ACMUI Sub-Committee Comments on NRC Draft Final Rule, 10 CFR Parts 30, 32 and 35

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Advisory Committee on Medical Uses of Isotopes (ACMUI) 

Sub-Committee on Draft Final Rule, 10 CFR Parts 30, 32 and 35

Draft 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: 

Frank Costello, Ronald Ennis, Susan Langhorst, Steven Mattmuller,

Laura Weil, and Pat Zanzonico (Chair)

Date of Submission: December 23, 2015

Executive Summary

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, 

hereafter identified as the “Proposed Rule.” (The Sub-Committee identifies its comments with 

respect to the relevant page and line numbers in a version of the foregoing document in which it 

has inserted line numbers.) This ACMUI Sub-Committee had previously reviewed the Draft 

Proposed Rule and submitted a report dated March 28, 2013 (revised April 5, 2013) with its 

comments on that Draft. The NRC formally responded to the ACMUI comments in a document 

entitled, “The US Nuclear Regulatory Commission Staff Responses to the Advisory Committee 

on the Medical Uses of Isotopes Comments on the Draft Part 35 Proposed Rule” (Enclosure 5 

of SECY-13-0084). The Draft Final Rule incorporates revisions made in response to that SubCommittee Report as well as comments submitted by professional societies and other 

stakeholders.

Our recommendations on the major elements of the current Draft Final Rule are as follows.

• The Sub-Committee endorses that component of the current proposed rule re-defining 

medical events in permanent implant brachytherapy in terms of activity (i.e., source strength) 

rather than radiation dose. [General Comments. Section 1.a.-d.]

• The Sub-Committee endorses, with reservations, designating the current proposed rule redefining medical events in permanent implant brachytherapy as Compatibility Category C,

with activity-based medical event metrics defined as an essential program element. [General 

Comments 1.e.]

• The Sub-Committee recommends changing the language for a “wrong-location” medical 

event in permanent implant brachytherapy from the current proposed language,
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“Sealed source(s) implanted directly into a location where the 

radiation from the source(s) will not contribute dose to the 

treatment site, as defined in the written directive,” to

“Sealed source(s) implanted directly into a location discontiguous 

from the treatment site, as defined in the written directive.”

[General Comments Section 1.f.]

• The Sub-Committee recommends revising the passage in lines 4182-4186 on page 167 in 

the Draft Final Rule as follows, thereby eliminating the dose-based criteria for a “leakingsource” medical event

“3) An administration that includes the wrong radionuclide; the 

wrong individual or human research subject; a leaking sealed 

source; or a sealed source or sources implanted into a location 

discontiguous from the treatment site, as defined in the written 

directive.”

[General Comments 1.g.]

• The Sub-Committee endorses the elimination of the preceptor-statement requirement for 

Board-certified individuals for an individual seeking regulatory authorization as an authorized 

user, authorized medical physicist, Radiation Safety Officer, or authorized nuclear 

pharmacist. [General Comments 2.a.]

• With respect to the amended requirements for preceptor attestation for an individual seeking 

regulatory authorization as an authorized user, authorized medical physicist, Radiation 

Safety Officer, or authorized nuclear pharmacist through the alternate pathway, the SubCommittee endorses changing the language for the preceptor attestation from

the individual “...has achieved a level of competency to function

independently...” for the authorization to

the individual can “...independently fulfill the radiation safetyrelated duties...” associated with the authorization being 

requested.

[General Comments 2.b.]

• The Sub-Committee recommends 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 

medical physicist, Radiation Safety Officer, or authorized nuclear pharmacist through the 

certification pathway. [General Comments 3.a.-c.]

• The Sub-Committee recommends that the NRC adopt the parent-breakthrough limits for 

radioisotope generators specified in the relevant FDA-approved package inserts. [General 

Comments [ 4.a.-b.]

• The Sub-Committee does not endorse the new requirement in the Draft Final Rule that 
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licensees report to the NRC as well as to the manufacturer/vendor generator elutions with 

out-of-tolerance parent-breakthrough but, instead, recommends a single reporting 

requirement to the manufacturer/vendor. [General Comments 4.c.]

• The Sub-Committee endorses allowing Associate Radiation Safety Officers (ARSO) to be 

named on a medical license. [General Comments 5.a.-b.]

• The Sub-Committee recommends that the designation of a board-certified an authorized 

user, authorized medical physicist, or authorized nuclear pharmacist as the RSO or as an 

ARSO requires their board certification to include the designation, “RSO Eligible”. [General 

Comments 6.a.]

• The Sub-Committee does not endorse establishing a separate category of Authorized Users 

for parenteral administration of alpha-emitting radiopharmaceuticals but, instead, 

recommends deleting § 35.390(b)(1)(ii)(G)(4) in the current Draft Final Rule and revising the 

pertinent passage in § 35.390(b)(1)(ii)(G)(3) as follows,

“Parenteral administration of any radioactive drug for which a 

written directive is required.”

[General Comments Section 7.a.]

• The Sub-Committee endorses the elimination of the requirement to submit copies of NRC 

Form 313, Application for Material License, or a letter containing information required by 

NRC Form 313 when applying for a license, an amendment, or renewal.

• The Sub-Committee recommends changing the “medical-events” language in lines 5531-

5532 (page 232) of the Draft Final Rule from,

“A licensee shall report as a medical event, any administration 

requiring a written directive, except for an event that results from 

patient intervention...,” back to the language in the current Draft 

Final Rule,

“A licensee shall report any event, except for an event that results 

from patient intervention...”

Relevant background material and commentary as well as the NRC’s responses to the ACMUI’s 

previously submitted comments on the Draft Proposed Rule (where applicable) are provided in 

the General Comments and the Specific Comments below. Suggested editorial revisions are 

provided in an Addendum.

General Comments

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

a. The text in § 35.41(b)(6) in the Draft Final Rule was modified to remove § 35.41(b)(6)(ii) 

and (iii) which would have required the licensee to determine absorbed dose to the 

maximally exposed 5 contiguous cubic centimeters of normal tissue located both outside 

and within the treatment site. The NRC acknowledges that while some treatment 
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planning systems can identify contiguous volumes, others may not. In response to this 

concern and others raised by various commenters, the NRC removed § 35.41(b)(6)(ii) 

and (iii).

The NRC retained the requirement to determine the total source strength administered 

outside of the treatment site compared to the total source strength documented in the 

post-implantation written directive.

NRC Staff’s response to the comment as previously submitted: The staff agrees with 

the ACMUI recommendation to allow licensees the 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. In this regard, in a Staff Requirements Memo dated, 

May 21, 2013, the Commission has approved the staff’s proposed interim enforcement 

policy as described in SECY-13-0044, “Interim Enforcement Policy for Permanent 

Implant Brachytherapy Medical Event Reporting.” On July 9, 2013, the NRC issued the 

interim enforcement policy for permanent implant brachytherapy ME reporting. End of

NRC Staff’s response

b. Inclusion of additional language is recommended to clarify explicitly what is meant by the 

“treatment field.” As noted by the NRC in Lines 1170-1171 on page 47, “The authorized 

user may define the treatment site to include all tissues into which sources will be 

purposely implanted.” This may include tissues (i.e., normal tissues) outside the clinical 

tumor volume.

c. 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 judgment during the implant

procedure. 

d. There was originally some concern that the proposed ME definition for permanent 

implant brachytherapy, which included dose-based criteria, might discourage 

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

had therefore recommended that NRC solicit information on whether the previously 

proposed ME definition for permanent implant brachytherapy would discourage 

licensees from using this therapy option or will otherwise adversely impact clinical 

practice. The NRC has solicited such information on the Draft Final Rule and has 

amended the Rule, in the form of the Draft Final Rule, accordingly.

NRC Staff’s response to the comment as previously submitted: Although the ACMUI’s 

specific recommendation to solicit information on this subject was not incorporated into 

the Federal Register notice (FRN), we believe we addressed the intent of the ACMUI 

comment in our general solicitation of information related to the economic impact of the 

proposed rule. Additionally, the staff has prepared a regulatory analysis which will be 

available for public comment when the proposed rule is published. End of NRC Staff’s 

response

e. There is also concern that the draft rule designating MEs in permanent implant 

brachytherapy as Compatibility Category C would allow Agreement States to retain the 

dose-based criteria for definition of a ME. The ACMUI and its Rulemaking SubCommittee had therefore originally recommended that the draft rule re-defining medical 

events in permanent implant brachytherapy be designated as Compatibility Category B.
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The reasons for conversion from dose-based to activity-based criteria are: (1) the failure 

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

misadministrations in permanent implant brachytherapy and (2) the practical difficulties 

in implementing and regulating dose-based criteria. Retaining the dose-based criteria 

would still result in clinically insignificant occurrences being identified as MEs and 

thereby perpetuate the confusion associated with such criteria. It was based on these 

compelling considerations that the ACMUI and its Rulemaking Sub-Committee had 

recommended that the activity-based rule re-defining medical events in permanent 

implant brachytherapy be designated as Compatibility Category B. The NRC’s argument 

for retaining Compatibility Category C defining MEs in permanent implant brachytherapy 

- that MEs do not have significant “transboundary” health and safety implications (i.e.,

direct and significant effects in multiple jurisdictions) - is persuasive, however. 

Specifically, the NRC designates regulatory program elements as Compatibility Category 

B only if they have significant direct transboundary implications, not simply for the 

purpose of ensuring uniformity across the country with respect to a program element. It 

must be noted, however, that a single “national” definition of an ME serves to minimize 

the risk of such an event through the standardization of all processes involved in the 

procedure - from administrative to logistical to treatment planning to the actual 

performance of the procedure by the AU. Embedding safe and consistent procedures 

into the workflow of an AU and her/his department and team is perhaps the most 

important consideration in minimizing MEs, and it is not uncommon for AUs to practice in 

multiple jurisdictions, which are not uncommon. Compatibility C is therefore suboptimal 

and actually increases the risk of an ME. Nevertheless, based on its recognition of the 

regulatory distinction between Compatibility Category B and C designations, the ACMUI 

now agrees with Compatibility Category C designation for the current activity-based 

definition of MEs in permanent implant brachytherapy - contingent on this definition of an 

ME being considered an “essential element” of the regulation of MEs in permanent 

implant brachytherapy and thereby requiring an Agreement State to use the activitybased definition.

Importantly, the ACMUI and its Rulemaking Sub-Committee strongly advise that 

Agreement States not also adopt dose-based criteria for MEs. If such problematic 

multiplicity of criteria (i.e., activity- and dose-based criteria) in different jurisdictions (i.e., 

Agreement States and NRC-regulated states) were to occur, the ACMUI’s 

recommendation to designate MEs in permanent implant brachytherapy as Compatibility 

Category C, rather than Compatibility Category B, would have to be reconsidered.

NRC Staff’s response to the comment as previously submitted: The issue of the 

Compatibility Category for MEs is discussed in detail in the draft FRN. Currently, MEs 

are designated as Compatibility Category C. The Standing Committee on Compatibility 

(SCC) reviewed the proposed rule and strongly supported retaining Compatibility 

Category C designation for § 35.3045, the section that contains the criteria for 

determining if a ME has occurred. As noted in the discussion in the proposed draft FRN, 

with a Compatibility Category C designation, Agreement States would have the flexibility 

to require both the dose-based criteria and source strength-based criteria as long as the 

Agreement States’ reports to NRC related to MEs are based on the requirements in § 

35.3045.

The SCC stated that many Agreement States have additional state requirements and 

laws to gather information on MEs. A Compatibility Category B requirement would 

prohibit the Agreement States from gathering additional information, such as diagnostic 
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reports, shorter reporting times, or lower dose limits for reporting. After reviewing the 

issue, the SCC determined that identical reporting requirements were not necessary for 

the national program on a transboundary basis. The SCC concluded that a change to a 

Compatibility B would not acknowledge the inherent state function to protect public 

health and safety of its citizens which forms the basis of the Section 274b amendment to 

the Atomic Energy Act of 1959.

Although the staff is proposing to retain the proposed Compatibility for MEs at 

Compatibility Category C, the NRC is seeking specific comments on the Compatibility 

Category in the draft FRN. End of NRC Staff’s response

f. There is concern regarding the meaning and implementation of the “Wrong-location” 

criterion for an ME. The current proposed criterion for a “Wrong-location” ME is, “Sealed 

source(s) implanted directly into a location where the radiation from the source(s) will not 

contribute dose to the treatment site, as defined in the written directive.” Given the 

exponential attenuation of gamma- and x-rays in stopping media such as tissue, a seed 

anyway in the body actually would deliver some non-zero (though insignificant) dose to a 

tumor elsewhere in the body. More importantly, an AU may purposely implant seeds in 

muscle or other normal tissue adjacent to (i.e., outside of) what might be considered the 

nominal treatment site to achieve the desired dose distribution to the clinical tumor 

volume (CTV); this conceivably could be misinterpreted by regulators as a ME based on 

the foregoing “Wrong-location” criterion. The Sub-Committee therefore proposes the 

following language for the “Wrong-location” ME criterion, “Sealed source(s) implanted 

directly into a location discontiguous from the treatment site, as defined in the written 

directive.” The term, “discontiguous,” is defined as “disconnected or without contact.” 

Note that it is the seed location, not the seed itself, which is discontiguous for an ME 

based on the suggested “Wrong-location” ME criterion. For example, if a seed were 

implanted into muscle or other non-CTV tissues adjacent to the CTV (in order to deliver 

a satisfactory dose distribution), the location of that seed would not be discontiguous 

and, appropriately, an ME would not result. Further, inserting the term, “directly,” 

eliminates the possibility that migration of seeds, edema-related mispositioning of seeds, 

and patient-related processes would precipitate an ME. Finally, by appending the 

phrase, “as defined in the written directive,” the treatment site could be broadened 

beyond the CTV and even including adjacent normal tissues, if deemed appropriate by 

the AU.

g. For consistency with the new activity-based criteria for an ME in permanent implant 

brachytherapy, the passage in lines 4182-4186 on page 167 should be revised as 

follows, “3) An administration that includes the wrong radionuclide; the wrong individual 

or human research subject; a leaking sealed source; or a sealed source or sources 

implanted into a location discontiguous from the treatment site, as defined in the written 

directive.” Note that for the leaking-sealed source ME criterion it is recommended that 

the tissue or organ radiation dose threshold (i.e., 0.5 Sv (50 rem)) be eliminated. This is 

not only consistent with the transition from dose-based to activity-based criteria for an 

ME in permanent implant brachytherapy but also eliminates the practical difficulty of 

estimating organ or tissue dose from a leaking source or sources.

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

physicists, Radiation Safety Officers (RSOs), and nuclear pharmacists. 

a. The Sub-Committee reiterates its enthusiastic support for eliminating the preceptor 

statement requirement for Board-certified individuals.
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b. With respect to the amended requirements for preceptor attestation for an individual 

seeking regulatory authorization as an RSO, AMP, ANP, or AU via the alternate 

pathway, the Sub-Committee endorses the attestation language in the proposed rule 

stating that the individual can “...independently fulfill the radiation safety-related 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). 

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 Final Rule

contains 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.” 

b. Some of the terminology NRC has historically used and now uses in discussing the draft 

final rule continues to be confusing. The NRC Staff did not accept all of the ACMUI 

recommendations made in preparation of the Proposed Rule, explaining their reasons in 

Enclosure 5 of SECY-13-0084. The ACMUI had suggested for clarification that the 

meaning of 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.

NRC Staff’s response to the comment as previously submitted: The term “type of use” is 

already defined in Part 35.2: Type of use means use of byproduct material under §§ 

35.100, 35.200, 35.300, 35.400, 35.500, 35.600, or 35.1000. The terms “category” and 

“modality” were reviewed and determined to be defined by common use (i.e., what is 

found in a dictionary): “Category” - any of several fundamental and distinct classes to 

which entities or concepts belong; “Modality” - the classification of logical propositions 

according to their asserting or denying the possibility, impossibility, contingency, or 

necessity of their content; or a usually physical therapeutic agency. End of NRC Staff’s 

response

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 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. At this point in time, individuals who received board 

certification prior to October 24, 2005 and were not named on a license for a given type 
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of use will continue to have difficulty knowing how to obtain approval for a new type of 

use. The Sub-Committee suggests that guidance be included in the revise NUREG 

1556 Vol 9 to describe how these individuals can apply for a new type of use without 

having to repeat the entire training-and-experience pathway. The NRC has already 

included this kind of guidance in its licensing guidance for Leksel Gamma Knife 

Perfexion.

NRC Staff’s response to the comment as previously submitted: The date of the 

individual’s board certification is relevant. Boards that were recognized by the NRC or 

Agreement State on or prior to October 24, 2005 (listed in the now removed Subpart J), 

met different T&E requirements than boards whose processes have been recognized by 

the NRC or Agreement States after October 24, 2005.

Further, the staff determined that the ACMUI recommendation that all individuals who 

were able to meet the requirements of the previous Subpart J should be grandfathered 

would go beyond the intent of the resolution of the Ritenour petition, which requested 

recognition of individuals who were certified by boards listed under former Subpart J to 

perform AMP and RSO duties on or prior to October 24, 2005, but were not named on a 

license. The NRC, in resolving the Ritenour petition, determined that other medical 

professionals may have also been adversely affected when Subpart J expired. The 

intent of the resolution was to include all these individuals and grandfather them for the 

modalities they practiced on or prior to October 24, 2005. Grandfathering individuals 

who met the Subpart J requirements but were not board certified would also negate the 

new T&E requirements that became effective on October 25, 2005. End of NRC Staff’s 

response

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)/rubidium82 (Rb-82) generators.

The current Food and Drug Administration (FDA) labeling requirement (i.e., 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 μCi of Mo-99 per mCi of 

Tc-99m at the time of patient administration. The originally proposed paragraph (b) of § 

35.204 with its requirement to comply with § 35.204(a) essentially makes the NRC 

regulation equivalent to the FDA labeling requirements. The draft final NRC regulation, 

specifically, the passage that includes the language, “...at the time of elution...,” is 

unnecessary and confusing. Therefore, the ACMUI and its Rulemaking Sub-Committee 

recommend that the NRC adopt the FDA-approved package insert for parentbreakthrough limits for radioisotope generators.

Pursuant to its recently revised labeling requirement for strontium-89 (Sr-89)/rubidium-82

(Rb-82) 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 

be consistent with all of the FDA-approved package inserts. The NRC limits are 

consistent with those for the Tc-99m generator, but not those for the Rb-82 generator. 

As discussed at the 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 
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the applicable FDA regulatory requirements. This position, however, seems to be 

inconsistent with the Memorandum of Understanding between the NRC and the FDA.

The NRC staff expressed concerns with ACMUI’s previous recommendation that the 

NRC adopt language for radionuclidic purity limits for radioisotope generators consistent 

with the FDA-approved package insert.

NRC Staff’s response to the comment as previously submitted: The ACMUI 

recommendation that the NRC adopt the FDA-approved package insert for breakthrough 

limits for radioisotope generators was not accepted because revising the regulations to 

require licensees to follow the FDA-accepted package inserts with regard to testing 

eluates would reverse the NRC’s December 2, 1994 rulemaking (59 FR 61781) that 

removed the requirements to follow the FDA package inserts for preparation of 

radiopharmaceuticals from NRCs regulations.

Finally, the staff has determined the NRC’s current breakthrough limits for both Tc-99m 

and Rb-82 radioisotope generators are safe. End of NRC Staff’s response

b. For generator breakthrough testing, conformity between the corresponding FDA 

regulations and NRC rules is highly recommended, and the ACMUI is recommending 

conformity specifically with the one section of the respective package insert that deals

with breakthrough testing of the generator’s parent radionuclide. This would be 

especially beneficial as new generators (e.g., the germanium-68 (Ge-68)/gallium-68 (Ga68) 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. Our Rulemaking Sub-Committee unanimously recommends that the NRC

adopt the parent-breakthrough limits for radioisotope generators as described in the 

relevant FDA-approved package inserts.

The NRC’s December 2, 1994 rulemaking (59 FR 61781) cited above dealt with the 

preparation of radiopharmaceuticals and would allow, for example, radiopharmacists to 

add a quantity of Tc-99m pertechnetate to a kit that exceeded the amount that was listed 

in the kit’s FDA package insert. As stated in the summary of the rulemaking:

“This final rule is intended to provide greater flexibility by 

allowing properly qualified nuclear pharmacists and 

authorized users who are physicians greater discretion to 

prepare radioactive drugs containing byproduct material for 

medical use.”

This rulemaking did not alter the NRC’s regulatory authority to regulate radiation safety 

associated with the use of radiopharmaceuticals. The NRC addressed this issue in the 

same rulemaking as follows.

This final rule is not duplicating regulation by other federal 

or state agencies. In fact, this rule is designed to avoid 

duplication of the regulations of other federal agencies 

(e.g., see response to comments on Sec. 35.6). In the 

area of medical use of byproduct material, the NRC and 

FDA signed a Memorandum of Understanding (58 FR 
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47300; September 8, 1993) to coordinate existing NRC 

and FDA regulatory programs.

In general terms, the FDA regulates the manufacture and distribution of radioactive 

drugs and medical devices for safety and efficacy, while the NRC regulates radiation 

safety associated with the actual use of these products (emphasis added).

The ACMUI’s recommendation for conformity between the corresponding FDA 

regulations and NRC rules regarding breakthrough testing of the generator’s parent 

radionuclide is consistent, we feel, with the NRC’s position in that regulating the 

radionuclidic purity of generator elutions is essential to protecting patients from 

prohibitively high radiation doses. This issue, therefore, is one of the radiation safety of 

radiopharmaceuticals, rather than regulation of radiopharmaceutical preparation.

It was during the recall of the strontium-82 (Sr-82)/rubidium-82 (Rb-82) generator when 

the FDA extensively re-examined every aspect of that generator. Subsequently, the 

FDA revised the radionuclidic purity limits to 1⁄2 of their previous levels. The NRC staff 

subsequently stated that staff determined that the older, higher levels were safe but 

provided no data to support this position. Although the NRC staff noted that the new 

FDA limits are at (but not below) the lower limit of the assay capabilities of dose 

calibrators, this does not negate the effectiveness of the newly issued FDA limits.

NRC Staff’s response to the comment as previously submitted: Currently there are no 

other generator systems that are available for general medical use. Any new generator 

system that becomes available would need to be evaluated by the NRC before 

developing any requirements and would be authorized under § 35.1000. Additionally, 

expanding the regulations from the specific requirements for Mo-99/Tc-99m and Sr82/Rb-82 generators to apply to generators generally is beyond the scope of this 

rulemaking. End of NRC Staff’s response

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

debated at length by the ACMUI at the time it reviewed the Draft Proposed Rule. 

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 three times, twice to the NRC and once 

to the manufacturers or distributors of medical generators, any measurement that 

exceeds the limits specified in § 35.204(a). This reporting requirement is the one which 

currently appears in the Draft Final Rule. The second, alternative requirement would 

require manufacturers/distributors to report to the NRC when they receive such a 

notification from a licensee. To lessen the reporting burden on licensees, the ACMUI 

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

namely, reporting to the manufacturer/distributor. If licensees were required to report 

out-of-tolerance elution results to the manufacturers/distributor, then a requirement for 

the manufacturer/distributor to report such results to the NRC or their Agreement State 

should be imposed. Reports sent directly from licensees to the NRC could conceivably

take 38 different pathways (corresponding to the NRC and the 37 Agreement States) 

before finally reaching the NRC. Once the reports arrive at the NRC, it would then be 

tasked with collating the information. The vendor is best situated to collate all relevant 

information and to prepare an accurate and timely summary reports for the NRC. Our

Sub-Committee reiterates that it does not support the new requirement in the Draft Final 
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Rule that licensees report to the NRC as well as the manufacturer/distributor generator 

elutions with out-of-tolerance parent-breakthrough.

In practice, compliant licensees already appropriately report out-of-tolerance parentbreakthrough results. That is, if a licensee has a generator that produces an unusable 

elution (i.e., one with out-of-tolerance parent-breakthrough results), this elution is not 

used in patients. Without a usable elution, the licensee is highly motivated to contact the 

manufacturer immediately to report the unusable elution and to request a replacement 

generator and/or otherwise solicit assistance. Further, although NRC staff had 

expressed concern regarding the content of out-of-tolerance parent-breakthrough 

reports (i.e., inclusion of the appropriate information in these reports), the requisite 

content of the reports can be easily standardized in regulation or guidance. NRC staff 

was also concerned about gathering patient-exposure information. However, even if 

such data were solicited, it is unlikely to generate anything beyond anecdotal 

information. Otherwise, to accrue relevant information, a compliant licensee would have 

to first determine their elution is unusable, contact the manufacturer/vendor, and then 

take the implausible step of actually administering the out-of-tolerance elution to 

patients. It should be noted that the past incident involving patients who were 

administered out-of-tolerance strontium-82 (Sr-82)/rubidium-82 (Rb-82) generator

elutions occurred among licensees who were not compliant in performing the 

breakthrough tests in the first place. It should also be noted that in past events with Mo99 generator elutions where the radiopharmacists determined that the elutions were 

unusable, they were fully compliant and did not use these out-of-tolerance elutions in 

patients.

NRC staff described multiple possible causes for failed breakthrough tests, but did not 

provide any substantive information to support these hypothetical causes and thereby 

justify the number of reports proposed. In the past, there have been rare and anecdotal 

potential failed breakthrough tests due to human error and/or faulty equipment. 

However, these are typically corrected by the licensee’s internal procedures; such 

procedures include critical review of the elution and radioassay techniques, re-checking 

of dose-calibrator quality-control results, and careful examination of the Mo-99 assay 

shield for possible damage.

Failed breakthrough tests on a larger scale are due to manufacturing, rather than enduser, issues, and the manufacturer/distributor is best positioned to collate all relevant 

information (such as the generator size, the day generator was manufactured, the age of 

generator when it was eluted, the geographic areas affected etc) and also to submit an 

accurate, informative, and timely report to the NRC. The Sub-Committee thus 

recommends such manufacturer/distributor-generated reports as being the most 

effective mechanism for the NRC to collect the relevant information on out-of-tolerance 

parent-breakthrough results.

NRC Staff’s response to the comment as previously submitted: The staff agrees with 

the ACMUI that the FDA authority in relationship to foreign manufacturers or distributors 

of generators was incorrect and has revised the FRN for the proposed rule.

However, the staff determined that licensees should report to both the NRC and the 

manufacturer or distributor when a generator fails a breakthrough test because the 

information that would be reported by medical use licensees to the NRC is different than 

the information that would be reported to the manufacturers or distributors. For 
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example, reports from a medical use licensee to the NRC would have information on 

patient exposures, probable cause and assessment of failure in the licensee’s 

equipment, and procedures or training that contributed to the excessive readings if an 

error occurred in the licensee’s breakthrough determination. The licensee would only 

report information related to the generator failure to the manufacturer or distributor. 

Also, the corrective actions reported to the NRC by the licensee and the manufacturer or 

distributor would be different for each. The licensees’ corrective actions would focus on 

procedures while the manufacturers or distributors’ corrective actions would focus on 

manufacturing processes. Breakthrough tests exceeding the regulatory standard could 

be due to many different issues including from problems with the generator elution 

procedures, as a result of transportation, or problems with the manufacturer’s production 

of the generator. The two separate reporting requirements would provide the NRC with 

the necessary information to determine the scope of the issue and the appropriate 

actions applicable to each entity. 

Although both NRC/Agreement States and FDA have regulatory authority over the 

radioactive drug manufacturers, their regulatory responsibilities are different. The NRC 

regulates both the end user and the radioactive drug manufacturer whereas FDA 

regulates only the product and drug manufacturer. The NRC/FDA MOU was initiated to 

provide a mechanism for sharing information that is of mutual regulatory interest to both 

agencies. The NRC believes that it is important for medical use licensees and 

commercial nuclear pharmacies that elute generators (i.e., the end users) as well as 

manufacturers or distributors to report breakthrough failures to NRC as quickly as 

possible. If the generator breakthrough values exceed the regulatory limits, the problem 

could be with the procedures of the generator elution site, a result of transportation, or 

with the manufacturer’s production of the generator. The NRC believes that 24-hour

notification will assist in quickly differentiating generator elution licensee problems from 

those of the manufacturer. Requiring end user reporting also provides the NRC with a 

confirmation of whether patients were administered radiopharmaceuticals with excessive 

breakthrough. The generator manufacturer/distributor report to the NRC of breakthrough 

within 24 hours would assist the NRC and the Agreement States in identifying the scope 

of the problem and the regulatory efforts needed to address it. End of NRC Staff’s 

response

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

license

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

licenses of broad scope) should also be updated. The ACMUI and its Rulemaking SubCommittee 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 are

allowed to be named on medical licenses.

NRC Staff’s response to the comment as previously submitted: Unlike ANPs, AMPs, 

and AUs, who are not specifically listed on the broad scope medical use license, RSOs 

are listed on a broad scope medical use license, and the NRC specifically reviews the 

T&E of each individual before he/she is listed as an RSO on every medical use license 

including a broad scope medical license. This review is important because the RSO is 

responsible for implementing the radiation safety program for the licensee. An ARSO 

will have similar duties working under the RSO, and like the RSO, would be listed

specifically on the license. Because of this, the staff has determined that the NRC needs 
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to review the T&E of each individual before he/she is listed as an ARSO. The NRC does 

not exempt the medical broad scope licensee in § 35.15 from notifying NRC when it 

appoints a temporary RSO because the NRC needs to know when an RSO leaves any 

medical use licensee and the licensee has to name a temporary RSO.

For these reasons, the provisions in § 35.15 for a temporary RSO is unchanged from the 

current regulations that allow a licensee to permit a qualified individual to serve as the 

RSO for up to 60 days each year. Additionally, changes to the temporary RSO provision 

are beyond the scope of this rulemaking. End of NRC Staff’s response

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 in the 

revised NUREG 1556 Vol 9 guidance.

NRC Staff’s response to the comment as previously submitted: Under the proposed 

rule, RSOs, ARSOs, or other authorized individuals who are not board certified would 

need to obtain a written attestation. The associated guidance will clarify that all 

individuals coming through the alternate pathway will need a preceptor statement for the 

additional training. End of NRC Staff’s response

6. “RSO- Eligible” designation on board certificates

a. The Draft Final Rule discusses designation of an AU, AMP, or ANP as the RSO or 

ARSO on medical licenses. The Sub-Committee suggests that the NRC include in this 

discussion a declaration that for a board-certified AU, AMP, or ANP to be named as the 

RSO or an ARSO the board certification of the AU, AMP, or ANP must include the 

designation, “RSO Eligible”.

7. § 35.390(b)(1)(ii)(G)(4) (Based on the NRC’s determination that there are fundamental 

radiation safety differences between alpha- and beta/gamma-emitting radionuclide)

a. Our Sub-Committee continues to disagree with maintaining a separate category for 

parenteral administration of alpha-emitting radiopharmaceuticals in the Draft Final Rule.

As stated in the ACMUI Report on Licensing for Radium-223 (223Ra), 223RaCl2 and, by 

extension, other alpha-emitting radiopharmaceuticals do not differ significantly in terms 

of clinical use and management, radiation safety, and logistics from currently approved 

radiopharmaceuticals. Therefore, physicians already authorized to use therapeutic 

radiopharmaceuticals under § 35.390 or § 35.396 have the requisite education, training, 

and experience to safely and effectively use alpha-emitting radiopharmaceuticals As 

such, licensing of authorized users of 223RaCl2 under § 35.390 (Category (G)(3) or 

(G)(4)), or § 35.396(d)(2), was therefore recommended.

The NRC’s response in justifying the need to keep a separate category for parenteral 

administration of alpha-emitting radiopharmaceuticals [§ 35.390(b)(1)(ii)(G)(4)] stated 

that “...there are fundamental differences between the clinical use and the radiation 

safety of the radioactive drugs used primarily for their alpha emission versus beta 

emission.” The Sub-Committee, as noted, disagrees with this assertion and believes the 

NRC staff has not provided a sufficient basis to state there are such “fundamental 

differences”. Addendum 2 presents a tabulation of the physical properties of current or 
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under-development therapeutic radionuclides. Note that each of the alpha-emitting 

radionuclides emit gamma radiation and two also emit beta radiation, so these 

radionuclides do not require different radiation-detection equipment. AUs training for 

clinical use includes not only what radionuclide properties must be considered, but also 

the pharmaceutical properties. The only fundamental difference in the list of.§ 

35.390(b)(1)(ii)(G) “categories” is the route of administration being parenteral. The SubCommittee strongly recommends that.§ 35.390(b)(1)(ii)(G)(4) should be deleted and the 

pertinent passage in § 35.390(b)(1)(ii)(G)(3) revised as follows, “Parenteral 

administration of any radioactive drug for which a written directive is required.”

NRC Staff’s response to the comment as previously submitted: The staff has 

determined that there are fundamental differences between the clinical use and the 

radiation safety of the two groups identified in proposed § 35.390(b)(1)(G)(3) or (4). The 

radiation detection equipment used to monitor and detect photons, electrons, and beta 

particles can be very different from that used to monitor and detect alpha particles, and 

calibration procedures for measuring activities of beta emitters and alpha emitters are 

more complicated than for photon emitters. Further, the relationship between activity 

and radiation dose delivered to the patient for alpha emitters is not the same as that for 

low-energy photons, beta particles and electron emitters.

The staff recognizes that medical use licensees have radiation safety T&E, medical use 

experience, and ready access to low-energy photon and beta-emitting radionuclides. 

However, radioactive drugs primarily used for their alpha radiation characteristics are 

new to most medical use licensees (the first alpha-emitting radiopharmaceutical was 

approved by Food and Drug Administration (FDA) in May 2013). The staff determined 

that there are important radiation safety considerations associated with alpha-emitting 

radiopharmaceuticals. They include patient radiation safety (e.g., administrative controls 

to prevent an ME), steps to ensure the proper dosage is delivered (e.g., quality control 

procedures on instruments used to determine the activity of dosages, calculating, 

measuring, and safely preparing dosages), and radiation safety (e.g., ordering, 

receiving, performing radiation surveys, containing spills safely and proper 

decontamination procedures). Therefore, the staff has determined that an AU should 

have experience with alpha-emitting radiopharmaceuticals in addition to the experience 

the AU may have with the low-energy photon- and beta-emitting radionuclides.

The staff has determined that this requirement would not be a burden on licensees. The 

proposed requirements will ensure that AU’s have the proper radiation safety training in 

the use of alpha emitters. Licensees only need to document the physician’s T&E using 

the broad categories listed in § 35.390(b)(1)(G) and need not document each individual 

radionuclide used in a category. End of NRC Staff’s response

Specific Comments

Pg 5 Lines 110-113 Regarding the statement, “This cost will be spread over the 

7,418 impacted licensees for an average implementation cost 

of approximately $1,100 per licensee,” does the number refer 

to NRC licensees , Agreement-State licensees or both?

Pg 5 Lines 113-114 Does this sentence refer to net or gross revenues?
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Pg 5 Lines 117-118 This sentence should be revised as follows, “The benefits of 

this final rule are associated with reducing unnecessary 

radiation exposure to patients, modifying requirements for 

T&E, and affording more latitude to licensees.” 

Pg 10 Lines 245-246 The phrase, “..., as RSOs who have relevant timely work 

experience (even if they have not been formally named as an 

RSO), is confusing, as it makes the meaning of this sentence 

unclear in that the prior portion of this sentence and the 

Ritenour petition itself refers to all board-certified medical 

physicists, not only RSOs.

Pg 13 Lines 313-314 This sentence should be revised as follows, “The final rule 

clarifies the current regulations and provides greater flexibility 

to licensees without compromising patient, worker, or public 

health and safety and without unnecessarily restricting 

patients’ access to medical procedures.”

Pg 14 Line 335 The phrase , “...no suitable clinically used dose metric...,” 

should be changed to, “...no clinically meaningful and practical 

dose metric...”

Pg 16 Lines 384-396 The statement in lines 305-396, “The ME criteria in the final 

rule do not include absorbed doses to normal tissues located 

outside of the treatment site or located within the treatment 

site,” is confusing in that it apparently contradicts what was 

stated in the preceding paragraph. That paragraph states in 

lines 387-390, “...this ACMUI-recommended ME reporting 

criterion for normal tissue structures located within the 

treatment site was retained in SECY-12-0053 because the 

ACMUI and the staff determined there should be some form of 

ME reporting criterion for overdosing of normal tissue 

structures located within the treatment site.” If the latter 

statement (i.e., in the preceding paragraph) was included in 

order to recount the evolution of the current ME criteria in the 

final rule, the distinction between the previously recommended 

and the current ME criteria must be made clearer and more 

explicit.

Pg 19 Line 455 The phrase, “...will not contribute dose to the treatment 

site...,” should be changed to, “...will not contribute a 

therapeutically significant dose to the treatment site...” 

Although not perhaps true of iodine-125 (which emits only very 

low-energy and relatively non-penetrating gamma radiations), 

most radionuclides emit gamma- radiations sufficiently 

penetrating to deliver, from any location in the body, some 

non-zero dose to any other location of the body; this is the 

rationale for including the qualifier, “therapeutically significant.”
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Pg 19 Line 460 The phrase, “...a location far from the treatment site,” should 

be changed to, “...a location discontiguous from the intended 

treatment site.”

Pg 19 Line 464-465 The phrase, “...will not contribute dose to the treatment 

site...,” should be changed to, “...will not contribute a 

therapeutically significant dose to the treatment site...” 

Pg 22 Line 528 The phrase, “...for individuals with whom the preceptor is not 

personally familiar,” should be appended to the end of this 

sentence.

Pg 22 Lines 533-534 Here and elsewhere in the rule, the term, “board certified,” 

should be changed to, “board-certified.”

Pg 22 Line 542 The parenthetical phrase, “...(such as the attending staff or 

faculty of the attestor’s clinical service)...,” should be inserted 

between the comma and the word, “irrespective.”

Pg 24 Line 594 The phrase, “...however a generator can be eluted several 

times...,” should be changed to, “however, a generator can be 

eluted multiple times...”

Pg 71 Lines 1772-1773 The statement, “The NRC agrees that the proposed language 

could be clearer,” is unnecessary and actually somewhat 

confusing, as the preceding statement declares that the 

clarifying change has been made.

Pg 75 Lines 1871-1874 Regarding the statement, “The NRC is retaining the separate 

dosage category used primarily for alpha emitters because 

there are fundamental differences between the clinical use and 

the radiation safety of the radioactive drugs used primarily for 

their alpha emission versus beta emission,” the ACMUI and its 

Sub-Committee strongly disagree with this and similar 

assertions by the NRC. The ACMUI and its Sub-Committee 

feel that that there are no fundamental differences in the 

clinical use and radiation safety of radioactive drugs used 

between those used primarily for their alpha emission versus 

beta emission, and, as noted, the NRC has provided no basis 

for its assertion to the contrary.

Pg 82 Line 2045-2047 The meaning of the statement, “The proposed rule change 

was made in part to ensure that the ophthalmology physicist 

(or authorized medical physicist) performs a minimum number 

of tasks at the ophthalmology office,” is unclear. It should be 

deleted.

Pg 133 Lines 3320-3323 The Sub-Committee does not support the proposed change in 

wording from “commits” to “satisfies” the label requirements in 

§ 32.72 Manufacture, preparation, or transfer for commercial 
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distribution of radioactive drugs containing byproduct material 

for medical use under 10 CFR part 35. This change appears 

to be an inappropriate regulatory action in that it has no 

substantiated basis for remediating any harm being caused. 

This change will increase costs for commercial 

radiopharmacies and for drug manufacturers in order to 

comply with this new, but unnecessary, standard beyond what 

they are meeting now - with no perceptible improvement in 

patient safety.

Pg 135 Lines 3354-3356 This passage should be revised as follows, “For license 

amendments or renewals, this paragraph is amended to 

remove the requirement to submit a copy in addition to the 

original of NRC Form 313 or a letter containing information 

required by NRC Form 313. This change will relieve the 

burden on the licensee by requiring less paperwork to be 

submitted.”

Pg 163 Lines 4071-4073 Our Sub-Committee endorses the extension of the full 

inspection and servicing interval between each full inspection 

for gamma stereotactic radiosurgery units from 5 to 7 years.
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Addendum 1

Editorial Revisions

Pg 3 Line 64 The semi-colon between the words, “amended” and “and,” 

should be changed to a comma.

Pg 4 Lines 89-90 The phrase, “...for failed Mo-99/Tc-99m and strontium-82 (Sr82)/Rb-82 generators,” should be changed to, “...out-oftolerance parent breakthrough results for Mo-99/Tc-99m and 

strontium-82 (Sr-82)/rubidium-82 (Rb-82) generators.”

Pg 5 Line 103 The comma between the terms, “2005” and “be,” should be 

deleted.

Pg 8 Line 178 The comma between the closing parenthesis and the word, 

“for,” should be deleted.

Pg 9 Line 205 The comma between the words, “rule” and “see,” should be 

changed to a semi- colon.

Pg 14 Lines 329-330 The phrase , “..., as well as with substantial input from various 

stakeholders, and the public comments received on the 

proposed rule,” should be changed to, “... and on substantial 

input from the public and various other stakeholders on the 

proposed rule.”

Pg 15 Line 360 A comma should be inserted between the words, “report” and 

“was.”

Pg 15 Line 361 The comma between the terms, “2011” and “teleconference,” 

should be deleted.

Pg 15 Line 364 The term, “source-strength based,” should be changed to, 

““source strength-based.”

Pg 16 Line 386 The comma between the words, “reporting” and “that,” should 

be deleted.

Pg 19 Line 455 The phrase, “This wrong treatment site medical event 

criterion...,” should be changed to, “This wrong treatment-site 

ME criterion...”

Pg 19 Line 466 The phrase, “..., however it is defined as a medical event...,” 

should be changed to, “...; however, it is defined as such...”

Pg 19 Line 467 The term, “treatment site,” should be changed to, “treatmentsite.”
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Pg 19 Line 472 The phrase, “...in tissue immediately adjacent to the 

misplaced seed,” should be appended to the end of this 

sentence.

Pg 24 Line 600 The word, “may,” should be changed to, “will.”

Pg 24 Line 610 Here and in line 622, the word, “numerous,” should be 

changed to, “multiple,” as the former term seems excessive.

Pg 25 Line 622 The term, “contamination issues,” should be changed to, 

“parent-breakthrough issues.”

Pg 25 Line 624 The phrase, “...unexpected levels...,” should be changed to,

“...unexpectedly high levels...”

Pg 26 Line 635 The word, “can,” should be changed to, “will.”

Pg 29 Line 709 The term, “120 day,” should be changed to, “120-day.”

Pg 29 Line 711 The comma at the end of this line should be deleted.

Pg 29 Line 714 The comma between the terms, “2015” and “to,” should be 

deleted.

Pg 29 Line 722 The semi-colon between the terms, “2011” and “and,” should 

be deleted.

Pg 30 Line 727 The comma between the terms, “SECY-10-0062” and “to,” 

should be deleted.

Pg 31 Line 751 The word, “the,” between the words, “of” and “Congress,” 

should be deleted.

Pg 31 Line 764 The comma between the words, “outside” and “or,” should be 

deleted.

Pg 32 Line 779 The comma between the words, “individuals” and “and,” 

should be deleted.

Pg 33 Line 813 The comma between the words, “modalities” and “or,” should 

be deleted.

Pg 33 Line 820 The term, “180 day,” should be changed to, “180-day.”

Pg 34 Line 826 The comma between the words, “petition” and “should,” should 

be deleted.

Pg 34 Line 829 The word, “determined,” should be changed to, “decided.”

Pg 34 Lines 839 The word, “products,” should be changed to, 

and 840 “radiopharmaceuticals.”
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Pg 34 Line 840 The term, “lower risk,” should be changed to, “lower-risk.”

Pg 35 Line 867 The word, “meets,” should be changed to, “meet.”

Pg 43 Line 1066 A comma should be inserted between the words, “Therefore” 

and “for.”

Pg 44 Line 1099 The word, “judgment,” is misspelled.

Pg 44 Line 1102 A comma should be inserted between the word, “language,” 

and the quotation mark.

Pg 45 Lines 1117 The terms, “before implantation” and “after implantation,” when

and 1118 used as compound adjectives, should be changed to, “beforeimplantation” and “after-implantation,” respectively.

Pg 46 Line 1139 The term, “two part,” should be changed to, “two-part.”

Pg 46 Lines 1143 The term, “post treatment,” should be changed to, “posttreatment.”

Pg 54 Line 1340 The term, “medical use,” should be changed to, “medical-use.”

Pg 66 Line 1666 The term, “board certified,” when used as a compound 

adjective, should be changed to, “board-certified.”

Pg 71 Line 1765 The word, “was,” should be changed to, “were.”

Pg 79 Line 1964 The comma between the words, “characteristic” and “can,” 

should be removed.

Pg 82 Lines 2055-2056 The sources to which the phrase, “...the full calibration 

measurements and decay corrections...,” refers should be 

identified explicitly.

Pg 84 Line 2112 The comma between the words, “supervision” and “or,” should 

be removed.

Pg 87 Line 2164 The term, “photon emitting,” should be changed to, “photonemitting.”

Pg 89 Line 2232 The comma between the words, “basis” and “each,” should be 

removed.

Pg 93 Line 2312 The term, “medical event,” when used as a compound 

adjective, should be changed to, “medical-event.”

Pg 93 Line 2314 The term, “absorbed dose based,” should be changed to, 

“absorbed dose-based.”
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Pg 96 Line 2393 The term, “post Dosimetry CT scan,” should be changed to, 

“post-dosimetry CT scan.”

Pg 97 Line 2411 The term, “normal tissue,” when used as a compound 

adjective, should be changed to, “normal-tissue.”

Pg 97 Line 2415-2416 The term, “treatment planning software,” when used as a 

compound adjective, should be changed to, “treatmentplanning software.” 

Pg 103 Line 2566 The comma between the words, “migrated” and “‘would,” 

should be removed.

Pg 109 Line 2708 The word, “is,” should be changed to, “are.”

Pg 110 Line 2746 The comma between the words, “policy” and “that,” should be 

removed.

Pg 115 Line 2873 The term, “high-quality implant,” should be changed to, “highquality implant.”

Pg 116 Line 2875 The term, “prostate implant program,” should be changed to, 

“prostate-implant program.”

Pg 117 Lines 2903- The statement, “The NRC is not aware of cases where

2905 medically significant events have occurred and 20 percent or 

less of the source strength was implanted outside the 

treatment site,” is somewhat confusing as well as 

unnecessary; it should be removed.

Pg 117 Line 2915 The word, “judgment,” is misspelled.

Pg 119 Line 2953 The comma between the words, “requirements” and “and,” 

should be removed.

Pg 120 Line 2993 A comma should be inserted between the words, “Therefore” 

and “Agreement.”

Pg 121 Line 3027 The term, “medical event reporting criteria,” should be 

changed to, “medical-event reporting criteria.”

Pg 122 Line 3031 The comma between the words, “program” and “because,” 

should be removed.

Pg 125 Line 3127 The word, “assure,” should be changed to, “ensure."

Pg 128 Line 3190 The phrase, “...then the rule language be changed...,” should 

be changed to, “...then the rule language should be 

changed...”
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Pg 128 Line 3198 The word, “the,” between the words, “are” and “more,” should 

be removed.

Pg 129 Line 3206 The comma between the words, “procedures” and “such,” 

should be removed.

Pg 129 Line 3217 The comma between the words, “criteria” and “because,” 

should be removed.

Pg 148 Line 3697 The word, “several,” should be changed to, “multiple.”

Pg 171 Line 4254 Can the parenthetical placeholder now be replaced with the 

actual pertinent material?

Pg 181 Line 4326 Can the parenthetical placeholder now be replaced with the 

actual pertinent material?

Pg 181 Lines 4328-4335 The Draft Final Rule could be shortened, and improved, by 

eliminating redundancies and consolidating related sections, 

eliminating identical or nearly identical passages appearing 

multiple times throughout the document.

Pg 182 Lines 4344-4356 Confirm that the US Pharmacopeia does not include a 

recommendation to perform an assay of parent breakthrough 

on every generator elution. If it does, that would like constitute 

an applicable “voluntary consensus standard.”

Pg 183 Line 4382 This line, in Section XV. Environmental Assessment and Final

Finding of No Significant Environmental Impact, is simply, 

“Place holder for the final Environmental Assessment.” What 

is the status of this assessment? Can this section now be 

appropriately updated?

Pg183 (5th line from bottom) Can the placeholder, “xxxx,” now be replaced with the 

appropriate number in the number?

Pg183 (4th line from bottom) Can the placeholder, “____,” now be replaced with the 

appropriate number of hours?

Pg184 (3rd line from top) Can the placeholder, “xxxx,” now be replaced with the 

appropriate number in the number?

Pg 184 Line 4392 This line, in Section XVII. Regulatory Analysis, is simply, 

“Place holder for the final Environmental Assessment.” What 

is the status of this analysis? Can this section now be 

appropriately updated?

Pg 184 Line 4404 The word, “from,” should be deleted.

Pg 186 Line 4344 The comma between the words, “that” and “the,” should be 

deleted.
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Pg 192 Lines 4524-4534 Here and elsewhere in the document, what is the meaning of 

the asterisks (in lines that are otherwise blank)?

Pg 193 Lines 4556 The term, “medical use,” when used as a compound adjective, 

should be changed to, “medical-use.”

Pg 196 Line 4628 The phrase, “...reduces radiation safety...,” is rather 

ambiguous criterion. Could more explicit and precise 

language be used instead?

Pg 196 Line 4644 The term, “Device specific training,” should be changed to, 

“Device-specific training.”

Pg 197 Line 4651 The comma between the terms, “2007” and “or,” should be 

removed.

The comma between the terms, “2009” and “or,” should be 

removed.

Pg 198 Line 4695 Does the term, “60 days per year,” refer to actual calendar 

days or business days?

Pg 204 Line 4833 The comma between the terms, “section” and “and,” should be 

removed.

Pg 206 Line 4890 Is the section number, 15, correct?

Pg 207 Line 4907 Is the section number, 16, correct?

Pg 211 Line 5000 Is the section number, 17, correct?

Pg 212 Lines 5029-5030 Is the section number, 18, correct?

Pg 213 Line 5057 Is the section number, 19, correct?

Pg 213 Lines 5069-5070 Is the section number, 20, correct?

Pg 215 Line 5103 Is the section number, 21, correct?

Pg 215 Lines 5110-5111 Is the section number, 22, correct?

Pg 217 Line 5165 Is the section number, 23, correct?

Pg 218 Line 5195 Is the section number, 24, correct?

Pg 220 Line 5225 Is the section number, 25, correct?

Pg 222 Line 5288 Is the section number, 26, correct?

Pg 223 Line 5300 Is the section number, 27, correct?
ACMUI Sub-Committee Comments on NRC Draft Final Rule, 10 CFR Parts 30, 32 and 35

Submitted 12/23/15

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Pg 224 Lines 5328-5329 Is the section number, 28, correct?

Pg 225 Line 5360 Is the section number, 29, correct?

Pg 225 Line 5371 Is the section number, 30, correct?

Pg 226 Line 5391 Is the section number, 31, correct?

Pg 227 Line 5421 Is the section number, 32, correct?

Pg 227 Line 5434 Is the section number, 33, correct?

Pg 229 Line 5454 Is the section number, 34, correct?

Pg 229 Lines 5465-5566 Is the section number, 35, correct?

Pg 231 Line 5501 Is the section number, 36, correct?

Pg 231 Line 5512 Is the section number, 37, correct?

Pg 231 Line 5520 Is the section number, 38, correct?

Pg 232 Line 5528 Is the section number, 39, correct?

Pg 234 Line 5590 Is the section number, 40, correct?
ACMUI Sub-Committee Comments on NRC Draft Final Rule, 10 CFR Parts 30, 32 and 35

Submitted 12/23/15

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Addendum 2

Physical Properties of Radionuclides

Currently in Use or Under Development for Therapeutic Radiopharmaceuticals

Major Radiation Emissions+

Radionuclide Half-Life Radiations Yield (Bq-sec)-1 Energy( MeV)

Actinium-225 (Ac-225) 10.0 days α 10 2.30x10-03 5.286

α recoil 2.30x10-03 9.486x10-02

α 13 1.40x10-03 5.443

α recoil 1.40x10-03 9.767x10-02

α 18 1.20x10-02 5.580

α recoil 1.20x10-02 1.001x10-01

α 20 1.10x10-02 5.609

α recoil 1.10x10-02 1.007x10-01

α 21 4.40x10-02 5.637

α recoil 4.40x10-02 1.012x10-01

α 22 1.30x10-02 5.682

α recoil 1.30x10-02 1.020x10-01

α 23 3.10x10-02 5.724

α recoil 3.10x10-02 1.027x10-01

α 24 8.70x10-03 5.731

α recoil 8.70x10-03 1.028x10-01

α 25 1.32x10-02 5.732

α recoil 1.32x10-02 1.029x10-01

α 26 8.00x10-02 5.732

α recoil 8.00x10-02 1.029x10-01

α 27 8.60x10-02 5.791

α recoil 8.60x10-02 1.039x10-01

α 28 1.81x10-01 5.793

α recoil 1.81x10-01 1.039x10-01

α 29 3.30x10-03 5.805

α recoil 3.30x10-03 1.042x10-01

α 33 5.07x10-01 5.83

α recoil 5.07x10-01 1.046x10-01

γ 1 8.50x10-02 1.064x10-02
ACMUI Sub-Committee Comments on NRC Draft Final Rule, 10 CFR Parts 30, 32 and 35

Submitted 12/23/15

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ce-L, γ 2 6.58x10-02 7.361x10-03a

ce-M, γ 2 1.76x10-02 2.135x10-02a

ce-N+, γ 2 5.67x10-03 2.485x10-02a

ce-L, γ 3 6.20x10-02 1.806x10-02a

ce-M, γ 3 1.70x10-02 3.205x10-02a

ce-N+, γ 3 6.20x10-03 3.555x10-02a

ce-L, γ 4 5.99x10-02 1.986x10-02a

ce-M, γ 4 1.61x10-02 3.385x10-02a

ce-N+, γ 4 5.18x10-03 3.735x10-02a

γ 8 4.30x10-03 6.290x10-02

ce-L, γ 8 3.55x10-02 4.426x10-02a

ce-M, γ 8 8.47x10-03 5.825x10-02a

ce-N+, γ 8 2.80x10-03 6.175x10-02a

ce-L, γ 9 6.15x10-03 4.566x10-02a

ce-M, γ 9 1.60x10-03 5.965x10-02a

ce-L, γ 11 2.31x10-03 5.276x10-02a

ce-L, γ 12 4.00x10-03 5.486x10-02a

ce-M, γ 12 1.00x10-03 6.885x10-02a

γ 13 2.64x10-03 7.390x10-02

γ 16 2.26x10-03 8.740x10-02

ce-L, γ 17 4.20x10-03 7.626x10-02a

ce-M, γ 17 1.18x10-03 9.025x10-02a

ce-L, γ 18 1.12x10-03 7.806x10-02a

γ 19 7.00x10-03 9.960x10-02

ce-L, γ 19 1.61x10-02 8.096x10-02a

ce-M, γ 19 3.92x10-03 9.495x10-02a

ce-N+, γ 19 1.28x10-03 9.845x10-02a

γ 20 1.00x10-02 9.980x10-02

ce-L, γ 21 3.15x10-03 8.216x10-02a

γ 23 2.16x10-03 1.084x10-01

ce-K, γ 23 1.56x10-02 7.263x10-03

ce-L, γ 23 4.97x10-03 8.976x10-02a

ce-M, γ 23 1.25x10-03 1.037x10-01a

γ 24 2.64x10-03 1.115x10-01
ACMUI Sub-Committee Comments on NRC Draft Final Rule, 10 CFR Parts 30, 32 and 35

Submitted 12/23/15

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γ 37 1.26x10-03 1.452x10-01

γ 38 6.00x10-03 1.501x10-01

γ 40 1.82x10-03 1.539x10-01

γ 41 3.20x10-03 1.573x10-01

ce-K, γ 41 5.41x10-03 5.616x10-02

ce-L, γ 41 2.24x10-03 1.387x10-02a

γ 50 4.50x10-03 1.880x10-01

γ 51 1.23x10-03 1.958x10-01

ce-K, γ 51 1.37x10-03 9.466x10-02

γ 56 2.71x10-03 2.169x10-01

γ 63 1.16x10-03 2.535x10-01

Bismuth-213 (Bi-213) 45.61 minutes α 1 1.81x10-03 5.558

α recoil 1.81x10-03 1.055x10-01

α 2 1.96x10-02 5.875

α recoil 1.96x10-02 1.115x10-01

β- 3 5.86x10-03 9.080x10-02*

β- 8 3.07x10-01 3.204x10-01*

β- 9 2.29x10-03 3.768x10-01*

β- 3 6.58x10-01 4.922x10-01*

γ 1 4.29x10-03 2.928x10-01

γ 2 1.67x10-03 3.237x10-01

γ 9 2.92x10-03 8.074x10-01

γ 15 2.59x10-03 1.100

Iodine-131 (I-131) 8.0252 days β- 1 2.08x10-02 6.936x10-02*

β- 2 6.45x10-03 8.694x10-02*

β- 3 7.23x10-02 9.662x10-02*

β- 4 8.96x10-01 1.916x10-01*

β- 6 3.90x10-03 2.832x10-01*

γ 1 2.62x10-02 8.019x10-02

ce-K, γ 1 3.14x10-02 4.562x10-02

ce-L, γ 1 4.45x10-03 7.473x10-02a

γ 3 2.69x10-03 1.772x10-01

γ 6 6.12x10-02 2.843x10-01

ce-K, γ 6 2.50x10-03 2.497x10-01
ACMUI Sub-Committee Comments on NRC Draft Final Rule, 10 CFR Parts 30, 32 and 35

Submitted 12/23/15

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γ 11 2.73x10-03 3.258x10-01

γ 13 8.15x10-01 3.645x10-01

ce-K, γ 13 1.56x10-02 3.299x10-01

ce-L, γ 13 2.44x10-03 3.590x10-01a

γ 15 3.59x10-03 5.030x10-01

γ 16 7.16x10-02 6.370x10-01

γ 17 2.17x10-03 6.427x10-01

γ 18 1.77x10-02 7.299x10-01

Lead-212 (Pb-212) 10.64 hours β- 1 5.08x10-02 4.110x10-02*

β- 2 8.31x10-01 9.350x10-02*

β- 3 1.19x10-01 1.717x10-01*

γ 1 5.96x10-03 1.152x10-01

ce-K, γ 1 3.45x10-02 2.466x10-02

ce-L, γ 1 6.05x10-03 9.880x10-02a

γ 4 5.96x10-03 1.152x10-01

ce-K, γ 4 3.23x10-01 1.481x10-01

ce-L, γ 4 5.60x10-02 2.222x10-01a

ce-M, γ 4 1.32x10-02 2.346x10-01a

ce-N+, γ 4 4.40x10-03 2.377x10-01a

γ 5 3.30x10-02 3.001x10-01

ce-K, γ 5 1.30x10-02 2.096x10-01

ce-L, γ 5 2.25x10-03 2.837x10-01a

Lutitium-177 (Lu-177) 6.647 days β- 1 1.16x10-01 4.766x10-02*

β- 3 9.00x10-02 1.117x10-01*

β- 4 7.94x10-01 1.494x10-01*

γ 1 1.72x10-03 7.164x10-02

γ 2 6.17x10-02 1.129x10-01

ce-K, γ 2 5.12x10-02 4.760x10-02

ce-L, γ 2 6.73x10-02 1.017x10-01a

ce-M, γ 2 1.67x10-02 1.103x10-01a

ce-N+, γ 2 4.80x10-03 1.124x10-01a

γ 4 1.04x10-01 2.084x10-01

ce-K, γ 4 5.70x10-03 1.430x10-01

γ 5 2.01x10-03 2.497x10-01
ACMUI Sub-Committee Comments on NRC Draft Final Rule, 10 CFR Parts 30, 32 and 35

Submitted 12/23/15

29 of 31

γ 6 2.10x10-03 3.213x10-01

Phosphorus-32 (P-32) 14.268 days β- 1 1.00 6.950x10-01*

Radium-223 (Ra-223) 11.43 days α 14 1.50x10-03 5.287

α recoil 1.50x10-03 9.575x10-02

α 15 1.30x10-03 5.339

α recoil 1.30x10-03 9.668x10-02

α 16 1.30x10-03 5.366

α recoil 1.30x10-03 9.717x10-02

α 17 2.22x10-02 5.434

α recoil 2.22x10-02 9.840x10-02

α 19 1.00x10-02 5.502

α recoil 1.00x10-02 9.963x10-02

α 20 9.00x10-02 5.540

α recoil 9.00x10-02 1.003x10-01

α 21 2.52x10-01 5.607

α recoil 2.52x10-01 1.015x10-01

α 22 5.16x10-01 5.716

α recoil 5.16x10-01 1.035x10-01

α 23 9.00x10-02 5.747

α recoil 9.00x10-02 1.041x10-01

α 24 3.10x10-03 5.858

α recoil 3.10x10-03 1.061x10-01

α 25 1.00x10-02 5.871

α recoil 1.00x10-02 1.063x10-01

ce-K, γ 13 2.18x10-03 9.281x10-02a

γ 16 1.21x10-02 1.223x10-01

ce-K, γ 16 7.47x10-02 2.391x10-02

ce-L, γ 16 1.40x10-02 1.043x10-01a

ce-M, γ 16 3.36x10-03 1.178x10-01a

ce-N+, γ 16 1.17x10-03 1.212x10-01a

γ 19 3.27x10-02 1.442x10-01

ce-K, γ 19 1.27x10-01 4.583x10-02

ce-L, γ 19 2.35x10-02 1.262x10-01a

ce-M, γ 19 5.59x10-03 1.398x10-01a
ACMUI Sub-Committee Comments on NRC Draft Final Rule, 10 CFR Parts 30, 32 and 35

Submitted 12/23/15

30 of 31

ce-N+, γ 19 1.95x10-03 1.431x10-01a

γ 21 5.70x10-02 1.542x10-01

ce-K, γ 21 1.85x10-01 5.580x10-02

ce-L, γ 21 3.36x10-02 1.362x10-01a

ce-M, γ 21 7.98x10-03 1.497x10-01a

ce-N+, γ 21 2.78x10-03 1.531x10-01a

γ 22 6.95x10-03 1.586x10-01

ce-K, γ 22 2.03x10-02 6.023x10-02

ce-L, γ 22 3.82x10-03 1.406x10-01a

γ 26 1.53x10-03 1.795x10-01

ce-K, γ 26 2.58x10-03 8.114x10-02

γ 35 1.39x10-01 2.695x10-01

ce-K, γ 35 9.29x10-02 1.711x10-01

ce-L, γ 35 1.70x10-02 2.514x10-01a

ce-M, γ 35 4.02x10-03 2.650x10-01a

ce-N+, γ 35 1.37x10-03 2.684x10-01a

γ 38 1.60x10-03 2.882x10-01

γ 39 3.99x10-02 3.329x10-01

ce-K, γ 39 1.60x10-02 2.255x10-01

ce-L, γ 39 2.90x10-02 3.058x10-01a

γ 43 2.22x10-03 3.429x10-01

γ 49 4.87x10-03 3.717x10-01

ce-K, γ 49 1.38x10-03 2.733x10-01

γ 57 1.29x10-02 4.450x10-01

ce-K, γ 57 2.25x10-03 3.466x10-01

Rhenium-186 (Re-186) 3.7183 days γ 1 6.03x10-03 1.226x10-01

ce-L, γ 1 5.55x10-03 1.105x10-01a

β- 3 2.15x10-01 3.061x10-01*

β- 4 7.10x10-01 3.529x10-01*

γ 1 9.47x10-02 1.372x10-01

ce-K, γ 1 4.16x10-02 6.329x10-02

ce-L, γ 1 6.05x10-02 1.242x10-01a

ce-M, γ 1 1.53x10-02 1.341x10-01a

ce-N+, γ 1 4.63x10-03 1.365x10-01a
ACMUI Sub-Committee Comments on NRC Draft Final Rule, 10 CFR Parts 30, 32 and 35

Submitted 12/23/15

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Samarium-153 (Sm-153) 46.50 hours β- 14 3.13x10-01 1.995x10-01*

β- 16 4.94x10-01 2.253x10-01*

β- 17 6.00x10-03 2.274x10-01*

β- 18 1.84x10-01 2.643x10-01*

γ 5 4.73x10-02 6.967x10-02

ce-K, γ 5 2.12x10-01 2.115x10-02

ce-L, γ 5 3.45x10-02 6.162x10-02a

ce-M, γ 5 7.52x10-03 6.787x10-02a

γ 6 1.93x10-03 7.542x10-02

γ 7 1.92x10-03 8.337x10-02

γ 8 1.58x10-03 8.949x10-02

γ 10 7.72x10-03 9.743x10-02

γ 11 2.92x10-01 1.032x10-01

ce-K, γ 11 4.24x10-01 5.466x10-02

ce-L, γ 11 6.32x10-02 9.513x10-02a

ce-M, γ 11 1.37x10-02 1.014x10-01a

ce-N+, γ 11 3.95x10-03 1.028x10-01a

Strontium-89 (Sr-89) 50.563 days β- 2 1.00 5.871x10-01*

Yttrium-90 (Y-90) 64.00 hours β- 3 1.00 9.337x10-01*

Zirconium-89 (Zr-89) 78.41 hours β+ 1 2.27x10-01 3.955x10-01*

γ ± 4.55x10-01 5.110x10-01

γ 1 9.90x10-01 9.092x10-01

ce-K, γ 1 7.36x10-03 8.921x10-01

γ 3 1.06x10-03 1.657

γ 4 7.45x10-03 1.713

γ 5 1.23x10-03 1.745

+ Data from the Nuclear Decay Data in the MIRD Format at http://www.nndc.bnl.gov/mird/ -

yields >1.00 x 10-3

* Average Energy (MeV)

a Maximum Energy (MeV) for subshell