[Federal Register Volume 70, Number 60 (Wednesday, March 30, 2005)]
[Rules and Regulations]
[Pages 16336-16367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6103]



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Part II





Nuclear Regulatory Commission





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10 CFR Part 35



Medical Use of Byproduct Material--Recognition of Specialty Boards; 
Final Rule

  Federal Register / Vol. 70, No. 60 / Wednesday, March 30, 2005 / 
Rules and Regulations  

[[Page 16336]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

RIN 3150-AH19


Medical Use of Byproduct Material--Recognition of Specialty 
Boards

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations governing the medical use of byproduct material to change 
its requirements for recognition of specialty boards whose 
certifications may be used to demonstrate the adequacy of the training 
and experience of individuals to serve as radiation safety officers, 
authorized medical physicists, authorized nuclear pharmacists, or 
authorized users. The final rule also revises the requirements for 
demonstrating the adequacy of training and experience for pathways 
other than the board certification pathway. This final rule grants, in 
part, a petition for rulemaking submitted by the Organization of 
Agreement States (PRM-35-17) and completes action on the petition.

DATES: Effective Date: This final rule is effective on April 29, 2005.

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

SUPPLEMENTARY INFORMATION:

I. Background
II. Petition for Rulemaking
III. Discussion
IV. Summary of Public Comments and Responses to Comments
V. Summary of Final Revisions
VI. Agreement State Compatibility
VII. Implementation
VIII. Voluntary Consensus Standards
IX. Finding of No Significant Environmental Impact: Environmental 
Assessment
X. Paperwork Reduction Act Statement
XI. Regulatory Analysis
XII. Regulatory Flexibility Certification
XIII. Backfit Analysis
XIV. Small Business Regulatory Enforcement Fairness Act

I. Background

    During development of revised 10 CFR Part 35, published as a 
proposed rule on August 13, 1998 (63 FR 43516) and as a final rule on 
April 24, 2002 (67 FR 20249), there was a general belief that the 
boards, whose certifications were recognized by the NRC, would meet, or 
could make adjustments to meet, the new requirements established by 
that rulemaking governing recognition of specialty boards by the NRC 
and that the certifications of these boards would continue to be 
recognized by NRC. However, when applications for recognition were 
received, the NRC staff determined that, except for one board, the 
boards did not meet all the requirements specified in the final rule. 
Specifically, the boards' certification programs failed to meet the 
requirements in the final rule regarding preceptor (i.e., an individual 
who provides, directs, or verifies training and experience) attestation 
and work experience. The only board that currently meets the revised 
requirements is the Certification Board of Nuclear Cardiology (CBNC) 
because it developed its certification program based on the final rule 
(published on April 24, 2002 (67 FR 20249)).
    The current regulations in 10 CFR Part 35 offer three pathways for 
individuals to satisfy training and experience (T&E) requirements to be 
approved as a radiation safety officer (RSO), authorized medical 
physicist (AMP), authorized nuclear pharmacist (ANP), or authorized 
user (AU). These pathways are: (1) Approval of an individual who is 
certified by a specialty board whose certification has been recognized 
by the NRC or an Agreement State as meeting the NRC's requirements for 
training and experience (a ``recognized board''); (2) Approval based on 
an evaluation of an individual's training and experience; or (3) 
Identification of an individual's approval on an existing NRC or 
Agreement State license. For this discussion, pathway (1) will be 
referred to as the certification pathway, and pathway (2) as the 
alternate pathway.
    On February 19, 2002, in a briefing of the Commission, the Advisory 
Committee on Medical Uses of Isotopes (ACMUI \1\) expressed concern 
about requirements for T&E in the revised 10 CFR Part 35, approved by 
the Commission on October 23, 2000 (SRM-SECY-00-0118). The ACMUI was 
concerned that if the requirements for recognition of specialty board 
certifications were to become effective as drafted, there could be 
potential shortages of individuals qualified to serve as RSOs, AMPs, 
ANPs, and AUs because they would no longer meet the requirements for 
T&E under the certification pathway. The ACMUI indicated that, without 
changes to the requirements for T&E in the final rule approved by the 
Commission in October 2000, the boards would no longer be qualified for 
recognition by NRC and, therefore, a board's future diplomates could no 
longer be approved as RSOs, AMPs, ANPs, or AUs.
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    \1\ The Advisory Committee on the Medical Uses of Isotopes 
(ACMUI) advises NRC on policy and technical issues that arise in the 
regulation of the medical uses of radioactive material. the ACMUI 
membership includes a representative of Agreements States and health 
care professionals from various disciplines who comment on changes 
to NRC regulations and guidance; evaluate certain non-routine uses 
of radioactive material; provide technical assistance in licensing, 
inspection, and enforcement cases; and bring key issues to the 
attention of the Commission for appropriate action.
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    The ACMUI also expressed the concern that the boards might be 
``marginalized.'' Specifically, under the draft final rule, to gain 
approval via the certification pathway, a candidate for certification 
would have been required to meet all of the requirements in the 
alternate pathway, thereby imposing more requirements beyond those 
already required by boards, on candidates using the certification 
pathway for approval. The extra requirements of concern to the ACMUI, 
incorporated from the alternate pathway by reference, include a 
specification for length-of-training as well as obtaining a written 
attestation signed by a preceptor. Taken together with other 
requirements of boards, such as requiring candidates for certification 
to take written and/or oral examinations, the concern was that 
candidates seeking approval might bypass the board certification 
pathway and select the alternate pathway.
    Based on these concerns, the ACMUI urged the Commission to 
implement measures to address the training and experience issues 
associated with recognition of specialty boards by the NRC in the draft 
final rule and to find a permanent solution after publication of the 
final rule. Subsequently, the NRC modified the final rule by 
reinserting Subpart J (as contained in the proposed rule before 
publication of revised Part 35 in April 2002) for a 2-year transition 
period. Subpart J provides for continuing recognition of the specialty 
boards listed therein during the transition period. The final rule was 
published in the Federal Register on April 24, 2002 (67 FR 20249), and 
became effective on October 24, 2002. As specified in Sec.  35.10(c), 
the 2-year transition period ended on October 24, 2004. In a Staff 
Requirements Memorandum (SRM-COMSECY-02-0014) dated April 16, 2002, the 
Commission directed the NRC staff to develop options for addressing the 
training and experience issue. The intent was to have this final rule 
in place before the end of the 2-year transition period. Public comment 
on

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the proposed rule led the NRC to conclude that the transition period 
should be extended for 1 year to October 24, 2005, to allow time for 
implementation of amendments to requirements for recognition of 
specialty board certifications. This extension was effected through a 
separate rulemaking (69 FR 55736; September 16, 2004).
    The issue in question concerns the requirements in the rule 
governing the recognition of specialty boards by the NRC. These 
requirements are located in the current regulations at Sec. Sec.  
35.50, 35.51, 35.55, 35.190, 35.290, 35.390, 35.392, 35.394, 35.490, 
35.590, and 35.690.
    The ACMUI submitted a report to the NRC on August 1, 2002 related 
to the T&E requirements. The NRC staff presented three options to the 
Commission in a Commission paper, SECY-02-0194, dated October 30, 2002, 
which included the recommendations of the ACMUI in an attachment. The 
three options were: (1) Retain the existing requirements in the current 
regulations; (2) Prepare a proposed rule to modify training and 
experience requirements based on the recommendations submitted by the 
ACMUI; and, (3) The same as Option 2 with a minor modification (i.e., 
listing all specialty boards' certifications recognized by NRC on the 
NRC's Web site rather than, as recommended by the ACMUI, listing some 
boards in the regulation and others on the Web site). In SRM-02-0194, 
dated February 12, 2003, the Commission approved Option 3, directing 
the NRC staff to prepare a proposed rule based on the ACMUI's 
recommendations with certain exceptions. The Commission directed that a 
list of recognized board certifications be posted on the NRC's Web 
site, that the preceptor statement remain as written in the current 
regulations (published April 24, 2002; 67 FR 20249), and that the staff 
should clarify that the preceptor language does not require an 
attestation of general clinical competency, but does require sufficient 
attestation to demonstrate that the candidate has the knowledge to 
fulfill the duties of the position for which certification is sought. 
This form of attestation should be preserved both for the certification 
pathway and the alternate pathway.
    During a teleconference with the ACMUI, conducted on July 17, 2003, 
the ACMUI members continued to voice concern about having recognition 
of board certifications conditioned on requiring candidates for 
certification to obtain written attestation of competency signed by a 
preceptor. The ACMUI recommended that if the Commission still 
maintained that it was necessary to include a preceptor statement for 
all authorized positions named in 10 CFR Part 35, this requirement 
should be separated from the criteria for recognition of board 
certifications, as well as for the alternative pathway. Agreement State 
representatives participated in the teleconference and agreed with this 
recommendation. In a letter, dated July 23, 2003, the ACMUI recommended 
that the requirements for a preceptor statement be removed from the 
certification pathway; however, if the Commission still believed it 
necessary to include a preceptor statement for all ``authorized 
positions'' named in 10 CFR Part 35, the ACMUI recommended that this 
requirement be separated from the board certification pathway and that 
it be specified separately as a new paragraph in each training section.
    The NRC staff submitted a proposed rule to the Commission on August 
21, 2003 (SECY-03-0145). The Commission approved the NRC staff's 
recommendation to publish the proposed rule, with certain changes 
directed by the Commission, in SRM-03-0145, dated October 9, 2003. The 
Commission approved the recommendation of the ACMUI that the 
requirement for a preceptor statement be removed from the requirements 
for recognition of specialty board certifications. The Commission also 
indicated it should be made clear in the proposed rule language that a 
preceptor statement is required regardless of which training pathway is 
chosen. The proposed rule was published for a 75-day comment period on 
December 9, 2003 (68 FR 68549). The NRC staff posted a comparison 
document, with differences between the current and proposed rule 
highlighted, on the NRC's rulemaking forum on December 19, 2003, to 
facilitate public understanding and stakeholder review of proposed 
changes to 10 CFR Part 35.
    The ACMUI provided comments on the proposed rule at its meeting on 
March 1-2, 2004. The ACMUI also conducted a public meeting via 
teleconference on March 22, 2004, to discuss, in part, additional 
recommendations related to the proposed rule. Following receipt of 
public comments, the NRC staff distributed a draft final rule to ACMUI 
and Agreement States for their 30-day review and comment. The NRC 
considered the additional comments received in developing the final 
rule. These comments are discussed in Section IV, ``Summary of Public 
Comments and Responses to Comments.''

II. Petition for Rulemaking

    The Organization of Agreement States (OAS) (petitioner) filed a 
Petition for Rulemaking (petition) dated September 3, 2004 (PRM-35-17) 
requesting that the NRC amend Sec. Sec.  35.55, 35.190, 35.290 and 
35.390 to define and specify the minimum number of ``didactic'' 
training hours for Authorized Nuclear Pharmacists and Authorized Users 
identified in these sections. Notice of receipt of the petition was 
published in the Federal Register on October 28, 2004 (69 FR 62831). 
The terms ``didactic training'' and ``classroom and laboratory 
training'' were used interchangeably by the Agreement States in their 
comments and both terms are used in the current regulations in Part 35. 
The term ``classroom and laboratory'' will be used hereinafter to refer 
to this type of training.
    The petitioner states that, in the current regulations in these 
sections, the minimum numbers of hours of classroom and laboratory 
training in radiation safety are not specified or separated from the 
total training hours. The petitioner notes that Subpart J does include 
a requirement for a minimum number of classroom and laboratory training 
hours as well as supervised work experience.
    The petitioner asserts that the T&E requirements have been 
designated as ``Category B'' for Agreement State compatibility to 
provide nationwide consistency and uniformity of authorized user 
credentialing, and that the lack of clearly defined classroom and 
laboratory training hours for these authorized users weakens the 
consistency and uniformity of the rule. The petitioner also believes 
that the need for specified classroom and laboratory training hours is 
a radiation safety issue rather than a ``practice of medicine'' issue 
in that radiation safety for the patient and the occupational radiation 
workers may be compromised, and that a majority of radiation safety 
principles and procedures are learned during classroom and laboratory 
training.
    As discussed further in subsequent sections of the SUPPLEMENTARY 
INFORMATION, during the 75-day public comment period for the proposed 
rule, ending on February 23, 2004, the NRC received comments which 
raised the same issues as those raised by the petitioner. Because of 
the similarity in issues raised, the NRC has determined to consider the 
OAS petition as part of this rulemaking.
    During resolution of the comments, the NRC staff consulted with the 
ACMUI and Agreement States on how to

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ensure adequacy of T&E in radiation safety and consistency of 
requirements for T&E between Agreement States and between Agreement 
States and the NRC. Agreement State representatives served as members 
on an NRC working group to develop this rule. A steering group was 
formed to provide recommendations to resolve the issue raised by the 
Agreement States, during comments on the proposed rule, on requirements 
for classroom and laboratory training. The working group addressed 
issues raised in the petition related to specifying hours of classroom 
and laboratory training in 10 CFR Part 35. The NRC staff consulted with 
and received comments from the ACMUI via a public teleconference on the 
issue on October 5, 2004, with participation of Agreement States, and 
during its meeting on October 13-14, 2004. After consideration of the 
input from these sources, as well as review and analysis of the issue 
by the working and steering groups, the NRC has determined to grant the 
petition in part, and is revising Sec. Sec.  35.55, 35.190, 35.290, and 
35.390, in the final rule, to establish a requirement for minimum 
number of hours of classroom and laboratory training for the alternate 
pathway. The petition is denied, in part, in so far as the NRC is not 
requiring a minimum number of hours of classroom and laboratory 
training for the certification pathway. The NRC staff believes that 
such a requirement would unnecessarily limit the flexibility of boards 
to determine their certification requirements. The rationale for this 
change to requirements for T&E is explained in the NRC's response to 
comments on the proposed rule in Section IV. Summary of Public Comments 
and Responses to Comments, under Part II--General Issues (Issue 1), and 
Part IV--Implementation by Agreement States--Timing and Compatibility 
(Issue 2).
    This completes action on PRM-35-17.

III. Discussion

    The principal changes in the final rule involve revising the 
criteria for recognizing the certifications of specialty boards. These 
changes relate to the requirements for T&E that boards would place on 
candidates seeking board certification. The NRC staff reviewed board 
certification procedures and made a determination that, with one 
exception, the boards' certification programs failed to meet the 
requirements in the current regulations regarding preceptor 
certification (attestation) and work experience. This assessment \2\ 
resulted from a detailed comparison, performed by the NRC staff, 
between requirements in the regulations (in Subparts B and D through H) 
and specialty board requirements for certification. The changes 
resulting from adoption of the final rule will resolve the issues 
related to recognition of board certifications by instituting 
requirements that are less prescriptive, while maintaining public 
health and safety. These changes will ensure that a clear regulatory 
determination can be made that specialty boards, both new and existing, 
meet the relevant criteria for recognition by the NRC or an Agreement 
State. Changes have also been made to the T&E requirements for the 
alternate pathway. The final rule provides a more flexible and 
performance-based approach to specifying requirements for training and 
experience, using a graded approach to ensure that training in 
radiation protection is consistent with the need for adequate 
understanding and skills.
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    \2\ ``Comparison between NRC requirements and boards' 
certification programs,'' attachment 2 to SECY-02-0194, ``options 
for addressing Part 35 Training and Experience Issues Associated 
With Recognition of Speciality Boards by NRC.'' SECY-02-0194 is 
available on the NRC's Web site, http://www.nrc.gov, in the 
``Electronic Reading Room.''
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    The changes to T&E requirements are intended to address issues 
raised by the ACMUI. However, the NRC disagrees with the ACMUI's belief 
that the T&E criteria in the current rule would result in candidates 
bypassing board certification. The NRC believes that board 
certification has been, and will continue to be, essential for 
physicians, including AUs, to practice medicine. While health 
physicists, medical physicists, nuclear pharmacists, and physicians can 
serve in the respective categories of RSO, AMP, ANP, and AU by 
satisfying T&E requirements under the alternate pathway, the NRC 
believes that individuals who would have sought certification are 
likely to continue to do so because certifications are useful to 
individuals for reasons other than satisfying requirements in 10 CFR 
Part 35, e.g., measuring areas of competence that go beyond regulatory 
requirements established under the Atomic Energy Act. Furthermore, some 
State agencies now require that individuals be certified by specialty 
boards before they can practice in some specialties, e.g., as medical 
physicists and nuclear pharmacists.

Changes to the Certification Pathway

    For the certification pathway, the current regulations incorporate 
the more prescriptive requirements from the alternate pathway. This 
final rule establishes less prescriptive criteria for board 
certifications to be recognized by the NRC or an Agreement State.
    For the RSO, AMP, and ANP, the revised criteria include a degree 
from an accredited college or university, professional experience, 
passing an examination administered by the board, and in some cases, 
additional training related to the type of use for which an individual 
would be responsible. The requirement for passing an examination 
reflects the current practice of certification boards.
    The addition of a requirement in Sec.  35.50(a) for candidates for 
RSO to have a degree is consistent with current standards of 
certification boards to require a minimum of a baccalaureate degree. 
The NRC believes that this requirement helps ensure that a candidate 
for RSO has the level of knowledge necessary to fulfill the duties of 
an RSO. However, this final rule retains current regulatory provisions 
that allow candidates who do not hold a degree required under revisions 
to Sec.  35.50(a) to qualify for positions as RSO under provisions in 
Sec.  35.50(b). Requirements for T&E of candidates to serve as AMPs 
have been revised for the board certification pathway, in Sec.  
35.51(a)(2), to require 2 years of full-time practical training and/or 
supervised experience under the supervision of a medical physicist 
certified by a specialty board, whose certification is recognized by 
the NRC or an Agreement State, or in clinical radiation facilities 
providing high-energy, external beam therapy and brachytherapy services 
under the direct supervision of physicians who meet the requirements 
for AUs in Sec. Sec.  35.490 or 35.690 or under supervision of a 
certified medical physicist in clinical radiation facilities. This T&E 
will help ensure that candidates have the level of knowledge necessary 
to fulfill the duties of an AMP.
    The current regulations in 10 CFR Part 35 provide for a preceptor, 
defined in Sec.  35.2, to certify that individuals have satisfactorily 
completed requirements for T&E and have achieved a level of radiation 
safety knowledge sufficient to function independently as RSOs, AMPs, 
ANPs, and AUs. In response to public comments, as discussed under the 
heading ``IV. Summary of Public Comments and Responses to Comments,'' 
the NRC is now using ``attestation'' and ``attest'' in place of 
``certification'' and ``certify'' in 10 CFR Part 35. A preceptor 
attestation is commonly referred to as a ``preceptor statement,'' and 
this term is used

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interchangeably with the term ``preceptor attestation'' in the 
SUPPLEMENTARY INFORMATION, particularly in the summary of public 
comments, to reflect this usage by commenters.
    The requirement that boards must have candidates for certification 
obtain a preceptor attestation as a condition for NRC recognition of 
certifications has been removed in the final rule; however, individuals 
are still required to obtain preceptor attestations, and licensees are 
required to submit them to the NRC (except as provided in Sec.  
35.15(d)). This is an addition to the current requirement in Sec.  
35.14(a) to provide a copy of board certifications to the NRC. Further 
discussion of the requirement for a preceptor attestation appears under 
the heading ``Preceptor Attestation.'' The certification pathway also 
includes a specification for the number of hours of training and 
experience for ANPs and AUs for certain uses of byproduct material 
under Sec. Sec.  35.100, 35.200, 35.300 (in Sec. Sec.  35.390, 35.392, 
35.394, and 35.396 for uses under Sec.  35.300), and 35.500. The ACMUI 
recommended, for the proposed rule, that the requirement for 200 hours 
of classroom and laboratory training, now required in Sec. Sec.  35.490 
and 35.690, be removed because it believes that the combination of 
degree, practical experience, and examination in the criteria for 
recognizing certifying boards is equivalent to the number of hours of 
classroom and laboratory training specified for the alternative 
pathway. A detailed analysis of T&E requirements was performed by NRC 
staff and appears as Attachment 1 to SECY-02-0194, ``OPTIONS FOR 
ADDRESSING PART 35 TRAINING AND EXPERIENCE ISSUES ASSOCIATED WITH 
RECOGNITION OF SPECIALTY BOARDS BY NRC.'' The NRC believes that, 
although the requirements are not identical, the T&E standard for 
recognizing certifying boards will be equivalent to the standard for 
the alternate pathway. The board certification process requires a 
candidate to have an academic degree, complete practical experience or 
a residency program, and pass an examination. Examinations test the 
knowledge and skills required to perform the applicable activities, 
including those in Sec. Sec.  35.490(a)(2) and 35.690(a)(2), to ensure 
radiation safety. The NRC believes that the combination of a degree, 
practical experience, and an examination, in the criteria for 
recognizing certifying boards, will be equivalent to the number of 
hours of classroom and laboratory training specified for the alternate 
pathway. Further, the requirement in the certification pathway for 
Sec. Sec.  35.490 and 35.690 for completion of an approved residency 
program, provides added assurance that T&E is sufficient. Therefore, 
the requirement for 200 hours of classroom and laboratory training does 
not apply to the criteria for recognition of board certification 
processes in Sec. Sec.  35.490, and 35.690 of the final rule.
    The ACMUI's recommendations included the addition of the Royal 
College of Physicians and Surgeons of Canada (RCPSC) in listings of 
entities which approve residency training to satisfy requirements for 
the board certification pathway for uses under Sec. Sec.  35.300, 
35.400, and 35.600. While the RCPSC was named in Subpart J of the 
current rule, it is not named in other subparts. There are reciprocal 
arrangements between U.S. entities and the RCPSC regarding approval of 
residency programs. Thus, the NRC finds these reciprocal agreements to 
be a sufficient basis to provide that RCPSC be included in various 
sections of 10 CFR Part 35.
    The final rule provides the boards more latitude in making the 
determination that individuals are fully trained and capable of 
performing their duties involving radiation safety. These changes to 
the certification pathway continue to ensure the safe use of byproduct 
material by medical licensees by establishing criteria for specialty 
boards to use in granting certifications. The NRC made a determination 
that, with the exception of one specialty board, the boards do not meet 
the requirement in the current rule regarding preceptor certification 
and work experience. With more latitude under the certification pathway 
in the final rule, the NRC believes that boards will be able to meet 
the revised requirements for recognition of board certification 
processes.

Changes to the Alternate Pathway

    The final rule also contains revised requirements for some of the 
alternate pathways. Some of these changes are minor and clarify the 
requirements for T&E.
    The ACMUI's recommendations for approval as an AU in the alternate 
pathway in Sec. Sec.  35.490(b) and 35.690(b) include the addition of 
the RCPSC to the listings of organizations that approve residency 
programs. The NRC finds that RCPSC should be included in the listing 
for the reasons previously discussed under the heading, ``Changes to 
the Certification Pathway.''
    In comments on the proposed rule, Agreement States recommended that 
a minimum number of hours of ``didactic'' training in basic 
radionuclide handling techniques should be specified for individuals to 
qualify as ANPs under Sec.  35.51 and as AUs under Sec. Sec.  35.190, 
35.290, and 35.390. The NRC understands that references by Agreement 
States to ``didactic training'' refers both to the ``didactic 
training,'' currently required to qualify as an authorized nuclear 
pharmacist under current regulations in Sec.  35.55(b)(1)(i), as well 
as the ``classroom and laboratory training'' required to qualify as an 
authorized user in Sec. Sec.  35.190(c)(1)(i), 35.290(c)(1)(i) and 
35.390(b)(1)(i). The term ``classroom and laboratory training'' will be 
used hereinafter to refer to this type of training. As discussed in 
Part II, Issue 1, and Part IV, Issue 2, of the Summary of Public 
Comments, the final rule specifies minimum number of hours of classroom 
and laboratory training for the alternate pathway.

Training Specific to Type of Use

    The ACMUI recommended that, in addition to meeting minimum T&E 
requirements, authorized individuals should have training or experience 
in the use of byproduct material or specific modalities (types of use), 
as appropriate, for which a licensee is authorized. The ACMUI also 
recommended that the requirement apply to newly hired, authorized 
individuals and when a new type of use is added to the licensee's 
program. The NRC supports these changes, believing that they will 
ensure that a licensee's staff has adequate knowledge and experience to 
fulfill the duties for which they are responsible. The final rule 
includes new paragraphs that add this requirement in Sec.  35.50(e) for 
RSOs, Sec.  35.51(c) for AMPs, and for AUs in Sec.  35.690(c) for 
remote afterloader, teletherapy and gamma stereotactic radiosurgery 
units. For uses under Sec.  35.300, requirements in Sec. Sec.  
35.390(b)(1) and 35.396(d) provide for training specific to type of use 
which applies to both the board certification and alternate pathways.

Other Changes

    In the current regulations, Sec.  35.390(b)(1)(ii)(G) specifies 
that work experience for uses of byproduct material in unsealed form, 
for which a written directive (WD) is required, must include 
administering dosages of radioactive drugs involving a minimum of three 
cases in each of the categories for which the individual is requesting 
authorized user status. Sections 35.390, paragraphs (b)(1)(ii)(G)(1), 
(3) and (4) refer to oral and parenteral administration of certain 
radionuclides.

[[Page 16340]]

The final rule clarifies that this training must be with quantities of 
radionuclides for which a WD is required. The NRC believes these 
changes are necessary because, without them, an individual might cite 
experience with low-level dosages to satisfy requirements for work 
experience; the changes place emphasis on the need for AUs to have work 
experience with higher level dosages, for which a WD is required. 
Similar requirements have also been incorporated into new Sec.  
35.396(d).
    The ACMUI and public commenters on the proposed rule stated that 
the physicians, who have sufficient T&E to serve as AUs for the medical 
use of unsealed byproduct material for which a WD is required, are 
unable to meet the requirements for use in Subpart E. As discussed in 
response to public comments on Sec.  35.390, this issue was resolved by 
the inclusion of a new Sec.  35.396, entitled, ``Training for the 
parenteral administration of unsealed byproduct material requiring a 
written directive.'' A conforming change was also made to Sec.  35.8, 
``Information collection requirements: OMB approval,'' to indicate that 
an information collection requirement applies to Sec.  35.396.
    The ACMUI recommended that the requirements for work experience for 
authorized users in Sec. Sec.  35.190, 35.290, and 35.390 be changed to 
require experience with performing quality control check of instruments 
rather than with calibrating instruments. In addition to instrument 
calibration, quality control procedures commonly include checks of 
parameters such as linearity, constancy, and functionality (including 
battery checks). The NRC agrees with the ACMUI's recommendation because 
ensuring proper function of these instruments involves more than 
periodic calibration. The final rule effects these recommendations with 
changes to Sec. Sec.  35.190(c)(1)(ii)(B), 35.290(c)(1)(ii)(B), 
35.390(b)(1)(ii)(B), 35.392(c)(2)(ii), and 35.394(c)(2)(ii). Similar 
requirements have also been incorporated into new Sec.  35.396(d)(2).
    Training requirements for authorization as a medical physicist have 
been changed in Sec.  35.51(b)(1) to remove specific requirements for a 
degree in biophysics, radiological physics, and health physics, and add 
the more general, other physical sciences, as well as engineering and 
applied mathematics. The requirement for 1 year of full-time training 
in therapeutic radiological physics has been changed to a more general 
requirement for 1 year of full-time training in medical physics. In 
Sec.  35.690(b)(2), the requirement for candidates to be approved as 
AUs has been changed to broaden the requirement that supervised 
clinical experience be received in ``radiation therapy'' rather than in 
``radiation oncology.'' These changes are needed to allow for the 
therapeutic use of byproduct material in applications other than cancer 
therapy.
    Current regulations in Sec.  35.50(c) provide that an AMP 
identified on a licensee's license can serve as an RSO, provided that 
the individual has experience with the radiation safety aspects of 
similar types of use of byproduct material for which the individual has 
responsibilities as an RSO. However, current regulations only require 
services of an AMP for uses under Sec. Sec.  35.433 and 35.600; a few 
AMPs are also named on licenses for uses under Sec.  35.1000. 
Therefore, individuals who may have adequate T&E to serve as AMPs for 
types of use licensed under Sec. Sec.  35.100, 35.200, 35.300, 35.400 
and 35.500, are not listed on an NRC or Agreement State license under 
current rules. Medical physicists who are certified by a specialty 
board whose certification is recognized by the Commission or an 
Agreement State have training and experience in radiation safety 
aspects of the use of byproduct material for medical purposes. The 
regulations in Sec.  35.50 have been changed to allow medical 
physicists, who are certified by a specialty board whose certification 
is recognized by the NRC or an Agreement State, to serve as RSOs, while 
retaining the requirement that these individuals have experience 
specific to the types of use for which they would be responsible. This 
change removes an impediment for individuals who have adequate T&E to 
become approved as RSOs. It also avoids placing a burden on licensees 
to apply for an exemption to regulations and on NRC and Agreement State 
staff who would be required to process an application for an exemption 
to regulations to approve a licensee's request to have a medical 
physicist, certified by a specialty board whose certifications are 
recognized by the NRC, serve as an RSO. Comments on the proposed rule 
indicated that medical physicists generally have adequate T&E to serve 
as RSOs. As discussed in response to comments on Sec.  35.50, this 
section has also been amended to provide criteria for medical 
physicists, other than those who are AMPs, to serve as RSOs.
    The term ``high-energy'' is used in the rule text in Sec. Sec.  
35.51(a)(2)(ii) and 35.51(b)(1) to specify the type of training to be 
included in T&E for AMPs. High-energy radiation is specified, in 
Sec. Sec.  35.51(a)(2)(ii) and 35.51(b)(1) of the final rule, as 
photons and electrons with energies greater than or equal to 1 million 
electron volts, which is consistent with the definition of high-energy 
used by the International Commission on Radiation Units and 
Measurements in Report 42, Use of Computers in External Beam 
Radiotherapy Procedures with High-Energy Photons and Electrons.
    In Sec.  35.75(a), reference is made to ``draft'' licensing 
guidance in NUREG-1556, Vol. 9. This guidance was published in final 
version in October 2002. Therefore, the ``draft'' designation is being 
removed.

Preceptor Attestation

    Part 35 currently requires a written certification, termed 
attestation in this final rule (and referred to as attestation in this 
discussion, when appropriate), that the individual has satisfactorily 
completed the required training, has achieved a level of knowledge or 
competency sufficient to function independently, and requires that the 
written certification be signed by a preceptor who is a radiation 
safety officer, authorized medical physicist, authorized nuclear 
pharmacist or authorized user. This requirement applies to both the 
board certification and alternate pathways.
    The ACMUI recommended that, instead of certifying ``competency,'' 
the preceptor should attest that the individual has satisfactorily 
completed the required training and experience. It further recommended 
that a training program director be allowed to sign the written 
attestation.
    As explained previously, the Commission considered recommendations 
of the ACMUI and determined in SRM-02-0194, ``OPTIONS FOR ADDRESSING 
PART 35 TRAINING AND EXPERIENCE ISSUES ASSOCIATED WITH RECOGNITION OF 
SPECIALTY BOARDS BY NRC,'' that the preceptor statement should remain 
as written in the current regulations. However, the Commission 
emphasized that the preceptor language does not require an attestation 
of general clinical competency, but requires sufficient attestation to 
demonstrate that the candidate has the knowledge to fulfill the duties 
of the position for which certification is sought.
    The ACMUI also recommended that the Commission separate the 
requirement to obtain a preceptor statement from the certification and 
alternate pathways, and to specify this requirement as a new paragraph 
in the sections dealing with T&E for RSOs, AMPs, ANPs, and AUs. The

[[Page 16341]]

Commission approved this recommendation of the ACMUI, placing the 
requirement on licensees to submit the preceptor statements to the NRC. 
This requirement appeared in the proposed rule. The regulations retain 
the requirements that individuals obtain preceptor attestations for 
both the certification and alternate pathways.
    The requirement for licensees to submit a preceptor attestation to 
the NRC appears in revised Sec.  35.14(a).

Listing of Recognized Board Certifications

    The NRC will list on its Web site (http://www.nrc.gov/materials/miau/med-use-toolkit.html), instead of in its regulations, the names of 
board certifications for those boards whose certification processes 
meet the NRC's requirements. This approach has the advantage of 
eliminating the need to amend 10 CFR Part 35 to effect recognition each 
time a new board needs to be added to the listing. The ACMUI and 
specialty board representatives who participated in a public meeting on 
May 20, 2003, were in agreement with this approach.
    Because of the importance of board certification in establishing 
the adequacy of T&E for individuals to serve as RSO, AMPs, ANPs, and 
AUs, a clear regulatory determination must be made that all boards, 
both new and existing, meet the relevant regulatory criteria. 
Evaluation of board requirements against revised criteria in the final 
rule is necessary to make this determination. Boards that are currently 
listed in Subpart J of Part 35 and other boards are required to apply 
for recognition under this rule. When necessary, the NRC staff will 
review a board's submittal with the ACMUI before a decision on 
recognition of a board is made.
    The NRC will place the procedures for listing and delisting of 
specialty boards on its Web site at the time of publication of the 
final rule. Because of the important role of board certification, the 
procedures will provide for making a clear regulatory determination 
that boards, both new and existing, meet the relevant criteria in the 
revised regulations. The procedures provide for both adding new 
specialty boards to the listing of recognized certifications and for 
removal from the list.
    The NRC staff does not intend to conduct inspections of the 
specialty boards whose certification processes it recognizes but will 
monitor trends in medical events. If the NRC staff determines that a 
series of medical events is associated with a particular specialty, and 
the trend can be attributed to inadequate radiation safety training, 
the staff will determine whether the inadequate training is related to 
a deficiency in a board's evaluation of the radiation safety competency 
of the board's diplomates. The NRC conducts a comprehensive regulatory 
program to ensure safety. This regulatory program is also important to 
the identification of issues related to T&E that may, in turn, point to 
issues associated with the certification process of a specialty board. 
If these activities result in identification of a deficiency in a 
board's evaluation of the radiation safety competency of the board's 
diplomates, the NRC staff will review the specialty board's 
certification program. The assessment will include a determination of 
whether the board's examination adequately assesses the requisite 
knowledge and skills in radiation safety. If the staff determines that 
changes in the board's evaluation of competency in radiation safety are 
necessary, and the board either cannot or will not make adequate 
changes to its program to address these needs, then the NRC will 
withdraw recognition of that specialty board's certification processes 
and delist that board. The NRC staff will inform the Commission and the 
ACMUI of an NRC staff decision to withdraw recognition. The NRC has 
reviewed existing procedures for the conduct of inspections and has 
determined that they provide for collection of the information 
necessary to evaluate trends in medical events possibly related to 
requirements for T&E of specialty boards. The NRC staff provided a copy 
of draft plans for implementation of the procedures for listing and 
delisting of board certifications to Agreement States and the ACMUI 
during the development of the proposed rule. The comments provided by 
these groups were considered by the NRC staff in developing final 
procedures for implementation.

Stakeholder Interactions

    On May 20, 2003, a public meeting was held to solicit early input 
on the proposed rule from representatives of professional specialty 
boards and other interested stakeholders. The NRC staff also made a 
presentation to the ACMUI on May 20, 2003, regarding the staff's 
approach to the proposed rule. The ACMUI provided input and a comment 
was received via e-mail from a participant in the meeting with the 
boards.
    The proposed rule was published in the Federal Register on December 
9, 2003 (68 FR 68549). The NRC staff briefed the ACMUI on the proposed 
rule during its meeting on March 2, 2004, and received comments from 
the ACMUI on the proposed rule during this meeting and a public 
teleconference conducted on March 22, 2004. Comments of the ACMUI, 
Agreement States, board members, and members of the public provided 
useful information to the NRC in preparing the proposed and final rule. 
A person from the State of Alabama, nominated by the Organization of 
Agreement States, participated as a member of the working group with 
the NRC staff in the development of the proposed and final rule. A 
person from the State of New York, nominated by the CRCPD, was added to 
the working group and participated in the resolution of comments on the 
proposed and draft final rule. The NRC staff distributed a draft final 
rule to the Agreement States and the ACMUI for 30-day review, ending on 
October 18, 2004. During this time, the ACMUI held a publicly announced 
meeting, via teleconference, on October 5, 2004, with Agreement State 
participation, to discuss requirements for a minimum number of hours of 
classroom and laboratory training in Sec. Sec.  35.55, 35.190, 35.290, 
and 35.390. The meeting was announced in the Federal Register on 
September 28, 2004 (69 FR 57977). Approximately 37 representatives of 
22 Agreement States participated in the meeting. The ACMUI also 
discussed the draft final rule, and made recommendations to the NRC, 
during its meeting on October 13-14, 2004. These comments are discussed 
in Section IV. Summary of Public Comments and Responses to Comments.

Additional Recommendations of the ACMUI

    At the teleconference held on July 17, 2003, the ACMUI discussed 
the draft proposed rule; Agreement State representatives also 
participated in the teleconference. During the teleconference, the 
ACMUI agreed with the NRC staff recommendation to broaden the 
requirement that supervised clinical experience be received in a 
``radiation facility'' rather than in a ``radiation oncology facility'' 
for individuals to qualify as AMPs, in Sec.  35.51(b)(1) of the 
proposed rule, and to change the requirement for experience in 
``radiation oncology'' in Sec.  35.690(b)(2) to allow for experience in 
``radiation therapy.'' Parallel changes were made to the certification 
pathway for AMPs in the proposed rule in Sec.  35.51(a)(2)(ii) and in 
Sec.  35.690(a)(1) for uses under Sec.  35.600. These changes were 
retained in the final rule.
    The ACMUI recommended that the requirements for experience, 
described

[[Page 16342]]

in the current rule in Sec.  35.390(b)(1)(ii)(G), not be included in 
criteria for recognition of specialty board certifications, but that 
they continue to be required for AUs meeting T&E requirements for both 
the certification and alternate pathways. This recommendation was not 
incorporated into the proposed rule, because the NRC staff believed 
that the requirements for work experience in Sec.  35.390(b)(1)(ii)(G) 
are essential for an individual to be able to function independently as 
an AU for administration of byproduct material for which a WD is 
required. As discussed in the response to public comments on the 
proposed rule, the ACMUI raised this recommendation again, indicating 
that many individuals obtain the experience required in Sec.  
35.390(b)(1)(ii)(G) after they have obtained their board certification. 
After further consideration, the requirement for this experience was 
removed from requirements for recognition of board certifications in 
the final rule but retained as a requirement for individuals to be AUs.
    At the teleconference held on March 22, 2004, the ACMUI recommended 
removal of requirements, in Sec.  35.390(b)(1)(ii)(F), for experience 
with elution of generators and measuring, testing, and preparation of 
radiolabeled drugs. As indicated in the discussion of public comments 
on Sec.  35.390, this requirement has been removed from this section in 
the final rule but retained in other sections when individuals qualify 
as AUs by virtue of being approved as an AU under Sec.  35.390. 
Additional recommendations, made by the ACMUI during the meeting on 
October 13-14, 2004, are discussed in Section IV. Summary of Public 
Comments and Responses to Comments.

Timing of Agreement State Implementation

    Normally, Agreement States have 3 years in which to adopt a 
compatible rule. Agreement States have until October 24, 2005, to adopt 
the revised 10 CFR Part 35 published on April 24, 2002. It was noted in 
the SUPPLEMENTARY INFORMATION for the proposed rule that, for Agreement 
States to adopt the proposed training and experience requirements and 
have them in place by October 24, 2005, the Agreement States would have 
a shortened time frame for developing compatible requirements. Because 
Agreement States had voiced concern regarding this shortened time 
frame, the NRC invited public comment on this issue. As indicated in 
``IV. Summary of Public Comments and Responses to Public Comments,'' 
the NRC is allowing 3 years for adoption of this final rule.

Revision of Guidance for Licensing of Medical Use of Byproduct Material

    Licensing guidance for medical uses of byproduct material is 
available in NUREG-1556, Vol 9, ``Consolidated Guidance About Materials 
Licenses. Program-Specific Guidance About Medical Use Licenses.'' The 
NRC has revised this guidance to conform to the revisions in this final 
rule and is making it available to the public coincident with 
publication of the final rule.

Extension of Subpart J to October 24, 2005

    The NRC has extended the expiration date for Subpart J to October 
24, 2005, through a separate rulemaking (69 FR 55736, September 16, 
2004).

IV. Summary of Public Comments and Responses to Comments

    The NRC received 27 comments on the proposed rule. The commenters 
included members of the general public and the ACMUI as well as 
representatives of Agreement States, professional societies, and 
certification boards. Additional comments from Agreement States were 
received on a draft of the final rule distributed made available to 
Agreement States for a 30 day comment period, ending on October 18, 
2004. Copies of the public comments are available for review in the NRC 
Public Document Room, 11555 Rockville Pike, Rockville, MD.
    This section summarizes the written and oral comments received and 
provides responses to these comments. Part I contains a list of the 
acronyms used in this section. Part II contains a discussion of general 
issues that were considered during the rulemaking. Part III contains a 
discussion of comments on specific sections in the proposed rule. 
Comments on timing of adoption of the rule by Agreement States and 
compatibility are discussed in Part IV.
    The NRC posed three questions in the ``Invitation for Public 
Comment on Specific Issues'' section of the proposed rule. These 
questions were:
    1. Do the proposed revisions to requirements for training and 
experience provide reasonable assurance that RSOs, AMPs, ANPs, and AUs 
will have adequate training in radiation safety? (This question is 
discussed in Part II--General Issues, Issue 1.)
    2. Should Agreement States establish the requirements to conform 
with this proposed rule by October 24, 2005, or should they follow the 
normal process and be given a full 3 years to develop a compatible 
rule? (This question is discussed in Part IV--Implementation by 
Agreement States--Timing and Compatibility.)
    3. Should the word ``attestation'' be used in place of the word 
``certification'' in preceptor statements? (This question is discussed 
in Part II--General Issues, Issue 2.)

Part I--Acronyms

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

ACGME--Accreditation Council for Graduate Medical Education
ACMUI--Advisory Committee on the Medical Uses of Isotopes
ACPE--American Council on Pharmaceutical Education
ABMS--American Board of Medical Specialties
AMP--Authorized medical physicist
ANP--Authorized nuclear pharmacist
AU--Authorized user
FPGEC--Foreign Pharmacy Graduate Examination Committee
NMED--Nuclear Materials Events Database
OAS--Organization of Agreement States
RSO--Radiation safety officer
T&E--Training and experience
WD--Written directive

Part II--General Issues

    Several commenters expressed general support for the proposed rule 
as well as offering comments on specific aspects of the proposed rule, 
which are discussed further in succeeding sections. Support was also 
voiced for the listing of recognized board certifications on the NRC's 
Web site rather than in regulations.
    Issue 1: Do the proposed revisions to requirements for training and 
experience (T&E) provide reasonable assurance that RSOs, AMPs, ANPs, 
and AUs will have adequate training in radiation safety?
    Comment: One commenter suggested that the NRC should go back to its 
original preceptor concept, under which no board certifications were 
required, but the preceptor (mentor) had the responsibility to ensure 
that training was adequate to ensure health and safety and medical 
efficacy. The commenter expressed concern that applicants could receive 
certification without complete knowledge and skills in a particular 
discipline, i.e., board certification may omit or excuse lack of 
knowledge and skill (if the applicant passes the requisite examination 
with a score of less than 100 percent) where the alternate pathway 
would require demonstration of 100 percent in a given discipline.

[[Page 16343]]

    Response: The NRC believes that RSOs, AMPs, ANPs, and AUs should 
have T&E sufficient to ensure radiation safety in the medical use of 
byproduct material. The NRC believes that it is necessary to specify 
requirements for T&E to accomplish this objective, either by requiring 
that candidates for approval as RSOs, AMPs, ANPs, or AUs are certified 
by a board which has a certification process that has been recognized 
by the NRC, or by meeting the requirements for T&E for the alternate 
pathway, combined with attestation by a preceptor that the individual 
has satisfactorily completed these requirements and has achieved a 
level of competency sufficient to function independently in the 
position for which approval is sought. The NRC believes that 
requirements for both pathways are similarly and sufficiently rigorous, 
and, that by passing a board examination, together with meeting the 
other requirements in the board certification pathway, a candidate will 
have demonstrated the knowledge and skill necessary to safely handle 
byproduct material. The NRC believes that this combination of 
requirements will ensure the safe medical use of byproduct material and 
has retained the option for AUs to meet requirements for T&E via the 
certification pathway.
    Comment: One commenter indicated, given that new problems 
consistently arise, specialty board training should only be accepted if 
it can be shown that there is a recertification/required continuing 
education every 10 years or less and that the recertification/
continuing education process can be shown to encompass the radiation 
protection aspects of newer technologies.
    Response: The NRC plans to periodically review the requirements of 
boards for certification to accommodate changing needs for T&E. 
However, the NRC does not depend solely on board certification to 
ensure adequacy of T&E. The regulations also provide, in Sec.  35.59, 
that T&E must have been obtained within 7 years preceding the date of 
an application to the NRC or that the individual had related continuing 
T&E. They also provide, in Sec.  35.57, for accommodating experienced 
AUs (e.g., individuals identified on a license), allowing those who 
serve as AUs under existing licenses and permits to continue medical 
uses for which they have been authorized. NRC regulations also provide 
requirements for licensing of new medical uses of byproduct material, 
including assessment of the adequacy of T&E of AUs for proposals for 
new uses in requests for amendments to licenses.
    Comment: One Agreement State commenter on the draft final rule 
stated that the NRC appears to want only limited submittal of the 
training programs for review and approval from medical boards and does 
not plan to conduct inspections of specialty boards to insure that they 
meet the latest certification requirements. Rather, the intent is to 
wait and see if specific medical events related to training occur in 
the field before investigating. The commenter does not believe this is 
acceptable, especially when considering the number of hospital staff 
and patients that may be at risk before this type of link to training 
can or will be made once an incident occurs.
    Response: In order to have their certification processes 
recognized, specialty boards must demonstrate that their certification 
processes meet the specific criteria established in the regulations. 
The NRC will carefully review the documentation submitted before 
recognizing a board's certification program. The NRC believes that this 
process for board recognition, taken together with the NRC's 
coordination with ACMUI, its inspection of licensed facilities, and its 
continued monitoring of medical events, will be sufficient to ensure 
public health and safety.
    Comment: Commenters from Agreement States expressed concern that 
the regulations no longer specify the number of classroom and 
laboratory or supervised clinical and work hours necessary for the 
various types of use. One commenter indicated that this could 
jeopardize radiation safety, and recommended that the NRC include a 
minimum acceptable number of hours of classroom and laboratory training 
in the SUPPLEMENTARY INFORMATION for the final rule (i.e., a minimum of 
200 hours of classroom and laboratory training out of the total of 700 
hours for those types of use for which a WD is required (Sec.  35.390); 
80 hours of classroom and laboratory training for those uses for which 
a WD is not required but for which 700 hours is still required (Sec.  
35.290); and a minimum of 8 hours of classroom and laboratory training 
for types of use for which 60 hours of training is required (Sec.  
35.190)), based on the risk to patients, occupational workers, and the 
public, for each type of use, and assuming class days are 8 hours. 
Three other commenters from Agreement States recommended that 
regulatory agencies should specify a minimum number of hours of 
classroom and laboratory training under Sec. Sec.  35.190, 35.290, and 
35.390. One commenter suggested that individuals qualifying as ANPs 
under Sec.  35.55 and as AUs under Sec.  35.390 should be required to 
have 200 hours of classroom and laboratory training. Also, the 
Organization of Agreement States (OAS) (petitioner) filed a Petition 
for Rulemaking (petition) dated September 3, 2004 (PRM-35-17) 
requesting that the NRC amend Sec. Sec.  35.55, 35.190, 35.290 and 
35.390 to define and specify the minimum number of didactic training 
hours for Authorized Nuclear Pharmacists and Authorized Users 
identified in these sections.
    Response: The NRC agrees with the Agreement States' assertion that 
the inclusion of a requirement for minimum number of hours of classroom 
and laboratory training (in Sec. Sec.  35.55, 35.190, 35.290, and 
35.390) for the alternate pathway only, will ensure safety and 
consistency of regulation on a national basis. Therefore, requirements 
for a minimum number of hours of classroom and laboratory training have 
been included in Sec. Sec.  35.55(b)(1)(i), 35.190(c)(1), 35.290(c)(1), 
and 35.390(b)(1) of the final rule. However, the added requirements, 
specifying a minimum number of hours of classroom and laboratory 
training, were not added to the requirements for recognition of 
specialty board certifications because the NRC believes that it is 
important to provide flexible options for boards to evaluate the 
adequacy of T&E related to radiation safety. This flexibility is 
provided by a combination of evaluation through examinations, and 
academic and practical T&E. The NRC believes that the requirements of 
certifying boards, including requirements for examinations, whose 
certification processes have been recognized by the Commission or an 
Agreement State, will ensure the adequacy of radiation safety training. 
As part of their application for recognition of certifications, boards 
will be asked to provide information on how their examination process 
assesses the candidates' knowledge related to radiation safety as it 
pertains to the subject areas enumerated in the regulations. The NRC 
believes that specifying a minimum for the number of hours of classroom 
and laboratory training, in the alternate pathway, will help to ensure 
that training programs are of adequate length to properly cover the 
topics important to safe medical use of byproduct material, 
supplementing the T&E gained during supervised clinical training. Doing 
so will increase the rigor of the alternate pathway and provide useful 
and consistent standards for developing training programs. Specifying a 
minimum number of hours of classroom and laboratory training will also 
be useful to States in reviewing the adequacy of training programs and 
assist Agreement States in developing

[[Page 16344]]

their T&E regulations to be consistent with the compatibility category 
B designation for T&E regulations.
    The draft final rule, circulated to Agreement States for a 30-day 
comment period, ending on October 18, 2004, included requirements for a 
minimum number of hours of classroom and laboratory training 
(applicable to the alternate pathway only) as follows: Sec.  35.55--200 
hours, Sec.  35.190--8 hours, Sec.  35.290--80 hours, and Sec.  
35.390--200 hours. Twelve Agreement States provided comments on this 
issue, with nine of them being in favor of a minimum of 200 hours of 
classroom and laboratory training for Sec.  35.390. Two Agreement 
States recommended minimums of 120 and 160 hours of classroom and 
laboratory training, respectively, for Sec.  35.390. Eight Agreement 
States supported the proposed number of hours for Sec. Sec.  35.55, 
35.190 and 35.290, and two States suggested requirements ranging from 
120 to 200 hours for these four sections. One commenter from an 
Agreement State stated that the risks associated with uses under Sec.  
35.200 is similar to those for uses under Sec.  35.300 because the 
higher frequency of uses under Sec.  35.200 results in more risk and 
that, therefore, the number of hours of classroom and laboratory 
training should be the same (200 hours) in Sec. Sec.  35.290 and 
35.390. This commenter suggested that, for clarity, the term 
``classroom and laboratory training'' be used in place of the term 
``didactic training'' in sections where the latter term appears. The 
commenter also stated that the way the draft revisions to the 
regulations are now written, the preceptor statement seems to apply 
only to the alternate pathway, and that they should be restructured to 
ensure that information is provided in preceptor statements about hours 
of training and experience, including classroom and laboratory 
training. The commenter suggested restructuring the regulations and re-
designating paragraphs so that paragraph ``(d)'' always included the 
requirements for preceptor statements.
    During the ACMUI meeting on October 14, 2004, the ACMUI passed a 
motion recommending that the requirement for classroom and laboratory 
training, in Sec.  35.390, be 80 rather than 200 hours. The ACMUI 
believes that the requirements for training in radiation safety and 
safe handling for medical uses under Sec. Sec.  35.200 (no written 
directive required) and Sec.  35.300 (written directive required), 
including the use of beta emitters, are similar. The total hours of 
training (classroom and laboratory, combined with work experience) is 
the same (700 hours) in Sec. Sec.  35.290 and 35.390. Therefore, the 
ACMUI recommended that the number of hours required for classroom and 
laboratory training be the same as that required for Sec.  35.290, 
i.e., 80 hours, because the knowledge required for radiation safety is 
similar for uses under both Sec. Sec.  35.290 and 35.390. The ACMUI was 
also concerned that time taken for classroom and laboratory training 
required under Sec.  35.390(b)(1)(i) would detract from time needed for 
training in other areas required of clinicians.
    After consideration of both the ACMUI's and Agreement States' 
recommendations, the NRC staff analyzed the issue to determine the 
appropriate amount of classroom and laboratory training for approval of 
AUs under Sec.  35.390. The NRC is adopting a requirement for 200 hours 
of classroom and laboratory training for the alternate pathway in Sec.  
35.390 because more knowledge is necessary in the topic areas listed in 
Sec.  35.390(b)(1)(i)(A) through (E), as enumerated below, to ensure 
the safe use of byproduct material for which a written directive is 
required.
    1. Radiation physics and instrumentation--a wider variety of 
radionuclides, having a wider range of energies, both for beta and 
gamma emitters, is used. This affects understanding of how radiation 
interacts with matter, which impacts understanding of shielding as well 
as the effects of radiation, and choice and use of instrumentation to 
detect and measure radiation and to measure quantities of 
radionuclides.
    2. Radiation protection--more knowledge of principles and practices 
of radiation protection is needed because of the wider variety of 
radionuclides and associated types and energies of radiations used 
under Sec.  35.300. Because greater quantities of byproduct material 
are commonly used for therapeutic purposes, risks are greater for 
patients and patient care personnel as well as for the public after the 
release of patients. Evaluation of these risks and associated 
protective measures and practices necessitates more knowledge for uses 
under Sec.  35.300 than for uses under Sec.  35.200. More knowledge of 
principles and practices in radiation protection is needed because of a 
wider variety of modes of administration and physical forms of 
byproduct material, e.g., intravenous, intra-peritoneal, oral and 
liquids in catheters. Each of these factors necessitates different 
radiation safety considerations for patients, occupationally exposed 
personnel and members of the public. Radiation safety considerations 
relate both to the preparation and use of byproduct material for 
medical purposes, and may extend to the treatment of patients in the 
operating room and to the pathology staff.
    3. Mathematics pertaining to the use and measurement of 
radioactivity--Mathematics related to dosimetry is more complex for the 
wider variety of radionuclides, greater quantities, different types of 
radiation, and the broader purposes of use. Whereas byproduct material 
is used for diagnostic purposes under Sec.  35.290, uses under Sec.  
35.390 are common for various therapeutic purposes.
    4. Chemistry of byproduct material for medical use--a wide variety 
of chemical forms of byproduct material is used under Sec.  35.300. 
These forms include ionic, bound-to-antibodies, and simpler chemical 
species, resulting in differences in uptake in the body and various 
organs and tissues (biodistribution), and elimination. Agents are used 
both for diagnostic and therapeutic purposes.
    5. Radiation biology--more knowledge of radiation biology is needed 
because byproduct material are administered in greater quantities, both 
for diagnostic and therapeutic purposes, resulting in the potential for 
a greater variety of radiation effects and greater potential for harm. 
Risk assessments sometimes involve consideration of immediate 
biological effects whereas this is not usually a consideration in 
diagnostic applications under Sec.  35.200.
    In addition to these considerations, the NRC notes that new medical 
applications of byproduct material are evolving under Sec.  35.300. 
Examples include more common use of byproduct material for alleviation 
of bone pain and for treatment of metastatic disease. This results in a 
need for additional knowledge of a wider variety of applications of 
physical and chemical forms of byproduct material.
    The NRC determined that the minimum amount of classroom and 
laboratory training should be 200 hours by reviewing the content of 
training courses that an individual might attend to satisfy the 
requirements in Sec.  35.390(b)(1)(i). This training involved 200 hours 
of classroom and laboratory training.
    The requirement for 200 hours of classroom and laboratory training 
is also incorporated into the final rule for individuals to qualify as 
ANPs because nuclear pharmacists may be involved in the preparation of 
dosages of byproduct material for uses under Sec.  35.300 as well as 
under Sec. Sec.  35.100, 35.200 and other uses specified in 10 CFR Part 
35. Therefore, these individuals will be

[[Page 16345]]

involved in high-risk activities related to use of byproduct material, 
including wet chemistry. Their work may also involve greater quantities 
of byproduct material because they may dispense dosages from stock-
quantities. Greater quantities are also used for short half-life 
radionuclides which decay between preparation and administration to 
patients.
    The minimum number of hours of classroom and laboratory training 
for uses under Sec.  35.200 is 80 hours because the complexity and 
level of knowledge required is less than for uses under Sec.  35.300. 
The NRC believes that the frequency of use of byproduct material should 
not be considered in evaluating the risk to individuals from uses of 
byproduct material under Sec.  35.200, for the purpose of determining 
the requirement for hours of classroom and laboratory training to be 
required for such uses. Rather, the NRC believes that other factors 
should be considered in this regard, e.g., adequacy of size and scope 
of a radiation safety program to ensure safe uses of byproduct 
material. However, because procedures such as elution of radionuclide 
generators and preparation of drugs labeled with byproduct material are 
conducted under Sec.  35.200, the minimum was set at a greater level 
than for uses under Sec.  35.100, for which risks are significantly 
less and for which the minimum requirement was set at 8 hours of 
classroom and laboratory training, in Sec.  35.190.
    The NRC recognizes that the minimum number of hours of classroom 
and laboratory training for uses of licensed byproduct material 
specified in these sections differs to some extent from the minimum 
number of hours of classroom and laboratory training specified for 
similar uses of such material in Subpart J. However, in determining the 
minimum number of hours of classroom and laboratory training to be 
required for each use, the NRC also recognized that the uses specified 
in sections of Subpart J are different from those covered in Subparts D 
through H and that the medical use of byproduct material has evolved 
and changes have taken place in the available technology for use in 
each of these areas since the promulgation of Subpart J. The NRC has 
considered these factors in determining the minimum number of hours of 
classroom and laboratory training to be required for uses in Subparts B 
and D through H.
    The NRC also agrees with the comment that the term ``classroom and 
laboratory training'' should be used in place of the term ``didactic 
training.'' The regulations in Sec. Sec.  35.50(b)(1)(i) and 
35.55(b)(1)(i) have been revised to use the term ``classroom and 
laboratory'' in place of ``didactic training.''
    The NRC has revised the language in the final rule so that the 
requirement for a preceptor attestation, for individuals to be approved 
as RSOs, AMPs, ANPs and AUs, now appears in Sec. Sec.  35.50(a), 
35.51(a), 35.55(a), 35.190(a), 35.290(a), 35.390 (a), 35.392(a), 
35.394(a), 35.396(a), 35.490(a), and 35.590(a). This approach helps 
make it clear that a preceptor statement is required for both the 
certification and alternate pathways. The NRC did not re-designate 
paragraphs to have the requirement for preceptor statements appear in 
paragraphs ``(d)'' in order to avoid extensive renumbering that would 
be necessary for other paragraphs.
    Comment: One Agreement State commenter stated that there is too 
great of a reliance on a preceptor's attestation/certification for 
physicians who qualify as AUs under the alternate pathway to provide 
adequate assurance that the individual will have obtained adequate 
radiation safety training. The criteria used by preceptors must be 
specifically and clearly defined and the qualifications for preceptors 
should be defined as well. Otherwise, AUs may give undue weight to the 
clinical aspects of training rather than to safety, and a clinically 
competent AU who has a poor radiation safety compliance history may 
provide a strong statement for an individual for whom radiation safety 
training was minimal.
    Response: The criteria to be used by preceptors are stated in the 
regulations, including the qualifications required for an individual to 
serve as an AU. The NRC believes that competency of candidates to 
function independently as AUs is best assessed by AUs who have 
experience performing the duties of an AU. The definition of 
``preceptor'' appears in Sec.  35.2. The qualifications for an 
individual to serve as a preceptor are specified in the requirements 
for preceptor statements in Subparts B and D through H. In general, 
they require that the preceptor be an individual who serves in the same 
capacity as the candidate for approval as RSO, AMP, ANP, or AU. The 
criteria for evaluation of T&E by preceptors are specified in each 
section of Subparts B and D through H. These criteria were chosen to 
ensure that they are risk-informed and performance-based and not unduly 
prescriptive in relation to the degree of risk associated with various 
types of use. Moreover, reflecting a performance-based approach, an AU 
is considered qualified to serve as a preceptor as long as his or her 
authorized status remains current. However, if an individual's status 
as an RSO, AMP, ANP, or AU, is revoked for non-compliance with the 
NRC's regulations, that person could no longer serve as a preceptor.
    Issue 2: Should the word ``attestation'' be used in place of the 
word ``certification'' in preceptor statements? Should other changes to 
the wording or preceptor statements be made?
    Comment: One commenter observed that ``attest'' and ``certify'' 
mean the same thing, and, because preceptors have been ``attesting'' 
for years, questioned changing terminology. Other commenters expressed 
support for making the change, with two commenters noting that the word 
``certification'' should only be used in connection with the board 
process. Another commenter believes that the use of the word ``attest'' 
in place of ``certify'' would alleviate certain obstacles to 
individuals willing to serve as proctors.
    Response: The NRC agrees that the use of the word ``attest'' and 
its various other forms (attestation, attesting) is more appropriate 
than the use of the word ``certify'' and would lead to more clarity in 
the regulations. Therefore, appropriate changes were made in the 
definition of ``preceptor'' and in the requirements for preceptor 
attestations in the regulations. This change was also made, as a 
conforming change, in Sec.  35.980(b)(2) of Subpart J to maintain 
consistency with other Subparts of 10 CFR Part 35.
    Comment: The preceptor statement should be reworded to indicate 
that a preceptor ``attest[s] to the candidate's knowledge and ability 
to handle radioisotopes in preserving the health and safety of the 
patient and the provider.'' The preceptor should not be required to 
attest to the general clinical competency of the candidate.
    Response: The NRC agrees with the suggestion that the word 
``attest'' should be used in place of ``certify'' in preceptor 
statements and has made these changes in the final rule. However, the 
other changes to the preceptor statements suggested by the commenter 
would result in the elimination of essential elements of a preceptor 
statement that the NRC continues to rely on to determine if an 
individual has satisfactorily completed requirements for T&E and has a 
level of competency sufficient to function independently as an RSO, 
AMP, ANP, or AU. The NRC clarified the meaning of the word 
``competency'' in the section of the SUPPLEMENTARY INFORMATION entitled 
``Preceptor Attestation,'' by indicating that preceptors are not 
attesting to the general clinical competency of the

[[Page 16346]]

candidate; this interpretation represents a restatement of the NRC's 
intent stated in the SUPPLEMENTARY INFORMATION for the current 
regulations, published on April 24, 2002 (67 FR 20249). Therefore, the 
other changes suggested by the commenter were not adopted in the final 
rule.
    Comment: One Agreement State commenter believes that preceptors are 
not certifying ``individuals,'' but they certify that the training 
received by an individual meets regulatory requirements. Otherwise, 
there may be an implication that organizations which provide training 
are relieved of any responsibility.
    Response: The NRC agrees with the commenter's statement that 
preceptors do not ``certify individuals.'' The purpose of preceptor 
attestations is stated in the regulations (e.g., in the case of RSOs), 
to attest to the satisfactory completion of requirements for T&E to 
serve as an RSO and to an individual's having achieved a level of 
radiation safety knowledge sufficient to function independently as an 
RSO for a medical use licensee.
    Comment: An Agreement State commenter on the draft final rule 
stated that the definition for preceptor should confirm that the 
individual verifying training for another authorized user, medical 
physicist, nuclear pharmacist or RSO is also a licensed user/RSO on a 
specific medical license. The commenter indicated that it is also 
important for the preceptor to know that his or her own authorization 
on a medical license is at risk when signing a preceptor attestation.
    Response: As stated above, the qualifications required for an 
individual to serve as preceptor are specified in the requirements for 
preceptor statements in Subparts B and D through H, and require that 
the preceptor be an individual who serves in the same capacity as the 
candidate for approval as RSO, AMP, ANP, or AU. Therefore, the NRC does 
not believe that the definition for preceptor should be revised. The 
NRC notes that a preceptor's authorization on a medical license is not, 
per se, ``at risk'' for signing a preceptor attestation. However, under 
Section 186 of the Atomic Energy Act, as well as the Commission's 
regulations in 10 CFR 30.10, a licensee, or applicant for a license, 
who deliberately submits to the NRC information that a person 
submitting the information knows to be inaccurate in some respect 
material to the NRC, may be subject to enforcement action. Under 18 
U.S.C. Sec.  1001, any person who makes a willful false statement to 
the NRC may be subject to criminal sanctions.
    Issue 3: Comments on other requirements related to preceptor 
statements.
    Comment: Some commenters stated that the wording of the 
requirements for preceptor statements in the proposed rule implies that 
the preceptor has knowledge that an individual meets all of the 
requirements for board certification, including passing of a 
certification examination, thereby establishing an unintended link 
between preceptor statements and examinations administered by boards. 
This may or may not be true, since, in some cases, a preceptor 
statement may be signed before the individual sitting for the board 
examination.
    Response: The NRC agrees that preceptors should not be required to 
certify that individuals have completed all of the requirements that 
candidates for certification by a specialty board would be required to 
meet to obtain certification. The requirements for preceptor statements 
have been reworded in Subparts B and D through H of the final rule to 
remove requirements to attest to candidates having passed board 
administered examinations.
    Comment: While agreeing that the change from certification to 
attest should be made, other commenters recommended that the following 
be inserted in place of the first sentence of all preceptor paragraphs 
in the December 9, 2003, draft: ``Has obtained written attestation that 
the individual has satisfactorily completed the required training in 
paragraph (a)(1) or (b)(1) of this section and has achieved a level of 
knowledge and demonstrated the ability to safely handle radioisotopes 
to ensure adequate protection of public health and safety. The written 
attestation must be signed by a preceptor. * * *''
    One commenter indicated that the word ``competency'' should be 
dropped from the suggested preceptor statement because the phrase ``has 
achieved a level of knowledge and demonstrated ability'' is a 
demonstration of competency.
    Response: As noted in the Discussion section of the SUPPLEMENTARY 
INFORMATION, the Commission directed the NRC staff, in SRM-02-0194 
(dated February 12, 2003), that the preceptor statement remain as 
written in the current regulations (published April 24, 2002), and that 
the staff should clarify that the preceptor language does not require 
an attestation of general clinical competency but does require 
sufficient attestation to demonstrate that the candidate has the 
knowledge to fulfill the duties of the position for which certification 
is sought. Further, this form of attestation should be preserved both 
for the certification pathway and the alternate pathway. Therefore, the 
suggestion related to the use of the word ``competency'' was not 
adopted in the final rule.
    Comment: One Agreement State commenter stated that the proposed 
language regarding the requirement for obtaining preceptor statements 
is not the same in different sections. For example, Sec.  35.290(a) 
reads, ``meets the requirements in paragraph (c)(2) [has obtained a 
preceptor statement] and is certified.'' But Sec.  35.390(a) reads, 
``is certified by a medical speciality board * * *'' and ``(c) has 
obtained written certification (from a preceptor).'' While this 
accomplishes the same purpose, at first glance it appears that some 
boards do not require preceptor statements while others do. The 
language should be made more uniform for each discipline.
    Response: The NRC agrees that parallel construction should be used 
in the language for requirements for preceptor statements for 
individuals who are board certified, and this approach was taken in the 
final rule. The requirement for a preceptor attestation for individuals 
to be approved as RSOs, AMPs, ANPs, and AUs now appears in Sec. Sec.  
35.50(a), 35.51(a), 35.55(a), 35.190(a), 35.290(a), 35.390(a), 
35.392(a), 35.394(a), 35.396(a), 35.490(a), and 35.690(a). This 
approach also helps make it clear that a preceptor statement is 
required regardless of which training pathway is chosen.
    Comment: One Agreement State commenter agreed that a preceptor 
statement should continue to be required for board certified 
individuals, stating that it is important for a person who knows a 
candidate to attest to the individual's competence in radiation safety.
    Response: The NRC agrees with this comment. The NRC continues to 
rely on preceptor statements to determine if an individual has 
satisfactorily completed requirements for T&E and has a level of 
knowledge sufficient to serve as an RSO, AMP, ANP, or AU.
    Comment: Several commenters expressed the opinion that the change 
in the requirements that de-couples requirements for a preceptor 
statement from requirements for recognition of board certifications 
will result in a shift of burden for obtaining the statement from 
boards to individuals. One Agreement State commenter supported placing 
the responsibility for obtaining preceptor statements on individuals 
rather than on certification boards as a prerequisite to the 
certification process.

[[Page 16347]]

Other commenters recommended that the NRC retain the preceptor letter 
requirement as a prerequisite to recognition of board certifications. 
They questioned what is gained by dropping requirements for preceptor 
statements from requirements for recognition of board certifications. 
An Agreement State commenter opposed separating requirements for 
preceptor statements from requirements for recognizing board 
certifications on the grounds that it integrates less uniformity and 
reliability into the training process. According to the commenter, a 
large number of physicians are currently denied authorizations because 
of inadequate preceptor statements, and this will only increase if 
these statements are not reviewed and issued by a valid source such as 
approved certification boards, thereby increasing the shortage of 
approved AUs.
    Response: The NRC believes that individuals will continue to be 
involved in the process of documenting T&E and that the shift in 
responsibility is primarily from the involvement of boards in the 
process to licensees, which will be subject to the new requirement for 
submitting the preceptor statement to the NRC under Sec.  35.14(a). The 
NRC removed the requirement for boards to obtain preceptor 
attestations, as a condition of recognition of board certifications, 
upon the recommendation of the ACMUI, which indicated that the 
requirement should be de-coupled from requirements for recognition of 
board certifications because individuals may obtain the preceptor 
statement required by the NRC after they have obtained their board 
certifications. This approach will enable a more flexible approach to 
satisfying the requirement for preceptor statements. The NRC believes 
removal of the requirement for a preceptor statement from requirements 
for recognition of specialty board certifications will not result in 
less uniformity in the process of training or decrease the number of 
individuals who are approved as AUs because the responsibility for 
obtaining preceptor statements will still rest with individual 
candidates for approval as AUs, and the statements now must be 
submitted to the NRC or an Agreement State, rather than to a 
certification board. The NRC also notes that the final rule does not 
prevent specialty boards from requiring preceptor statements.
    Comment: One commenter stated that the NRC should not require 
written preceptor certifications for the certification pathway because 
certification boards already require letters of endorsement to verify 
candidates' work experience and qualifications, and candidates must 
also pass a multi-part examination to assess knowledge and fitness to 
practice in a particular medical specialty. Therefore, it is redundant 
for the NRC to require preceptor statements. Furthermore, preceptors 
who are not involved in a specialty board's certification practice can 
only verify that an individual possesses a valid certificate. In 
addition, the commenter questions the justification for this new 
requirement.
    Some commenters stated that the requirement for preceptor 
statements should be eliminated for board certified AUs, AMPs, and 
ANPs; they should only be required for those requesting authorization 
via the alternate pathway and for RSOs. Board certification and 
continued experience are satisfactory demonstration for meeting the 
radiation safety requirements to perform those authorized activities as 
AU, AMP, or ANP. The commenters believe that there is no evidence to 
support that any added benefit would be provided by requiring a 
preceptor statement for these individuals. Removing requirements for 
obtaining preceptor statements would also minimize the delay in 
approval of these individuals by the appropriate regulatory agency or 
the Radiation Safety Committee.
    Response: The NRC continues to rely on preceptor statements to 
determine if an individual has satisfactorily completed requirements 
for T&E and has a level of knowledge sufficient to serve as an RSO, 
AMP, ANP, or AU. The NRC believes that it is essential to have 
individuals who are familiar with the duties of RSOs, AMPs, ANPs, and 
AUs, through personal experience, to serve as preceptors. Individuals 
who serve in these positions are best qualified to attest that an 
individual has achieved a level of competency sufficient to function 
independently as an AMP, ANP, AU, or RSO. The concern expressed about 
the unavailability, or inability, of an authorized individual to 
complete a preceptor statement for an individual seeking authorized 
status was addressed in the final rule by modifying the definition of a 
preceptor, in Sec.  35.2, to permit verification by the preceptor of 
required training and/or experience obtained previously or elsewhere. 
As indicated under the discussion of comments on the definition of 
``preceptor,'' the word ``the'' was removed from the phrase ``the 
training and experience'' in the definition of preceptor to help 
clarify that more than one individual may serve as a preceptor. The NRC 
does not agree that removing the requirement to obtain a preceptor 
statement would minimize the delay in approvals of individuals to serve 
as RSOs, AMPs, ANPs and AUs because other means would have to be used 
to evaluate the competency of these individuals, which would increase 
the amount of time needed for these approvals.
    Comment: Some commenters stated that clarification that individuals 
may submit more than one preceptor statement, as applicable, for all 
categories of AU, AMP, or RSO, should be provided in the SUPPLEMENTARY 
INFORMATION for the final rule. Proposed Sec. Sec.  35.490(c) and 
35.690(c) indicate that the preceptor must be an AU of each type of 
medical unit for which the individual is requesting AU status. The 
language must be clarified to allow for different preceptors for 
multiple devices for which AU status is sought.
    Response: The NRC recognizes that separate preceptor statements may 
be needed to document the T&E of individuals, e.g., in the case of an 
individual who receives training at different times in his or her 
career or in other circumstances when it may not be possible for only 
one preceptor to attest to some of the T&E that an individual has 
received. The NRC accepts multiple preceptor statements from licensees 
in these circumstances. As indicated under the discussion of comments 
on the definition of ``preceptor'' in Part III, the word ``the'' was 
removed from the phrase ``the training and experience'' in the 
definition of preceptor to help clarify that more than one individual 
may serve as a preceptor.

Other Issues

    Issue 4: Should the NRC continue to recognize the certifications of 
boards that have been recognized under the current regulations?
    Comment: Two commenters believe that the CBNC (Certification Board 
of Nuclear Cardiology) should not be required to reapply for 
recognition of its certification because it was the only board that 
complied with the NRC requirements in 10 CFR Part 35 as promulgated on 
April 24, 2002 (67 FR 20249).
    Response: The NRC believes that, because of the importance of board 
certification to establishing the adequacy of T&E for individuals to 
serve as RSO, AMPs, ANPs, and AUs, it is necessary to make a clear 
regulatory determination that all boards, both new and existing, meet 
the relevant regulatory criteria. Evaluation of board requirements 
against revised criteria in the final rule is necessary to make this 
determination. The NRC notes that, via a separate rulemaking, the 
expiration of Subpart J was extended for 1 year to

[[Page 16348]]

October 24, 2005 (69 FR 55736, September 16, 2004); this will provide 
time for boards to apply for recognition under the revised regulation 
in the final rule. During this period, the NRC will continue to 
recognize the certifications of boards, including the CBNC's, which are 
recognized under current regulations.
    Issue 5: How will the NRC implement procedures for recognition of 
specialty board certifications? How will the NRC monitor trends in 
medical events to evaluate whether they are associated with a 
certification board's requirements for certification?
    Comment: In the SUPPLEMENTARY INFORMATION for the proposed rule, 
the NRC briefly discussed plans for implementation of changes to 
requirements for recognition of specialty board certifications. One 
commenter questioned these plans, asking how the NRC will monitor 
trends in medical events to see if they can be associated with 
inadequate training in radiation safety and if these trends can be 
related to a specialty board's requirements for training. The commenter 
agreed that the NRC should not conduct routine inspections of boards. 
The commenter indicated that the number of medical events reported by a 
certain board's diplomates is small, making it difficult to develop 
associations between trends and a board's requirements. The commenter 
also asked what statistical methods the NRC would use to make these 
determinations. One Agreement State commenter stated that the process 
by which a board would be delisted appears to be ineffective. For 
example, it is unclear how the NRC will track trends in diagnostic 
medical events and relate those trends to the adequacy of the radiation 
safety training component of a specific board certification, 
considering the fact that most diagnostic medical events are not 
reportable. The commenter stated that an analysis of current data 
should have been performed to determine if this approach would be 
effective.
    Response: The NRC conducts a regulatory program to ensure safety. 
This regulatory program is also important to the identification of 
issues related to T&E that may, in turn, point to issues associated 
with the certification process of a specialty board. The NRC also 
requires that medical events be reported to the NRC and Agreement 
States. Bi-monthly reviews of events in the Nuclear Materials Events 
Database (NMED) provide a means for identifying trends in medical 
events in Agreements States and among NRC licensees that may lead to 
follow-up and review of adequacy of specialty board certification 
requirements. The NRC reviewed recent data and determined that 
radiation safety training related to board certification programs is 
adequate. The NRC staff has initiated consultations with the ACMUI to 
review medical events to determine if action is needed when problems 
arise including trends in medical events reflected in NMED data. The 
NRC has a broad regulatory framework associated with medical T&E, 
involving review of specialty board certification processes, licensing 
and inspections of licensees, and medical event follow up and analysis. 
The NRC believes that these measures are sufficient to determine the 
adequacy of training related to a board's certification process.
    Comment: One commenter believes that the NRC's plan to review a 
specialty board's certification program is particularly troubling. The 
NRC should not expect a certification board to jeopardize the security 
of its examination by allowing the NRC to review the examination and 
should not influence the content of a board's examination. The 
commenter believes that, because of the NRC's lack of expertise 
concerning the practice of medicine, the NRC is not in a position to 
determine the content of an examination. Rather, only a specialty board 
can make this judgement.
    Response: The NRC will only review board examinations if it 
determines that a series of medical events is associated with a 
particular type of use and if the trend can be attributed to inadequate 
training in radiation safety. In addition, the NRC has methods to 
protect proprietary information in examinations; 10 CFR 2.390, ``Public 
inspections, exemptions, requests for withholding,'' provides 
procedures for protection and nondisclosure of information that 
contains trade secrets, commercial or financial information obtained 
from a person, and privileged or confidential information. The NRC will 
consult with the ACMUI to seek advice, as necessary. Further, if safety 
problems are found that relate to the requirements of specialty boards 
for certifications, the NRC will work with boards to resolve these 
problems, including inadequacies in examinations if that is identified 
as a source of the problem.
    Comment: One commenter stated that, while it is acceptable that the 
NRC does not plan to implement the rule by inspecting boards, the 
entire program for recognition of board certifications is in question 
unless the NRC reviews copies of training programs used by the boards 
and has some kind of regulatory basis to implement enforcement of these 
commitments, if necessary.
    Response: While the NRC does not plan to inspect training programs, 
it believes that specialty boards have a strong incentive to ensure 
that their certification procedures will ensure the safe use of 
byproduct material in medicine to protect the integrity of their 
certifications as well as to gain recognition from the NRC or an 
Agreement State. The NRC also believes that if a board's certification 
requirements are deficient, the possibility of delisting and loss of 
recognition is also a strong incentive for a specialty board to correct 
deficiencies. Further, as stated in the SUPPLEMENTARY INFORMATION for 
the current regulations, the NRC will investigate any allegations 
regarding inadequate training programs on a case-by-case basis.
    Comment: One Agreement State commenter stated that, while it 
appears that posting approved boards on the NRC Web site is 
appropriate, it is not clear that Agreement States will have input into 
the review/approval process.
    Response: The NRC's current regulations for recognition of 
specialty board certification processes provide for recognition by 
either the NRC or Agreement States but do not require consultation 
between States or between States and the NRC. The regulations provide 
clear criteria for recognition of board certification processes.
    Issue 6: How will revised requirements for T&E affect individuals 
who are now in training?
    Comment: One commenter stated that there has been no requirement 
for fellows or residents currently in training to document T&E on a 
case-by-case basis. Therefore, physicians would be adversely affected 
by this new requirement, which would require a retrospective analysis 
of data that may not have been kept. Accordingly, the proposed T&E 
requirements must be applicable only to those who begin training after 
the date of implementation of the final rule.
    Response: The NRC believes that the revisions to requirements for 
T&E of AUs do not result in such extensive changes from current 
requirements that it should create difficulty for individuals to 
document their T&E. The ACMUI noted in its recommendations to the NRC 
for the development of the proposed rule (see SECY-02-0194) that it 
expected that the requirements of all boards for certification, that 
are currently recognized, would satisfy revised requirements. Thus, 
there should be little change in what an individual would be expected 
to present to a board to gain certification. Further,

[[Page 16349]]

the changes to the requirements for the alternate pathway are 
relatively few. Thus, these changes will not make the task of 
documenting T&E significantly more difficult. The NRC believes that 
these requirements are essential to ensuring adequacy of T&E for 
medical uses of byproduct material for which a WD is required and, 
therefore, that they should not apply only to individuals who begin 
training after the final rule is implemented. Further, under the 
provisions of Sec.  35.57(b), experienced AUs (e.g., individuals 
identified on a license) are not required to comply with requirements 
for T&E in Subparts D through H of Part 35. Therefore, the suggestion 
offered by the commenter was not adopted.
    Issue 7: Should the term ``laboratory training'' be defined?
    Comment: One Agreement State Commenter expressed concern that the 
meaning of the term, ``laboratory training,'' should be more clearly 
defined. The commenter expressed concern that ``laboratory'' time could 
be interpreted as ``clinical lab'' which would be patient-care oriented 
rather than radiation-safety oriented.
    Response: The NRC believes that defining the terms ``classroom'' 
and ``laboratory'' would not ensure compliance and would only serve to 
create a more prescriptive rule. However, the NRC expects that clinical 
laboratory hours that will be credited toward meeting the requirements 
for classroom and laboratory training in Subparts B and D through H 
will involve training in radiation safety aspects of the medical use of 
byproduct material. The NRC recognizes, for example, that physicians in 
training may not dedicate all of their clinical laboratory time 
specifically to the subject areas covered in these subparts and will be 
attending to other clinical matters involving the medical use of the 
material under the supervision of an AU (e.g., reviewing case histories 
or interpreting scans). However, those hours spent on other duties, not 
related to radiation safety, should not be counted toward the minimum 
number of hours of required classroom and laboratory training in 
radiation safety. This type of supervised work experience, even though 
not specifically required by the NRC, may be counted toward the 
supervised work experience to obtain the required total hours of 
training (e.g., 700 hours for Sec.  35.390). Similarly, the NRC 
recognizes that clinicians will not dedicate all of their time in 
training specifically to the subject areas described in Subparts D 
though H and will be attending to other clinical matters. The NRC will 
broadly interpret ``classroom training'' to include various types of 
instruction received by candidates for approval, including online 
training, as long as the subject matter relates to radiation safety and 
safe handling of byproduct material.
Part III--Comments on Specific Sections in the Proposed Rule

Subpart A--General Information

Section 35.2--Definitions

    Issue 1: Definitions of ``authorized medical physicist'' and 
``authorized nuclear pharmacist.''
    Comment: One Agreement State commenter stated that the current 
proposed definitions for ``authorized medical physicist'' and 
``authorized nuclear pharmacist'' did not include individuals who had 
obtained preceptor statements and met the requirements for the 
alternate pathway, and that this did not appear to be correct.
    Response: The NRC has considered this comment and determined not to 
change the definitions in Sec.  35.2 for ``authorized medical 
physicist'' or ``authorized nuclear pharmacist' to include individuals 
who are not board certified. These definitions clearly specify the 
individuals who are to be included within their scope and are not the 
same as the requirements for demonstrating the adequacy of training and 
experience. The means for a person to become an AMP, ANP, or AU, via 
the alternate pathway, are provided in Subparts B and D through H.
    Authorized medical physicists are defined as individuals who are 
certified by specialty boards whose certifications are recognized by 
the NRC or an Agreement State or are identified as authorized 
individuals on a Commission or Agreement State license or permit. 
Authorized nuclear pharmacists are similarly defined and also include 
individuals who have been identified by a commercial nuclear pharmacy 
that has been authorized to identify authorized nuclear pharmacists, or 
are designated as authorized nuclear pharmacists in accordance with the 
requirements of Sec.  32.72(b)(4). Although not noted by the commenter, 
the definitions similarly define an authorized user as a physician, 
dentist, or podiatrist who has been certified by a board whose 
certification has been recognized by the NRC or an Agreement State, or 
is identified as an authorized user on a Commission or Agreement State 
license or permit. These definitions are consistent with the 
requirements of Sec.  35.13, which provide that a licensee must apply 
for and receive a license amendment before it permits anyone to work as 
an authorized user, authorized nuclear pharmacist, or authorized 
medical physicist under the license unless they are authorized 
individuals who either are certified by a board whose certification is 
recognized or are identified on a Commission or Agreement State license 
or by a commercial pharmacy authorized to identify authorized nuclear 
pharmacists. Neither the language of these provisions nor the 
SUPPLEMENTARY INFORMATION accompanying the initial promulgation of, and 
modifications to, these sections indicate an intent to include within 
their scope individuals who are not board certified and who meet the 
training and experience requirements of the alternate pathway. In fact, 
there is a clear indication in the SUPPLEMENTARY INFORMATION of a 
specific intent that before allowing a physician who does not have 
board certification or is not listed on a license or permit to work as 
an authorized user, the specific licensee of limited scope must 
continue to submit a license amendment and obtain NRC approval (58 FR 
33401; June 17, 1993).
    As these definitions are not intended to parallel the training and 
experience requirements, the NRC has determined that changing the 
definitions as the commenter has suggested would be outside the scope 
of this rulemaking.
    Issue 2: Definition of ``stereotactic radiosurgery.''
    Comment: One commenter made a distinction between ``stereotactic 
radiosurgery procedures,'' which the commenter indicated must be 
conducted in one session, and ``stereotactic radiotherapy,'' which is 
conducted over extended periods of time with a linear accelerator. The 
commenter recommended amending the definition of ``stereotactic 
radiosurgery'' to include the words ``in one session,'' and to add a 
new definition of ``stereotactic radiotherapy'' as ``the use of 
external radiation in conjunction with a stereotactic guidance device 
to deliver partial therapeutic dose to a tissue volume over a series of 
sessions.
    Response: The NRC believes that it is not necessary to qualify the 
definition of stereotactic radiosurgery as suggested by the commenter, 
or to add a new definition, because the more general term used, 
``stereotactic radiosurgery,'' is sufficient to include both types of 
treatments, and addition of the qualifiers could be unduly restrictive 
in the future.
    Issue 3: Definition of ``preceptor.'' As currently defined, 
``preceptor'' means an individual who provides or directs the training 
and experience required for an individual to become an authorized

[[Page 16350]]

user, an authorized medical physicist, an authorized nuclear 
pharmacist, or a Radiation Safety Officer.
    Comment: One commenter suggested that the NRC revise the definition 
of ``preceptor'' to read ``an individual who provides, directs, or has 
knowledge of training and experience required for an individual to 
become. * * *'' Deleting the definite article ``the'' before 
``training'' would clarify that more than one person may serve as a 
preceptor, and would clarify that the preceptor does not need to be the 
individual who trained the applicant. Addition of the phrase ``or has 
knowledge of,'' allows preceptors to address T&E that was not received 
under the supervision of the preceptor, e.g., training for new uses for 
which no AU exists, such as those that might be licensed under Sec.  
35.1000. Other commenters supported removal of the word ``the'' in the 
phrase, ``the training and experience,'' in the current definition. 
Another commenter also recommended rewording the definition of 
preceptor to include individuals who verify the training because, in 
some cases, the person who provides training, such as a vendor, may not 
meet the definition of a preceptor who provides or directs training and 
experience.
    Response: The NRC agrees with the commenters and has removed the 
word ``the'' from the phrase ``the training and experience'' in the 
definition of preceptor. This change helps clarify that more than one 
individual may serve as a preceptor and that the regulations do not 
require the preceptor to be the same person who provides or directs 
training for an individual to be approved as an RSO, AMP, ANP, or AU. 
The NRC also agrees that there may be cases when the person who serves 
as preceptor may be able to verify that the training and experience 
meet requirements for T&E in the regulations (for example, training 
provided by a vendor for a specific type of use) and the definition of 
preceptor has been changed accordingly in the final rule.

Section35.10--Implementation

    Comment: One commenter stated that the current transition period, 
which ends on October 24, 2004, must be extended to allow time for 
boards to prepare applications and for processing of applications by 
the NRC, including review by the ACMUI.
    Response: The NRC agrees that additional time for the changes to 
T&E should be allowed beyond October 24, 2004. Therefore, by way of a 
separate rulemaking, the NRC has amended 10 CFR Part 35 to extend the 
expiration of Subpart J for 1 year beyond the current expiration date 
to October 24, 2005 (69 FR 55736, September 16, 2004). This will allow 
time for specialty boards to prepare and submit applications for 
recognition under the revised regulations.
    The final rule also contains amendments to requirements for T&E 
that relate to the alternate pathway and the submission of preceptor 
statements for board certified individuals under Sec.  34.14(a). The 
NRC is providing, in Sec.  35.10, for implementation of these 
requirements, on or before October 25, 2005, to allow time for 
licensees and license reviewers to adopt revisions to requirements for 
T&E.
    The NRC also notes that those board(s) whose certifications have 
been recognized by the NRC will continue to be listed on the NRC's Web 
site until Subpart J expires on October 24, 2005; only those boards 
whose certifications are recognized under the provisions of this final 
rule will be listed after October 24, 2005.

Section35.14--Notifications

    Section 35.14(a) is being amended to require the submission of 
statements, signed by preceptors, in addition to a copy of a board's 
certification (required under current regulations). This change was 
made as a conforming change necessitated by amendments to requirements 
in Subparts B and D through H of Part 35 which removed the requirement 
for specialty boards to obtain preceptor statements as a condition of 
recognition of their certifications and, instead, requires applicants 
for licenses to submit preceptor statements, effected by the amendment 
to Sec.  35.14(a).
    Comment: One Agreement State commenter noted that it is unfortunate 
that certification by an accepted board alone will no longer be 
adequate to become an AU, AMP, RSO, or ANP. Initially this could be 
confusing to licensees who will need to become accustomed to submitting 
copies of valid preceptor statements and board certificates with the 
notification required by Sec.  35.14.
    Response: The NRC removed the requirements for boards to obtain 
preceptor attestations, as a condition of recognition of board 
certifications, upon the recommendation of the ACMUI, which indicated 
that the requirement should be de-coupled from requirements for 
recognition of board certifications. The revised regulations require 
applicants to submit preceptor attestations along with copies of board 
certifications. The NRC believes that the regulations, as amended, 
clarify this change, and the NRC staff will work with applicants to 
resolve questions, should they arise.
    Comment: One commenter stated that the requirements in Sec.  
35.14(a) should call for written attestation, not a written 
certification.
    Response: The NRC agrees with the comment and made this change in 
the final rule. This change also brings the paragraph into conformance 
with changes made in requirements for preceptor statements in Subparts 
B and D through H of Part 35.

Subpart B--General Administrative Requirements

Section 35.50--Training for Radiation Safety Officer

    Comment: One commenter suggested that the NRC should define 
``professional experience in health physics'' and ``at least 3 years in 
applied health physics'' in Sec.  35.50(a)(2), expressing concern that, 
if full-time experience is required in the practice of health physics, 
then most radiologists would not qualify as RSOs.
    Response: The NRC believes that these terms are in common usage and 
that it is not necessary to define the terms. The NRC believes that it 
is appropriate to require 1 year of full-time experience under the 
supervision of an RSO for candidates to meet requirements for T&E, via 
the alternate pathway, to ensure that they are able to serve 
independently as RSOs. Therefore, the NRC has retained the requirement 
for 1 year of full-time, supervised experience, with the exception of 
the new provisions in Sec.  35.50 for approval of medical physicists as 
RSOs, for which a requirement for 2 years of full-time experience is 
required.
    Comment: After stating support for proposed changes to Sec.  35.50 
that would permit medical physicists who are not AMPs to serve as RSOs, 
some commenters also indicated that the phrase referring to 
certification by a board whose certification process has been 
recognized ``under Sec.  35.51(a)'' should be deleted from Sec.  
35.50(d)(2)(i). These commenters believe that including the connection 
would limit RSO medical physicists to medical physicists practicing in 
therapy. These commenters believe that it is critical that qualified 
medical physicists other than AMPs be able to serve as an RSO. Medical 
physicists, who are certified in diagnostic radiology or nuclear 
medicine, need to continue to be able to serve as an RSO.
    Response: The NRC agrees that certain medical physicists may be 
well qualified to serve as RSOs. AMPs may now serve as RSOs. Therefore, 
Sec.  35.50

[[Page 16351]]

has been amended to provide additional criteria for a medical physicist 
to qualify as an RSO. The new requirement for certification in medical 
physics by a specialty board that is recognized by the NRC or an 
Agreement State appears in Sec.  35.50(c)(1), with requirements for 
recognition set out in Sec.  35.50(a)(2). The criteria for NRC 
recognition of certification in medical physics for RSOs does not 
include a requirement for examination in ``clinical radiation 
therapy,'' but provides a pathway for approval as RSOs of medical 
physicists certified in diagnostic radiology or nuclear medicine. The 
adequacy of T&E for individuals to serve as RSOs is ensured by 
requirements in the final rule for a preceptor statement and for 
training in radiation safety, regulatory issues, and emergency 
procedures for the types of use for which a licensee seeks approval. 
The NRC agrees with the commenters and believes that these requirements 
are appropriate to demonstrating the adequacy of T&E in radiation 
safety for individuals to serve as RSOs.

Section 35.51--Training for an Authorized Medical Physicist

    Issue 1: The requirements for T&E for AMPs include, in Sec.  
35.51(b)(1), that the training and work experience must be conducted in 
clinical radiation facilities that provide high-energy, external beam 
therapy and brachytherapy services.
    Comment: Two Agreement State commenters questioned the use of the 
term ``high-energy'' in the requirement for training of AMPs, 
suggesting that there is no definition for the term and that it might 
be interpreted differently by different States and individuals. The 
commenter asserted that, because experience with high-energy, external 
beam therapy is essential for approval of a medical physicist, it would 
seem appropriate that the term be understood.
    Response: The term ``high-energy'' is used in the rule text in 
Sec. Sec.  35.51(a)(2)(ii) and 35.51(b)(1) to specify the type of 
training to be included in T&E for AMPs. The NRC revised Sec. Sec.  
35.51(a)(2)(ii) and 35.51(b)(1) to indicate that high-energy radiation 
is considered to be photons and electrons with energies greater than or 
equal to 1 million electron volts, which is consistent with the 
definition of high-energy used by the International Commission on 
Radiation Units and Measurements in Report 42, Use of Computers in 
External Beam Radiotherapy Procedures with High-Energy Photons and 
Electrons.
    Issue 2: During the transition from previous regulations and 
changes under the final rule on T&E, should medical physicists, serving 
in functional roles as AMPs but not named on licenses, be allowed to 
continue serving as AMPs?
    Comment: The ACMUI suggested that the rule grandfather those 
medical physicists, who serve as authorized medical physicists for 
intravascular brachytherapy, high-dose rate brachytherapy, cobalt-60 
teletherapy, and cobalt-60 gamma knife therapy, to allow them to serve 
as AMPs in these respective categories regardless of whether they are 
currently listed on Agreement State or NRC licenses. Other commenters 
agreed, expressing concern that some Agreement States have not 
established processes for credentialing physicists authorized to 
perform critical QA and safety checks for intravascular brachytherapy, 
or gamma stereotactic treatments, and that some Agreement States, which 
have established requirements for T&E for these AMPs, do not explicitly 
list them on licenses. Therefore, this issue should be clarified so 
there could be an initial pool of AMPs to serve as preceptors and any 
physicist who meets the requirements of the board certification or 
alternate pathway under Sec.  35.51, and has clinical experience 
performing AMP duties in the past 7 years, should be grandfathered.
    Response: Prior to the implementation of current regulations in 
Part 35 (published on April 24, 2002; 67 FR 20249), the NRC staff 
evaluated, on a case-by-case basis, the qualifications of individuals 
to perform the functions of medical physicists and identified them as 
AMPs on NRC licenses. These individuals are ``grandfathered'' under 
Sec.  35.57(a). Hence, the concern of the ACMUI would relate primarily 
to those medical physicists performing functions for licensees of 
Agreement States but who are not identified on Agreement State 
licenses. To ``grandfather'' (approve as AMPs) these medical physicists 
in Agreement State, it is necessary to evaluate the training and 
experience of these individuals to serve as AMPs to ensure that they 
have achieved a level of radiation safety knowledge sufficient to 
function independently as an AMP for each type of medical unit for 
which the individual would be responsible. The NRC staff does not 
believe that it is appropriate to ``grandfather'' medical physicists to 
allow them to serve as AMPs, absent such an evaluation having been 
conducted. Regulatory agencies in Agreement States, that have not been 
identifying on licenses those individuals who have been authorized to 
serve as medical physicists for the types of use and of concern to the 
ACMUI should identify (approve) medical physicists on licenses and 
amendments for types of use for which status as an AMP is required 
under revised regulations, including previously authorized medical 
physicists. These individuals, who have been identified on a license, 
would also be able to serve as preceptors for individuals to become 
AMPs.
    Issue 3: Requirements for clinical experience to serve as an AMP.
    Comment: Some commenters believe that proposed Sec.  35.51(a)(2)(i) 
would allow individuals with no clinical experience (e.g., research 
post-doctoral candidates supervised by a boarded physicist), to sit for 
board certification examinations. Therefore, they suggested the 
following change to Sec.  35.51(a)(2): ``Have 2 years of full-time 
practical training and/or experience in a clinical radiation oncology 
facility providing high-energy external beam therapy and brachytherapy 
services under the supervision of (i) a medical physicist who is 
certified by a board recognized by the Commission or an Agreement 
State, or (ii) physicians who meet the requirements for Sec. Sec.  
35.490 or 35.690 authorized users.''
    Response: As in the proposed rule, the regulations in the final 
rule for recognition of specialty board certifications for AMPs require 
candidates for certification to have 2 years of practical training and/
or supervised experience in medical physics and to pass an examination 
which assesses knowledge and competence in clinical radiation therapy, 
radiation safety, calibration, quality assurance, and treatment 
planning for external beam therapy, brachytherapy, and stereotactic 
radiosurgery. The NRC believes that these requirements, in combination 
with the requirements for type of use specific training and for a 
preceptor attestation that a candidate for AMP has achieved a level of 
competency sufficient to function independently as an AMP, are adequate 
to assess the T&E of candidates for status as AMPs.

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

    Comment: The ACMUI suggested that licenses should be amended to 
provide that current authorized users of sodium iodine-131 for imaging 
and localization, involving greater than 30 microcuries, continue to be 
authorized for these uses.
    Response: Section 35.57(b)(1) provides that AUs who are identified 
on a license or permit are not required to comply with the training 
requirements

[[Page 16352]]

in Subparts D through H to continue performing those medical uses for 
which they were authorized before October 24, 2002 (the effective date 
of the current regulations). Under Sec.  35.57(b)(2), the same 
provision applies to AUs authorized between October 24, 2002 and the 
effective date of this final rule, (April 29, 2005). NRC licenses are 
being amended accordingly.

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

Section 35.290--Training for Imaging and Localization Studies

    Comment: The ACMUI suggested that the revised regulations should, 
in the future, allow Sec.  35.200 practitioners to conduct any I-131 
imaging and localization involving greater than 30 microcuries, 
excluding sodium iodine, without further training and experience.
    Response: Section 35.57(b)(1) provides the exception sought by the 
commenter by not requiring AUs to comply with the training requirements 
in Subparts D through H and to continue performing those medical uses 
for which they were authorized before October 24, 2002 (the effective 
date of the current regulations). Section 35.57(b)(2) allows AUs, 
authorized between October 24, 2002 and the effective date of this 
final rule (April 29, 2005 ) to continue performing those medical uses 
for which they were authorized during this period. NRC licenses are 
being modified accordingly.
    Comment: The ACMUI recommended that the NRC provide a clarification 
that, for the diagnostic use of I-131 as sodium iodide which falls 
under Sec.  35.392 for diagnostic use only, the training which an 
individual may cite for uses under Sec.  35.392 may also serve as 
credit as part of the 700 hours of training for uses under Sec.  
35.200.
    Response: The NRC requirement for 80 hours of training for uses 
under Sec.  35.392 may be credited towards the 700 hours of training 
for uses under Sec.  35.200 under the current regulations in Sec.  
35.290 and under the final rule.

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

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

    Comment: A commenter indicated that the NRC is imposing a new 
requirement in its regulations for 700 hours of training for uses for 
which a WD is required. The commenter indicated that this is 620 hours 
more than is required for the use of sodium iodide I-131 in quantities 
up to 1.2 GBq (33 millicuries) for therapeutic applications, for which 
80 hours of training is required under Sec.  35.392. Further, an 
examination is required for recognition of certifications of specialty 
boards under Sec.  35.390, but not under Sec.  35.392. The commenter 
stated that risk-based regulations could not be used to justify the 
requirement for 620 more hours of training given that only 80 hours of 
training are required for the use of I-131 for treatment, and that 
virtually all medical events related to the use of unsealed sources are 
due to the use of I-131. Another commenter expressed similar views and 
added that it is inconsistent to have minimal requirements for 
alternate training pathways while placing more prescriptive 
requirements for training on specialty boards that already require far 
more than the alternative pathway. The commenter stated that the NRC 
should reconsider the requirements for the alternate pathway to remove 
these inconsistencies.
    Response: The NRC did not propose to change requirements for the 
number of hours of T&E for individuals to qualify as AUs via the 
alternate pathway under Sec. Sec.  35.390, 35.392, or 35.394. The 
issues raised by the commenter were discussed extensively in the 
SUPPLEMENTARY INFORMATION for the current rule in response to public 
comments in Part II, General Issues, Section E, Training and 
Experience, published in the Federal Register on April 24, 2002 (67 FR 
20249). That discussion indicates that the NRC agreed with comments 
indicating that the T&E requirements should be increased for 
individuals who wish to use byproduct material for which a WD is 
required. The number of hours required were increased from 80 to 700 
hours in Sec.  35.390 for uses of unsealed byproduct material for which 
a WD is required. In addition, the work experience in the 
administration of such dosages to patients must include at least three 
cases in each of the following categories for which the individual is 
requesting AU status: (1) Oral administration of less than or equal to 
1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131, for which 
a written directive is required; (2) Oral administration of greater 
than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131; (3) 
Parenteral administration of any beta-emitter or a photon-emitting 
radionuclide with a photon energy less than 150 keV, for which a 
written directive is required; and/or (4) Parenteral administration of 
any other radionuclide, for which a written directive is required. 
Physicians who are authorized under Sec.  35.390 for all of these types 
of administrations also meet the requirements in Sec. Sec.  35.190, 
35.290, 35.392, and 35.394. The NRC continues to believe that the 
increase in T&E hours was needed because these physicians are 
authorized to elute generators and prepare radioactive drugs, as well 
as to administer a wide variety of radionuclides for which WDs are 
required. Thus, the associated radiation risks of the use could be 
greater. The discussion in the SUPPLEMENTARY INFORMATION for the 
current rule also indicates that requirements for T&E were carried 
forward into the current rule, in Sec.  35.392, for AUs to perform oral 
administration of sodium iodide I-131 in dosages less than or equal to 
1.22 gigabecquerels (GBq) (33 millicuries (mCi)), if they do not 
prepare radioactive drugs using generators and reagent kits. To qualify 
as an AU under this limited authorization, an individual must have 80 
hours of classroom and laboratory training and supervised work 
experience that includes 3 cases involving the oral administration of 
sodium iodide I-131 in dosages less than or equal to 1.22 GBq (33 mCi). 
Finally, the discussion indicated that requirements were carried 
forward to the current rule, in Sec.  35.394, for AUs to perform oral 
administration of sodium iodide I-131 in dosages greater than 1.22 GBq 
(33 mCi), and do not prepare radioactive drugs using generators and 
reagent kits. To qualify as an AU under this limited authorization, an 
individual must have 80 hours of classroom and laboratory training and 
work experience that includes 3 cases involving the oral administration 
of sodium iodide I-131 in quantities greater than 1.22 GBq (33 mCi). 
Physicians authorized under Sec.  35.394 also meet the T&E criteria in 
Sec.  35.392. Based on licensee use, NRC inspections, and experience 
with medical events reported since the current rule became effective, 
on October 24, 2002, the NRC continues to believe that the requirements 
in Sec. Sec.  35.390, 35.392, and 35.394 are necessary and sufficient.
    Comment: One commenter suggested that the NRC add ``diagnostic 
radiology'' to the description of residency programs, which now 
includes ``residency training in radiation therapy or nuclear medicine 
training program or a program in a related medical specialty.''
    Response: The NRC believes that the description of ``residency 
programs'' should be limited to those which have direct applicability 
to the use of byproduct material for which a WD is required. Use of the 
general term

[[Page 16353]]

``related medical specialty,'' allows for training in diagnostic 
radiology.
    Comment: Some commenters believe that to recognize radiation 
therapy and nuclear medicine residency programs as they now exist, the 
T&E criteria in Sec.  35.390(a)(1) should be changed to allow for a 2-
year nuclear medicine residency program as an alternative to a 3-year 
residency program in radiation therapy.
    Another commenter indicated that the requirement for a 3-year 
residency should be removed from Sec.  35.390 because it is 
inappropriate for the NRC to specify training requirements related to 
the practice of medicine.
    Response: The NRC agrees that the requirement for residency 
programs to be 3 years in duration should be removed from Sec.  35.390. 
In the final rule, this section no longer refers to the duration of 
residency programs.
    Comment: Two commenters requested that the requirements in Sec.  
35.390 be changed to permit individuals trained in radiation oncology 
residency programs to use unsealed sources under Sec.  35.300. The 
totality of all work experience possessed by individuals who have 
completed an accredited residency program in radiation oncology should 
be considered. The rule should exempt these individuals from 
requirements in Sec.  35.390(b)(1)(ii) because radiation oncologists 
have unique experience that qualifies them to perform therapeutic 
procedures using unsealed sources. Another commenter stated that the 
American Board of Medical Specialties (ABMS) certified nuclear medicine 
physicians, radiologists, and radiation oncologists have unique 
training, experience, and examinations that go well beyond the minimum 
requirements of the alternate pathway. Therefore, the NRC should only 
require in Sec.  35.390 that any ABMS medical specialty board meet the 
same minimal requirements specified for the alternate pathway in 
proposed Sec.  35.390(b)(1)(ii). The commenter also suggested removal 
of any additional requirements for an ABMS board such as an 
examination, and approval of ABMS boards based upon their formal 
training and examination procedures which would be outlined by the 
boards in their applications for approval.
    Response: The NRC agrees that physicians trained in radiation 
oncology may have adequate T&E for certain medical uses of unsealed 
byproduct material for which a WD is required. One pathway now exists 
(i.e., licensees may apply for approval of physicians to serve as AUs 
for use under Sec.  35.300 via the alternate pathway), which includes a 
requirement for completion of a residency program that includes 700 
hours of training and experience in basic radionuclide handling 
techniques, applicable to the medical use of unsealed byproduct 
material for which a WD is required, as specified in Sec.  
35.390(b)(1). The NRC understands, however, that there are classes of 
physicians who may be well qualified but do not meet the requirement 
for 700 hours of T&E for unsealed byproduct material. For example, 
physicians who meet the requirements for T&E for uses under Sec. Sec.  
35.490 or 35.690 have a good understanding of radiation which applies 
to the use of sealed sources that is common to the use of unsealed 
sources. However, the NRC believes that, because of the increased risk 
associated with the use of unsealed sources for which a WD is required, 
it is essential to ensure that AUs have adequate T&E for this use. 
Commenters suggested removing requirements for 700 hours of T&E for 
uses under Sec.  35.300, but that would remove essential requirements 
for T&E for use of unsealed byproduct material for which a WD is 
required. Therefore, the NRC has included a new Sec.  35.396 in the 
final rule to provide a pathway for becoming a AU for uses of byproduct 
material under Sec.  35.300, for individuals who may have acquired 
adequate T&E other than that specified in Sec.  35.390 and other 
sections of Subpart E. This new Sec.  35.396, ``Training for the 
parenteral administration of unsealed byproduct material for which a 
written directive is required,'' specifies requirements for T&E that 
relate to the use of unsealed byproduct material for which a WD is 
required. These requirements were modeled after the requirements in 
other sections of Subpart E and include 80 hours of T&E specific to the 
use of unsealed sources and experience with at least three cases 
involving parenteral administration of byproduct material for which a 
WD is required. Section 35.396 allows for individuals to take credit 
for T&E associated with other medical uses of byproduct material that 
may be applicable to the uses of unsealed byproduct material, e.g., 
individuals who are certified by boards who meet the requirements of 
Sec. Sec.  35.490 or 35.690 for the use of sealed sources. The NRC 
believes that this new section will provide the flexibility needed to 
allow individuals, who do not meet other requirements in Subpart E, to 
serve as AUs for parenteral administration of byproduct material for 
which a WD is required while ensuring adequacy of T&E for these uses to 
be safe.
    Comment: One commenter stated that Sec.  35.390(b)(1)(ii)(G) deals 
with the therapeutic administration of certain unsealed sources orally 
and by parenteral administration, i.e., by way of the intestines. The 
commenter stated that, because radiopharmaceutical therapies are now 
delivered by a variety of routes, the term ``parenteral 
administration'' should be changed to ``administration by any route.''
    Response: The NRC believes that the hazards and precautions 
associated with parenteral administrations of unsealed byproduct 
material are significantly different from those associated with oral 
administrations and that the requirements in Sec.  35.390(b)(1)(ii)(G) 
are sufficiently broad as to cover the various uses for which a WD is 
required. Therefore, the NRC has retained requirements for experience 
with both oral and parenteral administrations for which a WD is 
required. The NRC also notes that the medical use of byproduct material 
under Sec.  35.300 is not limited to ``therapeutic'' administrations, 
but applies to uses for which a WD is required (see Sec.  35.40 for 
related requirements).
    Comment: The ACMUI recommended removing the requirement for work 
experience with elution of generators and measuring, testing, and 
processing of eluates for preparation of radiolabeled drugs in Sec.  
35.390(b)(1)(ii)(F). The ACMUI believes that it is not necessary to 
require all users of byproduct material, under Sec.  35.300, to have 
experience with elution of generators and, further, that it is 
sufficient to require, in Sec.  35.390(b)(1)(ii)(C), work experience 
with safely preparing patient or human research dosages. However, the 
ACMUI recommended that the requirement for elution of generators be 
retained for training in the use of byproduct material for individuals 
who may become AUs under provisions of Sec.  35.290(b) by virtue of 
having been approved as an AU under Sec.  35.390. A conforming change 
was recommended for Sec.  35.100(b) for those AUs who qualify to 
prepare dosages if they meet the requirements in Sec.  35.390, and in 
[revised] Sec.  35.290(c)(2) for requirements for preceptors who meet 
the requirements of Sec.  35.390.
    Response: The NRC agrees with the recommendation of the ACMUI to 
remove the requirement for elution of generators and eluates in Sec.  
35.390(b)(1)(ii)(F) because this should not be required for AUs who do 
not need to use generators for uses of byproduct material under Sec.  
35.300 and because there is a requirement for safely preparing dosages 
in Sec.  35.390(b)(1)(ii)(C). This change was made in the final rule 
along with conforming changes to retain the

[[Page 16354]]

requirement for this experience in Sec. Sec.  35.100(b), 35.200(b) and 
35.290(b).
    Comment: One commenter stated that the Accreditation Council for 
Graduate Medical Education (ACGME) was incorrectly referred to as the 
``Accreditation Council on Medical Education.''
    Response: References to the ACGME have been corrected in the 
discussion of changes to Sec. Sec.  35.390, 35.490, and 35.690.

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)

    Comment: One commenter suggested that there should be a 
grandfathering clause in Sec.  35.392 to allow AUs who were permitted 
to perform diagnostic total body imaging scans, previously under Sec.  
35.200, when the scans were classified as ``diagnostic'' and 
``therapeutic'' rather than as procedures for which WD is required, to 
continue to perform these procedures.
    Response: Section 35.57(b) provides that experienced AUs, 
identified on a license or permit, are not required to comply with the 
training requirements in Subparts D through H to continue performing 
those medical uses for which they were authorized before October 24, 
2002 (the effective date of the current regulations). This provides the 
``grandfathering'' requested by the commenter.

Subpart H of Part 35--Photon Emitting Remote Afterloader Units, 
Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

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

    Comment: One commenter stated that AUs should be required to be 
neurosurgeons for use of gamma stereotactic radiosurgery treatments 
because a neurosurgeon is the only trained physician who has the 
knowledge unique to understanding the neuroanatomy of the brain. The 
commenter also suggested other changes to regulations, including a 
recommendation that the NRC require that WDs for gamma stereotactic 
radiosurgery be signed by both a treating neurosurgeon and radiation 
oncologist and that a neurosurgeon should be required to be physically 
present during treatments involving the gamma unit, with the radiation 
oncologist also present during the initiation of treatment.
    Response: The NRC believes that it would be an unwarranted 
intrusion into the practice of medicine to specify that only 
neurosurgeons may serve as AUs for the use of byproduct material in 
stereotactic radiosurgery. The NRC believes that sufficient protections 
are included in Subpart H of Part 35 and other applicable sections of 
10 CFR Part 35 to ensure that licensees develop safety procedures and 
training to ensure safety. They include several requirements for safe 
use of byproduct material specific to high dose rate units in Sec.  
35.615(a)-(g) as well as requirements for the physical presence of an 
authorized user and authorized medical physicist (in Sec.  
35.615(f)(3)).

Part IV--Implementation by Agreement States--Timing and Compatibility

    Issue 1: Should Agreement States establish the requirements to 
conform with this proposed rule by October 24, 2005, or should they 
follow the normal process and be given a full 3 years to develop a 
compatible rule?
    Comment: Agreement State commenters were generally in agreement 
that they should have 3 years to adopt the final rule. One commenter 
stated that there is not a basis for considering emergency action, and 
that time is needed to allow for States to develop implementation 
procedures as well as revising their regulations. Another commenter 
noted that a requirement to adopt the final rule by October 25, 2005, 
would result in that State not meeting Compatibility B requirements.
    Other commenters indicated that it may take a full 3 years for some 
Agreement States to adopt comparable regulations, but they should be 
urged to do so as soon as practical, and the compatibility level for 
these regulations should remain as compatibility B. One commenter 
states that Agreement States can and should meet the October 24, 2005, 
deadline for developing a compatible rule. The commenter believes there 
is much confusion and misunderstanding on the part of applicants 
seeking AU status as they have one [or more] sets of requirements in 
Agreement States and another in non-Agreement States. In some States, 
these changes will require legislative action and the process needs to 
be started immediately to achieve compliance with the NRC's 
requirements. The commenter opposed this delay in the final 
implementation, indicating that extension of the deadline is quite 
unreasonable and unnecessary.
    Response: The NRC acknowledges that the adoption of the final rule 
may take legislative action in some Agreement States and that some 
legislative cycles are up to 2 years in length. To allow adequate time 
for all Agreement States to adopt the final rule, and help avoid 
transboundary issues relating to differing standards between States, 
the NRC has determined that 3 years will be allowed for adoption of 
this Compatibility B final rule.
    Comment: One commenter stated that obstacles to obtaining licensure 
in individual States discourage endocrinologists from providing 
treatment with I-131 when, in fact, endocrinologists, with their broad 
base of experience and training in all forms of thyroid disease and 
access to various forms of thyroid testing, are in the best position to 
judge the timing and appropriateness of radioiodine treatment.
    Response: Current regulations, in Sec. Sec.  35.392 and 35.394, 
include requirements that are specifically intended to enable 
endocrinologists (and other physicians) to obtain authorized user 
status for oral administration of sodium iodide I-131 for which a 
written directive is required. The requirements include 80 hours of 
classroom and laboratory training in subjects applicable to this usage 
plus work experience covering procedures important to this usage, 
including administering dosages to at least 3 patients or human 
research subjects. Preceptor statements required in the regulations can 
be completed by users authorized under these sections. The revised rule 
maintains these provisions. Because requirements for T&E are designated 
as compatibility category B, Agreement States must establish 
requirements that are essentially identical to NRC's.
    Comment: One commenter suggested that the NRC enforce the 
compatibility requirements for Agreement States to comply with the 
requirements for T&E, published in the revised 10 CFR Part 35 on April 
24, 2002, by October 25, 2005. The issues in the proposed rule are 
limited and do not affect the core of the training and experience 
requirements. The commenter indicated that progress on implementing 
compatibility in the Agreement States has been very slow. In some 
States, the regulatory changes must be implemented by legislative 
action, and the process should be started immediately to achieve 
compliance with the Federal mandate. Further delay in the adoption of 
the T&E requirements will inject added uncertainty into the process and 
delay unnecessarily the final resolution of the T&E issue.
    Response: The NRC disagrees with the commenter's assertion that the

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amendments proposed do not affect ``core'' requirements for T&E. 
Changes between current regulations and the final rule are substantial 
and Agreement States will need time to adopt the regulations, as noted 
in the commenter's observation that, in some States, legislative action 
will be required to adopt revised requirements for T&E. Therefore the 
NRC is allowing the full three years for adoption of the final rule.
    Issue 2: Additional issues relating to implementation by Agreement 
States: Consistency of requirements.
    Comment: Three commenters indicated that the regulations on T&E 
should remain classified as Compatibility B.
    Response: The NRC has not changed its compatibility designation for 
requirements for T&E in the final rule; they remain classified as 
Compatibility B.
    Comment: Some Agreement State commenters stated that T&E 
requirements are designated as Compatibility B because of transboundary 
issues. However, consistency will not be ensured unless a minimum 
number of classroom hours are specified for AUs in Sec. Sec.  35.190, 
35.290, and 35.390, and for nuclear pharmacists in Sec.  35.55. Each 
Agreement State will either accept whatever is submitted by an 
applicant or will designate a minimum number of hours that will be 
accepted. In either situation, inconsistency will exist.
    Response: The NRC's designation of requirements for T&E as 
Compatibility B is intended to establish uniformity regarding 
requirements to ensure consistency of requirements for T&E between 
Agreement States and between the NRC and Agreement States. The NRC 
agrees with the assertion of the Agreement States that a specification 
for a minimum number of hours of classroom and laboratory training will 
promote consistency of regulations between Agreement States, and 
between the NRC and Agreement States when applied to the alternate 
pathway. However, this requirement need not be added to requirements 
for recognition of specialty board certifications to ensure 
consistency. For these reasons and those discussed in Part II, Issue 1, 
of the Summary of Public Comments, requirements for a minimum number of 
hours of classroom and laboratory training have been included in 
Sec. Sec.  35.55(b)(1)(i), 35.190(c)(1), 35.290(c)(1), and 35.390(b)(1) 
of the final rule. These amendments to the regulations will also help 
ensure that Agreement States maintain Compatibility B status of their 
regulations for T&E.
    Comment: A commenter for OAS indicated that, in response to a poll, 
some Agreement State commenters argued against categorizing 
requirements for T&E as Compatibility B. Comments included the argument 
that this has diminished safety for certain uses of byproduct material, 
e.g., for oral administrations of I-131 under Sec. Sec.  35.392 and 
35.394. One commenter also noted that a national standard for T&E makes 
sense because some States use the T&E evaluation of other licensing 
jurisdictions as part or all of their review of qualifications of 
applicants to become AUs. One commenter noted, however, that some 
Agreement States have, in the past, disagreed with the NRC's 
requirements for T&E and have effectively licensed users with differing 
qualifications, and recommended a change of designation for T&E 
regulations to Compatibility C.
    Response: The issue of adequacy of T&E for oral administration of 
I-131 sodium iodide was thoroughly reviewed by the NRC in the 
SUPPLEMENTARY INFORMATION when the current regulations for medical use 
of byproduct material were developed for the revision of 10 CFR Part 
35, published on April 24, 2002 (67 FR 20249). This analysis included a 
careful consideration to numerous public comments in relation to 
adequacy of T&E. Many of the issues raised by the commenters to justify 
a redesignation of T&E requirements as Compatibility C were also given 
considerable review during the development of the current regulations 
and the conclusion was reached that the assignment of the specific 
compatibility categories to the requirements in the current regulations 
was necessary to assure that byproduct material is used with a uniform 
level of radiation safety nationwide. Therefore, a basis for 
redesignation of Compatibility is unnecessary. Further discussion of 
the Compatibility designation for requirements for T&E appears above.

V. Summary of Final Revisions

Section 35.2--Definitions

    The definition of ``preceptor'' is changed from ``Preceptor means 
an individual who provides or directs the training and experience * * 
*.'' to read ``Preceptor means an individual who provides, directs, or 
verifies training and experience * * *.'' The definition of ``Radiation 
Safety Officer'' is changed to include individuals who qualify as RSOs 
by meeting the new requirements in Sec.  35.50(c)(1).

Section 35.8--Information Collection Requirements: OMB Approval

    This section is amended to incorporate a conforming change related 
to the addition of Sec.  35.396 to Subpart E of Part 35. The 
information collection related to this new section is noted in 
paragraph (b) by the addition of ``Sec.  35.396'' to the list of 
sections appearing therein.

Section 35.10--Implementation

    This section is amended to incorporate a conforming change 
necessitated by the amendment of other sections. Paragraph (b) is 
amended to require implementation, on or before October 25, 2005, of 
Sec. Sec.  35.50(a) and (e), 35.51(a) and (c), 35.55(a), 
35.55(b)(1)(i), 35.190(a), 35.190(c)(1), 35.290(a), 35.290(c)(1), 
35.390(a), 35.390(b)(1), 35.392(a), 35.394(a), 35.396(a), 35.396(c), 
35.490(a), 35.590(a) and (c), and 35.690(a) and (c) and the 
requirement, in Sec.  35.14(a), to provide a copy of written 
attestations to the Commission.

Section 35.13--License Amendments

    This section is amended to incorporate conforming changes 
necessitated by amendments of other sections. Paragraph (b)(3) is 
amended to reference requirements for training specific for types of 
use specified in new Sec.  35.51(c).

Section 35.14--Notifications

    This section is amended to add a requirement to paragraph (a) to 
submit a copy of a written attestation, signed by a preceptor, in 
addition to a copy of the board certification now required in this 
paragraph. The section is also amended to require licensees to provide 
verification of completion of relevant training for individuals 
permitted to work as authorized individuals under Sec.  34.13(b)(4).

Section 35.50--Training for Radiation Safety Officer

    This section is amended to modify the requirements that must be met 
as part of a specialty board certification process for the specialty 
board's certification to be recognized by the Commission or an 
Agreement State. Instead of requiring that the certification process 
include the same criteria as the alternate pathway (Sec.  35.50(b) in 
the current regulations), paragraph (a) is amended to provide separate 
requirements for a specialty board's certification process. This 
includes a requirement to pass an examination, administered by 
diplomates of the specialty board, that evaluates knowledge and 
competency in areas that are important to functioning

[[Page 16356]]

as an RSO. Requirements for training are changed to add requirements 
for a bachelor's or graduate degree from an accredited college or 
university in physical science, engineering, or biological science with 
a minimum of 20 college credits in physical science. Training 
requirements also include a minimum of 5 years of professional 
experience in health physics, including at least 3 years in applied 
health physics (graduate training could be substituted for up to 2 
years of experience). Paragraph (a) is amended to include a statement 
that the names of recognized board certifications will be posted on the 
NRC's web page. The requirement for obtaining a preceptor statement is 
removed from the requirements for recognition of specialty board 
certifications. This requirement appears in paragraph (d) and applies 
to individuals for both the certification and alternate pathways. New 
paragraphs (a)(2) and (c)(1) are added that specify requirements for 
medical physicists to serve as RSOs. The term ``classroom and 
laboratory training'' is substituted for the word ``didactic'' in 
paragraph (b)(1)(i) to be consistent with usage in other sections. A 
new paragraph (e) is added to require training in radiation safety, 
regulatory issues, and emergency procedures for the types of use for 
which a licensee seeks authorization. Paragraph (e) applies to all 
pathways. The requirement for a ``written certification,'' signed by a 
preceptor, is changed to a requirement for a ``written attestation,'' 
signed by a preceptor, in paragraph (d).

Section 35.51--Training for an Authorized Medical Physicist

    This section is amended to modify the requirements that must be met 
as part of a specialty board certification process for the specialty 
board's certification to be recognized by the Commission or an 
Agreement State. Instead of requiring that the certification process 
include the same criteria as the alternate pathway, paragraph (a) is 
amended to provide separate requirements for a specialty board's 
certification process. This process includes a requirement to pass an 
examination, administered by diplomates of the specialty board, that 
evaluates knowledge and competency in areas that are important to 
functioning as a medical physicist. Paragraph (a) is also amended to 
include a statement that the names of recognized board certifications 
will be posted on the NRC's web page. The requirement for obtaining a 
preceptor statement is removed from the requirements for recognition of 
specialty board certifications and now applies to each individual 
seeking approval as an AMP via either the certification or alternate 
pathway and is added to paragraph (a). A new paragraph (c) is added to 
require training related to the type of use for which authorization is 
sought that includes ``hands on'' device operation, safety procedures, 
clinical use, and operation of a treatment planning system. Paragraph 
(c) applies to the certification and alternate pathways. In addition, 
for the alternate pathway (paragraph (b)(1)), the acceptable areas of 
concentration for degrees are expanded, and a requirement that the 
degree be from an accredited college or university is added. Paragraph 
(b)(1) is also amended to list the specific areas for which the 
individual needs to have training and work experience, instead of 
referring to other sections of 10 CFR Part 35, and allows for the T&E 
to be received in clinical radiation facilities that provide high-
energy, external beam therapy with photons and electrons with energies 
greater than or equal to 1 million electron volts and brachytherapy 
services. The term ``written certification'' in paragraph (b)(2) is 
changed to ``written attestation.''

Section 35.55--Training for an Authorized Nuclear Pharmacist

    This section is amended to modify the requirements that must be met 
as part of a specialty board certification process for the specialty 
board's certification to be recognized by the Commission or an 
Agreement State. Instead of requiring that the certification process 
include the same criteria as the alternate pathway, paragraph (a) is 
amended to provide separate requirements for a specialty board's 
certification process. This certification process includes a 
requirement to pass an examination, administered by diplomates of the 
specialty board, that evaluates knowledge and competency in areas that 
are important to functioning as an ANP. Paragraph (a) is also amended 
to include a statement that the names of recognized board 
certifications will be posted on the NRC's web page. The requirement 
for didactic training in paragraph (b)(1)(i) is changed to specify that 
200 hours of the 700 hours of training required under paragraph (b)(1) 
must be classroom and laboratory training; the term ``classroom and 
laboratory training'' is substituted for the word ``didactic'' to be 
consistent with usage in other sections. The requirement for obtaining 
a preceptor statement is removed from the requirements for recognition 
of specialty board certifications and now applies to each individual 
seeking approval as an AMP and is referenced in paragraph (a). The term 
``written certification'' in paragraph (b)(2) is changed to ``written 
attestation.''

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

    This section is amended by adding two paragraphs, (a)(2) and 
(b)(2), to provide that (1) individuals identified as RSO's, AMPs or 
ANPs on a Commission or Agreement State license or permit, after the 
effective date (October 24, 2002) of the current requirements in 
Subpart B, and before the effective date of this final rule, may 
continue to serve in these positions; and (2) physicians, dentists or 
podiatrists identified as AUs on a Commission or Agreement State 
license or permit, who perform only those medical uses for which they 
were authorized between October 24, 2002, and the effective date of 
this final rule, need not comply with the training requirements of 
Subparts D through H.

Section 35.75--Release of Individuals Containing Unsealed Byproduct 
Material or Implants Containing Byproduct Material

    Paragraph (a) is amended to remove ``(draft)'' from footnote 1.

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

    A conforming change is made in Sec.  35.100(b)(2) to add, and 
thereby retain, a requirement, formerly incorporated by reference to 
Sec.  35.390(b)(1)(ii)(F), for work experience with elution of 
generators and the measuring, testing, and preparation of labeled 
radioactive drugs for those individuals who qualify for preparation of 
dosages for use under Sec.  35.100 as AUs approved under Sec.  35.390. 
The addition is accomplished by adding a reference to Sec.  
35.290(c)(1)(ii)(G) in Sec.  35.100(b).

Section 35.190--Training for Uptake, Dilution, and Excretion Studies

    Paragraph (a) is amended to modify the requirements that must be 
met as part of a specialty board certification process for the 
specialty board's certification to be recognized by the Commission or 
an Agreement State for uses under Sec.  35.190. A requirement is added 
that candidates must pass an examination administered by diplomates of 
the specialty board. The requirement for obtaining a preceptor 
statement is removed from the

[[Page 16357]]

requirements for recognition of specialty board certifications and now 
applies to each individual seeking approval as an AU under Sec.  35.100 
and is referenced in paragraph (a). Paragraph (a) is also amended to 
include a statement that the names of recognized board certifications 
will be posted on the NRC's web page. The introductory text of 
paragraph (c)(1) is amended to provide that a minimum of 8 hours of the 
60 of training and experience, required in this paragraph, must be 
classroom and laboratory training. Paragraph (a)(1) is amended to 
clarify that this requirement does not apply to the certification 
pathway. The introductory text of paragraph (c)(1)(ii)(B) is amended to 
reflect that the work experience must include performing quality 
control procedures on instruments used to determine the activity of 
dosages, a change from requiring only the calibration of these 
instruments. The term ``written certification'' is changed to ``written 
attestation'' in paragraph (c)(2).

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

    A conforming change is made in Sec. Sec.  35.200(b) to add, and 
thereby retain, a requirement, formerly incorporated by reference to 
Sec.  35.390(b)(1)(ii)(F), for work experience with elution of 
generators and the measuring, testing, and preparation of labeled 
radioactive drugs, for those individuals who qualify for use under 
Sec.  35.200 as AUs approved under Sec.  35.390. The addition is 
accomplished by adding a reference to Sec.  35.290(c)(1)(ii)(G) in 
Sec.  35.200(b)(2).

Section 35.290--Training for Imaging and Localization Studies

    Paragraph (a) is amended to modify the requirements that must be 
met as part of a specialty board certification process for the 
specialty board's certification to be recognized by the Commission or 
an Agreement State for uses under Sec.  35.290. A requirement is added 
that candidates must pass an examination administered by diplomates of 
the specialty board. The requirement for obtaining a preceptor 
statement is removed from the requirements for recognition of specialty 
board certifications and now applies to each individual seeking 
approval as an AU under Sec.  35.200. Paragraph (a) is also amended to 
include a statement that the names of recognized board certifications 
will be posted on the NRC's web page. The introductory text of 
paragraph (c)(1) is amended to provide that a minimum of 80 hours of 
the 700 hours of training and experience, required in this paragraph, 
must be classroom and laboratory training. Paragraph (a)(1) is amended 
to clarify that this requirement does not apply to the certification 
pathway. Paragraph (c)(1)(ii)(B) is amended to reflect that the work 
experience must include performing quality control procedures on 
instruments used to determine the activity of dosages, a change from 
requiring only the calibration of these instruments. The term ``written 
certification'' is changed to ``written attestation'' in paragraph 
(c)(2). A conforming change is made in Sec. Sec.  35.290(b) and 
35.290(c)(1)(ii) to add a requirement for work experience with elution 
of generators and the measuring, testing, and preparation of labeled 
radioactive drugs for those individuals who qualify for use under Sec.  
35.290 as AUs approved under Sec.  35.390. These requirements are also 
applicable to individuals serving as preceptors under Sec.  
35.290(c)(2).

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

    This section is amended to modify the requirements that must be met 
as part of a specialty board certification process for the specialty 
board's certification process to be recognized by the Commission or an 
Agreement State for uses under Sec.  35.390. Instead of requiring that 
the certification process include the same criteria as the alternate 
pathway, paragraph (a) is amended to provide separate requirements for 
a specialty board's certification process. The requirement for 
experience with administration of dosages in paragraph (b)(1)(ii)(G) is 
no longer included in requirements for recognition of board 
certifications, but is retained as a requirement for individuals to 
become AUs for uses for which a WD is required by adding a reference, 
in paragraph (a), to paragraph (b)(1)(ii)(G). In paragraph (a)(1), the 
training and experience required for the certification pathway is 
changed to include a requirement that individuals complete residency 
training in a radiation therapy, nuclear medicine, or a related medical 
specialty 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. A 
requirement is added that candidates must pass an examination 
administered by diplomates of the specialty board. Paragraph (a) is 
also amended to include a statement that the names of recognized board 
certifications will be posted on the NRC's web page. The requirement 
for obtaining a preceptor statement is removed from the requirements 
for recognition of specialty board certifications and now applies to 
each individual seeking approval as an AU under Sec.  35.390 and is 
referenced in paragraph (a). The introductory text of paragraph (b)(1) 
is amended to provide that a minimum of 200 hours of the 700 hours of 
training and experience, required in this paragraph, must be classroom 
and laboratory training. Paragraph (b)(1)(ii)(B) is amended to reflect 
that the work experience must include performing quality control 
procedures on instruments used to determine the activity of dosages, a 
change from requiring only the calibration of these instruments. 
Paragraphs (b)(1)(ii)(G)(1), (3) and (4) are amended to revise 
requirements for work experience involving parenteral administration of 
dosages, clarifying them to indicate that the experience is to be with 
cases for which written directives are required. Paragraph (a)(2) is 
amended to clarify that candidates must pass an examination that tests 
knowledge and competence in use of unsealed byproduct material for 
which a WD is required. Paragraph (b)(1)(ii)(F) is removed to eliminate 
the requirement for work experience with elution of generators and the 
measuring, testing, and processing of eluates for preparing labeled 
radioactive drugs. The term ``written certification'' in paragraph 
(b)(2) is changed to ``written attestation.''

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) is amended to include a statement that the names of 
recognized board certifications will be posted on the NRC's web page. 
The requirement for obtaining a preceptor statement is removed from the 
requirements for recognition of specialty board certifications and now 
applies to each individual seeking approval as an AU under Sec.  35.392 
and is referenced in paragraph (a). Paragraph (c)(2)(ii) is amended to 
reflect that the work experience must include performing quality 
control procedures on instruments used to determine the activity of 
dosages, a change from requiring only the calibration of these 
instruments. The term ``written certification'' in paragraph (c)(3) is 
changed to ``written attestation.''

[[Page 16358]]

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) is amended to include a statement that the names of 
recognized board certifications will be posted on the NRC's web page. 
The requirement for obtaining a preceptor statement is removed from the 
requirements for recognition of specialty board certification processes 
and now applies to each individual seeking approval as an AU under 
Sec.  35.392 and is referenced in paragraph (a). Paragraph (c)(2)(ii) 
is amended to reflect that the work experience must include performing 
quality control procedures on instruments used to determine the 
activity of dosages, a change from requiring only the calibration of 
these instruments. The term ``written certification'' in paragraph 
(c)(3) is changed to ``written attestation.''

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

    A new Sec.  35.396 is added to Subpart E. The section establishes 
T&E requirements applicable to AUs for the parenteral administration of 
unsealed byproduct material for which a written directive is required. 
The following individuals may serve as AUs under this section if they 
meet specified T&E requirements--
     Under paragraph (a), AUs under Sec.  35.390 or, before 
October 24, 2005, Sec.  35.930 for uses listed in Sec. Sec.  
35.390(b)(1)(ii)(G)(3) and 35.390(b)(1)(ii)(G)(4), or equivalent 
Agreement State requirements.
     Under paragraph (b), AUs for uses under Sec. Sec.  35.400 
or 35.600 or, before October 24, 2005, Sec. Sec.  35.940 or 35.960, or 
equivalent Agreement State requirements.
     Under paragraph (c), physicians certified by a medical 
specialty board whose certification process has been recognized by the 
Commission or an Agreement State under Sec. Sec.  35.400 or 35.600 or, 
before October 24, 2005, Sec. Sec.  35.940 or 35.960.
    The specified requirements for AUs under Sec.  35.396 are as 
follows:
     T&E specific to the use specified in paragraphs (d)(1) and 
(d)(2), including 80 hours of classroom and laboratory training that 
includes topics and experience necessary for the safe use of unsealed 
byproduct material for parenteral administrations for which a written 
directive is required, and;
     Preceptor statements as specified in paragraph (d)(3).

Section 35.490--Training for Use of Manual Brachytherapy Sources

    This section is amended to modify the requirements that must be met 
as part of a specialty board certification process for the specialty 
board's certification processes to be recognized by the Commission or 
an Agreement State. Instead of requiring that the certification process 
include the same criteria as the alternate pathway, paragraph (a) 
provides separate requirements for a specialty board's certification 
process. In paragraph (a)(1), the training and experience required for 
the certification pathway is changed to include a requirement that 
individuals complete a minimum of 3 years of residency training in a 
radiation oncology 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. A 
requirement is added that candidates must pass an examination 
administered by diplomates of the specialty board. Paragraph (a) is 
also amended to include a statement that the names of recognized board 
certifications will be posted on the NRC's web page. The requirement 
for obtaining a preceptor statement is removed from the requirements 
for recognition of specialty board certification processes and now 
applies to each individual seeking approval as an AU under Sec.  35.490 
and is referenced in paragraph (a). The term ``written certification'' 
is changed to ``written attestation'' in the requirements for preceptor 
attestation in paragraph (b)(3). Paragraph (b)(2) is amended to include 
the Royal College of Physicians and Surgeons of Canada in the listing 
of organizations that can provide approval of the formal training 
program.

Section 35.491--Training for Ophthalmic Use of Strontium-90

    Paragraph (b)(3) is amended to change the term ``written 
certification'' to ``written attestation.''

Section 35.590--Training for Use of Sealed Sources for Diagnosis

    Paragraph (a) is also amended to include a statement that the names 
of recognized board certifications will be posted on the NRC's web 
page. Paragraph (c) was added and applies to both the certification and 
the alternate pathways. This revision separates the requirement for 
training in the use of the device for the uses requested from the 
requirement for 8 hours of classroom and laboratory training in basic 
radionuclide handling techniques.

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

    This section is amended to modify the requirements that must be met 
as part of a specialty board certification process for the specialty 
board's certification processes to be recognized by the Commission or 
an Agreement State for uses under Sec.  35.600. Instead of requiring 
that the certification process include the same criteria as the 
alternate pathway, paragraph (a) is amended to provide separate 
requirements for a specialty board's certification process. Paragraph 
(a) is also amended to include a statement that the names of recognized 
board certifications will be posted on the NRC's web page. In paragraph 
(a)(1) the training and experience required for the certification 
pathway is changed to include a requirement that individuals complete a 
minimum of 3 years of residency training in a radiation therapy 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. A requirement is added, in paragraph 
(a)(2), that candidates must pass an examination administered by 
diplomates of the specialty board. The requirement for obtaining a 
preceptor statement is removed from the requirements for recognition of 
specialty board certifications and now applies to each individual 
seeking approval as an AU under Sec.  35.690. Additionally, for the 
alternate pathway, paragraph (b)(2) is amended to include the Royal 
College of Physicians and Surgeons of Canada in the listing of 
organizations that can provide approval of the formal training program. 
The requirement for experience in ``radiation oncology'' in paragraph 
(b)(2) is changed to require experience in ``radiation therapy.'' The 
term ``written certification'' is changed to ``written attestation'' in 
the requirements for preceptor attestation in paragraph (b)(3). A new 
paragraph (c) is added to require training in device operation, safety 
procedures, and clinical use for the type(s) of use for which approval 
as an AU is sought. Paragraph (c) applies to all pathways.

Section 35.980--Training for an Authorized Nuclear Pharmacist

    Paragraph (b)(2) is amended to change the term ``written 
certification'' to ``written attestation,'' a conforming

[[Page 16359]]

change made to maintain consistency with other subparts of 10 CFR Part 
35.

VI. 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 on September 3, 1997 (62 FR 
46517), this final rule is a matter of compatibility between NRC and 
the Agreement States, thereby providing consistency among Agreement 
State and NRC requirements. The Compatibility classifications for 
sections amended in the final rule are unchanged. The new Sec.  35.396 
is classified as Compatibility Category B. A summary of compatibility 
classifications for amended sections in the final rule appears below.
    Compatibility: Section.
    Compatibility Category B: Sec.  35.2, Definitions: Preceptor, 
radiation safety officer; Sec. Sec.  35.50, 35.51, 35.55, 35.57, 
35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.491, 35.590, 
35.690.
    Compatibility Category C: Sec. Sec.  35.11, 35.75(a).
    Compatibility Category H&S: Sec. Sec.  35.100, 35.200.
    Compatibility Category D: Sec. Sec.  35.8, 35.10, 35.13, 35.14, 
35.980.
    A Compatibility Category B designation means the requirement has 
significant direct transboundary implications. Compatibility Category B 
designated Agreement State requirements should be essentially identical 
to those of NRC.
    A Compatibility Category C designation means the essential 
objectives of this section should be adopted by the State to avoid 
conflicts, duplications, or gaps. The manner in which the essential 
objectives are addressed need not be the same as NRC, provided the 
essential objectives are met.
    A Compatibility Category H&S designation means program elements are 
not required for purposes of compatibility; however, they do have 
particular health and safety significance. The State should adopt the 
essential objectives of such program elements to maintain an adequate 
program.
    A Compatibility Category D designation means that the essential 
objectives of the section are not required for purposes of 
compatibility and do not need to be adopted by the Agreement States.

VII. Implementation

    The revised regulations in 10 CFR Part 35 become effective on April 
29, 2005. The Commission provides, by amendments to Sec.  35.10(b), 
that licensees will have until October 24, 2005, to comply with the 
training requirements for authorized users, authorized medical 
physicists, authorized nuclear pharmacists, and Radiation Safety 
Officers. During this period, licensees will have the option of 
complying with either requirements of Subpart J, the expiration of 
which was extended by a separate rulemaking to October 24, 2005 (69 FR 
55736, September 16, 2004), or the requirements in Subparts B and D 
through H of Part 35. The transition period will allow additional time 
for other specialty boards to seek NRC recognition of certifications as 
provided in Sec. Sec.  35.50(a), 35.51(a), 35.55(a), 35.190(a), 
35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 
35.690(a). The transition period will also allow individuals from 
Agreement States time to satisfy the training requirements to work in 
NRC jurisdictions. The Commission also provides, by amendment to Sec.  
35.57, that individuals who have been named on existing Commission or 
Agreement State licenses and permits, between the October 24, 2002 (the 
effective date of current requirements for T&E, revised on April 24, 
2002) and the effective date of this final rule, are exempt from the 
new requirements in Subparts D through H. The effect of this change to 
the regulations is to ``grandfather'' those individuals named on an 
existing Commission or Agreement State license or permit, for those 
use(s) for which they have been approved to serve as an RSO, AMP, ANP, 
or AU.

VIII. Voluntary Consensus Standards

    The National Technology Transfer 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 final rule, the NRC is modifying the training and 
experience requirements for radiation safety officers, authorized 
medical physicists, authorized nuclear pharmacists, or authorized 
users. This action does not constitute the establishment of a standard 
that establishes generally applicable requirements.

IX. Finding of No Significant Environmental Impact: Environmental 
Assessment

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the Commission's regulations in 
Subpart A of 10 CFR Part 51, that this rule is not a major Federal 
action significantly affecting the quality of the human environment. 
Therefore, an environmental impact statement is not required. The 
environmental assessment is presented below.

Introduction

    The NRC is amending its regulations governing the medical use of 
byproduct material to change its requirements for recognition of 
specialty boards whose certification may be used to demonstrate the 
adequacy of the training and experience of individuals to serve as 
radiation safety officers (RSOs), authorized medical physicists (AMPs), 
authorized nuclear pharmacists (ANPs), or authorized users (AUs). The 
final rule also revises requirements for demonstrating the adequacy of 
training and experience for pathways other than the board certification 
pathway. This rulemaking is necessary to address the training and 
experience issue for recognition of specialty board certifications.

The Final Action

    This action amends the Commission's regulations governing the 
medical use of byproduct material (10 CFR Part 35). The final rule 
changes the requirements for recognition of specialty boards whose 
certification may be used to demonstrate the adequacy of the training 
and experience of individuals to serve as an RSO, AMP, ANP, or AU. This 
action also amends certain requirements for the training and experience 
of individuals who do not choose the board certification pathway.
    During its revision of 10 CFR Part 35, the Commission became aware 
that, as a result of the changes to its training and experience 
requirements, specialty board certifications recognized by the NRC 
under the former regulations no longer would be qualified for 
recognition, and that this could result in a shortage of authorized 
individuals. As a temporary measure to address this issue, the 
Commission reinserted Subpart J to Part 35 into the final rule which 
was published in the Federal Register on April 24, 2002 (67 FR 20249). 
Subpart J to Part 35 was effective for a 2-year transition period, 
which would have expired on October 24, 2004. This action addresses the 
issue relating to recognition of board certifications after expiration 
of Subpart J on October 24, 2005.

Need for the Action

    This rulemaking is needed to address the training and experience 
issue for recognition of certifications of specialty boards by the NRC 
for approval of individuals to serve as RSOs, AMPs,

[[Page 16360]]

ANPs, or AUs. Without this rulemaking, the issue of board recognition 
would not be addressed. Subpart J to Part 35 expires on October 24, 
2005, and without this rulemaking, there could be a potential shortage 
of individuals authorized to perform medical procedures involving the 
use of byproduct material.

Alternatives to This Action

    An alternative to this final rule would be to take no action. 
Subpart J to Part 35 would expire on October 24, 2005. The no-action 
alternative is not favored because the issues related to training and 
experience, as they relate to NRC's recognition of specialty boards, 
would not be resolved, and this could result in a shortage of RSOs, 
AMPs, ANPs, and AUs.

Environmental Impacts of the Final Action

    The NRC prepared an environmental assessment as part of the 
development of the Part 35 final rule published in the Federal Register 
on April 24, 2002 (67 FR 20249). The conclusion from this environmental 
assessment was that the 10 CFR Part 35 amendments would have no 
significant impact on the public and the environment. Specifically, 
pertaining to the training and experience requirements, the 
environmental assessment stated: ``The amendments to the training and 
experience requirements in 10 CFR Part 35 focus on knowledge and 
experience that is integral to radiation safety. These changes are 
expected to have no significant impact on public health and safety, 
occupational health and safety, and the environment.'' The NRC finds 
that the conclusion is still valid for the revisions to the training 
and experience requirements in this final rule. The revisions also 
focus on the knowledge and experience that is integral to radiation 
safety. The amendments to 10 CFR Part 35 are expected to have no 
significant impact on the public health and safety, occupational health 
and safety, and the environment.

Agencies and Persons Consulted and Sources Used

    The environmental assessment for the final 10 CFR Part 35 
rulemaking (67 FR 20249; April 24, 2002), was used in the preparation 
of this environmental assessment. The draft environmental assessment 
was sent to Agreement States and the Advisory Committee on the Medical 
Use of Isotopes for review and comment. The NRC staff has determined 
that this final action will not affect listed species or critical 
habitat. Therefore, no further consultation is required under Section 7 
of the Endangered Species Act (16 U.S.C. 1531 et seq.). The NRC staff 
has determined that this action is not the type of activity that has 
potential to cause effects on historic properties. Therefore, no 
further consultation is required under Section 106 of the National 
Historic Preservation Act (16 U.S.C. 470 et seq.).

Finding of No Significant Impact

    Based on the foregoing environmental assessment, the NRC concludes 
that this rulemaking will not have a significant effect on the quality 
of the human environment. Therefore, the NRC has determined that an 
environmental impact statement is not necessary for this rulemaking.
    The determination of this environmental assessment is that there 
will be no significant impact to the public from this action.

X. Paperwork Reduction Act Statement

    This final rule contains new or amended information collection 
requirements that are subject to the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.). These requirements were approved by the 
Office of Management and Budget, approval numbers 3150-0010 and 3150-
0120.
    The burden to the public for these information collections is 
estimated to average 1.4 hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
information collection. Send comments on any aspect of these 
information collections, including suggestions for reducing the burden, 
to the Records and FOIA/Privacy Services Branch (T-5 F52), U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, or by Internet 
electronic mail to [email protected]; and to the Desk Officer, 
Office of Information and Regulatory Affairs, NEOB-10202, (3150-0010/
3150-0120), Office of Management and Budget, Washington, DC 20503.

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.

XI. Regulatory Analysis

    The Commission has prepared a regulatory analysis on this 
regulation. The analysis examines the costs and benefits of the 
alternatives considered by the Commission. The analysis is available 
for inspection in the NRC Public Document Room, 11555 Rockville Pike, 
Rockville, MD. Single copies of the regulatory analysis are available 
from Roger W. Broseus, Office of Nuclear Material Safety and 
Safeguards, telephone (301) 415-7608, e-mail [email protected].

XII. Regulatory Flexibility Certification

    In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 
605(b)), the NRC certifies that this rule will not have a significant 
economic impact on a substantial number of small entities. This final 
rule amends the regulations governing the medical use of byproduct 
material to change its requirements for recognition of specialty boards 
whose certification may be used to demonstrate the adequacy of the 
training and experience of individuals to serve as radiation safety 
officers, authorized medical physicists, authorized nuclear 
pharmacists, or authorized users. This rule also revises the 
requirements for demonstrating the adequacy of training and experience 
of individuals who do not choose pathways other than the board 
certification pathway. This rule will have no burden or economic impact 
on licensees because it does not add new requirements; it provides a 
revision to an existing option. Therefore, it does not fall within the 
scope of the definition of ``small entities'' set forth in the 
Regulatory Flexibility Act or the Small Business Size Standards set out 
in regulations issued by the Small Business Administration at 10 CFR 
Part 121.

XIII. Backfit Analysis

    The Commission has determined that a backfit analysis is not 
required for this final rule because these amendments do not include 
any provisions that would require backfits as defined in 10 CFR Chapter 
1.

XIV. Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, the NRC has determined that this action is not a 
major rule and has verified this determination with the Office of 
Information and Regulatory Affairs of OMB.

List of Subjects in 10 CFR Part 35

    Byproduct material, Criminal penalties, Drugs, Health facilities, 
Health professions, Medical devices, Nuclear materials, Occupational 
safety

[[Page 16361]]

and health, Radiation protection, Reporting and recordkeeping 
requirements.

0
For the reasons set out in the preamble and under the authority of the 
Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 
1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the 
following amendments to 10 CFR Part 35.

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

0
1. The authority citation for Part 35 continues to read as follows:

    Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, 
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 
1242, as amended (42 U.S.C. 5841); Sec. 1704, 112 Stat. 2750 (44 
U.S.C. 3504 note).


0
2. In Sec.  35.2, the definition ``Radiation Safety Officer'' is 
amended by republishing the introductory text and revising paragraph 
(1) of the definition, and the definition of ``Preceptor'' is revised 
to read as follows:


Sec.  35.2  Definitions.

* * * * *
    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, or a Radiation Safety Officer.
* * * * *
Radiation Safety Officer means an individual who--
    (1) Meets the requirements in Sec. Sec.  35.50(a) or (c)(1) and 
35.59; or, before October 24, 2005, Sec. Sec.  35.900(a) and 35.59; or
* * * * *

0
3. In Sec.  35.8, paragraph (b) is revised to read as follows:


Sec.  35.8  Information collection requirements: OMB approval.

* * * * *
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.  35.6, 35.12, 35.13, 35.14, 35.19, 35.24, 
35.26, 35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 35.63, 
35.67, 35.69, 35.70, 35.75, 35.80, 35.92, 35.190, 35.204, 35.290, 
35.310, 35.315, 35.390, 35.392, 35.394, 35.396, 35.404, 35.406, 35.410, 
35.415, 35.432, 35.433, 35.490, 35.491, 35.590, 35.604, 35.605, 35.610, 
35.615, 35.630, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, 35.647, 
35.652, 35.655, 35.690, 35.900, 35.910, 35.920, 35.930, 35.940, 35.950, 
35.960, 35.961, 35.980, 35.981, 35.1000, 35.2024, 35.2026, 35.2040, 
35.2041, 35.2060, 35.2061, 35.2063, 35.2067, 35.2070, 35.2075, 35.2080, 
35.2092, 35.2204, 35.2310, 35.2404, 35.2406, 35.2432, 35.2433, 35.2605, 
35.2610, 35.2630, 35.2632, 35.2642, 35.2643, 35.2645, 35.2647, 35.2652, 
35.2655, 35.3045, 35.3047 and 35.3067.
* * * * *

0
4. In Sec.  35.10, paragraph (b) is revised to read as follows:


Sec.  35.10  Implementation.

* * * * *
    (b) A licensee shall implement the training requirements in 
Sec. Sec.  35.50(a) and (e), 35.51(a) and (c), 35.55(a) and (b)(1)(i), 
35.59, 35.190(a) and (c)(1), 35.290(a) and (c)(1), 35.390(a) and 
(b)(1), 35.392(a), 35.394(a), 35.396(b) and (c), 35.490(a), 35.590(a), 
and 35.690(a) and (c) on or before October 25, 2005. A licensee shall 
implement the requirement in Sec.  35.14(a) to provide to the 
Commission a copy of written attestation(s), signed by a preceptor, on 
or before October 25, 2005.
* * * * *

0
5. In Sec.  35.13, paragraphs (b)(1) and (b)(3) are revised to read as 
follows:


Sec.  35.13  License amendments.

* * * * *
    (b) * * *
    (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), 35.690(a), 35.910(a), 
35.920(a), 35.930(a) and 35.390(b)(1)(ii)(G), 35.392, 35.394, 
35.940(a), 35.950(a), or 35.960(a) and 35.690(c);
* * * * *
    (3) For an authorized medical physicist, an individual who meets 
the requirements in Sec. Sec.  35.59 and 35.51(a) and (c); or 
Sec. Sec.  35.59 and 35.961(a) or (b);
* * * * *

0
6. In Sec.  35.14, paragraph (a) is revised to read as follows:


Sec.  35.14  Notifications.

    (a) A licensee shall provide the Commission a copy of the board 
certification and the written attestation(s), signed by a preceptor, 
the Commission or Agreement State license, the permit issued by a 
Commission master material licensee, the permit issued by a Commission 
or Agreement State licensee of broad scope, or the permit issued by a 
Commission master material license broad scope permittee for each 
individual no later than 30 days after the date that the licensee 
permits the individual to work as an authorized user, an authorized 
nuclear pharmacist, or an authorized medical physicist, under Sec.  
35.13(b). For individuals permitted to work under Sec.  35.13(b)(4), 
within the same 30 day time frame, the licensee shall also provide, as 
appropriate, verification of completion of;
    (1) Any additional case experience required in Sec.  
35.390(b)(1)(ii)(G) for an authorized user under Sec.  35.300;
    (2) Any additional training required in Sec.  35.690(c) for an 
authorized user under Sec.  35.600; and
    (3) Any additional training required in Sec.  35.51(c) for an 
authorized medical physicist.
* * * * *

0
7. In Sec.  35.50, paragraph (a), the introductory text of paragraph 
(b)(1)(i), paragraphs (b)(1)(ii)(G), and (c) are revised, paragraph 
(b)(2) is removed and reserved, and paragraphs (d) and (e) are added to 
read as follows:


Sec.  35.50  Training for Radiation Safety Officer.

* * * * *
    (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 paragraphs (d) and (e) of this section. (The 
names of board certifications which 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

[[Page 16362]]

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.  35.290, 35.390, or, 
before October 24, 2005, Sec. Sec.  35.920, or 35.930; 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) * * *
    (i) 200 hours of classroom and laboratory training in the following 
areas-(ii) * * *
    (G) Disposing of byproduct material; or
* * * * *
    (c)(1) Is a medical physicist who has been certified by a specialty 
board whose certification process has been 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 and who meets the requirements in paragraphs 
(d) and (e) of this section; or
    (2) Is an authorized user, authorized medical physicist, or 
authorized nuclear pharmacist identified on the licensee's license and 
has experience with the radiation safety aspects of similar types of 
use of byproduct material for which the individual has Radiation Safety 
Officer responsibilities; and,
    (d) Has obtained written attestation, signed by a preceptor 
Radiation Safety Officer, that the individual has satisfactorily 
completed the requirements in paragraph (e) and in paragraphs (a)(1)(i) 
and (a)(1)(ii) or (a)(2)(i) and (a)(2)(ii) or (b)(1) or (c)(1) of this 
section, and has achieved a level of radiation safety knowledge 
sufficient to function independently as a Radiation Safety Officer for 
a medical use licensee; and
    (e) 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, 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
8. In Sec.  35.51, paragraphs (a) and (b) are revised, and paragraph 
(c) is added 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 paragraphs (b)(2) and (c) of this section. 
(The names of board certifications which 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) 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;
    (2) Have 2 years of full-time practical training and/or supervised 
experience in medical physics--
    (i) 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
    (ii) In clinical radiation facilities providing high-energy, 
external beam therapy (photons and electrons with energies greater than 
or equal to 1 million electron volts) and brachytherapy services under 
the direction of physicians who meet the requirements for authorized 
users in Sec. Sec.  35.490 or 35.690, or, before October 24, 2005, 
authorized users who meet the requirements in Sec. Sec.  35.940 or 
35.960; and
    (3) Pass an examination, administered by diplomates of the 
specialty board, that assesses knowledge and competence in clinical 
radiation therapy, radiation safety, calibration, quality assurance, 
and treatment planning for external beam therapy, brachytherapy, and 
stereotactic radiosurgery; or
    (b)(1) Holds a master's or doctor's degree in physics, medical 
physics, other physical science, engineering, or applied mathematics 
from an accredited college or university; and has completed 1 year of 
full-time training in medical physics and an additional year of full-
time work experience under the supervision of an individual who meets 
the requirements for an authorized medical physicist for the type(s) of 
use for which the individual is seeking authorization. This training 
and work experience must be conducted in clinical radiation facilities 
that provide high-energy, external beam therapy (photons and electrons 
with energies greater than or equal to 1 million electron volts) and 
brachytherapy services and must include:
    (i) Performing sealed source leak tests and inventories;
    (ii) Performing decay corrections;
    (iii) Performing full calibration and periodic spot checks of 
external beam treatment units, stereotactic radiosurgery units, and 
remote afterloading units as applicable; and
    (iv) Conducting radiation surveys around external beam treatment 
units, stereotactic radiosurgery units, and remote afterloading units 
as applicable; and
    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (c) and (a)(1) 
and (2), or (b)(1) and (c) of this section, and has achieved a level of 
competency sufficient to function independently as an authorized 
medical physicist for each type of therapeutic medical unit for which 
the individual is requesting authorized medical physicist status. The 
written attestation must be signed by a preceptor authorized medical 
physicist who meets the requirements in Sec.  35.51, or, before October 
24, 2005, Sec.  35.961, 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
    (c) Has training for the type(s) of use for which authorization is 
sought that includes hands-on device operation, safety procedures, 
clinical use, and the operation of a treatment planning system. This 
training requirement may be satisfied by satisfactorily completing 
either a training program provided by the vendor or by training 
supervised by an authorized medical physicist authorized for the 
type(s) of use for which the individual is seeking authorization.

0
9. In Sec.  35.55, paragraphs (a), (b)(1)(i) introductory text, and 
(b)(2) are revised 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 and who 
meets the requirements in paragraph (b)(2) of this section. (The names 
of board certifications which have been recognized by the Commission or 
an Agreement State will be posted on the NRC's Web page.) To have its

[[Page 16363]]

certification process recognized, a specialty board shall require all 
candidates for certification to:
    (1) Have graduated from a pharmacy program accredited by the 
American Council on Pharmaceutical Education (ACPE) or have passed the 
Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;
    (2) Hold a current, active license to practice pharmacy;
    (3) Provide evidence of having acquired at least 4000 hours of 
training/experience in nuclear pharmacy practice. Academic training may 
be substituted for no more than 2000 hours of the required training and 
experience; and
    (4) Pass an examination in nuclear pharmacy administered by 
diplomates of the specialty board, that assesses knowledge and 
competency in procurement, compounding, quality assurance, dispensing, 
distribution, health and safety, radiation safety, provision of 
information and consultation, monitoring patient outcomes, research and 
development; or
    (b) * * *
    (1) * * *
    (i) 200 hours of classroom and laboratory training in the following 
areas--
* * * * *
    (2) Has obtained written attestation, signed by a preceptor 
authorized nuclear pharmacist, that the individual has satisfactorily 
completed the requirements in paragraphs (a)(1), (a)(2), and (a)(3) or 
(b)(1) of this section and has achieved a level of competency 
sufficient to function independently as an authorized nuclear 
pharmacist.

0
10. Section 35.57 is revised 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 as a Radiation Safety Officer, a 
teletherapy or medical physicist, or a nuclear pharmacist on a 
Commission or Agreement State license or a permit issued by a 
Commission or Agreement State broad scope licensee or master material 
license permit or by a master material license permittee of broad scope 
before October 24, 2002, need not comply with the training requirements 
of Sec. Sec.  35.50, 35.51, or 35.55, respectively.
    (2) An individual identified as a Radiation Safety Officer, an 
authorized medical physicist, or an authorized nuclear pharmacist on a 
Commission or Agreement State license or a permit issued by a 
Commission or Agreement State broad scope licensee or master material 
license permit or by a master material license permittee of broad scope 
between October 24, 2002 and April 29, 2005 need not comply with the 
training requirements of Sec. Sec.  35.50, 35.51, or 35.55, 
respectively.
    (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 Agreement State, a permit issued by a 
Commission master material licensee, a permit issued by a Commission or 
Agreement State broad scope licensee, or a permit issued by a 
Commission master material license broad scope permittee before October 
24, 2002, who perform only those medical uses for which they were 
authorized on that date need not comply with the training requirements 
of Subparts D through H of this part.
    (2) Physicians, dentists, or podiatrists identified as authorized 
users for the medical use of byproduct material on a license issued by 
the Commission or Agreement State, a permit issued by a Commission 
master material licensee, a permit issued by a Commission or Agreement 
State broad scope licensee, or a permit issued by a Commission master 
material license broad scope permittee who perform only those medical 
uses for which they were authorized between October 24, 2002 and April 
29, 2005, need not comply with the training requirements of Subparts D 
through H of this part.


Sec.  35.75  [Amended]

0
11. In Sec.  35.75, paragraph (a), footnote 1, remove ``(draft)''.

0
12. In Sec.  35.100, paragraph (b)(2) is revised to read as follows:


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

* * * * *
    (b) * * *
    (2) A physician who is an authorized user and who meets the 
requirements specified in Sec. Sec.  35.290, or 35.390 and 
35.290(c)(1)(ii)(G), or, before October 24, 2005, Sec.  35.920; or
* * * * *

0
13. In Sec.  35.190, paragraphs (a), the introductory text of (c)(1), 
(c)(1)(ii)(B) and (c)(2) are revised 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 and 
who meets the requirements in paragraph (c)(2) of this section. (The 
names of board certifications which 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) Complete 60 hours of training and experience in basic 
radionuclide handling techniques and radiation safety applicable to the 
medical use of unsealed byproduct material for uptake, dilution, and 
excretion studies that includes the topics listed in paragraphs 
(c)(1)(i) and (c)(1)(ii) of this section; and
    (2) Pass an examination, administered by diplomates of the 
specialty board, that assesses knowledge and competence in radiation 
safety, radionuclide handling, and quality control; or
* * * * *
    (c) * * *
    (1) Has completed 60 hours of training and experience, including a 
minimum of 8 hours of classroom and laboratory training, in basic 
radionuclide handling techniques applicable to the medical use of 
unsealed byproduct material for uptake, dilution, and excretion 
studies. The training and experience must include--
    (ii) * * *
    (B) Performing quality control procedures on instruments used to 
determine the activity of dosages and performing checks for proper 
operation of survey meters;
* * * * *
    (2) Has obtained written attestation, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.  35.190, 
35.290, or 35.390, or, before October 24, 2005, Sec. Sec.  35.910, 
35.920, or 35.930, or equivalent Agreement State requirements, that the 
individual has satisfactorily completed the requirements in paragraph 
(a)(1) or (c)(1) of this section and has achieved a level of competency 
sufficient to function independently as an authorized user for the 
medical uses authorized under Sec.  35.100.

0
14. In Sec.  35.200, paragraph (b)(2) is revised to read as follows:


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

* * * * *
    (b) * * *
    (2) A physician who is an authorized user and who meets the 
requirements specified in Sec. Sec.  35.290, or 35.390 and

[[Page 16364]]

35.290(c)(1)(ii)(G), or, before October 24, 2005, Sec.  35.920; or
* * * * *
0
15. In Sec.  35.290, paragraphs (a), (b), the introductory text of 
(c)(1) and (c)(1)(ii) introductory text, (c)(1)(ii)(B), and (c)(2) are 
revised 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 and 
who meets the requirements in paragraph (c)(2) of this section. (The 
names of board certifications which 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) Complete 700 hours of training and experience in basic 
radionuclide handling techniques and radiation safety applicable to the 
medical use of unsealed byproduct material for uptake, dilution, and 
excretion studies that includes the topics listed in paragraphs 
(c)(1)(i) and (c)(1)(ii) of this section; and
    (2) Pass an examination, administered by diplomates of the 
specialty board, which assesses knowledge and competence in radiation 
safety, radionuclide handling, and quality control; or
    (b) Is an authorized user under Sec.  35.390 and meets the 
requirements in Sec.  35.290(c)(1)(ii)(G), or, before October 24, 2005, 
Sec.  35.920, or equivalent Agreement State requirements; or
    (c)(1) Has completed 700 hours of training and experience, 
including a minimum of 80 hours of classroom and laboratory training, 
in basic radionuclide handling techniques applicable to the medical use 
of unsealed byproduct material for imaging and localization studies. 
The training and experience must include, at a minimum--
* * * * *
    (ii) Work experience, under the supervision of an authorized user, 
who meets the requirements in Sec. Sec.  35.290, or 35.290(c)(1)(ii)(G) 
and 35.390, or, before October 24, 2005, Sec.  35.920, or equivalent 
Agreement State requirements, involving--
* * * * *
    (B) Performing quality control procedures on instruments used to 
determine the activity of dosages and performing checks for proper 
operation of survey meters;
* * * * *
    (2) Has obtained written attestation, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.  35.290 or 
35.390 and 35.290(c)(1)(ii)(G), or, before October 24, 2005, Sec.  
35.920, or equivalent Agreement State requirements, that the individual 
has satisfactorily completed the requirements in paragraph (a)(1) or 
(c)(1) of this section and has achieved a level of competency 
sufficient to function independently as an authorized user for the 
medical uses authorized under Sec. Sec.  35.100 and 35.200.

0
16. In Sec.  35.390, paragraph (a), the introductory text of paragraphs 
(b)(1) and (b)(1)(ii) introductory text, paragraphs (b)(1)(ii)(B), 
(b)(1)(ii)(G)(1), (3) and (4), and (b)(2) are revised, and paragraph 
(b)(1)(ii)(F) is removed and reserved.


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) and (b)(2) of 
this section. (Specialty boards whose certification processes 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:
    (1) Successfully complete residency training in a radiation therapy 
or nuclear medicine training program or a program in a related medical 
specialty. These residency training programs must include 700 hours of 
training and experience as described in paragraphs (b)(1)(i) through 
(b)(1)(ii)(E) of this section. Eligible training programs must be 
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; and
    (2) Pass an examination, administered by diplomates of the 
specialty board, which tests knowledge and competence in radiation 
safety, radionuclide handling, quality assurance, and clinical use of 
unsealed byproduct material for which a written directive is required; 
or
    (b)(1) Has completed 700 hours of training and experience, 
including a minimum of 200 hours of classroom and laboratory training, 
in basic radionuclide handling techniques applicable to the medical use 
of unsealed byproduct material requiring a written directive. The 
training and experience must include--
* * * * *
    (ii) Work experience, under the supervision of an authorized user 
who meets the requirements in Sec.  35.390, or, before October 24, 
2005, Sec.  35.930, or equivalent Agreement State requirements. A 
supervising authorized user, who meets the requirements in Sec.  
35.390(b) or, before October 24, 2005, Sec.  35.930(b), must also have 
experience in administering dosages in the same dosage category or 
categories (i.e., Sec.  35.390(b)(1)(ii)(G)) as the individual 
requesting authorized user status. The work experience must involve--
* * * * *
    (B) Performing quality control procedures on instruments used to 
determine the activity of dosages, and performing checks for proper 
operation of survey meters;
* * * * *
    (G) * * *
    (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;
* * * * *
    (3) Parenteral administration of any beta emitter or a photon-
emitting radionuclide with a photon energy less than 150 keV, for which 
a written directive is required; and/or
    (4) Parenteral administration of any other radionuclide, for which 
a written directive is required; and
    (2) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (a)(1) and 
(b)(1)(ii)(G) or (b)(1) of this section, and has achieved a level of 
competency sufficient to function independently as an authorized user 
for the medical uses authorized under Sec.  35.300. The written 
attestation must be signed by a preceptor authorized user who meets the 
requirements in Sec.  35.390, or, before October 24, 2005, Sec.  
35.930, or equivalent Agreement State requirements. The preceptor 
authorized user, who meets the requirements in Sec.  35.390(b), or, 
before October 24, 2005, Sec.  35.930(b), must have experience in 
administering dosages in the same dosage category or categories (i.e., 
Sec.  35.390(b)(1)(ii)(G)) as the individual requesting authorized user 
status.

0
17. In Sec.  35.392, paragraphs (a), (c)(2)(ii) and (c)(3) are revised 
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).

* * * * *

[[Page 16365]]

    (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 and who meets the 
requirements in paragraph (c)(3) of this section. (The names of board 
certifications which have been recognized by the Commission or an 
Agreement State will be posted on the NRC's Web page.); or
* * * * *
    (c) * * *
    (2) * * *
    (ii) Performing quality control procedures on instruments used to 
determine the activity of dosages and performing checks for proper 
operation of survey meters;
* * * * *
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and 
(c)(2) of this section, and has achieved a level of competency 
sufficient to function independently as an authorized user for medical 
uses authorized under Sec.  35.300. The written attestation must be 
signed by a preceptor authorized user who meets the requirements in 
Sec. Sec.  35.390, 35.392, or 35.394, or, before October 24, 2005, 
Sec. Sec.  35.930, 35.932, or 35.934, or equivalent Agreement State 
requirements. A preceptor authorized user, who meets the requirement in 
Sec.  35.390(b), must also have experience in administering dosages as 
specified in Sec.  35.390(b)(1)(ii)(G)(1) or (2).

0
18. In Sec.  35.394, paragraphs (a), (c)(2)(ii) and (c)(3) are revised 
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, and who meets the requirements in 
paragraph (c)(3) of this section. (The names of board certifications 
which have been recognized by the Commission or an Agreement State will 
be posted on the NRC's Web page.); or
* * * * *
    (c) * * *
    (2) * * *
    (ii) Performing quality control procedures on instruments used to 
determine the activity of dosages and performing checks for proper 
operation of survey meters;
* * * * *
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (c)(1) and 
(c)(2) of this section, and has achieved a level of competency 
sufficient to function independently as an authorized user for medical 
uses authorized under Sec.  35.300. The written attestation must be 
signed by a preceptor authorized user who meets the requirements in 
Sec. Sec.  35.390 or 35.394, or, before October 24, 2005, Sec. Sec.  
35.930 or 35.934, or equivalent Agreement State requirements. A 
preceptor authorized user, who meets the requirements in Sec.  
35.390(b), must also have experience in administering dosages as 
specified in Sec.  35.390(b)(1)(ii)(G)(2).

0
19. Section 35.396 is added 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 or, before October 24, 2005, Sec.  35.930 for uses listed in 
Sec. Sec.  35.390(b)(1)(ii)(G)(3) or 35.390(b)(1)(ii)(G)(4), or 
equivalent Agreement State requirements; or
    (b) Is an authorized user under Sec. Sec.  35.490 or 35.690, or, 
before October 24, 2005, Sec. Sec.  35.940 or 35.960, or equivalent 
Agreement State requirements and who meets the requirements in 
paragraph (d) of this section; or
    (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, or, before October 24, 2005, 
Sec. Sec.  35.940 or 35.960; and who meets the requirements in 
paragraph (d) of this section.
    (d)(1) Has successfully completed 80 hours of classroom and 
laboratory training, applicable to parenteral administrations, for 
which a written directive is required, of any beta emitter or any 
photon-emitting radionuclide with a photon energy less than 150 keV, 
and/or parenteral administration of any other radionuclide for which a 
written directive is required. The training must include--
    (i) Radiation physics and instrumentation;
    (ii) Radiation protection;
    (iii) Mathematics pertaining to the use and measurement of 
radioactivity;
    (iv) Chemistry of byproduct material for medical use; and
    (v) Radiation biology; and
    (2) Has work experience, under the supervision of an authorized 
user who meets the requirements in Sec. Sec.  35.390 or 35.396, or, 
before October 24, 2005, Sec.  35.930, or equivalent Agreement State 
requirements, in the parenteral administration, for which a written 
directive is required, of any beta emitter or any photon-emitting 
radionuclide with a photon energy less than 150 keV, and/or parenteral 
administration of any other radionuclide for which a written directive 
is required. A supervising authorized user who meets the requirements 
in Sec. Sec.  35.390 or 35.930 must have experience in administering 
dosages as specified in Sec. Sec.  35.390(b)(1)(ii)(G)(3) and/or 
35.390(b)(1)(ii)(G)(4). 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 3 cases involving the parenteral administration, 
for which a written directive is required, of any beta emitter or any 
photon-emitting radionuclide with a photon energy less than 150 keV 
and/or at least 3 cases involving the parenteral administration of any 
other radionuclide, for which a written directive is required; and
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraph (b) or (c) of 
this section, and has achieved a level of competency sufficient to 
function independently as an authorized user for the parenteral 
administration of unsealed byproduct material requiring a written 
directive. The written attestation must be signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.  35.390, 
35.396, or, before October 24, 2005, Sec.  35.930, or equivalent 
Agreement State

[[Page 16366]]

requirements. A preceptor authorized user, who meets the requirements 
in Sec.  35.390, or, before October 24, 2005, Sec.  35.930, must have 
experience in administering dosages as specified in Sec. Sec.  
35.390(b)(1)(ii)(G)(3) and/or 35.390(b)(1)(ii)(G)(4).

0
20. In Sec.  35.490, paragraphs (a), (b)(2) and (b)(3) are revised 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, 
and who meets the requirements in paragraph (b)(3) of this section. 
(The names of board certifications which 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) Successfully complete a minimum of 3 years of residency 
training in a radiation oncology 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; and
    (2) Pass an examination, administered by diplomates of the 
specialty board, that tests knowledge and competence in radiation 
safety, radionuclide handling, treatment planning, quality assurance, 
and clinical use of manual brachytherapy; or
    (b) * * *
    (2) Has completed 3 years of supervised clinical experience in 
radiation oncology, under an authorized user who meets the requirements 
in Sec.  35.490, or, before October 24, 2005, Sec.  35.940, or 
equivalent Agreement State requirements, as part of a formal training 
program approved by the Residency Review Committee for Radiation 
Oncology of the Accreditation Council for Graduate Medical Education or 
the Royal College of Physicians and Surgeons of Canada or the Committee 
on Postdoctoral Training of the American Osteopathic Association. This 
experience may be obtained concurrently with the supervised work 
experience required by paragraph (b)(1)(ii) of this section; and
    (3) Has obtained written attestation, signed by a preceptor 
authorized user who meets the requirements in Sec.  35.490, or, before 
October 24, 2005, Sec.  35.940, or equivalent Agreement State 
requirements, that the individual has satisfactorily completed the 
requirements in paragraphs (a)(1), or (b)(1) and (b)(2) of this section 
and has achieved a level of competency sufficient to function 
independently as an authorized user of manual brachytherapy sources for 
the medical uses authorized under Sec.  35.400.

0
21. In Sec.  35.491, paragraph (b)(3) is revised to read as follows:


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

* * * * *
    (b) * * *
    (3) Has obtained written attestation, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.  35.490 or 
35.491, or, before October 24, 2005, Sec. Sec.  35.940 or 35.941, or 
equivalent Agreement State requirements, that the individual has 
satisfactorily completed the requirements in paragraphs (a) and (b) of 
this section and has achieved a level of competency sufficient to 
function independently as an authorized user of strontium-90 for 
ophthalmic use.

0
22. In Sec.  35.590, paragraphs (a) and (b) are revised and paragraph 
(c) is added to read as follows:


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

* * * * *
    (a) Is certified by a specialty board whose certification process 
includes all of the requirements in paragraphs (b) and (c) of this 
section and whose certification has been recognized by the Commission 
or an Agreement State. (The names of board certifications which have 
been recognized by the Commission or an Agreement State will be posted 
on the NRC's Web page.); or
    (b) 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
    (c) Has completed training in the use of the device for the uses 
requested.

0
23. In Sec.  35.690, paragraphs (a), (b)(2) and (b)(3) are revised, and 
paragraph (c) is added 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 paragraphs (b)(3) and (c) of this 
section. (The names of board certifications which 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) Successfully complete a minimum of 3 years of residency 
training in a radiation therapy 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; and
    (2) Pass an examination, administered by diplomates of the 
specialty board, which tests knowledge and competence in radiation 
safety, radionuclide handling, treatment planning, quality assurance, 
and clinical use of stereotactic radiosurgery, remote afterloaders and 
external beam therapy; or
    (b) * * *
    (2) Has completed 3 years of supervised clinical experience in 
radiation therapy, under an authorized user who meets the requirements 
in Sec.  35.690, or, before October 24, 2005, Sec.  35.960, or 
equivalent Agreement State requirements, as part of a formal training 
program approved by the Residency Review Committee for Radiation 
Oncology of the Accreditation Council for Graduate Medical Education or 
the Royal College of Physicians and Surgeons of Canada or the Committee 
on Postdoctoral Training of the American Osteopathic Association. This 
experience may be obtained concurrently with the supervised work 
experience required by paragraph (b)(1)(ii) of this section; and
    (3) Has obtained written attestation that the individual has 
satisfactorily completed the requirements in paragraphs (a)(1) or 
(b)(1) and (b)(2), and (c) of this section, and has achieved a level of 
competency sufficient to function independently as an authorized user 
of each type of therapeutic medical unit for which the individual is 
requesting authorized user status. The written attestation must be 
signed by a preceptor authorized user who meets the requirements in 
Sec.  35.690, or, before October 24, 2005, Sec.  35.960, or equivalent 
Agreement State requirements for an authorized user for each type of 
therapeutic medical unit for which the individual is requesting 
authorized user status; and

[[Page 16367]]

    (c) Has received training in device operation, safety procedures, 
and clinical use for the type(s) of use for which authorization is 
sought. This training requirement may be satisfied by satisfactory 
completion of a training program provided by the vendor for new users 
or by receiving training supervised by an authorized user or authorized 
medical physicist, as appropriate, who is authorized for the type(s) of 
use for which the individual is seeking authorization.

0
24. In Sec.  35.980, paragraph (b)(2) is revised to read as follows:


Sec.  35.980  Training for an authorized nuclear pharmacist.

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

    Dated at Rockville, Maryland, this 22nd day of March, 2005.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 05-6103 Filed 3-29-05; 8:45 am]
BILLING CODE 7590-01-P