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Advisory Committee on the Medical Use of Isotopes (ACMUI) 

Comments on the Nuclear Regulatory Commission (NRC) 

Draft NUREG-1556, Volume 9, Rev. 3 

Consolidated Guidance about Materials Licenses 

Program-Specific Guidance about Medical Use Licenses 

Report Date: October 09, 2015 

Subcommittee Members: F. Costello; S. Langhorst (Chair); S. Mattmuller; C. Palestro; J. Suh; 

and P. Zanzonico 

Charge: To provide comments on the non-rulemaking update1

 draft NUREG-1556, Volume 9, 

Rev. 3, “Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 

Medical Use Licenses,” with particular attention to how changes might impact medical licensees 

and to make recommendation for ACMUI action. 

Recommendations 

1. This updated draft of NUREG-1556, Volume 9, Rev. 3 will be made available for public 

comment on the NRC NUREG-1556 website2. Due to the extensive reorganization of this 

revision and the complication of this draft being a separate but parallel update of the 

document, the Committee recommends that the comment period be extended to a minimum 

of 90 days. 

2. Further specific discussions by the medical and regulatory communities and other 

stakeholders on the application of NRC safety culture traits are needed before specific safety 

culture examples are given or safety culture items are included in a model medical licensee 

audit program. The Committee recommends removing the medical use example in Section 

3.2 and the safety culture audit item listed in Appendix L. 

 

1

 The NRC has split updating of NUREG-1556 Volume 9 into two separate but parallel tasks. The first task to 

update guidance for NUREG-1556 Volume 9 occurred contingent with the current 10 CFR 35 rulemaking. Request 

for comment on the first task was published in July 2014 (79 FR 42224, July 21, 2014). The final update of this 

rulemaking-related guidance is being completed as part of the final rulemaking for 10 CFR 35. The second task to 

update guidance for NUREG-1556 Volume 9 is the draft being reviewed for this ACMUI report which contains no 

updates from the first task. Instead, the draft reviewed in this report contains only updates of remaining portions of 

the guidance document not impacted by the 10 CFR 35 rulemaking, except as noted later in this report for patient 

release guidance. As such, the AMCUI recommendations provided in this report do not include 10 CFR 35 

rulemaking nor certain patient release portions of the guidance document. 

2

 http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/. 
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3. The Committee recommends that identification of locations for medical use of byproduct 

materials be limited to specific addresses (e.g., street and building) rather than using global 

positioning system coordinates. 

4. The Committee recommends that the description of information required by the NRC to be 

included in a license application or amendment pertaining to a consultant Radiation Safety 

Officer be accompanied by the criteria used by the NRC to judge the acceptability of a 

candidate’s qualifications. 

5. The Committee recommends a footnote be added in Section 8.9.3 to clarify that the term 

“dose” continues to be used by many medical licensees to refer to the activity of unsealed 

byproduct material. 

6. The Committee recommends that the “CardioGen-82 Highlights of Prescribing Information” 

document be removed from the reference list in Section 8.9.3 because the document does not 

address the equipment used to measure the Rb-82 dosage. The Committee also recommends 

that the paragraph discussing the Rb-82 generator be moved to the end of the “Discussion” 

segment. 

7. The Committee recommends adding reference to RIS 2013-12, to EMG 2013-003, and to the 

“CardioGen-82 Highlights of Prescribing Information” document in Section 8.10.20 after the 

paragraph discussing Sr-82 and Sr-85 concentrations so that licensees are reminded of the 

circumstances regarding the NRC’s use of enforcement discretion not to issue a violation 

regarding use of Rb-82 generator systems. The Committee also recommends that a footnote 

be added to the Appendix L medical audit section on generator use which references this 

important issue on the use of Rb-82 generator systems in Section 8.10.20. 

8. The Committee commends the effort by the NRC to minimize duplicate guidance documents 

by removing the Rev 2 Appendix AA on licensee use of a consortium and instead directing 

licensees to the primary reference document. The Committee recommends that the NRC take 

similar action by removing the Rev 2 Appendix U on patient release and instead reference 

Regulatory Guide 8.39. 

9. The Committee recommends that the NRC not include guidance on patient release that 

completely reverses the NRC final rule statements that the dose limit of 5 mSv (0.5 rem) is 

anything other than a per-release limit. 

10. The Committee recommends adding reference to NCRP Report No. 173 in Appendix L for 

conducting self-assessment of radiation safety programs. 
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General Comments on Draft NUREG-1556, Volume 9, Rev. 3

Sections have been revised to conform to Items 5-11 listed on the NRC Form 313 

“Application for Materials License”. Although the ACMUI finds the reorganization of the 

guidance document to be an overall improvement, it is challenging to identify the changes that 

have been made. Review of this draft document is also complicated by the NRC’s decision to 

split the update of NUREG-1556 Volume 9 into two separate but parallel tasks. The Committee 

therefore recommends that the comment period be extended to a minimum of 90 days. 

Specific Comments on Draft NUREG-1556, Volume 9, Rev. 3

Safety Culture 

The Section 3.2 on Safety Culture is new. The NRC issued its final safety culture policy 

statement3 since the last revision of this guidance document. The NRC’s positive safety culture 

traits are listed in Table 3.1. The policy statement ends with the following statements regarding 

implementation and inspection of a licensee’s safety culture. 

“There may be traits not included in this Statement of Policy that are also important in a 

positive safety culture. It should be noted that these traits were not developed to be used 

for inspection purposes. 

It is the Commission’s expectation that all individuals and organizations, performing or 

overseeing regulated activities involving nuclear materials, should take the necessary 

steps to promote a positive safety culture by fostering these traits as they apply to their 

organizational environments. The Commission recognizes the diversity of these 

organizations and acknowledges that some organizations have already spent significant 

time and resources in the development of a positive safety culture. The Commission will 

take this into consideration as the regulated community addresses the Statement of 

Policy.” 

Appendix L of the draft guidance document provides a model medical licensee audit. Item 5 

under “Radiation Safety Program” states: 

“Is a positive safety culture program in place? Are the traits identified in NRC’s Safety 

Culture Policy Statement addressed [NUREG/BR-0500]?” 

The Committee recommends that this item be deleted from the model audit because it contradicts 

the NRC’s statement that “these safety culture traits were not developed to be used for inspection 

purposes.” 

 

3

 NRC Final Safety Culture Policy Statement (76 FR 34773, June 14, 2011). 
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 The Committee agrees that maintenance of a positive safety culture is important for 

medical licensees. The NRC’s development of its safety culture policy has focused primarily on 

nuclear power and non-medical uses of byproduct material. The Committee believes that the 

application of the NRC’s safety culture policy to medical use of byproduct material should be 

addressed in a dialogue between the medical and regulatory communities if the NRC plans to 

develop specific safety culture guidance or examples specific to medical licensees. The special 

circumstances of purposely exposing patients to radiation, the measure of the benefits of this 

exposure, patient safety programs developed by medical licensees, and the impact of NRC 

regulations on patient safety and accessibility to medical care all need to be fully explored in 

order to properly define and apply the meaning of NRC safety culture traits to the medical use of 

byproduct material. The Committee therefore recommends Section 3.2 “Safety Culture” be 

modified to remove the specific medical use example as follows: 

“The NRC, as the regulatory agency with an independent oversight role, reviews the 

performance of individuals and organizations to determine compliance with requirements 

and commitments through its existing inspection and assessment processes. However, 

the NRC’s safety culture policy statement and traits are not incorporated into the 

regulations. Many of the safety culture traits may be inherent to an organization’s 

existing radiation safety practices and programs. For instance, time-outs before a 

therapeutic procedure provide an opportunity for the medical team to double-check 

treatment parameters and the WD to reduce the likelihood of a medical event. The use of 

time-outs may correspond with the safety culture training specified in Table 3.1 as “Work 

Processes” (the process of planning and controlling work activities is implemented so that 

safety is maintained). However, licensees should be aware that this is just an example, 

and should consider reviewing their radiation safety programs in order to develop and 

implement a safety culture commensurate with the nature and complexity of their 

organizations and functions.” 

Global Positioning System (GPS) Coordinate 

Section 8.3 encourages the applicant “to provide global positioning system coordinates, 

as appropriate.” The Committee recommends that specific facility addresses be used, rather than 

GPS coordinates, to specify the locations of byproduct material use for a medical licensee. GPS 

coordinates are not as descriptive and certainly not as familiar, as street or building addresses, 

especially in the setting of a large medical facility. 

Outside Consultant or Contractor Appointed as RSO 

Section 8.7.1 requires that an applicant provide new specific information when an outside 

consultant or contractor is appointed as the Radiation Safety Officer (consultant-RSO). This 

information includes: identification of other licenses the consultant-RSO covers; the minimum 

time (hours per week) the consultant-RSO will be onsite; appointment of in-house point of 

contact during consultant-RSO’s absence; overall availability of the consultant-RSO to respond 

to radiation safety program and regulatory questions or operational issues; and maximum amount 
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of time needed for the consultant-RSO to arrive at the facility. The Committee recommends that 

the description of information the NRC requires an applicant to provide in a license application 

or amendment regarding a consultant-RSO be accompanied by the NRC criteria used to judge 

the acceptability of a consultant-RSO. 

Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Byproduct 

Material 

Section 8.9.3 provides guidance on measuring dosages of unsealed byproduct material. 

The term, “dosage”, was introduced in the 2002 revision4

 of 10 CFR 35 with the new definitions 

of prescribed dosage, therapeutic dosage, and unit dosage to signify the activity of unsealed 

byproduct material. This regulatory terminology change was made in an effort to replace the 

previous term, “dose”, which also refers to the amount of energy absorbed per unit mass. 

However, this regulatory definition has not been universally applied as is evident by the primary 

equipment used to measure dosage still being identified as a “dose calibrator”. The Committee 

recommends the addition of the following footnote at the end of the “Criteria” section 

recognizing that the term “dose” continues to be used by medical licensees to refer to the activity 

of unsealed byproduct material: 

“... and check of instruments (e.g., doseFN calibrators) used to measure patient dosages. 

FN The term, ‘dose’, continues to be used by many medical licensees to refer to the 

activity of unsealed byproduct material.” 

Rubidium-82 Generator Systems 

Following the 2011 recall of Rb-82 generators by the manufacturer, NRC initiated a 

detailed examination of its current regulations with respect to the operation of the generator, the 

infusion cart, the radiation detector used to measure the Rb-82 dosage, and the Sr-82/Sr-85 

concentration determination process5

. The NRC determined that licensees using the generators 

could not meet the current NRC regulatory requirements in: (1) 10 CFR 35.60 to calibrate the 

instrument used to measure the activity of the dosage administered to each patient or human 

research subject in accordance with nationally recognized standards or calibration instructions 

provided by the manufacturer, and (2) 10 CFR 35.63 to determine the activity of each dosage 

administered before medical use. The NRC issued an enforcement guidance memorandum6

which provides three criteria that, if met, will permit NRC to use enforcement discretion and not 

 

4

 79 FR 20250, “Medical Use of Byproduct Material – Final Rule,” April 24, 2002. 

5

 RIS 2013-012, “Notice Of Issuance Of Enforcement Guidance Memorandum – Interim Guidance For 

Dispositioning Violations Involving 10 CFR 35.60 And 10 CFR 35.63 For The Calibration Of Instrumentation To 

Measure The Activity Of Rubidium-82 And The Determination Of Rubidium-82 Patient Dosages,” August 23, 

2013. 

6

 EGM 2013-003, “Enforcement Guidance Memorandum - Interim Guidance for Dispositioning Violations 

Involving 10 CFR 35.60 and 10 CFR 35.63 for the Calibration of Instrumentation to Measure the Activity of 

Rubidium-82 and the Determination of Rubidium-82 Patient Dosages,” April 18, 2013. 
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cite violations for failure to comply with the requirements for Rb-82 generator systems in 10 

CFR 35.60 and 10 CFR 35.63. This action taken by the NRC was crucial to allow licensees to 

reinitiate use of Rb-82 generators for cardiac PET exams, and it is important to remind licensees 

of these special circumstances surrounding the medical use of a Rb-82 generator. 

The “Discussion” section of Section 8.9.3 lists further guidance for the measurement of 

dosages from Rb-82/Sr-82 generators. The Committee agrees that RIS 2013-12 and EGM-13-

003 are important guidance documents for this list as these documents address the circumstances 

regarding the NRC’s use of enforcement discretion not to issue a violation regarding use of Rb82 generator systems. However, the Committee recommends that the “CardioGen-82 Highlights 

of Prescribing Information” document be removed from this list because this document does not 

address issues regarding the equipment used to measure the Rb-82 dosage. The Committee also 

recommends moving this paragraph to the end of the “Discussion” segment of this section. 

Section 8.10.20 includes guidance on recording and maintaining documentation of each 

dosage to reflect proper use and accountability. The Committee recommends adding reference to 

RIS 2013-12, to EMG 2013-003, and to the “CardioGen-82 Highlights of Prescribing 

Information” document in Section 8.10.20 after the paragraph discussing Sr-82 and Sr-85 

concentrations so that licensees are reminded of the circumstances regarding the NRC’s use of 

enforcement discretion not to issue a violation regarding use of Rb-82 generator systems. This 

reference can read as follows: 

“Licensees who use rubidium-82 (Rb-82)/strontium-82 (Sr-82) generators should also 

refer to the following for further guidance on documentation and recordkeeping: 

 Regulatory Issues Summary 2013-012, ‘Notice of Issuance of Enforcement 

Guidance Memorandum—Interim Guidance for Dispositioning Violations 

Involving 10 CFR 35.60 and 10 CFR 35.63 for the Calibration of Instrumentation 

to Measure the Activity of Rubidium-82 and the Determination of Rubidium-82 

Patient Dosages,’ August 23, 2013 

 Enforcement Guidance Memorandum 2013-003, ‘Interim Guidance for 

Dispositioning Violations Involving 10 CFR 35.60 and 10 CFR 35.63 for the 

Calibration of Instrumentation to Measure the Activity of Rubidium-82 and the 

Determination of Rubidium-82 Patient Dosages,’ April 18, 2013 

 CardioGen-82 Highlights of Prescribing Information, label approved on 

02/08/2012 for NDA No. 019414.” 

The Committee also recommends that a footnote be added to the Appendix L medical 

audit section on generator use which references this important issue on the use of Rb-82 

generator systems in Section 8.10.20. This footnote can read as follows under segment for 

“Dose or Dosage Measuring Equipment”: 

“3. Licensee uses generators?FN
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FN See Section 8.10.20 for additional information regarding Rb-82 generators.” 

Guidance Regarding Licensees Use of a Consortium 

The Committee notes that the Rev. 2 Appendix AA “Production and Noncommercial 

Distribution by the Medical Facility of PET Radioactive Drugs to Consortium Members under 

Authorization of 10 CFR 30.32(j)” was removed. Instead in Section 8.5.1, licensees are 

encouraged to review NUREG-1556, Volumes 13 and 21 for use of a consortium for 

noncommercial distribution of PET radionuclides. The Committee commends the NRC on its 

effort to minimize duplication of guidance documents. By referencing a primary guidance 

document rather than duplicating that same guidance in a second location, maintenance of the 

primary document is easier and the possibility that these multiple documents diverge into 

inconsistent guidance is eliminated. 

Guidance Regarding Patient Release 

The Committee recommends that the NRC remove the Rev. 2 Appendix U “Model 

Procedures for Release of Patients or Human Research Subjects Administered Radioactive 

Materials” and instead refer licensees to Regulatory Guide 8.39 “Release of Patients 

Administered Radioactive Materials”. Again, the removal of this duplicate model procedure will 

make maintenance of patient release guidance easier and minimize chance of confusing licensees 

and patients with potential differences that may arise in separate guidance documents. The 

Committee supports and considers it most appropriate to maintain the primary guidance for 

patient release in Regulatory Guide 8.39. Use of the NUREG-1556 series of guidance volumes 

largely resides with individuals responsible for licensing and managing radiation safety 

programs. Guidance for patient release is of more universal interest not only to licensees, but 

also to the general medical community, patients, patient families, and the public. In the 

Committee’s opinion, the stand-alone primary guidance document, Regulatory Guide 8.39, is the 

most appropriate type of guidance document for this subject to support the NRC’s commitment 

to conducting its regulatory responsibilities in an open and transparent manner. 

With the recommended removal of Appendix U, the information contained in the 

introductory sections, “Model Procedures for Release of Patients or Human Research Subjects 

Administered Radioactive Materials” and “Special Considerations and Guidance for Release of 

Patients Following I-131 Therapy” can be included in Section 8.10.18 “Item 10: Release of 

Patients of Human Research Subjects” in the main document. However, the following sentence 

at the beginning of Appendix U “Special Considerations and Guidance for Release of Patients 

Following I-131 Therapy” is misleading and should be deleted. 

“Although the regulations are not explicit, licensees should consider implementing the 5 

mSv (0.5 rem) as an annual limit for multiple administrations during a calendar year.” 
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The Committee again reemphasizes7 that 5 mSv (0.5 rem) was set as the basis for patient release 

established by the NRC in its final rulemaking8 for each patient release, as explicitly stated in 

these two sentences: 

“The NRC is establishing a dose limit of 5 millisieverts (0.5 rem) total effective dose 

equivalent to an individual from exposure to the released patient for each patient release.” 

[Page 4122, Column 3, beginning of first full paragraph] 

 

and 

“Each patient release is to be treated as a separate event, and licensee knowledge of 

previous administrations is unnecessary.” [Page 4130, Column 3, end of first full 

paragraph] 

These explicit statements by the NRC in the patient release final rulemaking conflict with the 

guidance encouraging licensees to consider 5 mSv (0.5 rem) as an annual limit. The Committee 

is concerned that introducing this inconsistency could cause patient anxiety and licensee 

confusion about how to maintain compliance with patient release criteria, both of which could 

result in the procedure being delayed, replaced by a less effective medical procedure, or even 

cancelled. The NRC recently stated9

 its intention to pursue rulemaking on this topic. Until that 

rulemaking process is completed, the Committee feels it is inappropriate for NRC guidance 

on patient release to completely reverse the NRC final rule statements that the dose limit of 

5 mSv (0.5 rem) is anything other than a per-release limit. 

The Committee did not review and comment on the body of Appendix U because update 

of that guidance is being conducted by another separate task to update patient release guidance10. 

NCRP Reference 

The Committee recommends including NCRP Report No. 173, “Investigation of 

Radiological Incidents” (2012), as a reference by adding the following paragraph before the 

“Annual Radiation Protection Medical Licensee Audit” in Appendix L: 

“NCRP Report No. 173 states the two general objectives of a self-assessment process are 

to: (1) self-identify and correct deficiencies or weaknesses in the radiation protection 

program; and (2) improve the performance of the radiation protection program by 

ensuring that its design, development, and implementation are effective and efficient.” 

 

7

 ACMUI “Patient Release Report”, December 13, 2010 – See section “Annual Dose Limits versus Per-Release 

Dose Limits (http://pbadupws.nrc.gov/docs/ML1034/ML103481099.pdf) 

8 62 FR 4120: “Criteria for the Release of Individuals Administered Radioactive Material - Final Rule”, NRC 

Docket No. RIN 3150-AE41, January 29, 1997. 

9

 NRC RIS 2008-07, “Dose Limits for Patient Release Under 10 CFR 35.75”, March 27, 2008. 

10 The Commission has directed the NRC Staff to revise Regulatory Guide 8.3 as part of the Patient Release Project 

(COMAMM-14-001/COMWDM-14-001 “Background and Proposed Direction to NRC Staff to Verify Assumptions 

Made Concerning Patient Release Guidance,” March 10, 2014).