Medical Use of Byproduct Material-Recognition of Specialty Boards, 16336-16367 [05-6103]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 70, Number 60 (Wednesday, March 30, 2005)]
[Rules and Regulations]
[Pages 16336-16367]
From the Federal Register Online via the Government Printing 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 
rwb@nrc.gov.

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, https://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 (https://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