ACMUI Sub-Committee Comments on NRC Proposed Rule, Final, 3/28/13 

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Advisory Committee on Medical Uses of Isotopes (ACMUI) 

Sub-Committee on Proposed Rule 

Comments on

NUCLEAR REGULATORY COMMISSION (NRC)

10 CFR Parts 30, 32 and 35

RIN: 3150-AI63 [NRC-2008-0175]

Medical Use of Byproduct Material 

- Medical Event Definitions, Training and Experience, and Clarifying Amendments 

Subcommittee Members: 

Susan Langhorst, Ph.D., Steven Mattmuller, Bruce Thomadsen, Ph.D., Laura Weil, 

James Welsh, M.D., Pat Zanzonico, Ph.D. (Chair) 

 Date: March 28, 2013

revised, April 5, 2013

Note

This document provides comments by a Sub-Committee of the ACMUI on the public version of 

10 CFR Parts 30, 32 and 35, RIN: 3150-AI63 [NRC-2008-0175] - Medical Use of Byproduct 

Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments. The 

Sub-Committee identifies many of its comments with respect to the relevant page and/or line 

numbers in a version of the foregoing document in which it has inserted line numbers. 

The ACMUI has unanimously approved this current, final version of this report. 

General Comments

1. Medical event (ME) definitions for permanent implant brachytherapy 

a. Historical review of permanent implant brachytherapy misadministration/medical event. 

In considering the criteria for an ME in permanent implant brachytherapy, it would be 

helpful to review the recent regulatory history of MEs for this form of therapy. In the 

current 10 CFR 35.2 (Definitions), “prescribed dose” for manual brachytherapy is defined 

as “...either the total source strength and exposure time or the total dose, as 

documented in the written directive.” This definition implies that total source strength 

(activity) or exposure time is interchangeable with total dose. The current ME criteria in 

10 CFR 35.3045 (a) (1) (i) do not include any dose unit and so do not appear to exclude 

use of total source strength (activity) or exposure time. The activity-based criterion for 

permanent implant brachytherapy MEs in proposed rule thus does not actually differ 

from that in the current. 

To explore this further, previous Part 35 rulemakings were reviewed. NRC’s final rule for 

“Quality Management Program and Misadministrations” published July 25, 1991 [58 FR 

34104] established the first definition of a misadministration, which for brachytherapy is 

as follows. 
ACMUI Sub-Committee Comments on NRC Proposed Rule, Final, 3/28/13 

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“A brachytherapy radiation dose: 

(i) Involving the wrong patient, wrong radioisotope, or wrong treatment site 

(excluding, for permanent implants, seeds that were implanted in the correct site 

but migrated outside the treatment site); 

(ii) Involving a sealed source that is leaking; 

(iii) When, for a temporary implant one or more sealed sources are not removed 

upon completion of the procedure; or 

(iv) When the calculated administered dose differs from the prescribed dose by more 

than 20 percent of the prescribed dose.” [58 FR 34120].

While item (iv) uses the term, “calculated administered dose,” the document also 

provides the following discussion of a brachytherapy misadministration: 

“Paragraph (6) applies to brachytherapy procedures other than those specified in 

paragraph (5) above. This paragraph is essentially the same as paragraph (d) in the 

proposed definition of prescription. This paragraph requires the authorized user (AU) to 

specify, before implantation, the radioisotope, the source strengths, and the number of 

sources, but does not require the total dose because detailed calculations are required 

to determine the total dose after the sources are implanted. However, following 

implantation but before completion of the procedure, AU must specify, among other 

parameters, the total source strength and exposure time. If the AU prefers, the total 

dose may be used instead of the total source strength and exposure time. This change, 

using total source strength and exposure time, provides an easy way of specifying the 

total dose and simplifies the determination of a misadministration. Since the total source 

strength is fixed when the sources are implanted, delivering the prescribed dose is a 

matter of using the correct (ie prescribed) exposure time. In other words, after 

implanting the correct sources, the exposure time (and total dose) will be correct if the 

sources are removed at the correct time.” [58 FR 34115]. 

The foregoing discussion suggests that the current rule allows use of total source 

strength and exposure time to identify whether there was a misadministration. 

In NRC’s final rule for “Medical Use of Byproduct Material” published April 24, 2002 [67 

FR 20250], the requirements of 35.3045 “...are based on the current requirements in 

Section35.33, Notifications, reports, and records of misadministrations” [67 FR 20363]. 

This rulemaking description does not indicate that NRC will no longer allow use of total 

source strength and exposure time in determination of a ME. Would that not mean that 

the 1991 statement allowing use of total source strength and exposure time also applies 

to identifying a brachytherapy ME? The ACMUI and its Rulemaking Sub-Committee 

unanimously recommend NRC staff allow use of total source strength as a substitute for 

total dose for determining MEs for permanent implant brachytherapy until the Part 35 

rulemaking is complete. 

b. Changing the number-of-seeds component of the ME definition to be compared to the 

post-implant written directive (WD) is appreciated, since it clarifies that the AU is allowed 

to change the implant plan based on his/her medical decision during the implant 

procedure. 
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c. There is some concern that the proposed ME definition may discourage practitioners 

from utilizing this therapy. The ACMUI and its Rulemaking Sub-Committee therefore 

unanimously recommend that NRC solicit information on whether the proposed ME 

definition for permanent implant brachytherapy will discourage licensees from using this 

therapy option or will otherwise adversely impact clinical practice, with the recognition 

that NRC may utilize language it deems most appropriate for soliciting this type of 

information from its stakeholders. 

d. There is also concern with the OAS’s position (page 29, lines 871-879, and page 77 

(“Draft Compatibility Table for Proposed Rule”)) that the draft rule re-defining MEs in 

permanent implant brachytherapy should be designated as Compatibility Category C for 

the Agreement States, thereby allowing them to retain the dose-based criteria for 

definition of a ME. The rationale for conversion from dose-based to activity-based 

criteria has been detailed, with the most important component of this rationale being the 

failure of dose-based criteria to sensitively and specifically capture clinically significant 

“misadministrations” in permanent implant brachytherapy. Retaining the current dosebased criteria (as specified in Section 35.3045), would still result in clinically insignificant 

occurrences being identified as MEs and thereby perpetuate the confusion associated 

with the current activity-based criteria. The ACMUI and its Rulemaking Sub-Committee 

recommend that the draft rule re-defining medical events in permanent implant 

brachytherapy be designated as Compatibility Category B. This recommendation was 

approved by the ACMUI with one dissenting vote. 

e. Rather than ascribing the rationale for the ME criteria based on the absorbed dose to 5 

cubic centimeters of contiguous normal tissue “...to the literature...,” the following 

reference should be cited: 

S Nag, H Cardenes, S Chang, I Das, B Erickson, G Ibbott, J Lowenstein, J Roll, B 

Thomadsen, M Varia. Proposed guidelines for image-based intracavitary brachytherapy for 

cervical carcinoma: Report from Image-Guided Brachytherapy Working Group Int J Radiat 

Oncol Biol Phys 60:1160-1172, 2004. 

The ACMUI and its Rulemaking Sub-Committee unanimously recommend citation of this 

reference in the proposed rule. 

2. Training and experience (T&E) requirements for authorized users (AU), medical 

physicists, Radiation Safety Officers (RSO), and nuclear pharmacist. 

a. There is enthusiastic support for eliminating the preceptor statement requirement for 

Board-certified individuals. 

b. With regard to the sentence on page 48, lined 1447-1448, why do AUs need to have 

work experience on the elution of generators? This topic should be covered as part of 

their didactic (ie classroom and laboratory) training. It is likely that the vast majority of § 

35.200 AUs are not responsible for a generator system because they obtain unit 

dosages or bulk radionuclide from a commercial radiopharmacy. Would it not make 

more sense, therefore, that licensees approved to use generator systems show specific 

training on the requirement now listed under § 35.290 (c) (1) (ii)( G) for those individuals 

(AUs and others) who are responsible for proper operation and test of the generator as 

part of their license conditions? This could be similar to the way boiler-plate license 

conditions are used for sealed-source leak test requirements or for decay-in-storage 

requirements. The ACMUI and its Rulemaking Sub-Committee thus recommend 
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unanimously that (a) licensees approved to use generator systems show specific training 

on the requirement now listed under 35.290 (c) (1) (ii) (G) for those individuals 

(Authorized Users and others) who are responsible for proper operation and testing of 

the generator as part of their license conditions and (b) that Authorized Nuclear 

Pharmacists who have the adequate training and experience (T&E) are able to provide 

the supervised work experience for Authorized Users on the elution of generators. 

c. With respect to the amended requirements for preceptor attestation for an individual 

seeking regulatory authorization as an RSO, AMP, ANP, or AU, the ACMUI and its 

Rulemaking Sub-Committee unanimously endorse the attestation language in the 

proposed rule stating that the individual can “...independently fulfill the radiation safetyrelated duties...” associated with the authorization being requested. This replaces the 

language in the current rule requiring the preceptor to attest that the individual “...has 

achieved a level of competency to function independently...” for the authorization. The 

proposed language thus eliminates burdening preceptors with making a subjective 

judgment as to the professional competency of an individual. The latter language 

requires, more reasonably, the preceptor to simply attest that an individual satisfactorily 

completed the residency and other requirements of a training program (an objective 

determination) but does not require the preceptor to make a judgment as to the actual 

competency of the individual (a subjective determination). 

d. The ACMUI has reservations about certain elements of Section 35.390 (Training for use 

of unsealed byproduct material for which a written directive is required) (pages 49-51) 

and of Section 35.396 (Training for the parenteral administration of unsealed byproduct 

material requiring a written directive) pages (53-55). Specifically, lines 1503 to 1508 

(Section 35.390) state, “The current regulations include a broad category for parenteral 

administrations of ‘any other’ radionuclide. This broad category would be removed as 

any new parenteral administration of radionuclides not listed in this paragraph would be 

regulated under § 35.1000. This approach would allow the NRC to review each new 

proposed radionuclide for parenteral administration and determine the appropriate T&E 

for its use.” And lines 1628-1632 (Section 35.396) state, “AUs authorized to use any of 

the categories for parenteral administration of radionuclides in § 35.390(b) (1) (ii) (G) 

would also have to meet the supervised work experience requirements in paragraph (d) 

of this section for each new parenteral administration listed in § 35.390(b) (1) (ii) (G) for 

which the individual is requesting AU status.” The proposed radionuclide-byradionuclide determination by the NRC of T&E requirements is unnecessary, places an 

unnecessary regulatory burden on practitioners, and may delay or prevent patient 

access to effective radionuclide-based diagnostics and therapeutics. There are only 

several types of radiations associated with radioactive decay: photons (x- and gammarays), beta particles (positrons and negatrons), electrons (internal conversion and 

Auger), and alpha particles, and there is no fundamental difference in the clinical 

applications and radiation safety among these radiations. The ACMUI believes the 

training and experience a physician receives to perform parenteral administration of a 

radiopharmaceutical, including the three cases of work experience, is sufficient in 

demonstrating that physician’s competency to function as an AU for both beta-/gammaemitting and alpha-emitting radiopharmaceuticals. NRC staff has not provided a 

compelling radiation-safety need for emission-specific T&E requirements. The ACMUI is 

concerned that this separation would have the opposite effect: the separation of beta-

/gamma-emitting alpha-emitting radiopharmaceuticals expends licensee and regulatory 

staff resources in the prescriptive bookkeeping needed to track all these separate work 

experiences that the supervising AU and the physician being trained has had. In 
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addition, the ACMUI is concerned that the proposed separation does not address how 

AUs currently approved under § 35.390 and § 35.396 will be grandfathered to allow 

parenteral administration alpha-emitting radiopharmaceuticals and to act as supervising 

AUs for § 35.390 (b) (1) (ii) (G). Therefore, The ACMUI and its Rulemaking SubCommittee recommend unanimously (with one abstention) that the work experience for 

parenteral administrations under § 35.390 (b) (1) (ii) (G) and § 35.396 not be separated 

between parenteral administration of a beta/gamma-emitting radiopharmaceutical versus 

an alpha-emitting radiopharmaceutical as proposed. 

3. Extending grandfathering to certain certified individuals (Ritenour petition) 

a. The ACMUI recommended in September 2012 that all individuals who were able to meet 

the requirements of the previous Subpart J for an authorized user, authorized radiation 

safety office, authorized medical physicist, or authorized nuclear pharmacist before that 

subpart was eliminated as of October 24, 2005 should be grandfathered, thus relieving 

them of meeting the current training and experience requirements. The draft proposed 

regulations contain the provision, “...for the modalities that they practiced as of October 

24, 2005 and that their previously-acceptable qualifications for authorized status should 

continue to be adequate and acceptable from a health and safety standpoint such as to 

allow them to continue to practice using the same modalities.” See related Specific 

Comments below. 

b. Some of the terminology NRC has historically used and now uses in the proposed rule is 

somewhat confusing. For clarification of meaning, it is suggested that the terms, “type of 

use”, “modality”, and “category,” be explicitly defined in Section 35.2 (Definitions), so that 

the regulatory meaning of these three terms is clearly understood. 

c. What remains unclear with respect to the Ritenour petition is the impact of the date of 

recognition of a certifying board by the NRC. The ACMUI and its Rulemaking SubCommittee unanimously recommend that the date of recognition by the NRC of a 

certifying board should not impact individuals seeking to be named as an authorized 

user, authorized radiation safety office, authorized medical physicist, or authorized 

nuclear pharmacist through the certification pathway. Once a board has been 

recognized by the NRC, the date of recognition is irrelevant. This point should be stated 

explicitly in the proposed rule. 

4. Measuring molybdenum contamination for each elution and reporting of failed 

breakthrough tests 

a. Only two generator systems are specified in the current and proposed rules, 

molybdenum-89 (Mo-99)/technetium-99m (Tc-99m) and strontium-82 (Sr-82)/rubidium89 (Rb-89) generators. Should other generator systems be included or should this 

section be generalized to all medical generator systems? 

The current Food and Drug Administration (FDA) labeling requirements (ie the package 

insert) for a Mo-99/Tc-99m generator states that each eluate should be tested for Mo-99 

content, to verify it does not exceed the stipulated limit of 0.15 Ci of Mo99 per mCi of 

Tc99m at the time of patient administration. The current FDA labeling is therefore more 

restrictive than the current NRC rule, while the proposed rule will match that of the FDA 

in terms of frequency of eluate testing (ie for each elution). Therefore, The ACMUI and 

its Rulemaking Sub-Committee unanimously recommend the NRC adopt the FDAapproved package insert for parent-breakthrough limits for radioisotope generators. 
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Pursuant to its recently revised labeling requirements for strontium-89 (Sr-89)/rubidium89 (Rb-89) generators, the FDA’s regulation is now more restrictive than the NRC’s rule 

in terms of breakthrough limits. The new FDA limits are one-half of those of the NRC 

and an action level limit has been introduced. The NRC, however, is not revising its rule 

to comply with the FDA regulation. As discussed at the 4/17/2012 ACMUI meeting on 

April 18, 2012, the NRC encourages licensees to follow good medical practice but would 

not cite a licensee if the licensee did not follow the applicable FDA requirements 

regulation. 

For generator breakthrough testing, conformity between the corresponding FDA 

regulations and NRC rules is highly recommended. This would be especially beneficial 

as new generators (eg the germanium-68 (Ge-68)/gallium-68 (Ga-68) generator) 

become FDA-approved products. The NRC would be able to inspect, immediately, for 

compliance with the applicable FDA breakthrough testing requirements and thus would 

not have to await revision of its rules for testing newly introduced generators. Of course, 

if the NRC feels it cannot inspect a licensee for compliance with the applicable FDA 

regulation at this time, then the proposed rule for breakthrough testing of Mo-99/Tc-99m 

generators is recommended. 

b. The proposed NRC reporting requirement for out-of-tolerance generator elutions was 

debated at length by the ACMUI. Specifically, “The NRC proposes to add two new 

reporting requirements related to breakthrough of Mo-99 and Sr-82 and Sr-85 

contamination. One reporting requirement in § 35.3204(a) would require licensees to 

report to the NRC and the manufacturers or distributers of medical generators any 

measurement that exceeds the limits specified in § 35.204(a) within 24 hours. The 

second requirement in § 30.50 would require manufacturers/distributors to report to the 

NRC when they receive such a notification from a licensee” (page 26 (lines 788-793), 

Section IV. f. (Requiring reporting and notification of failed Mo-99/Tc-99m and Sr-82/Rb82 generators)). To lessen the reporting burden on licensees, the ACMUI considered 

reducing the reporting requirement for licensees to a single requirement, namely, 

reporting to the vendor. If licensees were required to report out-of-tolerance elution 

results to the vendor (which is the standard prevailing practice when out-of-tolerance 

generator elutions are found), then a requirement for the vendor to report such results to 

the NRC could be imposed. By a split vote, the ACMUI does not support the 

requirement in the proposed rule that licensees report to the NRC generator elutions 

with out-of-tolerance parent-breakthrough, as discussed below. 

The ACMUI does not find the NRC’s rationale - in lines 768-804 on pages 26 and 27 - 

for its proposed dual-reporting requirement (to the vendor and to the NRC) for out-oftolerance generator elutions compelling. In the exposition of its rationale, the NRC 

states, for example, that, “The FDA may not investigate each reported incident and may 

take a considerable amount of time in investigating the cause of reported failures.” 

Given the FDA’s long-standing experience and expertise in the regulation of 

radiopharmaceuticals, however, it is the regulatory agency of choice for dealing with outof-tolerance generator elutions. Further, the assertion that, “...some incidents of failed 

generators may not be reported to the FDA because certain manufacturers are not in the 

United States, and the generators are distributed by vendors who are not required to 

report to the FDA,” is somewhat specious. If a drug product in used in the United States, 

it requires FDA approval. And, in either the new drug or an abbreviated new drug 

application, the manufacturing standard operating procedures (SOPs) and 

manufacturing site will be reviewed, inspected and approved by the FDA before the 
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product is actually marketed. If a licensee’s generator is not performing to specifications 

and thus cannot be used for patient studies, the manufacturer will be notified 

immediately, either directly or indirectly through a vendor. The foregoing SOPs include 

protocols for documenting and reporting a product failure when the manufacturer is 

contacted by a customer/licensee, including how to form and implement a Deviation 

Investigation Team (DIT) to investigate such a failure. These SOPs also include a 

procedure for implementing and performing a Corrective and Preventative Action 

investigation if a DIT is unsuccessful. Finally, a formal mechanism in already in place for 

sharing of information among federal agencies, with a memorandum of understanding 

(MOU) dated December 4, 2002 between the FDA and the NRC - “The purpose of this 

MOU is to coordinate existing NRC and FDA regulatory programs for (1) medical 

devices, drugs, and biological products utilizing byproduct, source, or special nuclear 

material...” The MOU also calls for an annual meeting between the two agencies, 

providing an appropriate mechanism for addressing criteria for the evaluation process 

and the assessment of the regulatory response to issues of mutual responsibility. 

c. With respect to Sr-82/Rb-82 generators, the proposed “reporting” rule does not actually 

address the underlying cause - the apparent failure of licensees to perform daily 

breakthrough testing - of the recent reported instances of excess radiostrontium 

breakthrough. Appropriate breakthrough testing at the two medical facilities involved 

very likely would have detected the out-of-tolerance breakthrough results and avoided 

the resulting large-scale disruption of Rb-82 myocardial perfusion studies. Has the NRC 

prepared an RIS or other document to emphasize the importance of and the proper 

method for breakthrough testing for this type of generator? Has it communicated with 

the Agreement States the importance of inspecting sites for not only regulatory 

compliance but also for demonstrated competency of a licensee’s staff in performing 

breakthrough tests for Sr-82/Rb-82 generators? Has the NRC addressed training 

requirements for AUs who wish to use generators under Section 35.290? The current 

training requirements are specific to Mo-99/Tc99m generators; training requirements 

have not kept pace with new and different generators. 

d. With respect to item c., it is suggested that NRC solicit comments in Supplementary 

Information Section IV. D. specifically on whether the proposed notification requirements 

will discourage licensees from using generators, potentially limiting development of 

generator-based radiopharmaceuticals and having an adverse economic impact on 

vendors of generator systems. 

5. Allowing Associate Radiation Safety Officers (ARSO) to be named on a medical 

license 

a. With the addition of the term, “ARSO,” Section 35.15 (Exemptions regarding Type A 

specific licenses of broad scope) should also be updated. The ACMUI and its 

Rulemaking Sub-Committee unanimously recommend that the addition of ARSOs and 

Temporary RSOs also be included in these exemptions in the same manner as AUs, 

ANPs, and AMPs and allowed to be named on medical licenses. Specific changes are 

suggested in the Specific Comments below. 

b. When an individual who does not have board certification is named as an RSO, ARSO, 

or any of the other authorized individuals, does any of their additional future training for 

an additional type of use (ie “modality” or “category”) require a preceptor signature? If 

so, examples of how this should be done (eg for an RSO) should be provided. 
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6. “Plain language” requirement 

a. Section X. Plain Language (lines 2198-2200) states, “The NRC requests comment on 

the proposed rule with respect to the clarity and effectiveness of the language.” Overall, 

the proposed rule is well-written and well-organized. It could be shortened, and 

improved, by eliminating redundancies and consolidating related sections, eliminating 

identical or nearly identical passages appearing multiple times throughout the draft rule. 

A further improvement would be the inclusion of a detailed “executive summary”-style 

section summarizing, perhaps in a “bullet” format, the key changes introduced in the 

draft rule. This would be in place of the current one-paragraph Summary. 

7. Additional general comments 

a. Elimination of the requirement to submit a second copy of the 313 application is 

excellent 

b. Use of different sealed sources is a helpful change. However, licensees will have the 

need to easily access device registry documents. Can NRC provide access to copies of 

these registrations? 

c. The gamma-knife change to 7-year full inspections is also helpful. 

Specific Comments - Significant

Pg 10 Lines 323-324 The phrase, “...for the modalities that they practiced as of 

October 24, 2005...,” should be changed to, “...for the 

modalities covered by their board certification as of October 

24, 2005...” 

Pg 10 Lines 325-326 The phrase, “...for the modalities that they practiced as of 

October 24, 2005...,” should be changed to, “...for the 

modalities covered by their board certification as of October 

24, 2005...” 

Pg 10 Line 343 The phrase, “...for the modalities that they practiced as of 

October 24, 2005...,” should be changed to, “...for the 

modalities covered by their board certification as of October 

24, 2005...” 

Pp 10-11 Lines 339-343 Amend Section 35.57 to recognize all individuals that were 

previously certified by boards recognized under the previous 

Subpart J as RSOs, teletherapy or medical physicists, AMPs, 

AUs , nuclear pharmacists, and ANPs for the modalities 

covered by their board certification as of October 24, 2005. 

The staff believes that these individuals should be eligible for 

grandfathering for the modalities that their board certification 

covered as of October 24, 2005 and that their previously 

acceptable qualifications for authorized status should continue 

to be adequate and acceptable from a health and safety 

standpoint such as to allow them to continue to practice using 

the same modalities. 
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 Therefore, the NRC believes that preceptor attestations are 

not warranted for these “grandfathered” individuals so long as 

the provisions of § 35.59 are met and the individual requests 

authorizations only for the modalities the individual’s board 

certification covered as of October 24, 2005. 

Pg 29 Lines 866-868 This sentence appears to be incomplete or otherwise 

grammatically incorrect. In any case, its meaning is not clear. 

It should be revised and clarified. 

Pg 32 Lines 960-963 This statement is not entirely accurate, as § 35.204 (b) 

requires “A licensee that uses molybdenum-99/technetium99m generators for preparing a technetium-99m 

radiopharmaceutical shall measure the molybdenum-99 

concentration of the first eluate after receipt of a generator to 

demonstrate compliance with paragraph (a) of this section.” 

The proposed rule would require such a measurement after 

every elution, as noted earlier. 

Pg 38 Lines 1155-1156 The phrase, “The maximum absorbed dose to any 5 

contiguous cubic centimeters...,” should be changed to, “The 

minimum absorbed dose to the maximally exposed 5 

contiguous cubic centimeters...” 

 Similar revisions are also suggested in the “Specific 

Comments - Minor” below. 

Pg 39 Lines 1181-1182 It is suggested to revise this passage as follows. 

 2) adding a provision that would allow individuals identified as 

an AU, AMP, or ANP, on a medical license to be an RSO or an 

ASRSO not only on their current license, but also on a 

different medical license. 

Pg 61 Lines 1852-1852 This sentence states the training must be provided by the 

device manufacturer or individuals certified by the device 

manufacturer. How will this requirement impact licensees? 

Will there be enough trainers for the number of unit operators? 

Will computer-based training be acceptable? 

Pg 90 Line 2653 After this line, insert the following and renumber the items 

following this addition. 

 11. In § 35.15, redesignate paragraphs (c), (d), (e), (f), and (g) 

as paragraphs (d), (e), (f), (h), and (i), respectively, revise 

newly redesignated paragraphs (d) and (f), and add new 

paragraphs (c) and (g) to read as follows: 

 § 35.15 Exemptions regarding Type A specific licenses of 

broad scope. 
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 * * * * *

 (c) The provisions of § 35.13(d); 

 (d) The provisions of § 35.13(f) regarding additions to or 

changes in the areas of use at the addresses identified in the 

application or on the license;

* * * * *

 (f) The provisions of § 35.14(b) (1) for an authorized user, an 

authorized nuclear pharmacist, an Associate Radiation Safety 

Officer, or an authorized medical physicist; 

 (g) The provisions of § 35.14(b) (2) for a temporary Radiation 

Safety Officer;

* * * * *

Pp 99-100 Lines 2944-2950 It is not clear what is meant at the end of this sentence by the 

phrase, “...any new material.” Is this yet another use term that 

needs to be defined for its regulatory meaning as discussed in 

Item 3.b. in the General Comments above? It is uncertain, for 

example, what additional training an experienced, boardcertified RSO would need and if a non-board-certified RSO 

would need a preceptor statement to document this T&E. 

Specific Comments - Minor

Pg 1 Line 37 Here and throughout the document, hyphens should be 

inserted in “compound” adjectives such as “medical use.” 

Pg 1 Line 37 The phrase, “...molybdenum contamination for each 

elution...,” should be changed to, “...molybdenum-99 

contamination for each generator elution...” 

Pg 6 Line 225 The phrase, “...on the dose administered to the patient,” 

should be changed to, “...on the radiation absorbed dose 

delivered to various tissues/structures of the patients body.” 

Pg 7 Lines 230-231 With the foregoing revision, this sentence should be revised as 

follows, “The ME criteria would include absorbed doses to 

normal tissues located outside of the treatment site as well as 

within the treatment site.” 

Pg 7 Line 237 The phrase, “...to convert...,” should be changed to, “...with 

the conversion...” 

Pg 8 Line 261 The phrase, “...the agency...,” should be changed to the word, 

“regulators.” 
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Pg 8 Line 262 The comma between the words, “training” and “as,” should be 

deleted. 

Pg 8 Line 267 The comma between the terms, “New York” and “in,” should 

be deleted. 

Pg 8 Line 268 The comma between the terms, “Texas” and “in,” should be 

deleted. 

Pg 8 Line 271 A comma should be inserted between the words, 

“stakeholders” and “to.” 

Pg 11 Line 353 The comma between the words, “regulations” and “and,” 

should be deleted. 

Pg 11 Line 372 Is the term, “noticed,” appropriate in the context in which it is 

being used? 

Pg 11 Line 387 The phrase, “...these definitions...,” should be changed to, 

“...the definition of an ME...” 

Pg 12 Line 399 The comma between the terms, “ACMUI” and “as,” should be 

deleted. 

Pg 12 Line 401 The phrase, “...for distinguishing truly significant events from 

those related to deviations from the WD but otherwise clinically 

inconsequential.” 

Pg 13 Lines 406-407 The phrase, “..., as there is no suitable clinically used dose 

metric available for judging the occurrence of MEs,” should be 

changed to, “..., as dose is generally not a reliable metric for 

identifying clinically significant MEs,” should be appended to 

the end of this sentence 

Pg 13 Line 413 The comma between the terms, “brachytherapy” and “the,” 

should be deleted. 

Pg 13 Line 421 The comma and the word, “and,” should be transposed. 

Pg 14 Line 433 The phrase, “...public involvement in...,” should be changed 

to, “...for further public comment on...” 

Pg 14 Line 433 The term, “regulation,” should be changed to, “MEs.” 

Pg 14 Line 438 The phrase, “..., noted earlier...,” should be deleted. 

Pg 14 Line 439 A hyphen should be inserted between the terms, “source 

strength” and “based.” 

Pg 14 Lines 439-442 This sentence should be revised as follows, “The final report 

also included a quantitative consideration of the target site 
ACMUI Sub-Committee Comments on NRC Proposed Rule, Final, 3/28/13 

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source distribution, the “octant approach,” for if the distribution 

of implanted sources was irregular enough (i.e., “bunched”) 

relative to the prescribed distribution to qualify as an ME.” 

Pg 14 Lines 442-443 The “dose-related ME criterion for the treatment site” should 

be specified. 

Pg 14 Line 445 The word, “by,” should be changed to the phrase, “...in a...” 

Pg 14 Line 447 The phrase, “...expressed criticism...,” should be changed to, 

“...criticized...” 

Pg 14 Line 450 The comma between the words, “site” and “removed,” should 

be changed to the word, “and.” 

Pg 14 Line 451 The comma between the words, “dose” and “was,” should be 

deleted. 

Pg 15 Line 457 A comma should be inserted between the terms, “2012” and 

“to.” 

Pg 15 Line 474 The comma between the words, “sources” and “for,” should be 

changed to the word, “and.” 

Pg 15 Line 477 The comma between the words, “site” and “and,” should be 

deleted. 

 A hyphen should be inserted between the words, “dose” and 

“based.” 

Pg 15 Line 482 The term, “written directive,” should be changed to the 

abbreviation, “WD.” 

Pg 16 Line 488 The comma between the terms, “ACMUI” and “for,” should be 

deleted. 

Pg 16 Line 499 The phrase, “...the high variation in dose sometimes seen in 

doses...,” should be changed to, “...the pronounced spatial 

variation in dose sometimes seen with ‘point’ sources (i.e., 

seeds)...” 

Pg 16 Line 501 The phrase, “...the size of the normal tissues,...,” should be 

changed to, “...the specified volume of the normal tissue 

affected,...” 

Pg 17 Line 514 A hyphen should be inserted in the term, “60-day.” 

Pg 17 Line 515 The phrase, “...come back...,” should be changed to, “...return 

to the treatment center...” 
ACMUI Sub-Committee Comments on NRC Proposed Rule, Final, 3/28/13 

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Pg 17 Line 524 The comma between the words, “sources” or “or,” should be 

deleted. 

 The comma between the closing parenthesis and the word, 

“A,” should be deleted. 

Pg 17 Line 529 A comma should be inserted between the words, “locations” 

and “results.” 

Pg 17 Line 531 Hyphens should be inserted in the terms, “0.5-sievert” and “50-

rem.” 

Pg 18 Line 541 The comma at the end of this line should be deleted. 

Pg 18 Line 543 A hyphen should be inserted in the term, “post-procedure.” 

Pg 18 Line 560 The phrase, “brachytherapy where...,” should be changed to, 

“brachytherapy procedures, where...” 

Pg 19 Line 591 The comma between the terms, “2008” and “with,” should be 

deleted. 

Pg 19 Line 593 Commas should be inserted before and after the phrase, “...if 

not corrected...” 

Pg 20 Line 597 The term, “authorized individuals,” should be changed to, 

“preceptors.” 

Pg 20 Lines 614-617 This sentence should be revised as follows, “The ACMUI 

advised that training of residents is a collective process and 

entails the collective judgment of an entire residency program 

faculty whereas preceptor attestation is an individual process. 

Pg 20 Line 618 The comma between the terms, “2008” and “with,” should be 

deleted. 

Pg 22 Line 652 Here and elsewhere in the draft rule, a hyphen should be 

inserted between the words, “board” and “certified.” 

Pg 22 Line 680 The between the terms, “who” and “RSO,” should be deleted. 

Pg 22 Line 691 The phrase, “...or other service-provider sites...,” should be 

inserted between the words, “hospitals” and “are.” 

Pg 24 Line 734 The phrase, “...at the time of administration,” should be 

inserted at the end of the sentence ending with, “99m.” 

Pg 24 Line 737 The word, “several,” should be changed to, “multiple.” 

Pg 25 Line 746 A period should be inserted at the end of this line. 
ACMUI Sub-Committee Comments on NRC Proposed Rule, Final, 3/28/13 

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Pg 25 Lines 753-760 Are there any relevant references which may be cited to 

support the statements in this paragraph? 

Pg 25 Line 756 The phrase, “...failed subsequent elutions,” should be 

changed to, “...excessive Mo-99 concentrations in subsequent 

elutions.” 

Pg 25 Line 769 The term, “radioactive drugs,” should be changed to, 

“radiopharmaceuticals.” 

Pg 25 Line 776 The word, “received,” should be changed to, “undergone.” 

Pg 25 Line 777 The word, “radionuclides,” should be changed to, 

“radionuclidic contaminants.” 

Pg 27 Line 804 The word, “vendors,” is misspelled. 

Pg 28 Line 857 The comma between the words, “event” and “is,” should be 

deleted. 

Pg 30 Line 908 The phrase, “...the high variation in dose sometimes seen in 

point doses...,” should be changed to, “...the pronounced 

spatial variation in dose sometimes seen with ‘point’ sources 

(i.e., seeds)...” 

Pg 31 Line 940 The semi-colon between the words, “issues” and “Section,” 

should be changed to a colon. 

Pg 32 Line 963 A period should be inserted at the end of this line. 

Pg 33 Lines 989-990 Here and subsequently in the draft rule, the phrase, “by the 

NRC or Agreement State...,” should be changed to, “...by the 

NRC or an Agreement State.” 

Pg 36 Line 1091 A comma should be inserted between the terms, “RSO” and 

“who.” 

Pg 37 Line 1118 Should the word, “allow,” be changed to, “require”? 

Pg 38 Lines 1147-1148 The phrase, “...include determining post implant source 

position verification and normal tissue dose assessment...,” 

should be changed to, “...include performing post-implant 

source-position verification and normal-tissue dose 

assessment...” 

Pg 38 Line 1154 The word, “minimum,” should be inserted between the words, 

“The” and “absorbed.” 

Pg 38 Line 1166 A hyphen should be inserted in the term, “60-calendar day.” 
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Pg 39 Line 1182 The comma between the terms, “ANP” and “on,” should be 

deleted. 

Pg 40 Line 1182 The comma between the words, “on” and “therefore,” should 

be changed to a semi-colon. 

Pg 40 Lines 1226-1228 This sentence (in particular, the phrase, “...same new medical 

license”) is confusing. It should be re-worded and clarified. 

Pg 46 Line 1394 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 47 Line 1418 The word, “several,” should be changed to, “multiple.” 

Pg 48 Line 1453 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 51 Line 1557 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 53 Line 1598 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 54 Line 1645 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 56 Lines 1707-1708 The phrase, “...to provide high confidence that...,” should be 

changed to, “...to ensure that...” 

Pg 57 Line 1736 Here and elsewhere, a hyphen should be inserted between the 

words, “single” and “discipline.” 

Pg 58 Line 1744 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 60 Line 1816 Here and elsewhere, a hyphen should be inserted between the 

words, “photon” and “emitting.” 

Pg 60 Line 1820 The comma between the terms, “SSDR” and “however,” 

should be changed to a semi-colon. 

Pg 63 Line 1909 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 64 Line 1924 The semi-colon between the words, “management” and “and,” 

should be deleted. 

Pg 64 Line 1961 The word, “have, “between the words, “provide” and “criteria,” 

should be deleted. 

Pg 65 Line 1971 The comma between the terms, “ME” and “an,” should be 

deleted. 
ACMUI Sub-Committee Comments on NRC Proposed Rule, Final, 3/28/13 

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Pg 65 Line 1981 The word, “radiation, should be deleted. 

Pg 65 Line 1986 The comma at the end of this line should be changed to a 

period. 

Pg 66 Line 1995 Here and elsewhere when used at an adjective, the term, 

“organ at risk,” should be changed to, “organ-at-risk.” 

Pg 66 Line 2016 A hyphen should be inserted between the terms, “20” and 

“percent.” 

Pg 67 Line 2037 The phrase, “...failed generators...,” should be changed to, 

“...out-of-tolerance generator elutions...” 

Pg 67 Line 2044 The comma at the end of this line should be changed to a 

semi-colon. 

Pg 67 Line 2045 The comma between the words, “notified” and “and,” should 

be changed to a semi-colon. 

Pg 70 Line 2127 The phrase, “..., and, thus,...,” should be changed to, “...and 

thus...” 

Pg 78 Line 2213 The word, “failures,” should be changed to, “deficiencies.” 

Pg 79 Line 2242 The comma between the words, “regulations and “meet,” 

should be deleted. 

Pg 82 Line 2336 The hyphen at the end of this line should be changed to a 

colon. 

Pg 87 Line 2526 The hyphen at the end of this line should be changed to a 

colon. 

Pg 91 Line 2695 The hyphen at the end of this line should be changed to a 

colon. 

Pg 93 Line 2750 The hyphen at the end of this line should be changed to a 

colon. 

Pp 93-94 Lines 2761-2765 This item is confusing (grammatically incomplete?) as written. 

It should be revised and clarified. 

Pg 94 Line 2769 The word, “mean,” should be inserted between the words, 

“The” and “mean.” 

Pg 94 Line 2771 The phrase, “The maximum absorbed dose to any 5 

contiguous cubic centimeters...,” should be changed to, “The 

mean absorbed dose to the maximally exposed 5 contiguous 

cubic centimeters...” 
ACMUI Sub-Committee Comments on NRC Proposed Rule, Final, 3/28/13 

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Pg 94 Line 2784 The hyphen at the end of this line should be changed to a 

colon. 

Pg 94 Line 2798 A comma should be inserted between the words, 

“examination” and “administered.” 

Pg 95 Line 2805 The hyphen at the end of this line should be changed to a 

colon. 

Pg 95 Line 2816 The hyphen at the end of this line should be changed to a 

colon. 

Pg 96 Line 2832 The hyphen at the end of this line should be changed to a 

colon. 

Pg 105 Line 3108 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 106 Line 3152 The hyphen at the end of this line should be changed to a 

colon. 

Pg 106 Line 3169 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 107 Line 3183 The hyphen at the end of this line should be changed to a 

colon. 

Pg 108 Line 3212 The hyphen at the end of this line should be changed to a 

colon. 

Pg 108 Line 3219 The comma between the words, “characteristics” and “or.” 

Pg 109 Line 3224 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 110 Line 3290 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 112 Line 3348 The hyphen at the end of this line should be changed to a 

colon. 

Pg 112 Line 3361 The hyphen at the end of this line should be changed to a 

colon. 

Pg 113 Line 3375 The hyphen at the end of this line should be changed to a 

colon. 

Pg 113 Line 3380 The comma between the words, “dosages” and “and,” should 

be deleted. 
ACMUI Sub-Committee Comments on NRC Proposed Rule, Final, 3/28/13 

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Pg 113 Line 3385 The comma between the words, “safely” and “and,” should be 

deleted. 

Pg 113 Line 3387 The comma between the words, “subjects” and “that,” should 

be deleted. 

Pg 114 Line 3413 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 114 Line 3425 Here and subsequently, the term, “Sealed Source and Device 

Registry,” should be replaced by the previously introduced 

abbreviation, “SSDR.” 

Pg 114 Line 3449 A hyphen should be inserted between the words, “full” and 

“time.” 

Pg 114 Line 3465 The phrase, “...to provide high confidence that...,” should be 

changed to, “...to ensure that...” 

Pg 116 Line 3491 The comma between the words, “experience” and “under,” 

should be deleted. 

Pg 116 Line 3493 The comma between the terms, “§ 35.400” and “involving,” 

should be deleted. 

 The hyphen at the end of this line should be changed to a 

colon. 

Pg 116 Line 3507 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 118 Line 3561 The hyphen at the end of this line should be changed to a 

colon. 

Pg 118 Line 3572 The hyphen at the end of this line should be changed to a 

colon. 

Pg 120 Line 3625 The hyphen at the end of this line should be changed to a 

colon. 

Pg 121 Line 3673 The hyphen at the end of this line should be changed to a 

colon. 

Pg 122 Line 3692 The word, “or,” between the words, “Education” and “the,” 

should be changed to a comma. 

Pg 123 Line 3747 The hyphen at the end of this line should be changed to a 

colon. 

Pg 123 Line 3758 The comma between the words, “fraction” and “by,” should be 

deleted. 
ACMUI Sub-Committee Comments on NRC Proposed Rule, Final, 3/28/13 

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Pg 124 Line 3762 The hyphen at the end of this line should be changed to a 

colon. 

Pg 124 Line 3782 The hyphen at the end of this line should be changed to a 

colon. 

Pg 125 Line 3790 The phrase, “An absorbed dose...,” should be changed to, “A 

mean absorbed dose...” 

Pg 125 Line 3794 The phrase, “An absorbed dose...,” should be changed to, “A 

mean absorbed dose...”