[Federal Register Volume 68, Number 236 (Tuesday, December 9, 2003)]
[Proposed Rules]
[Pages 68549-68563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30358]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 68, No. 236 / Tuesday, December 9, 2003 / 
Proposed Rules  

[[Page 68549]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

RIN 3150-AH19


Medical Use of Byproduct Material--Recognition of Specialty 
Boards

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend 
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 proposed rule would also revise the 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.

DATES: The comment period expires February 23, 2004. Comments received 
after this date will be considered if it is practical to do so, but the 
NRC can only assure consideration for comments received on or before 
this date.

ADDRESSES: You may submit comments by any one of the following methods. 
Please refer to RIN 3150-AH19 in the subject line of your comments. 
Comments on rulemakings submitted in writing or in electronic form will 
be made available to the public in their entirety on the NRC rulemaking 
web site. Personal information will not be removed from your comments.
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, Attn: Rulemakings and Adjudications Staff.
    E-mail comments to: [email protected]. If you do not receive a reply e-
mail confirming that we have received your comments, contact us 
directly at (301) 415-1966. You may also submit comments on this 
proposed rule, as well as the draft Regulatory Analysis, via the NRC's 
rulemaking Web site at http://ruleforum.llnl.gov. Address questions 
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail 
[email protected].
    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
20852, between 7:30 a.m. and 4:15 p.m. on Federal workdays (telephone 
(301) 415-1966).
    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 
(301) 415-1101.
    Publicly available documents related to this rulemaking may be 
examined and copied for a fee at the NRC's Public Document Room (PDR), 
Public File Area O1 F21, One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland. Selected documents, including comments, can be 
viewed and downloaded electronically via the NRC rulemaking Web site at 
http://ruleforum.llnl.gov.
    Publicly available documents created or received at the NRC after 
November 1, 1999, are available electronically at the NRC's Electronic 
Reading Room at http://www.nrc.gov/NRC/ADAMS/index.html. From this 
site, the public can gain entry into the NRC's Agencywide Document 
Access and Management System (ADAMS), which provides text and image 
files of NRC's public documents. If you do not have access to ADAMS or 
if there are problems in accessing the documents located in ADAMS, 
contact the PDR Reference staff at 1-800-397-4209, 301-415-4737 or by 
e-mail to [email protected].

FOR FURTHER INFORMATION CONTACT: Roger W. Broseus, Office of Nuclear 
Material Safety and Safeguards, Mail Stop T9 C24, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001; telephone (301) 415-
7608, e-mail [email protected].

SUPPLEMENTARY INFORMATION:

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 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 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 
certification 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. The NRC staff held several discussions with the 
boards to determine whether the boards would modify their certification 
processes to meet all the requirements specified in the rule. With the 
exception of the CBNC, no board indicated that it would modify its 
certification process.
    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 the sake of this discussion, pathway (1) 
will be referred to as the certification pathway, and pathway (2) as 
the alternate pathway. For example, in Sec.  35.50, the proposed 
criteria for meeting training and experience requirements for the 
certification pathway (1) appear in Sec.  35.50(a); those for the 
alternate pathway (2) appear in Sec.  35.50(b); and those for pathway 
(3) appear in Sec.  35.50(c).
    On February 19, 2002, in a briefing of the Commission, the Advisory

[[Page 68550]]

Committee on Medical Uses of Isotopes (ACMUI) 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. 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.
    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 
certification 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) 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 ends 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 is to have 
this new rule in place before the end of the 2-year transition period.
    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 10 CFR 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 formed a subcommittee to develop recommendations on the 
training and experience issue. A public subcommittee meeting was held 
on June 21, 2002, at NRC headquarters in Rockville, Maryland. 
Representatives from 13 boards, associations, and societies 
participated in the meeting. In addition, 8 boards and societies 
provided written comments to the ACMUI subcommittee on its 
recommendations. After considering the comments from the meeting and 
letters, the subcommittee developed final recommendations and submitted 
them to the ACMUI for consideration.
    The ACMUI full committee discussed the subcommittee's 
recommendations in a public teleconference meeting on July 8, 2002. 
Members of the public and representatives from the Society of Nuclear 
Medicine participated in the teleconference. The ACMUI approved the 
recommendations of the subcommittee and submitted them in a report to 
the NRC on August 1, 2002. The report provided a rationale for the 
recommendations accompanied by suggested rule language. 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 at Attachment 2. The three options were: Option (1) retain 
the existing requirements in the current regulations; Option (2) 
prepare a proposed rule to modify training and experience requirements 
based on the recommendations submitted by the ACMUI; and, Option (3) 
the same as Option 2 with a minor modification (i.e., listing all 
specialty boards 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. Current 
regulations in 10 CFR part 35 require that individuals obtain a written 
certification that they have satisfactorily completed requirements for 
T&E and have achieved a level of competency sufficient to function 
independently (see, e.g., Sec.  35.50(b)(2)). For the sake of 
discussion, this certification will be referred to herein as a 
preceptor statement. (The term ``preceptor'' is defined in Sec.  35.2.) 
The Commission directed that a list of recognized boards be posted on 
the NRC's web site, 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. 
This form of attestation should be preserved both for the certification 
pathway and the alternate pathway.
    The ACMUI briefed the Commission on May 28, 2003, and members 
conveyed their views regarding the Commission's direction to NRC staff, 
relating to preceptor statements, in SRM-02-0194. The Commission 
subsequently issued an SRM on June 20, 2003 (SRM-M030528B). This SRM 
directed that the staff continue its development of a proposed rule to 
modify the training and experience requirements in 10 CFR part 35, with 
appropriate interactions with the ACMUI, so that the revised rule can 
be in place as promptly as possible. The NRC staff met with the ACMUI 
via teleconference on July 17, 2003, to further discuss the ACMUI's 
comments on the proposed rule. This meeting was noticed in the Federal 
Register on July 14, 2003 (68 FR 41665).
    During the 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 
would be separated from the criteria for recognition of board 
certifications, as well as the alternative pathway. Agreement State 
representatives participated in the teleconference and agreed with this 
recommendation. In a letter, dated July 23, 2003, Dr. Manuel Cerqueira, 
Chair of the ACMUI, restated the ACMUI's recommendation that the 
requirements for a preceptor statement be removed from the 
certification pathway; however, if the Commission

[[Page 68551]]

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. In SRM-03-0145, issued on 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 clear in the proposed rule language that a preceptor statement is 
required regardless of which training pathway is chosen.

Discussion

    The principal changes proposed to 10 CFR part 35 involve revising 
the criteria for recognizing the certifications of specialty boards. 
These changes relate to the requirements for training and experience 
(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 and work experience. This 
assessment \1\ resulted from a detailed comparison, performed by the 
NRC staff, between requirements in the regulations (in subparts D-H) 
and specialty board requirements for certification. The changes 
resulting from adoption of the proposed rule would remedy this 
situation and result in requirements that are less prescriptive while 
maintaining public health and safety. These changes would 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. Minor changes would also be made to the training 
and experience requirements in the alternate pathway.
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    \1\ ``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 Specialty 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 proposed 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 training and experience 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 
also 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.
    The NRC is seeking public comment on specific issues related to 
this proposed rule (see the section entitled ``Invitation for Public 
Comment on Specific Issues,'' below).

Changes to the Certification Pathway

    For the certification pathway, the current regulations incorporate 
the more prescriptive requirements for the alternate pathway. The 
proposed rule would establish criteria for a board to be recognized by 
the NRC or an Agreement State.
    For the RSO, AMP, and ANP, the proposed 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 duties of an 
RSO. However, the proposed rule will retain current regulatory 
provisions that allow candidates who do not hold a degree required 
under proposed 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 would be revised for the board 
certification pathway, in proposed 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 recognized by the NRC or an Agreement State, or in clinical 
radiation facilities providing high energy, external beam therapy and 
brachtherapy services under the direct supervision of physicians who 
meet the requirements for AUs in Sec. Sec.  35.400 or 35.600 or under 
supervision of a certified medical physicist in clinical radiation 
facilities. This T&E would help ensure that candidates have the level 
of knowledge necessary to fulfill the duties of an AMP.
    The requirement that boards must have candidates for certification 
obtain a preceptor statement as a condition for NRC recognition of 
certifications would be removed in the proposed rule; however, 
individuals would still be required to obtain preceptor statements and 
licensees would be required to submit them to the NRC (broad scope, 
type A licensees would be exempt from this requirement as provided 
under Sec.  35.15(d)). This would be 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 
statement appears below under the heading ``Preceptor Certification.'' 
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 
35.390, 35.392, 35.394 for uses under 35.300), and 35.500. The ACMUI 
recommended 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 didactic training and 
experience 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. This assessment included a comparison of 
the number of hours of training required both for the board 
certification and alternate pathway, with estimates of the equivalency 
of hours of T&E leading to board certification in comparison to the 
hours required under the alternate pathway. The NRC believes that, 
although the requirements are not identical, the T&E standard for 
recognizing certifying boards would be equivalent to the standard for 
the alternate pathway. The board certification process requires a

[[Page 68552]]

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 proposed 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 proposed 
criteria for recognizing certifying boards would be equivalent to the 
number of hours of didactic training and experience specified for the 
alternate pathway. Further, the proposed requirement in the 
certification pathway for Sec. Sec.  35.390, 35.490 and 35.690 for 
completion of an approved, 3-year residency program provides added 
assurance that T&E is sufficient.
    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, as previously discussed.
    The proposed rule would provide the boards more latitude in making 
the determination that individuals are fully trained and capable of 
performing their duties involving radiation safety. These proposed 
changes to the certification pathway would 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. The proposed revisions for 
the certification pathway would remedy the problem of boards not 
meeting current requirements in 10 CFR part 35.

Changes to the Alternate Pathway

    The proposed rule also contains revised requirements for some of 
the alternate pathways. Most of these changes are minor and would 
clarify the requirements for training and experience.
    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 above under the heading, ``Changes 
to the Certification Pathway.''

Training Specific to Type of Use

    The ACMUI recommended that, in addition to meeting minimum training 
and experience 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 requirement would also 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 would 
ensure that a licensee's staff has adequate knowledge and experience to 
fulfill the duties for which they are responsible. The proposed rule 
includes new paragraphs that add this requirement in Sec.  35.50(e) for 
RSOs, Sec.  35.51(d) for AMPs and for AUs in Sec.  35.690(d) for remote 
afterloader, teletherapy and gamma stereotactic radiosurgery units. For 
uses under Sec.  35.300, requirements in Sec.  35.390(b)(1) provide for 
training specific to type of use which applies to both the board 
certification and alternate pathways.

Other Changes

    In the current rule, Sec.  35.390(b)(1) specifies that work 
experience for uses of byproduct material in unsealed form for which a 
written directive 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(b)(1)(ii)(G)(3) and (4) refer to parenteral 
administration of certain radionuclides. The proposed rule would 
clarify that this training must be with quantities of radionuclides for 
which a written directive is required. The NRC supports these changes 
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 written directive is required.
    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. The proposed rule would 
effect 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). The NRC agrees with this 
recommendation because ensuring proper function of these instruments 
involves more than periodic calibration. In addition to instrument 
calibration, quality control procedures commonly include checks of such 
parameters as linearity, constancy and functionality (including battery 
checks).
    Training requirements for authorizations as a medical physicist 
would be 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 would be changed 
to a more general requirement for 1 year of full-time training in 
medical physics. Similarly, the requirement for training in a clinical 
radiation oncology facility would be changed to a requirement for 
training in ``clinical radiation facilities.'' Pluralizing ``facility'' 
makes it possible for candidates to receive training in more than one 
institution. In Sec.  35.690(b)(2), the requirement for candidates to 
be approved as AUs would be 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 and allowing for T&E to be obtained in more 
than one facility.
    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 recognized by the Commission or an

[[Page 68553]]

Agreement State have training and experience in radiation safety 
aspects of the use of byproduct material for medical purposes. A change 
to the regulations in Sec.  35.50(c) is proposed that would allow 
medical physicists, who are certified by a specialty board recognized 
by the NRC or an Agreement State, to serve as RSOs, while retaining the 
requirement that such individuals have experience specific to the types 
of use for which they would be responsible. This change would remove an 
impediment for individuals who have adequate T&E to become approved as 
RSOs. It would also avoid 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 
in order to approve a licensee's request to have a medical physicist, 
certified by a recognized specialty board, serve as an RSO.
    The term ``high energy'' is used in the proposed rule text in Sec.  
35.51(a)(2)(ii) to specify the type of training to be included in T&E 
for AMPs. The NRC has not defined the term ``high energy'' because, to 
do so, would be overly prescriptive and such definition might be 
misinterpreted as establishing a threshold for the minimum photon 
energy for which experience with external beam therapy is appropriate 
to qualify as an AMP.

Preceptor Certification

    10 CFR part 35 currently requires a written certification that the 
individual has satisfactorily completed the required training and 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 
certification.
    As explained above, the Commission considered recommendations of 
the ACMUI and determined in SRM-02-0194 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 
Commission approved this recommendation of the ACMUI, placing the 
requirement on licensees to submit the preceptor statements to the NRC. 
The proposed regulations retain the requirements that individuals 
obtain preceptor statements for both the certification and alternate 
pathways.
    The requirement for licensees to submit a preceptor statement to 
the NRC appears in the proposed rule in Sec.  35.14(a). Conforming 
changes are proposed for definitions of RSO, AMP, ANP, and AU in Sec.  
35.2 to include the references to a requirement for preceptor 
statements. Conforming changes are also proposed to include appropriate 
references to the requirement for a preceptor statement in Sec. Sec.  
35.13(b)(1), 35.13(b)(2), and 35.13(b)(3).

Listing of Recognized Boards

    The NRC would list on its Web site, instead of in its regulations, 
the names of boards whose certification process meets the NRC's 
criteria. 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.
    Boards that are currently listed in subpart J of part 35 and other 
boards would be required to apply for recognition under this rule. NRC 
staff will review a board's submittal with the ACMUI before a decision 
on recognition of a board is made.
    The NRC plans to place the procedures for listing and delisting of 
specialty boards on its Web site before the effective date of the final 
rule, if adopted. 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 will provide for both adding new 
specialty boards to the recognized listing and for removing boards from 
the recognized list.
    The NRC staff does not intend to conduct inspections of the 
recognized specialty boards, 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 board's requirements 
for radiation safety training. If this is the case, 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. If the staff determines 
that changes in the board's requirements for training in radiation 
safety are necessary and the board either cannot or will not make 
adequate changes to its training program to address these needs, then 
the NRC will withdraw recognition of that specialty board's 
certification and delist that board. The NRC staff will consult with 
the ACMUI regarding such actions and will inform the Commission 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.

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 meeting was conducted as 
a facilitated, roundtable discussion with representatives of specialty 
boards; members of the public also had the opportunity to present their 
views. NRC staff also made a presentation to the ACMUI on May 20, 2003, 
regarding the staff's approach to the proposed rule; subsequent to 
this, further input was obtained from the Chair of the ACMUI and the 
Chair of the ACMUI subcommittee as well as a comment received via e-
mail from a participant in the meeting with the boards.
    A draft of this proposed rule was sent to the Agreement States and 
the ACMUI for 30-day review and comment. A teleconference between NRC 
staff and the ACMUI was held on July 17, 2003; approximately 12 
Agreement State representatives participated in this conference, notice 
of which appeared in the Federal Register on July 14, 2003 (68 FR 
41665). Comments of the ACMUI, Agreement States, board

[[Page 68554]]

members, and members of the public provided useful information to the 
NRC in preparing the proposed rule. A person from the State of Alabama 
represented the Organization of Agreement States and participated as a 
member of the working group with the NRC staff in the development of 
this proposed rule.

Additional Recommendations of the ACMUI

    At the teleconference held on July 17, 2003, the full ACMUI 
discussed the draft proposed rule. During the teleconference, the ACMUI 
approved 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 
paragraph 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. Secondly, the ACMUI 
recommended that the requirements for experience, described 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 
adopted because the NRC staff believes 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 written directive is required. 
Furthermore, if the requirement were removed from the certification 
pathway, individuals and applicants for licenses or amendments would be 
required to provide documentation of completion of requirements for 
experience required under Sec.  35.390(b)(1)(ii)(G), in addition to 
evidence of board certification, to gain approval as AUs. Therefore, 
this requirement was retained in the proposed rule. Thirdly, the ACMUI 
recommended that the requirement for a preceptor statement be separated 
from the board certification pathway and the alternate pathway, and 
specified separately as a new paragraph in each training section. This 
recommendation was approved by the Commission in SRM-03-0145 and 
incorporated into the proposed rule. Lastly, the ACMUI recommended that 
the word ``attest'' should be used in place of certify (certification) 
in preceptor statements. The ACMUI explained that the reason for this 
recommendation was to reflect the current practice that preceptors do 
not ``certify'' individuals, but ``attest.'' As noted below under the 
heading ``Invitation for Public Comment on Specific Issues,'' the NRC 
is inviting comment on the issue of whether the word ``attestation'' 
should be used in place of the word ``certification'' in preceptor 
statements.

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. For Agreement 
States to adopt the proposed training and experience requirements 
contained in this proposed rule and have them in place by October 24, 
2005, the Agreement States would have a shortened time frame for 
developing compatible requirements. Agreement States have voiced 
concern regarding this shortened time frame. As indicated below under 
the heading ``Invitation for Public Comment on Specific Issues,'' the 
NRC is inviting comment on the timing of implementation of the proposed 
rule in Agreement States.

Invitation for Public Comment on Specific Issues.

    The NRC is seeking public comment on the following issues:
    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?
    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? (See discussion under the heading, ``Timing of Agreement State 
Implementation,'' above.)
    3. Should the word ``attestation'' be used in place of the word 
``certification'' in preceptor statements? (See discussion under the 
topic ``Recommendations of the ACMUI,'' above.)

Section-by-Section Analysis

Section 35.2--Definitions

    This section would be amended to incorporate conforming changes 
necessitated by amendments to other sections. The definition of 
authorized medical physicist (AMP) would be changed to include a 
reference in paragraph (1) to the requirement for obtaining a preceptor 
statement in proposed Sec.  35.51(c) and the proposed requirement for 
training specific to type of use in proposed Sec.  35.51(d). The 
definition for authorized nuclear pharmacist (ANP) would be changed in 
paragraph (1) to include a reference to the requirement for obtaining a 
preceptor statement in proposed Sec.  35.55(c). The definition of 
authorized user (AU) would be changed in paragraph (1) to include 
references to the requirement for obtaining a preceptor statement in 
proposed Sec. Sec.  35.390(c), 35.490(c), and 35.690(c). The 
requirement for training specific to type of use in proposed Sec.  
35.690(d) would also be added to the definition of AU. The definition 
of radiation safety officer (RSO) would be changed in paragraph (1) to 
include references to the requirements for obtaining a preceptor 
statement in proposed Sec.  35.50(c) and 35.50(d)(ii) and to the 
requirement for training specific to type of use in proposed Sec.  
35.50(e).

Section 35.10--Implementation

    This section would be amended to incorporate conforming changes 
necessitated by amendments to other sections. Paragraph (b) would be 
amended to require implementation of Sec. Sec.  35.50(c), 35.50(e), 
35.51(c), 35.51(d), 35.55(c), 35.390(c), 35.490(c), 35.690(c) and 
35.690(d) by the effective date of the regulation.

Section 35.13--License Amendments

    Paragraphs (b)(1), (b)(2), and (b)(3) of this section would be 
amended conform with changes to Sec.  35.14(a) and proposed addition of 
Sec. Sec.  35.390(c), 35.490(c), and 35.690(c) which would require 
submission of preceptor statements to the NRC. Paragraphs (b)(1) and 
(b)(3) would be amended to reference requirements for T&E specific for 
types of use added in proposed amendments Sec.  35.690(d) and Sec.  
35.51(d), respectively.

Section 35.14--Notifications

    This section would be amended to add a requirement to paragraph (a) 
to submit a copy of a written certification signed by a preceptor in 
addition to a copy of the board certification now required in this 
paragraph.

Section 35.50--Training for Radiation Safety Officer

    This section would be amended to modify the requirements that must 
be met as part of a specialty board certification process for the 
specialty board to be recognized by the

[[Page 68555]]

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 rule), paragraph (a) would be 
amended to provide separate requirements for a specialty board's 
certification process. This process would include a requirement to pass 
an examination, administered by diplomates of the specialty board, 
which would evaluate knowledge and competency areas that are important 
to functioning as an RSO. Requirements for training would be changed to 
add requirements for 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, and 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) would also 
be amended to include a statement that recognized board certifications 
will be posted on the NRC's Web page. The requirement for obtaining a 
preceptor statement would be removed from the requirements for 
recognition of specialty board certifications. This requirement, now in 
paragraph (b)(2), would be moved to paragraph (c) and apply to both the 
certification and alternate pathway. A new paragraph (d)(2)(i) would be 
added to allow medical physicists to serve as RSOs if they are 
certified by a specialty board whose certification process has been 
recognized by the Commission or an Agreement State, with the 
requirement for a preceptor statement included in paragraph (d)(2)(ii). 
A new paragraph (e) would be added to require training in radiation 
safety, regulatory issues, and emergency procedures for the types of 
use for which an applicant seeks authorization. Paragraph (e) would 
apply to all pathways.

Section 35.51--Training for an Authorized Medical Physicist

    This section would be amended to modify the requirements that must 
be met as part of a specialty board certification process for the 
specialty board 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) would be amended 
to provide separate requirements for a specialty board's certification 
process. This process would include a requirement to pass an 
examination, administered by diplomates of the specialty board, which 
would evaluate knowledge and competency areas that are important to 
functioning as a medical physicist. Paragraph (a) would also be amended 
to include a statement that recognized board certifications will be 
posted on the NRC's Web page. The requirement for obtaining a preceptor 
statement would be removed from the requirements for recognition of 
specialty board certifications but would, instead, apply to each 
individual seeking recognition as an AMP and be moved from paragraph 
(b)(2) to paragraph (c). A new paragraph (d) would be 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 
(d) would apply to the certification and alternate pathways. In 
addition, for the alternate pathway (paragraph (b)(1)), the acceptable 
areas of concentration for degrees would be expanded, and a requirement 
that the degree be from an accredited college or university would be 
added. Paragraph (b)(1) would also be 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 would allow for the T&E to be received in clinical radiation 
facilities that provide high energy, external beam therapy and 
brachytherapy services.

Section 35.55--Training for an Authorized Nuclear Pharmacist

    This section would be amended to modify the requirements that must 
be met as part of a specialty board certification process for the 
specialty board 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) would be amended 
to provide separate requirements for a specialty board's certification 
process. This certification process would include a requirement to pass 
an examination, administered by diplomates of the specialty board, 
which would evaluate knowledge and competency areas that are important 
to functioning as an ANP. Paragraph (a) would also be amended to 
include a statement that recognized board certifications will be posted 
on the NRC's Web page. The requirement for obtaining a preceptor 
statement would be removed from the requirements for recognition of 
specialty board certifications but would, instead, apply to each 
individual seeking recognition as an AMP; the requirement would be 
moved from paragraph (b)(2) to a new paragraph (c).

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

    Paragraphs (a) and (b) would be amended to change ``October 24, 
2002,'' to the effective date of the final rule, if adopted.

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

    Paragraph (a) would be amended to modify the requirements that must 
be met as part of a specialty board certification process for the 
specialty board to be recognized by the Commission or an Agreement 
State for uses under Sec.  35.190. A requirement would be added that 
candidates must pass an examination administered by diplomates of the 
specialty board. The requirement for obtaining a preceptor statement 
would be removed from the requirements for recognition of specialty 
board certifications but would, instead, apply to each individual 
seeking recognition as an AU under Sec.  35.100. Paragraph (a) would 
also be amended to include a statement that recognized board 
certifications will be posted on the NRC's Web page. Paragraph 
(c)(1)(ii)(B) would be 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.

Section 35.290--Training for Imaging and Localization Studies

    Paragraph (a) would be amended to modify the requirements that must 
be met as part of a specialty board certification process for the 
specialty board to be recognized by the Commission or an Agreement 
State for uses under Sec.  35.290. A requirement would be added that 
candidates must pass an examination, administered by diplomates of the 
specialty board. The requirement for obtaining a preceptor statement 
would be removed from the requirements for recognition of specialty 
board certifications but would, instead, apply to each individual 
seeking recognition as an AU under Sec.  35.200. Paragraph (a) would 
also be amended to include a statement that recognized board 
certifications will be posted on the NRC's Web page. Paragraph 
(c)(1)(ii)(B) would be amended to reflect that the work experience must 
include performing quality control procedures on instruments used to 
determine the

[[Page 68556]]

activity of dosages, a change from requiring only the calibration of 
these instruments.

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

    This section would be amended to modify the requirements that must 
be met as part of a specialty board certification process for the 
specialty board 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) would be amended to provide separate 
requirements for a specialty board's certification process. The 
training and experience required for the certification pathway would be 
changed to include, in Sec.  35.390(a)(1), a requirement that 
individuals complete 3 years of 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 Medical Education, the Royal College of Physicians and 
Surgeons of Canada, or the Committee on Post-Graduate Training of the 
American Osteopathic Association. Paragraph (a) would also be amended 
to include a statement that recognized board certifications will be 
posted on the NRC's Web page. The requirement for obtaining a preceptor 
statement would be removed from the requirements for recognition of 
specialty board certifications but would, instead, apply to each 
individual seeking recognition as an AU under Sec.  35.390. The 
requirement for a preceptor statement would be moved from paragraph 
(b)(2) to a new paragraph (c). Paragraph (b)(1)(ii)(B) would be 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. In addition, paragraphs (b)(1)(ii)(G)(3) and (4) would be 
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.

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) would be amended to include a statement that 
recognized board certifications will be posted on the NRC's Web page. 
Paragraph (c)(2)(ii) would be 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 requirement 
for obtaining a preceptor statement would be removed from the 
requirements for recognition of specialty board certifications but 
would, instead, apply to each individual seeking recognition as an AU 
under Sec.  35.392. The requirement for a preceptor statement would be 
moved from paragraph (c)(3) to a new paragraph (d).

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) would be amended to include a statement that 
recognized board certifications will be posted on the NRC's Web page. 
Paragraph (c)(2)(ii) would be 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 requirement 
for obtaining a preceptor statement would be removed from the 
requirements for recognition of specialty board certifications but 
would, instead, apply to each individual seeking recognition as an AU 
under Sec.  35.392. The requirement for a preceptor statement would be 
moved from paragraph (c)(3) to a new paragraph (d).

Section 35.490--Training for Use in Manual Brachytherapy Sources

    This section would be amended to modify the requirements that must 
be met as part of a specialty board certification process for the 
specialty board 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) would provide 
separate requirements for a specialty board's certification process. 
The training and experience required for the certification pathway 
would be changed to include, in Sec.  35.490(a)(1), a requirement that 
individuals complete 3 years of residency training in a radiation 
oncology program approved by the Residency Review Committee of the 
Accreditation Council for Medical Education, the Royal College of 
Physicians and Surgeons of Canada, or the Committee on Post-Graduate 
Training of the American Osteopathic Association. Paragraph (a) would 
also be amended to include a statement that recognized board 
certifications will be posted on the NRC's Web page. The requirement 
for obtaining a preceptor statement would be removed from the 
requirements for recognition of specialty board certifications but 
would, instead, apply to each individual seeking recognition as an AU 
under Sec.  35.490. Additionally, paragraph (b)(2) would be 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 35.590--Training for Use of Sealed Sources for Diagnosis

    Paragraph (a) would be amended to include a statement that 
recognized boards would be posted on the NRC's Web page. Paragraph 
(b)(5) would be redesignated as paragraph (c) and would apply to both 
the certification and the alternate pathways. This revision would 
separate 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 would be amended to modify the requirements that must 
be met as part of a specialty board certification process for the 
specialty board to be recognized by the Commission or an Agreement 
State for uses under 35.600. Instead of requiring that the 
certification process include the same criteria as the alternate 
pathway, paragraph (a) would be amended to provide separate 
requirements for a specialty board's certification process. Paragraph 
(a) would also be amended to include a statement that recognized board 
certifications will be posted on the NRC's web page. The training and 
experience required for the certification pathway would be changed to 
include, in Sec.  35.690(a)(1), a requirement that individuals complete 
3 years of residency training in a radiation therapy program approved 
by the Residency Review Committee of the Accreditation Council for 
Medical Education, the Royal College of Physicians and Surgeons of 
Canada, or the Committee on Post-Graduate Training of the American 
Osteopathic Association. The requirement for obtaining a preceptor 
statement would be removed from the requirements for recognition of 
specialty board certifications but would, instead,

[[Page 68557]]

apply to each individual seeking recognition as an AU under Sec.  
35.690. Additionally, for the alternate pathway, paragraph (b)(2) would 
be 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) would be modified to allow for 
experience in ``radiation therapy.'' A new paragraph (c) would be 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) would apply to all pathways.

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 proposed rule would be a matter of compatibility between 
NRC and the Agreement States, thereby providing consistency among 
Agreement State and NRC requirements. The Compatibility Categories for 
the sections amended in this proposed rule would be the same as for the 
sections in the current regulations. The revisions to Sec. Sec.  35.2, 
35.10, 35.13, 35.14, 35.50, 35.51, 35.190, 35.290, 35.390, 35.392, 
35.394, 35.490, 35.590, and 35.690 are classified as Compatibility 
Category B. 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.

Plain Language

    The Presidential Memorandum dated June 1, 1998, entitled, ``Plain 
Language in Government Writing'' directed that the Government's writing 
be in plain language. This memorandum was published on June 10, 1998 
(63 FR 31883). The NRC requests comments on this proposed rule 
specifically with respect to the clarity and effectiveness of the 
language used. Comments should be sent to the address listed under the 
heading ADDRESSES above.

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 proposed rule, the NRC would modify the training 
and experience requirements for radiation safety officer, authorized 
medical physicists, authorized nuclear pharmacists or authorized users. 
This action does not constitute the establishment of a standard that 
establishes generally applicable requirements.

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, if adopted, would not be 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 Nuclear Regulatory Commission (NRC) is proposing to amend 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 officer 
(RSOs), authorized medical physicists (AMPs), authorized nuclear 
pharmacists (ANPs) or authorized users (AUs). The proposed rule would 
also revise the 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 Proposed Action

    The proposed action under consideration is an amendment to the 
Commission's regulations governing the medical use of byproduct 
materials (10 CFR part 35). The proposed action would change 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. The proposed action 
would also amend 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 boards 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 into 
the final rule which was published in the Federal Register on April 24, 
2002 (67 FR 20249). Subpart J is effective for a 2-year transition 
period which will expire on October 24, 2004. The proposed action would 
address this issue relating to recognition of board certifications 
after expiration of the 2-year transition period.

Need for the Proposed 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, ANPs or AUs. 
Without this rulemaking, the issue of board recognition would not be 
addressed. Subpart J expires on October 24, 2004, 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 the Proposed Action

    An alternative to the proposed action would be to take no action. 
Subpart J will expire on October 24, 2004. 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 Proposed 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 proposed revisions to the 
training and experience requirements in 10 CFR part 35. The revisions 
currently under consideration also focus on the

[[Page 68558]]

knowledge and experience that is integral to radiation safety. The 
proposed 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, published in the Federal Register (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 the proposed 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). Likewise, the NRC staff has determined that 
the proposed 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. However, 
the general public should note that the NRC seeks public participation. 
Comments on any aspect of the Environmental Assessment may be submitted 
to the NRC as indicated under the ADDRESSES heading.
    The NRC has sent a copy of this proposed rule to every State 
Liaison Officer and requested their comments on the environmental 
assessment.

Paperwork Reduction Act Statement

    This rule amends information collection requirements that are 
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). This proposed rule has been submitted to the Office of 
Management and Budget for review and approval of the information 
collection requirements.
    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. The U.S. Nuclear Regulatory Commission is 
seeking public comment on the potential impact of the information 
collections contained in the proposed rule and on the following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the NRC, including whether the 
information will have practical utility?
    2. Is the estimate of burden accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques?
    Send comments on any aspect of these proposed information 
collections, including suggestions for reducing the burden, to the 
Records and FOIA/Privacy Services Branch (T5 F52), U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, or by Internet 
electronic mail at [email protected]; and to the Desk Officer, 
Office of Information and Regulatory Affairs, NEOB-10202, (3150-0010 
and 3150-0120), Office of Management and Budget, Washington, DC 20503.
    Comments to OMB on the information collections or on the above 
issues should be submitted by January 8, 2004. Comments received after 
this date will be considered if it is practical to do so, but assurance 
of consideration cannot be given to comments received after this date.

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.

Regulatory Analysis

    The Commission has prepared a draft regulatory analysis on this 
proposed regulation. The analysis examines the costs and benefits of 
the alternatives considered by the Commission.
    The Commission requests public comment on the draft regulatory 
analysis. Comments on the analysis may be submitted to the NRC as 
indicated under the ADDRESSES heading. The analysis is available for 
inspection in the NRC Public Document Room, 11555 Rockville Pike, 
Public File Area O1 F21, Rockville, Maryland. Single copies of the 
draft regulatory analysis are available from Roger W. Broseus, Office 
of Nuclear Material Safety and Safeguards, telephone (301) 415-7608, e-
mail [email protected].

Regulatory Flexibility Certification

    As required by the Regulatory Flexibility Act of 1980 (5 U.S.C. 
605(b)), the Commission certifies that this proposed rule, if 
promulgated, will not have a significant economic impact on a 
substantial number of small entities. The Nuclear Regulatory Commission 
(NRC) is proposing to amend 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, authorized medical physicists, authorized 
nuclear pharmacists or authorized users. The proposed rule would also 
revise the requirements for demonstrating the adequacy of training and 
experience of individuals who do not choose pathways other than the 
board certification pathway. The regulatory flexibility analysis 
prepared for the final rule on part 35 (67 FR 20249; April 24, 2002) 
indicated that about 740 out of 1688 licensees could be considered 
small entities. The proposed rule should have no burden or economic 
impact on licensees because it does not add new requirements; it would 
provide a revision to an existing option.
    Any small entity subject to this regulation that determines, 
because of its size, it is likely to bear a disproportionate adverse 
economic impact should notify the Commission of this opinion in a 
comment that indicates--
    (a) The licensee's size and how the proposed regulation would 
result in a significant economic burden upon the licensee as compared 
to the economic burden on a larger licensee;
    (b) How the proposed regulations could be modified to take into 
account the licensee's differing needs or capabilities;
    (c) The benefits that would accrue, or the detriments that would be 
avoided, if the proposed regulations were modified as suggested by the 
licensee;
    (d) How the proposed regulation, as modified, would more closely 
equalize the impact of NRC regulations or create more equal access to 
the benefits of Federal programs as opposed to providing special 
advantages to any individual or group; and

[[Page 68559]]

    (e) How the proposed regulation, as modified, would still 
adequately protect public health and safety.

Backfit Analysis

    The Commission has determined that the backfit rule does not apply 
to this proposed rule because these amendments would not involve any 
provision that would impose backfits as defined in 10 CFR Chapter 1. 
Therefore, a backfit analysis is not required for this proposed rule.

List of Subjects in 10 CFR Part 35

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

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

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

    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).

    2. In Sec.  35.2, the definitions of ``authorized medical 
physicist,'' ``authorized nuclear pharmacist,'' ``authorized user,'' 
and ``radiation safety officer'' are amended by republishing the 
introductory text and revising paragraph (1) of each definition to read 
as follows:


Sec.  35.2  Definitions.

* * * * *
    Authorized medical physicist means an individual who--
    (1) Meets the requirements in Sec. Sec.  35.51(a), 35.51(c), 
35.51(d), and 35.59; or, before October 24, 2004, meets the 
requirements in Sec. Sec.  35.961(a), or (b), and 35.59; or
* * * * *
    Authorized nuclear pharmacist means a pharmacist who--
    (1) Meets the requirements in Sec. Sec.  35.55(a), 35.55(c) or 
35.55(d)(2), 35.55(e), and 35.59; or, before October 24, 2004, meets 
the requirements in Sec. Sec.  35.980(a) and 35.59; or
* * * * *
    Authorized user means a physician, dentist, or podiatrist who--
    (1) Meets the requirements in Sec. Sec.  35.59 and 35.190(a), 
35.290(a), 35.390(a) and (c), 35.392(a), 35.394(a), 35.490(a) and (c), 
35.590(a), or 35.690(a), 35.690(c) and 35.690(d); or, before October 
24, 2004, meets the requirements in Sec. Sec.  35.910(a), 35.920(a), 
35.930(a), 35.940(a), 35.950(a), 35.960(a) and 35.59; or
* * * * *
    Radiation Safety Officer means an individual who--
    (1) Meets the requirements in Sec. Sec.  35.50(a), 35.50(c), 
35.50(e), and 35.59; or 35.50(d), 35.50(e), and 35.59; or, before 
October 24, 2004, Sec. Sec.  35.900(a) and 35.59; or
* * * * *
    3. 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), 35.50(c), 35.50(e), 35.51(a), 35.51(b), 35.51(c), 
35.51(d), 35.55(a), 35.55(c), 35.59, 35.190(a), 35.190(c), 35.290(a), 
35.290(c), 35.390(a), 35.390(b), 35.390(c), 35.392(a), 35.392(c), 
35.394(a), 35.394(c), 35.490(a), 35.490(b), 35.490(c), 35.590(a), 
35.590(b), 35.690(a), 35.690(b), 35.690(c), and 35.690(d) on or before 
``[insert effective date of final rule]''.
* * * * *
    4. In Sec.  35.13, paragraphs (b)(1), (b)(2) 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.  35.190(a); 35.290(a); 35.390(a) and 
35.390(c); 35.392(a); 35.394(a); 35.490(a) and 35.490(c); 35.590(a); 
35.690(a), 35.690(c) and 35.690(d); 35.910(a); 35.920(a); 35.930(a); 
35.932; 35.934; 35.940(a); 35.950(a); or 35.960(a) and 35.59;
    (2) For an authorized nuclear pharmacist, an individual who meets 
the requirements in Sec. Sec.  35.59 and--
    (i) 35.55(a) and 35.55(c) or
    (ii) 35.980(a);
    (3) For an authorized medical physicist, an individual who meets 
the requirements in Sec. Sec.  35.59 and--
    (i) 35.51(a), 35.51(c) and 35.51(d) or
    (ii) 35.961(a) or (b);
* * * * *
    5. 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 certification(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)(1) through (b)(4).
* * * * *
    6. In Sec.  35.50, paragraphs (a) 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. (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) 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;
    (2) 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
    (3) 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
    (b) * * *
    (2) [Reserved]
    (c) Has obtained written certification, signed by a preceptor 
Radiation Safety Officer, that the individual has satisfactorily 
completed the requirements in paragraph (a) or (b) of this section and 
has achieved a level of radiation safety knowledge sufficient to 
function independently as a Radiation Safety Officer for a medical use 
licensee; or
    (d)(1) Is an authorized user, authorized medical physicist, or

[[Page 68560]]

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; or,
    (2)(i) 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 with the 
radiation safety aspects of similar types of use of byproduct material 
for which the individual has Radiation Safety Officer responsibilities; 
and
    (ii) Has obtained written certification, signed by a preceptor 
Radiation Safety Officer, that the individual has satisfactorily 
completed the requirements in paragraph (a) or (b) 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.
    7. In Sec.  35.51, paragraphs (a) and (b)(1) are revised, paragraph 
(b)(2) is removed and reserved, and paragraphs (c) and (d) are 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. (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) 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 and brachytherapy services under the direction of 
physicians who meet the requirements for authorized users in Sec. Sec.  
35.490 or 35.690;
    (3) Pass an examination, administered by diplomates of the 
specialty board, 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; 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 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) [Reserved]
    (c) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraph (a) or (b)(1) of 
this section and has achieved a level of competency sufficient to 
function independently as an authorized medical physicist for each type 
of therapeutic medical unit for which the individual is requesting 
authorized medical physicist status. The written certification must be 
signed by a preceptor authorized medical physicist who meets the 
requirements in Sec.  35.51, or, before October 24, 2004, 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
    (d) 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.
    8. In Sec.  35.55, paragraph (a) is revised, paragraph (b)(2) is 
removed and reserved, and paragraph (c) is added 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. (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) 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;
    (4) Pass an examination in nuclear pharmacy administered by 
diplomates of the specialty board, which 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) * * *
    (2) [Reserved]
    (c) Has obtained written certification, signed by a preceptor 
authorized nuclear pharmacist, that the individual has satisfactorily 
completed the requirements in paragraph (a) or (b) of this section and 
has achieved a level of competency sufficient to function independently 
as an authorized nuclear pharmacist.

[[Page 68561]]

Sec.  35.57  [Amended]

    9. In Sec.  35.57, replace both references to ``October 24, 2002'' 
with ``[insert effective date of final rule]''.
    10. In Sec.  35.190, paragraphs (a) and (c)(1)(ii)(B) are revised 
to read as follows:


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

* * * * *
    (a) Meets the requirements in paragraph (c)(2) of this section and 
is certified by a medical specialty board whose certification process 
has been recognized by the Commission or an Agreement State. (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) Meet the requirements in paragraph (c)(1) of this section;
    (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
* * * * *
    (c) * * *
    (1) * * *
    (ii) * * *
    (B) Performing quality control procedures on instruments used to 
determine the activity of dosages and performing checks for proper 
operation of survey meters;
* * * * *
    11. In Sec.  35.290, paragraphs (a) and (c)(1)(ii)(B) are revised 
to read as follows:


Sec.  35.290  Training for imaging and localization studies.

* * * * *
    (a) Meets the requirements in paragraph (c)(2) of this section and 
is certified by a medical specialty board whose certification process 
has been recognized by the Commission or an Agreement State. (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) Meet the requirements in paragraph (c)(1) of this section;
    (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
* * * * *
    (c) * * *
    (1) * * *
    (ii) * * *
    (B) Performing quality control procedures on instruments used to 
determine the activity of dosages and performing checks for proper 
operation of survey meters;
* * * * *
    12. In Sec.  35.390, paragraph (a), paragraphs (b)(1)(ii)(B), and 
(b)(1)(ii)(G)(3) and (4) are revised, paragraph (b)(2) is removed and 
reserved, and paragraph (c) is added to read as follows:


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

* * * * *
    (a) Is certified by a medical specialty board whose certification 
process has been recognized by the Commission or an Agreement State. 
(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 a minimum of 3 years of residency 
training in a radiation therapy or nuclear medicine training program or 
a program in a related medical specialty that includes 700 hours of 
training and experience as described in paragraph (b)(1) of this 
section. Eligible training programs must be approved by the Residency 
Review Committee of the Accreditation Council for Graduate Medical 
Education or Royal College of Physicians and Surgeons of Canada or the 
Committee on Post-Graduate Training of the American Osteopathic 
Association;
    (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; or
    (b) * * *
    (1) * * *
    (ii) * * *
    (B) Performing quality control procedures on instruments used to 
determine the activity of dosages, and performing checks for proper 
operation of survey meters;
* * * * *
    (G) * * *
    (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) [Reserved]
    (c) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraph (a) 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 certification must be signed 
by a preceptor authorized user who meets the requirements in Sec.  
35.390(a), Sec.  35.390(b), or, before October 24, 2004, Sec.  35.390, 
or equivalent Agreement State requirements. The preceptor authorized 
user, who meets the requirements in Sec.  35.390(b), or, before October 
24, 2004, 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)(1), (2), (3), or (4)) as the individual requesting 
authorized user status.
* * * * *
    13. In Sec.  35.392, paragraphs (a) and (c)(2)(ii) 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).
* * * * *
    (a) Meets the requirements in paragraph (c)(3) of this section and 
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.(Specialty boards whose certification 
processes 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;
* * * * *
    14. In Sec.  35.394, paragraphs (a) and (c)(2)(ii) 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) Meets the requirements in paragraph (c)(3) of this section and 
is

[[Page 68562]]

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. (Specialty boards whose certification 
processes 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;
* * * * *
    15. In Sec.  35.490, paragraphs (a) and (b)(2) are revised, 
paragraph (b)(3) is removed, and paragraph (c) is added 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. 
(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 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 Royal College of Physicians and Surgeons of Canada or the 
Committee on Post-Graduate Training of the American Osteopathic 
Association;
    (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 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, 2004, 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
    (c) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Sec.  35.490, or, before 
October 24, 2004, Sec.  35.940, or equivalent Agreement State 
requirements, that the individual has satisfactorily completed the 
requirements in paragraphs (a) or (b) 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.
    16. 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. (Specialty boards whose certification processes 
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;
    (4) Radiation biology; and
    (c) Has completed training in the use of the device for the uses 
requested.
    17. In Sec.  35.690, paragraphs (a) and (b)(2) are revised, 
paragraph (b)(3) is removed, and paragraphs (c) and (d) are 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. 
(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 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 Royal College of Physicians and Surgeons of Canada or the 
Committee on Post-Graduate Training of the American Osteopathic 
Association;
    (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, 2004, 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 
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
    (c) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraphs (a) or (b) of 
this section and has achieved a level of competency sufficient to 
function independently as an authorized user of each type of 
therapeutic medical unit for which the individual is requesting 
authorized user status. The written certification must be signed by a 
preceptor authorized user who meets the requirements in Sec.  35.690, 
or, before October 24, 2004, 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
    (d) 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.


[[Page 68563]]


    Dated at Rockville, Maryland, this 2nd day of December, 2003.
    For the Nuclear Regulatory Commission.

Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 03-30358 Filed 12-8-03; 8:45 am]
BILLING CODE 7590-01-P