View source for RIS 2006-26, Training and Experience and Grandfather Provisions for Authorized Medical Physicists Under 10 CFR 35

{{Adams
| number = ML062550222
| issue date = 12/07/2006
| title = Training and Experience and Grandfather Provisions for Authorized Medical Physicists Under 10 CFR 35
| author name = Schlueter J R
| author affiliation = NRC/FSME/DMSSA
| addressee name = 
| addressee affiliation = 
| docket = 
| license number = 
| contact person = 
| document report number = RIS-06-026
| document type = NRC Regulatory Issue Summary
| page count = 7
| revision = 0
}}{{Adams
| number = ML062630010
| issue date = 12/07/2006
| title = SECY-06-0248 Enclosure 2 - Regulatory Issue Summary 2006-26, Training and Experience and Grandfather Provisions for Authorized Medical Physicists Under 10 CFR Part 35
| author name = Schlueter J R
| author affiliation = NRC/FSME/DMSSA
| addressee name = 
| addressee affiliation = 
| docket = 
| license number = 
| contact person = Zelac R E
| document report number = RIS-06-026, SECY-06-0248
| document type = NRC Regulatory Issue Summary
| page count = 6
| revision = 0
}}
{{#Wiki_filter:UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF FEDERAL AND STATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMSWASHINGTON, December 07, 2006NRC REGULATORY ISSUE SUMMARY 2006-26TRAINING AND EXPERIENCE AND GRANDFATHER PROVISIONS FORAUTHORIZED MEDICAL PHYSICISTS UNDER 10 CFR PART 35.

==ADDRESSEES==
All NRC medical-use licensees and Radiation Control Program Directors.

==INTENT==
The U.S. Nuclear Regulatory Commission (NRC) is issuing this regulatory issue summary (RIS)to clarify the provisions for recognizing and "grandfathering" authorized medical physicists(AMPs) under 10 CFR 35.2, 35.14, 35.51 and 35.5 The regulatory use of the term authorizedmedical physicist includes only medical physicists for the following medical uses: Strontium-90(Sr-90) eye applicators, remote afterloader units, teletherapy units, and gamma stereotacticradiosurgery (Gamma Knife) unit Therefore, this RIS applies only to licensees with thesedevice No specific action nor written response is required.

==BACKGROUND==
On March 30, 2005, the Commission published a final rule, in the Federal Register, amendingspecific sections in 10 CFR Part 35 (70 FR 19336). The rule revised regulations for therecognition of specialty boards, whose certification processes can demonstrate the training andexperience of individuals for serving as radiation safety officers, authorized nuclearpharmacists, AMPs, or authorized user The rule also included additional revisions to othertraining and attestation requirements for these individual Subpart J, of prior 10 CFR Part 35(Training and Experience Requirements), remained in effect for a transition period, and expiredon October 25, 200 Agreement States have until April 29, 2008, three years from theeffective date of the final rule, to establish regulations compatible with the revised rule. All specialty boards listed in former 10 CFR Part 35, Subpart J, were contacted aboutapplication for NRC recognition of one or more of their certification processes, under theboards' recognition requirements, in the revised training and experience sections of Part 35,Subparts B, and D through Each specialty board was requested to supply NRC with aneffective date for when its certification process met, or would meet, the revised training andexperience requirements in 10 CFR Part 3 The procedures for NRC recognition of boardcertifications and the recognized certification processes, with the associated effective dates, arelisted on NRC's medical-use tool kit web site under "Other Guidance" at: http://www.nrc.gov/materials/miau/med-use-toolkit.html. The revised Part 35 offers four methods for individuals seeking to be recognized as AMPs atNRC licensed medical-use facilitie The regulations in 10 CFR 35.51 specify two of thesemethods: (1) Approval of an individual who is certified by a specialty board whose certificationprocess has been recognized by the NRC or an Agreement State as meeting the NRC'srequirements for training and experience, referred to as the "certification pathway"; or (2)Approval by NRC, an NRC master materials licensee (MML), an NRC broad-scope medical-uselicensee, or an MML broad-scope medical-use permittee, based on an evaluation of anindividual's training and experience, against the requirements described in 10 CFR 35.51(b),referred to as the "alternate pathway." The third method is described in the provisions of 10 CFR 35.5 Under this section,teletherapy or medical physicists identified on existing Commission or Agreement State licensesor permits before October 24, 2002, or AMPs identified on Commission or Agreement Statelicenses or permits between October 24, 2002, and April 29, 2005, are exempt from therequirements in 10 CFR 35.5 The intent of 10 CFR 35.57 is to "grandfather" those individualsnamed on existing Commission or Agreement State licenses or permits, so that they maycontinue functioning as AMPs for those uses for which they have been previously approve The fourth method is implemented through the definition of an AMP in 10 CFR 35.2 and10 CFR 35.14, medical physicists who are listed as AMPs or teletherapy physicists onCommission or Agreement State medical-use licenses or permits may work as AMPs withoutthe licensee needing to apply for a license amendmen The limited-specific medical-uselicensee or permittee only has to notify the NRC or the NRC MML that the individual is workingas an AMP, and provide documentation required in 10 CFR 35.1 Some Agreement Stateshave not adopted the notification provisions in 10 CFR 35.1 Accordingly, this method may notbe available to medical physicists moving to a new licensee in a particular Agreement State.There are approximately 109 Gamma Knife units, 765 remote afterloader units, 12 teletherapyunits, and 100 Sr-90 eye applicators licensed in the NRC licenses about 260 of thesedevices, and approximately 725 devices are licensed by Agreement States.

==SUMMARY OF ISSUE==
For many years, NRC has listed medical physicists on licenses for remote afterloader units,teletherapy units, Sr-90 eye applicators, and Gamma Knife unit In the 2002 revision of10 CFR Part 35, NRC began identifying these medical physicists as AMP However, not allthe Agreement States list medical physicists on medical-use license Based on a recent NRCsurvey, 28 of the 34 Agreement States indicated that they have been or are now listing AMPson their limited-specific medical-use license The remaining six States indicated they did notpreviously list AMPs on their licenses, but they will list them by the April 29, 2008, deadline forestablishing regulations compatible with the revised rule.A medical physicist moving from an Agreement State to an NRC licensed medical facility, whowas named on a Commission or Agreement State medical-use license or permit that was validon April 29, 2005, is eligible to use the grandfather provision, in 10 CFR 35.57, to be named asan AMP on the new facility's NRC licens If the medical physicist is listed as a teletherapyphysicist, medical physicist, or AMP on an Agreement State license issued subsequent to April 29, 2005, the new NRC licensed medical facility can permit the individual to work as anAMP under the provisions of 10 CFR 35.2 and 35.1 Medical physicists for whom the grandfather provisions do not apply, but who are professionallyactive in Agreement States that do not list medical physicists on their limited-specific medical-use licenses, must apply by either the board certification pathway or the alternate pathway,described in 10 CFR Part 35.51, when seeking AMP recognition on an NRC license or a licensein another Agreement Stat A board certified medical physicist may not be able to use theboard certification pathway to obtain recognition as an AMP if his or her certification board andcertification year are not listed on NRC's web sit Furthermore, medical physicists applying forrecognition as AMPs by either the board certification pathway or the alternate pathway aresubject to the recentness-of-training provisions in 10 CFR 35.5 Therefore, a medical physicist to whom the grandfather provisions and the notificationprovisions do not apply and who is practicing in an Agreement State licensed limited-specificmedical-use facility is strongly encouraged to request being identified as an AMP listed on theAgreement State license for his or her present facility if the medical physicist may in the futureseek to be listed as an AMP on an NRC license or on a license in another Agreement State. Once listed on an Agreement State license, the medical physicist can seek recognized statusvia the notification provisions described in 10 CFR 35.2 and 10 CFR 35.14, or equivalentregulations in the particular Agreement State.Even if an Agreement State does not identify teletherapy physicists, medical physicists, orAMPs on limited-specific medical-use licenses, a medical physicist located at a broad-scopemedical-use facility licensed in such an Agreement State is encouraged to have the licenseename the physicist on a permi This will enable the medical physicist to use the notification provisions described in 10 CFR 35.2 and 10 CFR 35.14, if he or she seeks to be listed as anAMP on an NRC license, or a license in another Agreement State.

===FEDERAL REGISTER NOTIFICATION===
A notice of opportunity for public comment on this RIS was not published in the FederalRegister because this RIS is informational and does not represent a departure from currentregulatory requirements.SMALL BUSINESS REGULATORY ENFORCEMENT FAIRNESS ACTNRC has determined that this action is not subject to the Small Business RegulatoryEnforcement Fairness Act of 1996.

===PAPERWORK REDUCTION ACT STATEMENT===
This RIS does not contain information collections and, therefore, is not subject to therequirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.). 

==CONTACT==
This RIS requires no specific action nor written respons If you have any questions about thissummary, please contact the individual listed below or the appropriate regional office./RA/
Janet R. Schlueter, Director Division of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs

===Technical Contact:===
Ronald Zelac, FSME Duane White, FSME (301) 415-7635 (301) 415-6272 E-mail: rez@nrc.gov E-mail: dew2@nrc.gov 

===Enclosure:===
"List of Recently Issued NMSS Generic Communications" 

==CONTACT==
This RIS requires no specific action nor written respons If you have any questions about thissummary, please contact the individual listed below or the appropriate regional office./RA/
Janet R. Schlueter, Director Division of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs

===Technical Contact:===
Ronald Zelac, NMSS Duane White, FSME (301) 415-7635 (301) 415-6272 E-mail: rez@nrc.gov E-mail: dew2@nrc.gov

===Enclosure:===
"List of Recently Issued NMSS Generic Communications"DISTRIBUTION:DMSSA r/f RZelac DWhite CHawesML062550222OFFICE IMNS/MSIB IMNS/MSIB IMNS/MSIB IMNS/MSIB IMNS/MSIBNAME DWhite AMcIntosh RZelac CFlannery SWastlerDATE 09 / 06 / 06 09 / 07 / 06 09 / 25 / 06 09 / 22 / 06 09 / 25 / 06OFFICE OIS TechEd OGC FSME/MSSANAME ESt.Mary EKraus STreby JSchlueterDATE 09 /14 / 06 09 / 13 / 06 11 / 21 /06 12 / 1 /06OFFICIAL RECORD COPY Recently Issued FSME/NMSS Generic Communications DateGC No.Subject

==Addressees==
Guidance for Receiving09/14/06RIS-06-20Enforcement Discretion WhenConcentrating Uranium atCommunity Water SystemsAll community water systems (CWSs), inU.S. Nuclear Regulatory Commission(NRC) non-Agreement States, that duringthe treatment of drinking water, mayaccumulate and concentrate naturally-occurring uranium in media, effluents,and other residuals, above 0.05 percentby weight.08/15/06RIS-06-16 Transfer of the ManagementOversight Of Certain NRC Region ILicensees in Mississippi To the NRC Region IV OfficeAll NRC materials licensees.09/14/06RIS-06-19 Availability of Guidance onRadioactive Seed LocalizationAll NRC medical licensees.08/31/06RIS-06-18 Requesting Exemption from thePublic Dose Limits for CertainCaregivers of Hospital PatientsAll NRC medical licensees.09/22/06RIS-06-14 Enforcement Discretion for FacilityChanges Under 10 CFR70.72(c)(2)All fuel cycle licensees regulated underTitle 10 of the Code of FederalRegulations (10 CFR) Part 70, Subpart H.07/20/06RIS-06-11 Requesting Quality AssuranceProgram Approval RenewalsOnline by Electronic InformationExchange All 10 CFR Part 71 quality assuranceprogram and certificate holders.04/23/06RIS-06-10 Use of Concentration Control forCriticality SafetyAll licensees authorized to possess acritical mass of special nuclear material.01/26/06RIS-02-15,Rev. 1NRC Approval of Commercial DataEncryption Products For theElectronic Transmission OfSafeguards InformationAll authorized recipients and holders ofsensitive unclassified safeguardsinformation (SGI).01/24/06RIS-06-01 Expiration Date for NRC-ApprovedSpent Fuel Transportation RoutesThe U.S. Nuclear Regulatory Commission(NRC) licensees who transport, or deliverto a carrier for transport, irradiatedreactor fuel (spent nuclear fuel (SNF)).01/13/06RIS-05-27,Rev. 1NRC Timeliness Goals,Prioritization of Incoming LicenseApplications and VoluntarySubmittal of Schedule for FutureActions for NRC ReviewAll 10 CFR Parts 71 and 72 licenseesand certificate holder DateGC No.Subject

==Addressees==
07/10/06IN-06-13Ground-Water ContaminationDue to Undetected Leakage ofRadioactive WaterAll holders of operating licenses fornuclear power and research and testreactors including those who havepermanently ceased operations andhave certified that fuel has beenpermanently removed from thereactor and those authorized by Title10 of the Code of Federal Regulations(10 CFR) Part 72 licenses to storespent fuel in water-filled structures.07/06/06IN-06-12Exercising Due Diligence WhenTransferring RadioactiveMaterialsAll materials licensees.06/12/06IN-06-11 Applicability of Patient Interventionin Determining Medical Events forGamma Stereotactic Radiosurgeryand Other Therapy ProceduresAll medical licensees.03/31/06 IN-06-07 Inappropriate Use of a Single-parameter Limit as a NuclearCriticality Safety LimitAll licensees authorized to possess acritical mass of special nuclear material.03/21/06IN-02-23,Supl. 1Unauthorized Administration ofByproduct Material for Medical UseAll medical licensees.01/19/06IN-06-02 Use of Galvanized Supports andCable Trays with Meggitt Si 2400Stainless- Steel-jacketed ElectricalCablesAll holders of operating licenses fornuclear reactors except those who havepermanently ceased operations and havecertified that fuel has been permanentlyremoved from the reactor vessel; and fuelcycle licensees and certificate holders.Note: NRC generic communications may be found on the NRC public website at http://www.nrc.gov, under ElectronicReading Room/Document Collections.
Enclosure 2UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF FEDERAL AND STATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMSWASHINGTON, December 07, 2006NRC REGULATORY ISSUE SUMMARY 2006-26TRAINING AND EXPERIENCE AND GRANDFATHER PROVISIONS FORAUTHORIZED MEDICAL PHYSICISTS UNDER 10 CFR PART 35.

==ADDRESSEES==
All NRC medical-use licensees and Radiation Control Program Directors.

==INTENT==
The U.S. Nuclear Regulatory Commission (NRC) is issuing this regulatory issue summary (RIS)to clarify the provisions for recognizing and "grandfathering" authorized medical physicists (AMPs) under 10 CFR 35.2, 35.14, 35.51 and 35.5 The regulatory use of the term authorizedmedical physicist includes only medical physicists for the following medical uses: Strontium-90(Sr-90) eye applicators, remote afterloader units, teletherapy units, and gamma stereotacticradiosurgery (Gamma Knife) unit Therefore, this RIS applies only to licensees with thesedevice No specific action nor written response is required.

==BACKGROUND==
On March 30, 2005, the Commission published a final rule, in the Federal Register, amendingspecific sections in 10 CFR Part 35 (70 FR 19336). The rule revised regulations for the recognition of specialty boards, whose certification processes can demonstrate the training and experience of individuals for serving as radiation safety officers, authorized nuclear pharmacists, AMPs, or authorized user The rule also included additional revisions to other training and attestation requirements for these individual Subpart J, of prior 10 CFR Part 35 (Training and Experience Requirements), remained in effect for a transition period, and expired on October 25, 200 Agreement States have until April 29, 2008, three years from the effective date of the final rule, to establish regulations compatible with the revised rule. All specialty boards listed in former 10 CFR Part 35, Subpart J, were contacted aboutapplication for NRC recognition of one or more of their certification processes, under the boards' recognition requirements, in the revised training and experience sections of Part 35, Subparts B, and D through Each specialty board was requested to supply NRC with an effective date for when its certification process met, or would meet, the revised training and experience requirements in 10 CFR Part 3 The procedures for NRC recognition of board certifications and the recognized certification processes, with the associated effective dates, are  listed on NRC's medical-use tool kit web site under "Other Guidance" at: http://www.nrc.gov/materials/miau/med-use-toolkit.html.The revised Part 35 offers four methods for individuals seeking to be recognized as AMPs atNRC licensed medical-use facilitie The regulations in 10 CFR 35.51 specify two of thesemethods: (1) Approval of an individual who is certified by a specialty board whose certification process has been recognized by the NRC or an Agreement State as meeting the NRC's requirements for training and experience, referred to as the "certification pathway"; or (2)
Approval by NRC, an NRC master materials licensee (MML), an NRC broad-scope medical-use licensee, or an MML broad-scope medical-use permittee, based on an evaluation of an individual's training and experience, against the requirements described in 10 CFR 35.51(b),
referred to as the "alternate pathway." The third method is described in the provisions of 10 CFR 35.5 Under this section,teletherapy or medical physicists identified on existing Commission or Agreement State licenses or permits before October 24, 2002, or AMPs identified on Commission or Agreement State licenses or permits between October 24, 2002, and April 29, 2005, are exempt from the requirements in 10 CFR 35.5 The intent of 10 CFR 35.57 is to "grandfather" those individuals named on existing Commission or Agreement State licenses or permits, so that they may continue functioning as AMPs for those uses for which they have been previously approve The fourth method is implemented through the definition of an AMP in 10 CFR 35.2 and10 CFR 35.14, medical physicists who are listed as AMPs or teletherapy physicists on Commission or Agreement State medical-use licenses or permits may work as AMPs without the licensee needing to apply for a license amendmen The limited-specific medical-use licensee or permittee only has to notify the NRC or the NRC MML that the individual is working as an AMP, and provide documentation required in 10 CFR 35.1 Some Agreement States have not adopted the notification provisions in 10 CFR 35.1 Accordingly, this method may not be available to medical physicists moving to a new licensee in a particular Agreement State.There are approximately 109 Gamma Knife units, 765 remote afterloader units, 12 teletherapyunits, and 100 Sr-90 eye applicators licensed in the NRC licenses about 260 of thesedevices, and approximately 725 devices are licensed by Agreement States.

==SUMMARY OF ISSUE==
For many years, NRC has listed medical physicists on licenses for remote afterloader units,teletherapy units, Sr-90 eye applicators, and Gamma Knife unit In the 2002 revision of 10 CFR Part 35, NRC began identifying these medical physicists as AMP However, not all the Agreement States list medical physicists on medical-use license Based on a recent NRC survey, 28 of the 34 Agreement States indicated that they have been or are now listing AMPs on their limited-specific medical-use license The remaining six States indicated they did notpreviously list AMPs on their licenses, but they will list them by the April 29, 2008, deadline for establishing regulations compatible with the revised rul A medical physicist moving from an Agreement State to an NRC licensed medical facility, whowas named on a Commission or Agreement State medical-use license or permit that was valid on April 29, 2005, is eligible to use the grandfather provision, in 10 CFR 35.57, to be named as an AMP on the new facility's NRC licens If the medical physicist is listed as a teletherapy physicist, medical physicist, or AMP on an Agreement State license issued subsequent to April 29, 2005, the new NRC licensed medical facility can permit the individual to work as an AMP under the provisions of 10 CFR 35.2 and 35.1 Medical physicists for whom the grandfather provisions do not apply, but who are professionallyactive in Agreement States that do not list medical physicists on their limited-specific medical- use licenses, must apply by either the board certification pathway or the alternate pathway,described in 10 CFR Part 35.51, when seeking AMP recognition on an NRC license or a license in another Agreement Stat A board certified medical physicist may not be able to use the board certification pathway to obtain recognition as an AMP if his or her certification board and certification year are not listed on NRC's web sit Furthermore, medical physicists applying for recognition as AMPs by either the board certification pathway or the alternate pathway are subject to the recentness-of-training provisions in 10 CFR 35.5 Therefore, a medical physicist to whom the grandfather provisions and the notification provisions do not apply and who is practicing in an Agreement State licensed limited-specific medical-use facility is strongly encouraged to request being identified as an AMP listed on the Agreement State license for his or her present facility if the medical physicist may in the future seek to be listed as an AMP on an NRC license or on a license in another Agreement Stat Once listed on an Agreement State license, the medical physicist can seek recognized status via the notification provisions described in 10 CFR 35.2 and 10 CFR 35.14, or equivalent regulations in the particular Agreement State.Even if an Agreement State does not identify teletherapy physicists, medical physicists, orAMPs on limited-specific medical-use licenses, a medical physicist located at a broad-scopemedical-use facility licensed in such an Agreement State is encouraged to have the licensee name the physicist on a permi This will enable the medical physicist to use the notification provisions described in 10 CFR 35.2 and 10 CFR 35.14, if he or she seeks to be listed as an AMP on an NRC license, or a license in another Agreement State.

===FEDERAL REGISTER NOTIFICATION===
A notice of opportunity for public comment on this RIS was not published in the FederalRegister because this RIS is informational and does not represent a departure from currentregulatory requirements.SMALL BUSINESS REGULATORY ENFORCEMENT FAIRNESS ACTNRC has determined that this action is not subject to the Small Business RegulatoryEnforcement Fairness Act of 199 

===PAPERWORK REDUCTION ACT STATEMENT===
This RIS does not contain information collections and, therefore, is not subject to therequirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.).

==CONTACT==
This RIS requires no specific action nor written respons If you have any questions about thissummary, please contact the individual listed below or the appropriate regional office./RA/Janet R. Schlueter, DirectorDivision of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs

===Technical Contact:===
Ronald Zelac, FSMEDuane White, FSME (301) 415-7635 (301) 415-6272 E-mail: rez@nrc.gov E-mail: dew2@nrc.gov

===Enclosure:===
"List of Recently Issued NMSS Generic Communications" 

==CONTACT==
This RIS requires no specific action nor written respons If you have any questions about thissummary, please contact the individual listed below or the appropriate regional office./RA/Janet R. Schlueter, DirectorDivision of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs

===Technical Contact:===
Ronald Zelac, NMSSDuane White, FSME (301) 415-7635 (301) 415-6272 E-mail: rez@nrc.govE-mail: dew2@nrc.gov

===Enclosure:===
"List of Recently Issued NMSS Generic Communications"DISTRIBUTION:DMSSA r/fRZelacDWhiteCHawesML062550222OFFICEIMNS/MSIBIMNS/MSIB IMNS/MSIB IMNS/MSIBIMNS/MSIBNAMEDWhiteAMcIntoshRZelacCFlannerySWastlerDATE 09 / 06 / 06 09 / 07 / 06 09 / 25 / 06 09 / 22 / 06 09 / 25 / 06OFFICEOISTechEdOGCFSME/MSSANAMEESt.MaryEKrausSTrebyJSchlueterDATE 09 /14 / 06 09 / 13 / 06 11 / 21 /06 12 / 1 /06OFFICIAL RECORD COPY
}}

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