies.
    (g) A licensee shall have applicable emergency response equipment 
available near each treatment room to respond to a source--
    (1) Remaining in the unshielded position; or
    (2) Lodged within the patient following completion of the 
treatment.


Sec. 35.630  Dosimetry equipment.

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


Sec. 35.632  Full calibration measurements on teletherapy units.

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


Sec. 35.633  Full calibration measurements on remote afterloader units.

    (a) A licensee authorized to use a remote afterloader unit for 
medical use shall perform full calibration measurements on each unit--
    (1) Before the first medical use of the unit;
    (2) Before medical use under the following conditions:
    (i) Following replacement of the source or following reinstallation 
of the unit in a new location outside the facility; and
    (ii) Following any repair of the unit that includes removal of the 
source or major repair of the components associated with the source 
exposure assembly; and
    (3) At intervals not exceeding 1 quarter for high dose-rate, medium 
dose-rate, and pulsed dose-rate remote afterloader units with sources 
whose half-life exceeds 75 days; and
    (4) At intervals not exceeding 1 year for low dose-rate remote 
afterloader units.
    (b) To satisfy the requirement of paragraph (a) of this section, 
full calibration measurements must include, as applicable, 
determination of:
    (1) The output within  5 percent;
    (2) Source positioning accuracy to within 1 millimeter;
    (3) Source retraction with backup battery upon power failure;
    (4) Length of the source transfer tubes;

[[Page 20387]]

    (5) Timer accuracy and linearity over the typical range of use;
    (6) Length of the applicators; and
    (7) Function of the source transfer tubes, applicators, and 
transfer tube-applicator interfaces.
    (c) A licensee shall use the dosimetry system described in 
Sec. 35.630(a) to measure the output.
    (d) A licensee shall make full calibration measurements required by 
paragraph (a) of this section in accordance with published protocols 
accepted by nationally recognized bodies.
    (e) In addition to the requirements for full calibrations for low 
dose-rate remote afterloader units in paragraph (b) of this section, a 
licensee shall perform an autoradiograph of the source(s) to verify 
inventory and source(s) arrangement at intervals not exceeding 1 
quarter.
    (f) For low dose-rate remote afterloader units, a licensee may use 
measurements provided by the source manufacturer that are made in 
accordance with paragraphs (a) through (e) of this section.
    (g) A licensee shall mathematically correct the outputs determined 
in paragraph (b)(1) of this section for physical decay at intervals 
consistent with 1 percent physical decay.
    (h) Full calibration measurements required by paragraph (a) of this 
section and physical decay corrections required by paragraph (g) of 
this section must be performed by the authorized medical physicist.
    (i) A licensee shall retain a record of each calibration in 
accordance with Sec. 35.2632.


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

    (a) A licensee authorized to use a gamma stereotactic radiosurgery 
unit for medical use shall perform full calibration measurements on 
each unit--
    (1) Before the first medical use of the unit;
    (2) Before medical use under the following conditions--
    (i) Whenever spot-check measurements indicate that the output 
differs by more than 5 percent from the output obtained at the last 
full calibration corrected mathematically for radioactive decay;
    (ii) Following replacement of the sources or following 
reinstallation of the gamma stereotactic radiosurgery unit in a new 
location; and
    (iii) Following any repair of the gamma stereotactic radiosurgery 
unit that includes removal of the sources or major repair of the 
components associated with the source assembly; and
    (3) At intervals not exceeding 1 year, with the exception that 
relative helmet factors need only be determined before the first 
medical use of a helmet and following any damage to a helmet.
    (b) To satisfy the requirement of paragraph (a) of this section, 
full calibration measurements must include determination of--
    (1) The output within 3 percent;
    (2) Relative helmet factors;
    (3) Isocenter coincidence;
    (4) Timer accuracy and linearity over the range of use;
    (5) On-off error;
    (6) Trunnion centricity;
    (7) Treatment table retraction mechanism, using backup battery 
power or hydraulic backups with the unit off;
    (8) Helmet microswitches;
    (9) Emergency timing circuits; and
    (10) Stereotactic frames and localizing devices (trunnions).
    (c) A licensee shall use the dosimetry system described in 
Sec. 35.630(a) to measure the output for one set of exposure 
conditions. The remaining radiation measurements required in paragraph 
(b)(1) of this section may be made using a dosimetry system that 
indicates relative dose rates.
    (d) A licensee shall make full calibration measurements required by 
paragraph (a) of this section in accordance with published protocols 
accepted by nationally recognized bodies.
    (e) A licensee shall mathematically correct the outputs determined 
in paragraph (b)(1) of this section at intervals not exceeding 1 month 
for cobalt-60 and at intervals consistent with 1 percent physical decay 
for all other radionuclides.
    (f) Full calibration measurements required by paragraph (a) of this 
section and physical decay corrections required by paragraph (e) of 
this section must be performed by the authorized medical physicist.
    (g) A licensee shall retain a record of each calibration in 
accordance with Sec. 35.2632.


Sec. 35.642  Periodic spot-checks for teletherapy units.

    (a) A licensee authorized to use teletherapy units for medical use 
shall perform output spot-checks on each teletherapy unit once in each 
calendar month that include determination of--
    (1) Timer accuracy, and timer linearity over the range of use;
    (2) On-off error;
    (3) The coincidence of the radiation field and the field indicated 
by the light beam localizing device;
    (4) The accuracy of all distance measuring and localization devices 
used for medical use;
    (5) The output for one typical set of operating conditions measured 
with the dosimetry system described in Sec. 35.630(b); and
    (6) The difference between the measurement made in paragraph (a)(5) 
of this section and the anticipated output, expressed as a percentage 
of the anticipated output (i.e., the value obtained at last full 
calibration corrected mathematically for physical decay).
    (b) A licensee shall perform measurements required by paragraph (a) 
of this section in accordance with written procedures established by 
the authorized medical physicist. That individual need not actually 
perform the spot-check measurements.
    (c) A licensee shall have the authorized medical physicist review 
the results of each spot-check within 15 days. The authorized medical 
physicist shall notify the licensee as soon as possible in writing of 
the results of each spot-check.
    (d) A licensee authorized to use a teletherapy unit for medical use 
shall perform safety spot-checks of each teletherapy facility once in 
each calendar month and after each source installation to assure proper 
operation of--
    (1) Electrical interlocks at each teletherapy room entrance;
    (2) Electrical or mechanical stops installed for the purpose of 
limiting use of the primary beam of radiation (restriction of source 
housing angulation or elevation, carriage or stand travel and operation 
of the beam on-off mechanism);
    (3) Source exposure indicator lights on the teletherapy unit, on 
the control console, and in the facility;
    (4) Viewing and intercom systems;
    (5) Treatment room doors from inside and outside the treatment 
room; and
    (6) Electrically assisted treatment room doors with the teletherapy 
unit electrical power turned off.
    (e) If the results of the checks required in paragraph (d) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning 
system.
    (f) A licensee shall retain a record of each spot-check required by 
paragraphs (a) and (d) of this section, and a copy of the procedures 
required by paragraph (b), in accordance with Sec. 35.2642.

[[Page 20388]]

Sec. 35.643  Periodic spot-checks for remote afterloader units.

    (a) A licensee authorized to use a remote afterloader unit for 
medical use shall perform spot-checks of each remote afterloader 
facility and on each unit--
    (1) Before the first use of a high dose-rate, medium dose-rate, or 
pulsed dose-rate remote afterloader unit on a given day;
    (2) Before each patient treatment with a low dose-rate remote 
afterloader unit; and
    (3) After each source installation.
    (b) A licensee shall perform the measurements required by paragraph 
(a) of this section in accordance with written procedures established 
by the authorized medical physicist. That individual need not actually 
perform the spot check measurements.
    (c) A licensee shall have the authorized medical physicist review 
the results of each spot-check within 15 days. The authorized medical 
physicist shall notify the licensee as soon as possible in writing of 
the results of each spot-check.
    (d) To satisfy the requirements of paragraph (a) of this section, 
spot-checks must, at a minimum, assure proper operation of--
    (1) Electrical interlocks at each remote afterloader unit room 
entrance;
    (2) Source exposure indicator lights on the remote afterloader 
unit, on the control console, and in the facility;
    (3) Viewing and intercom systems in each high dose-rate, medium 
dose-rate, and pulsed dose-rate remote afterloader facility;
    (4) Emergency response equipment;
    (5) Radiation monitors used to indicate the source position;
    (6) Timer accuracy;
    (7) Clock (date and time) in the unit's computer; and
    (8) Decayed source(s) activity in the unit's computer.
    (e) If the results of the checks required in paragraph (d) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning 
system.
    (f) A licensee shall retain a record of each check required by 
paragraph (d) of this section and a copy of the procedures required by 
paragraph (b) of this section in accordance with Sec. 35.2643.


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

    (a) A licensee authorized to use a gamma stereotactic radiosurgery 
unit for medical use shall perform spot-checks of each gamma 
stereotactic radiosurgery facility and on each unit--
    (1) Monthly;
    (2) Before the first use of the unit on a given day; and
    (3) After each source installation.
    (b) A licensee shall--
    (1) Perform the measurements required by paragraph (a) of this 
section in accordance with written procedures established by the 
authorized medical physicist. That individual need not actually perform 
the spot check measurements.
    (2) Have the authorized medical physicist review the results of 
each spot-check within 15 days. The authorized medical physicist shall 
notify the licensee as soon as possible in writing of the results of 
each spot-check.
    (c) To satisfy the requirements of paragraph (a)(1) of this 
section, spot-checks must, at a minimum--
    (1) Assure proper operation of--
    (i) Treatment table retraction mechanism, using backup battery 
power or hydraulic backups with the unit off;
    (ii) Helmet microswitches;
    (iii) Emergency timing circuits; and
    (iv) Stereotactic frames and localizing devices (trunnions).
    (2) Determine--
    (i) The output for one typical set of operating conditions measured 
with the dosimetry system described in Sec. 35.630(b);
    (ii) The difference between the measurement made in paragraph 
(c)(2)(i) of this section and the anticipated output, expressed as a 
percentage of the anticipated output (i.e., the value obtained at last 
full calibration corrected mathematically for physical decay);
    (iii) Source output against computer calculation;
    (iv) Timer accuracy and linearity over the range of use;
    (v) On-off error; and
    (vi) Trunnion centricity.
    (d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of 
this section, spot-checks must assure proper operation of--
    (1) Electrical interlocks at each gamma stereotactic radiosurgery 
room entrance;
    (2) Source exposure indicator lights on the gamma stereotactic 
radiosurgery unit, on the control console, and in the facility;
    (3) Viewing and intercom systems;
    (4) Timer termination;
    (5) Radiation monitors used to indicate room exposures; and
    (6) Emergency off buttons.
    (e) A licensee shall arrange for the repair of any system 
identified in paragraph (c) of this section that is not operating 
properly as soon as possible.
    (f) If the results of the checks required in paragraph (d) of this 
section indicate the malfunction of any system, a licensee shall lock 
the control console in the off position and not use the unit except as 
may be necessary to repair, replace, or check the malfunctioning 
system.
    (g) A licensee shall retain a record of each check required by 
paragraphs (c) and (d) and a copy of the procedures required by 
paragraph (b) of this section in accordance with Sec. 35.2645.


Sec. 35.647  Additional technical requirements for mobile remote 
afterloader units.

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

[[Page 20389]]

Sec. 35.652  Radiation surveys.

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


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

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


Sec. 35.657  Therapy-related computer systems.

    The licensee shall perform acceptance testing on the treatment 
planning system of therapy-related computer systems in accordance with 
published protocols accepted by nationally recognized bodies. At a 
minimum, the acceptance testing must include, as applicable, 
verification of:
    (a) The source-specific input parameters required by the dose 
calculation algorithm;
    (b) The accuracy of dose, dwell time, and treatment time 
calculations at representative points;
    (c) The accuracy of isodose plots and graphic displays;
    (d) The accuracy of the software used to determine sealed source 
positions from radiographic images; and
    (e) The accuracy of electronic transfer of the treatment delivery 
parameters to the treatment delivery unit from the treatment planning 
system.


Sec. 35.690  Training for use of remote afterloader units, teletherapy 
units, and gamma stereotactic radiosurgery units.

    Except as provided in Sec. 35.57, the licensee shall require an 
authorized user of a sealed source for a use authorized under 
Sec. 35.600 to be a physician who--
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraph (b) of this 
section and whose certification has been recognized by the Commission 
or an Agreement State; or
    (b)(1) Has completed a structured educational program in basic 
radionuclide techniques applicable to the use of a sealed source in a 
therapeutic medical unit that includes--
    (i) 200 hours of classroom and laboratory training in the following 
areas--
    (A) Radiation physics and instrumentation;
    (B) Radiation protection;
    (C) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (D) Radiation biology; and
    (ii) 500 hours of work experience, under the supervision of an 
authorized user who meets the requirements in Sec. 35.690 or equivalent 
Agreement State requirements at a medical institution, involving--
    (A) Reviewing full calibration measurements and periodic spot-
checks;
    (B) Preparing treatment plans and calculating treatment doses and 
times;
    (C) Using administrative controls to prevent a medical event 
involving the use of byproduct material;
    (D) Implementing emergency procedures to be followed in the event 
of the abnormal operation of the medical unit or console;
    (E) Checking and using survey meters; and
    (F) Selecting the proper dose and how it is to be administered; and
    (2) Has completed 3 years of supervised clinical experience in 
radiation oncology, under an authorized user who meets the requirements 
in Sec. 35.690 or equivalent Agreement State requirements, as part of a 
formal training program approved by the Residency Review Committee for 
Radiation Oncology of the Accreditation Council for Graduate Medical 
Education or the Committee on Postdoctoral Training of the American 
Osteopathic Association. This experience may be obtained concurrently 
with the supervised work experience required by paragraph (b)(1)(ii) of 
this section; and
    (3) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and 
(b)(2) of this section and has achieved a level of competency 
sufficient to function independently as an authorized user of each type 
of therapeutic medical unit for which the individual is requesting 
authorized user status. The written certification must be signed by a 
preceptor authorized user who meets the requirements in Sec. 35.690 or 
equivalent Agreement State requirements for an authorized user for each 
type of therapeutic medical unit for which the individual is requesting 
authorized user status.

Subpart I--[Reserved]

Subpart J--Training and Experience Requirements


Sec. 35.900  Radiation Safety Officer.

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


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

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized

[[Page 20390]]

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


Sec. 35.920  Training for imaging and localization studies.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a radiopharmaceutical, generator, or reagent kit in 
Sec. 35.200(a) to be a physician who--
    (a) Is certified in--
    (1) Nuclear medicine by the American Board of Nuclear Medicine;
    (2) Diagnostic radiology by the American Board of Radiology;
    (3) Diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology;
    (4) Nuclear medicine by the Royal College of Physicians and 
Surgeons of Canada; or
    (5) American Osteopathic Board of Nuclear Medicine in nuclear 
medicine; or
    (b) Has had classroom and laboratory training in basic radioisotope 
handling techniques applicable to the use of prepared 
radiopharmaceuticals, generators, and reagent kits, supervised work 
experience, and supervised clinical experience as follows--
    (1) 200 hours of classroom and laboratory training that includes--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Radiopharmaceutical chemistry; and
    (v) Radiation biology; and
    (2) 500 hours of supervised work experience under the supervision 
of an authorized user that includes--
    (i) Ordering, receiving, and unpacking radioactive materials safely 
and performing the related radiation surveys;
    (ii) Calibrating dose calibrators and diagnostic instruments and 
performing checks for proper operation of survey meters;
    (iii) Calculating and safely preparing patient or human research 
subject dosages;
    (iv) Using administrative controls to prevent the medical event of 
byproduct material;
    (v) Using procedures to contain spilled byproduct material safely 
and using proper decontamination procedures; and
    (vi) Eluting technetium-99m from generator systems, measuring and 
testing the eluate for molybdenum-99 and alumina contamination, and 
processing the eluate with reagent kits to prepare technetium-99m 
labeled radiopharmaceuticals; and
    (3) 500 hours of supervised clinical experience under the 
supervision of an authorized user that includes--
    (i) Examining patients or human research subjects and reviewing 
their case histories to determine their suitability for radioisotope 
diagnosis, limitations, or contraindications;
    (ii) Selecting the suitable radiopharmaceuticals and calculating 
and measuring the dosages;
    (iii) Administering dosages to patients or human research subjects 
and using syringe radiation shields;
    (iv) Collaborating with the authorized user in the interpretation 
of radioisotope test results; and
    (v) Patient or human research subject follow up; or
    (c) Has successfully completed a 6-month training program in 
nuclear medicine that has been approved by the Accreditation Council 
for Graduate Medical Education and that included classroom and 
laboratory training, work experience, and supervised clinical 
experience in all the topics identified in paragraph (b) of this 
section.


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

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


Sec. 35.932  Training for treatment of hyperthyroidism.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of only iodine-131 for the treatment of hyperthyroidism 
to be a physician with special experience in thyroid disease who has 
had classroom and laboratory training in basic radioisotope

[[Page 20391]]

handling techniques applicable to the use of iodine-131 for treating 
hyperthyroidism, and supervised clinical experience as follows--
    (a) 80 hours of classroom and laboratory training that includes--
    (1) Radiation physics and instrumentation;
    (2) Radiation protection,
    (3) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (4) Radiation biology; and
    (b) Supervised clinical experience under the supervision of an 
authorized user that includes the use of iodine-131 for diagnosis of 
thyroid function, and the treatment of hyperthyroidism in 10 
individuals.


Sec. 35.934  Training for treatment of thyroid carcinoma.

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


Sec. 35.940  Training for use of brachytherapy sources.

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


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

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of only strontium-90 for ophthalmic radiotherapy to be 
a physician who is in the active practice of therapeutic radiology or 
ophthalmology, and has had classroom and laboratory training in basic 
radioisotope handling techniques applicable to the use of strontium-90 
for ophthalmic radiotherapy, and a period of supervised clinical 
training in ophthalmic radiotherapy as follows--
    (a) 24 hours of classroom and laboratory training that includes--
    (1) Radiation physics and instrumentation;
    (2) Radiation protection;
    (3) Mathematics pertaining to the use and measurement of 
radioactivity; and
    (4) Radiation biology;
    (b) Supervised clinical training in ophthalmic radiotherapy under 
the supervision of an authorized user at a medical institution that 
includes the use of strontium-90 for the ophthalmic treatment of five 
individuals that includes--
    (1) Examination of each individual to be treated;
    (2) Calculation of the dose to be administered;
    (3) Administration of the dose; and
    (4) Follow up and review of each individual's case history.


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

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


Sec. 35.960  Training for use of therapeutic medical devices.

    Except as provided in Sec. 35.57, the licensee shall require the 
authorized user of a sealed source listed in Sec. 35.600 to be a 
physician who--
    (a) Is certified in--
    (1) Radiology, therapeutic radiology, or radiation oncology by the 
American Board of Radiology;

[[Page 20392]]

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


Sec. 35.961  Training for authorized medical physicist.

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


Sec. 35.980  Training for an authorized nuclear pharmacist.

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


Sec. 35.981  Training for experienced nuclear pharmacists.

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

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


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

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

Subpart L--Records


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

    (a) A licensee shall retain a record of actions taken by the 
licensee's management in accordance with Sec. 35.24(a) for 5 years. The 
record must include a summary of the actions taken and a signature of 
licensee management.

[[Page 20393]]

    (b) The licensee shall retain a copy of both authority, duties, and 
responsibilities of the Radiation Safety Officer as required by 
Sec. 35.24(e), and a signed copy of each Radiation Safety Officer's 
agreement to be responsible for implementing the radiation safety 
program, as required by Sec. 35.24(b), for the duration of the license. 
The records must include the signature of the Radiation Safety Officer 
and licensee management.


Sec. 35.2026  Records of radiation protection program changes.

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


Sec. 35.2040  Records of written directives.

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


Sec. 35.2041  Records for procedures for administrations requiring a 
written directive

    A licensee shall retain a copy of the procedures required by 
Sec. 35.41(a) for the duration of the license.


Sec. 35.2060  Records of calibrations of instruments used to measure 
the activity of unsealed byproduct material.

    A licensee shall maintain a record of instrument calibrations 
required by Sec. 35.60 for 3 years. The records must include the model 
and serial number of the instrument, the date of the calibration, the 
results of the calibration, and the name of the individual who 
performed the calibration.


Sec. 35.2061  Records of radiation survey instrument calibrations.

    A licensee shall maintain a record of radiation survey instrument 
calibrations required by Sec. 35.61 for 3 years. The record must 
include the model and serial number of the instrument, the date of the 
calibration, the results of the calibration, and the name of the 
individual who performed the calibration.


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

    (a) A licensee shall maintain a record of dosage determinations 
required by Sec. 35.63 for 3 years.
    (b) The record must contain--
    (1) The radiopharmaceutical;
    (2) The patient's or human research subject's name, or 
identification number if one has been assigned;
    (3) The prescribed dosage, the determined dosage, or a notation 
that the total activity is less than 1.1 MBq (30 Ci);
    (4) The date and time of the dosage determination; and
    (5) The name of the individual who determined the dosage.


Sec. 35.2067  Records of leaks tests and inventory of sealed sources 
and brachytherapy sources.

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


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

    A licensee shall retain a record of each survey required by 
Sec. 35.70 for 3 years. The record must include the date of the survey, 
the results of the survey, the instrument used to make the survey, and 
the name of the individual who performed the survey.


Sec. 35.2075  Records of the release of individuals containing unsealed 
byproduct material or implants containing byproduct material.

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


Sec. 35.2080  Records of mobile medical services.

    (a) A licensee shall retain a copy of each letter that permits the 
use of byproduct material at a client's address, as required by 
Sec. 35.80(a)(1). Each letter must clearly delineate the authority and 
responsibility of the licensee and the client and must be retained for 
3 years after the last provision of service.
    (b) A licensee shall retain the record of each survey required by 
Sec. 35.80(a)(4) for 3 years. The record must include the date of the 
survey, the results of the survey, the instrument used to make the 
survey, and the name of the individual who performed the survey.


Sec. 35.2092  Records of decay-in-storage.

    A licensee shall maintain records of the disposal of licensed 
materials, as required by Sec. 35.92, for 3 years. The record must 
include the date of the disposal, the survey instrument used, the 
background radiation level, the radiation level measured at the surface 
of each waste container, and the name of the individual who performed 
the survey.


Sec. 35.2204  Records of molybdenum-99 concentrations.

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


Sec. 35.2310  Records of safety instruction.

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


Sec. 35.2404  Records of surveys after source implant and removal.

    A licensee shall maintain a record of the surveys required by 
Secs. 35.404 and 35.604 for 3 years. Each record must include the date 
and results of the survey, the survey instrument used, and the name of 
the individual who made the survey.

[[Page 20394]]

Sec. 35.2406  Records of brachytherapy source accountability.

    (a) A licensee shall maintain a record of brachytherapy source 
accountability required by Sec. 35.406 for 3 years.
    (b) For temporary implants, the record must include--
    (1) The number and activity of sources removed from storage, the 
time and date they were removed from storage, the name of the 
individual who removed them from storage, and the location of use; and
    (2) The number and activity of sources returned to storage, the 
time and date they were returned to storage, and the name of the 
individual who returned them to storage.
    (c) For permanent implants, the record must include--
    (1) The number and activity of sources removed from storage, the 
date they were removed from storage, and the name of the individual who 
removed them from storage;
    (2) The number and activity of sources not implanted, the date they 
were returned to storage, and the name of the individual who returned 
them to storage; and
    (3) The number and activity of sources permanently implanted in the 
patient or human research subject.


Sec. 35.2432  Records of calibration measurements of brachytherapy 
sources.

    (a) A licensee shall maintain a record of the calibrations of 
brachytherapy sources required by Sec. 35.432 for 3 years after the 
last use of the source.
    (b) The record must include--
    (1) The date of the calibration;
    (2) The manufacturer's name, model number, and serial number for 
the source and the instruments used to calibrate the source;
    (3) The source output or activity;
    (4) The source positioning accuracy within the applicators; and
    (5) The signature of the authorized medical physicist.


Sec. 35.2433  Records of decay of strontium-90 sources for ophthalmic 
treatments.

    (a) A licensee shall maintain a record of the activity of a 
strontium-90 source required by Sec. 35.433 for the life of the source.
    (b) The record must include--
    (1) The date and initial activity of the source as determined under 
Sec. 35.432; and
    (2) For each decay calculation, the date and the source activity as 
determined under Sec. 35.433.


Sec. 35.2605  Records of installation, maintenance, adjustment, and 
repair of remote afterloader units, teletherapy units, and gamma 
stereotactic radiosurgery units.

    A licensee shall retain a record of the installation, maintenance, 
adjustment, and repair of remote afterloader units, teletherapy units, 
and gamma stereotactic radiosurgery units as required by Sec. 35.605 
for 3 years. For each installation, maintenance, adjustment and repair, 
the record must include the date, description of the service, and 
name(s) of the individual(s) who performed the work.


Sec. 35.2610  Records of safety procedures.

    A licensee shall retain a copy of the procedures required by 
Secs. 35.610(a)(4) and (d)(2) until the licensee no longer possesses 
the remote afterloader, teletherapy unit, or gamma stereotactic 
radiosurgery unit.


Sec. 35.2630  Records of dosimetry equipment used with remote 
afterloader units, teletherapy units, and gamma stereotactic 
radiosurgery units.

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


Sec. 35.2632  Records of teletherapy, remote afterloader, and gamma 
stereotactic radiosurgery full calibrations.

    (a) A licensee shall maintain a record of the teletherapy unit, 
remote afterloader unit, and gamma stereotactic radiosurgery unit full 
calibrations required by Secs. 35.632, 35.633, and 35.635 for 3 years.
    (b) The record must include--
    (1) The date of the calibration;
    (2) The manufacturer's name, model number, and serial number of the 
teletherapy, remote afterloader, and gamma stereotactic radiosurgery 
unit(s), the source(s), and the instruments used to calibrate the 
unit(s);
    (3) The results and an assessment of the full calibrations;
    (4) The results of the autoradiograph required for low dose-rate 
remote afterloader units; and
    (5) The signature of the authorized medical physicist who performed 
the full calibration.


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

    (a) A licensee shall retain a record of each periodic spot-check 
for teletherapy units required by Sec. 35.642 for 3 years.
    (b) The record must include--
    (1) The date of the spot-check;
    (2) The manufacturer's name, model number, and serial number of the 
teletherapy unit, source and instrument used to measure the output of 
the teletherapy unit;
    (3) An assessment of timer linearity and constancy;
    (4) The calculated on-off error;
    (5) A determination of the coincidence of the radiation field and 
the field indicated by the light beam localizing device;
    (6) The determined accuracy of each distance measuring and 
localization device;
    (7) The difference between the anticipated output and the measured 
output;
    (8) Notations indicating the operability of each entrance door 
electrical interlock, each electrical or mechanical stop, each source 
exposure indicator light, and the viewing and intercom system and 
doors; and
    (9) The name of the individual who performed the periodic spot-
check and the signature of the authorized medical physicist who 
reviewed the record of the spot-check.
    (c) A licensee shall retain a copy of the procedures required by 
Sec. 35.642(b) until the licensee no longer possesses the teletherapy 
unit.


Sec. 35.2643  Records of periodic spot-checks for remote afterloader 
units.

    (a) A licensee shall retain a record of each spot-check for remote 
afterloader units required by Sec. 35.643 for 3 years.
    (b) The record must include, as applicable--
    (1) The date of the spot-check;
    (2) The manufacturer's name, model number, and serial number for 
the remote afterloader unit and source;
    (3) An assessment of timer accuracy;
    (4) Notations indicating the operability of each entrance door 
electrical interlock, radiation monitors, source exposure indicator 
lights, viewing and intercom systems, and clock and decayed source 
activity in the unit's computer; and
    (5) The name of the individual who performed the periodic spot-
check and

[[Page 20395]]

the signature of the authorized medical physicist who reviewed the 
record of the spot-check.
    (c) A licensee shall retain a copy of the procedures required by 
Sec. 35.643(b) until the licensee no longer possesses the remote 
afterloader unit.


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

    (a) A licensee shall retain a record of each spot-check for gamma 
stereotactic radiosurgery units required by Sec. 35.645 for 3 years.
    (b) The record must include--
    (1) The date of the spot-check;
    (2) The manufacturer's name, model number, and serial number for 
the gamma stereotactic radiosurgery unit and the instrument used to 
measure the output of the unit;
    (3) An assessment of timer linearity and accuracy;
    (4) The calculated on-off error;
    (5) A determination of trunnion centricity;
    (6) The difference between the anticipated output and the measured 
output;
    (7) An assessment of source output against computer calculations;
    (8) Notations indicating the operability of radiation monitors, 
helmet microswitches, emergency timing circuits, emergency off buttons, 
electrical interlocks, source exposure indicator lights, viewing and 
intercom systems, timer termination, treatment table retraction 
mechanism, and stereotactic frames and localizing devices (trunnions); 
and
    (9) The name of the individual who performed the periodic spot-
check and the signature of the authorized medical physicist who 
reviewed the record of the spot-check.
    (c) A licensee shall retain a copy of the procedures required by 
Sec. 35.645(b) until the licensee no longer possesses the gamma 
stereotactic radiosurgery unit.


Sec. 35.2647  Records of additional technical requirements for mobile 
remote afterloader units.

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


Sec. 35.2652  Records of surveys of therapeutic treatment units.

    (a) A licensee shall maintain a record of radiation surveys of 
treatment units made in accordance with Sec. 35.652 for the duration of 
use of the unit.
    (b) The record must include--
    (1) The date of the measurements;
    (2) The manufacturer's name, model number and serial number of the 
treatment unit, source, and instrument used to measure radiation 
levels;
    (3) Each dose rate measured around the source while the unit is in 
the off position and the average of all measurements; and
    (4) The signature of the individual who performed the test.


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

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

Subpart M--Reports


Sec. 35.3045  Report and notification of a medical event.

    (a) A licensee shall report any event, except for an event that 
results from patient intervention, in which the administration of 
byproduct material or radiation from byproduct material results in--
    (1) A dose that differs from the prescribed dose or dose that would 
have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) 
effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 
0.5 Sv (50 rem) shallow dose equivalent to the skin; and
    (i) The total dose delivered differs from the prescribed dose by 20 
percent or more;
    (ii) The total dosage delivered differs from the prescribed dosage 
by 20 percent or more or falls outside the prescribed dosage range; or
    (iii) The fractionated dose delivered differs from the prescribed 
dose, for a single fraction, by 50 percent or more.
    (2) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 
0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose 
equivalent to the skin from any of the following--
    (i) An administration of a wrong radioactive drug containing 
byproduct material;
    (ii) An administration of a radioactive drug containing byproduct 
material by the wrong route of administration;
    (iii) An administration of a dose or dosage to the wrong individual 
or human research subject;
    (iv) An administration of a dose or dosage delivered by the wrong 
mode of treatment; or
    (v) A leaking sealed source.
    (3) A dose to the skin or an organ or tissue other than the 
treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue 
and 50 percent or more of the dose expected from the administration 
defined in the written directive (excluding, for permanent implants, 
seeds that were implanted in the correct site but migrated outside the 
treatment site).
    (b) A licensee shall report any event resulting from intervention 
of a patient or human research subject in which the administration of 
byproduct material or radiation from byproduct material results or will 
result in unintended permanent functional damage to an organ or a 
physiological system, as determined by a physician.
    (c) The licensee shall notify by telephone the NRC Operations 
Center \3\ no later than the next calendar day after discovery of the 
medical event.
---------------------------------------------------------------------------

    \3\ The commercial telephone number of the NRC Operations Center 
is (301) 951-0550.
---------------------------------------------------------------------------

    (d) The licensee shall submit a written report to the appropriate 
NRC Regional Office listed in Sec. 30.6 of this chapter within 15 days 
after discovery of the medical event.
    (1) The written report must include--
    (i) The licensee's name;
    (ii) The name of the prescribing physician;
    (iii) A brief description of the event;
    (iv) Why the event occurred;
    (v) The effect, if any, on the individual(s) who received the 
administration;
    (vi) What actions, if any, have been taken or are planned to 
prevent recurrence; and
    (vii) Certification that the licensee notified the individual (or 
the individual's responsible relative or guardian), and if not, why 
not.

[[Page 20396]]

    (2) The report may not contain the individual's name or any other 
information that could lead to identification of the individual.
    (e) The licensee shall provide notification of the event to the 
referring physician and also notify the individual who is the subject 
of the medical event no later than 24 hours after its discovery, unless 
the referring physician personally informs the licensee either that he 
or she will inform the individual or that, based on medical judgment, 
telling the individual would be harmful. The licensee is not required 
to notify the individual without first consulting the referring 
physician. If the referring physician or the affected individual cannot 
be reached within 24 hours, the licensee shall notify the individual as 
soon as possible thereafter. The licensee may not delay any appropriate 
medical care for the individual, including any necessary remedial care 
as a result of the medical event, because of any delay in notification. 
To meet the requirements of this paragraph, the notification of the 
individual who is the subject of the medical event may be made instead 
to that individual's responsible relative or guardian. If a verbal 
notification is made, the licensee shall inform the individual, or 
appropriate responsible relative or guardian, that a written 
description of the event can be obtained from the licensee upon 
request. The licensee shall provide such a written description if 
requested.
    (f) Aside from the notification requirement, nothing in this 
section affects any rights or duties of licensees and physicians in 
relation to each other, to individuals affected by the medical event, 
or to that individual's responsible relatives or guardians.
    (g) A licensee shall:
    (1) Annotate a copy of the report provided to the NRC with the:
    (i) Name of the individual who is the subject of the event; and
    (ii) Social security number or other identification number, if one 
has been assigned, of the individual who is the subject of the event; 
and
    (2) Provide a copy of the annotated report to the referring 
physician, if other than the licensee, no later than 15 days after the 
discovery of the event.


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

    (a) A licensee shall report any dose to an embryo/fetus that is 
greater than 50 mSv (5 rem) dose equivalent that is a result of an 
administration of byproduct material or radiation from byproduct 
material to a pregnant individual unless the dose to the embryo/fetus 
was specifically approved, in advance, by the authorized user.
    (b) A licensee shall report any dose to a nursing child that is a 
result of an administration of byproduct material to a breast-feeding 
individual that--
    (1) Is greater than 50 mSv (5 rem) total effective dose equivalent; 
or
    (2) Has resulted in unintended permanent functional damage to an 
organ or a physiological system of the child, as determined by a 
physician.
    (c) The licensee shall notify by telephone the NRC Operations 
Center no later than the next calendar day after discovery of a dose to 
the embryo/fetus or nursing child that requires a report in paragraphs 
(a) or (b) in this section.
    (d) The licensee shall submit a written report to the appropriate 
NRC Regional Office listed in Sec. 30.6 of this chapter within 15 days 
after discovery of a dose to the embryo/fetus or nursing child that 
requires a report in paragraphs (a) or (b) in this section.
    (1) The written report must include--
    (i) The licensee's name;
    (ii) The name of the prescribing physician;
    (iii) A brief description of the event;
    (iv) Why the event occurred;
    (v) The effect, if any, on the embryo/fetus or the nursing child;
    (vi) What actions, if any, have been taken or are planned to 
prevent recurrence; and
    (vii) Certification that the licensee notified the pregnant 
individual or mother (or the mother's or child's responsible relative 
or guardian), and if not, why not.
    (2) The report must not contain the individual's or child's name or 
any other information that could lead to identification of the 
individual or child.
    (e) The licensee shall provide notification of the event to the 
referring physician and also notify the pregnant individual or mother, 
both hereafter referred to as the mother, no later than 24 hours after 
discovery of an event that would require reporting under paragraph (a) 
or (b) of this section, unless the referring physician personally 
informs the licensee either that he or she will inform the mother or 
that, based on medical judgment, telling the mother would be harmful. 
The licensee is not required to notify the mother without first 
consulting with the referring physician. If the referring physician or 
mother cannot be reached within 24 hours, the licensee shall make the 
appropriate notifications as soon as possible thereafter. The licensee 
may not delay any appropriate medical care for the embryo/fetus or for 
the nursing child, including any necessary remedial care as a result of 
the event, because of any delay in notification. To meet the 
requirements of this paragraph, the notification may be made to the 
mother's or child's responsible relative or guardian instead of the 
mother. If a verbal notification is made, the licensee shall inform the 
mother, or the mother's or child's responsible relative or guardian, 
that a written description of the event can be obtained from the 
licensee upon request. The licensee shall provide such a written 
description if requested.
    (f) A licensee shall:
    (1) Annotate a copy of the report provided to the NRC with the:
    (i) Name of the pregnant individual or the nursing child who is the 
subject of the event; and
    (ii) Social security number or other identification number, if one 
has been assigned, of the pregnant individual or the nursing child who 
is the subject of the event; and
    (2) Provide a copy of the annotated report to the referring 
physician, if other than the licensee, no later than 15 days after the 
discovery of the event.


Sec. 35.3067  Report of a leaking source.

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

Subpart N--Enforcement


Sec. 35.4001  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued under those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under Section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;

[[Page 20397]]

    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued under the sections 
specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
Section 186 of the Atomic Energy Act of 1954, as amended.


Sec. 35.4002  Criminal penalties.

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

    Dated at Rockville, Maryland, this 16th day of April, 2002.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 02-9663 Filed 4-23-02; 8:45 am]
BILLING CODE 7590-01-P