Frequently Asked Questions About Licensing Medical Uses of Byproduct Material Under Revised 10 CFR Part 35
NRC developed these questions and answers as guidance to illustrate issues that may arise in licensing under 10 CFR Part 35, "Medical Use of Byproduct Material." The answers represent NRC staff positions only and do not constitute formal interpretations of the regulations recognized as binding on the Commission (10 CFR 30.5). They are arranged under the following topics.
On this page:
Index to All Frequently Asked Questions Pages
Acceptable Variation from Prescribed Dosage
a) Does the requirement for ±20% for dosage apply to both therapeutic and diagnostic dosages? [10 CFR 35.63] (Q&A ID 0802026a)
b) Can a dosage that differs from the prescribed dosage by more than 20% or is outside of the prescribed dosage range be used for medical purposes? [10 CFR 35.63] (Q&A ID 0802026b)
a) Yes. Under §35.63, that applies to all dosages of unsealed byproduct material for medical use, an authorized user (AU) may prescribe a dosage or a dosage range. The permitted variation for an administered dose from a prescribed dose is ±20%.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.63, as published in the Federal Register on April 24, 2002.
b) Yes. A dosage that differs from the prescribed dosage by more than 20% or is outside of the prescribed dosage range can be used for medical purposes if the AU so directs. This effectively means that before administration of the dosage, the AU modifies the prescription from one prescribed dosage or dosage range to a revised prescribed dosage or a revised prescribed dosage range that encompasses the dosage to be administered.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.63, as published in the Federal Register on April 24, 2002.
Accuracy of Unit Doses
If a unit dose is received from a nuclear pharmacy, and the licensee does not assay that unit dose (because it is not required to), but the dose was outside the ±20% of the prescription, would the licensee be cited? [10 CFR 35.63] (Q&A ID 0902014)
If the licensee was aware (for example, through the labeling, the procedure manual, or decay correction calculation) that the dosage differed from the prescribed dosage by more than 20% but administered it anyway, without being directed to do so by the authorized user, the licensee would be cited under § 35.63(d).
Activity "Dosage" Measurements of Unsealed Byproduct Material for Medical Use
How long before an administration ("medical use") may a dosage determination be performed under §35.63(a)? [10 CFR 35.63] (Q&A ID 0103012)
The NRC does not have a prescriptive requirement for when dosage measurements must be performed prior to administration, but licensees must ensure that the administered dosage is within the prescribed range or within ±20 percent of the prescribed dosage, as applicable.
Agreement States
What specific requirements within the revised rule do Agreement States have to adopt, and how long do Agreement States have to adopt them? [N/A] (Q&A ID 0302003)
For purposes of compatibility or because of health and safety significance, certain requirements in the revised rule have to be adopted by Agreement States. The specific sections and their compatibility designations are listed in "Supplementary Information," Section X, "Issues of Compatibility for Agreement States," of 10 CFR Part 35, as published in the Federal Register on April 24, 2002 (67 FR 20249). With the exception of the training and experience requirements, the deadline for Agreement States to adopt specific requirements within the revised rule was October 24, 2005, three years after the effective date of the 2002 revised Part 35 as published in the Federal Register on April 24, 2002.
Further amendments to Part 35 training and experience requirements, including recognition of specialty board certification processes and certain other conforming changes, became effective April 29, 2005, thirty days after the publication in the Federal Register on March 30, 2005 (70 FR 16336). The compatibility between NRC and the Agreement States for amended sections is unchanged. These training and experience requirements must be adopted by Agreement States by April 29, 2008, three years after the effective date of the 2005 amendments.
Is there a document that addresses the degree of compatibility for Agreement States that is required for various sections of the rule? [N/A] (Q&A ID 0103038)
Yes, Section X, "Issues of Compatibility for Agreement States", in the Supplemental Information section of the Final Rule, as published in the Federal Register on April 24, 2002, addresses the degree of compatibility for Agreement States that is required for various sections of the rule.
Will Agreement States have a grace period to adopt the NRC's revised training and experience (T&E) requirements, after the revised T&E for the Rule is published? [N/A] (Q&A ID 0902008)
Yes, the Agreement States will have 3 years from April 29, 2005, the effective date of the 2005 final rule amending the Part 35 T&E requirements, to adopt compatible regulations.
Agreement States Recognizing Specialty Boards
Can certifying specialty boards be recognized by an Agreement State? [N/A] (Q&A ID 0103040)
The NRC has in place procedures for recognizing certification processes of specialty boards. In accordance with these procedures, Agreement States may recognize the certification processes of specialty boards that meet requirements of rules compatible, under Compatibility Category B, with those in 10 CFR Part 35. The names of these board certification processes will be included in the listing of recognized board certification processes on the NRC's web site, with annotations indicating which Agreement States recognized the boards' certification processes, after the NRC is notified of the recognition.
a) If an Agreement State (AS) recognizes a certification board that the NRC has not recognized, how will the NRC handle this?
b) Will the AS-recognized board be listed on the NRC Web site? [10 CFR 35.50, 35.51, 35.55, 35.190, 35.290, 35.390, 35.392, 35.394, 35.490, 35.491, 35.590, 35.690] (Q&A ID 0902006)
a) For all training requirements in the Final Rule (radiation safety officers, authorized medical physicists, authorized nuclear pharmacists, authorized user physicians), the specialty certification board can be recognized by the NRC or by an AS; there is no requirement that a certification board be recognized by both NRC and one or more ASs. Moreover, the criteria for recognition of a specialty board appear in the section of the Final Rule appropriate to the specialty, so NRC and ASs will be utilizing the same criteria in considering applications from specialty boards for recognition, since AS training requirements must be essentially identical to those of the NRC. Therefore, NRC will accept certifications from boards recognized by ASs.
b) Yes, as are the NRC-recognized boards. (Recognition of certification boards is discussed under paragraphs (a) and (b) of each of the subsections cited in the Rule Sections.)
Refer to "Supplementary Information," Section X, "Issues of Compatibility for Agreement States," "Summary of NRC Rules With Compatibility or Health and Safety Designations Under the Revision of 10 CFR Parts 20, 32, and 35," as published in the Federal Register on April 24, 2002.
Amendments for New Modalities under §35.1000
If a licensee currently has approval for therapeutic medical uses and wants to add a newly- developed therapeutic modality, is a license amendment required? [10 CFR 33.11, 35.13(a), 35.15(a), 35.400, 35.600, 35.1000] (Q&A ID 0303012)
Yes, if the newly-developed modality is a type of use that is regulated under Part 35, but not specifically authorized on its license. If this is the case, before beginning use, the licensee must apply for and receive a license amendment under §35.1000 to add the new modality to the license. However, for Type A medical broad scope licensees that possess sufficient authorization for licensed material to cover the addition of the new modality, under §35.15(a), a license amendment will probably not be necessary. A medical broad scope licensee wishing to add a new modality should contact the NRC Regional Office for advice prior to submitting an amendment request.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.13, as published in the Federal Register on April 24, 2002.
Application for License, Amendment, or Renewal -- Meaning of "Equipment"
a) In §35.12, what is the definition of "equipment"?
b) What equipment has to be specifically described? [10 CFR 35.12(b)] (Q&A ID 0802037)
a) For information on NRC's regulatory requirements on equipment for medical use licensees, see NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Section 8.9, "Facilities and Equipment". Equipment includes radiation monitoring instruments, dose calibrators, and other equipment used to measure dosages of unsealed byproduct material, dosimetry equipment, and other equipment, such as fume hoods.
b) Radiation monitoring instruments to be used have to be identified in applications.
Approval for AUs
If a physician is listed as an AU on an Agreement State (AS) license for a medical use, will the NRC accept that physician's training and experience (or authorization as an AU) as evidence that the physician may be listed as an AU for the same medical use on an NRC license? [10 CFR 35.13(b), 35.14(a), 35.15, 35.57, 35.190, 35.290, 35.390, 35.392, 35.394, 35.490, 35.491, 35.590, 35.690] (Q&A ID 0301010)
Yes. If a physician is identified as an AU for a medical use on an AS license, the physician may be listed as an AU on an NRC license for the same medical use. See 10 CFR 35.13(b) and §35.57. Note that a license amendment is not needed to permit the physician to begin work as an AU under the NRC license. However, for licensees other than those possessing a Type A specific license of broad scope for medical use (issued under 10 CFR Part 33), a copy of the AS license would have to be submitted to the NRC within 30 days. See 10 CFR 35.14(a).
Could a physician moving to a new facility, listed as an AU on an NRC or Agreement State (AS) license for a medical use (e.g., HDR) under a 'type of use' as defined in 10 CFR 35.2 (e.g., 10 CFR 35.600), be listed on an NRC license for a different medical use under the same type of use (e.g., Gamma Knife)? [10 CFR 35.390, 35.392, 35.394, 35.396, 35.690] (Q&A ID 0106001)
Only if the physician who is seeking to be listed as an AU for a different medical use under the same type of use complies with any additional case experience or training required as specified in the regulations for the medical use for which the physician is seeking recognition. The licensee would have to provide 1) a copy of the AS or NRC license and 2) verification of completion of the required additional case experience or training specified in 10 CFR 35.14(a).
Approval for AUs -- Other Medical Uses
a) What are the training and experience (T&E) requirements for 10 CFR 35.1000?
b) Will a preceptor statement be required? [10 CFR 35.12, 35.1000] (Q&A ID 0902007)
10 CFR 35.1000, "Other medical uses of byproduct material or radiation from byproduct material," does not include specific training and experience requirements for AUs of emerging technologies because training requirements necessary for the safe use of byproduct material in new technologies are not known in advance.
a) 10 CFR 35.12(b)(1) requires applicants to submit T&E information for individuals who are to serve as authorized user(s), authorized medical physicist(s), authorized nuclear pharmacist(s), and radiation safety officer(s) for the purpose(s) for which licensed material will be used, as specified in the application for license or amendment. NRC will be evaluating this information on a case-by-case basis to determine whether the T&E of the identified individuals is appropriate for the proposed use. NRC staff will look first to the T&E requirements in other sections of 10 CFR Part 35 for similarities to evaluate the sufficiency of T&E of individuals identified in the application. It is likely, except for unique circumstances, that the T&E requirements for individuals identified for a Subpart K (§35.1000) use will closely match the established T&E requirements in other sections of 10 CFR Part 35. Additionally, licensing guidance for 10 CFR 35.1000 uses that have already been identified is provided on the NRC Web site and addresses T&E requirements for each medical use.
b) Not specifically; however, NRC has established in its other training and experience requirements that a preceptor statement concerning the individuals' completion of appropriate training and experience and ability to function independently is a necessary component for evaluating the individual's qualification. Individuals seeking AU recognition for new (i.e., not previously licensed) medical uses under 10 CFR 35.1000 should submit a written attestation from a person (or persons) knowledgeable about the radiation safety aspects of the new medical use and the associated equipment, if applicable. A preceptor statement should also be submitted for medical uses that are or have been licensed under 10 CFR 35.1000. In this case, the preceptor could be an AU for the same 10 CFR 35.1000 use.
Approval for Authorized Medical Physicist, Authorized Nuclear Pharmacist, Ophthalmic Physicist, or Authorized User
Is NRC's approval required before an individual can begin duties as an AMP, ANP, or AU under an NRC license? [10 CFR 35.13(b), 35.14(a), 35.15, 35.59] (Q&A ID 0301001)
In accordance with 10 CFR 35.13(b), an individual can begin duties as long as one of the following three conditions applies:
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(a) is certified by a specialty board recognized by NRC that is appropriate for his or her intended responsibilities under the license,
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(b) has a written attestation signed by a preceptor, and
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(c) has any additional training beyond the specialty board training, as specified in 10 CFR 35.14(a), §35.51(a), §35.390(a), or §35.690(a), as applicable
Note that, for this condition, the individual's training and experience must have been obtained within the preceding seven years, or the individual must have had related continuing education and experience.
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(a) a Commission or Agreement State (AS) medical use license or nuclear pharmacy license recognized by NRC, or
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(b) a permit issued by a Commission or AS licensee of broad scope, including medical use or nuclear pharmacy activities, or
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(c) a permit issued by a Commission master material licensee authorized for medical use or nuclear pharmacy activities.
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The individual
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The individual is similarly identified (i.e., as an AMP, ANP, or AU) on
- For ANPs, the individual is identified as an ANP by a commercial nuclear pharmacy licensee authorized to identify ANPs.
However, except for licensees possessing a Type A specific license of broad scope for medical use (issued under 10 CFR Part 33), the licensee is required by §35.14(a) to provide to the Commission within 30 days of the individual beginning work for the licensee as an AMP, ANP, or AU a copy of 1) the relevant board certification, the preceptor written attestation, and documentation of additional training, if specified; 2) the license; or 3) the permit. For individuals identified on a license or permit, the new licensee is also required by 10 CFR 35.14(a) to provide verification of completion of any added case experience or training requirements in 1) §35.390(b)(1)(ii)(G) for an AU under §35.300, 2) §35.690(c) for an AU under §35.600, and 3) §35.51(c) for an AMP.
Authorization for High Does-rate Remote Afterloading Brachytherapy Authorized Users and Authorized Medical Physicists
Personnel currently authorized for remote afterloader use on an existing license(s), both medical physicists and physicians, were previously authorized under §35.400 but, under the revised rule, this authorization changes to under §35.600. If an authorized individual is named on an existing license, does the licensee have to submit a license amendment request to the NRC for this change? [10 CFR 35.13] (Q&A ID 0103021)
A license amendment request is not required from the licensee. Under §35.13, a licensee does not need to apply for a license amendment before it permits an individual presently identified as an AMP or AU on an existing license to work. At the time of the next amendment or renewal of the license, the NRC will make the necessary changes to the license to clarify the device used and uses as described in the current rule.
Authorization for Manual Brachytherapy Seeds
Regarding sealed sources for manual brachytherapy, "seeds" do two different models, from two different manufacturers, have to be listed on an application for license or license amendment? [10 CFR 30.32(g), 32.210(c)] (Q&A ID 0303016)
Yes. Section 30.32(g) requires applicants to provide the manufacturer's name and model number for each sealed source requested for use or supply the information identified in §32.210(c).
Authorized Medical Physicist on a License
For what uses under Part 35 must a licensee have an authorized medical physicist (AMP) named on the license? [10 CFR, 35.433, 35.610, 35.615, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645] (Q&A ID 0103033)
An AMP(s) must be named on licenses authorizing the medical uses of strontium-90 ophthalmic applicators, teletherapy units, photon-emitting remote after loader units, and gamma stereotactic radiosurgery units.
If a licensee is approved for Sr-90 eye applicators, must an AMP be listed on the license? [10 CFR 35.12, 35.400, 35.433] (Q&A ID 0802014)
Yes. § 35.433 requires that an AMP calculate the activity of each Sr-90 source used for brachytherapy. § 35.12 requires that applications for a license, an amendment, or a renewal include the training and experience qualifications of the AMP(s) to be involved in medical use of byproduct material as described in § 35.400.
For a sample license, see NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Appendix F.
Authorized Nuclear Pharmacist
Will I need to get a license amendment before letting someone work as an ANP? [10 CFR 35.13, 35.14, 35.15, 35.55, 35.59] (Q&A ID 0301021)
Yes, except when one of the following three conditions applies: (1) The individual meets the board certification criteria and recentness of training requirements; (2) The individual is identified as an ANP on (a) a Commission or Agreement State medical use license or nuclear pharmacy license, (b) a permit issued by a Commission or Agreement State licensee of broad scope including medical use or nuclear pharmacy activities, or (c) a permit issued by a Commission master material licensee authorized for medical use or nuclear pharmacy activities; or (3) The individual is identified as an ANP by a commercial nuclear pharmacy authorized to identify ANPs.
However, like for the AU or AMP, except for licensees possessing a Type A specific license of broad scope for medical use (issued under 10 CFR Part 33), the licensee must provide to the Commission a copy of the relevant board certification and the written attestation(s) signed by a preceptor, license, or permit within 30 days of the individual beginning work for the licensee as an ANP. Note that, except for the written attestation(s) for board-certified ANPs, a requirement added in 2005, this is not a change from the rule in effect prior to the 2002 revision.
Can an authorized nuclear pharmacist (ANP) identified on a license become the radiation safety officer (RSO) for that license? [10 CFR 35.13(c), 35.24(b), 35.50(c)(2),(d) and (e), 35.55] (Q&A ID 0301020)
Yes. However, the ANP, like the AU or authorized medical physicist (AMP), must have 1) experience with the radiation safety aspects of similar types of byproduct material for which the individual would have RSO responsibilities, 2) training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval, and 3) a preceptor RSO written attestation for this training that: (a) the individual is an ANP identified on the licensee's license; (b) the ANP has satisfactorily completed the training in (2); and (c) the AU has achieved a level of radiation safety knowledge sufficient to function independently as an RSO for a medical use licensee. Additionally, the ANP must agree, in writing, to be responsible for implementing the radiation protection program.
Further, the licensee must apply to NRC for an amendment, as required under 10 CFR 35.13(c), and submit the ANP's training and experience qualifications to serve as RSO.
Authorized User as Radiation Safety Officer -- Qualifications
When can an AU be appointed as the RSO for a medical-use license? [10 CFR 35.13(c), 35.24(b), 35.50] (Q&A ID 0802009)
An AU can be appointed as the RSO for a license if the AU (1) is identified as an AU in the license, (2) has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual will have RSO responsibilities, (3) has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval, (4) has obtained written attestation, signed by a preceptor RSO, that: (a) the individual is an AU identified on the licensee's license; (b) the AU has satisfactorily completed the training in (3); and (c) the AU has achieved a level of radiation safety knowledge sufficient to function independently as an RSO for a medical use licensee. Additionally, the AU must agree, in writing to be responsible for implementing the radiation protection program.
Note that a license amendment is needed before the individual can begin work as the RSO for the license. See 10 CFR 35.13(c).
Authorized User Work Experience and Clinical Experience for Multiple Therapeutic Devices
Can a physician be granted authorized user status for multiple therapeutic units (teletherapy units and/or remote afterloader units and/or gamma stereotactic radiosurgery units) based on completion of a single structured educational program? [10 CFR 35.13, 35.690] (Q&A ID 0301003)
Yes, if the program covers the requirements in 10 CFR 35.690, .
Beta-Emitting Remote Afterloaders
Does the new 10 CFR 35.600 apply to beta-emitting remote afterloaders in addition to addressing photon-emitting afterloader units? [10 CFR 35.600, 35.1000] (Q&A ID 0301004)
No. Use of beta-emitting afterloader devices must be addressed under 10 CFR 35.690, “Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.”
Calibration for Brachytherapy Sources, Timing of
Must brachytherapy sources that were calibrated before October 24, 2002, the effective date of the Final Rule, be calibrated again before first medical use on or after October 24, 2002? [10 CFR 35.432(a)] (Q&A ID 0802032)
Not necessarily. Under § 35.432(a), brachytherapy sources must be calibrated in a specific manner before first medical use on or after October 24, 2002. If the pre-October 24, 2002 calibration was done in accordance with § 35.432(a) requirements, recalibration of the sources before first medical use on or after October 24, 2002, is not required. Note that the required calibration measurements include determining source positioning accuracy within applicators.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.432, as published in the Federal Register on April 24, 2002.
Calibration Measurements for Intravascular Brachytherapy Sources
According to the intravascular brachytherapy (IVB) licensing guidance, IVB source output/activity must be checked by the licensee using a dosimetry system described in 10 CFR 35.630.
a) Why does this measurement have to be done using dosimetry equipment having the same requirements as for measurements of high dose-rate remote afterloader sources?
b) Why can't the licensee rely on the source output/activity as measured by the manufacturer, as is permitted for manual brachytherapy sources? [10 CFR 35.2, 35.12(d), 35.432, 35.630, 35.633, 35.1000] (Q&A ID 0802050)
a) The measurement requirement in the IVB licensing guidance reflects the high dose rates from sources used in IVB. These dose rates exceed the threshold for classifying remote afterloader brachytherapy devices as high dose-rate type. NRC believes that for such high dose-rate sources, use of the dosimetry equipment described in § 35.630 is warranted, to ensure that the correct dose is administered to patients.
b) Use of manufacturer-supplied measurements is only permitted for low dose-rate remote afterloader units and for sources used for manual brachytherapy, when such measurements are made in accordance with the requirements in § 35.432 (for manual use sources) or § 35.633 (for low dose-rate remote afterloader units). As noted above, the dose rates from IVB sources exceed the limit for classification as low-dose rate sources.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.432 and § 35.630, as published in the Federal Register on April 24, 2002.
Calibration Measurements of Batched Brachytherapy Sources
If a licensee receives a "batch" of manual brachytherapy sources (e.g., iodine-125 seeds), does the licensee have to determine source output or activity of each brachytherapy source before the first medical use or can the licensee take a representative sample from the batch of seeds and use that output/activity for all of the seeds in the batch? [10 CFR 35.432] (Q&A ID 0301018)
The NRC does not preclude a sampling of short half-life sources when received in a large batch. The rule requires that the calibration be performed using published protocols accepted by nationally recognized bodies, such as the American Association of Physicists in Medicine (AAPM). Such protocols require calibration of varying percentages of samples of seeds, depending on whether the seeds are loose or in ribbons. If applicable, the licensee must ensure that the published protocol allows for sampling of sources that have not been previously calibrated.
To fulfill the calibration requirement, the licensee can also use calibration measurements provided by the source manufacturer or by a calibration laboratory accredited by AAPM, as long as the measurements are done in accordance with a published protocol accepted by a nationally recognized body and using appropriately calibrated equipment. However, NRC believes that it is good practice to verify the calibration provided by the manufacturer. Reference "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.432, as published in the Federal Register on April 24, 2002.
Calibration Measurements of Brachytherapy Sources
Provide guidance for the historic quality of calibrations for older brachytherapy sources to meet the new requirements in § 35.432. [10 CFR 35.432, 35.630(a)] (Q&A ID 0802042)
Under § 35.432(a), brachytherapy sources require calibration in a specific manner before first medical use on or after October 24, 2002. Pre-October 24, 2002 calibrations performed by the licensee, or others,* would have to have been done in accordance with all of the requirements in § 35.432(a) in order to be acceptable for source usage on or after October 24, 2002, the effective date of the Final Rule. Note that the required calibration measurements include determining source positioning accuracy within applicators.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.432 and § 35.630, as published in the Federal Register on April 24, 2002.
*A licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine as long as the measurements were made in accordance with § 35.432(a).
What explicitly is required for licensee calibration measurements of sources to be used for manual brachytherapy? [10 CFR 35.432, 35.630(a)] (Q&A ID 0802022)
The requirements for licensees doing calibration measurements of brachytherapy sources are contained in 10 CFR 35.432, “Calibration measurements of brachytherapy sources.” The licensee doing such measurements must (1) determine the source output or activity using a dosimetry system that meets the requirements of § 35.630(a) and (2) use a published protocol that is currently accepted by a nationally recognized body.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.432, as published in the Federal Register on April 24, 2002.
Do licensees have to independently verify the output or activity of their brachytherapy sources (Cs-137, Ir-192, I-125, Pd-103) to make sure the information supplied by the manufacturers of these sources is correct? If so, do licensees have to verify each individual brachytherapy source or is an assay of, say, 10% good enough?[10 CFR 35.432, 35.630(a)] (Q&A ID 0802001)
For the first medical use of a brachytherapy source on or after October 24, 2002, licensees are not required to independently verify (determine) the source output or activity provided that the licensee is using measurements of source output or activity provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine and that the measurements were obtained using a published protocol currently accepted by a nationally recognized body.
With respect to the question regarding statistical sampling, see Q&A ID 0301018.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.432, as published in the Federal Register on April 24, 2002.
I-125 implant seeds come to us from another licensee. We do not have the capability to assay these seeds before use, as described in § 35.432. Is this a violation? [10 CFR 35.432, 35.630(a)] (Q&A ID 0802013)
Generally, if you, as an NRC licensee, use these seeds without assaying them, it would be a violation. As written, the requirement is that each licensee must calibrate its brachytherapy sources before the first medical use at the licensee's facility unless the output or activity information used by the licensee was supplied by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM) and the measurements were made using a dosimetry system that meets the requirements of § 35.630(a) and following a published protocol currently accepted by nationally recognized bodies. Accordingly, calibrations of the seeds that are supplied to or done by the other licensee will not satisfy this requirement.
However, if the seeds were delivered to you from the other licensee as an unopened identified transshipment from the manufacturer or from an AAPM-accredited calibration laboratory who also supplied the activity information, this would be considered to be the same as if the seeds were directly shipped to you. A similar situation would exist if the seeds, as well as the corresponding measurements made by the supplying manufacturer or AAPM-accredited calibration laboratory, were shipped by a supplying licensee who, pursuant to authorization under its license, had established and implemented quality assurance procedures, geared to ensure that seeds supplied to it, with the corresponding measurements were directly transmitted to you.
In either of these cases, measurements made by the manufacturer or by the AAPM-accredited calibration laboratory in accordance with § 35.432(a) and provided to you could be used to satisfy the requirement.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.432, as published in the Federal Register on April 24, 2002.
Can a licensee use a dose calibrator to meet the intent of §35.630 (Dosimetry equipment) to achieve compliance with §35.432 (Calibration measurements of brachytherapy sources)? [10 CFR 35.432, 35.630(a)] (Q&A ID 1202011)
Yes, as long as the various calibration conditions for the equipment specified in §35.630(a) are met.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.432, as published in the Federal Register on April 24, 2002.
Calibration Measurements of Manual Brachytherapy Sources
Who is to perform required calibrations of sources used for manual brachytherapy? [10 CFR 35.432] (Q&A ID 0103015)
10 CFR 35.432, “Calibration measurements of brachytherapy sources,” allows for these measurements to be provided by the source manufacturer or an American Association of Physicists in Medicine-accredited calibration laboratory, or to be performed by the licensee. The licensee is responsible for ensuring that the calibration requirements of §35.432 are met, regardless of who performs the measurements. For licensees who perform their own source calibrations, the rule does not specify a particular staff position among the licensee's staff who is to perform the calibrations.
Calibration of "Dose Calibrators"
If a manufacturer's instructions for calibrating an instrument state that the person carrying out the calibration "should" do something, but not "shall" do something, what is the regulatory requirement? [10 CFR 35.60] (Q&A ID 0902012)
10 CFR 35.60, “Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material,” permits calibration of instrumentation used to measure the activity of unsealed byproduct material to be done in accordance with the manufacturer's instructions (or in accordance with nationally recognized standards). If a step or procedure in the manufacturer's instructions for calibration is not identified as required, but is specified as optional, the licensee need not perform the step or procedure in order to have carried out a calibration meeting the requirement of § 35.60.
Under the revised rule, can I continue to calibrate dose calibrators following NRC's Regulatory Guide (RG) 10.8? [10 CFR 35.60] (Q&A ID 0103025)
No. Under 10 CFR 35.60, licensees must perform the required calibrations in accordance with nationally recognized standards or the manufacturer's instructions. RG 10.8 is not a nationally recognized standard or a manufacturer's instruction and may not be used. (Note also that RG 10.8 has been superseded by NUREG-1556, Vol. 9, “Program-Specific Guidance About Medical Use Licenses,.”)
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.60, as published in the Federal Register on April 24, 2002.
To be in compliance with the 2002 requirements, does a licensee have to recalibrate a dose calibrator that was in use prior to October 24, 2002? [10 CFR 35.60] (Q&A ID 0303015)
Not necessarily. If the dose calibrator was calibrated in compliance with the NRC requirements that were in effect prior to October 24, 2002,* and the licensee has continued to perform calibrations at the frequency specified in the prior rule, the requirements of the present §35.60, "Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material," would be satisfied, since the prior requirements aligned with ANSI N42.13-1986 (R1993), a current national consensus standard. Section 35.60 requires calibrations to be in accordance with nationally recognized standards or the manufacturer's instructions.
*10 CFR 35.50, "Possession, use, calibration, and check of dose calibrators."
Do dose calibrators used for purposes other than patient dosage assay need to be calibrated? [10 CFR 35.432, 35.630] (Q&A ID 1202032)
Yes - If used for other measurements required under Part 35, such as source activity measurements of manual brachytherapy sources. In this case, the dose calibrator would need to meet the requirements in §35.630(a).
No - If used for measurements not required under Part 35, such as verifying the activity of licensed material used for diagnostic imaging equipment calibration, and not required under other NRC regulations, then calibration of the dose calibrator is not required.
Calibration of Instruments for Measuring Activity
For an instrument used to measure the activity of unsealed byproduct material, does the absence of manufacturer's instructions for calibration mean that calibration is not required? [10 CFR 35.60] (Q&A ID 1202026)
No. Section 35.60 requires calibration of such instrumentation in accordance with either the manufacturer's instructions or nationally recognized standards. Therefore, if the manufacturer did not provide calibration instructions, the licensee must calibrate the instrument in accordance with nationally recognized standards.
For calibration, using the manufacturer's instructions, of an instrument for measuring activity of unsealed byproduct material, do the instructions have to be written? Can they be oral? Do they need to be "official"? [10 CFR 21.3, 21.21, 35.60] (Q&A ID 0802011)
Instrument calibration instructions received from a manufacturer do not have to be written; they can be transmitted orally. Regardless of whether the instructions are received in writing or orally, they can be considered "official" if they are received from an individual who is representing the manufacturer.
However, for assurance that instructions that are received orally are correctly interpreted and followed, particularly for future calibrations, the licensee should promptly commit the instructions to writing, to establish a "procedure," and ask the manufacturer that supplied the instructions to review the "procedure" for correctness.
Note that a prudent manufacturer would document its verbal instructions in writing (via procedure or via documentation of phone call). Also note that the manufacturer has reporting responsibilities under 10 CFR 21.21 if inadequate or incorrect instrument calibration procedures are supplied and later require modification or revision to eliminate a substantial safety hazard, as defined in § 21.3.
Calibration of Therapy Units
With respect to the requirements for performing calibrations on therapy units (e.g., 10 CFR 35.632, etc.), the regulation states that the calibrations must be performed by an authorized medical physicist (AMP). In practice, the actual work is often performed under the supervision of the AMP. Will this continue to be an acceptable practice? [10 CFR 35.51, 35.632(f), 35.633(h), 35.635(f)] (Q&A ID 1002005)
No. In fact, the former Part 35 regulations required that full calibrations (and physical decay corrections) for teletherapy units be performed by an authorized medical (teletherapy) physicist. The requirement for full calibrations and physical decay corrections of teletherapy, remote afterloader, and gamma stereotactic radiosurgery units to be performed by an AMP is clearly stated in § 35.632(f), §35.633(h), and §35.635(f), respectively.
This requirement does not preclude an AMP from providing training and experience in therapy unit calibration to a medical physicist in training, under § 35.51, as long as the AMP is physically present during and directly involved in all required calibrations of such units.
Calibration, Transmission, and Reference Sources
Is bundling or aggregating of single calibration, transmission, or reference sealed sources authorized by 10 CFR 35.65 allowed under regulation?
Sometimes. Bundling or aggregating of single sealed sources is allowed when the combined source activity is not greater than the activities authorized by 10 CFR 35.65. Bundling or aggregating of single sealed sources is not allowed when the combined source activity is greater than the activities authorized by 10 CFR 35.65, and in this case, the source needs to be specifically listed on the license.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Does NRC define bundling?
Although bundling is not defined in 10 CFR 35.2, "Definitions," in 10 CFR 35.65(b)(2) "combined to create" an activity is described as being the same as "bundled or aggregated." Examples of bundled sources are those transmission sources used in PET scanners that are each less than the limits of individual sources in 10 CFR 35.65, but only used together as an aggregated group. NRC does not consider individual sources placed together for storage to be bundled.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
May a licensee use calibration, transmission, or reference sources to aid in performance of patient imaging and localization procedures if the sources otherwise meet the requirements of 10 CFR 35.65?
Yes. Some licensees may not recognize that use of calibration, transmission, or reference sources during imaging procedures meets the definition of medical use if this results in radiation exposure to the patient.10 CFR 35.65(b)(1) recognizes that medical use of calibration, transmission, and reference sources must be performed in accordance with the requirements in 10 CFR 35.500, "Use of Sealed Sources and Devices for Medical Diagnosis," and a physician authorized for 10 CFR 35.200 medical uses is authorized by 10 CFR 35.590(b) to use these sources under § 35.500.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
If a licensee uses calibration, transmission, or reference sources in patient imaging and localization procedures when the sources otherwise meet the requirements of 10 CFR 35.65, do these sources need to be specifically listed on the license?
No. Calibration, transmission, or reference sources that are used for medical use in accordance with the requirements of 10 CFR 35.500, and are not bundled to result in an activity greater than that specified in 10 CFR 35.65, do not have to be listed on the license.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Change of Mailing Address
Is a license amendment request required for a change of [mailing] address? [10 CFR 35.13(f), 35.14(b)(2)] (Q&A ID 0103039a)
No. The licensee can use the notification process in §35.14 for a change in the licensee's mailing address. However, a licensee must apply for and receive an amendment before it changes the address(es) of use identified in the application or on the license.
Change of Licensee Name
Is a license amendment request required for a change in the company name? [10 CFR 30.34(b), 35.14(b)(3)] (Q&A ID 0103039b)
The licensee can use the notification process in §35.14 for a simple name change as long as the name change does not constitute a transfer of control of the license as described in 10 CFR 30.34(b). However, a licensee must apply for and receive a license amendment if the name change constitutes a transfer of control of the license.
Clarification on the Definition of "Annual"
What is the policy on "annual?" For example, when is an action late? (±25%, calendar year?) [10 CFR 35.61, 35.310, 35.410, 35.610, 36.2] (Q&A ID 1202005)
Use of the word "annual," as it appears in Part 35 is usually associated with the frequency with which a function must be performed. For example, §35.310 requires licensees to provide radiation safety instruction annually. While there is no definition of "annual" in Part 35, NRC staff looks to other Parts of 10 CFR in order to implement the requirements of Part 35. The staff uses the definition of "annual" as it appears in §36.2. The definition of "annual" in §36.2 is: 1) at intervals not to exceed 1 year or 2) once per year, at about the same time each year, plus or minus one (calendar) month.
Classification and Uses of Sources and Devices
What FDA category are Novoste and any other beta-emitting intravascular brachytherapy (IVB) devices with cranks (remote or manual) under? Should the Sealed Source and Device (SS&D) Registry make a distinction?
[10 CFR 35.400, 35.500, 35.600, 35.1000] (Q&A ID 0103022)
FDA uses very broad classification categories, such as medical device, pharmaceutical, or biologic. Thus, under FDA's classification system, all sources and devices used to perform brachytherapy procedures would be classified as medical devices. Since October 24, 2002, all SS&D certificates classify sources and devices into §35.400, 35.500, 35.600, and 35.1000 uses. A supplement to the SS&D Registry does the same for Agreement State-generated certificates issued before October 24, 2002. All beta-emitting IVB sources are currently classified under §35.1000.
Decay-In-Storage for Radioactive Wastes
Do the decay-in-storage provisions of §35.92 apply to radioactive wastes from in-vitro or animal use of byproduct material that the medical licensee may conduct? [10 CFR 20.2001, 31.11, 33.11, 35.92] (Q&A ID 0303004)
No. In-vitro or animal uses of byproduct material are regulated under 10 CFR Parts 31 and 33, and not under Part 35.
Part 20, Subpart K, provides general requirements for various waste disposal methods, including decay-in-storage. When appropriate for authorized non-medical uses, the license will be amended to include a standard condition to address the decay-in-storage disposal process requirements, under Part 20, for these uses.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.92, as published in the Federal Register on April 24, 2002.
Definition for "Misadministration"
Is a definition for "misadministration" missing from the Final Rule? [10 CFR 35.2, 35.3045(a)] (Q&A ID 0802003)
No. The term "misadministration" does not appear in the Final Rule and, therefore, no definition is needed. The term "medical event" does appear and is defined.
For discussion of replacement of "misadministration" by "medical event" in the Final Rule, refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.3045, as published in the Federal Register on April 24, 2002.
Delegation of Supervisory Responsibilities
Can the authorized user (AU) delegate supervisory responsibilities to a chief technician who supervises others in specific tasks associated with using or preparing byproduct material? [10 CFR 35.27] (Q&A ID 0103043)
Only AUs and authorized nuclear pharmacists (ANPs) are authorized to use or prepare, respectively, byproduct material in the practice of medicine. However, it is frequently necessary for an AU or ANP to delegate specific tasks associated with the use or preparation of byproduct material in the practice of medicine to other individuals. Section 35.27 allows for this delegation of tasks as long as the individuals are properly supervised and instructed. The AUs and ANPs are best suited for determining tasks that supervised individuals can perform and the degree of supervision that each individual needs.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.27, as published in the Federal Register on April 24, 2002.
Difference Between "Address of Use" and "Areas of Use"
For license amendment requests, what is the difference between "address of use identified in the application or on the license" [§35.13(f)] and "areas [locations] of use identified in the application or on the license" [§35.13(e)]? [10 CFR 35.2, 35.12, 35.13] (Q&A ID 1202029)
As defined in 10 CFR 35.2, the "address of use" is the building or buildings, identified on the license, at which byproduct material may be received, prepared, used, or stored. "Areas of use" means a portion of an address of use that has been designated for the purpose of receiving, preparing, using, or storing byproduct material. For example, if radioactive material is to be used at 123 Main Street in Rooms 2A, 7A, and 12A, the "address of use" is 123 Main Street, while the "areas of use" are Rooms 2A, 7A, and 12A. The "address of use" would be indicated on the facility diagram accompanying the application.
Dosage Determination
Do the determination of dosages provisions of §35.63 apply only to dosages to be used for therapeutic purposes? [10 CFR35.63] (Q&A ID 0303005)
No. The provisions of §35.63 apply to both diagnostic and therapeutic applications of unsealed byproduct material for medical use.
Dosage Determinations of Unsealed Byproduct Material for Medical Use Using Volumetric Measurement Techniques
When a unit dosage is manipulated in any way, it stops being considered a unit dosage. If I modify the volume of a unit dosage under the direction of an Authorized User and do not have a dose calibrator, can I use volumetric data/decay correction as an assay method? [10 CFR 35.63] (Q&A ID 1202045)
Yes, provided that the requirements of §35.63(c)(3) are met. In addition, you should confirm that your modification of the volume will not adversely impact the homogeneous distribution of the byproduct material throughout the volume dosage. For example, volume variation procedures that induce either plating out or precipitation of the byproduct material(s) would be disallowed.
Dose; Embryo/Fetus
Assume that a dose received by an embryo/fetus for a medical use was not specifically approved in advance by the AU. Should the licensee treat the whole embryo/fetus as one organ and assess its dose equivalent (DE) or evaluate the DE for the maximally exposed organ or tissue of the embryo/fetus, to determine if the 50 mSv (5 rem) threshold for reporting and notification is exceeded? [10 CFR 20.1003, 35.3047] (Q&A ID 0301009a)
The licensee should evaluate the DE for the maximally exposed organ or tissue of the embryo/fetus, in determining if the 50 mSv (5 rem) threshold for reporting and notifications is exceeded. [This position is based on the definition of DE in Part 20, which applies to DEs specified in Part 35.] Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.3047, as published in the Federal Register on April 24, 2002.
In the example above, assume that a dose equivalent of 50 mSv (5 rem) to the embryo/fetus was approved by the authorized user before the dose was administered to a pregnant patient. Assume that after administration, the dose equivalent for the embryo/fetus was determined to be greater than 50 mSv (5 rem) Would this dose to the embryo/fetus require that the licensee report the event to NRC and make the notifications specified in 10 CFR 35.3047? [10 CFR 35.3047] (Q&A ID 0301009b)
No. This would not be a reportable event because the AU made the assessment of the embryo/fetus dose equivalent and approved it, in advance of administering the dose to the pregnant patient. Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.3047, as published in the Federal Register on April 24, 2002.
(The discussion of this issue in the Supplementary Information emphasizes that only unintended exposures must be reported to the NRC. The Supplementary Information is written in terms of a licensee not needing to report a dose if the AU specifically approved, in advance, the "administration" of the resultant dose to the embryo/fetus, not in terms of whether the AU approved the magnitude of the resultant dose. As stated in the Supplementary Information, commenters noted that "the lack of adequate data makes it virtually impossible to accurately calculate radiation doses to an embryo/fetus at various gestational periods from radiopharmaceuticals." The accuracy of a dose assessment changes, and improves, post-administration, when uptake/localization information is available, compared to a pre-administration dose assessment, when these parameters for dose computation must be estimated. A modified embryo/fetus dose estimate post-administration is typical, rather than the exception.)
Dose Limit of Nursing Infants/Children
Does the Part 20 public dose limit apply to infants/children being breast-fed by patients receiving NRC-licensed radioactive material for medical purposes? [10 CFR 20.1003, 20.1301(c), 35.75(a)] (Q&A ID 0802006)
No. Public dose does not include dose received from exposure to individuals administered radioactive material and released under § 35.75.
A licensee may authorize the release from its control of any individual who has been administered radioactive material for medical purposes if the total effective dose equivalent (TEDE) to any other individual, including infants/children being breast-fed, from exposure to the released individual is not likely to exceed 0.5 rem. Additionally, if the TEDE could exceed 0.1 rem assuming there were no interruption of breast-feeding, the licensee must provide instructions to the patient in accordance with 10 CFR 35.75.
In the case of a breast-feeding mother not released from the licensee's control, the authorized user must determine, in advance of visits, that it is appropriate for visitors to receive in excess of 0.1 rem. Each visitor, including a nursing infant/child, shall not receive a radiation dose exceeding 0.5 rem.
Where can I find guidance for licensees regarding patients to whom unsealed byproduct material is administered and who are breast-feeding infants or children? [10 CFR 35.75] (Q&A ID 0802004)
The “Advisory Committee on Medical Uses of Isotopes (ACMUI) Sub-Committee on Nursing Mother Guidelines for the Medical Administration of Radioactive Materials,” issued on January 31, 2019, provides guidance on breastfeeding patients to licensees.
The printable brochure, “What You Should Know About Treatment With Radioactive Drugs,” issued in May 2019, was created to inform patients about radiation safety precautions (including breastfeeding instructions) that they need to follow before, during, and after treatment with radioactive drugs. The brochure is intended to foster a radiation-safety oriented dialogue between patients and their health care team.
Dose Limit—Patient Intervention
Two brachytherapy patients are sharing the same room (which is allowed under the revised Part 35). One patient removes the source(s), exposing other persons. What dose limits apply? [10 CFR 20.1301, 20.2203(a), 35.415(a), 30.3045(b)] (Q&A ID 1202013)
For this occurrence, the dose limit for all non-occupationally exposed persons, except the other brachytherapy patient sharing the room, is 100 mrem (1 mSv) in a year (the dose limit for members of the public), per §20.1301*, and if exceeded, is reportable under §20.2203(a). For either patient, the event, which resulted from intervention of a patient, is reportable as a medical event, per §35.3045, if the dose received from the removed source(s) results or will result in permanent functional damage to an organ or a physiological system of either patient, as determined by a physician.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.315, 35.415, and 35.3045, as published in the Federal Register on April 24, 2002.
*Visitors to either of the brachytherapy patients may be permitted to receive radiation doses up to 500 mrem (5 mSv) in a year from exposure to the patient being visited if deemed appropriate, prior to the visit or visits, by the authorized user involved in the patient's treatment(s).
Dose Limit for Visitors to Hospitalized Therapy Patients
Has there been any change to the dose limit for members of the public who visit hospitalized individuals that cannot be released under §35.75? [10 CFR 20.1301(c), 35.75] (Q&A ID 1202023)
Yes. While the dose limit for routine visitations remains at the dose limit for individual members of the public in §20.1301 of 100 mrem (1 mSv) per year, a licensee may permit visitors to an individual that cannot be released under §35.75 to receive up to 500 mrem (5 mSv) in a year if the authorized user involved in the patient's treatment(s) has determined before the visit(s) that the increased dose limit is appropriate.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §20.1301, as published in the Federal Register on April 24, 2002.
a) Does §20.1301(c) allow a visitor to receive 500 mrem each time he or she visits a hospitalized therapy patient?
b) Does the 500 mrem apply per patient visited or 500 mrem per individual who visits the patient? [10 CFR 20.1301(c)] (Q&A ID 0802031)
a) No. The pre-authorized elevated limit of 500 mrem applies to the total dose accumulated by the visitor through visits (one or more) to a particular individual who cannot be released under § 35.75. The 500 mrem is the annual dose limit, with pre-authorization, for an individual member of the public from the licensed operations of a single medical use licensee.
b) The pre-authorized elevated limit of 500 mrem applies to the total dose accumulated by a visitor through visits (one or more) to a particular individual who cannot be released under § 35.75. If pre-authorized by the authorized user for the individual who cannot be released under § 35.75, multiple visitors to the individual could receive up to 500 mrem each through visits (one or more) to the individual.
Refer to "Supplementary Information," Section II, "Petitions for Rulemaking (PRM)" and Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 20.1301(c), as published in the Federal Register on April 24, 2002.
Does 10 CFR 20.1301(c) allow a visitor who is a minor to receive up to 500 mrem when visiting a hospitalized therapy patient? [10 CFR 20.1301(c)] (Q&A ID 0902001)
Yes. Any person, including a minor, who is permitted by the medical facility/licensee to visit the therapy patient can be allowed by the licensee to receive up to 500 mrem through such visitation, as long as the authorized user has determined before the visit that a dose not exceeding 500 mrem is appropriate.
a) Must a licensee train members of the public who may receive up to 500 mrem from exposure to individuals administered radioactive material and released under § 35.75?
b) Must a licensee train members of the public who may receive up to 500 mrem from exposure to individuals administered radioactive material and not released under § 35.75? [10 CFR 19.12(a), 20.1301(a), 20.1301(c), 35.75(a)] (Q&A ID 0802007)
a) No. There is no regulatory requirement for the provision of training to members of the public receiving such exposure. Note that even though the dose to a person may exceed the Part 20 public dose limit (100 mrem in a year) through such exposure, public dose does not include dose received from exposure to individuals administered radioactive material and released under § 35.75. Also note that while there is a requirement in Part 19 for instruction of workers who may receive greater than 100 mrem occupational dose in a year, for this exposure, the limit does not apply, as occupational dose does not include dose received from exposure to individuals administered radioactive material and released under § 35.75.
b) No. NRC believes that licensees should have flexibility in determining how they will effectively limit radiation exposure of the visitors to levels that are as low as is reasonably achievable. Refer to "Supplementary Information," Section II, "Petitions for Rulemaking (PRM)" for PRM-20-24, as published in the Federal Register on April 24, 2002.
a) Will an inspector review a licensee's documentation associated with an authorized user (AU) under the license determining that a visitor (or visitors) to a hospitalized radiation therapy patient can receive up to 500 mrem during visitation? [10 CFR 20.1301(c), 35.75] (Q&A ID 0802024)
b) Can an AU issue a blanket order for visitors to patients who are held under § 35.75 to be permitted to receive up to 500 mrem through visitation? [10 CFR 20.1301(c), 35.75] (Q&A ID 0802029)
a) Not necessarily. As part of an inspector possibly verifying that visitor control is adequate to ensure compliance with the regulations for doses to members of the public, including visitors under 20.1301(c), the inspector may review a limited number of licensee records and interview AUs to verify that AUs did determine the appropriateness of the 500 mrem dose limit for some or all visitors to particular patients before visitations began.
Yes. Nothing in Part 20 or in Part 35 precludes the AU from determining that the higher dose limit for visitors should apply for all radiation therapy patients for which he or she has or will have AU responsibilities. Such a determination would be reflecting a determination by the AU, based on judgment, considering their condition, that all of the AU's radiation therapy patients would benefit from allowing visitors to these patients to receive doses up to 500 mrem.
b) Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 20.1301(c), as published in the Federal Register on April 24, 2002.
Effective Date for the Revised Rule
When did the revised rule become effective?
The July 16, 2018 Final Rule, "Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments," (83 FR 33046) and associated guidance were effective on January 14, 2019.
The July 14, 2009 Final Rule, "Medical Use of Byproduct Material—Authorized User Clarification" (72 FR 33901) was effective September 28, 2009.
The effective date of the Final Rule, "Requirements for Expanded Definition of Byproduct Material (NARM)," (72 FR 55864) issued on October 1, 2007 was 60 days after publication in the Federal Register on November 30, 2007.
The Final Rule, Medical Use or Byproduct Material – Recognition of Specialty Boards, (70 FR 16336) issued on March 30, 2005 was effective on April 29, 2005.
The Final Rule, "10 CFR Parts 20, 32, and 35; Medical Use of Byproduct Material," (67 FR 20249) issued on April 24, 2002 became effective on October 24, 2002.
Emergency Response Equipment for Brachytherapy
What is the definition of "emergency response equipment" under 10 CFR 35.415? [10 CFR 35.415(b)] (Q&A ID 1002006)
Emergency response equipment is equipment to respond to a source (1) dislodged from the patient or (2) lodged within the patient following removal of the source applicators and may include shielded storage containers, remote handling tools and, as appropriate, supplies necessary to remove applicators or sources from the patient. The licensee has the flexibility to determine the type of emergency response equipment needed. Responders should also have ready access to an appropriate survey instrument, which is often needed for locating dislodged sources and/or for assessing doses to people from dislodged sources.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.415, as published in the Federal Register on April 24, 2002. Also see NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Section 8.9.5, “Other Equipment and Facilities.”
Exemptions for Type A Broad Scope Licensees
Are Type A broad scope licensees exempt from the requirement to submit an amendment request to use § 35.1000 material, even if they do not have an appropriate possession limit? [10 CFR 35.12(d), 35.15(a), 35.1000] (Q&A ID 0902009)
No. The Type A broad scope license must authorize the material, form, and amount required for conduct of the § 35.1000 medical use. If it does not, an amendment request must be submitted by the licensee and approved by the NRC before the use can begin.
See NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Section 1.2.2, "Specific License of Broad Scope."
Facility Diagram Submission to NRC
Are licensees required to submit updated diagrams to the NRC when changes to or additions of areas of use under §35.100 and/or §35.200 occur? [10 CFR 35.12(b), 35.14(b), 35.100, 35.200] (Q&A ID 1202012)
Section 35.12(b)(1) requires that a licensee, in its original application, submit a facility diagram. Section 35.14(b)(4) requires a licensee to notify the NRC by letter no later than 30 days after changes to or additions to areas of use under §35.100 and/or §35.200 are made.
If the change/addition of areas of use does not result in a change in the diagram originally submitted under 35.12(b)(1), then the licensee does not need to submit another diagram. However, if the change/addition of areas of use does result in a change in the diagram originally submitted under 35.12(b)(1), then the licensee should submit an updated diagram.
Gamma Knife Neurosurgeons as Authorized Users
Do neurosurgeons who are named on the license for gamma stereotactic radiosurgery (gamma knife) qualify as authorized users (AUs) with regard to the 10 CFR 35.615 requirement for an AU to be physically present throughout the entire patient treatment involving the unit? [10 CFR 35.2, 35.615(f), 35.690] (Q&A ID 0802021)
No. A neurosurgeon named on the license for gamma stereotactic radiosurgery (gamma knife) does not qualify as an authorized user and cannot meet the physical presence requirement of an AU unless that neurosurgeon meets the definition of an AU in 10 CFR 35.2 or the T&E requirements in 10 CFR 35.690. Note that with the 2002 addition of 10 CFR 35.615 to the regulations an authorized medical physicist is also required to be physically present during all gamma stereotactic radiosurgery patient treatments.
Note that an earlier license condition requiring a neurosurgeon to be physically present was superseded in the 2002 revision of 10 CFR Part 35 by the provisions of 10 CFR 35.615(f)(3), and neurosurgeons are no longer listed on the license.
Generator Breakthrough
Why is NRC requiring an increased frequency under section 10 CFR 35.204 for Mo-99 breakthrough tests?
Prior to 2002, licensees' data showed few breakthroughs and those that did occur were identified on measurement of the Mo-99 concentration in the first eluate. For this reason, the 2002 revision of Part 35 removed the requirement to measure the Mo-99 concentration in each eluate. However, in 2006, medical use licensees reported that numerous generators had shown no Mo-99 breakthrough in the first eluate, but failed the Mo-99 breakthrough tests performed on subsequent eluates. NRC now believes that it is important to measure the Mo-99 concentration in each eluate to ensure patients are not administered amounts of Mo-99 in excess of regulatory limits.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Who needs to report breakthrough values in excess of regulatory limits for Mo 99/Tc 99m and Sr-82/Rb-82 generators? Who do they have to report to?
Under 10 CFR 35.3204, a licensee that elutes the generator has to report the results to the NRC and the distributor. This could be a commercial nuclear pharmacy or a medical use licensee who elutes their own generators.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
How long do licensees that elute generators have to notify the NRC when an eluate from a generator exceeds the permissible concentration listed in 10 CFR 35.204(a)?
Under 10 CFR 35.3204, licensees eluting generators must make a telephone notification to the NRC Operations Center and the distributor within 7 calendar days after discovering that an eluate exceeded the permissible concentration listed in 10 CFR 35.204(a). The licensee must also submit a written report to the NRC within 30 days of this discovery.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
What reports are made to NRC by the licensee who eluted the generator when an eluate exceeds the permissible concentrations listed in 10 CFR 35.204(a)?
The licensee eluting the generator must report generator and elution information, whether dosages were administered, and when the distributor was notified. If patient dosages were administered, a dose assessment must be performed and the methodology of the dose assessment described. If an error occurred in the licensee's breakthrough determination, the report must include action taken by the licensee, probable cause, evaluations and assessments of failure in the licensee's equipment, procedures, or training that contributed to the excessive readings.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Can mobile medical service providers transport and use radioisotope generators? [10 CFR 35.80] (Q&A ID 1002008)
Yes, if the authorization to possess and use generators is listed in the license issued to the mobile medical service.
See NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Section 8.10.17, "Mobile Medical Service," and Appendix V, "Guidance for Mobile Medical Services."
"Grandfathering" Experienced Individuals
Will an experienced RSO, teletherapy or medical physicist, ANP, or AU need to comply with the training requirements in the current 2005 Part 35? [10 CFR 35.57, 35.59] (Q&A ID 0301022)
No. If the individual was listed on a license or permit on April 29, 2005, the individual is a "grandfathered" individual provided he/she performs only those medical activities for which he or she was authorized before the effective date of the "Medical Use of Byproduct Material - Specialty Boards; Final Rule, April 29, 2005".
Under §35.57, would a presently-authorized medical physicist (AMP) or authorized user (AU) be grandfathered for all modalities in §35.600, even if the individual was only authorized for one or two of these modalities on the implementation date of the new rule? [10 CFR 35.57] (Q&A ID 0103020)
No. There would be no change in what the individual is authorized to do. For example, an individual currently recognized as a "teletherapy physicist" would be recognized as an AMP for teletherapy units under the revised Part 35. The same criteria would apply in determining if AUs have "deemed status" under the revised rule. They would continue to be recognized as AUs for the type(s) of use of byproduct material for which they had approval under the previous rule. An AMP or AU cannot be authorized for a type of use for which training and experience is inadequate or not documented.
Refer to "Supplementary Information," Section III, "Summary of Public Comments", Part II, "General Issues," Subpart E.2., "Training and Experience - Unsealed Byproduct Material," as published in the Federal Register on April 24, 2002.
Guide for Diagnostic Nuclear Medicine
Is the 2002 Guide for Diagnostic Nuclear Medicine still endorsed by the NRC?
On November 27, 2002, the NRC issued NRC Regulatory Issue Summary 2002-23, "Availability of Guide for Diagnostic Nuclear Medicine." Through this generic communication, the NRC made the 2002 Guide for Diagnostic Nuclear Medicine available to the public through the NRC website. The guide was published by the American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM). This guide provided information that could have been useful to nuclear medicine professionals in understanding the applicability of NRC requirements to the medical use of byproduct material in diagnostic settings. It provided measures that practitioners could have used to facilitate implementation of the 2002 revision of 10 CFR Part 35. Subsequently, NRC revised 10 CFR Part 35 multiple times and the 2002 ACNP/SNM guide may no longer reflect current requirements. Although, SNM later expanded its guide to include therapeutic nuclear medicine in its publication titled, "Guide for Diagnostic Nuclear Medicine and Radiopharmaceutical Therapy," NRC has neither approved nor endorsed this new guide.
Human Research
Are requests to conduct human research treated as requests for a license amendment? [10 CFR 35.6] (Q&A ID 0103031a)
A licensee that intends to conduct research on human subjects must meet the requirements in §35.6(b) or receive a license amendment before conducting the research. As long as the conditions in §35.6(b) are met, it is not necessary for a medical licensee to apply for and receive an amendment to its NRC license prior to conducting research involving human subjects. A license amendment request is required if the licensee wishes to use a radionuclide or type of use that is not currently authorized on its license.
a) In the model license in NUREG-1556, Vol. 9, Rev 1 for a medical licensee of limited scope, licensees may use any byproduct material permitted by §35.100, 200, and 300. What byproduct materials are "permitted" for research use? [10 CFR 32.72, 32.74, 35.2, 35.6, 35.100, 35.200, 35.300] (Q&A ID 1202019a)
b) In §35.100, 200, and 300, it appears that "permitted" research is restricted in the regulations for these parts to research that either has approval from a Radioactive Drug Research Committee (RDRC) or is conducted under an Investigational New Drug (IND) protocol (for §35.300, only an IND). Is this correct? [10 CFR 32.72, 35.100, 35.200, 35.300] (Q&A ID 1202019b)
a) Section 35.2 defines "medical use" as the intentional internal or external administration of byproduct material or the radiation from byproduct material to patients or human research subjects under the supervision of an authorized user. Accordingly, each licensee authorized for medical use is authorized for medical research as long as the requirements of §35.6, "Provisions for the protection of human research subjects" are met.
Any byproduct material that meets §32.72 requirements for administration to humans or is contained in a sealed source meeting §32.74 regulatory requirements for application of radiation from such sources to humans can be used, by a licensee authorized for medical use, for research involving human subjects.
Other research not involving administration to humans, must be specifically requested and authorized on the license.
b) No. The authorizations in §35.100, 200, and 300 do not restrict research to RDRC-approved or IND protocols. Licensees conducting medical research in humans are not limited to use of byproduct materials prepared for use in research in accordance with a RDRC-approved application or an IND protocol accepted by the U.S. Food and Drug Administration (FDA). These authorizations permit licensees to use materials that are not obtained from a §32.72 licensee (radioactive drug manufacturer or commercial nuclear pharmacy) or prepared by the properly trained authorized user, as long as the radioactive drug was prepared in accordance with an RDRC-approved or IND protocol.
Byproduct materials obtained from manufacturers or preparers meeting the requirements listed in Sections 35.100(a) or (b), 35.200(a) or (b), and 35.300(a) or (b) may also be used for medical research in humans. For example, byproduct material obtained from a manufacturer licensed under §32.72 can be used in research.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.100, §35.200, and §35.300, as published in the Federal Register on April 24, 2002.
Identification of Sealed Sources in Application and Licenses
When must an applicant provide the manufacturer and model number for a sealed source as part of a license application? If this information has been provided for a source, and acquisition of a similar source from another manufacturer is contemplated, must an application for an amendment be submitted? Is it sufficient to merely indicate on an application that sources to be used will be registered in the Sealed Source and Device Registry (SSDR)? [10 CFR 30.32(g), 30.210(c)] (Q&A ID 1202028)
Under provisions of 10 CFR 30.32, “Application for specific licenses” subpart (g), an applicant for a specific license to use byproduct material in the form of a sealed source or in a device that contains a sealed source must either (1) identify the source or device by manufacturer and model number as registered with the Commission under 10 CFR 32.210, “Registration of product information,” or with an Agreement State; or (2) contain the information identified in §32.210(c). Thus, individuals contemplating use of sealed sources must apply for a license amendment and supply the manufacturer and model number. It is insufficient to indicate that a license is sought for use of sealed sources listed under the Sealed Source and Device Registry without providing this information.
Applicants should consider the potential for ordering similar sources from multiple vendors and request authorization to possess and use these sources, identifying the manufacturer(s) and model number(s). Following this procedure can help avoid situations where a licensee wishes to substitute a sealed source from an alternate supplier but does not have authorization under its license to possess and use a sealed source from an alternate manufacturer.
Instruction for Users of Teletherapy Units for Non-Medical Purposes
Is the instruction specified in 10 CFR 35.610(d) required for users of teletherapy units for non-medical purposes? [10 CFR 35.610(d), 36.51] (Q&A ID 1002009)
Yes, but only if the unit is licensed under Part 35 for medical use. If the unit is not used for medical purposes at all, including not being used for medical research involving human subjects, and is not licensed under Part 35, then 10 CFR 36.51 and conditions of the license addressing training requirements would apply instead, and the instruction specified in 10 CFR 35.610(d) would not be required.
Instructions for Written Directives for Tc-99m Users
Under §35.27, does a nuclear medicine technician who, under the supervision of an authorized user, only administers Tc-99m radiopharmaceuticals need instruction in the licensee's written directive procedures? [10 CFR 35.27, 35.40] (Q&A ID 0103044)
If the licensee is authorized for 10 CFR 35.300, “Use of unsealed byproduct material for which a written directive is required,” the licensee must have written directive procedures. Section 35.27, “Supervision,” subpart (a)(1) requires that the licensee instruct the supervised individual (the nuclear medicine technician) in their application. If, however, the licensee is not authorized for use requiring written directives, then the licensee need not have written directive procedures, and the licensee need not instruct the supervised individual in use of written directives.
Intravascular Brachytherapy Device Use Under § 35.1000
For intravascular brachytherapy (IVB) device use under § 35.1000 that does not have a tie-down condition in the license (referring to the application and other documents submitted to NRC), what keeps the licensee from changing the use without notifying the NRC? [10 CFR 30.52, 35.7, 35.12(d), 35.13(a), 35.1000, 35.4001] (Q&A ID 0802045)
Applications for possession and use of IVB devices, licensed under § 35.1000, must include information as described in § 35.12(b) through (d) that would then be tied-down to (referenced as a condition in) the issued license. Thus, licenses for IVB use always have tie down conditions that include the purpose(s) for which use of the licensed material is authorized. Because IVB is regulated under § 35.1000 in the Final Rule, conditions in a license for IVB usage issued under the provisions of the version of Part 35 in effect until October 24, 2002, the effective date of the Final Rule, remain in effect following implementation of the Final Rule. Reference § 35.1000(b).
If a licensee did institute a change in usage of an IVB device regulated under § 35.1000 from that described in its NRC application, without notification of and approval from NRC, that action would be subject to inspection and enforcement under § 30.52 and § 35.4001, respectively, with citation for violation of § 35.13(a).
Medical use of an IVB device under § 35.1000 also requires investigator (authorized user) compliance with an active FDA-accepted Investigational Device Exemption (IDE) application. This requirement, too, prohibits changes in usage without notification of and approval from the relevant regulatory authority (FDA). This relates to licensee compliance with § 35.7, "FDA, other Federal, and State requirements."
Iodine-131 Authorizations for Experienced Authorized Users
If an authorized user (AU) is presently authorized for use of §35.100 materials, I-131, and §35.200 materials, will that individual have to apply for a license amendment to update to the 2002 requirements for use of I-131? [10 CFR 35.392 ,35.394] (Q&A ID 0303010)
No. An AU who was authorized on a license to use I-131 prior to the effective date for the revised rule, October 24, 2002, may continue to perform those medical uses for which he or she was authorized. During the next revision of the license (amendment or renewal), the regional license reviewer will determine whether the authorization for the use of I-131 issued prior to October 24, 2002 required a written directive and if so, whether the AU administered less than or greater than 33 millicuries at a time. The license will be updated accordingly, to reflect the revised requirements.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for Part II E, "Training and Experience," as published in the Federal Register on April 24, 2002.
Leak Test
Under the Final Rule, applicants for medical licenses no longer submit procedures for leak testing sealed sources. Will this licensing approach eventually be used for other types of material licensees, and will it be reflected in the NUREG-1556 series? [10 CFR 35.12] (Q&A ID 0802039)
Keeping risk in mind, the requirements for a license under Part 35 do not necessarily reflect guidance that applies to sealed sources used in other applications (e.g., industrial gauges, irradiators [Part 36], radiography [Part 34], well-logging [Part 39], etc.). This licensing approach for Part 35 is an example of performance-based regulation. Volumes in the NUREG-1556 series are reviewed periodically for, in part, establishment or maintenance of consistency, as appropriate.
The Sealed Source and Device (SSD) Registry requires leak testing for iridium-192 seeds. For seeds of iridium-192 encased in nylon ribbon, what takes precedence: the regulations in Part 35 that exempt them from leak testing when encased in nylon ribbon or the SSD Registry that requires leak testing? [10 CFR 35.67(f)] (Q&A ID 0301017)
Leak testing is not required for iridium-192 seeds encased in nylon ribbon. However, § 35.67 requires iridium-192 seeds not encased in nylon ribbon and containing more than 3.7 MBq (100 uCi) to be leak tested.
Are leak tests required for alpha foil sources? [10 CFR 35.2, 35.67] (Q&A ID 0902004)
Leak testing requirements for most sealed sources and plated sources are documented in the Sealed Source and Device Registry for the source. The Registry indicates whether the source needs to be leak tested and indicates the required leak test frequency. In addition, 10 CFR 35.67(f)(3) states that "sources containing 0.37 MBq (10 uCi) or less of alpha-emitting material" need not be leak tested.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.67 as published in the Federal Register on April 24, 2002.
License Conditions versus Regulatory Requirements
If a license condition requires a licensee to use syringe shields, what happens under the revised Part 35? Will the licensee be required to keep the most restrictive requirement (still use syringe shields) or not? [10 CFR 20.1101, 35.10] (Q&A ID 1202006)
Under 10 CFR 35.10(e), when license conditions and the regulations of revised Part 35 differ, Part 35 regulations govern. However, §35.10(d) also provides that, if a license condition exempted a licensee from a provision of Part 35, the license condition continues to exempt the licensee from that requirement. Further, §35.10(f) mandates that a licensee must continue to comply with any license conditions requiring it to implement procedures required by §35.610, 642, 643, and 645 until there is a license amendment or renewal modifying these conditions.
Moreover, licensees are still obligated to comply with 10 CFR Part 20, including compliance with occupational dose limits. The use of syringe shields may help the licensee maintain occupational doses within the limits of Part 20.
In addition, when used to the extent practical, syringe shields will help achieve occupational doses that are as low as is reasonably achievable (ALARA) as required by §20.1101.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.10, as published in the Federal Register on April 24, 2002.
Loss of Control of Material; Departure of Patient Non-Releasable Under §35.75
a) If a non-releasable patient under §35.75 leaves on his or her own accord, would this be considered loss of control of material? [10 CFR 20.1002, 20.1802, 20.2202, 35.2, 35.75, 35.3045] (Q&A ID 1202001a)
b) If a non-releasable patient under §35.75 leaves on his or her own accord, would this be considered patient intervention? [10 CFR 20.1002, 20.1802, 20.2202, 35.2, 35.75, 35.3045] (Q&A ID 1202001b)
a) It depends. Under §20.1802, a licensee must control licensed material. Under §20.2202, a licensee must notify the NRC of events involving loss of control of licensed material that threaten to cause specified conditions. Under §20.1002, the dose limits in Part 20 do not apply to doses from individuals administered radioactive material and released under §35.75. However, if a patient not released under §35.75 leaves the facility on his or her own accord, then Part 20 applies and the licensee may be required to report the release under §20.2202.
The NRC recognizes that patients cannot be held against their will. The NRC would not penalize a licensee for the activities of a patient, if a patient were to leave "against medical advice."
However, the licensee has a responsibility to keep doses to members of the public from patients below 500 millirem (5 mSv) and should try every means available to have a patient that cannot be released under §35.75 remain hospitalized. When it is clear before treatment that a patient does not intend to be hospitalized, the licensee should consider the consequences and alternative treatments or actions.
Refer to Section III, "Public Comments on the Proposed Rule" for 10 CFR Part 20 and 35, as published in the Federal Register on January 29, 1997 (Vol. 62, No. 19, pp. 4120-4133).
b) Leaving the hospital while containing unsealed byproduct material or with radioactive sources securely in place is not considered patient intervention. The term "patient intervention" is defined in §35.2 as an action by a patient or human research subject such as dislodging or removing treatment devices or permanently terminating the administration, and refers to an exception to when an event must be reported as a medical event under §35.3045.
Master Material License
Is it necessary to define "master material license" (MML) in 10 CFR Part 35? (Note that the definition of MML appears in NUREG-1556, Vol. 10, "Consolidated Guidance About Material Licenses: Program-Specific Guidance About Master Material Licenses.") [10 CFR 35.2] (Q&A ID 0902002)
No. Even though the term appears in the rule (e.g., in § 35.14), the term is not specific to medical use of byproduct material.
Facilities of master material licensees (e.g., the Department of Veterans Affairs) are sometimes required to make certain name changes. Are license amendment requests required? [10 CFR 30.31, 35.13, 35.14] (Q&A ID 0103042)
Master material licensees (MMLs) are issued pursuant to 10 CFR Part 30. Only the MML medical use permittees are licensed pursuant to 10 CFR Part 35. If an MML medical use permittee has a simple name change, then the permittee may use the notification process in §35.14. However, if the name change results from a transfer of control of the license, the permit will need to be amended by the MML permit issuing authority.
Management
Will the NRC provide more guidance for the definition of "management" in the regulations? [10 CFR 35.2, 35.12, 35.24, 35.26] (Q&A ID 0103028)
No. Section 35.2 defines "management" as the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates. In addition, the responsibilities and duties of management are included in certain other regulations in Part 35; e.g., 35.12, 35.24 and 35.26.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.3, as published in the Federal Register on April 24, 2002.
To what extent can management responsibilities be delegated? [10 CFR 35.24, 35.26] (Q&A ID 0103032)
Licensee management has the ultimate responsibility for the radiation protection program. Management can delegate tasks or duties, but not the responsibility, to a management delegate. Therefore, management must approve, in writing, requests for a license application, renewal, or amendment before submittal to the Commission; any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist or authorized medical physicist; and radiation protection program changes that do not require a license amendment and are permitted under §35.26.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.24, as published in the Federal Register on April 24, 2002.
Medical Event and Patient Intervention
a) How does a licensee determine if an event is a "medical event" (which is reportable to NRC) or an event involving patient intervention (which is not reportable to NRC)?
b) What threshold is used to make that determination? [10 CFR 35.2, 35.3045] (Q&A ID 0902003)
a) "Patient intervention" is defined in § 35.2 as "actions by the patient or human research subject, whether intentional or unintentional..." and examples are provided in the definition, for guidance as to when patient intervention has occurred. Section 10 CFR 35.3045(b), “Report and notification of a medical event,” indicates when the consequences of patient intervention are serious enough for the event to be reported as a "medical event."
b) Per § 35.3045(b), if intervention of a patient or human research subject in the administration of byproduct material or radiation from byproduct material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician, the event is reportable to NRC as a "medical event." Even though the threshold for reporting medical events is high, licensees are expected to continue to act reasonably, in accordance with prevailing standards of care, to prevent medical events caused by intervention of patients or human research subjects.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" and Section V, "Summary of Changes Made Between the Current Part 35 and the Revised Part 35" for 10 CFR 35.3045, as published in the Federal Register on April 24, 2002.
Do medical events only apply to uses of byproduct material that require a written directive? [10 CFR 35.2, 35.3045(a)] (Q&A ID 0802030)
No. "Medical event" means an event that meets the criteria in § 35.3045(a). However, because these reporting criteria include dose-based thresholds, it is unlikely that a medical event would be associated with a medical use that does not require a written directive.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.3045, as published in the Federal Register on April 24, 2002.
Medical Event Reporting
Do administrations that do not require a written directive but meet the medical event criteria still need to be reported to the NRC?
Yes, criteria for reporting and notification of a medical event in 10 CFR 35.3045 do not require that the administration be one that requires a written directive. Although it is unlikely that a medical event would be associated with a medical use that does not require a written directive, they do happen. For example, diagnostic procedures, which do not require WDs, may meet the ME reporting criteria and are reportable to the NRC. The ME reporting criteria requires that a licensee shall report any medical event, except for one that results from patient intervention.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
What are the main changes to the medical event reporting requirements in 10 CFR 35.3045, "Report and Notification of a Medical Event," for permanent implant brachytherapy use?
The main changes are:
- Addition of a separate section for permanent implant brachytherapy medical events.
- A criterion involving total source strength administered differing by 20% or more from the total source strength documented in the post-implantation written directive. There is no longer a threshold dose criterion.
- A criterion for the difference between the total source strength implanted outside the treatment site exceeding 20 percent of the total source strength documented in the post-implant portion of the written directive.
- Including a dose threshold for the leaking sealed source criterion.
- Addition of a criterion for sealed source(s) implanted directly into a location discontinguous from the treatment site, as defined in the post-implatation portion of the written directive.
- Addition of a criterion for administration of the wrong radionuclide.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Are there any changes to the medical event reporting criteria for brachytherapy other than permanent implant brachytherapy?
Yes. Implantation of sealed sources containing the wrong radionuclide is now a medical event reporting criterion under 10 CFR 35.3045(a)(1)(ii)(A).
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
10 CFR 35.3045(a)(2)(iii)(C) lists the medical event criteria for permanent implant brachytherapy for administrations involving sealed sources implanted into a location "discontiguous" from the treatment site as documented in the post-implantation portion of the written directive. What does "discontiguous" mean?
Discontiguous in general terms is used to describe things that are not contiguous in space, things that are not adjacent or touching, and things that have a gap in between or are disconnected or separate. As it relates to the medical event criteria for permanent implant brachytherapy, discontiguous means a location that is not physically adjacent to or touching the treatment site.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Suppose that during a prostate implantation procedure several sealed sources are deposited into the adjacent urinary bladder, instead of into tissue comprising the intended treatment site. Also, suppose that the incorrect placement of those sources is promptly identified and the sources are removed before the implantation procedure is completed and all the other sources were implanted in the treatment site defined in the written directive. Does this occurrence require reporting as a medical event?
No, if the sources were removed before the post-implantation portion of the written directive was completed, and if the total activity in the treatment site in the post implant written directive include only those seeds implanted in the treatment site, this does not comprise a medical event.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Assume that during a permanent implant brachytherapy procedure one or more sources are directly deposited into tissue in a location near but discontiguous from the treatment site described in the post-implant written directive. Has a reportable medical event occurred?
Yes, this occurrence is a reportable medical event under the provisions of 10 CFR 35.3045(a)(2)(iii)(C), as a source was directly delivered to location discontiguous from the treatment site as documented in the post-implant written directive.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Assume that during a permanent implant brachytherapy procedure one or more sources are directly deposited into a far location discontiguous from the treatment site. Also, assume that the total source strength administered outside of the treatment site did not exceed 20% of the total source strength documented in the post implantation portion of the written directive. Has a reportable medical event occurred?
Yes, this occurrence is a reportable medical event under the provisions of 10 CFR 35.3045(a)(2)(iii)(C), as a source was directly implanted into a location discontiguous from the the treatment site, as defined in the post implant written directive. Although the total strength administered outside of the treatment site was less than 20% of the total source strength, this is an example of a case of where a medical event would have occurred because one source met the discontiguous or wrong treatment site criterion for a medical event.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Assume that during a permanent implant brachytherapy procedure one or more sources are directly deposited into contiguous tissue outside of the treatment site described in the post-implant written directive. Also assume that the total source strength administered differs by less than 20 percent from the total source strength documented in the post-implantation written directive, and that the total source strength administered outside of the treatment site differs by less than 20 percent from the total source strength documented in the post-implantation written directive. Has a reportable medical event occurred?
No, this occurrence is not a reportable medical event. Implantation of sources into tissue outside but contiguous with the treatment site described in the post implant written directive is not considered under the medical event provision of 10 CFR 35.3045(a)(2)(iii)(C) as "directly delivered to the discontiguous from the treatment site," nor has any other criteria under 10 CFR 35.3045(a)(2) been met.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
The medical event reporting criterion for the treatment site in permanent implant brachytherapy, 10 CFR 35.4035(a)(2)(i), does not include significant deviations of actual source placement within the treatment site volume relative to the intended source placement within the treatment site volume, which may impact the intended absorbed dose to the treatment site. For example, a physician authorized user prescribes a number of sources to be positioned in the treatment site volume at various intended positions to achieve the intended treatment site volume absorbed dose to treat cancer. During placement of the sources, 100 percent of the prescribed number of sources are positioned in the treatment site volume; however, most of the sources are placed in a small area within the treatment site volume such that the positions of most of the sources differ significantly from the intended positions to achieve the intended absorbed dose. As a result, a portion of the treatment site that is a distance away from the area containing most of the implanted sources receives significantly less absorbed dose than intended. Do these deviations in source positioning constitute a medical event?
No. The NRC does not consider the details of source placement within the treatment site to be a medical event. In SECY-12-0053, Recommendations on Regulatory Changes for Permanent Implant Brachytherapy Programs, NRC staff concluded that it is not necessary for an authorized user to affirm, in writing on the written directive after the implant is completed, that the distribution of the sources within the treatment site was as intended per the pre-implantation written directive. The Commission approved the staff"s recommendations in SRM SECY-12-0053.
10 CFR 35.40(b)(6)(i) does not require the authorized user to enter intended source placement within the treatment site into the pre-implantation portion of the written directive and 10 CFR 35.40(b)(6)(ii) does not require the authorized user to enter deviations from intended source placement into the post-implantation portion of the written directive.
If the actual positioning of implanted sources would not result in satisfactory absorbed doses to sections of the treatment site, it is expected that, as part of medical practice, the authorized user will take the actions that he or she deems are appropriate. This may include consideration of the need for additional treatment.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
During a manual brachytherapy implant treatment procedure, sources were implanted correctly into the treatment site, but later migrated to a location outside of the treatment site. Would this be considered a medical event?
No, this would not be considered a medical event. The migration of sources that were implanted into the correct site is not considered a medical event. The reporting and notification requirement for permanent implant brachytherapy in 10 CFR 35.3045(a)(2) provides that treatments sources that were implanted in the correct site, but migrated outside the treatment site, do not constitute medical events.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
As part of calculating the total source strength for a permanent implant brachytherapy procedure, is the licensee required to check their calculations and assay a portion of the seeds to ensure the total source strength is as ordered?
No, it is only a medical event if the total source strength administered differs from the total source strength documented in the post-implant written directive. While not required, it is encouraged that the licensee check its calculations and assay a portion of their seeds as these may identify an error in source strength or total source strength. A licensee may choose to adopt these practices as part their program to provide high confidence that the administration was in accordance with post implant written directive.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Mobile Medical Units and Unit Dose Radiopharmaceuticals
Does a mobile medical unit have to use a dose calibrator if using only unit doses? [10 CFR 35.63, 35.80] (Q&A ID 0902015)
No. For use of unit dosages, § 35.63 provides for determination of activity of each dosage by means other than direct measurement. Additionally, § 35.80 does not require a mobile medical service to determine the activity of each dosage by direct measurement.
Molybdenum Break-Through Test Requirements for Nuclear Pharmacies
Do nuclear pharmacies need to comply with the molybdenum break-through tests requirements under §35.204? [10 CFR 30.34(g), 35.204(b)] (Q&A ID 1202002)
Yes, 10 CFR 30.34(g) requires each licensee preparing unsealed byproduct material for medical use from Tc-99m/Mo-99 generators to test the generator eluants for molybdenum break-through in accordance with §35.204.
Multiple Medical Use Licenses
Our facility has separate licenses for nuclear medicine and brachytherapy, teletherapy, and gamma knife. Under the revised Part 35, can these licenses be combined into one? [10 CFR 35.12(b)] (Q&A ID 0301005)
Yes. Current licensees can request consolidation of existing separate medical use licenses. Reference "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.12, as published in the Federal Register on April 24, 2002. Also, note that a single, qualified RSO must be designated for the consolidated license.
"Name of Individual" in Record-Keeping Requirements
In the Part 35 record requirements, what does "name of the individual" mean? [10 CFR 35.2070] (Q&A ID 1202016)
"Name of Individual" means the entire name of the individual, NOT the individual's initials.
Refer to Supplementary Information, Section V, 'Summary of Changes Made Between the Current Part 35 and the Revised Part 35' for 10 CFR 35.2070, as published in the Federal Register on April 24, 2002.
National Institute of Standards and Technology and National Bureau of Standards
Is the National Institute of Standards and Technology (NIST) the same organization as the National Bureau of Standards (NBS)? [10 CFR 35.630] (Q&A ID 0103016)
Yes. NBS was renamed to NIST in 1988. Up-to-date standards designated as "NBS" standards are thus accepted as "NIST" standards.
Non-Commercial Transfer of Sealed Sources and Devices
Under §35.49(b), can NRC medical use licensees use sealed sources or devices non-commercially transferred from an Agreement State licensee? [10 CFR 35.49(b)] (Q&A ID 0103041)
No. The current regulation does not specifically include non-commercial transfers from Agreement State licensees. Presently, an NRC medical use licensee may only use sealed sources or devices obtained through non-commercial transfers if the transfers are from other NRC medical use licensees.
Non-commercial transfers from Agreement State medical use licensees may be requested by NRC medical use licensees, as exemptions for license amendments.
Non-Routine Diagnostic Procedures
If a physician, not supervised by an authorized user (AU), requests a non-routine diagnostic study, does the licensee have to develop a written procedure for the study? [10 CFR 35.27] (Q&A ID 0303001)
Although the licensee does not have to develop a written procedure for the study, medical use has to be under the supervision of an authorized user (AU).
If the request is non-routine and not already included in the directions of an AU, either the AU has to administer the dosage or instruct the supervised individual in its administration.
Notifications/Amendments
Are the notification requirements under 10 CFR 35.14 treated as requests for amendment of the license? [10 CFR 35.13, 35.14] (Q&A ID 0103031b)
If the licensee follows the requirements in 10 CFR 35.14, “Notifications,” and the requested information is appropriate and complete, the action is not an amendment request; the changes noted will be incorporated into the license during the next licensing action (amendment or renewal). However, if the NRC's license reviewer determines that the information provided does not meet the requirements in §35.14, the licensee will be notified that an amendment request is needed.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.14, as published in the Federal Register on April 24, 2002.
NRC Involvement When a Nuclear Pharmacy Distributes Unsealed Byproduct Material for Medical Use That Is Inconsistent with Prescriptions
What would the NRC's action be if a nuclear pharmacy distributed a "bad" batch of unsealed byproduct material for medical use to a licensee and did not notify the licensee of the problem?* An example might be mixing up the entire batches of Tc-99m with differing activities. [10 CFR 32.72, 35.3045] (Q&A ID 1202007)
In a situation when a nuclear pharmacy has distributed unsealed byproduct material to a medical use licensee that is not consistent with a prescription, the NRC would only become involved with the medical licensee if the administration of the "bad" unsealed byproduct material resulted in a medical event. In this scenario, the NRC would follow up with the licensee involved in the medical event and the nuclear pharmacy (if it was also an NRC licensee). The NRC would work in cooperation with the State radiation control agency if the nuclear pharmacy was located in an Agreement State.
In accordance with §32.72(a)(4)(i), nuclear pharmacies are required to label the transport shield of a radioactive drug for commercial distribution with, among other things, the name of the radioactive drug and the quantity of the radioactivity at a specified date and time.
Distributing a "bad" batch of Tc-99m, meaning having an incorrect activity at a specified date and time listed on the label, is in violation of NRC regulations. In this case, the licensee receiving that "bad" batch is not required to notify the NRC, although it may wish to discuss this issue with the nuclear pharmacy.
*There is no NRC requirement to report this occurrence to the licensee.
NRC Notifications Review
Will the NRC be reviewing the appropriateness of notifications received from licensees for moving the locations of use, within previously-specified addresses of use, for stress studies, other diagnostic studies, and waste storage? [10 CFR 35.13, 35.14] (Q&A ID 0103029)
Yes. NRC will review notifications to ensure the information received meets the requirements of 10 CFR 35.14, “Notifications,” and that license amendments are not necessary. If the information is incomplete, additional information will be requested. If NRC staff determines that the requirements for notification are not met, submission of an application for a license amendment may be necessary.
NRC Review of Disposal Procedures
Do procedures have to be reviewed by NRC for Part 35 licensees who perform alternative types of disposal under §20.2002? (a) Incineration (b) Sewer (c) Other [10 CFR 20.2002, 20.2003, 20.2005] (Q&A ID 1202004)
(a) Incineration - (1) No, review is not required for licensed materials listed in §20.2005 (certain quantities of H-3 & C-14 in liquid scintillation medium and animal carcasses). (2) Yes, review is required for all other licensed materials, since licensees need approval pursuant to §20.2002, which requires that an applicant submit proposed procedures.
(b) Sewer - In general, review is not required for sewer disposal of medical waste generated, including excreta from individuals undergoing medical diagnosis or therapy with licensed material, under §20.2003(b). However, the licensee must ensure that all conditions in §20.2003 are satisfied.
(c) Yes, see (a)(2) above.
Ophthalmic Physicist
Why is an ophthalmic physicist added to the regulations?
At about the time of the 2002 major revision to 10 CFR Part 35, there were a large number of medical events that were caused by fundamental errors in calculating doses for strontium-90 eye applicators, and the licensees did not have individuals that could identify these problems. Therefore, the requirement to have an authorized medical physicist (AMP) was added to the 2002 rule. After implementation of the 2002 rule, the NRC determined that there were a number of small ophthalmic therapy licensees in rural or isolated areas that had difficulty finding a local AMP. Therefore, the ophthalmic physicist has been added to identify another individual that could perform the medical physics tasks associated with ensuring that ophthalmic therapies are administered in accordance with written directives.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Why is NRC requiring the ophthalmic physicist to have training in creating, modifying and completing written directives and procedures for administrations requiring a written directive? Isn't this usually part of AU training?
This training is required, in addition to the basic medical physics training and experience, to ensure the ophthalmic physicist can assist the AU in developing, implementing and maintaining written procedures that provide high confidence that the therapeutic administrations are in accordance with the physician's direction and to help the licensee identify issues that could lead to medical events.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Will it be acceptable to NRC if an authorized medical physicist (AMP) develops an activity vs. time (decay) chart or table for a Sr-90 ophthalmic applicator that the licensee can use to determine patient treatment times? (This scenario would apply when the licensee does not have a full-time AMP on staff and relies on an AMP consultant.) [10 CFR 35.12, 35.400, 35.432, 35.433] (Q&A ID 0902005)
No. Section 35.433 requires that only an AMP calculate the activity of each Sr-90 source used for brachytherapy, with the decay based on the activity determined under § 35.432. The involvement of the AMP, whether a full-time associate or a consultant, is to include performing a periodic verification that the corrected activity is being applied correctly. The Supplementary Information clarifies that, given the risks associated with the use of strontium-90 and numerous misadministrations in this area, more prescriptive requirements are warranted to ensure that the activities of strontium-90 sources are correctly determined and applied.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments," and Section V, "Summary of Changes Made Between the Current Part 35 and the Revised Part 35," for 10 CFR 35.433, as published in the Federal Register on April 24, 2002.
Past Shortages of Molybdenum-99/Technetium-99m
How did the NRC handle past shortages of molybdenum-99?
In December 2007, the industry experienced intermittent shortages of molybdenum-99 (Mo-99) resulting from unplanned reactor outages. These outages were significant because the world's supply of medical Mo-99 was impacted. Mo-99 is required to produce Mo-99/technetium-99m (Tc-99m) generators for medical uses. During the Mo-99 shortages in the United States, the NRC issued an exemption to certain provisions of 10 CFR Parts 32 and 35 for medical use licensees on July 16, 2009.
Patient treatment with radioactive iodine
Why is the NRC issuing RIS 2011-01?
The NRC is issuing Regulatory Issues Summary (RIS) 2011-01, “NRC Policy on Release of Iodine-131 Therapy Patients Under 10 CFR 35.75 to Locations other than Private Residences,” to inform its licensees and others of NRC's guidelines for the release of iodine-131 therapy patients to locations other than private residences.
Does the NRC believe that the current regulations in 10 CFR 35.75 are protective of public health and safety?
The NRC believes that radiation exposure to other individuals from released patients can be safely controlled by the current 10 CFR 35.75 patient release criteria, patient dose calculations, and by the adherence to patient release instructions. The NRC believes that the current patient release criteria appropriately balances public safety with patient access to medical treatment.
Do NRC regulations prohibit the release of I-131 radioactive patients to hotels or motels?
Although 10 CFR 35.75 does not expressly prohibit the release from the hospital of a patient who has been administered radioactive iodine to a location other than a private residence, the NRC strongly discourages this practice because it can result in radiation exposures to members of the public for which the licensee may not be able to fully assess compliance with NRC requirements, and may result in doses which are not as low as reasonably achievable.
Is NRC concerned that hospitals and insurance companies deny hospitalization for patients who do not wish to go home immediately after treatment, saying the NRC doesn't allow it? [10 CFR 35.75(a)] (Q&A ID 0308002)
The rule does not preclude hospitalization of these patients. The licensee has a responsibility to keep doses to members of the public from patients below 5 millisieverts (mSv) (500 millirem [mrem]). The authorized physician has the primary responsibility for the health and safety of his/her patients and, therefore, is the appropriate individual to make the determination as to whether the patient should be released, considering the patient's condition and the unique living situation of the patient and evaluating, on a case-by-case basis, the ability of a patient to comply with the dose limit of 5 mSv (500 mrem) to others. NRC Regulatory Guide 8.39, Revision 1, “Release of Patients Administered Radioactive Material,” Section C.1, “Release Criteria,” provides additional information.
The NRC does not have regulatory jurisdiction over the practices and policies of insurance companies. However, NRC does encourage continued communication between regulatory bodies and insurance companies to clarify this issue.
Does NRC require medical licensees to give patients information about their radioactivity following treatment? [10 CFR 35.75(b)] (Q&A ID 0308003)
Yes. 10 CFR 35.37(b) requires licensees to provide instructions, including written instructions, to the patient or the patient's family, to keep exposure to other individuals as low as possible, if the projected radiation dose to another individual from exposure to the released patient could exceed a specified value, 1 millisievert (mSv) (100 millirem [mrem]). NRC Regulatory Guide 8.39, Revision 1, “Release of Patients Administered Radioactive Material,” Section C.2, “Instructions,” provides guidance on the content of the instructions.
The NRC staff developed a printable brochure to inform patients about radiation safety precautions that they need to follow before, during, and after treatment with radioactive drugs. The brochure is intended to foster a radiation-safety oriented dialogue between patients and their health care team. [NOTE: This tri-fold brochure is formatted to print double-sided].
Does NRC make any effort to verify if medical licensees are giving patients proper information/education about what dangers they may or may not pose to others, and what precautions they should take? [10 CFR 35.75(b)] (Q&A ID 0308004)
Yes. Licensees are routinely inspected, and our inspectors, through interviews and observations and reviews of licensees' procedures, verify that licensees are providing relevant information to the patients or their guardians. A special study in 2006-2007 focused on this issue and confirmed generally adequate practices by licensees; the results were published in The Journal of Nuclear Medicine, Vol. 48, No. 12, December, 2007.
Under what conditions would NRC regulations require hospitalization for radioactive iodine-131 patients? [10 CFR 35.75(a), 35.2075(a)] (Q&A ID 0308005)
Under current regulations, the authorized user (physician) makes an assessment of the individual patient, including anticipated living conditions, and determines whether the patient needs hospitalization or can be treated as an outpatient. The determination is based on projected radiation doses to other individuals. If the dose to another individual may exceed the 5 millisievert (500 millirem) regulatory limit, the patient cannot be released, i.e., treated as an outpatient, and must be hospitalized.
NRC regulations require licensees to keep a record of the basis for release of patients if the total effective dose equivalent is calculated by certain specified methods which are outside of the NRC's conservative default model procedures specified in NUREG-1556, Vol.9, Rev. 2, Appendix U, "Model Procedure for Release of Patients or Human Research Subjects Administered Radioactive Materials."
How fast does radioiodine clear from the body after administration? (Q&A ID 0308006)
The usual radioiodine used for patient therapeutic treatments is iodine-131 (I-131). The physical half-life of I-131, i.e., the time it takes to decay to half of its initial strength (or activity) is 8 days. However, when I-131 is administered to a patient, the amount of radioactivity in the patient also decreases due to biological elimination from the body, as well as by physical decay, so its effective half-life in the body is less than 8 days. While the effective half-life for I-131 in patients varies among individuals, depending on their medical conditions, for most cancer patients, most of the I-131 administered is excreted by the body in the first 2 days after treatment.
Can a patient who has received radioiodine therapy actually "contaminate" someone else with radioactive iodine (e.g., through saliva or other bodily fluids, or bodily contact)? Or is there just an issue of external exposure of others to radiation from the patient, due to decay of the radioiodine within the patient? (Q&A ID 0308007)
Exposure to relatives, caregivers, and the public can occur in two ways: (1) external irradiation of persons in close proximity to the patient and (2) internal and external contamination of people who come into contact with the radioiodine excreted or exhaled by the patient. The patient's saliva, sweat, and other bodily fluids all contain some radioactivity. Most of the activity is excreted through the urine. However, by following simple instructions provided by the treating physician or his/her designee, the spread of contamination from the patient to other persons can be minimized.
NRC's current guidance to medical licensees on instructions for patients being released from licensee control following administration of unsealed byproduct material or implants containing byproduct material includes recommending that released patients minimize being in "public places" for a period of time following release. What is the basis for this guidance on instructions? [10 CFR 35.75(b)] (Q&A ID 0308008)
The overall objective of minimizing released patient presence in "public places" for a specified period of time is to keep both external and internal radiation doses to others as low as reasonably achievable, by avoiding contact by the released patient with other individuals, especially infants and young children. Examples of "public places," contained in the current guidance, include grocery stores, shopping centers, theaters, restaurants, sporting events, and public transportation vehicles. The guidance description of "public places" is not all-inclusive–portions of other places, such as schools and hotels, may also be considered to be accessible to the public, depending on the circumstances.
(See NUREG-1556, Vol. 9, Rev. 2, "Consolidated Guidance About Medical Use Licenses: Program-Specific Guidance About Medical Use Licenses," Appendix U, which is available at the NRC public web site.)
What information can a patient who has been treated with radioactive iodine and is to be released expect to receive about the control of radioactive contamination? [10 CFR 35.75(b)] (Q&A ID 0308009)
The instructions provided by the licensee on actions recommended to maintain doses to other individuals as low as is reasonably achievable should include measures to limit the transfer of radioactive contamination to others. Because such transfer can occur through direct contact with the released patient and also indirectly, through individuals' contact with contaminated objects and surfaces within the patient's living quarters or elsewhere, the instructions provided by the licensee should cover both pathways. Accordingly, the instructions should include limiting direct contact with others and measures to limit the contamination of objects and surfaces and the spread of contamination. The instructions should also take into account the environment to which the patient will be released.
Permanent Implant Brachytherapy
How were the revised written directive requirements and medical event reporting requirements for permanent implant brachytherapy developed?
The revised regulations are based on recommendations provided to the NRC in February 2012 by the Advisory Committee on the Medical Uses of Isotopes plus stakeholder input obtained during two stakeholder public workshops (June 2011 and August 2011) that focused on issues associated with medical event definitions for permanent implant brachytherapy. The staff's recommendations, based on this input and other stakeholder input, were approved by the Commission in SRM-SECY-12-0053, "Recommendations on Regulatory Changes for Permanent Implant Brachytherapy Programs," issued August 2012. The revised regulations are also based on comments received from the public on the proposed rule "Medical Use of Byproduct Material – Medical Event Definitions, Training and Experience, and Clarifying Amendments," (79 FR 42410) published in the Federal Register on July 21, 2014.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Physical Presence of AUs and AMPs During Byproduct Material Medical Use
Must an AU and/or AMP be physically present during procedures? [10 CFR 35.615 (f)(2), (3)] (Q&A ID 0301012)
Not in most cases. However, for high dose-rate remote afterloader units (HDRs), the AU and AMP must be physically present during the initiation of all patient treatments. In addition, the AMP and either the AU or a physician under the supervision of the AU and trained in the operation and emergency response for the unit must also be physically present during continuation of all patient treatments involving HDRs.
For gamma stereotactic radiosurgery units, the AU and AMP must be physically present throughout all patient treatments involving the units. "Physically present" means within hearing distance of normal voice. (Refer to "Supplementary Information," Section V, "Summary of Changes," for 10 CFR 35.615, as published in the Federal Register on April 24, 2002.)
For medium dose-rate and pulsed dose-rate remote afterloaders, the AMP and either the AU or a physician under the supervision of the AU and trained in emergency response for the unit must be physically present during the initiation of all patient treatments and be immediately available during continuation of all patient treatments. "Immediately available" means available on an on-call basis (at minimum, available by telephone). (Refer to "Supplementary Information," Section V, "Summary of Changes," for 10 CFR 35.615, as published in the Federal Register on April 24, 2002.)
When particular individuals are required to be "physically present" during various phases of several therapeutic medical uses, does NRC's meaning of "within hearing distance of normal voice" include through use of "walkie-talkies"? [10 CFR 35.615(f)] (Q&A ID 0802016)
No. Use of communication devices, including "walkie-talkies," would enable the identified individuals to be at a distance from the location of therapeutic medical use, and thus not "physically present" (i.e., "within hearing distance of normal voice"). However, use of communication devices, including "walkie-talkies," by identified individuals is permitted when the requirement is for the individual to be "immediately available" (i.e., "available on an on-call basis to respond to an emergency").
Refer to "Supplementary Information," Section V, "Summary of Changes Made Between the Current Part 35 and the Revised Part 35" for 10 CFR 35.615, as published in the Federal Register on April 24, 2002.
Preceptor Attestations
Why did NRC eliminate the requirement for preceptor attestations for most individuals certified by boards identified on the NRC website or in NRC regulations?
In order for the boards to be recognized, they are required to give an examination that assesses knowledge and competency in areas that include radiation safety. Therefore, the NRC finds that preceptor attestations are unnecessary for individuals certified by the currently recognized boards or for "grandfathered" boards listed in 10 CFR 35.57, provided that the provisions of 35.59 are met.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Were attestations eliminated for all board-certified individuals?
Attestations were eliminated for almost all individuals certified by boards recognized by NRC on its website and in its regulations. The attestation in 10 CFR 35.396(b)(3) is required for board-certified individuals requesting approval under 10 CFR 35.396(a)(3), as well as for the training in 10 CFR 35.396(b)(1) and (b)(2).
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Who will continue to need a preceptor attestation?
Individuals applying under the alternate training and experience pathway and all physicians applying to be authorized users under the provisions of 10 CFR 35.396 will continue to need a preceptor attestation.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
If a physician authorized user met the training and experience criteria under 10 CFR 35.390 or 35.690 and receives additional training and experience for a new medical use under the same section of the regulation, is another attestation statement needed?
Yes, under certain circumstances. Another attestation statement is not needed if the authorized user initially qualified under the board certification pathway. However, another attestation is needed if the authorized user initially qualified for 10 CFR 35.390 or 35.690 under the alternate training and experience pathway.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
If an authorized medical physicist met the training and experience criteria under 10 CFR 35.51 and receives additional training and experience for a new medical use under the same section of the regulation, is another attestation statement needed?
Yes, under certain circumstances. Another attestation statement is not needed if the authorized medical physicist initially qualified under the board certification pathway. However, another attestation is needed if the authorized medical physicist initially qualified under the alternate training and experience pathway.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
If a licensee authorized for specific medical uses wants to expand those medical uses, and the RSO receives additional training specified in 10 CFR 35.50(d) for the new uses, does the RSO need a new attestation statement for this training?
Yes, under certain circumstances. An additional attestation statement is needed if the RSO initially qualified under the alternate training and experience pathway; i.e., 10 CFR 35.50(b)(1). However, an attestation statement is not necessary for an individual who qualified via any other pathway.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Why did NRC amend the wording of attestation statements?
The NRC had intended "level of competency" in current attestations to refer to radiation safety competency. However, the medical community expressed concern that this could be interpreted to be as an attestation of medical competency. Therefore, NRC's new attestation statements no longer include the word "competency."
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
May a non-authorized user residency program director sign an attestation form?
Yes, in most cases. The regulations specify the conditions necessary for a residency program director to sign an attestation. The attestation must represent the consensus of the residency program faculty where at least one faculty member is an authorized user for the same use and concurs with the attestation. The residency program must also be approved by one of the accreditation organizations listed in the regulation.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
May an individual who qualifies as an AU or AMP under 10 CFR 35.57 serve as a preceptor or supervisor for an applicant seeking authorization on NRC licenses for the same uses?
Yes.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
The wording of attestation statements changed in the rule and the number of individuals needing attestations has decreased. If a licensee submits an older version of the NRC Form 313A series for a proposed authorized individual and it includes an attestation that is now unnecessary or does not match the wording of the revised attestation, is it necessary for the proposed authorized individual to obtain a new NRC Form 313A?
No. Submission of information such as a preceptor statement that is not required is neither reviewed nor part of the license. While NRC expects future attestations to conform to the new rule, the former attestation language will be accepted as adequate to meet the current attestation requirements.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Preparation of Radioactive Material for Medical Use Under an IND
Is there a conflict between Part 32 and Part 35 with regard to who may prepare radioactive material for medical use under an FDA-accepted Investigational New Drug (IND) protocol? [10 CFR 32.72, 35.100, 35.200, 35.300] (Q&A ID 0802025)
No. 10 CFR 32.72, “Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35,” lists criteria for authorization of a license to manufacture, prepare, or transfer radioactive drugs for use by persons authorized pursuant to Part 35. However, § 35.100, 200, and 300 were specifically amended to allow a medical use licensee to receive radioactive drugs, for use in IND research protocols, that are prepared and distributed by NRC or Agreement State licensees who are not § 32.72 licensees.
Refer to "Supplementary Information," Section V, "Summary of Changes Made Between the Current Part 35 and the Revised Part 35" for 10 CFR 35.100, § 35.200, and § 35.300; "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.100, § 35.200, and § 35.300, as published in the Federal Register on April 24, 2002.
Prescribed Dosage Range
For the dosage determination provisions of §35.63, can the prescribed dosage range be broad enough to permit the use of a dosage that differs from the central value of the range by 30%? [10 CFR 35.63] (Q&A ID 0303006)
Yes. Under 10 CFR 35.63, “Determination of dosages for unsealed byproduct material for medical use,” section (d), the authorized user can prescribe any dosage range that he or she believes to be appropriate.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.63, as published in the Federal Register on April 24, 2002.
For a prescribed range of dosages, can the authorized user (AU) prescribe a "dosage plus or minus 'xx' percent"? [10 CFR 35.2, 35.40(c), 35.63, 35.3045(a)] (Q&A ID 0103030)
Yes. The AU can prescribe a dosage range, an exact dosage +/- "XX" percent, or he/she may specify an exact dosage and rely on the +/- 20 percent for permitted variation from the exact dosage specified in §35.63 and §35.3045(a). If the AU prescribes a dosage range, then the administered dosage must be within the stated range in order to be consistent with the prescription. Under 10 CFR 35.2, "Definitions" (for "prescribed dosage") and 10 CFR 35.40(c), for given types of usage, the AU is not precluded from changing the range at any time prior to administration of the dosage.
For a specific patient, however, whether or not a written directive is required under 10 CFR 35.40, once the dosage or dosage range is specified and the dosage administered, changes to the specified dosage or dosage range are not permitted.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.63, as published in the Federal Register on April 24, 2002.
Quartering Patients Who Cannot Be Released Under § 35.75
Can a patient with a therapy implant be quartered in a room with a patient receiving I-131 therapy? [10 CFR 35.75, 35.315, 35.415] (Q&A ID 0802027)
No. However, two patients with therapy implants can be quartered together. Similarly, two patients receiving I-131 therapy can be quartered together.
Radiation Safety Committee
Can the licensee's chief executive officer delegate his or her authority (to manage, direct or administer the licensee's activities) to a Radiation Safety Committee (RSC)? [10 CFR 35.24] (Q&A ID 0103037)
If an RSC is required under 10 CFR 35.24, “Authority and responsibilities for the radiation protection program,” section (f), its duty is to oversee all uses of byproduct material permitted by the licensee. However, licensee management has the ultimate responsibility for the radiation protection program. If the licensee is not required under §35.24(f) to create an RSC, but still decides to establish this committee, the RSC functions as management directs, and its duties are as assigned.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.24, as published in the Federal Register on April 14, 2002.
If a Radiation Safety Committee (RSC) is required, does the frequency of meetings of the RSC have to be established? [10 CFR 35.24] (Q&A ID 0103045)
The regulations require certain licensees to have radiation safety committees. However, the regulations do not include specific requirements for the frequency of RSC meetings.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.24, as published in the Federal Register on April 24, 2002.
If a Radiation Safety Committee (RSC) is required, do all designated members of the RSC have to be present to have a "meeting"? [10 CFR 35.24(f)] (Q&A ID 1202030)
No. 10 CFR 35.24(f) sets out the requirements for the RSC, should one be necessary. These requirements do not specify that all designated members of the RSC must be present. As explained in the Supplementary Information for this regulation, most of the prescriptive requirements and committee tasks formerly in Part 35 have been deleted from the current rule. Only the Committee membership is specified in §35.24(f).
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.24, as published in the Federal Register on April 24, 2002.
If a licensee previously committed to having a Radiation Safety Committee (RSC) but no longer wants to use its RSC, and the Final Rule does not require a RSC for the licensee's facility, does the licensee need to request and receive an amendment to the license before implementing the change? [10 CFR 35.10(e), 35.13, 35.24(f), 35.26, 35.2026] (Q&A ID 0802015)
No. Regardless of when after October 24, 2002, the effective date of the Final Rule, the licensee decides to discontinue use of its RSC, it need not apply for an amendment to its license before implementing the change. However, such a change to the licensee's radiation protection program must be done in accordance with the requirements of § 35.26 and be documented, with retention of the record for five years, per § 35.2026.
If the licensee wished to discontinue use of its RSC before October 24, 2002, it could only do so if it implemented all provisions of the revised Part 35 that were applicable to its license. In this case, too, the change(s) to the licensee's radiation protection program must have been done in accordance with the requirements of § 35.26 and be documented.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.10, as published in the Federal Register on April 24, 2002.
Radiation Safety Officers and Associate Radiation Safety Officers
Can a medical use licensee have more than one Radiation Safety Officer (RSO)?
No, there can be only one RSO, but there may be more than one Associate Radiation Safety Officer, or more than one temporary RSO in accordance with 10 CFR 35.24(c).
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Why would a licensee want to have an Associate Radiation Safety Officer (ARSO)?
The licensee may want to request a license amendment to identify one or more individuals to assist the Radiation Safety Officer (RSO). The approved ARSO(s) would be listed on the license. The ARSO(s) would be assigned duties and tasks in the oversight of the radiation safety operations of designated sections of the licensed program, while reporting to the named RSO.
The regulations continue to allow a licensee to name only one RSO on a license, who would be responsible for the day-to-day oversight of the entire radiation safety program. Similarly, licensees with multiple program components or operating locations could appoint one or more qualified ARSOs to perform duties and tasks in the oversight of designated program components or locations of byproduct material use.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
How does an Associate Radiation Safety Officer differ from an Assistant Radiation Safety Officer?
NRC recognizes that licensees may use a variety of different terms to identify members of their radiation safety staff. Some Agreement States may already have similar programs in place using similar terminology. It was necessary for NRC to select a single term to describe the person other than the Radiation Safety Officer identified in 10 CFR 35.2, 35.24, 35.50 and on the license. Several different terms were considered, but "Associate Radiation Safety Officer" was chosen.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Why do ARSO's need to be listed on a license? Why can't the licensee just designate ARSOs in their program?
NRC requires that the ARSO be listed on the license to avoid confusion between individuals working in a radiation program and those that meet uniform training and experience criteria and are formally delegated duties and task for oversight of parts of the radiation safety program. The regulator's review of the potential ARSO's training and experience ensures all individuals meet the same standards. This allows the individual who is named as an ARSO to be recognized by Agreement States and the NRC as an RSO or ARSO for the same medical uses on another license without resubmitting their training and experience documents.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Will NRC recognize an individual named as an "Associate Radiation Safety Officer" on an Agreement State License that does not meet the requirements in 10 CFR 35.50 to be an Associate Radiation Safety Officer?
No, the individual must meet the requirements in 10 CFR 35.50 for the NRC to list the individual as an ARSO on a medical use license. Therefore, until all the Agreement States have adopted the rule and list only individuals that meet the requirements in 10 CFR 35.50 or equivalent Agreement state requirements as ARSOs, the licensee will have to verify that a proposed ARSO meets the NRC requirements.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Will the Associate Radiation Safety Officer have any responsibility for the Radiation Protection Program?
No, only the Radiation Safety Officer has responsibility for the Radiation Protection Program.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
The Radiation Safety Officer (RSO) has full responsibility for the program. During a documented absence of the RSO, does the Alternate Radiation Safety Officer (ARSO) assume any responsibilities of the RSO?
No, the ARSO cannot assume any RSO responsibilities unless the licensee designates the ARSO as a temporary RSO.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
What training and experience requirements need to be satisfied for an Associate Radiation Safety Officer (ARSO) to be named in a medical license? And how do they differ from the Radiation Safety Officer (RSO) training and experience requirements?
An ARSO is required to complete the same training and experience requirements as a named RSO for the ARSO's assigned duties and tasks for the same types of use in a radiation safety program.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Can an Associate Radiation Safety Officer (ARSO) provide a preceptor statement for someone applying to be a Radiation Safety Officer?
Yes, provided the ARSO has experience with the radiation safety aspects of similar types of use of byproduct material for which the ARSO is providing the attestation.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
How does the rule change the potential pool of Radiation Safety Officers (RSOs) and RSO supervisors/preceptors?
It increases the potential pool, because when an Associate Radiation Safety Officer (ARSO) meets the same training and experience requirements as an RSO, the ARSO may supervise and be a preceptor for other individuals training to become RSOs or ARSOs for the same types of use for which the ARSO is qualified.
In addition, because an authorized user, authorized medical physicist, or authorized nuclear pharmacist listed on any license or permit may serve as an RSO or ARSO, there are now an increased number of qualified individuals available to serve as RSOs and ARSOs on NRC and Agreement State medical licenses.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Can only an ARSO be assigned radiation safety duties and tasks?
No, a radiation safety duty or task can be assigned to any individual a licensee feels can perform the assignment with appropriate training and supervision.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Will a license amendment be required before a licensee allows an individual to work as an Associate Radiation Safety Officer (ARSO)?
Yes, a licensee must request and receive an amendment before allowing an individual to work as an ARSO. An amendment is also required before the Radiation Safety Officer assigns the ARSO the duties and tasks in the oversight of a new section of the radiation safety program for which the ARSO is not currently authorized.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Will a licensee need to notify the Commission when the Associate Radiation Safety Officer (ARSO) discontinues performance of duties?
Yes, a licensee is required to notify the Commission no later than 30 days after the ARSO discontinues performance of duties under the license.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
If a licensee is authorized for specific medical uses and wants to expand those medical uses, does the Radiation Safety Officer (RSO) need additional training specified in 10 CFR 35.50(d) for the new uses?
Yes. The RSO needs to obtain additional training, or document that he or she received related training and experience within the past 7 years.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
It appears that 10 CFR 35.50(c)(2) and (3) are the same for physicians. What is the difference?
Current regulations, under 10 CFR 35.50(c)(2), allow a physician who is named as an authorized user (AU) on a medical license or permit to be named as the Radiation Safety Officer (RSO) on the same license for the same byproduct material for which the AU is authorized. The revised 10 CFR 35.50(c)(2) will permit the AU to be named as an RSO on any license. NRC regulatory changes in 10 CFR 35.50(c)(3) will allow an individual who is not yet named as an AU on a medical license or permit, but is qualified to be an AU, to be named simultaneously as the RSO and the AU on the same new medical license.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
What changed in 10 CFR 35.50(c)(2)?
Previously, 10 CFR 35.50(c)(2) permitted only an authorized user (AU), authorized medical physicist (AMP), or authorized nuclear pharmacist (ANP) who was listed on the licensee's license to be named as the Radiation Safety Officer (RSO). The new 10 CFR 35.50(c)(2) will allow the licensee to request an AU, AMP, or ANP on any medical license or permit to be authorized as the RSO or Associate Radiation Safety Officer (ARSO) when the individual has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual will have RSO responsibilities or ARSO duties and tasks.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Who can be the RSO for a private practice?
Anyone can be the RSO for a private practice license as long as he or she meets the requirements in 10 CFR 35.50 and has experience with the radiation safety aspects of similar types of use for which the applicant or licensee is seeking approval of the individual as the RSO. The applicant or licensee will need to provide documentation that the individual has training in radiation safety, regulatory issues, and emergency procedures for those types of use (i.e., meet the requirements in 10 CFR 35.50(d)). Therefore, a new AU, a new RSO, or an existing RSO, ARSO, AU, AMP, or ANP meeting these requirements can be the RSO for a private practice medical use license.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
If the radiation safety officer (RSO) is placed in the management structure, are actions of the RSO considered actions of management? [10 CFR 35.2, 35.24] (Q&A ID 0103036)
Yes, if the RSO meets the criteria of 'management' as defined in the regulations by being any of the following: i) the chief executive officer; ii) the individual having the authority to manage, direct or administer the licensee's activities; or iii) a delegate of either i or ii above. However, if the licensee has a radiation safety committee, the RSO is prohibited by §35.24(f) from serving as the management representative on the committee.
Does an individual who was appointed as RSO for a medical licensee before October 24, 2002, have to agree in writing to be responsible for implementing the licensee's radiation protection program? [10 CFR 35.24(b)] (Q&A ID 0802005)
No. Only an individual who assumed the duties of RSO after October 24, 2002, the effective date of the Final Rule, will be required to agree in writing that he or she is responsible for implementing the radiation safety program. The one exception would be for a licensee that notified NRC before October 24, 2002, that it was fully implementing the Final Rule and then appoints an RSO.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.24, as published in the Federal Register on April 24, 2002.
Management Delegation of Authority to the RSO
Will the final consolidated guidance for medical licenses (NUREG-1556, Vol. 9) require a licensee to "commit" to management delegation of authority to the RSO? [10 CFR 35.24] (Q&A ID 0802035)
10 CFR 35.24, “Authority and responsibilities for the radiation protection program,” section (e) requires that the licensee "establish the authority...of the Radiation Safety Officer in writing" and § 35.24(g) requires that the licensee "provide the Radiation Safety Officer sufficient authority...to...." It is not necessary for the licensee to submit this written authority to the NRC as part of the licensing process.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.24, as published in the Federal Register on April 24, 2002.
Would an individual be "grandfathered" if he/she stopped being a Radiation Safety Officer (RSO) in 2004? [10 CFR 35.50, 35.57, 35.59] (Q&A ID 0103024)
If an individual is listed as RSO on the licensee's current license, notwithstanding the fact that he/she is no longer actively working as an RSO, the individual would be "grandfathered" and would not need to comply with the T&E requirements in §35.50. Note that §35.59 would continue to apply, and the T&E would have to have been obtained within seven years preceding the date of the application, or the individual must have had related continuing education and experience. Also note, with regard to an individual's stopping work as an RSO in 2004, under section 35.14(b)(1), the licensee was required to provide letter notification to NRC within 30 days of an individual's (permanently) discontinuing performance of RSO duties under the license. However, if an individual is no longer listed on a current license, he/she would not be "grandfathered" and would have to meet the T&E requirements in §35.50, plus the recentness of training requirement in §35.59.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.50, as published in the Federal Register on April 24, 2002.
Will an authorized user (AU)/licensee in a small medical office who wishes to be identified as the Radiation Safety Officer (RSO) for the license need to comply with §35.24(b), which requires an RSO to accept, in writing, the duties and responsibilities of the position, since he/she is the same person? [10 CFR 35.24(b)] (Q&A ID 1202022)
Yes. The individual is now going to be taking on the responsibilities of an RSO, and as such, must specifically comply with the regulatory requirements applicable to the position of RSO. The regulations assign to the position of the RSO rather than to another position, the responsibility for implementing the radiation program, and in connection with that responsibility, explicitly require that the RSO acknowledge in writing responsibility for the radiation protection program.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.24, as published in the Federal Register on April 24, 2002.
Is NRC's approval required before an individual can begin duties as a permanent RSO for an existing license? [10 CFR 35.13(c), 35.14(b), 35.24(c), 35.24(d), 35.50, 35.59] (Q&A ID 0301002)
Yes. However, the licensee can appoint individuals as temporary RSOs under the license for up to 60 days each year without prior NRC approval. To be so appointed, an individual must either be qualified to be an RSO or be an AMP, ANP, or AU identified on the licensee's license and have experience with the radiation safety aspects of similar types(s) of use(s) of byproduct material for which the individual will have RSO responsibilities. If necessary, for complete radiation safety coverage of activities conducted under the license, the licensee may simultaneously appoint more than one temporary RSO.
If the RSO named on the license has permanently discontinued performance of duties under the license or has a name change, the licensee must notify the NRC by letter no later than 30 days after such discontinuation of performance of duties or name change.
If a licensee submits an amendment request to add a new Radiation Safety Officer (RSO), does this amendment request satisfy the notification requirement for announcing the departure of the previous RSO? [10 CFR 35.13, 35.14] (Q&A ID 0103027)
Yes, conditionally, the amendment request can satisfy the notification requirement. To do so, the amendment request must clearly reference the departure of the former RSO and clearly differentiate between the new RSO and the departing RSO. Also, the amendment request must be submitted within 30 days after the departing RSO discontinues performance of duties under the license.
If the Radiation Safety Officer (RSO) continues an association with the licensee after retirement, is NRC notification required? Can the former RSO stay on the license as an Authorized User (AU)? [10 CFR 35.12, 35.13, 35.14, 35.59] (Q&A ID 0103026)
Since the RSO retired, he or she is presumably no longer performing the duties of the RSO under the license. Accordingly, §35.14(b)(1) requires notification to the NRC, by letter, no later than 30 days after retirement. If the former RSO was also listed on the license as an AU, he or she can continue in that capacity if the licensee so desires. Otherwise, the former RSO can function under the license as an AU if the individual satisfies the training and experience requirements appropriate to the intended medical use and recentness of training requirements, as long as the licensee provides notification under §35.14(a) or applies for, under §35.13(b), and receives a license amendment.
Radiation Safety Procedures for Hospitalized Patients Released Under § 35.75
a) How should a hospital handle a patient who has been released under 10 CFR 35.75 but remains in the hospital for other reasons?
b) Is the hospital responsible for treating excreta from the patient as radioactive waste? [10 CFR 20.1003, 20.2003, 35.75] (Q&A ID 1002001)
a) If the "released" patient is not discharged from the hospital, the patient continues to represent a source of radiation exposure to others* and, for some treatments, potentially a source of radioactive contamination to the facility and persons in it. Licensees should consider the requirement regarding providing instructions on maintaining exposures ALARA in situations where the individual has been released under § 35.75 but remains hospitalized for other reasons; in this case the maximally exposed individual may be a member of the licensee's staff. Moreover, the basis for the "release" was a total effective dose to others, including hospital staff, patients, and visitors, not likely to exceed 500 mrem. Based on emerging conditions for the hospitalized patient, conditions that differ from those assumed in authorizing the "release" and that result in the possibility of the dose to someone exceeding 500 mrem, the hospital could reconsider the "release" status and consider revoking it, if warranted.
b) No. 10 CFR 20.2003(a) provides the regulatory framework for release of radioactive waste into the sanitary sewerage. However, 20.2003(b) specifically provides that excreta from individuals undergoing medical diagnosis or therapy with radioactive material is not subject to these requirements. Items contaminated with excreta from "released" patients should be handled in accordance with the hospital's procedures regarding non-"released" patients.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.75, as published in the Federal Register on April 24, 2002.
*Exposure from such patients does not constitute occupational dose for employees of the hospital or public dose for others.
Receipt of Material Delivered to a Mobile Medical Nuclear Licensee
For convenience of operation of a mobile nuclear medicine licensee, will the NRC approve an exemption to §35.80(b) to permit early morning receipt of short-term storage (less than 1 hour) of unsealed byproduct material for medical use in a non-licensee hospital's lab before licensee staff arrives on-site for shipment check-in and use? [10 CFR 35.80] (Q&A ID 0103018)
No. Licensee convenience is not considered adequate justification to issue an exemption. To institute this delivery and storage plan, either the receiving hospital should apply for a possession-only license or a staff member of the mobile nuclear medicine licensee should be at the client hospital at the time of delivery or the hospital's lab should be listed as a base location on the mobile nuclear medicine licensee's license.
Refer to "Supplementary Information," Sect on III, "Summary of Public Comments and Responses to Comments" for §35.80, as published in the Federal Register on April 24, 2002.
Redistribution of Sealed Sources
Does §35.65(b) authorize medical use of sealed sources redistributed by Agreement State licensees? [10 CFR35.65(b)] (Q&A ID 0303002)
No. Currently, §35.65(b) does not specifically include sources redistributed by Agreement State licensees.
Use of sealed sources redistributed by Agreement State licensees may be requested by licensees as exemptions for license amendments.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.65, as published in the Federal Register on April 24, 2002.
Can sources redistributed under §35.65(b) for medical use be manufactured and initially distributed by an Agreement State licensee? [10 CFR 35.65(b)] (Q&A ID 0303003)
No. Currently, §35.65(b) does not specifically include sources manufactured and initially distributed by Agreement State licensees.
Use of sealed sources manufactured and initially distributed by Agreement State licensees and redistributed by an individual licensed by NRC, or an Agreement State [see Q&A #0303002], may be requested by medical licensees as exemptions for license amendments.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.65, as published in the Federal Register on April 24, 2002.
Regulation of Attenuation Sources Used in Medicine
Which sections in Part 35 provide regulations for use of attenuation sources (e.g., Gd and Cs sources) in medicine? [10 CFR 35.65, 35.500, 35.590] (Q&A ID 0802033)
10 CFR 35.65, “Authorization for calibration, transmission, and reference sources,” authorizes the receipt, possession, and use of sealed sources of byproduct material for medical transmission and other purposes. The conditions that such sources must meet are listed in the section.
If the conditions of § 35.65 are not met, then Subpart G, "Sealed Sources for Diagnosis," provides those regulations applicable to attenuation sources used in medicine.
For information on use conditions approved for such sources, refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments," Part II, "General Issues," Section F, "Global Changes in the Rule," Issue 1, "What Is the Sealed Source and Device Registry and How Do I Access the Registry?" as published in the Federal Register on April 24, 2002.
Regulation of GliaSite®
Under what section(s) of the Final Rule is use of the GliaSite Radiation Therapy System (RTS) regulated? [10 CFR 35.12(d), 35.1000] (Q&A ID 0802018)
Use of the GliaSite
® RTS is considered as an application that involves a device and procedures that differ from those for conventional sealed source therapeutic medical usage. The I-125 Iotrex Liquid Brachytherapy Source in Cytyc GliaSite Radiation Therapy System was
licensed under 10 CFR 35.1000 in August 2006.
Regulation of Intravascular Brachytherapy
Under what section(s) of the Final Rule is intravascular brachytherapy (IVB) regulated? [10 CFR 35.12(d), 35.1000] (Q&A ID 0802017)
IVB using beta emitters and IVB with devices using gamma emitters are both considered as applications that involve devices and procedures that differ from those for conventional sealed source therapeutic medical usage. As such, IVB is presently to be regulated under 10 CFR 35.1000, rather than under Subpart F, "Manual Brachytherapy," or Subpart H "Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units".
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.1000, as published in the Federal Register on April 24, 2002.
If an Agreement State (AS) decides to add IVB to its regulations, what would the NRC compatibility category be, since the use of byproduct materials in IVB is not explicitly discussed in 10 CFR Part 35? [10 CFR 35.1000] (Q&A ID 0902010)
Presently, use of byproduct material in IVB is being licensed under 10 CFR 35.1000, rather than under Subpart F or Subpart H, of the Final Rule. The Agreement State Compatibility Category for § 35.1000 is "D," meaning the requirement does not need to be adopted by an Agreement State for purposes of compatibility. Until NRC issues a regulation with specific requirements for IVB and specifies a different compatibility category, compatibility of AS regulations for IVB with NRC regulations is not required.
Refer to "Supplementary Information," Section X, "Issues of Compatibility for Agreement States," as published in the Federal Register on April 24, 2002.
Regulation of Low Dose Rate Remote Afterloader Therapy Units
What section of Part 35 applies to the use and calibration of Low Dose Rate (LDR) therapy devices? [10 CFR 35.2, 35.12(d), 35.600, 35.10006] (Q&A ID 0802043)
10 CFR Part 35 Subpart H, "Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units," governs, unless the device employs a remote beta-emitting radioisotope or is not remotely driven. In these cases, § 35.1000, "Other Medical Uses of Byproduct Material or Radiation From Byproduct Material," is the appropriate section for remote beta-emitting sources and § 35.400,”Uses of sources for manual brachytherapy,” is the appropriate section for manual LDR sources.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.615, as published in the Federal Register on April 24, 2002.
Regulation of "New" Medical Uses of Byproduct Material
Relatively new medical uses of byproduct material, such as monoclonal antibodies labeled with byproduct material, are not mentioned in NUREG-1556, Vol. 9, Rev 1. Will "new" medical uses of byproduct material for imaging and localization studies and/or for therapeutic uses be regulated as §35.100, 200, or 300 entities, rather than §35.1000? [10 CFR 35.100, 35.200, 35.300, 35.1000] (Q&A ID 1202021)
The scope of new 35.100 (Part 35 Subpart K) is intended to include all new medical uses of byproduct materials or radiation from byproduct material. The NRC, with input from its Advisory Committee on the Medical Uses of Isotopes, as requested, will determine if the technology truly is a new technology and should be licensed under Subpart K, or if it is actually a type of use regulated under the other subparts. When determining which section of Part 35 applies, the form, type of use, training and experience, and any other necessary information will be considered.
Byproduct materials will not be licensed under §35.1000 when other sections provide appropriate regulations for an intended medical use.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.1000, as published in the Federal Register on April 24, 2002.
Regulation of "New" Medical Uses of Unsealed Byproduct Material
Relatively new medical uses of unsealed byproduct material, such as monoclonal antibodies labeled with byproduct material, are not mentioned in NUREG-1556, Vol 9. Will "new" medical uses of unsealed byproduct material for imaging and localization studies, and/or for therapeutic uses, be regulated as § 35.100, 200, or 300 entities, rather than under § 35.1000? [10 CFR 35.100 35.200 35.300, 35.1000] (Q&A ID 1202021)
While § 35.1000 is a new section, created to address "other" medical uses of byproduct material, the scope of this section includes medical uses of byproduct material that are not licensed under 10 CFR Subparts D through H. Thus, byproduct materials will not be licensed under § 35.1000 when other sections provide appropriate regulations for an intended medical use. This may be expected to be the case for most new medical uses of unsealed byproduct material for imaging and localization studies, and/or for therapeutic purposes. Monoclonal antibodies labeled with byproduct material will be regulated as § 35.200 or 300 entities based on their form (unsealed byproduct material) and use (medical).
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.1000, as published in the Federal Register on April 24, 2002.
Requirements for Use of Various Byproduct Materials
Does use of byproduct materials associated with FDA new drug applications (NDAs) and/or biologic license applications (BLAs) fall under NRC requirements for use of FDA investigational new drugs (INDs) and radioactive drug research committee (RDRC) byproduct materials or for byproduct materials in routine use? [10 CFR 35.6, 35.7, 35.100, 35.200, 35.300] (Q&A ID 0902016)
NRC's requirements are based on type of medical use, not type of byproduct material. The requirements are the same for use of byproduct materials associated with FDA IND applications and RDRC approvals and for byproduct materials in routine use. Note that licensees must also, as applicable, comply with the provisions of § 35.6, "Provisions for the protection of human research subjects" and § 35.7, "FDA, other Federal, and State requirements."
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.100, 35.200, 35.300, as published in the Federal Register on April 24, 2002.
Review of Applications Under § 35.1000
How are applications under § 35.1000 for new modalities, i.e., for presently unknown processes and materials, to be reviewed? [10 CFR 35.12(d), 35.1000] (Q&A ID 0802019)
Each technology is to be evaluated on a case-by-case basis. This process is to include working with the ACMUI, the medical community, the public, and the developers of the new technology, as appropriate, to determine the specific risks associated with the technology and any additional regulatory requirements for the medical use of the technology. The Emerging Medical Technologies website provides a chart of the technology name, status, and licensing guidance documents.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.1000, as published in the Federal Register on April 24, 2002.
Sealed Source and Device Registry
Why were 10 CFR 35.400, 35.500, and 35.600 revised to replace the requirement that the sealed sources be used "as approved in the Sealed Source and Device Registry" with the requirement that the sealed sources be used "in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry?"
The requirement to use sources in accordance with the Sealed Source and Device Registry (SSDR) was revised because NRC recognized that the SSDR might not include all the medical uses for a sealed source (for example, the SSDR may list only interstitial use when intracavitary, intraluminal or superficial uses may also be acceptable). Requiring only those uses listed in the SSDR may interfere with the practice of medicine.
During the SSDR review, safety conditions and limitations are determined based on a review of the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing of sources and installation, service and maintenance, operating and safety instructions, and potential hazards for devices. This is done to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property for the proposed use. Use of the sources or devices within the safety conditions and limitations assures that the sources and devices are used in a manner that protects workers, users and patients.
In addition, NRC regulations still require sources and devices to be used for the type of medical use for which they are listed in the Sealed Source and Device Registry. For example, a source or device listed for diagnostic purposes (under 10 CFR 35.500 medical uses) cannot be used for therapy purposes (under 10 CFR 35.400 or 35.600 medical uses) and a source or device that is listed for a high dose remote afterloader use (under 10 CFR 35.600 medical uses) cannot be used for manual brachytherapy purposes (under 10 CFR 35.400 medical uses).
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Why did NRC change the regulations to address sources and devices separately?
Many 10 CFR 35.500 and all 35.600 medical uses involve sources used with specific devices. NRC revised 10 CFR 35.500 and 35.600 to separately address the sources and devices containing sealed sources. For devices containing sealed sources, both the sources and devices have to be approved in the SSDR. The changes require licensees to use only sources approved to be used in those devices. This assures that the sources and devices have been reviewed and determined to protect public health and safety when used together.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
If device manufacturer training for units under 10 CFR 35.600 has been completed once at the facility, can the licensee train their own staff?
Sometimes. If there are no additional manufacturer upgrades that affect the operation and safety of the unit, the licensee can provide training to their staff under the provisions of 10 CFR 35.610(d)(2). If there are additional manufacturer upgrades that affect the operation and safety of the unit, the provisions of 10 CFR 35.610(d)(1) apply and only the device manufacturer or an individual certified by the device manufacturer to provide the training can train the licensee's staff. If the device manufacturer certifies someone on the licensee's staff to provide the training, that individual can provide the training to other licensee staff members.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
10 CFR 35.610(d) requires in part that prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, a licensee shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit. Is this just for actual operators or does this include AUs and AMPs?
The requirement in 10 CFR 35.610(d) is for all individuals, including AUs, AMPs, operators, and others that need to know how the new unit operates and understand how the upgrades affect safety and operations.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Source Output Measurement - Published Protocols
What are the "published protocols currently accepted by nationally recognized bodies"? Where can I find them? [10 CFR 35.432(a), 35.457, 35.630(a), 35.632(d), 35.633(d), 35.635(d), 35.657 ] (Q&A ID 1202041)
The Supplementary Information for 10 CFR 35.432 defines "nationally recognized bodies" as official standards consensus bodies on the National Institute of Standards and Technology (NIST) website and professional organizations that develop protocols using a consensus process and multiple peer reviews. Examples of nationally recognized bodies include the American Association of Physicists in Medicine, the American College of Radiology, and the National Institute of Standards and Technology.
Do we know of a "published protocol" under §35.432? Do Task Force Reports from the American Association of Physicists in Medicine (AAPM) qualify? [10 CFR 35.432] (Q&A ID 1202033)
10 CFR 35.432, “Calibration measurements of brachytherapy sources,” section (a)(3) provides that the licensee must use published protocols accepted by nationally recognized bodies to meet the requirements. The Supplementary Information defines "nationally recognized bodies" as official standards consensus bodies on the National Institute of Standards and Technology (NIST) website and professional organizations that develop protocols using a consensus process and multiple peer reviews, and AAPM is listed as an example of such a nationally recognized body. In fact, AAPM Task Group reports number 40 and 56 are cited in the Supplementary Information as the basis for the requirements in §35.432.
A fairly comprehensive listing of various published protocols can be found in Appendix AA, pages 6-9,of NUREG-1556, Vol.9, Rev. 1, published May 2005.
Refer to "Supplementary Information", Section V, "Summary of Changes Made Between the Current Part 35 and the Revised Part 35" for §35.432 as published in the Federal Register on April 24, 2002.
Specialty Board Certification Changes
What individuals are affected by the resolution of the Ritenour petition?
The affected individuals are those meeting all three of the following conditions: They are certified by boards that were formerly listed in 10 CFR Part 35, Subpart J and now listed in 10 CFR 35.57; they were certified on or before October 24, 2005; and they are requesting authorization for only those materials and uses that they performed on or before October 24, 2005.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Over time, some certifying Boards may have changed their names, as well as the names of some of their specialties. How can I tell if my certification is recognized?
If the board was included in former 10 CFR Subpart J, it has been listed in 10 CFR 35.57 as it appeared in the prior regulation. NRC posts the names of the boards that meet NRC's current requirements and includes a sample of the board's certificates on the NRC website. If a board changes its name, specialty, or other wording on a certificate, a sample of its new certificate is submitted and posted. The NRC will note by each certificate the time frame for recognition of that certificate (e.g. The American Board of Nuclear Medicine changed the wording of its certificates in 2007 so the web site provides sample certificates for 2005 to 2007 and for 2007 to present).
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Specialty Board Certification - NRC Recognition
What types of authorized uses have been approved by the NRC for individuals certified by the Certification Board of Nuclear Cardiology (CBNC)? [10 CFR 35.100, 35.190, 35.200, 35.290] (Q&A ID 0802036)
The CBNC requested recognition under § 35.290 for § 35.200 materials only, and that is what was granted. The list of NRC-recognized specialty boards for § 35.290 provides the name changes of the organization and certificates throughout the years. Accordingly, a physician who is certified by the CBNC for Nuclear Cardiology satisfies the training and experience requirements for an authorized user (AU) for use of § 35.200 materials. Note that an AU for use of § 35.200 materials also satisfies the training and experience requirements under § 35.190 for an AU for use of § 35.100 materials.
Specialty Board - Recency of Board Certification
When accepting a board-certified AU for §35.200 use, how recently should he or she have been certified? If the qualifications for certification were different several years ago, before NRC recognition, does NRC accept older certifications anyway? [10 CFR 35.59, 35.200, 35.290] (Q&A ID 1202008)
In general, if an individual became certified by the specialty board after the board's certification processes were recognized, his or her certification will be considered valid if it was granted during the time that the board's certification processes were NRC-recognized, even if the requirements at the time were different. In order to become an authorized user on a license, however, the individual will have to be currently certified and meet the recentness-of-training requirements of §35.59.
Submission of Non-Required Procedures
What is the administrative process the Regions are expected to use when an applicant for a medical use license submits procedures that are not required for review? [10 CFR 35.12, 35.26] (Q&A ID 0802040)
Non-required procedures are not to be reviewed as part of the licensing process. Regions are expected to use the revised standard license condition for medical use licenses that refers to the application and other documents submitted to NRC. The condition requires a licensee to conduct its program in accordance with submitted information, except supplied procedures that are not required to be submitted in accordance with the regulations.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.12 and § 35.26, as published in the Federal Register on April 24, 2002.
Submission of Shielding Calculations
Does the NRC require submission of shielding calculations for treatment rooms as part of the license application? [10 CFR 30.33(a), 35.18(a), 35.600] (Q&A ID 1202003)
While there is no "requirement" that shielding calculations be provided, in order to issue a license, the Commission must find that facilities are adequate to protect health and minimize danger to life or property as required under §30.33(a) and/or §35.18(a). For types of use permitted by §35.600, the shielding calculations for the facility are needed by the Commission to make this finding.
Survey Instrument Calibration
Will licensees need multiple survey instruments to meet the ±20% requirement in 10 CFR 35.61(b), for accuracy of survey instrument response, if both high energy and low energy photon-emitting byproduct material is authorized? [10 CFR 35.61] (Q&A ID 1002004)
Compliance with 10 CFR 35.61, “Calibration of survey instruments,” section (b) should not result in multiple survey instruments being required if use of both high energy and low energy photon-emitting byproduct material is authorized. Survey instruments are commonly available for which the response, when acceptably calibrated with high energy photon-emitting byproduct material, should, without further instrument response adjustment, be within the ±20% acceptable range for calibration with low energy photon emitters, if such calibration is undertaken. If the response of a survey instrument to low energy photon emitters is determined to be, or is otherwise known to be, outside of the ±20 % range, response correction factors for photon energy can be employed for use of such an instrument in low energy fields, as long as the high energy photon source calibration of the instrument is acceptable.
Survey Requirements
When and where are radiation and contamination surveys required for medical licensees? [10 CFR 20.1101, 20.1402, 20.1501, 35.70(a), 35.315(a)(4)] (Q&A ID 0301014)
10 CFR 35.70, “Surveys of ambient radiation exposure rate,” requires surveys at the end of each day in areas where unsealed byproduct material requiring a written directive is prepared for use or administered.
10 CFR 35.315, Safety precautions,” requires either monitoring material and items removed from the patient's room or handling the material and items as radioactive waste.
Other survey requirements can be found in:
NRC requires that surveys be conducted to satisfy the requirements of 10 CFR 20.1101, “Radiation Protection Programs” and § 20.1402, “Radiological criteria for unrestricted use.” Licensees are required to show compliance with the public and occupational dose limits specified in Part 20 and, specifically, to develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities and sufficient to ensure compliance with the provisions of Part 20 [10 CFR 20.1101(a)]. Subpart F, “Surveys and Monitoring” includes Section 10 CFR 20.1501, “General,” which requires licensees to perform necessary and reasonable surveys to evaluate the magnitude and extent of radiation levels; concentrations or quantities of radioactive material; and the potential radiological hazards.
Technologists Acting as Management
Can a nuclear medicine technologist be considered 'management'? [10 CFR 35.2] (Q&A ID 0103035)
Yes, if the nuclear medicine technologist meets the criteria of 'management' defined in the regulations by being any of the following: i) the chief executive officer; ii) the individual having the authority to manage, direct or administer the licensee's activities; or iii) a delegate of either i or ii above.
Technologist as Radiation Safety Officer -- Qualifications
When can a technologist (for example, a nuclear medicine technologist) be appointed as the radiation safety officer (RSO) for a medical use license? [10 CFR 35.10, 35.24(b), 35.50] (Q&A ID 0802010)
A technologist can be an RSO if he or she successfully completes all of the training and experience requirements in 10 CFR 35.50, “Training for the RSO and ARSO” and agrees, in writing, to be responsible for implementing the radiation protection program.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.50, as published in the Federal Register on April 24, 2002.
Therapy-Related Computer Systems
What is the frequency requirement for testing therapy-related computer systems under 10 CFR 35.457 and under 10 CFR 35.657? [10 CFR 35.457, 35.657] (Q&A ID 1002007)
10 CFR 35.457, “Therapy-related computer systems,” and 10 CFR 35.657, “Therapy-related computer systems,” each require "acceptance testing on the treatment planning system" for therapy-related computer systems, "in accordance with published protocols accepted by nationally recognized bodies." Accordingly, the testing is to be done at acceptance, unless the published protocol being used requires follow-up testing at some frequency to complete the acceptance testing. Similarly, acceptance testing of the treatment planning system should typically be performed following modification of the treatment planning system of a therapy-related computer system.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.457 and 35.657, as published in the Federal Register on April 24, 2002. Also refer to "Code of Practice for Brachytherapy Physics: Report of the AAPM Therapy Committee Task Group No. 56," Medical Physics 24(10): 1557-98 (October 1997).
10 CFR 35.657, “Therapy-related computer systems,” requires that "published protocols accepted by nationally recognized bodies" be used to validate therapy-related computer systems. Where can such protocols be found? [10 CFR 35.657] (Q&A ID 0103001)
NUREG 1556, Volume 9, “Program-specific Guidance about Medical Use Licensees,” provides guidance on published protocols. One example of a published protocol accepted by a nationally recognized body which may be used to validate therapy-related computer systems, as required in §35.657 is Report Number 62 of the American Association of Physicists in Medicine (AAPM), "Quality Assurance for Clinical Radiotherapy Treatment Planning."
This report, among other AAPM-published protocols, can be found on the AAPM website.
Does the acceptance testing described in §35.457 or §35.657, for the treatment planning system of therapy-related computer systems, have to precede the use of the therapeutic equipment? The 2002 revised rule is not clear in this aspect. [10 CFR 35.10, 35.457, 35.657] (Q&A ID 1202010)
Yes. User acceptance testing of a product is conducted by an end-user (licensee) to determine its fitness for use in the given operational environment. This must be accomplished prior to the first operational use of the product. In addition, §35.10 requires a licensee to implement the provisions of Part 35 on or before October 24, 2002. Therefore, systems in use before October 24, 2002 that may have been tested prior to use must be tested again, following the requirements of §35.457 or §35.657, respectively, prior to use after October 24, 2002. If the initial acceptance testing fulfilled the requirements of §35.457 or §35.657, no additional acceptance testing is required.
Under §35.457 or §35.657, are licensees required to have their computerized treatment systems functionally tested if their systems have been in service for a long time? [10 CFR 35.457, 35.657] (Q&A ID 0303013)
Yes. However, if the systems have been tested, when installed, or later, in accordance with published protocols currently accepted by nationally recognized bodies, and passed the testing, then the testing required in §35.457 or §35.657 has been satisfied and nothing further is required.
One example of a published protocol accepted by a nationally recognized body which may be used as guidance for testing therapy-related computer systems is Report Number 62 of the American Association of Physicists in Medicine (AAPM), Quality Assurance for Clinical Radiotherapy Treatment Planning. This report can be found on the AAPM website.
Will "grandfathering" of older treatment planning systems and software be allowed under Sections 35.457 and 35.657? [10 CFR 35.457, 35.657] (Q&A ID 0303014)
No. The rule does not differentiate on the basis of "age" of computer-based treatment planning systems in terms of either hardware or software. All treatment planning systems - new, old, or modified - must undergo acceptance testing prior to use, effective October 24, 2002. However, if the systems were tested, when installed, or later, in accordance with published protocols currently accepted by nationally recognized bodies, and passed the testing, then nothing further is needed.
Training and Experience
What changes were made to the training and experience requirements for authorized individuals in 2018?
- The significant changes included new individuals listed on the license
- Associate Radiation Safety Officer (ARSO). The ARSO is defined in 10 CFR 35.2 as an individual who meets training and experience requirements 10 CFR 35.50 and is identified on a license or a medical use permittee of an NRC Master Materials License licensee as an ARSO. The ARSO's role in the radiation safety program is described in 10 CFR 35.24(b).
- Ophthalmic physicist. Ophthalmic physicist is defined in 10 CFR 35.2 as an individual who meets the training requirements in 10 CFR 35.433(a)(2) and is identified on a license or permit as an ophthalmic physicist. The tasks of the ophthalmic physicist are described in 10 CFR 35.433(b).
- The significant changes included attestation changes
- The written attestation requirement was removed for nearly all individuals meeting the board certification training and experience pathway.
- The wording in the attestation statement for non board-certified individuals was revised to replace the attestation of competency with an attestation that the individual has demonstrated the ability to function independently to fulfill the required radiation safety-related duties.
- For most categories of authorized user physicians, the residency program director may now sign the attestation under certain conditions.
- The significant changes included specialty boards
- The specialty boards formerly listed in 10 CFR Part 35, Subpart J are now listed in 10 CFR 35.57.
- Individuals previously certified by specialty boards recognized under prior 10 CFR 35 Subpart J on or before October 24, 2005, are "grandfathered" so as to be authorized for those materials and uses that they performed on or before October 24, 2005.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Can a physician meeting the training and experience requirements for all three categories of radioactive drugs in paragraph 10 CFR 35.390(b)(1)(ii)(G) be authorized for the use of all unsealed byproduct material requiring a written directive?
No. 10 CFR 35.300 specifically limits the physician to the use of byproduct material identified in 10 CFR 35.390(b)(1)(ii)(G). In the future, there may be radioactive drugs that use radionuclides that are used for a primary emission that does not fall under the categories in 35.390(b)(1)(ii)(G). Therefore, the physician can be authorized for either the "use of all byproduct material identified in 10 CFR 35.390(b)(1)(ii)(G)" or for "use of all byproduct material identified in 10 CFR 35.300."
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
What are the training and experience (T&E) requirements for 10 CFR 35.1000?
The training and experience requirements for 10 CFR 35.1000 medical uses are determined on a case-by-case basis. NRC has developed licensing guidance, including T&E guidance, for certain 10 CFR 35.1000 medical uses. This information is available on the NRC public website titled "Emerging Medical Technologies."
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
How can a licensee or regulator determine if a residency training program is approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education (ACGME) or the Royal College of Physicians and Surgeons of Canada or the Committee on Post-Graduate Training of the American Osteopathic Association?
Licensees and regulators will have to confirm that a residency program is approved. In addition to asking the individual or licensee to provide documentation that the residency program met the appropriate approval, the following web sites can be used to identify the accredited residency programs and program directors for these organizations:
- ACGME under Data Collection Systems, Accredited Programs and Sponsoring Institutions for ACGME approvals from 2001-02 to present;
- ACGME for approved ACGME residency programs from 1942-43 through 2000-01;
- Royal College of Physicians and Surgeons of Canada, Search for the Discipline (e.g., Diagnostic Radiology) and/or Institutions; and
- American Osteopathic website. Although the Committee on Post-Graduate Training of the American Osteopathic Association had residency programs in the past, they do not have any at the time that the 2018 rule was finalized.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Why does 10 CFR 35.590 include the authorized user (AU) for 10 CFR 35.200 uses?
NRC revised 10 CFR 35.65 to make it clear that the use of any sources authorized under 10 CFR 35.65 to administer radiation to patients and human research subjects is medical use, and to be conducted in accordance with the requirements in 10 CFR 35.500. Most of the transmission and reference sources in 10 CFR 35.65 used for medical use are used in imaging and localization procedures performed under 10 CFR 35.200. Therefore, an AU for 10 CFR 35.200 uses was included as an individual qualified for 10 CFR 35.500 medical uses in 10 CFR 35.590.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
May clinical work experience that is not related to radiation safety, such as reviewing case histories or interpreting scans, be counted toward the 700-hour training and experience requirements in §35.290(c)(1) and §35.390(b)(1)? [10 CFR 35.290(c)(1), 35.390(b)(1)] (Q&A ID 0407001)
The regulatory requirements refer to two categories of training: (a) classroom and laboratory training, and (b) supervised work experience. All hours credited to "classroom and laboratory training" must relate directly to radiation safety and safe handling of byproduct material. The classroom and laboratory training may be obtained using a variety of instructional methods, as long it meets the specific clock hour requirements and the subject matter relates to radiation safety and safe handling of byproduct material for the uses for which authorization is being requested.
The supervised work experience for physicians must include, but is not limited to, the subject areas listed in the applicable training and experience requirements. The NRC recognizes that physicians in training may not dedicate all of their supervised work experience time specifically to the subject areas listed in the regulatory requirements (i.e., §35.290(c)(1)(ii) and §35.390(b)(1)(ii)) and will be attending to other clinical matters involving the medical use of the material (e.g., reviewing case histories or interpreting scans). Even though these clinical activities are not specifically required by the NRC, this type of supervised clinical experience may be credited toward the 'work experience' category to obtain the required total of 700 hours of T&E, but not to the 'classroom and laboratory training' category.
Refer to Supplementary Information, Section IV, 'Summary of Public Comments and Responses to Comments,’ Part II, 'General Issues,’ Issue 7, 'Should the term "laboratory training' be defined?" as published in the Federal Register on March 30, 2005, and Supplementary Information, Section III, "Summary of Public Comments and Responses to Comments," Part II, "General Issues," Item E, "Training and Experience," Issue 6, "How Long Should the Training Programs Be for Individuals Who Would Like To Become AUs Under "§35.190, 35.290, and 35.390?," as published in the Federal Register on April 24, 2002.
Transfer of Medical Devices Between Medical Licensees
Can a licensee transfer a licensed medical device to another licensee for use? [10 CFR 30.3, 35.1, 35.49(b)] (Q&A ID 0303008)
Yes. 10 CFR 35.49, “Suppliers of sealed sources and devices for medical use,” section (b) allows sealed sources or devices for medical use to be non-commercially transferred from a Part 35 licensee to another Part 35 licensee. Prior to transfer, the medical licensee receiving the sealed source or device must be authorized on its license to possess and use the device in accordance with applicable sections of Part 35 for which the sealed source or device will be used. See 10 CFR 30.3 and 35.1.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.49, as published in the Federal Register on April 24, 2002.
Treatment Site -- Definition
Does NRC plan to provide guidance on the definition of "treatment site," as used in the requirements for written directives? [10 CFR 35.2, 35.40] (Q&A ID 0902011)
No. The definition in the Final Rule, "the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive," is self-explanatory. Any specific questions on the meaning or usage of this term can be submitted to the NRC.
Unit Dosage Manipulation
Under §35.63, does changing the needle of a unit dosage or introducing a 3-way stopcock constitute a 'manipulation' of the unit dosage? [10 CFR 35.63] (Q&A ID 0303007)
If a unit dosage is changed or manipulated in any way, it is no longer considered to be a unit dosage and will need to be reassayed before it is administered. However, if changing the needle of a unit dosage or introducing a 3-way stopcock does not result in modification of the supplied volume of the unit dosage or adversely impact the homogeneous distribution of the byproduct material throughout the volume of the unit dosage, then such action is not a change or manipulation of the unit dosage.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.63, as published in the Federal Register on April 24, 2002.
Use of Sealed Sources for Medical Use as Approved
Is it the licensee's responsibility to ensure that sealed sources used for medical purposes are only used as approved in the Sealed Source and Device Registry (SSDR)? [10 CFR 33.11, 33.13, 33.17, 35.2, 35.49, 35.400, 35.500, 35.600] (Q&A ID 0802012)
Yes. The only exceptions are for sources used in research in accordance with an active Investigational Device Exemption application accepted by the FDA, provided the requirements of § 35.49(a), concerning suppliers for sealed sources for medical use, are met.
It is NRC's expectation that all sources currently approved for medical use will continue to be approved. NRC prepared an addendum to the SSDR to ensure this expectation is met. Going forward, NRC plans to issue guidance to SSD reviewers to ensure that the intended medical use for each medical use source is clearly identified in the SSDR, along with any applicable limitations on that use.
For a description of the SSDR, refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for Global Changes in the Rule, as published in the Federal Register on April 24, 2002. To access SSDR evaluations, refer to the SSDR webpage.
Note that Type A medical broad scope licensees are not licensed under § 35.400, § 35.500, or § 35.600. Accordingly, they are not limited to SSDR-indicated uses of sealed sources for medical purposes. Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.49, as published in the Federal Register on April 24, 2002.
Written Directives
What are the written directive and medical event reporting requirements for 10 CFR 35.1000?
The written directive requirements for 10 CFR 35.1000 medical uses are determined on a case-by-case basis. NRC has developed licensing guidance, including written directive and medical event guidance, for certain 10 CFR 35.1000 medical uses. If the 10 CFR 35.1000 medical use has unique properties that prevent the written directive requirements and medical event reporting requirements in the regulations from being met, specific written directive and medical event reporting commitments are developed for that use. This information is posted on the NRC public website titled "Emerging Medical Technologies."
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Why were the written directive requirements in 10 CFR 35.40, "Written Directives," and the medical event reporting requirements in 10 CFR 35.3045, "Reporting and Notification of a Medical Event," changed for permanent implant brachytherapy medical use?
The 2002 (67 FR 20250) requirements in 10 CFR 35.40 were for all brachytherapy procedures including permanent and temporary implant brachytherapy and reflect operational aspects of temporary and permanent implant brachytherapy medical use. Not all of the required information elements were appropriate for characterizing permanent implant brachytherapy use. The rule change makes it clear which information is needed for permanent implant brachytherapy. Moreover, for permanent implant brachytherapy, the current requirements were judged to interfere with physicians' ability to take actions relating to delivered dose that they deem to be medically appropriate for patients being treated. Consequently, the NRC determined that the requirements for permanent implant brachytherapy are different and needed to be addressed separately.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
What information is required for proper completion of the written directive for permanent implant brachytherapy?
The information required is:
- Before implantation: the treatment site, the radionuclide, and the total source strength; and
- After implantation but before the patient leaves the post-treatment recovery area: the treatment site, the number of sources implanted, the total source strength implanted, and the date.
Note that the requirement is retained that the written directive must also be signed and dated by an authorized user before administration.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
What does "post-treatment recovery area" mean in 10 CFR 35.40?
The term "post-treatment recovery area" as used in 10 CFR 35.40 means the area or place where a patient recovers immediately following the brachytherapy procedure before being released to a hospital intensive care unit or patient room or in the case of an outpatient treatment, released from the licensee's facility.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
For the two part written directive required for permanent implant brachytherapy medical use, when is the signature of an authorized user required?
An authorized user (AU) must sign the written directive after completion of the pre-implantation portion of the document (but before the administration begins). The current date must also be entered both before the administration begins and after implantation but before the patient leaves the post-treatment recovery area.
The requirement for the AU signature (pre-implantation portion) of the written directive is still addressed in 10 CFR 35.40(a), which refers to all administrations requiring a written directive. The second part of the written directive (post-implantation portion) is now addressed in 10 CFR 35.40(b)(6)(ii), which is specific to permanent implant brachytherapy.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
What are the main changes to the written directive requirements in 10 CFR 35.40, "Written Directives," for permanent implant brachytherapy use?
The changes are:
- Requiring inclusion in the pre-implantation portion of the written directive of the total source strength;
- Deleting the total dose from the post-implantation portion of the written directive and deleting the requirement to include dose; and
- Requiring completion of the post-implantation portion of the written directive before the patient leaves the post-treatment recovery area.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Written Procedures in 10 CFR 35.41
Define the meaning of "high level of assurance" under § 35.41. [10 CFR 35.40, 35.41] (Q&A ID 0802048)
10 CFR 35.41, “Procedures for administrations requiring a written directive,” section (a) provides that for any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide "high confidence" that the patient or human research subject's identity is verified before each administration and each administration is in accordance with the written directive. While "high confidence" is not defined in the regulations, § 35.41(b) establishes the minimum items that must be addressed in the procedures to provide this level of confidence. Licensees have flexibility to include additional information that they consider necessary for a supervised individual to perform a procedure according to the directions of the authorized user.
Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.40 and § 35.41, as published in the Federal Register on April 24, 2002.
What are the main changes to the procedural requirements in 10 CFR 35.41, "Procedures for Administrations Requiring a Written Directive," for permanent implant brachytherapy use?
The main changes are requiring development, implementation, and maintenance of written procedures for:
- Determining if a medical event, as defined in Section 35.3045, has occurred (note that this applies to all administrations requiring a written directive); and
- Determining, for permanent implant brachytherapy, within 60 calendar days from the day the implant was performed (unless accompanied by a written justification related to patient unavailability): The total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
What is the basis for the 60-day limit on verifying that at least 80% of the total source strength was implanted within the treatment site?
The 60-day time limit was recommended by NRC's Advisory Committee on the Medical Uses of Isotopes and reflects the American Association of Physicists in Medicine's (AAPM) suggested time for post implant assessment, which is 30 days for the longest half-life radioactive source used in permanent implant brachytherapy, Iodine-125, which has a half-life of 60 days. Refer to AAPM Report 137, "AAPM Recommendations on Dose Prescription and Reporting Methods for Permanent Interstitial Brachytherapy for Prostate Cancer," which is available on the AAPM website.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
What if the patient is not available within the 60-day time limit for determining whether or not 80% or more of the sources were implanted within the treatment site?
If the patient is unavailable to the licensee within 60 days from the day that the implant was performed, then the licensee cannot perform this assessment. The licensee is required to provide a written justification that explains why the patient was unavailable.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Is it permissible for the licensee to verify source positioning on the same day as the implant procedure or is it necessary to have the patient come in on a different day?
Yes. Although licensees usually make the source positioning determination on a day after the implant procedure, nothing in the regulations precludes licensees from verifying source position on the same day. The requirement in 10 CFR 35.41(b)(6) is for the determination to be made within 60 calendar days from the date the implant was performed. This is a performance-based requirement and does not specifically direct licensees as to how the objectives are to be achieved. One option could be to verify source positioning based on a CT scan performed immediately after a patient is discharged from the post-implant recovery area.
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Does the NRC require licensees conducting permanent implant brachytherapy to use a treatment planning software as well as perform post-implant imaging?
The requirements in 10 CFR 35.41, "Procedures for Administrations Requiring a Written Directive," are performance based and do not explicitly direct licensees as to how the objectives are to be achieved. Accordingly, using treatment planning software or post-implant imaging are not explicitly required. However, NRC believes the use of both is likely necessary to outline the treatment site and make the determination of implanted source positioning to decide whether a medical event has occurred according to the criteria in 10 CFR 35.3045, "Report and Notification of a Medical Event."
See "Guidance for the Final Rule "Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments," effective January 2019, for additional information.
Written Procedures -- Submission to NRC
What required written procedures must be submitted to NRC for review and approval? [10 CFR 20.1406, 35.12(b), 35.18(a)] (Q&A ID 0301006)
All procedures that must be submitted to NRC, with a license application or with an amendment application, involve therapeutic medical units (teletherapy units, remote afterloader brachytherapy units, gamma stereotactic radiosurgery units). The required procedures cover (1) response to abnormal occurrences with potential for unintended patient exposure and (2) steps to be followed when carrying out required periodic spot checks for medical therapeutic units as applicable.
Note that for all applications other than renewals, the applicant must also describe how facility design and procedures for operation will minimize, to the extent practicable, contamination and the generation of radioactive waste, per 10 CFR 20.1406, “Minimization of contamination.”