ML19016A334

Instructions for RSO and ARSO T&E for Use by Applicants January 11, 2019

ML19016A334
Person / Time
Issue date:	02/07/2019
From:	Office of Nuclear Material Safety and Safeguards
To:
Shared Package
ml19016a042	List: ML19016A330 ML19016A331 ML19016A332 ML19016A333 ML19016A334 ML19016A335
References
Download: ML19016A334 (4)

Text

Instructions for submitting training and experience information for a Radiation Safety Officer or an Associate Radiation Safety Officer NRC Medical Use Applicants, Licensees, and Master Materials Permittees This instruction describes the training and experience information that applicants, licensees and Master Material License (MML) permittees should submit for each Radiation Safety Officer (RSO) or Associate Radiation Safety Officer (ARSO) in Item 7, Individual(s)

Responsible for Radiation Safety Program and Their Training and Experience of NRC Form 313, Application for a Materials License. These instructions are effective until the Office of Management and Budget (OMB) approves the revisions to the NRC Form 313 A series.

Usually, applicants, licensees, and permittees use the NRC Form 313 A series to provide training and experience information. However, OMB has not yet approved the revisions to the revised NRC Form 313 A series that comports with the final rule, Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, 83 FR 33046 (July 16, 2018). Therefore, these forms should not be used by medical use applicants, licensees, or permittees in submissions to either the NRC or an MML. The current NRC Form 313 A series of forms should also not be used because they do not comport with the final rule.

Applicants, licensees, and permittees should follow the instructions provided below to provide training and experience information to the NRC and MMLs. These instructions are from pages 30 through 49 of Guidance for the Final Rule Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, which is available at https://www.nrc.gov/docs/ML1817/ML18176A377.pdf.

These instructions comport with the training and experience requirements in 10 CFR Part 35 that went into effect on January 14, 2019.

Radiation Safety Officer and Associate Radiation Safety Officer Provide the following:

Name of the individual.

AND Identify if applying for RSO or ARSO.

AND

For a proposed ARSO, identify the section(s) of the licensees program for which the individual will be given duties and task in the oversight of radiation safety operations (e.g.,

35.200 uses or 35.200 uses at one of the licensees alternate location)

AND For an individual previously identified as an RSO or ARSO on an NRC or Agreement State License or permit:

ML19016A334

Previous license number (if issued by the NRC) or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee on which the individual was named as the RSO or ARSO if requesting the same materials and medical uses; AND After January 14, 2019, documentation of completion of the training requirements in

§ 35.50(d) for any new materials or new medical uses requested.

For an individual qualifying under 10 CFR 35.57 (a)(4):

(Note: This is only for a new medical use license requesting use of only accelerator-produced radioactive material, discrete sources of Ra-226, or both, for the same uses authorized under NRCs waiver of August 31, 2005.)

Documentation that this individual functioned as an RSO for only accelerator-produced radioactive materials, discrete sources of Ra-226, or both, at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; AND Documentation that the individual performed as the RSO for the same medical uses requested.

For an individual qualifying under 10 CFR 35.50(a):

Copy of certification by a specialty board whose certification process has been recognized1 by the NRC or an Agreement State under 10 CFR 35.50(a);

AND Description of the training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO or ARSO is qualified by training in the radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.

For an individual qualifying under 10 CFR 35.50(c)(1):

Copy of the certification(s) as a medical physicist by a board whose certification process has been recognized2 by the NRC or an Agreement State under 10 CFR 35.51(a) and description of the experience specified in 35.50(c)(1) demonstrating that the proposed RSO or ARSO is qualified by experience with the radiation safety aspects of similar types 1 The names of board certifications that have been recognized by the NRC or an Agreement State are posted on NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.

2 The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.

2

of use of byproduct material for which the applicant seeks approval of an individual to serve as RSO or ARSO; AND Description of the training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.

For an individual qualifying under 10 CFR 35.57(a)(2):

Copy of certification by a specialty board whose certification is listed in 10 CFR 35.57(a)

(2);

AND Documentation demonstrating that the individual was using the requested materials and uses on or before October 24, 2005; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.

For an individual qualifying under 10 CFR 35.50(c)(2):

Copy of the Commission or Agreement State license, permit issued by a Commission master material license, permit issued by a Commission or Agreement State licensee of broad scope, or permit issued by a Commission master material license broad scope permittee indicating that the individual is an AU, AMP or ANP and has experience with the radiation safety aspects of similar types of use of byproduct material for which the applicant seeks approval of an individual to serve as RSO or ARSO ;

AND Description of the training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.

For an individual qualifying under 10 CFR 35.50(c)(3):

Documentation of training and experience required to be named as an AU when simultaneously applying to be the AU and RSO on a new medical license; 3

AND Description of the training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO; For an individual qualifying under 10 CFR 35.50(b):

Description of the training and experience specified in 10 CFR 35.50(b)(1) demonstrating that the proposed RSO or ARSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO; AND Description of the training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO; AND Written attestation, signed by a preceptor RSO3 or ARSO, that the individual has successfully completed the training and experience in 10 CFR 35.50(b)(1), as well as the required training and experience in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval and is able to independently fulfill the radiation safety-related duties as an RSO or as an ARSO for a medical use licensee; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.

3 Document that the preceptor RSO or ARSO meets the criteria to sign the attestation.

4