Medical Use of Byproduct Material-Medical Event Definitions, Training and Experience, and Clarifying Amendments, 42409-42447 [2014-16753]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Proposed Rules]
[Pages 42409-42447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16753]



[[Page 42409]]

Vol. 79

Monday,

No. 139

July 21, 2014

Part III





Nuclear Regulatory Commission





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10 CFR Parts 30, 32, and 35





Medical Use of Byproduct Material--Medical Event Definitions, Training 
and Experience, and Clarifying Amendments; Proposed Rule

Federal Register / Vol. 79 , No. 139 / Monday, July 21, 2014 / 
Proposed Rules

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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 30, 32, and 35

[NRC-2008-0175]
RIN 3150-AI63


Medical Use of Byproduct Material--Medical Event Definitions, 
Training and Experience, and Clarifying Amendments

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to 
amend its regulations related to the medical use of byproduct material. 
In this action the NRC addresses three ongoing rulemaking projects and 
several other related topics. First, this rule proposes amendments to 
the reporting and notification requirements for a medical event for 
permanent implant brachytherapy. Second, the rule proposes changes to 
the training and experience (T&E) requirements for authorized users, 
medical physicists, Radiation Safety Officers, and nuclear pharmacists; 
to the requirements for measuring molybdenum (Mo) contamination and 
reporting of failed technetium and rubidium generators; and to allow 
Associate Radiation Safety Officers to be named on a medical license. 
Third, the rule proposes changes to address a request filed in a 
petition for rulemaking (PRM), PRM-35-20, to exempt certain board-
certified individuals from certain T&E requirements (i.e., 
``grandfather'' these individuals) so they may be identified on a 
license or permit for materials and uses that they performed on or 
before October 24, 2005, the expiration date of the prior T&E 
requirements.

DATES: Submit comments by November 18, 2014. Submit comments specific 
to the information collections aspects of this proposed rule by August 
20, 2014. Comments received after these dates will be considered if it 
is practical to do so, but the NRC is able to assure consideration only 
for comments received on or before these dates.

ADDRESSES: You may submit comments by any one of the following methods 
(unless this document describes a different method for submitting 
comments on a specific subject):
     Federal rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2008-0175. Address 
questions about NRC dockets to Carol Gallagher, telephone: 301-287-
3422, email: Carol.Gallager@nrc.gov. For technical questions, contact 
the individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     Email comments to: Rulemaking.Comments@nrc.gov. If you do 
not receive an automatic email reply confirming receipt, then contact 
us directly at 301-415-1677.
     Fax comments to: Secretary, U.S. Nuclear Regulatory 
Commission at 301-415-1101.
     Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and 
Adjudications Staff.
     Hand deliver comments to: 11555 Rockville Pike, Rockville, 
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal 
workdays; telephone: 301-415-1677.
    For additional direction on accessing information and submitting 
comments, see ``Obtaining Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Neelam Bhalla, Office of Federal and 
State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-
0978, email: Neelam.Bhalla@nrc.gov.

SUPPLEMENTARY INFORMATION: 

Executive Summary

A. Need for the Regulatory Action and Legal Authority

    The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend 
its regulations related to the medical use of byproduct material. These 
regulations were last amended in their entirety in 2002. Over the last 
12 years, stakeholders and members of the medical community have 
identified certain issues in implementing these regulations. As a 
result, the NRC is proposing changes to update its regulations to 
address technological advances and changes in medical procedures. The 
proposed rule would also enhance patient safety. The NRC is proposing 
to revise parts 30, 32, and 35 of Title 10 of the Code of Federal 
Regulations (10 CFR) under the legal authority granted to the NRC by 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 552 and 553.

B. Major Provisions

     The proposed rule would establish separate requirements 
for identifying and reporting medical events (ME) involving permanent 
implant brachytherapy programs. These new regulations would require 
reporting of an event in which there is actual or potential harm to a 
patient resulting from an ME. Additionally, licensees would be required 
to develop, implement, and maintain procedures for determining if an ME 
has occurred, including, for permanent implant brachytherapy, 
procedures for making certain assessments within 60 days from the date 
the treatment was performed;
     Training and experience requirements would be amended in 
multiple sections to remove the requirement to obtain a written 
attestation for an individual who is certified by a specialty board 
whose certification process has been recognized by the NRC or an 
Agreement State. This requirement is being removed because the NRC has 
determined that certification by a specialty board, coupled with 
meeting the recentness of training requirements, is sufficient to 
demonstrate that an individual seeking authorization on a license has 
met the training and experience (T&E) requirements and has the 
requisite current knowledge and that additional attestation by a 
preceptor is therefore unnecessary. Individuals who are not board 
certified would still need to obtain a written attestation; however, 
the language of the attestation would be modified. Additionally, 
residency program directors would be able to provide these written 
attestations;
     The requirements for measuring the Mo-99 concentration for 
elutions of Mo-99m/Tc generators would be changed and reporting 
requirements added for failed Mo-99/Tc-99m and strontium-82 (Sr-82)/Rb-
82 generators. The current requirement to measure the Mo-99 
concentration after the first eluate would be changed to require that 
the Mo-99 concentration be measured in each eluate because of several 
incidents reported to the NRC of breakthrough; and
     Licensees would be allowed to appoint a qualified 
individual with expertise in certain uses of byproduct material to be 
named on a license to serve as an Associate Radiation Safety Officer 
(ARSO). This would make it easier for an individual to become a 
Radiation Safety Officer (RSO) on other medical licenses and would 
increase the number of individuals who would be available to serve as 
preceptors for individuals seeking to be appointed as RSOs or ARSOs.
    Additionally, the proposed rule would address the issues raised in 
a petition for rulemaking (PRM-35-20) that was submitted to the NRC in 
2006. The petition requested that experienced board-certified RSOs and 
medical

[[Page 42411]]

physicists not named on a license who had practiced certain modalities 
prior to October 24, 2005, be exempt from the specific T&E requirements 
in 10 CFR 35.50 and 35.51, respectively. In effect, they would be 
``grandfathered'' for these training requirements for the modalities 
that they practiced as of October 24, 2005. This petition is discussed 
in detail in Section III, Petition for Rulemaking, PRM-35-20, of this 
document.

C. Costs and Benefits

    The NRC has not established a quantitative cutoff for defining an 
economically significant regulatory action. The NRC assumes 
``significant'' impact if the ratio of annualized costs to estimated 
annual gross revenues for a licensee exceeds 1 percent. The proposed 
rule would have an estimated $8.3 million implementation cost for the 
medical community. This cost would be spread over the 7,845 impacted 
licensees for an average implementation cost of approximately $1,100 
per licensee. The NRC assumes that all affected licensees have annual 
revenues greater than $110,000. Therefore, the estimated cost impacts 
do not exceed the 1 percent criterion for ``significant'' impacts, and 
the proposed rule appears not to be an economically significant 
regulatory action. It would cost the NRC approximately $400,000 to 
implement this rule.
    The benefits of this proposed rule are associated with potentially 
reducing unnecessary radiation exposure to patients, potentially 
reducing requirements for T&E, and potentially affording more latitude 
to licensees. The proposed rule would also update, clarify, and 
strengthen the existing regulatory requirements, and thereby promote 
public health and safety.
    A draft regulatory analysis has been developed for this proposed 
rulemaking and is available for public comment (see Section XVI, 
Regulatory Analysis, of this document).

Table of Contents

I. Obtaining Information and Submitting Comments
II. Background
III. Petition for Rulemaking, PRM-35-20
IV. Discussion
    A. What action is the NRC proposing to take?
    B. When would these actions become effective?
    C. Are there any cumulative effects of regulation associated 
with this rule?
    D. Is the NRC requesting comments on other specific issues?
    E. What should I consider as I prepare my comments to the NRC?
V. Discussion of Proposed Amendments by Section
VI. Criminal Penalties
VII. Coordination With NRC Agreement States
VIII. Agreement State Compatibility
IX. Coordination With the Advisory Committee on the Medical Uses of 
Isotopes
X. Plain Writing
XI. Consistency With Medical Policy Statement
XII. Voluntary Consensus Standards
XIII. Environmental Impact: Categorical Exclusion
XIV. Finding of No Significant Environmental Impact: Availability
XV. Paperwork Reduction Act Statement
XVI. Regulatory Analysis
XVII. Regulatory Flexibility Certification
XVIII. Backfitting and Issue Finality

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2008-0175 when contacting the NRC 
about the availability of information for this proposed rule. You may 
access publicly-available information related to this proposed rule by 
any of the following methods:
     Federal Rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2008-0175.
     NRC's Agencywide Documents Access and Management System 
(ADAMS):

You may access publicly-available documents online in the ADAMS Public 
Documents collection at https://www.nrc.gov/reading-rm/adams.html. To 
begin the search, select ``ADAMS Public Documents'' and then select 
``Begin Web-based ADAMS Search.'' For problems with ADAMS, please 
contact the NRC's Public Document Room (PDR) reference staff at 1-800-
397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov. The ADAMS 
accession number for each document referenced in this document (if that 
document is available in ADAMS) is provided the first time that a 
document is referenced.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

B. Submitting Comments

    Please include Docket ID NRC-2008-0175 in the subject line of your 
comment submission, to ensure that the NRC is able to make your comment 
submission available to the public in this docket.
    The NRC cautions you not to include identifying or contact 
information that you do not want to be publicly disclosed in your 
comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into 
ADAMS. The NRC does not routinely edit comment submissions to remove 
identifying or contact information.
    If you are requesting or aggregating comments from other persons 
for submission to the NRC, then you should inform those persons not to 
include identifying or contact information that they do not want to be 
publicly disclosed in their comment submission. Your request should 
state that the NRC does not routinely edit comment submissions to 
remove such information before making the comment submissions available 
to the public or entering the comment submissions into ADAMS.

II. Background

    The NRC published a final rule in the Federal Register on April 24, 
2002 (67 FR 20250), that revised the medical use regulations in part 35 
of Title 10 of the Code of Federal Regulations (10 CFR) in their 
entirety. The training and experience (T&E) requirements in 10 CFR part 
35 were further revised through an additional rulemaking, ``Medical Use 
of Byproduct Material--Recognition of Specialty Boards,'' published in 
the Federal Register on March 30, 2005 (70 FR 16336).
     In implementing the current regulations in 10 CFR part 35, the NRC 
staff, stakeholders, and the Advisory Committee on the Medical Uses of 
Isotopes (ACMUI) have identified numerous issues that need to be 
addressed through the rulemaking process.
    As a result, the NRC is proposing to amend its regulations in 10 
CFR part 35 to address these issues. The proposed rule would modify the 
written directive (WD) requirements in 10 CFR 35.40 and the medical 
event (ME) reporting in 10 CFR 35.3045 to establish separate ME 
reporting criteria for permanent implant brachytherapy. The proposed 
rule would accordingly also modify the requirements for procedures for 
administrations requiring a WD in 10 CFR 35.41 to require licensees to 
develop written procedures for determining if an ME has occurred as a 
result of any administrations requiring a WD, including permanent 
implant brachytherapy.
    Currently, the ME criteria for brachytherapy implants in 10 CFR 
35.3045, ``Report and Notification of a Medical Event,'' are based on 
the dose administered to the patient. The proposed amendment would 
establish separate ME criteria for permanent implant brachytherapy in 
terms of the

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total source strength administered (activity-based) rather than the 
dose delivered (dose-based). The ME criteria would also include 
absorbed doses to normal tissues located outside of the treatment site 
as well as within the treatment site. The proposed amendments are based 
on the staff recommendations contained in SECY-12-0053, 
``Recommendations on Regulatory Changes for Permanent Implant 
Brachytherapy Programs'' (ADAMS Accession No. ML12072A306).
    The NRC previously published a proposed rule, ``Medical Use of 
Byproduct Material--Amendments/Medical Event Definitions,'' to revise 
ME definitions for permanent implant brachytherapy in the Federal 
Register on August 6, 2008 (73 FR 45635), for public comment. The 
majority of commenters were in agreement to convert the ME criteria 
from dose-based to activity-based. However, during late summer and 
early fall of 2008, a substantial number of MEs involving permanent 
implant brachytherapy were reported to the NRC. Based on the 
circumstances involving the MEs reported in 2008, the staff re-
evaluated the previously published proposed rule and developed a 
reproposed rule.
    In SECY-10-0062, ``Reproposed Rule: Medical Use of Byproduct 
Material--Amendments/Medical Event Definitions,'' dated May 18, 2010 
(ADAMS Accession No. ML100890121), the staff requested the Commission 
to approve for publication the revised proposed rule for public 
comment. Prior to Commission voting on the reproposed rule, a 
Commission briefing was held on the reproposed rule on July 8, 2010 
(ADAMS Package Accession No. ML101930532). The presenters included a 
member of the ACMUI, a representative from the Organization of 
Agreement States (OAS), a physician from the American Brachytherapy 
Society, the National Director of the Radiation Oncology Program of the 
Department of Veterans Affairs, a representative from the American 
Association of Physicists in Medicine (AAPM), and a representative from 
Us-TOO (a support group for prostate cancer patients). The presenters 
urged the Commission not to publish the reproposed rule as developed. 
They believed that MEs should be based on events of potential clinical 
significance and recommended that the NRC seek stakeholder input in 
revising this rule.
    In Staff Requirements Memorandum (SRM) SECY-10-0062, dated August 
10, 2010 (ADAMS Accession No. ML102220233), the Commission disapproved 
the staff's recommendation to publish the reproposed rule and directed 
the staff to work closely with the ACMUI and the broader medical and 
stakeholder community to develop ME definitions that would protect the 
interests of patients and allow physicians the flexibility to take 
actions that they deem medically necessary, while continuing to enable 
the agency to detect failures in process, procedure, and training, as 
well as any misapplication of byproduct materials by AUs. The NRC is 
addressing the issues in the reproposed rule (RIN 3150-AI26) in this 
proposed rulemaking; for more information, including public comments 
submitted on the earlier rule, see Docket ID NRC-2008-0071 on 
www.regulations.gov. The SRM also directed the staff to hold a series 
of stakeholder workshops to discuss issues associated with the ME 
definition.
    Following Commission direction, the NRC conducted two workshops in 
the summer of 2011. These facilitated workshops were held in New York, 
New York, in June 2011 (ADAMS Accession No. ML111930470), and in 
Houston, Texas, in August 2011 (ADAMS Accession No. ML112900094). The 
NRC staff also requested the ACMUI to prepare a report on ME 
definitions for permanent implant brachytherapy. In February 2012, the 
ACMUI submitted its final revised report to the NRC (ADAMS Accession No 
ML12038A279). The staff used the recommendations in the ACMUI revised 
final report, along with the substantial input from stakeholders, to 
develop the recommendations in SECY-12-0053, which provided the 
regulatory basis for the ME definitions in this proposed rule.
    In addition to revising the ME definitions for permanent implant 
brachytherapy, the NRC is proposing to amend its regulations in 10 CFR 
part 35 to revise the preceptor attestation requirements, require 
increased frequency of testing for measuring Mo-99 concentration in a 
Mo-99/Tc-99m generator, require reporting of failed tests of a Mo-99/
Tc-99m generator and failed strontium-82 (Sr-82) and strontium-85 (Sr-
85) tests of a Rb-82 generator, allow ARSOs to be named on a medical 
use license, extend the 5-year inspection frequency for a gamma 
stereotactic radiosurgery unit to 7 years, and to make several 
clarifying amendments.
    Finally, the proposed rule would address issues that were raised in 
PRM-35-20 (ADAMS Accession No. ML062620129) filed by E. Russell 
Ritenour, Ph.D., on behalf of the AAPM on September 13, 2006. The 
petition requested that the training requirements for experienced RSOs 
and medical physicists in 10 CFR 35.57 be amended to recognize board 
certified physicists and RSOs as ``grandfathered'' for the modalities 
that they practiced as of October 24, 2005. The following section 
discusses the petition in detail.

III. Petition for Rulemaking, PRM-35-20

    The NRC has incorporated into this proposed rulemaking the 
resolution of PRM-35-20 filed by E. Russell Ritenour, Ph.D. (the 
petitioner), dated September 10, 2006, on behalf of the AAPM. A notice 
of receipt and request for comments on this petition was published in 
the Federal Register on November 1, 2006 (71 FR 64168).
    The petitioner requested that 10 CFR 35.57, ``Training for 
experienced Radiation Safety Officer, teletherapy or medical physicist, 
authorized medical physicist, authorized user, nuclear pharmacist, and 
authorized nuclear pharmacist,'' be revised to: (1) Recognize medical 
physicists certified by either the American Board of Radiology or the 
American Board of Medical Physics on or before October 24, 2005, as 
``grandfathered'' for the modalities that they practiced as of October 
24, 2005, independent of whether or not a medical physicist was named 
on an NRC or an Agreement State license as of October 24, 2005; and (2) 
recognize all diplomates certified by the named boards in former 
subpart J of 10 CFR part 35, which was removed from 10 CFR part 35 in a 
rulemaking dated March 30, 2005 (70 FR 16336), as RSOs who have 
relevant timely work experience (even if they have not been formally 
named as an RSO). The petitioner requested that experienced board-
certified RSOs and medical physicists not named on a license who had 
practiced certain modalities prior to October 24, 2005, be exempted 
from the specific T&E requirements in 10 CFR 35.50, and 35.51, 
respectively. In effect, they would be ``grandfathered'' for these 
training requirements for the modalities that they practiced as of 
October 24, 2005. The petitioner was concerned that as a result of the 
amendments to the T&E regulations in 2005, an individual could become 
authorized on a license only if he or she had been certified by a 
specialty board whose certification process was recognized under the 
new regulations by the NRC or an Agreement State or was already 
identified on an existing NRC or Agreement State license. If the 
individual had been certified prior to the effective date for 
recognition of the certifying board but had not been listed on a 
license, he or she would not be ``grandfathered,'' and would have to 
obtain training through

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the so-called ``alternate pathway,'' which establishes the specific 
training requirements for the non-certified individuals. The petitioner 
did not believe that it was the intent of the Commission to deny 
recognition to individuals currently practicing or to minimize the 
importance of certification by a certifying board. The NRC received 168 
comments from professional organizations and individuals on the 
petition. The majority of the commenters supported the petition.
    The NRC reviewed the petitioner's request and comments received on 
the petition and concluded that revisions made to the regulations in 
2005 may have inadvertently affected a group of board certified 
professionals insofar as they may now have to use the alternate pathway 
option to demonstrate that they meet the T&E requirements in 10 CFR 
part 35 rather than the certification pathway for recognition on an NRC 
license as an RSO or an authorized medical physicist (AMP) (73 FR 
27773; May 14, 2008). Therefore, the NRC concluded that the issues 
raised in the petition would be considered in the rulemaking process if 
a regulatory basis could be developed to support a rulemaking.
    In October 2008, the NRC staff sent letters to all of the 
certifying boards whose certification processes are currently 
recognized by the NRC and to certifying boards previously named in the 
former 10 CFR part 35, subpart J, whose certification processes 
currently are not recognized by the NRC. To determine the scope of the 
medical community that might be negatively impacted by the T&E 
grandfathering provisions of the regulations, the NRC asked each 
organization to provide the number and percentage of its currently 
active diplomates who are not grandfathered under 10 CFR 35.57 by 
virtue of not being named on a license or permit. The organizations 
were asked to include individuals who are now or may in the future be 
seeking to be named as an RSO, AMP, AU, or authorized nuclear 
pharmacist (ANP) on an NRC or an Agreement State medical use license. 
Based on the responses, the NRC estimates that as many as 10,000 board 
certified individuals may have been affected by the 2005 T&E 
rulemaking.
    Accordingly, the NRC believes that these individuals should be 
eligible for grandfathering for the modalities that they practiced as 
of October 24, 2005, and that their previously-acceptable 
qualifications for authorized status should continue to be adequate and 
acceptable from a health and safety standpoint such as to allow them to 
continue to practice using the same modalities. This proposed rule, in 
response to the petition, would amend Sec.  35.57 to recognize all 
individuals that were previously certified by boards recognized under 
the previous 10 CFR part 35, subpart J, as RSOs, teletherapy or medical 
physicists, AMPs, AUs, nuclear pharmacists, and ANPs for the modalities 
that they practiced as of October 24, 2005.
    The petitioner, in his support for ``grandfathering'' the RSOs who 
have relevant work experience and were not formally named on an NRC or 
an Agreement State license or permit as an RSO, stated that these 
individuals will be required to provide preceptor attestations. In this 
proposed rulemaking, the NRC would eliminate the requirement for 
preceptor attestations for all individuals certified by NRC recognized 
boards. The NRC believes that attestations are not necessary in this 
particular situation because the provisions of Sec.  35.59, 
``Recentness of training,'' require that the T&E 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 T&E was completed. The ``grandfathered'' individuals 
would fall under the provisions of Sec.  35.59 and would need to 
provide evidence of continued education and experience. Therefore, the 
NRC believes that preceptor attestations are not warranted for these 
``grandfathered'' individuals so long as the provisions of Sec.  35.59 
are met and the individual requests authorizations only for the 
modalities the individual practiced as of October 24, 2005.

IV. Discussion

A. What action is the NRC proposing to take?

    In implementing the current regulations in 10 CFR part 35, the NRC 
staff, stakeholders, and the ACMUI identified numerous issues that need 
to be addressed through the rulemaking process. The proposed revisions 
would clarify the current regulations, and provide greater flexibility 
to licensees without compromising patient, worker, and public health 
and safety. The proposed amendments include:
    a. Adding separate ME definitions for permanent implant 
brachytherapy.
    b. Amending preceptor attestation requirements.
    c. ``Grandfathering'' certain board-certified individuals (PRM-35-
20) discussed in Section III, Petition for Rulemaking, PRM-35-20, of 
this document.
    d. Requiring increased frequency of testing to measure Mo-99 
breakthrough.
    e. Requiring reporting and notification of failed Mo-99/Tc-99m and 
Sr-82/Rb-82 generators.
    f. Allowing ARSOs to be named on a medical use license.
    g. Additional issues and clarifications.
    Early public input on this proposed rule was solicited through 
various mechanisms. For certain amendments the NRC posted preliminary 
draft rule text (ADAMS Accession No. ML111390420) for a 75-day comment 
period on www.regulations.gov. The availability of the draft rule 
language was noticed in the Federal Register on May 20, 2011 (76 FR 
29171). The NRC received 10 comment letters, which are also posted on 
www.regulations.gov under Docket ID NRC-2008-0175. The NRC staff 
reviewed the comments and considered them in developing the proposed 
rule text.
    The proposed amendments and preliminary draft rule text were also 
discussed at the two transcribed facilitated public workshops that were 
conducted in New York City, New York, on June 20-21, 2011, and in 
Houston, Texas, on August 11-12, 2011. The purpose of the workshops was 
to solicit key stakeholder input on topics associated with definition 
of an ME, including the requirements for reporting and notifications of 
MEs for permanent implant brachytherapy, and on other medical issues 
that are being considered in the proposed rulemaking. These workshops 
were initiated as a result of the Commission's direction to staff in 
SRM-SECY-10-0062 to work closely with the ACMUI and the medical 
community to develop event definitions that would protect the interests 
of patients. The Commission also directed that these definitions should 
allow physicians the flexibility to take actions that they deem 
medically necessary, while preserving the NRC's ability to detect 
misapplications of radioactive material and failures in processes, 
procedures, and training. The panelists for the workshops included 
representation from the ACMUI, Agreement States, professional 
societies, and a patients' rights advocate.
    The major proposed revisions are:
a. Adding Separate ME Definitions for Permanent Implant Brachytherapy
    The proposed rule would establish separate ME definitions and 
reporting requirements for permanent implant brachytherapy programs. As 
explained in Section II, Background, of this document, the proposed 
amendments are based on the recommendations developed in close 
cooperation with the

[[Page 42414]]

ACMUI, as well as with substantial input from various stakeholders. 
During its meeting in March 2004, the ACMUI recognized the existing 
inadequacy of defining MEs with regard to permanent implant 
brachytherapy. The ACMUI explained that for these implants, the plus or 
minus 20 percent variance from the prescription criterion in the 
existing rule was only appropriate if both the prescription and the 
variance could be expressed in units of activity, rather than in units 
of dose, as there is no suitable clinically used dose metric available 
for judging the occurrence of MEs. In June 2005, the ACMUI recommended 
that new language should be developed to define MEs related to 
permanent implant brachytherapy.
    In SECY-05-0234, ``Adequacy of Medical Event Definitions in 10 CFR 
35.3045, and Communicating Associated Risks to the Public,'' dated 
December 27, 2005 (ADAMS Accession No. ML053180408), based on 
recommendations received from the ACMUI, the staff recommended that for 
permanent implant brachytherapy the Commission approve the staff's plan 
to revise the ME definitions and the associated requirements for WDs to 
be activity-based, instead of dose-based. In SRM-SECY-05-0234, dated 
February 15, 2006 (ADAMS Accession No. ML060460594), the Commission 
directed the staff to proceed directly with the development of a 
proposed rule to modify both the WD requirements in 10 CFR 35.40(b)(6) 
and the ME reporting requirements in 10 CFR 35.3045 for permanent 
implant brachytherapy medical use, to convert from dose-based to 
activity-based ME criteria.
    As discussed in Section II, Background, of this document, a 
proposed rule was published in the Federal Register on August 6, 2008 
(73 FR 45635). Due to the substantial number of MEs reported in 2008, 
the staff submitted a reproposed rule to the Commission for 
consideration in May of 2010. However, the Commission disapproved the 
staff's recommendations and directed the staff to work closely with the 
ACMUI and the broader medical and stakeholder community to develop ME 
definitions and to hold a series of stakeholder workshops to discuss 
issues associated with the MEs.
    The ACMUI Permanent Implant Brachytherapy Subcommittee (PIBS) 
issued a report, with recommendations, which was unanimously approved 
by the ACMUI at its October 20, 2010, meeting (ADAMS Accession No. 
ML103540385). The PIBS report included the caveat that it was to be 
considered an interim report and that it might be revised in response 
to additional stakeholder input. The ACMUI meeting in April 2011 was 
devoted to issues associated with the ME definition. The meeting was 
webcast, providing an opportunity for further public involvement on 
this issue.
    The ACMUI final report (ADAMS Accession No. ML11292A139), which 
revised the earlier interim report on prostate brachytherapy 
regulation, was provided to the NRC following the ACMUI October 18, 
2011, teleconference public meeting. The final report reflected the 
principal positions and recommendations provided by participants during 
the NRC public workshops; in particular, the report included the 
recommendation to change from dose-based ME criteria for the treatment 
site to source-strength based criteria. The final report included a 
quantitative metric, the ``octant approach,'' for determining that a 
distribution of implanted sources was irregular enough (i.e., 
demonstrating ``bunching'') to consider the procedure as an ME. The 
final report also included a dose-related ME criterion for the 
treatment site.
    However, in a letter to the Chairman of the ACMUI dated November 
30, 2011 (ADAMS Accession No. ML11341A051), the American Society for 
Radiation Oncology (ASTRO) expressed criticism of the ACMUI final 
report. The ASTRO considered the ME definition recommended by the ACMUI 
to be complex, difficult to regulate, and likely to cause confusion in 
practice. Consequently, a revised final report (ADAMS Accession No. 
ML12038A279) that simplified the ME criteria for the treatment site, 
and removed the ``octant approach'' and direct reference to absorbed 
dose, was issued by the PIBS. The revised final report was, with minor 
modification, approved by the ACMUI during its February 7, 2012, 
teleconference public meeting and was subsequently, in a letter to the 
Chairman of the ACMUI (ADAMS Accession No. ML12044A358), characterized 
as an improvement by ASTRO.
    The staff used the recommendations in the ACMUI revised final 
report, along with the substantial input from stakeholders gathered in 
the two facilitated public workshops and the three ACMUI public 
meetings in 2011 and early 2012, to develop the recommendations 
conveyed to the Commission on April 6, 2012, in SECY-12-0053. In a 
Commission meeting held April 24, 2012 (ADAMS Accession No. 
ML12116A294), participating representatives from ACMUI, ASTRO, and 
American Brachytherapy Society (ABS) endorsed the recommendations for 
modification of the requirements in 10 CFR 35.40 and 35.3045 that are 
contained in SECY-12-0053. The NRC notes that ASTRO and ABS 
representatives suggested eliminating the criterion for ME reporting, 
which requires reporting of excessive dose to normal tissue structures 
within the treatment site. However, this ACMUI-recommended ME reporting 
criterion for normal tissue structures located within the treatment 
site was retained in SECY-12-0053 because ACMUI and the staff 
determined there needs to be some form of ME reporting criterion for 
overdosing of normal tissue structures located within the treatment 
site.
    The ACMUI recommendations, as approved by the Commission in SRM-
SECY-12-0053, ``Recommendations on Regulatory Changes for Permanent 
Implant Brachytherapy Programs'' (ADAMS Accession No. ML122260211), are 
applicable to all permanent implant brachytherapy procedures using 
radioactive sources for all treatment sites.
    Consistent with the ACMUI recommendations, all of the proposed ME 
criteria reflect circumstances in which there is actual or potential 
harm to a patient resulting from an ME. The proposed ME criteria are 
primarily source-strength based for the treatment site, and dose-based 
for the absorbed dose to normal tissues. The proposed ME criteria for 
permanent implant brachytherapy are:
    (1) For the treatment site (documented in the pre-implantation 
portion of the WD), an ME has occurred if 20 percent or more of the 
implanted sources documented in the post-implantation portion of the WD 
are located outside of the intended implant location.
    In supporting this recommendation, the NRC believes that source 
strength/positioning is the measurable metric/surrogate for dose, as 
related to harm/potential harm for permanent brachytherapy implant MEs. 
The 20 percent variance limit (from physician intention) is consistent 
with the recommendation of the ACMUI for all medical uses of byproduct 
material as described in SECY-05-0234.
    (2) For normal-tissue structures, an ME has occurred if: (a) For 
structures located outside of the treatment site (for example the 
bladder or rectum for prostate implant treatments), the dose to the 
maximally exposed 5 contiguous cubic centimeters of tissue exceeds 150 
percent of the absorbed dose prescribed to the treatment site in the 
pre-implantation portion of the WD; or (b) for intra-target normal 
structures, the

[[Page 42415]]

maximum absorbed dose to any 5 contiguous cubic centimeters of tissue 
exceeds 150 percent of the dose the tissue would have received based on 
the approved pre-implant dose distribution.
    The size of the normal tissue, 5 cubic centimeters, is based on 
ACMUI's recommendation in its report. In its recommendation, the ACMUI 
stated that the 5 contiguous cubic centimeters dose-volume 
specification avoids the high variation in dose sometimes seen in point 
doses and has cited literature to support that as being a relevant 
quantity for toxicity. In this proposed rule, the NRC is specifically 
inviting comments on the selection of the specified volume of the 
normal tissues located both outside and within the treatment site in 
defining MEs.
    The proposed rule specifies that these dose determinations must be 
made within 60 days from the date the treatment was administered unless 
accompanied by written justification about patient unavailability after 
treatment. The NRC believes that 60 days provides adequate time to make 
implanted source location and dose assessments to determine if an ME 
has occurred. The AAPM, in its Task Group Report 137, entitled, ``AAPM 
recommendations on dose prescription and reporting methods for 
permanent interstitial brachytherapy for prostate cancer,'' recommends 
that post-implant dosimetry for iodine-125 implants should be performed 
at 1 month (plus or minus 1 week) after the procedure. For palladium-
103 and cesium-131 implants, it recommends that post-implant dosimetry 
be performed at 16 (plus or minus 4) days and 10 (plus or minus 2) 
days, respectively. The 60-day time limit is also consistent with the 
ACMUI recommendation. The NRC recognizes that some patients may not be 
able to return to the treatment center for the dose assessment, and the 
proposed rule addresses that concern by adding ``unless accompanied by 
written justification about patient unavailability.''
    Because of this dose-based ME criterion for organs and tissues 
other than the treatment site, there is an implicit operational 
requirement for post-implant imaging, as strongly recommended during 
the public workshops and as practiced in most clinical facilities.
    (3) An ME has occurred if a treatment involves: (a) Using the wrong 
radionuclide; (b) delivery to the wrong patient or human research 
subject; (c) source(s) implanted directly into the wrong site or body 
part, i.e., not in the treatment site identified in the WD; (d) using 
leaking sources; or (e) a 20 percent or more error in calculating the 
total source strength documented in the pre-implantation WD (plus or 
minus 20 percent is used for the ME threshold for source strength 
variance because plus or minus 10 percent is considered too close to 
the actual variance associated with this quantity in clinically 
acceptable implant procedures).
    The proposed criterion related to sources implanted directly into 
the wrong site or body part (i.e., not in the treatment site identified 
in the WD) directly reflects an ACMUI recommendation. Note that the 
proposed criterion would require that even a single sealed source 
directly delivered to the wrong treatment site would constitute an ME 
that must be reported. However, this proposed criterion is not more 
restrictive than the current regulation, which requires reporting of a 
dose of 0.5 sievert (50 rem) to an organ or tissue, since the localized 
dose associated with even one misplaced source would far exceed the 
current 0.5 sievert (50 rem) dose threshold.
    The current WD requirements for manual brachytherapy in Sec.  
35.40(b)(6) primarily reflect requirements associated with temporary 
implant brachytherapy medical use. The WD requirements in Sec.  35.40 
would be amended to establish separate WD requirements appropriate for 
permanent implant brachytherapy. The WD for permanent implant 
brachytherapy would consist of two portions: The first portion of the 
WD would be prepared before the implantation, and the second portion of 
the WD would be completed after the procedure, but before the patient 
leaves the post-treatment recovery area. For permanent implant 
brachytherapy, the WD portion prepared before the implantation would 
require documentation of the treatment site, the radionuclide, the 
intended absorbed dose to the treatment site, and the corresponding 
calculated source strength to deliver that dose. If the treatment site 
has normal tissues located within it, the WD would also allow 
documentation of the expected absorbed dose to normal tissue as 
determined by the AU. The post-implantation portion of the WD would 
require the documentation of the number of sources implanted, the total 
source strength implanted, the signature of an AU for Sec.  35.400 uses 
for manual brachytherapy, and the date. It would not require the 
documentation of dose to the treatment site.
    Based on ACMUI input and information gained at public workshops, 
the NRC understands that the final WD documentation related to these 
Sec.  35.40 permanent implants must reflect the medical situation 
encountered during the surgical procedure. Therefore, in defining an ME 
involving the treatment site for permanent implants, the NRC based the 
criterion for an ME on the percentage of implanted sources that are 
outside the treatment site as documented in the post-implantation 
portion of the WD rather than defining an ME based on a comparison of 
the implanted total source strength to the calculated total source 
strength documented in the pre-implantation portion of the WD. This 
proposed definition differs from the ME definition for all other 
brachytherapy procedures where the dose comparisons are made with what 
was prescribed in the WD prepared/revised before the procedure.
    Conforming changes would be made to Sec.  35.41, ``Procedures for 
administrations requiring a written directive,'' to include permanent 
implant brachytherapy. Although the current Sec.  35.41(a)(2) requires 
licensees to determine if the administration is in accordance with the 
written directive, there is no specific requirement that a licensee 
determine that an administered dose or dosage has met an ME criterion 
defined in Sec.  35.3045. The ME reporting criteria are defined in 
Sec.  35.3045, but the current regulations do not require that a 
licensee have procedures to make that determination. Section 35.41 
would be amended to require that a licensee include procedures for 
determining if an ME has occurred. For all permanent implant 
brachytherapy, this section would also be amended to require that a 
licensee develop additional procedures to include an evaluation of the 
placement of sources as documented in the completion portion of the WD, 
dose assessments to maximally exposed 5 contiguous cubic centimeters of 
normal tissue located both inside and outside of the treatment site, 
and to include that these assessments be made within 60 days from the 
date the treatment was performed.
    Currently Sec.  35.3045, Report and notification of a medical 
event, is designated as Compatibility Category C for the Agreement 
States. Input provided at the public meetings conducted in New York 
City, New York, on June 20-21, 2011, and in Houston, Texas, on August 
11-12, 2011, and from the ACMUI prompted the NRC to revisit 
compatibility category. The Commission, after considering the issue, is 
proposing that the compatibility for reporting MEs for the Agreement 
States be designated as a Compatibility Category B.
    Additional information on Agreement State compatibility 
designations can be

[[Page 42416]]

found in Section VIII, Agreement State Compatibility, of this document.
b. Amending Preceptor Attestation Requirements
    The current regulations in 10 CFR part 35 provide three pathways 
for individuals to satisfy T&E requirements to be approved as an RSO, 
AMP, ANP, or AU. These pathways are: (1) Approval of an individual who 
is certified by a specialty board whose certification process has been 
recognized by the NRC or an Agreement State (certification pathway); 
(2) approval based on an evaluation of an individual's T&E (alternate 
pathway); or (3) identification of an individual's approval on an 
existing NRC or Agreement State license.
    Under both the certification and the alternate pathway, an 
individual seeking authorization for medical byproduct material must 
obtain written attestation signed by a preceptor with the same 
authorization. The attestation must state that the individual has 
satisfactorily completed the necessary T&E requirements and has 
achieved a level of competency sufficient to function independently in 
the position for which authorization is sought.
    During a briefing held on April 29, 2008 (ADAMS Accession No. 
ML12116A294), with the Commission, the ACMUI recommended that the 
attestation requirements be revised. The ACMUI expressed concern that 
the existing requirements have had unintended consequences that, if not 
corrected, would impact the availability of authorized individuals; 
i.e., there would likely be a shortage of authorized individuals to 
provide medical care as a result of the reluctance of preceptors to 
sign attestations. The ACMUI recommended that attestations be 
eliminated for the board certification pathway. In the ACMUI's view, by 
meeting the board requirements, a curriculum and a body of knowledge 
can be defined, and progress toward meeting defined requirements can be 
measured. Further, the ACMUI asserted that a board certification 
indicates that the T&E requirements have been met, and the Maintenance 
of Certification provides ongoing evidence of current knowledge. 
Therefore, the ACMUI argued that an additional attestation for the 
board certified individuals was not needed.
    The ACMUI also recommended that the attestation requirements 
associated with the alternate pathways be modified to delete the 
requirement for an attestation of an individual's radiation safety-
related competency being sufficient to function independently as an 
authorized person for the medical uses being requested. The reason for 
the recommendation was that the ACMUI believed that signing an 
attestation of competence results in a perceived risk of personal 
liability on the part of the individual signing the attestation and 
that preceptors are reluctant to accept this risk.
    In addition, the ACMUI recommended that the attestation submitted 
under the alternate pathway be considered acceptable if provided by a 
residency program director representing a consensus of an authoritative 
group, irrespective of whether the program director personally met the 
requirements for authorized user status. The ACMUI advised that 
training of residents is a collective process and entails the 
collective judgment of an entire residency program faculty, whereas 
preceptor attestation is an individual process, and an individual 
preceptor typically would provide only a small portion of the T&E.
    Following the April 29, 2008, meeting of the ACMUI, in an SRM dated 
May 15, 2008 (ADAMS Accession No. ML081360319), the Commission directed 
the staff to work with the ACMUI and the Agreement States to provide 
recommendations to the Commission with regard to amending the NRC's 
requirements for preceptor attestation for both board certified 
individuals and for individuals seeking authorization via the alternate 
pathway. The staff was also directed to consider additional methods, 
such as the attestation being provided by consensus of an authoritative 
group.
    Following both consideration of the position of the ACMUI, which 
the staff determined was clear and consistent with its long-held 
position on this issue, and interactions with regional NRC staff and 
the Agreement States, the staff provided its recommendations on this 
issue to the Commission on November 20, 2008, in SECY-08-0179, 
``Recommendations on Amending Preceptor Attestation Requirements in 10 
CFR part 35, Medical Use of Byproduct Material'' (ADAMS Accession No. 
ML083170176). The staff recommended that the Commission approve 
development of the following modifications to the 10 CFR part 35 
attestation requirements: (1) Eliminate the attestation requirement for 
individuals seeking authorized status via the board certification 
pathway; (2) retain the attestation requirement for individuals seeking 
authorized status via the alternate pathways; however, replace the text 
stating that the attestation demonstrates that the individual ``has 
achieved a level of competency to function independently'' with 
alternative text such as ``has demonstrated the ability to function 
independently'' to fulfill the radiation safety-related duties required 
by the license; and (3) accept attestations from residency program 
directors, representing consensus of residency program faculties as 
long as at least one member of the residency program faculty is an 
authorized individual in the same category as that requested by the 
applicant seeking authorized status.
    In an SRM dated January 16, 2009, to SECY-08-0179 (ADAMS Accession 
No. ML090160275), the Commission approved these recommendations and 
directed the staff to develop the proposed rule language for the 
attestation requirements for the alternate pathway in concert with the 
ACMUI and the Agreement States.
    The proposed changes to remove the attestation requirement for 
board certified individuals were broadly supported during the public 
workshops conducted in the summer of 2011. The panelists (which 
included members of the ACMUI and the Agreement States) at the 
workshops recommended that the NRC should remove the requirement for 
attestation for board certified individuals. They believed that board 
certification coupled with the recentness of training requirements 
should be sufficient for the regulator's needs. With regard to the 
language of attestation (for the alternate pathway), they believed that 
the preceptors should not be attesting to someone's competency; rather, 
they should be attesting to the individual's T&E necessary to carry out 
one's responsibility independently. At the April 2011 ACMUI meeting, 
the ACMUI advised that the attestation language should be revised to 
say that the individual has received the requisite T&E to fulfill the 
radiation safety-related duties required by the license. The proposed 
rule language reflects this approach.
    The proposed rule would amend T&E requirements in multiple sections 
of 10 CFR part 35 with regard to the attestation requirements in 
accordance with the staff's recommendations in SECY-08-0179.
c. Extending Grandfathering to Certain Certified Individuals (PRM-35-
20)
    The petition is discussed in Section III, Petition for Rulemaking 
(PRM-35-20), of this document.

[[Page 42417]]

d. Requiring Increased Frequency of Testing To Measure Mo-99 
Breakthrough
    Current regulations in Sec.  35.204(a) prohibit a licensee from 
administering a radiopharmaceutical to humans that exceeds 0.15 
microcuries of Mo-99 per millicurie of Tc99m. Section 35.204(b) 
requires that a licensee that uses Mo-99/Tc-99m generators for 
preparing a Tc-99m radiopharmaceutical measure the Mo-99 concentration 
of the first eluate to demonstrate compliance with the specified 
concentrations; however a generator can be eluted several times to 
obtain Tc-99m for formulating radiopharmaceuticals for patient use.
    The Mo-99 breakthrough, which exceeds the permissible concentration 
listed in Sec.  35.204(a), may cause unnecessary radiation exposures to 
patients. The administration of higher levels of Mo-99 could 
potentially affect health and safety, as well as have an adverse effect 
on nuclear medicine image quality and medical diagnosis.
    Generator manufacturers have always recommended testing each 
elution prior to use in humans. Before 2002, Sec.  35.204 required a 
licensee to measure the Mo-99 concentration of each eluate. However, 
the NRC revised Sec.  35.204 in April 2002 because the medical and 
pharmaceutical community considered frequency of Mo breakthrough to be 
a rare event. Therefore, the Commission decided that measuring only the 
first elution was necessary to detect manufacturing issues or 
generators that may have been damaged in transport.
    From October 2006 to February 2007, and again in January 2008, 
medical licensees reported to the NRC that numerous generators had 
failed the Mo-99 breakthrough tests. Some licensees reported the failed 
tests in the first elution, while some reported an acceptable first 
elution but failed subsequent elutions. One generator manufacturer 
voluntarily reported 116 total elution test failures in 2008. Based 
upon the numerous reports of failed Mo-99 breakthrough measurements 
noted in the subsequent elutions, the NRC proposes to amend Sec.  
35.204 to return to the pre-2002 performance standard, which required 
licensees to measure the Mo-99 concentration for each elution of the 
Mo-99/Tc-99m generator.
e. Requiring Reporting and Notification of Failed Mo-99/Tc-99m and Sr-
82/Rb-82 Generators
    The regulations do not currently require reporting to the NRC when 
an elution from a Mo-99/Tc-99m or Sr-82/Rb-82 generator exceeds the 
regulatory limit in Sec.  35.204(a). As discussed in this section, 
eluates from generators for making Tc-99m radioactive drugs exceeded 
the permissible concentration listed in Sec.  35.204(a) on numerous 
occasions in 2006, 2007, and 2008. Additionally, in 2011, contamination 
issues with Sr-82/Rb-82 generators were discovered when several 
individuals were identified with unexpected levels of Sr-82 and Sr-85. 
These individuals had undergone Rb-82 chloride cardiac scanning 
procedures several months before and had received these radionuclides 
in levels greatly in excess of the administration levels permitted in 
Sec.  35.204 for Sr-82/Rb-82 generators. Further investigations showed 
that at least 90 individuals at one facility and 25 at another facility 
received levels of Sr-82 or Sr-85 that exceeded the levels permitted in 
Sec.  35.204. Of these patients, at least three had levels of Sr-82 and 
Sr-85 high enough to result in reportable MEs as defined in Sec.  
35.3045.
    Because the reporting of a failed generator is voluntary, the NRC 
had difficulty determining the extent of the problem. Reporting of 
results in excess of the levels in Sec.  35.204 for the Sr-82/Rb-82 
generators could have alerted users and regulators to issues associated 
with these generators and possibly reduced the number of patients 
exposed to excess Sr-82 and Sr-85 levels. Breakthrough of Mo-99, Sr-82 
and Sr-85 contamination can lead to unnecessary radiation exposure to 
patients.
    The NRC proposes to add a new reporting requirement related to 
breakthrough of Mo-99, and Sr-82 and Sr-85 contamination. This new 
reporting requirement in Sec.  35.3204(a) would require a licensee to 
report to the NRC and the manufacturer or distributor of medical 
generators within 30 days any measurement that exceeds the limits 
specified in Sec.  35.204(a).
f. Allowing ARSOs To Be Named on a Medical Use License
    Currently, Sec.  35.24(b) requires a licensee's management to 
appoint an RSO who, in writing, agrees to be responsible for 
implementing the radiation protection program. However, the regulations 
in 10 CFR part 35 do not allow the naming of more than one permanent 
RSO on a license.
    During an ACMUI meeting in June 2007 (ADAMS Accession No. 
ML072060526), concern was expressed that this restriction has been 
contributing to a shortage of available RSOs to serve as preceptors. 
The ACMUI stated that the restriction has been creating a situation in 
which an individual who is qualified and performing the same duties as 
an RSO cannot be recognized or listed as an RSO, and that it has been 
creating a situation in which an individual working as a contractor RSO 
at several hospitals or other licensed locations is unable to have 
actual day-to-day oversight at the various facilities.
    The proposed rule would amend the regulations in 10 CFR part 35 to 
allow a licensee to appoint a qualified individual with expertise in 
certain uses of byproduct material to serve as an ARSO. This individual 
would be required to complete the same T&E requirements as the named 
RSO for the individual's assigned sections of the radiation safety 
program. The ARSOs would have oversight duties for the radiation safety 
operations of their assigned sections, while reporting to the named 
RSO. The proposed regulation would continue to allow a licensee to name 
only one RSO on a license. The RSO would continue to be responsible for 
the day-to-day oversight of the entire radiation safety program. 
Similarly, a licensee with multiple operating locations could appoint a 
qualified ARSO at each location where byproduct material is used; 
however, the named RSO would remain responsible for the overall 
licensed program. Under the proposed rule, the ARSO would be named on 
the license for the types of use of byproduct material for which this 
individual has been assigned duties and tasks by the RSO.
    The NRC believes that allowing an ARSO to be named on a license 
would increase the number of individuals who would be available to 
serve as preceptors for individuals seeking to be appointed as RSOs or 
ARSOs. Also, by being named on a license, an ARSO could more easily 
become an RSO on other licenses for the types of uses for which the 
ARSO is qualified.
    In addition, the current regulations allow AUs, AMPs and ANPs to 
serve as the RSO only on the license for which they are listed. Because 
AUs, AMPs and ANPs must meet the same requirements to serve as the RSO 
regardless of which Commission medical license they are identified on, 
the NRC believes that it is overly restrictive to not allow them to 
serve as an RSO on any Commission medical license. Therefore, a 
modification is proposed that would allow an AU, AMP, or ANP listed on 
any license or permit to serve as an RSO or ARSO. This proposed change 
would increase the number of individuals available to serve as RSOs and 
ARSOs on NRC medical licenses. Additionally, these ARSOs and RSOs could 
serve as preceptors for an individual seeking to be named as the RSO.
    The proposed change to allow an ARSO to be named on a license was

[[Page 42418]]

broadly supported during the public workshops conducted in the summer 
of 2011. The T&E requirements for an ARSO were discussed, and 
stakeholders strongly supported the NRC's position that the ARSOs must 
meet the same qualifications as the RSO for their assigned sections of 
the radiation safety program.
    The proposed rule would amend multiple sections of 10 CFR part 35 
to accommodate the new ARSO position.
g. Additional Issues and Clarifications
    There are additional amendments, which are discussed in Section V, 
Discussion of Proposed Amendments by Section, of this document.

B. When would these actions become effective?

    Generally, the NRC allows an adequate time (30 to 180 days) for a 
final rule to become effective. The time for the final rule to become 
effective depends on the scope of the rulemaking, availability of the 
conforming guidance, and the complexity of the final rule. With regard 
to this proposed rule, the NRC proposes that the final rule would 
become effective 180 days from its publication in the Federal Register.

C. Are there any cumulative effects of regulation associated with this 
rule?

    Cumulative effects of regulation (CER) describes the challenges 
that licensees, certificate holders, States, or other entities may 
encounter while implementing new regulatory requirements (e.g., rules, 
generic letters, orders, backfits, inspection findings). The CER is an 
organizational effectiveness challenge that results from a licensee or 
impacted entity implementing a significant number of new and complex 
regulatory actions stemming from multiple regulatory actions, within a 
limited implementation period and with available resources (which may 
include limited available expertise to address a specific issue). The 
CER can potentially distract licensee or entity staff from executing 
other primary duties that ensure safety or security. The NRC is 
specifically requesting comment on the cumulative effects of this 
rulemaking. In developing comments on CER, consider the following 
questions:
    (1) In light of any current or projected CER challenges, does the 
proposed rule's effective date, compliance date, or submittal date(s) 
provide sufficient time to implement the proposed requirements, 
including changes to programs, procedures, and the facility?
    (2) If current or projected CER challenges exist, what should be 
done to address this situation (e.g., if more time is required to 
implement the new requirements, what period of time would be 
sufficient)?
    (3) Do other (NRC, Agreement States, or other agency) regulatory 
actions (e.g., orders, generic communications, license amendment 
requests, and inspection findings of a generic nature) influence the 
implementation of the proposed requirements?
    (4) Are there unintended consequences? Does the proposed rule 
create conditions that would be contrary to the proposed rule's purpose 
and objectives? If so, what are the consequences and how should they be 
addressed?
    (5) Please comment on the NRC's cost and benefit estimates in the 
regulatory analysis that supports this proposed rule. The draft 
regulatory analysis is available in ADAMS under Accession No. 
ML14184A620.

D. Is the NRC requesting comments on other specific issues?

    (1) Volume for determining an absorbed dose to normal tissue for 
MEs under Sec.  35.3045, Report and notification of a medical event.
    Two new criteria for determining if a licensee must report an ME 
involving permanent implant brachytherapy have a dose-volume 
specification for an absorbed dose to normal tissue. One proposed 
criterion is for normal tissue within the treatment site (such as the 
urethra in prostate implants) and the other proposed criterion is for 
normal tissue outside the treatment site (such as the bladder or the 
rectum in prostate implants).
    The proposed volume, 5 contiguous cubic centimeters of normal 
tissue, is based on the recommendations from the ACMUI (ADAMS Accession 
No. ML12038A279). In its recommendation, the ACMUI stated that the 5 
contiguous cubic centimeters dose-volume specification avoids the high 
variation in dose sometimes seen in point doses and has literature to 
support it being a relevant quantity for toxicity to an organ at risk.
    Because the majority of permanent implants are performed to treat 
prostate cancer, examples and guidance for the ACMUI recommendations 
related extensively to that procedure. However, the proposed rule is 
intended to apply generally to all forms of permanent implants.
    The NRC is seeking specific comments, in defining MEs, on the 
proposed volume of 5 contiguous cubic centimeters dose-volume 
specification for an absorbed dose to normal tissue located both 
outside and within the treatment site.
    The NRC is also seeking specific comments on whether the 
application of the proposed medical event definition for normal tissue 
based on the absorbed dose to the maximally exposed 5 contiguous cubic 
centimeters during permanent implant brachytherapy is appropriate for 
all potential treatment modalities, or whether it may result in 
unintended consequences for tissues or organs adjacent to the treatment 
site.
    (2) Implementation Period.
    In Section IV.B of this document, the NRC is proposing the 
effective date of the final rule to be 180 days from the date it is 
published in the Federal Register. The NRC is seeking specific comments 
on whether a 180 day effective date for the final rule is sufficient to 
communicate the changes to all practitioners, revise procedures, train 
on them, and implement the changes.
    (3) Impact on Clinical Practice.
    The NRC is seeking comments on whether any of the proposed changes 
in this rulemaking are likely to discourage licensees from using 
certain therapy options or otherwise adversely impact clinical 
practice, and if so, how.
    (4) Compatibility Category for the Agreement States on Sec.  
35.3045, Report and notification of a medical event.
    Currently Sec.  35.3045, Report and notification of a medical 
event, is designated as Compatibility Category C for the Agreement 
States. This 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 requirements need not be the same as 
NRC requirements, provided the essential objectives are met. Under 
Compatibility Category C, Agreement States may require the reporting of 
MEs with more restrictive criteria than those required by the NRC.
    Some medical licensees have multiple locations, some of which are 
NRC-regulated and some which are Agreement State-regulated. These 
licensees would prefer a Compatibility Category B designation for 
uniformity of practice and procedures among their different locations. 
A Compatibility Category B designation is for those program elements 
that apply to activities that have direct and significant effects in 
multiple jurisdictions.
    The OAS has expressed a strong desire to retain a dose-based ME 
reporting criterion for the treatment site if NRC regulations are 
revised to include

[[Page 42419]]

source-strength based criteria for determining MEs for permanent 
implant brachytherapy. The OAS has no objection to the introduction of 
the source-strength based criteria, as long as the dose-based criteria 
can be retained by the Agreement States, which requires Sec.  35.3045 
to remain as Compatibility Category C. With a Compatibility Category C 
designation, the Agreement States could require both the dose-based 
criterion and source-strength based criterion, as long as the Agreement 
State reports to the NRC only include the information required by the 
NRC.
    For some Agreement States, Compatibility Category B is difficult to 
achieve because their regulations have to also meet specific state 
requirements based on the state agencies in which the radiation control 
regulators reside. Also, Agreement States may have existing laws 
requiring the collection of additional information on medical 
diagnostic and therapy procedures.
    If the level of compatibility for Sec.  35.3045 were to be raised 
to Compatibility Category B, Agreement State requirements would need to 
be essentially identical to those of the NRC. Compatibility Category B 
is applied to requirements that have significant direct transboundary 
health and safety implications. A Compatibility Category B designation 
would prevent the Agreement State requirements from including any 
additional requirements, such as diagnostic reports, shorter reporting 
times, or lower dose limits for reporting.
    The ACMUI in its report to the NRC (ADAMS Accession No. 
ML13071A690), recommended that MEs related to permanent implant 
brachytherapy be designated as Compatibility Category B. The ACMUI was 
concerned with proposed designation as Compatibility Category C which 
would allow the Agreement States to retain the dose-based criteria for 
definition of an ME for permanent implant brachytherapy. The ACMUI 
asserted that a Compatibility Category C would continue to result in 
clinically insignificant occurrences being identified as MEs by 
Agreement States and thereby perpetuate the confusion associated with 
the current dose-based criteria. The ACMUI stated that the most 
important component of the rationale for conversion from dose-based to 
activity-based criteria is the failure of dose-based criteria to 
sensitively and to only specifically capture clinically significant MEs 
in permanent implant brachytherapy.
    Because of these divergent positions (the OAS favoring 
Compatibility Category C and some medical use licensees and the ACMUI 
favoring Compatibility Category B), the NRC invites comments on the 
appropriate compatibility category for ME reporting under Sec.  
35.3045.
    In responding to these issues, please use one of the methods 
described in Section I, Obtaining Information and Submitting Comments, 
of this document.

E. What should I consider as I prepare my comments to the NRC?

    Tips for preparing your comments. When submitting your comments, 
remember to:
    i. Identify the rulemaking (RIN 3150- AI63; NRC-2008-0175).
    ii. Explain why you agree or disagree with the proposed rule; 
suggest alternatives and substitute language for your requested 
changes.
    iii. Describe any assumptions and provide any technical information 
and/or data that you used.
    iv. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    v. Provide specific examples to illustrate your concerns, and 
suggest alternatives.
    vi. Explain your views as clearly as possible.
    vii. Make sure to submit your comments by the comment period 
deadline identified.
    viii. The NRC is particularly interested in your comments 
concerning the following issues: Sections IV.C and D. of this document 
request comment on the cumulative effects of regulation, Whether the 
proposed volume for determining an absorbed dose to normal tissue for 
MEs is appropriate and applicable for all potential treatment 
modalities related to permanent implant brachytherapy, the proposed 
180-day effective date for the final rule, the proposed rule's impact 
on clinical practice, and Compatibility Category for the Agreement 
States on Sec.  35.3045, Report and notification of a medical event; 
Section X of this document requests comment on the use of plain 
writing; Section XIV requests comment on the draft environmental 
assessment; Section XV of this document requests comment on the 
information collection requirements; Section XVI of this document 
requests comment on the draft regulatory analysis; and Section XVII of 
this document requests comment on the impact of the proposed rule on 
small businesses.

V. Discussion of Proposed Amendments by Section

Section 30.34 Terms and Conditions of Licenses

    Paragraph (g). A new requirement would be added requiring 
radiopharmacy licensees to report to the NRC the results of testing of 
generator elutions for Mo-99 breakthrough or Sr-82 and Sr-85 
contamination that exceed the permissible concentration listed in Sec.  
35.204(a). Reporting would be in accordance with the reporting and 
notifications in Sec.  35.3204. While the proposed reporting 
requirement as well as the requirement to test every elution is new, 
the testing by licensees of the first elution to ensure that it does 
not exceed the permissible concentration listed in Sec.  35.204(a) and 
recording the results of these tests is already required by this 
paragraph.
    This change is being proposed to provide the information to allow 
the NRC to assess a potential situation quickly and efficiently when 
issues occur with generators that may cause unwarranted radiation 
exposure to patients. This issue is discussed further in Section IV, 
Discussion, of this document.

Section 32.72 Manufacture, Preparation, or Transfer for Commercial 
Distribution of Radioactive Drugs Containing Byproduct Material for 
Medical Use Under 10 CFR Part 35

    Paragraph (a)(4). This paragraph would be modified to clarify that 
the applicant ``commits to'' rather than ``satisfies'' the label 
requirements. Committing to the prescriptive labeling requirements in 
the regulation in the license application would remove ambiguity 
related to what must appear on the label.
    Paragraph (b)(5)(i). This paragraph would be amended to remove the 
requirement to obtain a written attestation for individuals seeking to 
be named as an ANP and who are certified by a specialty board whose 
certification process has been recognized by the NRC or an Agreement 
State to be an ANP. This is a conforming change in support of the 
removal of the attestation requirement in Sec.  35.55(a) of this 
chapter for a board certified ANP.
    Paragraph (d). The existing requirements in paragraph (d) would be 
redesignated as (e), and a new paragraph (d) would be added to clarify 
that the labeling requirements that applicants commit to in paragraph 
(a) of this section are also applicable to current licensees.

[[Page 42420]]

Section 35.2 Definitions

    New definitions for Associate Radiation Safety Officer and for 
Ophthalmic physicist would be added to this section and the definition 
for Preceptor would be amended.
    The new definition for Associate Radiation Safety Officer would 
identify the requirements an individual would need to meet to be 
recognized as an ARSO. These requirements include that the individual 
must meet the specified T&E criteria and that the individual be 
currently listed as an ARSO on a medical license or permit for the 
types of use of byproduct material for which the individual had been 
assigned tasks and duties by the RSO. Additional information on ARSOs 
is located in Section IV, Discussion, of this document.
    The new definition for Ophthalmic physicist would identify the 
requirements an individual would need to meet to be recognized as an 
ophthalmic physicist. These requirements include that the individual 
must meet the specified T&E criteria in Sec.  35.433(a)(2) and that the 
individual must be currently listed as an ophthalmic physicist on a 
specific medical use license issued by the Commission or an Agreement 
State or a medical use permit issued by a Commission master material 
licensee. A written attestation would not be required for this 
individual.
    The definition for Preceptor would be amended to add ARSO to the 
list of individuals who provide, direct, or verify T&E required for an 
individual to become an AU, an AMP, an ANP, or an RSO. This is a 
conforming change in support of the new definition for Associate 
Radiation Safety Officer.

Section 35.12 Application for License, Amendment, or Renewal

    This section would be amended to remove the requirement to submit 
copies of NRC Form 313, Application for Material License, or a letter 
containing information required by NRC Form 313 when applying for a 
license, an amendment, or renewal. This section would clarify what 
information should be submitted and add a requirement to submit 
information on an individual seeking to be identified as an ARSO or as 
an ophthalmic physicist.
    Paragraph (b)(1). As part of the application for a medical use 
license, this paragraph would be amended to remove the requirement to 
submit an additional copy of NRC Form 313. This change would relieve 
the burden on the applicant by requiring less paperwork to be 
submitted. It would also require the applicant to submit the T&E 
qualifications for one or more ARSOs and ophthalmic physicists that are 
to be identified on the license.
    Paragraph (c). For license amendments or renewals, this paragraph 
would be amended to remove the requirement to submit a copy of NRC Form 
313 or a letter containing information required by NRC Form 313. This 
change would relieve the burden on the licensee by requiring less 
paperwork to be submitted. Additionally, it would clarify that the 
letter submitted in lieu of NRC Form 313 must contain all the 
information required by NRC Form 313.
    Paragraph (d). This paragraph would be amended and restructured to 
clarify what information must be included in an application for a 
license or amendment for medical use of byproduct material as described 
in Sec.  35.1000.

Section 35.13 License Amendments

    This section would be amended by revising paragraph (b), 
redesignating paragraphs (d) through (g) as paragraphs (e) through (h), 
revising redesignated paragraphs (g) and (h), and adding new paragraphs 
(d) and (i).
    Paragraph (b). The paragraph would be amended to allow a licensee 
to permit an individual to work as an ophthalmic physicist before 
applying for a license amendment, provided that the individual is 
already listed on a medical license or permit. The definition of an 
Ophthalmic physicist in Sec.  35.2 would allow the ophthalmic physicist 
to be named only on a specific medical use license and not on a broad 
scope medical license. This limitation is to ensure that individuals 
seeking to be named as an ophthalmic physicist have their T&E reviewed 
by a regulatory authority as the position is new and unfamiliar to the 
medical community. Additionally, broad scope licensees already have 
ready access to AMPs to perform the requirements listed in Sec.  
35.433.
    Paragraph (d). This new paragraph would be added to require a 
licensee to apply for and receive a license amendment before permitting 
an individual to work as an ARSO or before the RSO assigns different 
tasks and duties to an ARSO currently authorized on the license.
    Paragraph (i). This new paragraph would be added to this section to 
allow a licensee to receive sealed sources from a new manufacturer or a 
new model number for a sealed source listed in the Sealed Source and 
Device Registry (SSDR) used for manual brachytherapy for quantities and 
isotopes already authorized by its license without first seeking a 
license amendment. This change is proposed to provide manual 
brachytherapy licensees greater flexibility in obtaining the sealed 
sources necessary for patient treatments in a timely manner.

Section 35.14 Notifications

    Paragraph (a). The paragraph would be restructured to separate the 
notification requirements for an individual who is certified by a board 
that is recognized by the NRC or an Agreement State from the 
requirements for an individual who is not certified by a board that is 
recognized by the NRC or an Agreement State but is listed on a license. 
Additionally, the requirement to provide a written attestation is 
removed for an individual who is certified by a board that is 
recognized by the NRC or an Agreement State. Further discussion on 
removing the written attestation requirement can be found in Section 
IV, Discussion, of this document. Licensees may not permit an 
individual who is not certified by a board that is recognized by the 
NRC or an Agreement State or does not meet the requirements in Sec.  
35.13(b) to work under their license without first obtaining an 
amendment to their license.
    Paragraph (a)(1). This paragraph would be restructured to more 
clearly identify the verification that a board certified individual 
would need to provide along with a copy of the individual's board 
certification. This proposed change does not impose any new 
requirements.
    Paragraph (a)(2). This paragraph would retain the notification 
requirements for individuals who are authorized to work under Sec.  
35.13(b) who are not certified by a board that is recognized by the NRC 
or an Agreement State but are listed on a license. These individuals 
would be only authorized for the materials and uses for which they were 
previously authorized. This proposed change does not impose any new 
requirements.
    Paragraph (b)(1). This paragraph would be amended to require a 
licensee to notify the Commission within 30 days after an ARSO or 
ophthalmic physicist has a name change or discontinues performance of 
their duties under the license.
    Paragraph (b)(6). This new paragraph would require a licensee to 
notify the NRC no later than 30 days after receiving a sealed source 
from a new manufacturer or a new model number listed in the SSDR for 
manual brachytherapy for quantities and

[[Page 42421]]

isotopes already authorized by the license.

Section 35.24 Authority and Responsibilities of the Radiation 
Protection Program

    This section would be amended to allow licensees to appoint 
qualified individuals with expertise in certain uses of byproduct 
material to be named as ARSOs on a license or permit.
    Paragraph (b). This paragraph would be modified to specify that a 
licensee's management may appoint one or more ARSOs. These appointed 
ARSOs would have to be named on a medical license or permit for the 
types of use of byproduct material for which the RSO, with the written 
agreement of the licensee's management, would assign tasks and duties.
    The licensee's management would still be limited to naming one RSO 
who would remain responsible for implementing the entire radiation 
protection program. The RSO would be prohibited from delegating 
authority and responsibilities for implementing the radiation 
protection program. Each ARSO would have to agree in writing to the 
tasks and duties assigned by the RSO.
    Paragraph (c). An administrative change would be made to this 
paragraph to remove the phrase ``an authorized user or'' as it is 
redundant with ``an individual qualified to be a Radiation Safety 
Officer under 35.50 and 35.59'' in the same sentence.
    The proposed position of ARSO is discussed further in Section IV, 
Discussion, of this document.

Section 35.40 Written Directives

    Paragraph (b) of this section would be restructured and amended to 
accommodate specific requirements for a WD for permanent implant 
brachytherapy. Existing paragraph (b)(6) would be redesignated as 
paragraph (b)(7) and a new paragraph (b)(6) would be added to specify 
the information that must be included in the pre-implantation (before 
implantation) and post-implantation (after implantation) portions of 
the WD for permanent implant brachytherapy.
    Paragraph (b)(6). This new paragraph would detail the specific WD 
requirements for permanent implant brachytherapy. Specifically, it 
would clarify that the WD is divided into two portions, i.e., the pre-
implantation portion and the post-implantation portion. The pre-
implantation WD portion would require documentation of the treatment 
site, the radionuclide, the intended absorbed dose to the treatment 
site, and the corresponding calculated source strength to deliver that 
dose. If the treatment site has normal tissues located within it (such 
as the urethra in prostate implants), the WD would also allow 
documentation of the expected absorbed dose to normal tissue as 
determined by the AU. The information required by the pre-implantation 
portion of the WD must be documented prior to the start of the 
implantation and cannot be modified once the implantation begins. The 
proposed rule would retain the current provision that an AU could 
revise an existing WD in writing or orally before the implantation 
begins.
    The post-implantation portion of the WD would require the 
documentation of the number of sources implanted, the total source 
strength implanted, the signature of an AU for Sec.  35.400 uses for 
manual brachytherapy, and the date. It would not require the 
documentation of dose to the treatment site. The information required 
by the post-implantation portion of the WD must be documented before 
the patient leaves the post-treatment recovery area. The term ``post-
treatment recovery area,'' as used in paragraph (b)(6)(ii), means the 
area or place where a patient recovers immediately following the 
brachytherapy procedure before being released to a hospital room or, in 
the case of an outpatient treatment, released from the licensee's 
facility.
    Paragraph (c) of this section would be restructured for clarity.

Section 35.41 Procedures for Administrations Requiring a Written 
Directive

    This section would be amended by adding two new paragraphs with 
requirements that the licensee must address when developing, 
implementing, and maintaining written procedures to provide high 
confidence that each administration requiring a WD is in accordance 
with the WD.
    Paragraph (b)(5). This new paragraph would require that the 
licensee's procedures for any administration requiring a WD must 
include procedures for determining if an ME, as defined in Sec.  
35.3045 of this part, has occurred.
    Paragraph (b)(6). This new paragraph would require the licensee to 
develop specific procedures for permanent implant brachytherapy 
programs. At a minimum, the procedures would include determining post-
implant source position verification and normal tissue dose assessment 
within 60 calendar days from the date the implant was performed. If the 
licensee cannot make these determinations within the 60 calendar days 
because the patient is not available, then the licensee would have to 
provide written justification that these determinations could not be 
made due to patient unavailability.
    The determinations that would be required include: (1) The total 
source strength administered outside of the treatment site compared to 
the total source strength documented in the post-implantation portion 
of the WD; (2) the absorbed dose to the maximally exposed 5 contiguous 
cubic centimeters of normal tissue located outside of the treatment 
site; and 3) the absorbed dose to the maximally exposed 5 contiguous 
cubic centimeters of normal tissue located within the treatment site.
    The NRC is proposing this change because the current regulations do 
not have a defined time within which the licensee must determine if the 
implantation of radioactive sealed sources was done as prescribed in 
the WD. The occurrence of a substantial number of MEs in 2008 
underscored the need to add this requirement to the regulations, as 
post-implant source position verifications and normal tissue dose 
assessments for some of these MEs were not determined for more than a 
year after the patient was treated. The NRC believes that these 
determinations must be made in a timely manner to ensure that patients 
and their physicians have information upon which to base decisions 
regarding remedial and prospective health care.
    A 60-calendar-day time frame is proposed to ensure that the 
licensee has ample time to make arrangements for the required 
determinations. These determinations would be used to partially assess 
if an ME, as defined in Sec.  35.3045, has occurred.

Section 35.50 Training for Radiation Safety Officer

    Multiple changes to this section are proposed. They include 
amending the title of the section to add ``and Associate Radiation 
Safety Officer'' as the T&E requirements for this new position would 
also be made applicable to the ARSO. Other changes proposed are: (1) 
Removing the requirement to obtain a written attestation for 
individuals qualified under paragraph (a) of this section; (2) adding a 
provision that would allow individuals identified as an AU, AMP, or ANP 
on a medical license to be an RSO or an ARSO not only on that current 
license but also on a different medical license; (3) adding a provision 
to allow an individual to be named simultaneously both as the RSO and 
AU on a new license application; and 4) certain administrative 
clarifications.

[[Page 42422]]

    Paragraph (a). The requirement for individuals seeking to be named 
as an RSO or ARSO to obtain a written attestation would be removed for 
those individuals who are certified by a specialty board whose 
certification process has been recognized by the NRC or an Agreement 
State. Individuals seeking to be named as RSOs or ARSOs via the 
certification pathway would still need to meet the training 
requirements in the new paragraph (d) of this section. Further 
discussion on removing the written attestation requirement can be found 
in Section IV, Discussion, of this document.
    Paragraph (b)(1)(ii). This paragraph is amended to allow an ARSO, 
in addition to the RSO, to provide supervised work experience for 
individuals under the alternate pathway. The ARSO would be limited to 
providing supervised work experience in those areas for which the ARSO 
is authorized on a medical license or permit.
    Paragraph (b)(2). Reserved paragraph (b)(2) would be revised to 
contain the requirements for an RSO or ARSO under the alternate pathway 
to obtain a written attestation signed by either an RSO or ARSO. The 
language that is required in the written attestation would be amended 
to state that the individual ``is able to independently fulfill the 
radiation safety-related duties as an RSO or ARSO,'' rather than that 
the individual ``has achieved a level of radiation safety knowledge to 
function independently'' as an RSO or ARSO.
    Paragraph (c)(1). This paragraph would be modified to allow medical 
physicists who have been certified by a specialty board whose process 
has been recognized by the Commission or an Agreement State under Sec.  
35.51(a) to be named as ARSOs. Additionally, the requirement for a 
written attestation for these medical physicists is removed. A medical 
physicist seeking to be named as an RSO or an ARSO would still need to 
meet the training requirements in paragraph (d) of this section.
    Paragraph (c)(2). This paragraph would be modified to allow AUs, 
AMPs, and ANPs identified on a Commission or an Agreement State medical 
license or permit to be an RSO or ARSO on any Commission or an 
Agreement State license or Commission master material permit provided 
that the AU, AMP, or ANP has experience with the radiation safety 
aspects of similar types of use of byproduct material. The current 
regulations limit AUs, AMPs and ANPs to serve as an RSO only on the 
license on which they are listed.
    The AUs, AMPs and ANPs must meet the same requirements to serve as 
the RSO regardless of which Commission medical license they are 
identified on; therefore, not allowing them to serve as an RSO on any 
Commission medical license is overly restrictive. This change would 
increase the number of individuals available to serve as RSOs and ARSOs 
on NRC medical licenses.
    Paragraph (c)(3). This new paragraph would allow an individual who 
is not named as an AU on a medical license or permit, but is qualified 
to be an AU, to be named simultaneously as the RSO and the AU on the 
same new medical license. Current regulations, under Sec.  35.50(c)(2), 
do not permit an individual who is not an AU on a license, but 
qualified to be an AU, to be an RSO. The individual must have the 
experience with the radiation safety aspects of the byproduct material 
for which the authorization is sought. An individual may meet the 
qualifications of an AU via the board certification or alternate 
pathway. An individual who is using the alternate pathway to be named 
simultaneously as the RSO and the AU on the same new medical license 
must obtain a written attestation.
    The provision would provide flexibility for an individual to serve 
as both an AU and as the RSO on a new medical license and would make 
medical procedures more widely available, especially in rural areas.
    Paragraph (d). This paragraph would be amended to include ARSOs as 
individuals who can provide supervised training to an individual 
seeking recognition as an RSO or ARSO.

Section 35.51 Training for an Authorized Medical Physicist

    Paragraph (a). The requirement for individuals seeking to be named 
as an AMP to obtain a written attestation would be removed for those 
individuals who are certified by a specialty board whose certification 
process has been recognized by the NRC or an Agreement State. Further 
discussion on removing the written attestation requirement can be found 
in Section IV, Discussion, of this document.
    Paragraph (a)(2)(i). This paragraph would be amended to clarify 
that an AMP who provides supervision for meeting the requirements of 
this section, be certified in medical physics by a specialty board 
whose certification process has been recognized under this section by 
the Commission or an Agreement State.
    Current regulations allow a medical physicist with any board 
certification in diagnostic or therapeutic medical physics to serve as 
a supervising medical physicist in therapeutic procedures. The NRC 
believes that the supervision for therapeutic procedures must be 
provided by a medical physicist who is certified in medical physics by 
a specialty board recognized under Sec.  35.51 by the Commission or an 
Agreement State.
    Paragraph (b)(2). The wording in this paragraph would be revised to 
conform to the removal of the attestation requirement in paragraph (a) 
of this section. It would also be amended to incorporate the new 
language that the written attestation would verify that the individual 
is able to independently fulfill the radiation safety-related duties, 
rather than has achieved a level of competency to function 
independently, as an AMP.

Section 35.55 Training for an Authorized Nuclear Pharmacist

    Paragraph (a). The requirement for individuals seeking to be named 
as an ANP to obtain a written attestation would be removed for those 
individuals who are certified by a specialty board whose certification 
process has been recognized by the NRC or an Agreement State.
    Paragraph (b)(2). The wording in this paragraph would be revised to 
conform to the removal of the attestation requirement in paragraph (a) 
of this section. It would also be amended to incorporate the new 
language that the written attestation would verify that the individual 
is able to independently fulfill the radiation safety-related duties, 
rather than has achieved a level of competency to function 
independently, as an ANP.

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

    Multiple changes to this section are proposed. Most of the proposed 
changes are to the T&E requirements in response to the requested 
amendments in the Ritenour petition. This includes recognizing the 
board certifications of individuals certified by boards recognized 
under subpart J, which was removed from 10 CFR part 35 in a rulemaking 
dated March 30, 2005 (70 FR 16336), and making administrative 
clarifications. Additional information on the Ritenour petition, as it 
relates to this rulemaking, is located in Section IV, Discussion, of 
this document.
    Paragraph (a)(1). This paragraph would be modified to add AMPs and 
ANPs identified on a Commission or an Agreement State license or a 
permit issued by a Commission or an Agreement State broad scope 
licensee or master material license permit or by a

[[Page 42423]]

master material license permittee of broad scope on or before October 
24, 2005, as individuals that would not need to comply with the 
training requirements of Sec. Sec.  35.50, 35.51, or 35.55, 
respectively. In addition, the date is changed for individuals named on 
a license as RSOs, teletherapy or medical physicists, AMPs, nuclear 
pharmacists, or ANPs from October 24, 2002, to October 24, 2005, 
because during the 3-year time frame applicants could have qualified 
under the now removed subpart J or the new T&E requirements under 
Sec. Sec.  35.50, 35.51, or 35.55.
    However, under the proposed rule, RSOs and AMPs identified by this 
paragraph would have to meet the training requirements in Sec. Sec.  
35.50(d) or 35.51(c) as appropriate, for any materials or uses for 
which they were not authorized prior to the effective date of the rule. 
This is not a new training requirement. Current regulations require 
individuals qualifying under Sec. Sec.  35.50 and 35.51 as RSOs and 
AMPs to meet the training requirements in Sec.  35.50(e) and Sec.  
35.51(c). Individuals excepted by this paragraph would still need to 
meet the recentness-of-training requirements in Sec.  35.59.
    Paragraph (a)(2). This paragraph would recognize individuals 
certified by the named boards in the now-removed subpart J of 10 CFR 
part 35 on or before October 24, 2005, who would not need to comply 
with the training requirements of Sec.  35.50 to be identified as an 
RSO or as an ARSO on a Commission or an Agreement State license or 
Commission master material license permit for those materials and uses 
that these individuals performed on or before October 24, 2005. 
Individuals excepted by this paragraph would still need to meet the 
recentness-of-training requirements in Sec.  35.59 and, for new 
materials and uses, the training requirements in Sec.  35.50(d).
    Paragraph (a)(3). This paragraph would recognize individuals 
certified by the named boards in the now-removed subpart J of 10 CFR 
part 35 on or before October 24, 2005, who would not need to comply 
with the training requirements of Sec.  35.51 to be identified as a AMP 
on a Commission or an Agreement State license or Commission master 
material license permit for those materials and uses that these 
individuals performed on or before October 24, 2005. Removal of subpart 
J from 10 CFR part 35 was effective on October 24, 2005. These 
individuals would be exempted from these training requirements only for 
those materials and uses these individuals performed on or before 
October 24, 2005. Individuals excepted by this paragraph would still 
need to meet the recentness-of-training requirements in Sec.  35.59 
and, for new materials and uses, the training requirements in Sec.  
35.51(c).
    Paragraph (a)(4). This paragraph would be renumbered from current 
paragraph (a)(3) and not be revised.
    Paragraph (b)(1). This paragraph would be amended to change the 
date an individual named on a license as an AU from October 24, 2002, 
to October 24, 2005, because during that 3-year time frame, an 
applicant could have qualified as an AU either under the former subpart 
J or the revised T&E requirements in subparts D through H of 10 CFR 
part 35.
    Additionally, the paragraph would be amended to clarify that an 
individual authorized before, rather than just on, October 24, 2005, 
would not be required to comply with the T&E requirements in subparts D 
through H of 10 CFR part 35 for those materials and uses that they 
performed on or before that date.
    Paragraph (b)(2). This paragraph would be restructured and expanded 
to recognize a physician, dentist, or podiatrist who was certified by 
the named boards in the now-removed subpart J of 10 CFR part 35 on or 
before October 24, 2005, and who would not need to comply with the 
training requirements of subparts D through H of 10 CFR part 35 to be 
identified as an AU on a Commission or an Agreement State license or 
Commission master material license permit for those materials and uses 
that the individual performed on or before October 24, 2005. Removal of 
subpart J from 10 CFR part 35 was effective on October 24, 2005. An 
individual excepted from the T&E requirements by this paragraph would 
still need to meet the recentness-of-training requirements in Sec.  
35.59.

Section 35.65 Authorization for Calibration, Transmission, and 
Reference Sources

    This section would be restructured and amended to include two new 
paragraphs.
    Paragraph (b)(1). This new paragraph would require that medical use 
of any byproduct material authorized by this section can only be used 
in accordance with the requirements in Sec.  35.500. This is a 
clarification that all of the specified byproduct material for medical 
use must be under the supervision of an AU.
    Paragraph (b)(2). This new paragraph would prohibit the bundling or 
aggregating of single-sealed sources to create a sealed source with an 
activity larger than authorized by Sec.  35.65. Sources that consist of 
multiple single sources (bundling) that exceed the limits authorized by 
Sec.  35.65 would no longer be regulated under Sec.  35.65, would be 
treated as one single source, and would have to meet all of the 
regulatory requirements for that single source including, if 
appropriate, listing on a specific medical license, leak testing, and 
security requirements.
    Paragraph (c). This new paragraph would clarify that a licensee 
using calibration, transmission, and reference sources in accordance 
with the requirements in paragraphs (a) or (b) of this section need not 
list these sources on a specific medical use license.

Section 35.190 Training for Uptake, Dilution, and Excretion Studies

    Paragraph (a). For a physician seeking to be named as an AU of 
unsealed byproduct material for uses authorized under Sec.  35.100, the 
requirement to obtain a written attestation would be removed for an 
individual who is certified by a specialty board whose certification 
process has been recognized by the NRC or an Agreement State. Further 
discussion on removing the written attestation requirement can be found 
in Section IV, Discussion, of this document.
    Paragraph (c)(2). This paragraph would be restructured and expanded 
to allow certain residency program directors to provide written 
attestations for a physician seeking to be named as an AU of unsealed 
byproduct material for uses authorized under Sec.  35.100. The 
residency program director must represent a residency training program 
approved by the Residency Review Committee of the Accreditation Council 
for Graduate Medical Education, the Royal College of Physicians and 
Surgeons of Canada, or the Committee on Post-Graduate Training of the 
American Osteopathic Association. The residency training program must 
include T&E specified in Sec.  35.190.
    The residency program director who provides written attestations 
does not have to be an AU who met the requirements in Sec. Sec.  35.57, 
35.190, 35.290, or 35.390, or equivalent Agreement State requirements. 
However, the director must affirm in writing that the attestation 
represents the consensus of the residency program faculty where at 
least one faculty member is an AU who meets the requirements in 
Sec. Sec.  35.57, 35.190, 35.290, or 35.390, or equivalent Agreement 
State requirements, and that the AU concurs with the attestation.
    Additionally, the paragraph would be amended to incorporate the new 
language that the written attestation would verify that the physician 
is able to independently fulfill the radiation safety-related duties, 
rather than has

[[Page 42424]]

achieved a level of competency to function independently, as an AU.

Section 35.204 Permissible Molybdenum-99, Strontium-82, and Strontium-
85 Concentrations

    Paragraph (b). The current requirement to measure the Mo-99 
concentration after the first eluate would be changed to require that 
the Mo-99 concentration be measured after each elution. A generator can 
be eluted several times to obtain Tc-99m for formulating 
radiopharmaceuticals for human use. Current regulations require 
licensees to measure the Mo-99 concentration only the first time a 
generator is eluted.
    Paragraph (e). This new paragraph would add a requirement that 
licensees report any measurement that exceeds the limits specified in 
Sec.  35.204(a) for Mo-99/Tc-99m and Sr-82/Rb-82 generators.
    Further discussion on this issue can be found in Section IV, 
Discussion, of this document.

Section 35.290 Training for Imaging and Localization Studies

    Paragraph (a). For physicians seeking to be named as an AU of 
unsealed byproduct material for uses authorized under Sec.  35.200, the 
requirement to obtain a written attestation would be removed for those 
individuals who are certified by a specialty board whose certification 
process has been recognized by the NRC or an Agreement State. Further 
discussion on removing the written attestation requirement can be found 
in Section IV, Discussion, of this document.
    Paragraph (c)(1)(ii). This paragraph would be amended to allow an 
ANP who meets the requirements in Sec. Sec.  35.55 or 35.57 to provide 
the supervised work experience specified in paragraph (c)(1)(ii)(G) of 
this section for individuals seeking to be named as an AU of unsealed 
byproduct material for uses authorized under Sec.  35.200. Paragraph 
(c)(1)(ii)(G) of this section requires supervised work experience in 
eluting generator systems. Many medical facilities no longer elute 
generators and receive unit doses from centralized pharmacies; 
therefore, training on eluting generators is not available at these 
facilities. ANPs have the T&E to provide the supervised work experience 
for AUs on the elution of generators.
    Paragraph (c)(2). This paragraph would be restructured and expanded 
to allow certain residency program directors to provide written 
attestations for individuals seeking to be named as an AU of unsealed 
byproduct material for uses authorized under Sec. Sec.  35.100 and 
35.200. The residency program director must represent a residency 
training program approved by the Residency Review Committee of the 
Accreditation Council for Graduate Medical Education, the Royal College 
of Physicians and Surgeons of Canada, or the Committee on Post-Graduate 
Training of the American Osteopathic Association. The residency 
training program must include T&E specified in Sec.  35.290.
    The residency program directors who provide written attestations do 
not have to be AUs who meet the requirements in Sec. Sec.  35.57, 
35.290, or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement 
State requirements. However, they must affirm in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an AU who meets the requirements 
in Sec. Sec.  35.57, 35.290, or 35.390 and 35.290(c)(1)(ii)(G) or 
equivalent Agreement State requirements, and that the AU concurs with 
the attestation.
    Additionally, the paragraph would be amended to incorporate the new 
language that the written attestation would verify that the individual 
is able to independently fulfill the radiation safety-related duties, 
rather than has achieved a level of competency to function 
independently, as an AU.

Sec.  35.300 Use of Unsealed Byproduct Material for Which a Written 
Directive Is Required

    The introductory paragraph would be amended to clarify that a 
licensee may only use unsealed byproduct material identified in Sec.  
35.390(b)(1)(ii)(G) under this section. Currently, Sec.  35.300 states 
that ``A licensee may use any unsealed byproduct material. . ..'' This 
change is proposed to clarify that a licensee's authorization of the 
radiopharmaceuticals requiring a WD is only for those types of 
radiopharmaceuticals for which the AU has documented T&E. An AU may be 
authorized for one or more of the specific categories described in 
Sec.  35.390(b)(1)(ii)(G), but not for all unsealed byproduct material.

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

    Paragraph (a). For physicians seeking to be named as an AU of 
unsealed byproduct material for uses authorized under Sec.  35.300, the 
requirement to obtain a written attestation would be removed for those 
individuals who are certified by a specialty board whose certification 
process has been recognized by the NRC or an Agreement State. Further 
discussion on removing the written attestation requirement can be found 
in Section IV, Discussion, of this document.
    Paragraph (b)(1)(ii)(G). This paragraph would be amended to expand 
and clarify the categories of parenteral administrations of 
radionuclides in which work experience is required for an individual 
seeking to be an AU for uses under Sec.  35.300. Most radionuclides 
used for parenteral administrations have more than one type of 
radiation emission. Under the proposed change, the type of radiation 
emissions of parenteral administrations would be based on the primary 
use of the radionuclide radiation characteristics. The proposed changes 
to this paragraph would also further expand the parenteral 
administration categories to include radionuclides that are primarily 
used for their alpha radiation characteristics.
    The current regulations include a broad category for parenteral 
administrations of ``any other'' radionuclide. This broad category 
would be removed, as any new parenteral administration of radionuclides 
not listed in this paragraph would be regulated under Sec.  35.1000. 
This approach would allow the NRC to review each new proposed 
radionuclide for parenteral administration and determine the 
appropriate T&E for its use.
    Current regulations require physicians requesting AU status for 
administering dosages of radioactive drugs to humans (including 
parenteral administration) to have work experience with a minimum of 
three cases in each category for which they are requesting AU status. 
This requirement would be retained in the proposed rule with regard to 
all categories in this paragraph.
    Paragraph (b)(2). This paragraph would be restructured and expanded 
to allow certain residency program directors to provide written 
attestations for physicians seeking to be named as an AU of unsealed 
byproduct material for uses authorized under Sec.  35.300. The 
residency program director must represent a residency training program 
approved by the Residency Review Committee of the Accreditation Council 
for Graduate Medical Education or the Royal College of Physicians and 
Surgeons of Canada or the Committee on Post-Graduate Training of the 
American Osteopathic Association. The residency training program must 
include T&E specified in Sec.  35.300.
    The residency program directors who provide written attestations do 
not have

[[Page 42425]]

to be AUs who meet the requirements in Sec. Sec.  35.57, 35.390, or 
equivalent Agreement State requirements, or have experience in 
administering dosages in the same dosage category or categories as the 
individual requesting AU status. However, they must affirm in writing 
that the attestation represents the consensus of the residency program 
faculty where at least one faculty member is an AU who meets the 
requirements in Sec. Sec.  35.57, 35.390, or equivalent Agreement State 
requirements, has experience in administering dosages in the same 
dosage category or categories as the physicians requesting AU status, 
and that the AU concurs with the attestation.
    Additionally, the paragraph would be amended to incorporate the new 
language that the written attestation would verify that the physician 
is able to independently fulfill the radiation safety-related duties, 
rather than has achieved a level of competency to function 
independently, as an AU.
    Paragraph (c). This new paragraph is added to clarify that if an 
individual is a user of any of the parenteral administrations specified 
in Sec.  35.390(b)(1)(ii)(G) or equivalent Agreement State requirements 
that individual would be only authorized for that use and not for all 
of the parenteral administrations. If an individual is seeking 
authorization for any new type of parenteral administrations then the 
supervised work experience requirements in paragraph (b)(1)(ii)(G) 
would have to be met.

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)

    Paragraph (a). For physicians seeking to be named as an AU for the 
oral administration of sodium iodide I-131 requiring a WD in quantities 
less than or equal to 1.22 gigabecquerels (33 millicuries), the 
requirement to obtain a written attestation would be removed for those 
individuals who are certified by a specialty board whose certification 
process has been recognized by the NRC or an Agreement State. Further 
discussion on removing the written attestation requirement can be found 
in Section IV, Discussion, of this document.
    Paragraph (c)(3). This paragraph would be restructured and expanded 
to allow certain residency program directors to provide written 
attestations for physicians seeking to be named as an AU of unsealed 
byproduct material for the oral administration of sodium iodide I-131 
requiring a WD in quantities less than or equal to 1.22 gigabecquerels 
(33 millicuries) authorized under Sec.  35.300. The residency program 
director must represent a residency training program approved by the 
Residency Review Committee of the Accreditation Council for Graduate 
Medical Education or the Royal College of Physicians and Surgeons of 
Canada or the Committee on Post-Graduate Training of the American 
Osteopathic Association. The residency training program must include 
T&E specified in Sec.  35.392.
    The residency program directors who provide written attestations do 
not have to be AUs who meet the requirements in Sec. Sec.  35.57, 
35.390, 35.392, 35.394, or equivalent Agreement State requirements, or 
have experience in administering dosages as specified in Sec. Sec.  
35.390(b)(1)(ii)(G)(1) or 35.390(b)(1)(ii)(G)(2). However, they must 
affirm in writing that the attestation represents the consensus of the 
residency program faculty where at least one faculty member is an AU 
who meets the requirements in Sec. Sec.  35.57, 35.390, 35.392, 35.394, 
or equivalent Agreement State requirements, and has experience in 
administering dosages as specified in Sec. Sec.  35.390(b)(1)(ii)(G)(1) 
or 35.390(b)(1)(ii)(G)(2) and that the AU concurs with the attestation.
    Additionally, the paragraph would be amended to incorporate the new 
language that the written attestation would verify that the physician 
is able to independently fulfill the radiation safety-related duties, 
rather than has achieved a level of competency to function 
independently, as an AU.

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)

    Paragraph (a). For physicians seeking to be named as an AU for the 
oral administration of sodium iodide I-131 requiring a WD in quantities 
greater than 1.22 gigabecquerels (33 millicuries), the requirement to 
obtain a written attestation would be removed for those individuals who 
are certified by a specialty board whose certification process has been 
recognized by the NRC or an Agreement State. Further discussion on 
removing the written attestation requirement can be found in Section 
IV, Discussion, of this document.
    Paragraph (c)(3). This paragraph would be restructured and expanded 
to allow certain residency program directors to provide written 
attestations for physicians seeking to be named as an AU of unsealed 
byproduct material for the oral administration of sodium iodide I-131 
requiring a WD in quantities greater than 1.22 gigabecquerels (33 
millicuries) authorized under Sec.  35.300. The residency program 
director must represent a residency training program approved by the 
Residency Review Committee of the Accreditation Council for Graduate 
Medical Education or the Royal College of Physicians and Surgeons of 
Canada or the Committee on Post-Graduate Training of the American 
Osteopathic Association. The residency training program must include 
T&E specified in Sec.  35.394.
    The residency program directors who provide written attestations do 
not have to be AUs who meet the requirements in Sec. Sec.  35.57, 
35.390, 35.394, or equivalent Agreement State requirements, or have 
experience in administering dosages as specified in Sec.  
35.390(b)(1)(ii)(G)(2). However, they must affirm in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an AU who meets the requirements 
in Sec. Sec.  35.57, 35.390, 35.394, or equivalent Agreement State 
requirements, and has experience in administering dosages as specified 
in Sec.  35.390(b)(1)(ii)(G)(2) and that the AU concurs with the 
attestation.
    Additionally, the paragraph would be amended to incorporate the new 
language that the written attestation would verify that the physician 
is able to independently fulfill the radiation safety-related duties, 
rather than has achieved a level of competency to function 
independently, as an AU.

Section 35.396 Training for the Parenteral Administration of Unsealed 
Byproduct Material Requiring a Written Directive

    Proposed amendments to this section include conforming changes to 
support the new categories for parenteral administration in Sec.  
35.390(b)(1)(ii)(G), changes to allow residency program directors to 
provide written attestations, and the change to the attestation 
language. Additionally, the section would be renumbered to accommodate 
the proposed changes.
    Paragraph (a). This paragraph would be amended to revise the 
categories for parenteral administration of radionuclides listed in 
Sec.  35.390(b)(1)(ii)(G). The AUs authorized to use any of the 
categories for parenteral administration of radionuclides in Sec.  
35.390(b)(1)(ii)(G) would also have to meet the supervised work 
experience requirements in paragraph (d)(2) of this section for each 
new parenteral administration listed in

[[Page 42426]]

Sec.  35.390(b)(1)(ii)(G) for which the individual is requesting AU 
status.
    Paragraph (d)(1). This paragraph would be amended to conform with 
the new categories for parenteral administration in Sec.  
35.390(b)(1)(ii)(G).
    Paragraph (d)(2). This paragraph would be amended to conform with 
the new categories for parenteral administration in Sec.  
35.390(b)(1)(ii)(G) and to clarify that a supervising AU must have 
experience in administering dosages in the same category or categories 
as the individual requesting AU status.
    Paragraph (d)(2)(vi). This paragraph would be amended to conform 
with the new categories for parenteral administration in Sec.  
35.390(b)(1)(ii)(G).
    Paragraph (d)(3). This paragraph would be restructured and expanded 
to allow certain residency program directors to provide written 
attestations for physicians seeking to be named as an AU of unsealed 
byproduct material for the parenteral administration requiring a WD. 
The residency program director must represent a residency training 
program approved by the Residency Review Committee of the Accreditation 
Council for Graduate Medical Education or the Royal College of 
Physicians and Surgeons of Canada or the Committee on Post-Graduate 
Training of the American Osteopathic Association. The residency 
training program must include T&E specified in Sec.  35.396.
    The residency program directors who provide written attestations do 
not have to be AUs who meet the requirements in Sec. Sec.  35.57, 
35.390, 35.396, or equivalent Agreement State requirements, or have 
experience in administering dosages in the same category or categories 
as the individual requesting AU status. However, they must affirm in 
writing that the attestation represents the consensus of the residency 
program faculty where at least one faculty member is an AU who meets 
the requirements in Sec. Sec.  35.57, 35.390, 35.396, or equivalent 
Agreement State requirements, and concurs with the attestation. An AU 
who meets the requirements in Sec. Sec.  35.390, 35.396, or equivalent 
Agreement State requirements, must have experience in administering 
dosages in the same category or categories as the individual requesting 
AU user status.
    Additionally, the paragraph would be amended to incorporate the new 
language that the written attestation would verify that the physician 
is able to independently fulfill the radiation safety-related duties, 
rather than has achieved a level of competency to function 
independently, as an AU.

Section 35.400 Use of Sources for Manual Brachytherapy

    This section would be expanded to allow sources that are listed in 
the SSDR for manual brachytherapy to be used for other medical uses 
that are not explicitly listed in the SSDR.
    Paragraph (a). This paragraph would be amended to allow sources 
that are listed in the SSDR for manual brachytherapy medical uses to be 
used for other manual brachytherapy medical uses that are not 
explicitly listed in the SSDR provided that these sources are used in 
accordance with the radiation safety conditions and limitations 
described in the SSDR. These radiation safety conditions and 
limitations described in the SSDR may apply to storage, handling, 
sterilization, conditions of use, and leak testing of radiation 
sources.
    The NRC recognizes that the medical uses specified in the SSDR may 
not be all inclusive. The proposed revision would permit physicians to 
use manual brachytherapy sources to treat sites or diseases not listed 
in the SSDR. For example, the SSDR may specify that the sources are for 
interstitial uses, but the proposed change would allow the physician to 
use the sources for a topical use. The NRC has determined this latitude 
should be afforded to physicians to use at their discretion in the 
practice of medicine.

Section 35.433 Decay of Strontium-90 Sources for Ophthalmic Treatments

    The section title would be modified to delete ``Decay of'' at the 
beginning of the title. The new title would reflect the expanded 
information and requirements in the section.
    Paragraph (a). This paragraph would be amended and expanded to 
allow certain individuals who are not AMPs to calculate the activity of 
strontium-90 (Sr-90) sources that is used to determine the treatment 
times for ophthalmic treatments. These individuals, defined in Sec.  
35.2 as ophthalmic physicists, would have to meet the T&E requirements 
detailed in the new paragraph (a)(2) of this section to perform the 
specified activities but would not require an attestation. These 
requirements are similar to the T&E requirements for an AMP, but 
include only the requirements related to brachytherapy programs.
    This amendment is proposed to increase the number of qualified 
individuals available to support the use of Sr-90 sources for 
ophthalmic treatments. Often, AUs who work in remote areas do not have 
ready access to an AMP to perform the necessary calculation to support 
the ophthalmic treatment. This proposed change would make the procedure 
involving use of Sr-90 sources for ophthalmic treatments available to 
more patients located in remote areas.
    Paragraph (b). This new paragraph would establish the tasks that 
individuals qualified in paragraph (a) of this section would be 
required to perform in supporting ophthalmic treatments with Sr-90. The 
first task is based upon the requirements in Sec.  35.432 for 
calculating the activity of each Sr-90 source used for ophthalmic 
treatments. This is not a new requirement, as it is required in the 
current regulation under Sec.  35.433(a).
    The second task is related to the requirements in Sec.  35.41 and 
is included in this proposed rule to ensure the safe use of Sr-90 for 
ophthalmic treatments. Both the AMP and the individuals identified 
under paragraph (a)(2) of this section would be required to assist the 
licensee in developing, implementing, and maintaining written 
procedures to provide high confidence that the dose administration is 
in accordance with the WD. Under this paragraph, the licensee would 
have to modify its procedures required under Sec.  35.41 to specify the 
frequencies that the AMP and/or the individuals identified under 
paragraph (a)(2) of this section would observe treatments, review the 
treatment methodology, calculate treatment time for the prescribed 
dose, and review records to verify that the treatment was administered 
in accordance with the WD.
    Paragraph (c). This new paragraph would be unchanged from the 
recordkeeping requirements in the current regulation under Sec.  
35.433(b).

Section 35.490 Training for Use of Manual Brachytherapy Sources

    Paragraph (a). For a physician seeking to be named as an AU of a 
manual brachytherapy source for the uses authorized under Sec.  35.400, 
the requirement to obtain a written attestation would be removed for an 
individual who is certified by a specialty board whose certification 
process has been recognized by the NRC or an Agreement State. Further 
discussion on removing the written attestation requirement can be found 
in Section IV, Discussion, of this document.
    Paragraph (b)(1)(ii). This paragraph would be amended to require 
that the work experience required by this section must be received at a 
medical facility authorized to use byproduct materials under Sec.  
35.400 rather than at a medical institution. The current term

[[Page 42427]]

``medical institution'' in this paragraph is defined in Sec.  35.2 as 
an organization in which more than one medical discipline is practiced. 
This definition unnecessarily limits where the work experience must be 
obtained. Moreover, the fact that an organization practices more than 
one medical discipline does not ensure that one of the medical 
disciplines will be related to uses authorized under Sec.  35.400. The 
proposed change would allow the work experience to be received at a 
stand-alone single discipline clinic and also ensure that the work 
experience is related to the uses authorized under Sec.  35.400.
    Paragraph (b)(3). This paragraph would be restructured and expanded 
to allow certain residency program directors to provide written 
attestations for physicians seeking to be named as an AU of a manual 
brachytherapy source for the uses authorized under Sec.  35.400. The 
residency program directors must represent a residency training program 
approved by the Residency Review Committee of the Accreditation Council 
for Graduate Medical Education or the Royal College of Physicians and 
Surgeons of Canada or the Committee on Post-Graduate Training of the 
American Osteopathic Association. The residency training program must 
include T&E specified in Sec.  35.400.
    The residency program directors who provide written attestations do 
not have to be AUs who meet the requirements in Sec. Sec.  35.57, 
35.490 or equivalent Agreement State requirements. However, they must 
affirm in writing that the attestation represents the consensus of the 
residency program faculty where at least one faculty member is an AU 
who meets the requirements in Sec. Sec.  35.57, 35.490, or equivalent 
Agreement State requirements, and that the AU concurs with the 
attestation.
    Additionally, the paragraph would be amended to incorporate the new 
language that the written attestation would verify that the physician 
is able to independently fulfill the radiation safety-related duties, 
rather than has achieved a level of competency to function 
independently, as an AU.

Section 35.491 Training for Ophthalmic Use of Strontium-90

    Paragraph (b)(3). This paragraph would be amended to incorporate 
the new language that the written attestation would verify that the 
physician is able to independently fulfill the radiation safety-related 
duties, rather than has achieved a level of competency to function 
independently, as an AU.

Section 35.500 Use of Sealed Sources for Diagnosis

    The section would be restructured and expanded to include the use 
of medical devices to allow sealed sources and medical devices that are 
listed in the SSDR for diagnostic medical uses to be used for 
diagnostic medical uses that are not explicitly listed in the SSDR, and 
to allow sealed sources and medical devices to be used in research in 
accordance with an active Investigational Device Exemption (IDE) 
application accepted by the FDA. The section title would be modified to 
add ``and medical devices'' as the use of medical devices is added to 
this section.
    Paragraph (a). This paragraph would be amended to clarify that 
sealed sources not in medical devices for diagnostic medical uses 
approved in the SSDR can be used for other diagnostic medical uses that 
are not explicitly listed in an SSDR provided that they are used in 
accordance with radiation safety conditions and limitations described 
in the SSDR. These radiation safety conditions and limitations 
described in the SSDR may include storage, handling, sterilization, 
conditions of use, and leak testing of radiation sources.
    Paragraph (b). This paragraph would be added to allow diagnostic 
devices containing sealed sources to be used for diagnostic medical 
uses if both are approved in the SSDR for diagnostic medical uses that 
are not explicitly listed in an SSDR, provided that they are used in 
accordance with radiation safety conditions and limitations described 
in the SSDR. These radiation safety conditions and limitations 
described in the SSDR may include storage, handling, sterilization, 
conditions of use, and leak testing of radiation sources.
    Paragraph (c). This new paragraph would allow sealed sources and 
devices for diagnostic medical uses to be used in research in 
accordance with an active IDE application accepted by the FDA, provided 
the requirements of Sec.  35.49(a) are met.

Section 35.590 Training for Use of Sealed Sources and Medical Devices 
for Diagnosis

    This section would be restructured and expanded to clarify that 
both diagnostic sealed sources and devices authorized in Sec.  35.500 
are included in the T&E requirements of this section.
    Paragraph (b). This new paragraph would recognize the individuals 
who are authorized for imaging uses listed in Sec.  35.200, or 
equivalent Agreement State requirements, for use of diagnostic sealed 
sources or devices authorized under Sec.  35.500.

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

    The section would be amended to separate the uses of photon-
emitting remote afterloader units, teletherapy units, or gamma 
stereotactic radiosurgery units from the uses of the sealed sources 
contained within these units. The amended section would allow only 
sealed sources approved in the SSDR in devices to deliver therapeutic 
medical treatments as provided for in the SSDR; however, the units 
containing these sources could be used for therapeutic medical 
treatments that are not explicitly provided for in the SSDR, provided 
that they are used in accordance with radiation safety conditions and 
limitations described in the SSDR. The purpose of this amendment is to 
allow physicians flexibility to exercise their medical judgment and to 
use these devices for new therapeutic treatments that may not have been 
anticipated when the devices were registered.
    Paragraph (a). This paragraph would require that a licensee use 
only sealed sources approved in the SSDR for therapeutic medical uses 
in photon-emitting remote afterloader units, teletherapy units, or 
gamma stereotactic radiosurgery units as provided for in the SSDR or 
for research in accordance with an active IDE application accepted by 
the FDA, provided the requirements of Sec.  35.49(a) are met.
    Paragraph (b). This paragraph would continue to require that a 
licensee only use photon emitting remote afterloader units, teletherapy 
units, or gamma stereotactic radiosurgery units approved in the SSDR or 
for research in accordance with an active IDE application accepted by 
the FDA provided the requirements of Sec.  35.49(a) are met. However, 
this paragraph would be amended to provide that these units may be used 
for medical uses that are not explicitly provided for in the SSDR, 
provided that these units are used in accordance with the radiation 
safety conditions and limitations described in the SSDR.

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

    Paragraph (d)(1). This paragraph would be amended and restructured 
to add a new training requirement for the

[[Page 42428]]

use of remote afterloader units, teletherapy units, and gamma 
stereotactic radiosurgery units. This proposed amendment would require 
all individuals who would operate these units to receive vendor 
operational and safety training prior to the first use for patient 
treatment of a new unit or an existing unit with a manufacturer upgrade 
that affects the operation and safety of the unit. This training must 
be provided by the device manufacturer or by an individual certified by 
the device manufacturer to provide the training.
    Currently, Sec.  35.610(d) requires that an individual who operates 
these units be provided safety instructions initially, and at least 
annually; however, there is no requirement for this individual to 
receive instructions when the unit is upgraded. In addition, the 
proposed amendment would require an individual who operates these new 
or upgraded units to receive training prior to first use for patient 
treatment.
    Paragraph (d)(2). This paragraph would be restructured and amended 
to clarify that the training required by this paragraph on the 
operation and safety of the unit applies to any new staff who will 
operate the unit or units at the facility. This requirement would be 
added to enhance the safety of patients by eliminating the potential 
for training of new staff to be delayed until the required annual 
training, which could lead to having undertrained individuals operating 
the unit.
    Paragraph (g). This paragraph would be amended to conform with the 
restructuring of paragraph (d)(2) of this section.

Section 35.655 Five-Year Inspection for Teletherapy and Gamma 
Stereotactic Radiosurgery Units

    The section title would be modified to delete ``Five-year 
inspection'' and insert ``Full-inspection servicing'' to more 
accurately reflect the requirements in the section of inspection and 
servicing of teletherapy unit and gamma stereotactic radiosurgery 
units.
    Paragraph (a). This paragraph would be amended to extend the full 
inspection and servicing interval between each full inspection 
servicing for gamma stereotactic radiosurgery units from 5 years to 7 
years to assure proper functioning of the source exposure mechanism. 
The interval between each full inspection and servicing of teletherapy 
units would remain the same (not to exceed 5 years). For gamma 
stereotactic radiosurgery units, the full inspection and servicing to 
assure proper functioning of the source exposure mechanism is performed 
when the sources are taken out of the unit and before the new sources 
are placed in the unit (source replacement). Since the cost to replace 
the decaying sources in a gamma stereotactic radiosurgery unit can be 
exorbitant, licensees have requested that the intervals between each 
full inspection servicing for these units be extended beyond 5 years. 
The NRC finds that the 6-month routine preventive maintenance that is 
performed on these units is adequate to assure the proper functioning 
of the source exposure mechanisms and that therefore this extension may 
be granted. Additionally, the paragraph would require that the full 
inspection and servicing of these units be performed during each source 
replacement regardless of the last time that the units were inspected 
and serviced.
    The full inspection and servicing interval of a teletherapy unit 
has not been extended from the current interval of 5 years to help 
prevent potentially serious radiation exposure of teletherapy operators 
and patients in the event that the source exposure mechanism failed. 
The radioactive source contained in a teletherapy unit produces 
radiation fields on the order of hundreds of rads per minute in areas 
accessible to patients and operators. In the event of a source exposure 
mechanism failure, the exposed source could result in overexposure of a 
patient or operating personnel in a short period of time.

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

    Paragraph (a). For a physician seeking to be named as an AU for 
sealed sources for uses authorized under Sec.  35.600, the requirement 
to obtain a written attestation would be removed for an individual who 
is certified by a specialty board whose certification process has been 
recognized by the NRC or an Agreement State. Further discussion on 
removing the written attestation requirement can be found in Section 
IV, Discussion, of this document.
    Paragraph (b)(1)(ii). This paragraph would be amended to require 
that the work experience required by this section must be received at a 
medical facility authorized to use byproduct materials under Sec.  
35.600 rather than at a medical institution. The current term ``medical 
institution'' in this paragraph is defined in Sec.  35.2 as an 
organization in which more than one medical discipline is practiced. 
This definition unnecessarily limits where the work experience must be 
obtained. Moreover, the fact that an organization practices more than 
one medical discipline does not ensure that one of the medical 
disciplines will be related to uses authorized under Sec.  35.600. The 
proposed change would allow the work experience to be received at a 
stand-alone single discipline clinic for the uses authorized under 
Sec.  35.600.
    Paragraph (b)(3). This paragraph would be restructured and expanded 
to allow certain residency program directors to provide written 
attestations for physicians seeking to be named as an AU for sealed 
sources for uses authorized under Sec.  35.600. The residency program 
directors must represent a residency training program approved by the 
Residency Review Committee of the Accreditation Council for Graduate 
Medical Education, the Royal College of Physicians and Surgeons of 
Canada, or the Committee on Post-Graduate Training of the American 
Osteopathic Association. The residency training program must include 
T&E specified in Sec.  35.690.
    The residency program directors who provide written attestations do 
not have to be AUs who meet the requirements in Sec. Sec.  35.57, 
35.690, or equivalent Agreement State requirements, for the type(s) of 
therapeutic medical unit(s) for which the individual is requesting AU 
status. However, they must affirm in writing that the attestation 
represents the consensus of the residency program faculty where at 
least one faculty member is an AU who meets the requirements in 
Sec. Sec.  35.57, 35.690, or equivalent Agreement State requirements, 
for the type(s) of therapeutic medical unit(s) for which the individual 
is requesting AU status and that the AU concurs with the attestation.
    Additionally, the paragraph would be amended to incorporate the new 
language that the written attestation would verify that the physician 
is able to independently fulfill the radiation safety-related duties, 
rather than has achieved a level of competency to function 
independently, as an AU.

Section 35.2024 Records of Authority and Responsibilities for Radiation 
Protection Programs

    Paragraph (c). This new paragraph would require the licensee to 
keep records of each ARSO assigned under Sec.  35.24(b) for 5 years 
after the ARSO is removed from the license. These records would have to 
include the written document appointing the ARSO signed by the 
licensee's management and each agreement signed by the ARSO listing the 
duties and tasks assigned by the RSO under Sec.  35.24(b).

[[Page 42429]]

Section 35.2310 Records of Safety Instruction

    This section would be amended to conform to the changes proposed in 
Sec.  35.610 by adding a requirement to maintain the operational and 
safety instructions required by Sec.  35.610.

Section 35.2655 Records of 5-Year Inspection for Teletherapy and Gamma 
Stereotactic Radiosurgery Units

    The section title would be modified to delete ``5-year inspection'' 
and insert ``full-inspection servicing'' to reflect the proposed 
changes to Sec.  35.655 requiring full inspection and servicing of 
teletherapy units and gamma stereotactic radiosurgery units.

Section 35.3045 Report and Notification of a Medical Event

    Paragraph (a) of this section would be restructured and amended to 
specify separate specific criteria for reporting an ME involving 
permanent implant brachytherapy. These new criteria would be different 
from the criteria for reporting an ME for other administrations that 
require a WD.
    Paragraph (a)(1). This new paragraph would have criteria for 
reporting an ME for administrations that require a WD other than 
permanent implant brachytherapy. Criteria for reporting an ME involving 
permanent implant brachytherapy would be in a new paragraph (a)(2) in 
this section. The criteria used to determine if an ME has occurred for 
administrations that require a WD other than permanent implant 
brachytherapy would be unchanged except (1) the current paragraph 
(a)(3) related to the dose to the skin or an organ or tissue other than 
the treatment site would be restructured for clarity as the new 
paragraph (a)(1)(iii); and (2) a criterion would be added in the new 
paragraph (a)(1)(ii)(A) of this section for reporting as an ME an 
administration involving the wrong radionuclide for a brachytherapy 
procedure.
    Paragraph (a)(2). This new paragraph would be added to establish 
separate criteria for reporting MEs involving permanent implant 
brachytherapy. These new criteria are designed to ensure reporting of 
situations where harm or potential harm to the patient may occur. The 
new criteria for reporting an ME involving permanent implant 
brachytherapy include:
    (1) The total source strength administered differing by 20 percent 
or more from the total source strength documented in the post-
implantation portion of the WD. An example of a situation that would 
meet this criterion would be if the sealed sources, which were 
implanted, had a different source strength than what was intended. This 
situation could occur from ordering, or a vendor shipping, sealed 
sources with the wrong activity;
    (2) The total source strength administered outside of the treatment 
site exceeding 20 percent of the total source strength documented in 
the post-implantation portion of the WD. An example of a situation that 
would meet this criterion would be if sealed sources are 
unintentionally implanted outside of the treatment site. This situation 
would be identified by the licensee when determinations are made that 
are related to 10 CFR 35.41;
    (3) An absorbed dose to the maximally exposed 5 contiguous cubic 
centimeters of normal tissue located outside of the treatment site that 
exceeds by 50 percent or more of the absorbed dose prescribed to the 
treatment site by an AU in the pre-implantation portion of the WD. The 
ACMUI recommended that for this criterion the absorbed dose to normal 
tissue should be measured in a volume large enough such that small 
fluctuations, such as a single source out of place, would not result in 
an ME. The ACMUI's recommendation for selecting 5 contiguous cubic 
centimeters volume related to organ at risk toxicity is based on an 
article entitled, ``Proposed guidelines for image-based intracavitary 
brachytherapy for cervical carcinoma: Report from Image-Guided 
Brachytherapy Working Group,'' by S. Nag, H. Cardenes, S. Chang, I. 
Das, B. Erickson, G. Ibbott, J. Lowenstein, J. Roll, B. Thomadsen, M. 
Varia, in the International Journal of Radiation Oncology and Bio 
Physics 60:1160-1172, 2004.
    An example of a situation that would meet this criterion would be 
if sealed sources are not implanted in the treatment site in a 
spatially distributed manner, i.e., they are bunched or grouped rather 
than spatially distributed. This could result in a higher dose than was 
expected or desired to normal tissues that are located close to the 
treatment site.
    (4) An absorbed dose to the maximally exposed 5 contiguous cubic 
centimeters of normal tissue located within the treatment site that 
exceeds by 50 percent or more of the absorbed dose to that tissue based 
on the pre-implantation dose distribution approved by an AU. The ACMUI 
recommended with regard to this criterion that the absorbed dose to 
normal tissue should be measured in a volume large enough such that 
small fluctuations, such as a single source out of place, would not 
result in an ME. The 5 contiguous cubic centimeters proposed is the 
largest volume related to organ at risk toxicity in the literature 
referenced in criterion 3.
    An example of a situation that would meet this criterion would be 
if sealed sources are not implanted in the treatment site as intended. 
The unintended higher dose could be from the sealed sources being 
bunched or grouped close to the normal tissue rather than spatially 
distributed or from sealed sources being unintentionally implanted into 
the normal tissue. This could result in a higher dose than was expected 
or desired to normal tissues that are located within the treatment 
site.
    (5) An administration that includes the wrong radionuclide; the 
wrong individual or human research subject; sealed sources directly 
delivered to the wrong treatment site; a leaking sealed source 
resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue; 
or a 20 percent or more error in calculating the total source strength 
documented in the pre-implantation portion of the WD. Only the proposed 
criteria for a leaking sealed source retains the dose threshold in 
current regulations because the NRC determined the leaking sealed 
source delivering a dose below this threshold does not need to be 
reported as a medical event.
    Several situations that would meet this criterion are self-evident, 
i.e., wrong patient, wrong treatment site, or leaking sealed source. An 
error of 20 percent or more in calculating the total source strength 
could lead to implanting the wrong number of sealed sources, which 
could result in an under- or over-dosing of the treatment area and 
possibly a higher dose to normal tissue than was expected.

Section 35.3204 Report and Notification for an Eluate Exceeding 
Permissible Molybdenum-99, Strontium-82, and Strontium-85 
Concentrations

    This new section would be added to require reporting and 
notification of an elution from a Mo-99/Tc-99m or Sr-82/Rb-82 generator 
that exceeds the regulatory requirements in Sec. Sec.  30.34 and 
35.204(a). Further discussion on reporting failed generators can be 
found in Section IV, Discussion, of this document.
    Paragraph (a). This new section would require a licensee to notify 
both the NRC Operations Center and the manufacturer/distributor of the 
generator by telephone within 30 calendar days after discovery that an 
eluate exceeds the permissible concentration listed in Sec.  35.204(a). 
This

[[Page 42430]]

notification would include the manufacturer, model number, and serial 
number (or lot number) of the generator; the results of the 
measurement; the date of the measurement; whether dosages were 
administered to patients or human research subjects; whether the 
manufacturer/distributor was notified; and the action taken.
    Paragraph (b). This new section would require a licensee to submit 
a written report to the appropriate NRC Regional Office listed in Sec.  
30.6 within 45 days after discovery of an eluate exceeding the 
permissible concentration. The report would have to be submitted by an 
appropriate method listed in Sec.  30.6(a). The report would include 
the action taken by the licensee, patient dose assessments, the 
methodology used in making the patient dose assessment if the eluate 
was administered to patients or human research subjects, probable cause 
and assessment of failure in the licensee's equipment, procedures or 
training that contributed to the excessive readings if an error 
occurred in the licensee's breakthrough determination, and the 
information in the telephone report as required by paragraph (a) of 
this section.
Administrative Changes to Authority Citations
    The authority citations for 10 CFR parts 30, 32, and 35 would be 
revised to make editorial changes that are administrative in nature, 
including inserting missing parentheses and punctuation. The proposed 
revisions would not change the statutory authority.

VI. Criminal Penalties

    For the purpose of Section 223 of the Atomic Energy Act of 1954, as 
amended (AEA), the Commission is proposing to amend 10 CFR parts 30, 
32, and 35 under one or more of Sections 161b, 161i, or 161o of the 
AEA. Willful violations of the rule would be subject to criminal 
enforcement.

VII. Coordination With NRC Agreement States

    The Agreement States have been involved throughout the development 
of this proposed rule. Agreement State representatives have served on 
the rulemaking working group that has developed the proposed amendments 
to 10 CFR part 35 and on the steering committee for the rulemaking.
    Through an All Agreement State Letter (FSME-11-044, dated May 20, 
2011, ADAMS Accession No. ML111400231), the Agreement States were 
notified of the availability of preliminary rule text for comments 
posted on www.regulations.gov and noticed in the Federal Register (76 
FR 29171; May 20, 2011). The Federal Register notice also invited the 
Agreement States to participate at the two public workshops that were 
held in New York City, New York, and Houston, Texas, during the summer 
of 2011. Finally, in preparing the proposed amendments, the rulemaking 
working group considered the comments provided by the Agreement States.

VIII. Agreement State Compatibility

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' approved by the Commission on June 30, 1997, 
and published in the Federal Register (62 FR 46517; September 3, 1997), 
this proposed rule would be a matter of compatibility between the NRC 
and the Agreement States, thereby providing consistency among the 
Agreement States and NRC requirements. The NRC staff analyzed the 
proposed rule in accordance with the procedure established within Part 
III, ``Categorization Process for NRC Program Elements,'' of Handbook 
5.9 to Management Directive 5.9, ``Adequacy and Compatibility of 
Agreement State Programs'' (a copy of which may be viewed at https://www.nrc.gov/reading-rm/doc-collections/management-directives/). The 
Agreement States have 3 years from the effective date of the final rule 
in the Federal Register to adopt compatible regulations.
    The NRC program elements (including regulations) are placed into 
four compatibility categories (See the Draft Compatibility Table for 
Proposed Rule in this section). In addition, the NRC program elements 
can also be identified as having particular health and safety 
significance or as being reserved solely by the NRC. Compatibility 
Category A contains those program elements that are basic radiation 
protection standards and scientific terms and definitions that are 
necessary to understand radiation protection concepts. An Agreement 
State should adopt Category A program elements in an essentially 
identical manner to provide uniformity in the regulation of agreement 
material on a nationwide basis. Compatibility Category B contains those 
program elements that apply to activities that have direct and 
significant effects in multiple jurisdictions. An Agreement State 
should adopt Category B program elements in an essentially identical 
manner. Compatibility Category C contains those program elements that 
do not meet the criteria of Category A or B, but provide the essential 
objectives, which an Agreement State should adopt to avoid conflict, 
duplication, gaps, or other conditions that would jeopardize an orderly 
pattern in the regulation of agreement material on a nationwide basis. 
An Agreement State should adopt the essential objectives of the 
Category C program elements. Compatibility Category D contains those 
program elements that do not meet any of the criteria of Categories A, 
B, or C, and, therefore, do not need to be adopted by the Agreement 
States for purposes of compatibility.
    The Health and Safety (H&S) category contains program elements that 
are not required for compatibility but are identified as having a 
particular health and safety role (i.e., adequacy) in the regulation of 
agreement material within the State. Although not required for 
compatibility, the State should adopt program elements in this H&S 
category based on those of the NRC that embody the essential objectives 
of NRC program elements because of particular health and safety 
considerations. Compatibility Category NRC are those program elements 
that address areas of regulation that cannot be relinquished to the 
Agreement States under the Atomic Energy Act, as amended, or provisions 
of 10 CFR. These program elements are not adopted by the Agreement 
States. The following table lists the parts and sections that would be 
revised and their corresponding categorization under the ``Policy 
Statement on Adequacy and Compatibility of Agreement State Programs.'' 
A bracket around a category means that the section may have been 
adopted elsewhere, and it is not necessary to adopt it again.
    The NRC invites comment on the compatibility category designations 
in the proposed rule and suggests that commenters refer to Handbook 5.9 
of Management Directive 5.9 for more information. The NRC notes that, 
like the rule text, the compatibility category designations can change 
between the proposed rule and final rule, based on comments received 
and Commission decisions regarding the final rule. The NRC encourages 
anyone interested in commenting on the compatibility category 
designations in any manner to do so during the comment period. 
Discussion on changing the Compatibility Category for Sec.  35.3045, 
Report and notification of a medical event, can be found in Section IV, 
Discussion, of this document.

[[Page 42431]]



                                   Draft Compatibility Table for Proposed Rule
----------------------------------------------------------------------------------------------------------------
                                                                                               Compatibility
               Section                          Change                   Subject         -----------------------
                                                                                           Existing       New
----------------------------------------------------------------------------------------------------------------
                                                     Part 30
----------------------------------------------------------------------------------------------------------------
30.34(g).............................  Amend...................  Terms and conditions of          B           B
                                                                  licenses.
----------------------------------------------------------------------------------------------------------------
                                                     Part 32
----------------------------------------------------------------------------------------------------------------
32.72(a)(4)..........................  Amend...................  Manufacture,                     B           B
                                                                  preparation, or
                                                                  transfer for
                                                                  commercial
                                                                  distribution of
                                                                  radioactive drugs
                                                                  containing byproduct
                                                                  material for medical
                                                                  use under 10 CFR part
                                                                  35.
32.72(b)(5)(i).......................  Amend...................  Manufacture,                     B           B
                                                                  preparation, or
                                                                  transfer for
                                                                  commercial
                                                                  distribution of
                                                                  radioactive drugs
                                                                  containing byproduct
                                                                  material for medical
                                                                  use under 10 CFR part
                                                                  35.
32.72(d).............................  New.....................  Manufacture,             ..........          B
                                                                  preparation, or
                                                                  transfer for
                                                                  commercial
                                                                  distribution of
                                                                  radioactive drugs
                                                                  containing byproduct
                                                                  material for medical
                                                                  use under 10 CFR part
                                                                  35.
----------------------------------------------------------------------------------------------------------------
                                                     Part 35
----------------------------------------------------------------------------------------------------------------
35.2.................................  New.....................  Definitions--Associate   ..........          B
                                                                  Radiation Safety
                                                                  Officer.
35.2.................................  New.....................  Definitions--Ophthalmic  ..........          B
                                                                  physicist.
35.2.................................  Amend...................  Definitions--Preceptor.          D           D
35.12(b)(1)..........................  Amend...................  Application for                  D           D
                                                                  license, amendment, or
                                                                  renewal.
35.12(c)(1)..........................  Amend...................  Application for                  D           D
                                                                  license, amendment, or
                                                                  renewal.
35.12(c)(1)(ii)......................  Amend...................  Application for                  D           D
                                                                  license, amendment, or
                                                                  renewal.
35.12(d).............................  Amend...................  Application for                  D           D
                                                                  license, amendment, or
                                                                  renewal.
35.12(d)(1)..........................  New.....................  Application for          ..........          D
                                                                  license, amendment, or
                                                                  renewal.
35.12(d)(2)..........................  New.....................  Application for          ..........          D
                                                                  license, amendment, or
                                                                  renewal.
35.12(d)(3)..........................  New.....................  Application for          ..........          D
                                                                  license, amendment, or
                                                                  renewal.
35.12(d)(4)..........................  Amend...................  Application for                  D           D
                                                                  license, amendment, or
                                                                  renewal.
35.13(b).............................  Amend...................  License amendments.....          D           D
35.13(d).............................  New.....................  License amendments.....  ..........          D
35.13(i).............................  New.....................  License amendments.....  ..........          D
35.14(a).............................  Amend...................  Notifications..........          D           D
35.14(b)(1)..........................  Amend...................  Notifications..........          D           D
35.14(b)(2)..........................  Amend...................  Notifications..........          D           D
35.14(b)(6)..........................  New.....................  Notifications..........  ..........          D
35.24(b).............................  Amend...................  Authority and                  H&S         H&S
                                                                  responsibilities for
                                                                  the radiation
                                                                  protection program.
35.24(c).............................  Amend...................  Authority and                    D           D
                                                                  responsibilities for
                                                                  the radiation
                                                                  protection program.
35.40(b)(6)..........................  Amend...................  Written directives.....        H&S         H&S
35.41(b)(5)..........................  New.....................  Procedures for           ..........        H&S
                                                                  administrations
                                                                  requiring a written
                                                                  directive.
35.41(b)(6)..........................  New.....................  Procedures for           ..........        H&S
                                                                  administrations
                                                                  requiring a written
                                                                  directive.
35.50................................  Amend...................  Training for Radiation           B           B
                                                                  Safety Officer and
                                                                  Associate Radiation
                                                                  Safety Officer.
35.50(a).............................  Amend...................  Training for Radiation           B           B
                                                                  Safety Officer and
                                                                  Associate Radiation
                                                                  Safety Officer.
35.50(a)(2)(ii)(B)...................  Amend...................  Training for Radiation           B           B
                                                                  Safety Officer and
                                                                  Associate Radiation
                                                                  Safety Officer.
35.50(b)(1)(ii)......................  Amend...................  Training for Radiation           B           B
                                                                  Safety Officer and
                                                                  Associate Radiation
                                                                  Safety Officer.
35.50(b)(2)..........................  New.....................  Training for Radiation   ..........          B
                                                                  Safety Officer and
                                                                  Associate Radiation
                                                                  Safety Officer.
35.50(c)(1)..........................  Amend...................  Training for Radiation           B           B
                                                                  Safety Officer and
                                                                  Associate Radiation
                                                                  Safety Officer.
35.50(c)(2)..........................  Amend...................  Training for Radiation           B           B
                                                                  Safety Officer and
                                                                  Associate Radiation
                                                                  Safety Officer.
35.50(c)(3)..........................  New.....................  Training for Radiation   ..........          B
                                                                  Safety Officer and
                                                                  Associate Radiation
                                                                  Safety Officer.
35.50(d).............................  Amend...................  Training for Radiation           B           B
                                                                  Safety Officer and
                                                                  Associate Radiation
                                                                  Safety Officer.
35.51(a).............................  Amend...................  Training for an                  B           B
                                                                  authorized medical
                                                                  physicist.
35.51(a)(2)(i).......................  Amend...................  Training for an                  B           B
                                                                  authorized medical
                                                                  physicist.
35.51(b)(2)..........................  Amend...................  Training for an                  B           B
                                                                  authorized medical
                                                                  physicist.
35.55(a).............................  Amend...................  Training for an                  B           B
                                                                  authorized nuclear
                                                                  pharmacist.
35.55(b)(2)..........................  Amend...................  Training for an                  B           B
                                                                  authorized nuclear
                                                                  pharmacist.
35.57(a)(1)..........................  Amend...................  Training for                     B           B
                                                                  experienced Radiation
                                                                  Safety Officer,
                                                                  teletherapy or medical
                                                                  physicist, authorized
                                                                  medical physicist,
                                                                  authorized user,
                                                                  nuclear pharmacist,
                                                                  and authorized nuclear
                                                                  pharmacist.
35.57(a)(2)..........................  New.....................  Training for             ..........          B
                                                                  experienced Radiation
                                                                  Safety Officer,
                                                                  teletherapy or medical
                                                                  physicist, authorized
                                                                  medical physicist,
                                                                  authorized user,
                                                                  nuclear pharmacist,
                                                                  and authorized nuclear
                                                                  pharmacist.

[[Page 42432]]

 
35.57(a)(3)..........................  New.....................  Training for             ..........          B
                                                                  experienced Radiation
                                                                  Safety Officer,
                                                                  teletherapy or medical
                                                                  physicist, authorized
                                                                  medical physicist,
                                                                  authorized user,
                                                                  nuclear pharmacist,
                                                                  and authorized nuclear
                                                                  pharmacist.
35.57(b)(1)..........................  Amend...................  Training for                     B           B
                                                                  experienced Radiation
                                                                  Safety Officer,
                                                                  teletherapy or medical
                                                                  physicist, authorized
                                                                  medical physicist,
                                                                  authorized user,
                                                                  nuclear pharmacist,
                                                                  and authorized nuclear
                                                                  pharmacist.
35.57(b)(2)..........................  Amend...................  Training for                     B           B
                                                                  experienced Radiation
                                                                  Safety Officer,
                                                                  teletherapy or medical
                                                                  physicist, authorized
                                                                  medical physicist,
                                                                  authorized user,
                                                                  nuclear pharmacist,
                                                                  and authorized nuclear
                                                                  pharmacist.
35.57(b)(2)(i).......................  New.....................  Training for             ..........          B
                                                                  experienced Radiation
                                                                  Safety Officer,
                                                                  teletherapy or medical
                                                                  physicist, authorized
                                                                  medical physicist,
                                                                  authorized user,
                                                                  nuclear pharmacist,
                                                                  and authorized nuclear
                                                                  pharmacist.
35.57(b)(2)(ii)......................  New.....................  Training for             ..........          B
                                                                  experienced Radiation
                                                                  Safety Officer,
                                                                  teletherapy or medical
                                                                  physicist, authorized
                                                                  medical physicist,
                                                                  authorized user,
                                                                  nuclear pharmacist,
                                                                  and authorized nuclear
                                                                  pharmacist.
35.57(b)(2)(iii).....................  New.....................  Training for             ..........          B
                                                                  experienced Radiation
                                                                  Safety Officer,
                                                                  teletherapy or medical
                                                                  physicist, authorized
                                                                  medical physicist,
                                                                  authorized user,
                                                                  nuclear pharmacist,
                                                                  and authorized nuclear
                                                                  pharmacist.
35.57(b)(2)(iv)......................  New.....................  Training for             ..........          B
                                                                  experienced Radiation
                                                                  Safety Officer,
                                                                  teletherapy or medical
                                                                  physicist, authorized
                                                                  medical physicist,
                                                                  authorized user,
                                                                  nuclear pharmacist,
                                                                  and authorized nuclear
                                                                  pharmacist.
35.65(b).............................  New.....................  Authorization for        ..........          D
                                                                  calibration,
                                                                  transmission, and
                                                                  reference sources.
35.65(b)(1)..........................  New.....................  Authorization for        ..........          D
                                                                  calibration,
                                                                  transmission, and
                                                                  reference sources.
35.65(b)(2)..........................  New.....................  Authorization for        ..........          D
                                                                  calibration,
                                                                  transmission, and
                                                                  reference sources.
35.65(c).............................  New.....................  Authorization for        ..........          D
                                                                  calibration,
                                                                  transmission, and
                                                                  reference sources.
35.190(a)............................  Amend...................  Training for uptake,             B           B
                                                                  dilution, and
                                                                  excretion studies.
35.190(c)(2).........................  Amend...................  Training for uptake,             B           B
                                                                  dilution, and
                                                                  excretion studies.
35.190(c)(2)(i)......................  New.....................  Training for uptake,     ..........          B
                                                                  dilution, and
                                                                  excretion studies.
35.190(c)(2)(ii).....................  New.....................  Training for uptake,     ..........          B
                                                                  dilution, and
                                                                  excretion studies.
35.204(b)............................  Amend...................  Permissible molybdenum-        H&S         H&S
                                                                  99, strontium-82, and
                                                                  strontium-85
                                                                  concentrations.
35.204(e)............................  New.....................  Permissible molybdenum-  ..........        H&S
                                                                  99, strontium-82, and
                                                                  strontium-85
                                                                  concentrations.
35.290(a)............................  Amend...................  Training for imaging             B           B
                                                                  and localization
                                                                  studies.
35.290(c)(1)(ii).....................  Amend...................  Training for imaging             B           B
                                                                  and localization
                                                                  studies.
35.290(c)(2).........................  Amend...................  Training for imaging             B           B
                                                                  and localization
                                                                  studies.
35.290(c)(2)(i)......................  New.....................  Training for imaging     ..........          B
                                                                  and localization
                                                                  studies.
35.290(c)(2)(ii).....................  New.....................  Training for imaging     ..........          B
                                                                  and localization
                                                                  studies.
35.300...............................  Amend...................  Use of unsealed                  B           B
                                                                  byproduct material for
                                                                  which a written
                                                                  directive is required.
35.390(a)............................  Amend...................  Training for use of              B           B
                                                                  unsealed byproduct
                                                                  material for which a
                                                                  written directive is
                                                                  required.
35.390(b)(1)(ii)(G)(3)...............  Amend...................  Training for use of              B           B
                                                                  unsealed byproduct
                                                                  material for which a
                                                                  written directive is
                                                                  required.
35.390(b)(1)(ii)(G)(4)...............  New.....................  Training for use of      ..........          B
                                                                  unsealed byproduct
                                                                  material for which a
                                                                  written directive is
                                                                  required.
35.390(b)(1)(ii)(G)(5)...............  New.....................  Training for use of      ..........          B
                                                                  unsealed byproduct
                                                                  material for which a
                                                                  written directive is
                                                                  required.
35.390(b)(2).........................  Amend...................  Training for use of              B           B
                                                                  unsealed byproduct
                                                                  material for which a
                                                                  written directive is
                                                                  required.
35.390(b)(2)(i)......................  New.....................  Training for use of      ..........          B
                                                                  unsealed byproduct
                                                                  material for which a
                                                                  written directive is
                                                                  required.
35.390(b)(2)(ii).....................  New.....................  Training for use of      ..........          B
                                                                  unsealed byproduct
                                                                  material for which a
                                                                  written directive is
                                                                  required.
35.390(c)............................  New.....................  Training for use of      ..........          B
                                                                  unsealed byproduct
                                                                  material for which a
                                                                  written directive is
                                                                  required.
35.392(a)............................  Amend...................  Training for the oral            B           B
                                                                  administration of
                                                                  sodium iodide I-131
                                                                  requiring a written
                                                                  directive in
                                                                  quantities less than
                                                                  or equal to 1.22
                                                                  gigabecquerels (33
                                                                  millicuries).
35.392(c)(3).........................  Amend...................  Training for the oral            B           B
                                                                  administration of
                                                                  sodium iodide I-131
                                                                  requiring a written
                                                                  directive in
                                                                  quantities less than
                                                                  or equal to 1.22
                                                                  gigabecquerels (33
                                                                  millicuries).
35.392(c)(3)(i)......................  New.....................  Training for the oral    ..........          B
                                                                  administration of
                                                                  sodium iodide I-131
                                                                  requiring a written
                                                                  directive in
                                                                  quantities less than
                                                                  or equal to 1.22
                                                                  gigabecquerels (33
                                                                  millicuries).
35.392(c)(3)(ii).....................  New.....................  Training for the oral    ..........          B
                                                                  administration of
                                                                  sodium iodide I-131
                                                                  requiring a written
                                                                  directive in
                                                                  quantities less than
                                                                  or equal to 1.22
                                                                  gigabecquerels (33
                                                                  millicuries).

[[Page 42433]]

 
35.394(a)............................  Amend...................  Training for the oral            B           B
                                                                  administration of
                                                                  sodium iodide I-131
                                                                  requiring a written
                                                                  directive in
                                                                  quantities greater
                                                                  than 1.22
                                                                  gigabecquerels (33
                                                                  millicuries).
35.394(c)(3).........................  Amend...................  Training for the oral            B           B
                                                                  administration of
                                                                  sodium iodide I-131
                                                                  requiring a written
                                                                  directive in
                                                                  quantities greater
                                                                  than 1.22
                                                                  gigabecquerels (33
                                                                  millicuries).
35.394(c)(3)(i)......................  New.....................  Training for the oral    ..........          B
                                                                  administration of
                                                                  sodium iodide I-131
                                                                  requiring a written
                                                                  directive in
                                                                  quantities greater
                                                                  than 1.22
                                                                  gigabecquerels (33
                                                                  millicuries).
35.394(c)(3)(ii).....................  New.....................  Training for the oral    ..........          B
                                                                  administration of
                                                                  sodium iodide I-131
                                                                  requiring a written
                                                                  directive in
                                                                  quantities greater
                                                                  than 1.22
                                                                  gigabecquerels (33
                                                                  millicuries).
35.396(a)............................  Amend...................  Training for the                 B           B
                                                                  parenteral
                                                                  administration of
                                                                  unsealed byproduct
                                                                  material requiring a
                                                                  written directive.
35.396(b)............................  Amend...................  Training for the         ..........          B
                                                                  parenteral
                                                                  administration of
                                                                  unsealed byproduct
                                                                  material requiring a
                                                                  written directive.
35.396(c)............................  Amend...................  Training for the                 B           B
                                                                  parenteral
                                                                  administration of
                                                                  unsealed byproduct
                                                                  material requiring a
                                                                  written directive.
35.396(d)(1).........................  Amend...................  Training for the                 B           B
                                                                  parenteral
                                                                  administration of
                                                                  unsealed byproduct
                                                                  material requiring a
                                                                  written directive.
35.396(d)(2).........................  Amend...................  Training for the                 B           B
                                                                  parenteral
                                                                  administration of
                                                                  unsealed byproduct
                                                                  material requiring a
                                                                  written directive.
35.396(d)(2)(iv).....................  Amend...................  Training for the                 B           B
                                                                  parenteral
                                                                  administration of
                                                                  unsealed byproduct
                                                                  material requiring a
                                                                  written directive.
35.396(d)(3).........................  Amend...................  Training for the                 B           B
                                                                  parenteral
                                                                  administration of
                                                                  unsealed byproduct
                                                                  material requiring a
                                                                  written directive.
35.396(d)(3)(i)......................  New.....................  Training for the         ..........          B
                                                                  parenteral
                                                                  administration of
                                                                  unsealed byproduct
                                                                  material requiring a
                                                                  written directive.
35.396(d)(3)(ii).....................  New.....................  Training for the         ..........          B
                                                                  parenteral
                                                                  administration of
                                                                  unsealed byproduct
                                                                  material requiring a
                                                                  written directive.
35.400(a)............................  Amend...................  Use of sources for                C           C
                                                                  manual brachytherapy.
35.400(b)............................  Amend...................  Use of sources for                C           C
                                                                  manual brachytherapy.
35.433(a)............................  Amend...................  Strontium-90 sources           H&S           B
                                                                  for ophthalmic
                                                                  treatments.
35.433(b)............................  New.....................  Strontium-90 sources     ..........        H&S
                                                                  for ophthalmic
                                                                  treatments.
35.433(b)(1).........................  New.....................  Strontium-90 sources     ..........        H&S
                                                                  for ophthalmic
                                                                  treatments.
35.433(b)(2).........................  New.....................  Strontium-90 sources     ..........        H&S
                                                                  for ophthalmic
                                                                  treatments.
35.433(c)............................  Redesignated............  Strontium-90 sources     ..........        H&S
                                                                  for ophthalmic
                                                                  treatments (Previously
                                                                  35.433(b)).
35.490(a)............................  Amend...................  Training for use of              B           B
                                                                  manual brachytherapy
                                                                  sources.
35.490(b)(1)(ii).....................  Amend...................  Training for use of              B           B
                                                                  manual brachytherapy
                                                                  sources.
35.490(b)(3).........................  Amend...................  Training for use of              B           B
                                                                  manual brachytherapy
                                                                  sources.
35.490(b)(3)(i)......................  New.....................  Training for use of      ..........          B
                                                                  manual brachytherapy
                                                                  sources.
35.490(b)(3)(ii).....................  New.....................  Training for use of      ..........          B
                                                                  manual brachytherapy
                                                                  sources.
35.491(b)(3).........................  Amend...................  Training for ophthalmic          B           B
                                                                  use of strontium-90.
35.500(a)............................  Amend...................  Use of sealed sources            [C]          C
                                                                  and medical devices
                                                                  for diagnosis
                                                                  (Previously 35.500).
35.500(b)............................  New.....................  Use of sealed sources    ..........           C
                                                                  and medical devices
                                                                  for diagnosis.
35.500(c)............................  New.....................  Use of sealed sources    ..........           C
                                                                  and medical devices
                                                                  for diagnosis.
35.590(a)............................  Amend...................  Training for use of              B           B
                                                                  sealed sources for
                                                                  diagnosis.
35.590(b)............................  New.....................  Training for use of      ..........          B
                                                                  sealed sources for
                                                                  diagnosis.
35.590(c)............................  Redesignated............  Training for use of              B           B
                                                                  sealed sources for
                                                                  diagnosis (Previously
                                                                  35.590(b)).
35.590(d)............................  Redesignated............  Training for use of              B           B
                                                                  sealed sources for
                                                                  diagnosis (Previously
                                                                  35.590(c)).
35.600(a)............................  Amend...................  Use of a sealed source            C           C
                                                                  in a remote
                                                                  afterloader unit,
                                                                  teletherapy unit, or
                                                                  gamma stereotactic
                                                                  radiosurgery unit.
35.600(b)............................  Amend...................  Use of a sealed source            C           C
                                                                  in a remote
                                                                  afterloader unit,
                                                                  teletherapy unit, or
                                                                  gamma stereotactic
                                                                  radiosurgery unit.
35.610(d)(1).........................  New.....................  Safety procedures and    ..........        H&S
                                                                  instructions for
                                                                  remote afterloader
                                                                  units, teletherapy
                                                                  units, and gamma
                                                                  stereotactic
                                                                  radiosurgery units.
35.610(d)(2).........................  Amend...................  Safety procedures and          H&S         H&S
                                                                  instructions for
                                                                  remote afterloader
                                                                  units, teletherapy
                                                                  units, and gamma
                                                                  stereotactic
                                                                  radiosurgery units.
35.610(g)............................  Amend...................  Safety procedures and          H&S         H&S
                                                                  instructions for
                                                                  remote afterloader
                                                                  units, teletherapy
                                                                  units, and gamma
                                                                  stereotactic
                                                                  radiosurgery units.
35.655(a)............................  Amend...................  Full-inspection                H&S         H&S
                                                                  servicing for
                                                                  teletherapy and gamma
                                                                  stereotactic
                                                                  radiosurgery units.
35.690(a)............................  Amend...................  Training for use of              B           B
                                                                  remote afterloader
                                                                  units, teletherapy
                                                                  units, and gamma
                                                                  stereotactic
                                                                  radiosurgery units.
35.690(b)(1)(ii).....................  Amend...................  Training for use of              B           B
                                                                  remote afterloader
                                                                  units, teletherapy
                                                                  units, and gamma
                                                                  stereotactic
                                                                  radiosurgery units.
35.690(b)(3).........................  Amend...................  Training for use of              B           B
                                                                  remote afterloader
                                                                  units, teletherapy
                                                                  units, and gamma
                                                                  stereotactic
                                                                  radiosurgery units.

[[Page 42434]]

 
35.690(b)(3)(i)......................  New.....................  Training for use of      ..........          B
                                                                  remote afterloader
                                                                  units, teletherapy
                                                                  units, and gamma
                                                                  stereotactic
                                                                  radiosurgery units.
35.690(b)(3)(ii).....................  New.....................  Training for use of      ..........          B
                                                                  remote afterloader
                                                                  units, teletherapy
                                                                  units, and gamma
                                                                  stereotactic
                                                                  radiosurgery units.
35.2024(c)...........................  New.....................  Records of authority     ..........          D
                                                                  and responsibilities
                                                                  for radiation
                                                                  protection programs.
35.2024(c)(1)........................  New.....................  Records of authority     ..........          D
                                                                  and responsibilities
                                                                  for radiation
                                                                  protection programs.
35.2024(c)(2)........................  New.....................  Records of authority     ..........          D
                                                                  and responsibilities
                                                                  for radiation
                                                                  protection programs.
35.2310..............................  Amend...................  Records of safety                D           D
                                                                  instruction.
35.2655(a)...........................  Amend...................  Records of full-                 D           D
                                                                  inspection servicing
                                                                  for teletherapy and
                                                                  gamma stereotactic
                                                                  radiosurgery units.
35.3045(a)(1)........................  Amend...................  Report and notification           C          B
                                                                  of a medical event.
35.3045(a)(2)........................  New.....................  Report and notification  ..........          B
                                                                  of a medical event.
35.3204(a)...........................  New.....................  Report and notification  ..........           C
                                                                  for an eluate
                                                                  exceeding permissible
                                                                  molybdenum-99,
                                                                  strontium-82, and
                                                                  strontium-85
                                                                  concentrations.
35.3204(b)...........................  New.....................  Report and notification  ..........           C
                                                                  for an eluate
                                                                  exceeding permissible
                                                                  molybdenum-99,
                                                                  strontium-82, and
                                                                  strontium-85
                                                                  concentrations.
----------------------------------------------------------------------------------------------------------------

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

    The NRC staff consults with the ACMUI whenever it identifies an 
issue with implementation of 10 CFR part 35 regulations. Accordingly, 
issues leading to these proposed amendments have been discussed at 
ACMUI meetings over the past 9 years. The ACMUI meetings are 
transcribed. Full transcripts of the ACMUI meetings can be found online 
in the NRC Library at https://www.nrc.gov/reading-rm/doc-collections/acmui/tr. In addition, in SRM-SECY-10-0062, the Commission specifically 
directed the staff to engage the ACMUI in developing the ME definition 
criterion for permanent implant brachytherapy. Further, the proposals 
to revise T&E requirements to eliminate preceptor attestation for 
board-certified individuals, change the language of the attestation, 
and allow a residency director to provide preceptor attestations were 
initiated by the ACMUI in its briefing to the Commission held on April 
29, 2008 (discussed in detail in item b in Section IV, Discussion, of 
this document). Similarly, the issue of naming more than one RSO was 
initiated by the ACMUI at the June 2007 ACMUI meeting (discussed in 
detail in item d in Section IV, Discussion, of this document). Finally, 
the entire ACMUI meeting held on April 20-21, 2011, was devoted to 
discussion of the rulemaking issues addressed in this proposed rule, so 
that the staff would be better able to understand ACMUI's position and 
views on the issues raised.
    In December 2012, the NRC provided the preliminary draft proposed 
rule to the ACMUI for a 90-day review. The draft (ADAMS Accession No. 
ML13014A487) was made public to facilitate the ACMUI review in a public 
forum. The ACMUI discussed the draft proposed rule at two publicly held 
teleconferences on March 5 and March 12, 2013 (conference transcripts 
are available in ADAMS at ML13087A474 and ML13087A477, respectively), 
and provided a final report to the NRC on April 9, 2013 (ADAMS 
Accession No. ML13071A690).
    While the ACMUI was supportive of most of the proposed amendments, 
it expressed concerns on some issues and provided its recommendations 
on those issues. Several comments resulted in revisions to the 
discussion section of this document to provide additional emphasis or 
clarity. However, the NRC did not accept all of the ACMUI 
recommendations. The recommendations that the staff did not accept are 
discussed in a document entitled, ``NRC Staff Responses to the ACMUI 
Comments on the draft Part 35 Proposed Rule'' (ADAMS Accession No. 
ML13179A073).
    In addition, in the report, the ACMUI recommended that for 
permanent implant brachytherapy procedures, licensees be allowed to use 
total source strength as a substitute for total dose for determining 
MEs until the 10 CFR part 35 rulemaking is completed. In response, on 
July 9, 2013, the Commission issued an interim enforcement policy (78 
FR 41125) that addresses this issue.

X. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal 
agencies to write documents in a clear, concise, and well-organized 
manner. The NRC has written this document to be consistent with the 
Plain Writing Act as well as the Presidential Memorandum, ``Plain 
Language in Government Writing,'' published June 10, 1998 (63 FR 
31883). The NRC requests comment on the proposed rule with respect to 
the clarity and effectiveness of the language used.

XI. Consistency With Medical Policy Statement

    The proposed amendments to 10 CFR part 35 are consistent with the 
Commission's Medical Use Policy Statement published August 3, 2000 (65 
FR 47654). This proposed rule is consistent with the Commission's 
statement because it balances the interests of the patient with the 
flexibility needed by the AU to take the actions that he or she deems 
medically necessary, while continuing to enable the NRC to detect 
deficiencies in processes, procedures, and training, as well as any 
misapplication of byproduct materials.

XII. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995 (Pub. 
L. 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 law or 
otherwise impractical. In this proposed rule, the NRC would amend its 
medical use

[[Page 42435]]

regulations related to ME definitions for permanent implant 
brachytherapy; T&E requirements for AUs, medical physicists, RSOs, and 
nuclear pharmacists; consideration of the Ritenour Petition (PRM-35-20) 
to ``grandfather'' certain experienced individuals; measuring Mo 
contamination for each elution and reporting of failed breakthrough 
tests; naming ARSOs on a medical license; and several minor 
clarifications.
    The NRC is not aware of any voluntary consensus standards that 
address the proposed subject matter of this proposed rule. The NRC will 
consider using a voluntary consensus standard if an appropriate 
standard is identified. If a voluntary consensus standard is identified 
for consideration, the submittal should explain why the standard should 
be used.

XIII. Environmental Impact: Categorical Exclusion

    The NRC has determined that the following actions in the proposed 
rule are the types of actions described in categorical exclusions in 10 
CFR 51.22(c)(2) and (c)(3)(i-v):
    (1) The amendments to the general administrative requirements and 
general technical requirements meet the categorical exclusion criteria 
under Sec.  51.22 (c)(2).
    (2) The amendments to sealed sources usage provide clarifications 
to the current regulations and meet the categorical exclusion criteria 
under Sec.  51.22(c)(2).
    (3) The amendments to the requirements for reporting MEs and 
reporting failed generator tests meet the categorical exclusion 
criteria under Sec.  51.22(c)(3)(iii).
    (4) The amendments related to the record-keeping requirements meet 
the categorical exclusion criteria under Sec.  51.22(c)(3)(ii).
    (5) The amendments related to the T&E requirements meet the 
categorical exclusion criteria under Sec.  51.22(c)(3)(iv).
    There are two proposed amendments that do not meet the categorical 
exclusions in Sec.  51.22. Therefore, a draft environmental assessment 
has been prepared for this proposed rule for the two proposed actions 
that do not meet the categorical exclusions in Sec.  51.22 and is 
discussed in Section XIV, Finding of No Significant Environmental 
Impact: Availability, of this document. The proposed amendments that do 
not meet the categorical exclusions in Sec.  51.22 are: (1) Increase 
frequency of measuring Mo-99 tests required in Sec.  35.204, and (2) 
increase the full inspection time interval for a gamma stereotactic 
radiosurgery unit from 5 years to 7 years in Sec.  35.655.

XIV. 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, not to prepare an environmental impact 
statement for this proposed rule because the Commission has concluded 
on the basis of a draft environmental assessment that this proposed 
rule, if adopted, would not be a major Federal action significantly 
affecting the quality of the human environment. The amendments would 
relax certain requirements and eliminate other procedural restrictions 
associated with the medical use of byproduct material. The Commission 
believes these amendments would provide greater flexibility in the 
medical use of byproduct material while continuing to adequately 
protect public health and safety. It is expected that this rule, if 
adopted, would not cause any significant increase in radiation exposure 
to the public or radiation release to the environment beyond the 
exposures or releases currently resulting from the medical use of 
byproduct material.
    The determination of this draft environmental assessment is that 
there will be no significant impact to the public from this action. 
However, the general public should note that the NRC welcomes public 
participation and comments on any aspect of the Environmental 
Assessment.
    The NRC has sent a copy of the Draft Environmental Assessment and 
this proposed rule to every State Liaison Officer and requested their 
comments on the Draft Environmental Assessment. The Draft Environmental 
Assessment is available in ADAMS under Accession No. ML14184A621.

XV. Paperwork Reduction Act Statement

    This proposed rule amends information collection requirements that 
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). The rule would reduce the burden for existing information 
collection requirements. This rule has been submitted to the Office of 
Management and Budget for review and approval of the paperwork 
requirements.
    Type of submission, new or revision: Revision.
    The title of the information collection: 10 CFR parts 30, 32, and 
35, Medical Use of Byproduct Material--Medical Event Definitions, 
Training and Experience, and Clarifying Amendments, Proposed Rule.
    The form number if applicable: NRC Form 313A Series, ``Authorized 
User Training and Experience and Preceptor Attestation.''
    How often the collection is required: The information is collected 
as needed. Reports required under the proposed rule are based on events 
that exceed limits stipulated by various sections of the proposed rule. 
The NRC Form 313A Series or equivalent is required when an applicant or 
licensee applies to have a new individual identified as an AU, RSO, 
ARSO, ANP, or an AMP on a medical use license during a new license, a 
renewal, or an amendment request.
    Who will be required or asked to report: Persons licensed under 10 
CFR parts 30, 32, and 35 who possess and use certain byproduct material 
for medical use.
    An estimate of the number of annual responses: 28,049 (4,095 NRC 
licensees/23,954 Agreement State licensees).
    The estimated number of annual respondents: 7,845 (1,085 NRC/6,401 
Agreement State medical use licensees) and (52 NRC and 307 Agreement 
State radiopharmacy licensees).
    An estimate of the total number of hours needed annually to 
complete the requirement or request: 6,671 hours (963.75 NRC licensees/
5,739.75 Agreement State licensees/-32.5 third-party burden).
    Abstract: The NRC is proposing to amend its regulations related to 
the medical use of byproduct material. In this action the NRC addresses 
three ongoing rulemaking projects and several other related topics. 
First, this rule proposes amendments to the reporting and notification 
requirements for a ME for permanent implant brachytherapy. Second, the 
rule proposes changes to the T&E requirements for AUs, medical 
physicists, RSOs, and nuclear pharmacists; changes to the requirements 
for measuring Mo contaminations and reporting of failed Tc and Rb 
generators; and changes that would allow ARSOs to be named on a medical 
license, as well as other clarifying and conforming amendments. Third, 
the NRC is considering a request filed in a petition for rulemaking 
(PRM-35-20) to ``grandfather'' certain board-certified individuals.
    The NRC is seeking public comment on the potential impact of the 
information collections contained in the proposed rule and on the 
following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the

[[Page 42436]]

NRC, including whether the information will have practical utility?
    2. Is the estimate of burden accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques?
    The public may examine and have copied, for a fee, publicly 
available documents, including the draft supporting statement, at the 
NRC's PDR, One White Flint North, 11555 Rockville Pike, Room O-1 F21, 
Rockville, MD 20852. The OMB clearance package and rule are available 
at the NRC's Web site: https://www.nrc.gov/public-involve/doc-comment/omb/ for 60 days after the signature date of this notice.
    Send comments on any aspect of these proposed information 
collections, including suggestions for reducing the burden and on the 
above issues, by August 20, 2014 to the FOIA, Privacy, and Information 
Collections Branch (T-5 F53), U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, or by Internet electronic mail to 
INFOCOLLECTS.RESOURCE@NRC.GOV and to the Desk Officer, Danielle Y. 
Jones, Office of Information and Regulatory Affairs, NEOB-10202, (3150-
AI63), Office of Management and Budget, Washington, DC 20503. Comments 
received after this date will be considered if it is practical to do 
so, but assurance of consideration cannot be given to comments received 
after this date. You may also email comments to Danielle_Y._Jones@omb.eop.gov or comment by telephone at (202) 395-1741.

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.

XVI. Regulatory Analysis

    The Commission has prepared a draft regulatory analysis on this 
proposed regulation. The analysis examines the costs and benefits of 
the alternatives considered by the Commission.
    The Commission requests public comment on the draft regulatory 
analysis. The draft regulatory analysis is available in ADAMS under 
Accession No. ML14184A620

XVII. Regulatory Flexibility Certification

    In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 
605(b)), the Commission certifies that this rule would not, if 
promulgated, have a significant economic impact on a substantial number 
of small entities. An estimate is provided in Appendix A of the draft 
Regulatory Analysis for this proposed regulation (ADAMS Accession No. 
ML14184A620). The NRC is seeking public comment on the potential impact 
of the proposed rule on small entities. The NRC particularly desires 
comment from licensees who qualify as small businesses, specifically as 
to how the proposed regulation will affect them and how the regulation 
may be tiered or otherwise modified to impose less stringent 
requirements on small entities while still adequately protecting the 
public health and safety and common defense and security. Comments on 
how the regulation could be modified to take into account the differing 
needs of small entities should specifically discuss--
    (a) The size of the business and how the proposed regulation would 
result in a significant economic burden upon it as compared to a larger 
organization in the same business community;
    (b) If the proposed regulation could be further modified to take 
into account the business's differing needs or capabilities;
    (c) The benefits that would accrue, or the detriments that would be 
avoided, if the proposed regulation was modified as suggested by the 
commenter;
    (d) How the proposed regulation, as modified, would more closely 
equalize the impact of the NRC's regulations as opposed to providing 
special advantages to any individuals or groups; and
    (e) How the proposed regulation, as modified, would still 
adequately protect the public health and safety and common defense and 
security.

XVIII. Backfitting and Issue Finality

    The backfitting rule and issue finality provisions of 10 CFR part 
52 (which are found in the regulations at Sec. Sec.  50.109, 70.76, 
72.62, 76.76, and in 10 CFR part 52) do not apply to this proposed 
rule. Title 10 of the CFR parts 30, 32, and 35 do not contain a 
backfitting requirement. Therefore, a backfitting analysis is not 
required.

List of Subjects

10 CFR Part 30

    Byproduct material, Criminal penalties, Government contracts, 
Intergovernmental relations, Isotopes, Nuclear materials, Radiation 
protection, Reporting and recordkeeping requirements.

10 CFR Part 32

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

10 CFR Part 35

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

    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is proposing 
to adopt the following amendments to 10 CFR parts 30, 32, and 35.

PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF 
BYPRODUCT MATERIAL

0
1. The authority citation for part 30 is revised to read as follows:

    Authority:  Atomic Energy Act secs. 81, 82, 161, 181, 182, 183, 
186, 223, 234 (42 U.S.C. 2111, 2112, 2201, 2231, 2232, 2233, 2236, 
2273, 2282); Energy Reorganization Act secs. 201, 202, 206 (42 
U.S.C. 5841, 5842, 5846); Government Paperwork Elimination Act sec. 
1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-
58, 119 Stat. 549 (2005).
    Section 30.7 also issued under Energy Reorganization Act sec. 
211, Pub. L. 95-601, sec. 10, as amended by Pub. L. 102-486, sec. 
2902 (42 U.S.C. 5851). Section 30.34(b) also issued under Atomic 
Energy Act sec. 184 (42 U.S.C. 2234). Section 30.61 also issued 
under Atomic Energy Act sec. 187 (42 U.S.C. 2237).

0
2. In Sec.  30.34, add a third sentence to paragraph (g) to read as 
follows:


Sec.  30.34  Terms and conditions of licenses.

* * * * *
    (g) * * * The licensee shall report the results of any test that 
exceeds the permissible concentration listed in Sec.  35.204(a), in 
accordance with Sec.  35.3204 of this chapter.
* * * * *

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

0
3. The authority citation for part 32 is revised to read as follows:

    Authority:  Atomic Energy Act secs. 81, 161, 181, 182, 183, 223, 
234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy

[[Page 42437]]

Reorganization Act sec. 201 (42 U.S.C. 5841); Government Paperwork 
Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act 
of 2005, sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 
2014, 2021, 2021b, 2111).

0
4. In Sec.  32.72, revise paragraphs (a)(4) and (b)(5)(i), redesignate 
paragraph (d) as paragraph (e), and add a new paragraph (d) to read as 
follows:


Sec.  32.72  Manufacture, preparation, or transfer for commercial 
distribution of radioactive drugs containing byproduct material for 
medical use under part 35.

    (a) * * *
    (4) The applicant commits to the following label requirements:
* * * * *
    (b) * * *
    (5) * * *
    (i) A copy of each individual's certification by a specialty board 
whose certification process has been recognized by the Commission or an 
Agreement State as specified in Sec.  35.55(a) of this chapter; or
* * * * *
    (d) A licensee shall satisfy the labeling requirements in (a)(4) of 
this section.
* * * * *

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

0
5. The authority citation for part 35 is revised to read as follows:

    Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223, 
234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy 
Reorganization Act sec. 201, 206 (42 U.S.C. 5841, 5842, 5846); 
Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504 
note); Energy Policy Act of 2005, sec. 651(e), Pub. L. No. 109-58, 
119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).

0
6. In Sec.  35.2, add, in alphabetical order, the definitions for 
Associate Radiation Safety Officer and Ophthalmic physicist and revise 
the definition for Preceptor to read as follows:


Sec.  35.2  Definitions.

* * * * *
    Associate Radiation Safety Officer means an individual who--
    (1) Meets the requirements in Sec. Sec.  35.50 and 35.59; and
    (2) Is currently identified as an Associate Radiation Safety 
Officer for the types of use of byproduct material for which the 
individual has been assigned duties and tasks by the Radiation Safety 
Officer on--
    (i) A specific medical use license issued by the Commission or an 
Agreement State; or
    (ii) A medical use permit issued by a Commission master material 
licensee.
* * * * *
    Ophthalmic physicist means an individual who meets the requirements 
in Sec.  35.433(a)(2) and is identified as an ophthalmic physicist on a 
specific medical use license issued by the Commission or an Agreement 
State or a medical use permit issued by a Commission master material 
licensee.
* * * * *
    Preceptor means an individual who provides, directs, or verifies 
training and experience required for an individual to become an 
authorized user, an authorized medical physicist, an authorized nuclear 
pharmacist, a Radiation Safety Officer, or an Associate Radiation 
Safety Officer.
* * * * *
0
7. In Sec.  35.12, revise paragraphs (b)(1), (c), and (d) to read as 
follows:


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

* * * * *
    (b) * * *
    (1) Filing an original NRC Form 313, ``Application for Material 
License,'' that includes the facility diagram, equipment, and training 
and experience qualifications of the Radiation Safety Officer, 
Associate Radiation Safety Officer(s), authorized user(s), authorized 
medical physicist(s), ophthalmic physicist(s), and authorized nuclear 
pharmacist(s); and
* * * * *
    (c) A request for a license amendment or renewal must be made by--
    (1) Submitting an original of either--
    (i) NRC Form 313, ``Application for Material License''; or
    (ii) A letter containing all information required by NRC Form 313; 
and
    (2) Submitting procedures required by Sec. Sec.  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:
    (1) Any additional aspects of the medical use of the material that 
are applicable to radiation safety that are not addressed in, or differ 
from, subparts A through C, L, and M of this part;
    (2) Identification of and commitment to follow the applicable 
radiation safety program requirements in subparts D through H of this 
part that are appropriate for the specific Sec.  35.1000 medical use;
    (3) Any additional 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
    (iii) Calibration, maintenance, and repair of instruments and 
equipment necessary for radiation safety; and
    (4) Any other information requested by the Commission in its review 
of the application.
* * * * *
0
8. In Sec.  35.13, revise paragraph (b), redesignate paragraphs (d) 
through (g) as paragraphs (e) through (h), revise redesignated 
paragraphs (g) and (h), and add new paragraphs (d) and (i) to read as 
follows:


Sec.  35.13  License amendments.

* * * * *
    (b) Before it permits anyone to work as an authorized user, 
authorized medical physicist, ophthalmic physicist, or authorized 
nuclear pharmacist under the license, except--
    (1) For an authorized user, an individual who meets the 
requirements in Sec. Sec.  35.59 and 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);
    (2) For an authorized nuclear pharmacist, an individual who meets 
the requirements in Sec. Sec.  35.55(a) and 35.59;
    (3) For an authorized medical physicist, an individual who meets 
the requirements in Sec. Sec.  35.51(a) and 35.59;
    (4) An individual who is identified as an authorized user, an 
authorized nuclear pharmacist, authorized medical physicist, or an 
ophthalmic physicist--
* * * * *
    (d) Before it permits anyone to work as an Associate Radiation 
Safety Officer, or before the Radiation Safety Officer assigns duties 
and tasks to an Associate Radiation Safety Officer that differ from 
those for which this individual is authorized on the license;
* * * * *
    (g) Before it changes the address(es) of use identified in the 
application or on the license;
    (h) Before it revises procedures required by Sec. Sec.  35.610, 
35.642, 35.643, and 35.645, as applicable, where such revision reduces 
radiation safety; and
    (i) Before it receives a sealed source from a different 
manufacturer or of a different model number than authorized by its 
license unless the sealed source is used for manual brachytherapy, is 
listed in the Sealed Source and Device Registry, and is in a quantity 
and for an isotope authorized by the license.
0
9. In Sec.  35.14, revise paragraphs (a) and (b) to read as follows:

[[Page 42438]]

Sec.  35.14  Notifications.

    (a) A licensee shall provide the Commission, no later than 30 days 
after the date that the licensee permits an individual to work under 
the provisions of Sec.  35.13(b) as an authorized user, authorized 
medical physicist, ophthalmic physicist, or authorized nuclear 
pharmacist--
    (1) A copy of the board certification and as appropriate, 
verification of completion of:
    (i) Training for the authorized medical physicist under Sec.  
35.51(c);
    (ii) Any additional case experience required in Sec.  
35.390(b)(1)(ii)(G) for an authorized user under Sec.  35.300; or
    (iii) Device specific training in Sec.  35.690(c) for the 
authorized user under Sec.  35.600; or
    (2) A copy of 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, the permit 
issued by a Commission master material license broad scope permittee, 
or documentation that only accelerator-produced radioactive materials, 
discrete sources of radium-226, or both, were used for medical use or 
in the practice of nuclear pharmacy at a Government agency or Federally 
recognized Indian Tribe before November 30, 2007, or at all other 
locations of use before August 8, 2009, or an earlier date as noticed 
by the NRC for each individual that the licensee permits to work under 
the provisions of this section. The licensee shall only permit the 
individual to work with materials and uses previously authorized as an 
authorized user, an authorized medical physicist, ophthalmic physicist, 
or an authorized nuclear pharmacist under Sec.  35.13(b).
    (b) A licensee shall notify the Commission no later than 30 days 
after:
    (1) An authorized user, an authorized nuclear pharmacist, a 
Radiation Safety Officer, an Associate Radiation Safety Officer, an 
authorized medical physicist, or ophthalmic physicist permanently 
discontinues performance of duties under the license or has a name 
change;
    (2) The licensee permits an individual qualified to be a Radiation 
Safety Officer under Sec. Sec.  35.50 and 35.59 to function as a 
temporary Radiation Safety Officer and to perform the functions of a 
Radiation Safety Officer in accordance with Sec.  35.24(c);
    (3) The licensee's mailing address changes;
    (4) 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;
    (5) 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--
    (i) Sec.  35.100 or Sec.  35.200 if the change does not include 
addition or relocation of either an area where PET radionuclides are 
produced, or
    (ii) A PET radioactive drug delivery line from the PET 
radionuclide/PET radioactive drug production area; or
    (6) The licensee obtains a sealed source for use in manual 
brachytherapy from a different manufacturer or with a different model 
number than authorized by its license for which it did not require a 
license amendment as provided in section 35.13(i). The notification 
must include the manufacturer and model number of the sealed source, 
the isotope, and the quantity per sealed source.
* * * * *
0
10. In Sec.  35.24, revise paragraphs (b) and (c) to read as follows:


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

* * * * *
    (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. The Radiation Safety Officer may delegate 
duties and tasks but shall not delegate the authority or 
responsibilities for implementing the radiation protection program. A 
licensee's management may appoint, in writing, one or more Associate 
Radiation Safety Officers to support the Radiation Safety Officer. The 
Radiation Safety Officer, with written agreement of the licensee's 
management, must assign the specific duties and tasks to each Associate 
Radiation Safety Officer. The Associate Radiation Safety Officer must 
agree, in writing, to the list of the specific duties and tasks. These 
duties and tasks are restricted to the types of use for which the 
Associate Radiation Safety Officer has radiation safety training.
    (c) For up to 60 days each year, a licensee may permit an 
individual qualified to be a Radiation Safety Officer, under Sec. Sec.  
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).
* * * * *
0
11. In Sec.  35.40, revise paragraphs (b) and (c) to read as follows:


Sec.  35.40  Written directives.

* * * * *
    (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 
[micro]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;
    (6) For permanent implant brachytherapy:
    (i) Before implantation: The treatment site, the radionuclide, the 
intended absorbed dose to the treatment site and the corresponding 
calculated total source strength required, and if appropriate, the 
expected absorbed doses to normal tissues located within the treatment 
site; and
    (ii) After implantation but before the patient leaves the post-
treatment recovery area: The number of sources implanted, the total 
source strength implanted, the signature of an authorized user for 
Sec.  35.400 uses for manual brachytherapy, and the date; or
    (7) 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, total source strength 
and exposure time (or the total dose), the signature of an authorized 
user for Sec.  35.400 uses for manual brachytherapy, and the date.
    (c)(1) 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

[[Page 42439]]

byproduct material, the brachytherapy dose, the gamma stereotactic 
radiosurgery dose, the teletherapy dose, or the next fractional dose.
    (2) 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.
* * * * *
0
12. In Sec.  35.41, revise paragraph (b) to read as follows:


Sec.  35.41  Procedures for administrations requiring a 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;
    (4) Verifying that any computer-generated dose calculations are 
correctly transferred into the consoles of therapeutic medical units 
authorized by Sec. Sec.  35.600 or 35.1000;
    (5) Determining if a medical event, as defined in Sec.  35.3045, 
has occurred; and
    (6) Determining, for permanent implant brachytherapy, within 60 
calendar days from the date the implant was performed unless 
accompanied by a written justification related to patient 
unavailability:
    (i) The total source strength administered outside of the treatment 
site compared to the total source strength documented in the post-
implantation portion of the written directive;
    (ii) The absorbed dose to the maximally exposed 5 contiguous cubic 
centimeters of normal tissue located outside of the treatment site; and
    (iii) The absorbed dose to the maximally exposed 5 contiguous cubic 
centimeters of normal tissue located within the treatment site.
* * * * *
0
13. Revise Sec.  35.50 to read as follows:


Sec.  35.50  Training for Radiation Safety Officer and Associate 
Radiation Safety Officer.

    Except as provided in Sec.  35.57, the licensee shall require an 
individual fulfilling the responsibilities of the Radiation Safety 
Officer or an individual assigned the duties and tasks as an Associate 
Radiation Safety Officer as provided in Sec.  35.24 to be an individual 
who--
    (a) Is certified by a specialty board whose certification process 
has been recognized by the Commission or an Agreement State and who 
meets the requirements in paragraph (d) of this section. (The names of 
board certifications that have been recognized by the Commission or an 
Agreement State will be posted on the NRC's Web page.) To have its 
certification process recognized, a specialty board shall require all 
candidates for certification to:
    (1)(i) Hold a bachelor's or graduate degree from an accredited 
college or university in physical science or engineering or biological 
science with a minimum of 20 college credits in physical science;
    (ii) Have 5 or more years of professional experience in health 
physics (graduate training may be substituted for no more than 2 years 
of the required experience) including at least 3 years in applied 
health physics; and
    (iii) Pass an examination administered by diplomates of the 
specialty board, which evaluates knowledge and competence in radiation 
physics and instrumentation, radiation protection, mathematics 
pertaining to the use and measurement of radioactivity, radiation 
biology, and radiation dosimetry; or
    (2)(i) Hold a master's or doctor's degree in physics, medical 
physics, other physical science, engineering, or applied mathematics 
from an accredited college or university;
    (ii) Have 2 years of full-time practical training and/or supervised 
experience in medical physics--
    (A) Under the supervision of a medical physicist who is certified 
in medical physics by a specialty board recognized by the Commission or 
an Agreement State; or
    (B) In clinical nuclear medicine facilities providing diagnostic 
and/or therapeutic services under the direction of physicians who meet 
the requirements for authorized users in Sec. Sec.  35.57, 35.290, or 
35.390; and
    (iii) Pass an examination, administered by diplomates of the 
specialty board, that assesses knowledge and competence in clinical 
diagnostic radiological or nuclear medicine physics and in radiation 
safety; or
    (b)(1) Has completed a structured educational program consisting of 
both:
    (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;
    (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 an Agreement State license or permit issued 
by a Commission master material licensee that authorizes similar 
type(s) of use(s) of byproduct material. An Associate Radiation Safety 
Officer may provide supervision for those areas for which the Associate 
Radiation Safety Officer is authorized on a Commission or an Agreement 
State license or permit issued by a Commission master material 
licensee. The full-time radiation safety experience must involve 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;
    (G) Disposing of byproduct material; and
    (2) This individual must obtain a written attestation, signed by a 
preceptor Radiation Safety Officer or Associate Radiation Safety 
Officer who has experience with the radiation safety aspects of similar 
types of use of byproduct material for which the individual is seeking 
approval as a Radiation Safety Officer or an Associate Radiation Safety 
Officer. The written attestation must state that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and (d) 
of this section, and is able to independently fulfill the radiation 
safety-related duties as a Radiation Safety Officer or as an Associate 
Radiation Safety Officer for a medical use license; or
    (c)(1) Is a medical physicist who has been certified by a specialty 
board whose certification process has been

[[Page 42440]]

recognized by the Commission or an Agreement State under Sec.  35.51(a) 
and has experience in radiation safety for similar types of use of 
byproduct material for which the licensee is seeking the approval of 
the individual as Radiation Safety Officer or an Associate Radiation 
Safety Officer and who meets the requirements in paragraph (d) of this 
section; or
    (2) Is an authorized user, authorized medical physicist, or 
authorized nuclear pharmacist identified on a Commission or an 
Agreement State license, a permit issued by a Commission master 
material licensee, a permit issued by a Commission or an Agreement 
State licensee of broad scope, or a permit issued by a Commission 
master material license broad scope permittee 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 or Associate Radiation Safety Officer duties and tasks 
and who meets the requirements in paragraph (d) of this section; or
    (3) Has experience with the radiation safety aspects of the types 
of use of byproduct material for which the individual is seeking 
simultaneous approval both as the Radiation Safety Officer and the 
authorized user on the same new Commission or Agreement State license; 
and
    (d) Has training in the radiation safety, regulatory issues, and 
emergency procedures for the types of use for which a licensee seeks 
approval. This training requirement may be satisfied by completing 
training that is supervised by a Radiation Safety Officer, an Associate 
Radiation Safety Officer, authorized medical physicist, authorized 
nuclear pharmacist, or authorized user, as appropriate, who is 
authorized for the type(s) of use for which the licensee is seeking 
approval.
0
14. In Sec.  35.51, revise the introductory text of paragraph (a), and 
revise paragraphs (a)(2)(i) and (b)(2) to read as follows:


Sec.  35.51  Training for an authorized medical physicist.

* * * * *
    (a) Is certified by a specialty board whose certification process 
has been recognized by the Commission or an Agreement State and who 
meets the requirements in paragraph (c) of this section. (The names of 
board certifications that have been recognized by the Commission or an 
Agreement State will be posted on the NRC's Web page.) To have its 
certification process recognized, a specialty board shall require all 
candidates for certification to:
* * * * *
    (2) * * *
    (i) Under the supervision of a medical physicist who is certified 
in medical physics by a specialty board whose certification process has 
been recognized under this section by the Commission or an Agreement 
State; or
* * * * *
    (b) * * *
    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and (c) 
of this section, and is able to independently fulfill the radiation 
safety-related duties as an authorized medical physicist for each type 
of therapeutic medical unit for which the individual is requesting 
authorized medical physicist status. The written attestation must be 
signed by a preceptor authorized medical physicist who meets the 
requirements in Sec. Sec.  35.51, 35.57, 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; and
* * * * *
0
15. In Sec.  35.55, revise the introductory text of paragraph (a) and 
revise paragraph (b)(2) to read as follows:


Sec.  35.55  Training for an authorized nuclear pharmacist.

* * * * *
    (a) Is certified by a specialty board whose certification process 
has been recognized by the Commission or an Agreement State. (The names 
of board certifications that have been recognized by the Commission or 
an Agreement State will be posted on the NRC's Web page.) To have its 
certification process recognized, a specialty board shall require all 
candidates for certification to:
* * * * *
    (b) * * *
    (2) Has obtained written attestation, signed by a preceptor-
authorized nuclear pharmacist, that the individual has satisfactorily 
completed the requirements in paragraph (b)(1) of this section and is 
able to independently fulfill the radiation safety-related duties as an 
authorized nuclear pharmacist.
0
16. Revise Sec.  35.57 to read as follows:


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

    (a)(1) An individual identified on a Commission or an Agreement 
State license or a permit issued by a Commission or an Agreement State 
broad scope licensee or master material license permit or by a master 
material license permittee of broad scope as a Radiation Safety 
Officer, a teletherapy or medical physicist, an authorized medical 
physicist, a nuclear pharmacist or an authorized nuclear pharmacist on 
or before October 24, 2005, need not comply with the training 
requirements of Sec. Sec.  35.50, 35.51, or 35.55, respectively. After 
January 20, 2015, Radiation Safety Officers and authorized medical 
physicists identified in this paragraph must meet the training 
requirements in Sec.  35.50(d) or Sec.  35.51(c), as appropriate, for 
any material or uses for which they were not authorized prior to this 
date.
    (2) Any individual certified by the American Board of Health 
Physics in Comprehensive Health Physics; American Board of Radiology; 
American Board of Nuclear Medicine; American Board of Science in 
Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear 
Pharmacy; American Board of Medical Physics in radiation oncology 
physics; Royal College of Physicians and Surgeons of Canada in nuclear 
medicine; American Osteopathic Board of Radiology; or American 
Osteopathic Board of Nuclear Medicine on or before October 24, 2005, 
need not comply with the training requirements of Sec.  35.50 to be 
identified as a Radiation Safety Officer or as an Associate Radiation 
Safety Officer on a Commission or an Agreement State license or 
Commission master material license permit for those materials and uses 
that these individuals performed on or before October 24, 2005.
    (3) Any individual certified by the American Board of Radiology in 
therapeutic radiological physics, Roentgen ray and gamma ray physics, 
x-ray and radium physics, or radiological physics, or certified by the 
American Board of Medical Physics in radiation oncology physics, on or 
before October 24, 2005, need not comply with the training requirements 
for an authorized medical physicist described in Sec.  35.51, for those 
materials and uses that these individuals performed on or before 
October 24, 2005.
    (4) A Radiation Safety Officer, a medical physicist, or a nuclear 
pharmacist, who used only accelerator-produced radioactive materials, 
discrete sources of radium-226, or both, for medical uses or in the 
practice of nuclear pharmacy at a Government agency or Federally 
recognized Indian Tribe before November 30, 2007, or at all other 
locations of use before August 8, 2009, or an earlier date as noticed 
by the NRC, need not comply with the

[[Page 42441]]

training requirements of Sec.  35.50, Sec.  35.51 or Sec.  35.55, 
respectively, when performing the same uses. A nuclear pharmacist, who 
prepared only radioactive drugs containing accelerator-produced 
radioactive materials, or a medical physicist, who used only 
accelerator-produced radioactive materials, at the locations and time 
period identified in this paragraph, qualifies as an authorized nuclear 
pharmacist or an authorized medical physicist, respectively, for those 
materials and uses performed before these dates, for purposes of this 
chapter.
    (b)(1) Physicians, dentists, or podiatrists identified as 
authorized users for the medical use of byproduct material on a license 
issued by the Commission or an Agreement State, a permit issued by a 
Commission master material licensee, a permit issued by a Commission or 
an Agreement State broad scope licensee, or a permit issued by a 
Commission master material license broad scope permittee before October 
24, 2005, who perform only those medical uses for which they were 
authorized on or before that date need not comply with the training 
requirements of subparts D through H of this part.
    (2) Physicians, dentists, or podiatrists not identified as 
authorized users for the medical use of byproduct material on a license 
issued by the Commission or an Agreement State, a permit issued by a 
Commission master material licensee, a permit issued by a Commission or 
an Agreement State broad scope licensee, or a permit issued by a 
Commission master material license of broad scope before October 24, 
2005, need not comply with the training requirements of Subparts D 
through H of this part for those materials and uses that these 
individuals performed before October 24, 2005, as follows:
    (i) For uses authorized under Sec.  35.100 or Sec.  35.200, or oral 
administration of sodium iodide I-131 requiring a written directive for 
imaging and localization purposes, a physician who was certified on or 
before October 24, 2005, in nuclear medicine by the American Board of 
Nuclear Medicine; diagnostic radiology by the American Board of 
Radiology; diagnostic radiology or radiology by the American 
Osteopathic Board of Radiology; nuclear medicine by the Royal College 
of Physicians and Surgeons of Canada; or American Osteopathic Board of 
Nuclear Medicine in nuclear medicine;
    (ii) For uses authorized under Sec.  35.300, a physician who was 
certified on or before October 24, 2005, by the American Board of 
Nuclear Medicine; the American Board of Radiology in radiology, 
therapeutic radiology, or radiation oncology; nuclear medicine by the 
Royal College of Physicians and Surgeons of Canada; or the American 
Osteopathic Board of Radiology after 1984;
    (iii) For uses authorized under Sec.  35.400 or Sec.  35.600, a 
physician who was certified on or before October 24, 2005, in 
radiology, therapeutic radiology or radiation oncology by the American 
Board of Radiology; radiation oncology by the American Osteopathic 
Board of Radiology; radiology, with specialization in radiotherapy, as 
a British ``Fellow of the Faculty of Radiology'' or ``Fellow of the 
Royal College of Radiology''; or therapeutic radiology by the Canadian 
Royal College of Physicians and Surgeons; and
    (iv) For uses authorized under Sec.  35.500, a physician who was 
certified on or before October 24, 2005, in radiology, diagnostic 
radiology, therapeutic radiology, or radiation oncology by the American 
Board of Radiology; nuclear medicine by the American Board of Nuclear 
Medicine; diagnostic radiology or radiology by the American Osteopathic 
Board of Radiology; or nuclear medicine by the Royal College of 
Physicians and Surgeons of Canada.
    (3) Physicians, dentists, or podiatrists who used only accelerator-
produced radioactive materials, discrete sources of radium-226, or 
both, for medical uses performed at a Government agency or Federally 
recognized Indian Tribe before November 30, 2007, or at all other 
locations of use before August 8, 2009, or an earlier date as noticed 
by the NRC, need not comply with the training requirements of subparts 
D through H of this part when performing the same medical uses. A 
physician, dentist, or podiatrist, who used only accelerator-produced 
radioactive materials, discrete sources of radium-226, or both, for 
medical uses at the locations and time period identified in this 
paragraph, qualifies as an authorized user for those materials and uses 
performed before these dates, for purposes of this chapter.
    (c) Individuals who need not comply with training requirements as 
described in this section may serve as preceptors for, and supervisors 
of, applicants seeking authorization on NRC licenses for the same uses 
for which these individuals are authorized.
0
17. Revise Sec.  35.65 to read as follows:


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

    (a) 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:
    (1) 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;
    (2) 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 or equivalent Agreement State regulations, 
providing the redistributed sealed sources are in the original 
packaging and shielding and are accompanied by the manufacturer's 
approved instructions;
    (3) Any byproduct material with a half-life not longer than 120 
days in individual amounts not to exceed 0.56 GBq (15 mCi);
    (4) Any byproduct material with a half-life longer than 120 days in 
individual amounts not to exceed the smaller of 7.4 MBq (200 micro Ci) 
or 1000 times the quantities in appendix B of part 30 of this chapter; 
or
    (5) Technetium-99m in amounts as needed.
    (b) Byproduct material authorized by this provision shall not be:
    (1) Used for medical use as defined in Sec.  35.2 except in 
accordance with the requirements in Sec.  35.500; or
    (2) Combined to create (i.e., bundled or aggregated) an activity 
greater than the maximum activity of any single sealed source 
authorized under this section.
    (c) A licensee using calibration, transmission, and reference 
sources in accordance with the requirements in paragraphs (a) or (b) of 
this section need not list these sources on a specific medical use 
license.
0
18. In Sec.  35.190, revise the introductory text of paragraph (a) and 
revise paragraph (c)(2) to read as follows:


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

* * * * *
    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State. 
(The names of board certifications that have been recognized by the 
Commission or an Agreement State will be posted on the NRC's Web page.) 
To have its certification process recognized, a specialty board shall 
require all candidates for certification to:
* * * * *
    (c) * * *
    (2) Has obtained written attestation that the individual has 
satisfactorily

[[Page 42442]]

completed the requirements in paragraph (c)(1) of this section and is 
able to independently fulfill the radiation safety-related duties as an 
authorized user for the medical uses authorized under Sec.  35.100. The 
attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in 
Sec. Sec.  35.57, 35.190, 35.290, or 35.390, or equivalent Agreement 
State requirements; or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec. Sec.  35.57, 35.190, 35.290, or 35.390, or 
equivalent Agreement State requirements, and concurs with the 
attestation provided by the residency program director. The residency 
training program must be approved by the Residency Review Committee of 
the Accreditation Council for Graduate Medical Education or the Royal 
College of Physicians and Surgeons of Canada or the Committee on Post-
Graduate Training of the American Osteopathic Association and must 
include training and experience specified in Sec.  35.190.
0
19. In Sec.  35.204, revise paragraph (b) and add a new paragraph (e) 
to read as follows:


Sec.  35.204  Permissible molybdenum-99, strontium-82, and strontium-85 
concentrations.

* * * * *
    (b) A licensee that uses molybdenum-99/technetium-99m generators 
for preparing a technetium-99m radiopharmaceutical shall measure the 
molybdenum-99 concentration in each eluate after receipt of a generator 
to demonstrate compliance with paragraph (a) of this section.
* * * * *
    (e) The licensee shall report any measurement that exceeds the 
limits in paragraph (a) of this section, in accordance with Sec.  
35.3204.
0
20. In Sec.  35.290, revise the introductory text of paragraphs (a) and 
(c)(1)(ii), and paragraph (c)(2) to read as follows:


Sec.  35.290  Training for imaging and localization studies.

* * * * *
    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State. 
(The names of board certifications that have been recognized by the 
Commission or an Agreement State will be posted on the NRC's Web page.) 
To have its certification process recognized, a specialty board shall 
require all candidates for certification to:
* * * * *
    (c)(1) * * *
    (ii) Work experience, under the supervision of an authorized user 
who meets the requirements in Sec. Sec.  35.57, 35.290, or 35.390 and 
35.290(c)(1)(ii)(G), or equivalent Agreement State requirements. An 
authorized nuclear pharmacist who meets the requirements in Sec. Sec.  
35.55 or 35.57 may provide the supervised work experience for paragraph 
(c)(1)(ii)(G) of this section. Work experience must involve--
* * * * *
    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraph (c)(1) of this 
section and is able to independently fulfill the radiation safety-
related duties as an authorized user for the medical uses authorized 
under Sec. Sec.  35.100 and 35.200. The attestation must be obtained 
from either:
    (i) A preceptor authorized user who meets the requirements in 
Sec. Sec.  35.57, 35.290, or 35.390 and 35.290(c)(1)(ii)(G) or 
equivalent Agreement State requirements; or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec. Sec.  35.57, 35.290, or 35.390 and 
35.290(c)(1)(ii)(G), or equivalent Agreement State requirements, and 
concurs with the attestation provided by the residency program 
director. The residency training program must be approved by the 
Residency Review Committee of the Accreditation Council for Graduate 
Medical Education or the Royal College of Physicians and Surgeons of 
Canada or the Committee on Post-Graduate Training of the American 
Osteopathic Association and must include training and experience 
specified in Sec.  35.290.
0
21. In Sec.  35.300, revise introductory text to read as follows:


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

    A licensee may use any unsealed byproduct material identified in 
Sec.  35.390(b)(1)(ii)(G) prepared for medical use and for which a 
written directive is required that is--
* * * * *
0
22. In Sec.  35.390, revise the introductory text of paragraph (a), and 
revise paragraphs (b)(1)(ii)(G) and (b)(2), and add a new paragraph (c) 
to read as follows:


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

* * * * *
    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State and 
who meets the requirements in paragraphs (b)(1)(ii)(G) of this section. 
(The names of board certifications that have been recognized by the 
Commission or an Agreement State will be posted on the NRC's Web page). 
To be recognized, a specialty board shall require all candidates for 
certification to:
* * * * *
    (b)(1) * * *
    (ii) * * *
    (G) Administering dosages of radioactive drugs to patients or human 
research subjects from the four categories in this paragraph. 
Radioactive drugs in categories not included in this paragraph are 
regulated under Sec.  35.1000. This work experience must involve 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, for which a 
written directive is required;
    (2) Oral administration of greater than 1.22 gigabecquerels (33 
millicuries) of sodium iodide I-131; \2\
    (3) Parenteral administration of any radionuclide that is primarily 
used for its electron emission, beta radiation characteristics, or for 
its photon energy of less than 150 keV, for which a written directive 
is required;
    (4) Parenteral administration of any radionuclide that is primarily 
used for its alpha radiation characteristics, for which a written 
directive is required; and
    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraph (b)(1) of this 
section and is able to independently fulfill the radiation safety-
related duties as an authorized user for the medical uses authorized 
under Sec.  35.300 for which the individual is requesting authorized 
user status. The attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in 
Sec. Sec.  35.57, 35.390, or equivalent Agreement State requirements 
and has experience in administering dosages in the same dosage category 
or categories as the individual requesting authorized user status; or
    (ii) A residency program director who affirms in writing that the 
attestation

[[Page 42443]]

represents the consensus of the residency program faculty where at 
least one faculty member is an authorized user who meets the 
requirements in Sec.  35.57, 35.390, or equivalent Agreement State 
requirements, has experience in administering dosages in the same 
dosage category or categories as the individual requesting authorized 
user status, and concurs with the attestation provided by the residency 
program director. The residency training program must be approved by 
the Residency Review Committee of the Accreditation Council for 
Graduate Medical Education or the Royal College of Physicians and 
Surgeons of Canada or the Committee on Post-Graduate Training of the 
American Osteopathic Association and must include training and 
experience specified in Sec.  35.390; or
    (c) Is an authorized user for any of the parenteral administrations 
specified in Sec.  35.390(b)(1)(ii)(G) or equivalent Agreement State 
requirements. This individual must meet the supervised work experience 
requirements in (b)(1)(ii) of this section for each new parenteral 
administration listed in Sec.  35.390(b)(1)(ii)(G) for which the 
individual is requesting authorized user status.
* * * * *
    \2\ Experience with at least three cases in Category (G)(2) also 
satisfies the requirement in Category (G)(1).

0
23. In Sec.  35.392, revise paragraphs (a) and (c)(3) to read as 
follows:


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).

* * * * *
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraphs (c)(1) and 
(c)(2) of this section and whose certification process has been 
recognized by the Commission or an Agreement State. (The names of board 
certifications that have been recognized by the Commission or an 
Agreement State will be posted on the NRC's Web page.); or
* * * * *
    (c) * * *
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and 
(c)(2) of this section, and is able to independently fulfill the 
radiation safety-related duties as an authorized user for oral 
administration of less than or equal to 1.22 gigabecquerels (33 
millicuries) of sodium iodide I-131 for medical uses authorized under 
Sec.  35.300. The attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in 
Sec. Sec.  35.57, 35.390, 35.392, 35.394, or equivalent Agreement State 
requirements and has experience in administering dosages as specified 
in Sec. Sec.  35.390(b)(1)(ii)(G)(1) or 35.390(b)(1)(ii)(G)(2); or (ii) 
A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec. Sec.  35.57, 35.390, 35.392, 35.394, or equivalent 
Agreement State requirements, has experience in administering dosages 
as specified in Sec. Sec.  35.390(b)(1)(ii)(G)(1) or 
35.390(b)(1)(ii)(G)(2), and concurs with the attestation provided by 
the residency program director. The residency training program must be 
approved by the Residency Review Committee of the Accreditation Council 
for Graduate Medical Education or the Royal College of Physicians and 
Surgeons of Canada or the Committee on Post-Graduate Training of the 
American Osteopathic Association and must include training and 
experience specified in Sec.  35.392.
0
24. In Sec.  35.394, revise paragraphs (a) and (c)(3) to read as 
follows:


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).

* * * * *
    (a) Is certified by a medical specialty board whose certification 
process includes all of the requirements in paragraphs (c)(1) and 
(c)(2) of this section, and whose certification has been recognized by 
the Commission or an Agreement State. (The names of board 
certifications that have been recognized by the Commission or an 
Agreement State will be posted on the NRC's Web page.); or
* * * * *
    (c) * * *
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and 
(c)(2) of this section, and is able to independently fulfill the 
radiation safety-related duties as an authorized user for oral 
administration of greater than 1.22 gigabecquerels (33 millicuries) of 
sodium iodide I-131 for medical uses authorized under Sec.  35.300. The 
attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in 
Sec. Sec.  35.57, 35.390, 35.394, or equivalent Agreement State 
requirements, and has experience in administering dosages as specified 
in Sec.  35.390(b)(1)(ii)(G)(2); or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec. Sec.  35.57, 35.390, 35.394, or equivalent 
Agreement State requirements, has experience in administering dosages 
as specified in Sec.  35.390(b)(1)(ii)(G)(2), and concurs with the 
attestation provided by the residency program director. The residency 
training program must be approved by the Residency Review Committee of 
the Accreditation Council for Graduate Medical Education or the Royal 
College of Physicians and Surgeons of Canada or the Committee on Post-
Graduate Training of the American Osteopathic Association and must 
include training and experience specified in Sec.  35.394.
0
25. Revise Sec.  35.396 to read as follows:


Sec.  35.396  Training for the parenteral administration of unsealed 
byproduct material requiring a written directive.

    Except as provided in Sec.  35.57, the licensee shall require an 
authorized user for the parenteral administration requiring a written 
directive, to be a physician who--
    (a) Is an authorized user under Sec.  35.390 for uses listed in 
Sec.  35.390(b)(1)(ii)(G)(3) or (b)(1)(ii)(G)(4), or equivalent 
Agreement State requirements. This individual must meet the supervised 
work experience requirements in (d)(2) of this section for each new 
parenteral administration listed in Sec.  35.390(b)(1)(ii)(G) for which 
the individual is requesting authorized user status;
    (b) Is an authorized user under Sec. Sec.  35.490, 35.690, or 
equivalent Agreement State requirements and who meets the requirements 
in paragraph (d) of this section;
    (c) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State 
under Sec. Sec.  35.490 or 35.690, and who meets the requirements in 
paragraph (d) of this section; or
    (d)(1) Has successfully completed 80 hours of classroom and 
laboratory training, applicable to parenteral administrations listed in 
Sec.  35.390(b)(1)(ii)(G). 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

[[Page 42444]]

    (v) Radiation biology; and
    (2) Has work experience, under the supervision of an authorized 
user who meets the requirements in Sec. Sec.  35.57, 35.390, 35.396, or 
equivalent Agreement State requirements, in the parenteral 
administrations listed in Sec.  35.390(b)(1)(ii)(G). A supervising 
authorized user who meets the requirements in Sec. Sec.  35.390, 
35.396, or equivalent Agreement State requirements, must have 
experience in administering dosages in the same category or categories 
as the individual requesting authorized user status. The work 
experience must involve--
    (i) Ordering, receiving, and unpacking radioactive materials 
safely, and performing the related radiation surveys;
    (ii) Performing quality control procedures on instruments used to 
determine the activity of dosages, and performing checks for proper 
operation of 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 unsealed 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 include at least three cases in each category of the parenteral 
administrations as specified in Sec.  35.390(b)(1)(ii)(G) for which the 
individual is requesting authorized user status; and
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraph (d)(1) and 
(d)(2) of this section, and is able to independently fulfill the 
radiation safety-related duties as an authorized user for the 
parenteral administration of unsealed byproduct material requiring a 
written directive. The attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in 
Sec. Sec.  35.57, 35.390, 35.396, or equivalent Agreement State 
requirements. A preceptor authorized user who meets the requirements in 
Sec.  35.390, 35.396, or equivalent Agreement State requirements, must 
have experience in administering dosages in the same category or 
categories as the individual requesting authorized user status; or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec. Sec.  35.57, 35.390, 35.396, or equivalent 
Agreement State requirements, has experience in administering dosages 
in the same dosage category or categories as the individual requesting 
authorized user status, and concurs with the attestation provided by 
the residency program director. The residency training program must be 
approved by the Residency Review Committee of the Accreditation Council 
for Graduate Medical Education or the Royal College of Physicians and 
Surgeons of Canada or the Committee on Post-Graduate Training of the 
American Osteopathic Association and must include training and 
experience specified in Sec.  35.396.
0
26. Revise Sec.  35.400 to read as follows:


Sec.  35.400  Use of sources for manual brachytherapy.

    A licensee must use only brachytherapy sources:
    (a) Approved in the Sealed Source and Device Registry to deliver 
therapeutic doses for medical use. The manual brachytherapy sources may 
be used for manual brachytherapy uses that are not explicitly listed in 
the Sealed Source and Device Registry, but must be used in accordance 
with the radiation safety conditions and limitations described in the 
Sealed Source and Device Registry; or
    (b) In research to deliver therapeutic doses for medical use in 
accordance with an active Investigational Device Exemption (IDE) 
application accepted by the FDA provided the requirements of Sec.  
35.49(a) are met.
0
27. Revise Sec.  35.433 to read as follows:


Sec.  35.433  Strontium-90 sources for ophthalmic treatments.

    (a) Licensees who use strontium-90 for ophthalmic treatments must 
ensure that certain activities as specified in paragraph (b) of this 
section are performed by either:
    (1) An authorized medical physicist; or
    (2) An individual who holds a master's or doctor's degree in 
physics, medical physics, other physical sciences, engineering, or 
applied mathematics from an accredited college or university and has 
successfully completed 2 years of full-time practical training and/or 
supervised experience in medical physics and has documented training 
in:
    (i) The creating, modifying, and completing of written directives;
    (ii) Procedures for administrations requiring a written directive; 
and
    (iii) Performing the calibration measurements of brachytherapy 
sources as detailed in Sec.  35.432.
    (b) The individuals who are identified in paragraph (a) of this 
section must:
    (1) Calculate the activity of 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; and
    (2) Assist the licensee in developing, implementing, and 
maintaining written procedures to provide high confidence that the 
administration is in accordance with the written directive. These 
procedures must include the frequencies that the individual meeting the 
requirements in paragraph (a) of this section will observe treatments, 
review the treatment methodology, calculate treatment time for the 
prescribed dose, and review records to verify that the administrations 
were in accordance with the written directives.
    (c) Licensees must retain a record of the activity of each 
strontium-90 source in accordance with Sec.  35.2433.
0
28. In Sec.  35.490, revise the introductory text of paragraphs (a) and 
(b)(1)(ii), and paragraph (b)(3) to read as follows:


Sec.  35.490  Training for use of manual brachytherapy sources.

* * * * *
    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State. 
(The names of board certifications that have been recognized by the 
Commission or an Agreement State will be posted on the NRC's Web page.) 
To have its certification process recognized, a specialty board shall 
require all candidates for certification to:
* * * * *
    (b)(1) * * *
    (ii) 500 hours of work experience, under the supervision of an 
authorized user who meets the requirements in Sec. Sec.  35.57, 35.490, 
or equivalent Agreement State requirements, at a medical facility 
authorized to use byproduct materials under Sec.  35.400, involving--
* * * * *
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and 
(b)(2) of this section and is able to independently fulfill the 
radiation safety-related duties as an authorized user of manual 
brachytherapy sources for the medical uses authorized under Sec.  
35.400. The attestation must be obtained from either:
    (i) A preceptor authorized user who meets the requirements in 
Sec. Sec.  35.57, 35.490, or equivalent Agreement State requirements; 
or

[[Page 42445]]

    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec. Sec.  35.57, 35.490, or equivalent Agreement State 
requirements, and concurs with the attestation provided by the 
residency program director. The residency training program must be 
approved by the Residency Review Committee of the Accreditation Council 
for Graduate Medical Education or the Royal College of Physicians and 
Surgeons of Canada or the Committee on Post-Graduate Training of the 
American Osteopathic Association and must include training and 
experience specified in Sec.  35.490.
0
29. In Sec.  35.491, revise paragraph (b)(3) to read as follows:


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

* * * * *
    (b)(1) * * *
    (3) Has obtained written attestation, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.  35.57, 35.490, 
35.491, or equivalent Agreement State requirements, that the individual 
has satisfactorily completed the requirements in paragraph (b) of this 
section and is able to independently fulfill the radiation safety-
related duties as an authorized user of strontium-90 for ophthalmic 
use.
0
30. Revise Sec.  35.500 to read as follows:


Sec.  35.500  Use of sealed sources and medical devices for diagnosis.

    (a) A licensee must use only sealed sources not in medical devices 
for diagnostic medical uses that are approved in the Sealed Source and 
Device Registry for diagnostic medicine. The sealed sources may be used 
for diagnostic medical uses that are not explicitly listed in the 
Sealed Source and Device Registry. The sealed sources must be used in 
accordance with the radiation safety conditions and limitations 
described in the Sealed Source and Device Registry.
    (b) A licensee must only use diagnostic devices containing sealed 
sources for diagnostic medical uses if both the sealed sources and 
diagnostic devices are approved in the Sealed Source and Device 
Registry for diagnostic medical uses. The diagnostic medical devices 
may be used for diagnostic medical uses that are not explicitly listed 
in the Sealed Source and Device Registry but must be used in accordance 
with the radiation safety conditions and limitations described in the 
Sealed Source and Device Registry.
    (c) Sealed sources and devices for diagnostic medical uses may be 
used 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.
0
31. Revise Sec.  35.590 to read as follows:


Sec.  35.590  Training for use of sealed sources and medical devices 
for diagnosis.

    Except as provided in Sec.  35.57, the licensee shall require the 
authorized user of a diagnostic sealed source or 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 paragraphs (c) and (d) of this 
section and whose certification has been recognized by the Commission 
or an Agreement State. (The names of board certifications that have 
been recognized by the Commission or an Agreement State will be posted 
on the NRC's Web page.);
    (b) Is an authorized user for imaging uses listed in Sec.  35.200 
or equivalent Agreement State requirements; or
    (c) Has completed 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; and
    (4) Radiation biology; and
    (d) Has completed training in the use of the device for the uses 
requested.
0
32. Revise Sec.  35.600 to read as follows:


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

    (a) A licensee must only use sealed sources:
    (1) Approved and as provided for in the Sealed Source and Device 
Registry in photon emitting remote afterloader units, teletherapy 
units, or gamma stereotactic radiosurgery units to deliver therapeutic 
doses for medical uses: or
    (2) In research involving photon-emitting remote afterloader units, 
teletherapy units, or gamma stereotactic radiosurgery units in 
accordance with an active Investigational Device Exemption (IDE) 
application accepted by the FDA provided the requirements of Sec.  
35.49(a) are met.
    (b) A licensee must use photon-emitting remote afterloader units, 
teletherapy units, or gamma stereotactic radiosurgery units:
    (1) Approved in the Sealed Source and Device Registry to deliver a 
therapeutic dose for medical use. These devices may be used for 
therapeutic medical treatments that are not explicitly provided for in 
the Sealed Source and Device Registry, but must be used in accordance 
with radiation safety conditions and limitations described in the 
Sealed Source and Device Registry; or
    (2) 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.
0
33. In Sec.  35.610, revise paragraphs (d) and (g) to read as follows:


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

* * * * *
    (d)(1) Prior to the first use for patient treatment of a new unit 
or an existing unit with a manufacturer upgrade that affects the 
operation and safety of the unit, a licensee shall ensure that vendor 
operational and safety instructions are provided to all individuals who 
will operate the unit. The vendor operational and safety instructions 
must be provided by the device manufacturer or by individuals certified 
by the device manufacturer.
    (2) A licensee shall provide operational and safety instructions 
initially and at least annually to all individuals who operate the unit 
at the facility, as appropriate to the individual's assigned duties. 
The instructions shall include instruction in--
    (i) The procedures identified in paragraph (a)(4) of this section; 
and
    (ii) The operating procedures for the unit.
* * * * *
    (g) A licensee shall retain a copy of the procedures required by 
paragraphs (a)(4) and (d)(2)(ii) of this section in accordance with 
Sec.  35.2610.
0
34. In Sec.  35.655, revise the section heading and paragraph (a) to 
read as follows:


Sec.  35.655  Full-inspection servicing 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 each 
source replacement to assure proper functioning of the source exposure 
mechanism and other safety components. The interval between each full-
inspection servicing shall not exceed 5 years for each teletherapy unit

[[Page 42446]]

and shall not exceed 7 years for each gamma stereotactic radiosurgery 
unit.
* * * * *
0
35. In Sec.  35.690, revise the introductory text of paragraphs (a) and 
(b)(1)(ii), and paragraph (b)(3) to read as follows:


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

* * * * *
    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State and 
who meets the requirements in paragraph (c) of this section. (The names 
of board certifications that have been recognized by the Commission or 
an Agreement State will be posted on the NRC's Web page.) To have its 
certification process recognized, a specialty board shall require all 
candidates for certification to:
* * * * *
    (b)(1) * * *
    (ii) 500 hours of work experience, under the supervision of an 
authorized user who meets the requirements in Sec. Sec.  35.57, 35.690, 
or equivalent Agreement State requirements, at a medical facility that 
is authorized to use byproduct materials in Sec.  35.600, involving--
* * * * *
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (b)(1) and 
(b)(2), and paragraph (c), of this section, is able to independently 
fulfill the radiation safety-related duties as an authorized user of 
each type of therapeutic medical unit for which the individual is 
requesting authorized user status. The attestation must be obtained 
from either.
    (i) A preceptor authorized user who meets the requirements in 
Sec. Sec.  35.57, 35.690, or equivalent Agreement State requirements 
for the type(s) of therapeutic medical unit for which the individual is 
requesting authorized user status; or
    (ii) A residency program director who affirms in writing that the 
attestation represents the consensus of the residency program faculty 
where at least one faculty member is an authorized user who meets the 
requirements in Sec. Sec.  35.57, 35.690, or equivalent Agreement State 
requirements, for the type(s) of therapeutic medical unit for which the 
individual is requesting authorized user status and concurs with the 
attestation provided by the residency program director. The residency 
training program must be approved by the Residency Review Committee of 
the Accreditation Council for Graduate Medical Education or the Royal 
College of Physicians and Surgeons of Canada or the Committee on Post-
Graduate Training of the American Osteopathic Association and must 
include training and experience specified in Sec.  35.690;
* * * * *
0
36. In Sec.  35.2024, add a new paragraph (c) to read as follows:


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

* * * * *
    (c) For each Associate Radiation Safety Officer appointed under 
Sec.  35.24(b), the licensee shall retain, for 5 years after the 
Associate Radiation Safety Officer is removed from the license, a copy 
of:
    (1) The written document appointing the Associate Radiation Safety 
Officer signed by the licensee's management; and
    (2) Each agreement signed by the Associate Radiation Safety Officer 
listing the duties and tasks assigned by the Radiation Safety Officer 
under Sec.  35.24(b).
0
37. Revise Sec.  35.2310 to read as follows:


Sec.  35.2310  Records of safety instruction.

    A licensee shall maintain a record of safety instructions required 
by Sec. Sec.  35.310, 35.410, and the operational and safety 
instructions required by Sec.  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.
0
38. In Sec.  35.2655, revise the section heading and paragraph (a) to 
read as follows:


Sec.  35.2655  Records of full-inspection servicing for teletherapy and 
gamma stereotactic radiosurgery units.

    (a) A licensee shall maintain a record of the full-inspection 
servicing for teletherapy and gamma stereotactic radiosurgery units 
required by Sec.  35.655 for the duration of use of the unit.
* * * * *
0
39. In Sec.  35.3045, revise paragraph (a) to read as follows:


Sec.  35.3045  Report and notification of a medical event.

    (a) A licensee shall report as a medical event any administration 
requiring a written directive, except for an event that results from 
patient intervention, in which--
    (1) The administration of byproduct material or radiation from 
byproduct material, except permanent implant brachytherapy, results 
in--
    (i) 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
    (A) The total dose delivered differs from the prescribed dose by 20 
percent or more;
    (B) The total dosage delivered differs from the prescribed dosage 
by 20 percent or more or falls outside the prescribed dosage range; or
    (C) The fractionated dose delivered differs from the prescribed 
dose for a single fraction, by 50 percent or more.
    (ii) 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--
    (A) An administration of a wrong radioactive drug containing 
byproduct material or the wrong radionuclide for a brachytherapy 
procedure;
    (B) An administration of a radioactive drug containing byproduct 
material by the wrong route of administration;
    (C) An administration of a dose or dosage to the wrong individual 
or human research subject;
    (D) An administration of a dose or dosage delivered by the wrong 
mode of treatment; or
    (E) A leaking sealed source.
    (iii) A dose to the skin or an organ or tissue other than the 
treatment site that exceeds by:
    (A) 0.5 Sv (50 rem) or more the expected dose to that site from the 
procedure if the administration had been given in accordance with the 
written directive prepared or revised before administration; and
    (B) 50 percent or more the expected dose to that site from the 
procedure if the administration had been given in accordance with the 
written directive prepared or revised before administration.
    (2) For permanent implant brachytherapy, the administration of 
byproduct material or radiation from byproduct material that results 
in--
    (i) The total source strength administered differing by 20 percent 
or more from the total source strength documented in the post-
implantation portion of the written directive;
    (ii) The total source strength administered outside of the 
treatment site exceeding 20 percent of the total source strength 
documented in the post-implantation portion of the written directive;
    (iii) An absorbed dose to the maximally exposed 5 contiguous cubic

[[Page 42447]]

centimeters of normal tissue located outside of the treatment site that 
exceeds by 50 percent or more the absorbed dose prescribed to the 
treatment site in the pre-implantation portion of the written directive 
approved by an authorized user;
    (iv) An absorbed dose to the maximally exposed 5 contiguous cubic 
centimeters of normal tissue located within the treatment site that 
exceeds by 50 percent or more the absorbed dose to that tissue based on 
the pre-implantation dose distribution approved by an authorized user; 
or
    (v) An administration that includes any of the following--
    (A) The wrong radionuclide;
    (B) The wrong individual or human research subject;
    (C) Sealed source(s) directly delivered to the wrong treatment 
site;
    (D) A leaking sealed source resulting in a dose that exceeds 0.5 Sv 
(50 rem) to an organ or tissue; or
    (E) A 20 percent or more error in calculating the total source 
strength documented in the pre-implantation portion of the written 
directive.
* * * * *
0
40. Add a new Sec.  35.3204 to read as follows:


Sec.  35.3204  Report and notification for an eluate exceeding 
permissible molybdenum-99, strontium-82, and strontium-85 
concentrations.

    (a) The licensee shall notify by telephone the NRC Operations 
Center and the manufacturer/distributor of the generator within 30 
calendar days after discovery that an eluate exceeded the permissible 
concentration listed in Sec.  35.204(a). The telephone report to the 
NRC must include the manufacturer, model number, and serial number (or 
lot number) of the generator; the results of the measurement; the date 
of the measurement; whether dosages were administered to patients or 
human research subjects, whether the manufacturer/distributor was 
notified: And the action taken.
    (b) By an appropriate method listed in Sec.  30.6(a) of this 
chapter, the licensee shall submit a written report to the appropriate 
NRC Regional Office listed in Sec.  30.6 of this chapter within 45 days 
after discovery of an eluate exceeding the permissible concentration. 
The written report must include the action taken by the licensee; the 
patient dose assessment; the methodology used to make this dose 
assessment if the eluate was administered to patients or human research 
subjects; and probable cause and assessment of failure in the 
licensee's equipment, procedures or training that contributed to the 
excessive readings if an error occurred in the licensee's breakthrough 
determination, and the information in the telephone report as required 
by paragraph (a) of this section.

    Dated at Rockville, Maryland, this 10th day of July, 2014.

    For the Nuclear Regulatory Commission.
Richard J. Laufer,
Acting, Secretary of the Commission.
[FR Doc. 2014-16753 Filed 7-18-14; 8:45 am]
BILLING CODE 7590-01-P