[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]
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Proposed Rules
Federal Register
________________________________________________________________________
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