To: Burke, Gerald; Casey, Richard W. LCDR; Clark, Dorothy M. (CIV); Ely, Karen D. (CIV); Fairchild Gregory R LT; Fong, Raynard K CAPT; Giel, Daniel T. (CIV); Hecht, Sheila C , LCDR; Herrera, Mark E; Hope, Lawanda P. HM1; Johnson, Gabrielle M.; Kennemur, Lisa K LCDR; LaFontaine, Richard L CT; Loscocco, Michele F (CDR); Maher, John M CDR; Ozeroglu, Muhammed A LT; Pomije, Brian D. (LCDR); Ruiz, Steven LCDR; Saylor, Tillman K (NNMC Contractor); Scott, John H., CIV.; Simays, Andrew E., CDR; Solanki, Haresh P; Swilley, Eugene A. (LT); Tu, Victor LT; Van Way, Rick L (LCDR); Younes, Georges E LCDR
Cc: Pomije, Brian D. (LCDR); Ely, Karen D. (CIV); Clark, Dorothy M. (CIV); Earles, Marvin R LCDR ; Glennon, Brendan K. CDR BUMED; Lino CDR Fragoso (E-mail) (Lino.Fragoso@navy.mil)
(Summary of Changes to 10 CFR Part 35) To all Radiation Safety Officers and Medical Permittees:
Each command with a "medical" Naval Radioactive Materials Permit (NRMP) was previously informed that the Nuclear Regulatory Commission (NRC) had published a Final Rule to amend its requirements for "Medical Use of Byproduct Material", 10 CFR Part 35, in the Federal Register on March 30, 2005. These revised regulations specifically pertain to the training and experience requirements for Authorized Users (AUs), Radiation Safety Officers (RSOs), Authorized Medical Physicists (AMPs) and Authorized Nuclear Pharmacists (ANPs).
The NRC recently published the following summary of "significant amendments" to 10 CFR Part 35:
The requirement in 10 CFR 35.390(b)(1)(ii)(F) for experience with the elution of generators, testing, processing, and preparation of labeled radioactive drugs, is removed from 10 CFR 35.390.
The requirements for experience with oral and parenteral administrations of byproduct material for which a written directive (WD) is required, currently in 10 CFR 35.390(b)(1)(ii)(G), are removed from the requirements for recognition of specialty board certification processes. However, the regulations continue to require this experience for individuals to qualify as AUs for uses of byproduct material for which a written directive is required under 10 CFR 35.300, for both the certification pathway and the alternate pathway.
A new 10 CFR 35.396, entitled "Training for the parenteral administration of unsealed byproduct material requiring a written directive", is included in the final rule. This allows individuals who do not meet other requirements in 10 CFR 35.390(b)(1), to serve as AUs for parenteral administration of byproduct material for which a WD is required, if they meet the requirements in 10 CFR 35.396.
Requirements for individuals to serve as RSOs were amended (10 CFR 35.50) to include medical physicists who meet the requirements specified therein.
A requirement is added for AUs in 10 CFR 35.190, 35.290, and 35.390, and for ANPs in 10 CFR 35.55, that training in basic radionuclide handling techniques must include a minimum number of hours of classroom and laboratory training, for individuals to be approved as AUs and ANPs under the alternate pathway. Specifically, the final rule requires 8, 80, and 200 hours of classroom and laboratory training for 10 CFR 35.190, 35.290, 35.55 and 35.390, respectively, under the alternate pathway.
"Attest" and "attestation" are used in place of "certify" and "certification", in requirements for the preceptor statements.
10 CFR 35.10 provides for implementation of the requirements in 10 CFR 35.14(a) to provide the NRC with a copy of written attestation, signed by a preceptor, on or before October 25, 2005. [Note that for U. S. Navy permittees, a copy will be forwarded to the Navy Environmental Health Center in lieu of the NRC.] Also, before October 25, 2005, a licensee shall satisfy the training requirements for an AU, AMP, ANP, or an RSO, by complying with either: (a) the training requirements in Subpart J, or (b) the appropriate training requirements in Subpart B or Subparts D through H.
The above and other changes to the rule are discussed in more detail in the Federal Register (70 FR 16335, March 30, 2005). Note also that licensing guidance for medical uses of byproduct material, NUREG-1556, Vol. 9, has been revised to conform to the revisions in the final rule.
As a reminder, Subpart J of 10 CFR Part 35 will officially be deleted from the regulations on 25 October, 2005, and after that date, all approval of individuals shall be based on compliance with the new regulations.
Brian D. Pomije, MS, DABR