1

Advisory Committee on the Medical Use of Isotopes (ACMUI)

Final Comments on Proposed Revision of the NRC Policy Statement on 

Reporting Abnormal Occurrences to Congress

November 6, 2015

Subcommittee Members: S. Langhorst (Chair); S. Mattmuller; C. Palestro; B. Thomadsen; and L. 

Weil

Charge: To review the proposed revision of the Nuclear Regulatory Commission (NRC) policy 

statement on reporting abnormal occurrences (AO) to Congress, and to provide comments and ACMUI 

recommendations on the application of the proposed AO criteria on events involving patients or human 

research subjects.

Need for Medical Abnormal Occurrence Criteria Update:

The Nuclear Regulatory Commission (NRC) is required to annually report abnormal occurrences to 

Congress as defined in Section 208 of the Energy Reorganization Act of 1974.1 This section states:

“For the purposes of this section an abnormal occurrence is an unscheduled incident or event 

which the Commission determines is significant from the standpoint of public health or safety.”

Establishment of the NRC Policy Statement on Abnormal Occurrence Criteria2 provides explanation 

of how the Commission determines the incidents or events to be significant and included in the annual 

abnormal occurrence (AO) report. The NRC Staff and the Advisory Committee on the Medical Use of 

Isotopes (ACMUI) have discussed concerns that the medical use-related incidents and events being 

included in AO reports may not be significant from the standpoint of public health or safety. During 

an ACMUI teleconference in December 20113, the ACMUI endorsed their 2008 position, which is 

summarized by the following: AOs for medical licensees should be events which result in death or 

threaten life; AOs should not capture those occurrences that are accepted risks of the treatment; AOs 

should be of significant adverse effect; AO criteria should be qualitative and not quantitative4.

 1

 U.S. Energy Reorganization Act of 1974, as Amended (Public Law 93-438), pages 252-253, 

http://pbadupws.nrc.gov/docs/ML1327/ML13274A489.pdf#page=275 (accessed September 14, 2015). 2 Nuclear Regulatory Commission, “Revised Policy Statement on Abnormal Occurrence Criteria,” 71 FR 60198, 

October 12, 2006, http://www.gpo.gov/fdsys/pkg/FR-2006-10-12/pdf/E6-16871.pdf (accessed March 25, 2013). 3 Official Transcript of Proceedings, Nuclear Regulatory Commission Advisory Committee on the Medical Use of 

Isotopes Teleconference, December 15, 2011, http://pbadupws.nrc.gov/docs/ML1206/ML12062A278.pdf (accessed 

March 25, 2013). 4 Meeting Summary, Nuclear Regulatory Commission Advisory Committee on the Medical Use of Isotopes

Teleconference, December 15, 2011, http://pbadupws.nrc.gov/docs/ML1135/ML11355A253.pdf (accessed April 4,

2013).
2

At the September 2012 ACMUI meeting5

, the NRC Staff asked the Committee to consider their

proposal to add dose-based criteria for medical licensee AO criteria to allow the NRC Staff a screening 

tool to decide which medical events should then be evaluated by a consultant physician to determine 

significant adverse effect. During discussion of this proposal, the ACMUI again voiced their concerns 

of using dose-based criteria to judge medical AOs. The ACMUI established a subcommittee to 

develop recommendations concerning the AO criteria related to medical use incidents and events.

At the request of the NRC Staff, the ACMUI subcommittee submitted recommendations6 in 2013 

for revising AO criteria related to events involving patients or human research subjects and in 

particular to address the use of a screening tool to decide which medical events should be evaluated 

by a consultant physician to determine significant adverse effect. 

The ACMUI report was included in the NRC Staff proposal presented to the Commission for 

revision of the AO policy statement7. The current NRC Policy Statement on Abnormal Occurrence 

Criteria is being revised8 to “clarify and restructure the criteria used by the NRC and Agreement 

States for determining whether to consider an incident or event as an AO” and to “ensure 

consistency with current NRC guidance and regulations”. 

ACMUI continues to have concerns with the proposed AO criteria. Future medical use-related 

incidents and events as defined by the proposed criteria will most likely continue to not be 

significant from the standpoint of public health or safety.

Comments and Recommendations

The following comments and ACMUI recommendations are submitted in response to the NRC 

request for comment on the proposed revisions to its policy statement on reporting abnormal 

occurrences (AO) to Congress8

. The Appendix Table attached to this report provides a comparison 

of these current comments and ACMUI recommended new wording to those portions of the 2006 

version and the 2015 proposed changes to AO Statement of Policy for which ACMUI has 

commented previously.

1. Statement Introduction – The Subcommittee agrees that the general descriptions of what 

constitutes an AO should be included in the Statement of Policy and recommends no 

additional changes be made to this proposed change.

 5 Official Transcript of Proceedings, Nuclear Regulatory Commission Advisory Committee on the Medical Use of 

Isotopes Teleconference, September 21, 2012, http://pbadupws.nrc.gov/docs/ML1232/ML12324A222.pdf (accessed 

April 4, 2013). 6 ACMUI, “Report on Abnormal Occurrence Criteria for Medical Use,” April 15, 2013, 

http://pbadupws.nrc.gov/docs/ML1311/ML13117A002.pdf (accessed September 14, 2015). 7 NRC SECY-15-0040, “Proposed Revisions to Policy Statement on Reporting Abnormal Occurrence Criteria,” March 

19, 2015, http://pbadupws.nrc.gov/docs/ML1216/ML12166A091.html (accessed September 14, 2015). 8 NRC “Abnormal Occurrence Reports – Proposed Revision to Policy Statement; Request for Comments,” 80 FR 

49177, August 17, 2015, http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20260.pdf (accessed September 14, 

2015).
3

2. AO Criteria I. Title and Footnote – The Subcommittee agrees with the change in title for this 

AO Criteria I. and the addition of footnote 2. The Subcommittee recommends the wording 

for footnote 2 be changed as follows with deletions noted with strikeout and additions noted 

in bold:

2 Medical patients and human research subjects are excluded from consideration 

under this criterion and these criteria do not apply to medical events defined in § 

35.3045 and § 35.3047 of Title 10 of the Code of Federal Regulations (10 CFR), 

which are considered in AO Criteria III.C, ‘‘Events involving the Medical Use of 

Radioactive Materials in Patients or Human Research Subjects.’’

This change addresses the Subcommittee’s recommendation that medical-related events 

reported under § 35.3047 be screened under AO Criteria III.C. to maintain consistency with 

NRC regulations because the event exposure was due to the medical use of byproduct 

material.

3. AO Criteria III.A. Title – The Subcommittee agrees with the change in title for this AO 

Criteria III.A.

4. AO Criteria III.C. Title – The Subcommittee agrees with the change in title for this AO 

Criteria III.C., but recommends changing “Radioactive” to “Byproduct” to be consistent 

with 10 CFR 35 regulations.

5. AO Criteria III.C. Footnote – The Subcommittee agrees with the addition of footnote 16 

clarifying that AO Criteria III.A.2, III.A.3, and III.A.4 also apply to medical licensees. The 

application of these criteria will allow the NRC to identify as an AO those circumstances 

involving the loss of management controls demonstrated by multiple medical-related events 

even in the absence of any one event meeting the AO Criteria III.C.

6. AO Criteria III.C.1. and 2. – The Subcommittee recommends that the proposed AO Criteria 

III.C.1. and 2. be replaced with the following modified wording for III.C.1.:

An medical event, as defined in 10 CFR 35.3045 or 35.3047, which results in a dose 

that, unintended permanent functional damage to an organ or a physiological 

system as determined by an independent physicianFN deemed qualified by the 

NRC or an Agreement State.

FNIndependent physician is defined as a physician not on the licensee's staff and 

who was not involved in the care of the patient or human research subject 

involved in the event.

This wording modification removes use of a dose criterion which may have identified events 

which have no evidence of probable consequence while possibly missing significant events 

which did not exceed the dose criterion but may have resulted in damage to an organ or 

physiological system. The addition of the requirement for an independent physician and the 

associated footnote is consistent with the statement and footnote used in AO Criterion I.A.3.
4

7. Cost of Independent Physician Review – The Subcommittee recommends that NRC Staff 

evaluates whether implementation of the Subcommittee’s recommended AO Criterion 

III.C.1. would trigger additional cost beyond the cost of providing independent medical 

consultation in support of the regulatory review conducted for a § 35.3045 or § 35.3047 

event.

8. Appendix B. Re-Designation and New Description – The Subcommittee agrees with the 

change in re-designating the previous AO Criteria IV. as the proposed Appendix B with the 

additional description for this new appendix to clarify that it is not part of the proposed AO 

Criteria.

Consideration of the Meaning of Abnormal in Abnormal Occurrences

The full Section 208 of the Energy Reorganization Act of 19749 (Act) is provided here. 

“Sec. 208. Abnormal Occurrence Reports

The Commission shall submit to the Congress an annual report listing for the 

previous fiscal year any abnormal occurrences at or associated with any facility which is 

licensed or otherwise regulated pursuant to the Atomic Energy Act of 1954 as amended, or 

pursuant to this Act. For the purposes of this section an abnormal occurrence is an 

unscheduled incident or event which the Commission determines is significant from the 

standpoint of public health or safety. Nothing in the preceding sentence shall limit the 

authority of a court to review the determination of the Commission. Each such report shall 

contain–

(1) the date and place of each occurrence;

(2) the nature and probable consequence of each occurrence;

(3) the cause or causes of each; and

(4) any action taken to prevent reoccurrence;

the Commission shall also provide as wide dissemination to the public of the information 

specified in clauses (1) and (2) of this section as reasonably possible within fifteen days of 

its receiving information of each abnormal occurrence and shall provide as wide 

dissemination to the public as reasonably possible of the information specified in clauses (3)

and (4) as soon as such information becomes available to it.”

The ACMUI notes that the Act grants the Commission full discretion in defining what it determines 

is significant in regard to public health and safety, but a court retains the authority to review the 

Commission’s determination. As part of the annual report, the probable consequences and actions 

taken to prevent reoccurrence are to be included for each AO.

The Subcommittee updated the list of medical use-related (i.e., those reported as 10 CFR 35.3045 or 

35.3047 events) AOs reported to Congress since 2007, as summarized in Table 1. 

 9 U.S. Energy Reorganization Act of 1974, as Amended (Public Law 93-438), pages 252-253, 

http://pdadupws.nrc.gov/docs/ML1327/ML13274A489.pdf#page=275 (accessed September 14, 2015).
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Table 1: Abnormal Occurrences Reported to Congress

FY All AO

AO I.A.2. 

from 10 CFR 

35.3047

AO III.C. 

from 10 CFR 

35.3045

201410 13 1 12

201311 10 2 8

201212 22 1 19

201113 24 2 19

201014 15 3 12 

200915 9 2 7

200816 10 2 8 

200717 11 1 10



Each AO listed here involved one I-131 therapy patient who following her therapy was found to be in early 

stage pregnancy (approximately 1 to 10 weeks) at the time of her therapy.



Each AO listed here involved one or two radiation therapy patients per medical licensee, except as noted.



One AO in this total involved three or more radiation therapy patients at one medical licensee.



Two AOs in this total involved three or more radiation therapy patients at one medical licensee.



One AO in this total (AS14-12) involved a patient who passed away. However, the cause of death and any 

potential association with the medical event are being evaluated.

 10 NUREG-0090, Vol. 37, “Report to Congress on Abnormal Occurrences – Fiscal Year 2014,” Nuclear Regulatory 

Commission, http://pbadupws.nrc.gov/docs/ML1514/ML15140A285.pdf (accessed August 23, 2015). 11 NUREG-0090, Vol. 36, “Report to Congress on Abnormal Occurrences – Fiscal Year 2013,” Nuclear Regulatory 

Commission, http://pbadupws.nrc.gov/docs/ML1415/ML14150A073.pdf (accessed August 23, 2015). 12 NUREG-0090, Vol. 35, Rev 1 “Report to Congress on Abnormal Occurrences – Fiscal Year 2012,” Nuclear 

Regulatory Commission, http://pbadupws.nrc.gov/docs/ML1322/ML13225A395.pdf (accessed August 23, 2015). 13 NUREG-0090, Vol. 34, “Report to Congress on Abnormal Occurrences – Fiscal Year 2011,” Nuclear Regulatory 

Commission, http://pbadupws.nrc.gov/docs/ML1214/ML12142A194.pdf (accessed August 23, 2015). 14 NUREG-0090, Vol. 33, “Report to Congress on Abnormal Occurrences – Fiscal Year 2010,” Nuclear Regulatory 

Commission, http://pbadupws.nrc.gov/docs/ML1117/ML11172A088.pdf (accessed August 23, 2015). 15 NUREG-0090, Vol. 32, “Report to Congress on Abnormal Occurrences – Fiscal Year 2009,” Nuclear Regulatory 

Commission, http://pbadupws.nrc.gov/docs/ML1020/ML102080078.pdf (accessed August 23, 2015). 16 NUREG-0090, Vol. 31, “Report to Congress on Abnormal Occurrences – Fiscal Year 2008,” Nuclear Regulatory 

Commission, http://pbadupws.nrc.gov/docs/ML0915/ML091540747.pdf (accessed August 23, 2015). 17 NUREG-0090, Vol. 30, “Report to Congress on Abnormal Occurrences – Fiscal Year 2007,” Nuclear Regulatory 

Commission, http://pbadupws.nrc.gov/docs/ML0813/ML081300424.pdf (accessed August 23, 2015).
6

Only the 2011 and 2012 annual reports included AOs not related to Part 35 events (AS11-02, AS11-

03, NRC11-02, AS12-02, and NRC12-01). Most of the medical use-related AO descriptions 

conclude that no adverse health effects are expected.

Since the previous revision of the AO criteria policy in 2006, 96% of the AOs reported to Congress 

are medical use-related, with an average of 2 per year reported under §35.3047 and 14 per year 

reported under §35.3045. The Subcommittee explored the NRC efforts in addressing how to reduce 

the number of these medical use-related abnormal events. One of these efforts is the Commission’s 

revision of the AO criteria policy to clarify and restructure the criteria to be consistent with current 

NRC guidance and regulations. Another one of NRC’s efforts is the current 10 CFR 35 rulemaking 

where changes to 10 CFR 35.3045 medical event criteria are being considered. The Subcommittee 

also reviewed the current NRC Strategic Plan for Fiscal Years 2014-201818 and the NRC Project 

Aim 2020 documents19 for mention of medical use of byproduct material and indication of plans to 

reduce medical use-related AOs. Table 2 shows the results of searching for the term “medical” in 

these NRC planning documents. Based on this review, the Subcommittee concluded that while the 

Commission considers certain medical use-related events to be abnormal, it appears that their 

significance do not warrant further NRC intervention beyond the current changes being considered 

for AO criteria and medical event criteria.

Table 2: Use of the Term “Medical” in NRC Planning Documents

Document Page number Topic Using the Term “Medical”

NRC Strategic Plan

Fiscal Year 2014-2018

1 What NRC regulates

2 Number of research, medical, industrial, government, academic 

materials licensees

4 Isotope production

10 Isotope production

30 Definition of byproduct material

31 Definition of byproduct material

NRC AIM 2020

9 Isotope production

10, 2 times Isotope production

18 Wellness program for NRC Employees

Encl 1, 4 Example of 3D printing

Encl 1, 8 World economy & costs of healthcare

 18 NRC “Strategic Plan, Fiscal Years 2014-2018”, September 4, 2014, 

http://pbadupws.nrc.gov/docs/ML1424/ML14246A439.pdf (accessed September 14, 2015). 19 NRC SECY-15-0015, “Project Aim 2020 Report and Recommendations”, January 30, 2015, 

http://pbadupws.nrc.gov/docs/ML1502/ML15023A558.html (accessed September 14, 2015)
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The National Council on Radiation Protection and Measurements (NCRP) published a report20 in 

2009 updating its estimates on the annual average U.S. exposure to radiation. As part of its analysis 

of exposure to man-made radiation sources, the NCRP reported the number of medical procedures 

shown in Table 3 which utilized byproduct materials as listed in the NCRP report Table D.3 for

2004 Medicare data. 

Also included in Table 3 are estimated numbers of medical procedures utilizing radiation for 

medical therapy patients from the IMV Benchmark Report Radiation Therapy October 2010 

report21. 

Comparison of the annual number of AOs reported to Congress (Table 1) to the number of medical 

procedures utilizing byproduct materials each year (Table 3) shows the low number of procedures 

which rise to the AO-significant reporting level (~0.1%). The Commission’s establishment of AO 

Criteria is done to meet the Act’s requirements in Section 208 to provide abnormal occurrence 

reports. The regulations in 10 CFR 35.3045 and 35.3047 define the criteria and review process 

which NRC has established to regulate the radiation safety of patients to assure the use of byproduct 

materials is in accordance with the physician's directions.

Table 3: Medical Procedures Utilizing Byproduct Material

Type of Medical Procedure Number in year noted

Total diagnostic nuclear medicine procedures* 5,048,231

Thyroid diagnostic nuclear medicine procedures (2% of total)* 99,457

Total nuclear-medicine unsealed-radionuclide therapy procedures* 17,660

Nuclear-medicine unsealed-radionuclide thyroid therapy procedures (92% of 

total)* 16,159

Estimated external beam therapy procedures* <900,000

Estimated total number of radiation therapy patients, excluding unsealedradionuclide therapy** 1,092,157

Estimated total number of patients receiving radiation therapy from byproduct 

materials, excluding unsealed-radionuclide therapy (~8% of total number of 

radiation therapy patients)**

~90,000

% by gamma knife therapy** ~35%

% by other Co-60 therapy** <1%

% by permanent implant therapy** ~23%

% by temporary implant therapy** ~5%

% by high dose rate remote after-loader therapy** ~36%

 20 NCRP Report No. 160, “Ionizing Radiation Exposure of the Population of the United States,” March 3, 2009. 21 IMV Benchmark Report Radiation Therapy October 2010, IMV Medical Information Division, Inc.
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* From NCRP Report No. 160 for 2004 data

** From IMV Benchmark Report Radiation Therapy October 2010 report

Comment on Proposed Abnormal Occurrence (AO) Statement of Policy

The Subcommittee presents the following comments on the Commission’s proposed changes to the 

AO criteria impacting events involving patients or human research subjects not to reduce the number 

of medical use-related (i.e., those reported as 10 CFR 35.3045 or 35.3047 events) AOs reported to 

Congress, but to provide ACMUI recommendations as requested for clarity and consistency with 

NRC guidance and regulations.

The Appendix Table attached to this report provides a comparison of portions of the AO Statement 

of Policy which ACMUI has commented on previously and now provides comments and 

recommended new wording for the 2015 proposed AO Criteria Policy change22. The bases for 

these comments and ACMUI recommended new wording are summarized here.

1. Statement Introduction

The Subcommittee noted that the Commission has included general descriptions of what 

constitutes an AO into the Statement of Policy. These general descriptions had been included in 

the 2006 Federal Register publication of the current AO Criteria Policy. The Subcommittee 

agrees that the general descriptions of what constitutes an AO should be included in the 

Statement of Policy and recommends no additional changes be made to this proposed change.

2. AO Criteria I. Title and Footnote

The Subcommittee agrees with the change in title for this AO Criteria I. The addition of the 

footnote clarifies that AO Criteria I.A. does not apply to medical patients and directs the reader 

to AO Criteria III.C. The Subcommittee recommends the addition of “... and human research 

subjects...” to be consistent with NRC regulations. The Subcommittee also recommends that 

events defined in 10 CFR 35.3047 “Report and notification of a dose to an embryo/fetus or a 

nursing child” be added to this footnote. This footnote addition of §35.3047 would take the 

place of the 2013 ACMUI recommendation to add AO Criterion I.A.4.

The NRC request for comment on the 2015 proposed AO Criteria Policy specifically 

requests public comment on use of AO Criteria I.A.2. versus use of AO Criteria III.C. and 

§35.3047 criteria for screening reports on exposures to embryo/fetus or nursing child. The NRC 

policy statement on the medical use of byproduct material23 includes the following statements:

“2. NRC .will not intrude into medical judgments affecting patients, except as necessary to 

provide for the radiation safety of workers and the general public.”

 22 NRC “Abnormal Occurrence Reports – Proposed Revision to Policy Statement; Request for Comments,” 80 FR 

49177, August 17, 2015, http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-20260.pdf (accessed September 14, 

2015).

23 NRC “Medical Use of Byproduct Material; Policy Statement, Revision”, August 3, 2000 (65 FR 47654), 

http://www.nrc.gov/reading-rm/doc-collections/commission/policy/65fr47654.pdf (accessed September 14, 2015).
9

and

“3. NRC will, when justified by the risk to patients, regulate the radiation safety of patients 

primarily to assure the use of radionuclides is in accordance with the physician's directions.”

The NRC has no dose limit established for patients24. Medical judgements on the use of 

byproduct materials reside with the physician and the patient, and the patient’s condition of 

pregnancy is included in these medical judgments. NRC regulations recognize pregnancy as 

part of a patient’s medical condition in §35.3047(a):

“A licensee shall report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) 

dose equivalent that is a result of an administration of byproduct material or radiation from 

byproduct material to a pregnant individual unless the dose to the embryo/fetus was 

specifically approved, in advance, by the authorized user.”

To maintain consistency with NRC regulations, screening of event reports from §35.3047 

criteria should be further screened using the AO Criteria III.C. established for the medical use of

radioactive materials in patients or human research subjects.

3. AO Criteria III.A. Title

The Subcommittee agrees with the change in title for this AO Criteria III.A

4. AO Criteria III.C. Title

The Subcommittee agrees with the change in title for this AO Criteria III.C., but recommends 

changing “Radioactive” to “Byproduct” to be consistent with 10 CFR 35 regulations.

5. AO Criteria III.C. Footnote

The Subcommittee agrees with the addition of footnote 16 clarifying that AO Criteria III.A.2, 

III.A.3, and III.A.4 also apply to medical licensees. The application of these criteria will allow 

the NRC to identify as an AO in particular those circumstances involving loss of management 

controls demonstrated by multiple medical-related events even in the absence of any one event 

meeting the criteria of AO Criteria III.C.

6. AO Criteria III.C.1. and 2.

The Subcommittee acknowledges and appreciates that the Commission attempted to modify the

dose criteria in AO Criteria III.C.1.b. to a value that exceeds the expected dose, but fundamental 

flaws remain. The Subcommittee again recommends that a dose criterion not be used in 

determining AOs for medical-related events.

 24 The Food and Drug Administration (FDA) has established dose limits for human research subjects in 21 CFR 

361.1(b)(3).
10

Improved precision of radiation therapy delivery, as in external beam therapy, increases the 

likelihood of delivering dose to nearby tissues that exceeds the proposed dose criterion in 

III.C.1.b. if the beam location is off even slightly, but this slight shift in dose is most often 

without consequence and may not even be recognized. It also is important to be cognizant of 

the fact that the use of a dose criterion can exclude an event that results in unintended permanent 

functional damage to an organ or physiological system but does not exceed the dose criterion. 

Dose to other tissues or organs can be a known risk or side effect associated with the medical 

procedure and the physician discusses these types of risk and side effects with the patient as part 

of the combined medical and personal decision about whether or not to perform the procedure. 

The ACMUI recently provided recommendations25 on NRC guidance regarding side effects 

associated with Y-90 microsphere radiotherapy. 

In view of the targeted nature of external radiotherapy techniques currently in use, the inclusion

of an undefined phrase, “a major portion of the bone marrow”, in III.C.1.a. is too vague a dose 

criterion without evidence of probable consequence. The proposed dose criterion in III.C.1.b. of 

exceeding a given expected dose to any other organ or tissue does not have the same meaning 

for high dose rate precision radiotherapy techniques in use today (modern techniques) as it did

when it was applied to past radiotherapy techniques (old techniques) in use at the time of the 

2002 update26 of 10 CFR 35. Using the old techniques, most patients were treated to the 

isocenter and any dose error was to that same point, which was in the middle of a relatively 

uniform field. Slight changes in beam location had little effect on dose to the target and nearby 

tissues and organs. Modern techniques, in contrast, specify the treatment dose at the periphery, 

not at the middle of the treatment volume. In addition, the penumbra for modern techniques is

only a few millimeters, which is smaller than the 2 centimeter penumbra for old techniques. 

Consequently, moving a modern technique field, even just a few millimeters, can result in an 

under-dose to the target and a significantly increased dose to nearby tissues or some of a nearby

organ. Invariably there is a certain amount of natural movement of the target location within a 

patient, and consequently, isocenter movement and field movement have always been within 

normal treatment uncertainties. The modern techniques of precise beam shaping have benefitted 

patients immensely. The medical event criteria applied to external beam therapies have not 

been modified to reflect this change in radiotherapy precision. 

The Subcommittee recommends that the proposed AO Criteria III.C.1. and 2. be replaced with 

the following wording for III.C.1.:

An medical event, as defined in 10 CFR 35.3045 or 35.3047, which results in a dose that, 

unintended permanent functional damage to an organ or a physiological system as 

determined by an independent physicianFN deemed qualified by the NRC or an 

Agreement State.

 25 “ACMUI Final Report on Yttrium-90 (Y-90) Microsphere Brachytherapy Medical Event Criteria”, September 29, 

2014, http://pbadupws.nrc.gov/docs/ML1430/ML14300A138.pdf (accessed September 19, 2015) 26 NRC “Medical Use of Byproduct Material – Final Rule,” 67 FR 20250, April 24, 2002, 

http://www.gpo.gov/fdsys/pkg/FR-2002-04-24/pdf/02-9663.pdf (accessed September 19, 2015)
11

FNIndependent physician is defined as a physician not on the licensee's staff and who 

was not involved in the care of the patient or human research subject involved in the 

event.

This general criterion is modified to include medical-related events reported under § 35.3047. 

Along with the Commission’s proposed modification to apply AO Criteria III.A.2., 3. and 4., the 

Subcommittee reviewed the AOs listed in Table 1 that were identified as medical-use events 

under the current AO Criteria I.A.2.27 Most of the female patients were described in the AO 

annual reports as indicating they were not pregnant which the Subcommittee assumed to be part 

of patient’s process of informed consent prior to their I-131 NaI therapy. In all but one of these 

events, the patient was later found to be in early stage of pregnancy (approximately 1 to 10 

weeks) at the time of her therapy. The Subcommittee applied the recommended AO Criteria 

changes to these reported AOs and came to the following conclusions.

• The one event noted above, AS10-01, involved a patient who was 6 months pregnant at the 

time of her I-131 therapy. The patient indicated that she was not pregnant and the licensee 

decided not to perform a pregnancy test. An independent physician review is not described 

in this AS10-01 event report, but the full-term child was described as being born without a 

thyroid. This event would be identified as an AO with the recommended AO criteria 

changes.

• Another event, AS14-01, which did not involve a probable negative consequence to the 

embryo/fetus. This event should be identified as an AO based on III.A.4. because the 

miscommunication indicates a series of events with implications for similar facilities 

(generic incidents) that raise a major safety concern.

• The remaining AOs listed in Table 1 from § 35.3047 events occurred as the result of the 

failure of the pregnancy test to confirm pregnancy in close proximity to conception. While 

there may lessons to learn from these § 35.3047 events, such as changing to a more sensitive 

pregnancy test identified in NRC08-01 and AS09-02, or emphasizing to the patient the need 

to abstain from unprotected intercourse for a time prior to her I-131 therapy identified in 

AS08-01, NRC11-01, and AS13-01, the Subcommittee recommends that these § 35.3047 

events not be identified as abnormal occurrences due the extensive review of the event 

already performed under the § 35.3047 regulatory requirement and due to the lack of 

probable negative consequences. 

The Subcommittee suggests that the regulatory reviews conducted for the § 35.3045 and § 

35.3047 events to identify unintended permanent functional damage to an organ or a 

physiological system are similar to the reviews conducted under 10 CFR 70.61 to identify highconsequence events for facilities licensed under 10 CFR part 70 and used in AO Criterion 

III.B.1. 

 27 “I. For All Licensees

A. Human Exposure to Radiation from Licensed Material

2. Any unintended radiation exposure to any minor (an individual less than 18 years of age) 

resulting in an annual TEDE of 50 mSv (5 rem) or more, or to an embryo/fetus resulting in a dose 

equivalent of 50 mSv (5 rem) or more.”
12

Therefore, the Subcommittee advises the Commission to adopt the recommended wording for 

AO Criterion III.C.1. presented above to be consistent in applying AO criteria with NRC 

regulations.

7. Additional Cost of Independent Physician

The Subcommittee notes that the Commission raised concern that the requirement to consult 

with an independent physician was being recommended only to reduce the number of AOs 

reported to Congress28. The consultation of an independent physician is an important aspect of 

the regulatory reviews conducted for the § 35.3045 and § 35.3047 events to confirm the medical 

evaluations for the event. This independent medical evaluation is particularly important when 

there is a concern that the event may result in permanent functional damage. This independent 

medical review is also essential to evaluating the application of AO Criteria III.A. 2., 3., or 4. to 

the medical-related event. The Subcommittee believes that an independent physician review of 

a medical-related event be required as part of the NRC determination that the event is an 

abnormal occurrence. The NRC has established program29 and procedures for assessing § 

35.3045 and § 35.3047 events which includes when and how to consult with an independent 

physician30. The Subcommittee recommends that NRC Staff evaluates whether implementation 

of the Subcommittee’s recommended AO Criterion III.C.1. would trigger additional cost beyond 

the cost of providing independent medical consultation in support of the regulatory review 

conducted for a § 35.3045 or § 35.3047 event.

8. Appendix B. Re-Designation and New Description

The Subcommittee agrees with the change in re-designating the previous AO Criteria IV. as the 

proposed Appendix B with the additional description for this new appendix to clarify it is not 

part of the proposed AO Criteria.

 28 Commission Voting Record on SECY-15-0040 “Proposed Revisions to Policy Statement on Reporting Abnormal 

Occurrences Criteria”, June 30, 2015, http://pbadupws.nrc.gov/docs/ML1518/ML15181A141.pdf (accessed on 

September 15, 2015).

29 NRC Medical Directive 8.10 “NRC Assessment Program for a Medical Event or an Incident Occurring at a Medical 

Facility”, March 28, 2014, http://pbadupws.nrc.gov/docs/ML1330/ML13301A732.pdf (accessed on September 15, 

2015). 

30 NRC Inspection Manual Chapter 1360 “Use of Physician and Scientific Consultants in the Medical Consultant 

Program”, November 2, 2006, http://pbadupws.nrc.gov/docs/ML0627/ML062720195.pdf (accessed on September 15, 

2015).
13

 

Conclusion:

Given the unique nature of the medical use of by-product material, where by-product material is 

intentionally administered to patients or research subjects it is important to include a qualitative 

analysis of a proposed AO. As doses measured above a set limit may or may not be accurate in 

measuring a meaningful effect. The proposed AO criteria will most likely continue to misscategorize future medical use related incidents and events as not meaningful or significant. The 

2015 ACMUI recommendations as listed in Appendix A have been designed to categorize future 

medical use related incidents and events to be meaningful and significant from the standpoint of 

public health or safety. ACMUI believes these appropriately categorized abnormal occurrences

will fully meet the intent and spirit of the reporting requirements of the Energy Reorganization Act 

of 1974

Endorsement

This report was presented and discussed with the full Committee on October 09, 2015. During the 

meeting, the Committee approved the report with nine approvals and one dissenting vote. 

The dissension opinion is included in the Enclosure.
L. Weil

Enclosure 14 

October 26, 2015 

Dissenting vote justification

Subcommittee Comments on Proposed Revision of the NRC Policy Statement on 

Reporting Abnormal Occurrences to Congress 

The subcommittee recommends the footnote: 

“Medical patients and human research subjects are excluded from consideration under this criterion and 

these criteria do not apply to medical events defined in § 35.3045 and § 35.3047 of Title 10 of the Code of 

Federal Regulations (10 CFR), which are considered in AO Criteria III.C, ‘‘Events involving the Medical 

Use of Radioactive Materials in Patients or Human Research Subjects.’’

This creates two distinct Congressional reporting standards for radiation exposure to an 

embryo/fetus. One is the standard of exposure of TEDE of 5 rem or more, as defined in Criteria I 

(2), and the other is the proposed threshold of permanent functional damage or worse in the 

situation where the embryo/fetus is exposed as a result of a medical administration to a pregnant 

woman. 

Creating two different thresholds for reporting an abnormal occurrence to Congress involving 

exposure to an embryo/fetus does not seem rational. The reasoning behind creating a less stringent 

threshold for reporting in the case of an unintended exposure of an embryo/fetus due to an intended 

medical administration should not trump the regulatory need to require reporting of exposures of 5 

rem or more as outlined in the existing AO criteria. The argument that the embryo/fetus has an 

indirect benefit, pertaining to the health of the mother, is not compelling. There is no intended 

direct benefit to the embryo/fetus, and the embryo/fetus is not the intended recipient of medical 

administration of radioactive material. 

Furthermore, there is considerable dissent among professionals as to whether or not, and the degree 

to which, an embryo/fetus is actually harmed by exposure to radioactive material, irrespective of 

gestational age. Therefore I vote against the Subcommittee recommendations, as I believe that the 

unintentional medical exposure of an embryo/fetus should not be held to a different standard for 

Abnormal Occurrence reporting than any other exposed embryo/fetus. Permanent harm or damage 

to the embryo/fetus due to radiation exposure is a controversial subject, and should not be an added 

requirement to register such an unintended medical exposure as an Abnormal Occurrence. 

Respectfully submitted,

Laura Weil
Appendix Table

Comparison of Portions of the Abnormal Occurrence (AO) Criteria Policy

No change No change No change

No change An accident or event is considered an 

abnormal occurrence (AO) if it involves 

a major reduction in the degree of 

protection of public health or safety. This 

type of incident or event has a moderate 

or severe impact on public health or 

safety and could include, but need not be 

limited to, the following:

No change

(1) Moderate exposure to, or release of, 

radioactive material licensed by or 

otherwise regulated by the Commission 

or Agreement States;

No change

(2) major degradation of essential safety 

related equipment;

No change

(3) major deficiencies in design, 

construction, use of, or management 

controls for facilities or radioactive 

material licensed by or otherwise 

regulated by the Commission

or Agreement States; or

No change

(4) substantiated case of actual loss, theft, or 

diversion of risk-significant radioactive 

material licensed by or otherwise 

regulated by the Commission or 

Agreement States.

No change

APPENDIX A: Abnormal Occurrence Criteria

2006 Abnormal Occurrence (AO) Criteria 

Policy

2013 ACMUI AO Criteria 

Recommendations on 2006 AO Policy

2015 Proposed AO Criteria Policy 

changes versus 2006 AO Criteria Policy

2015 ACMUI AO Criteria 

Recommendations on 2015 Proposed AO 

Criteria Policy - deletions noted by 

strikeout and additions by bold text

The following criteria are used to determine 

whether to consider events for reporting as 

AOs:
Appendix Table

Comparison of Portions of the Abnormal Occurrence (AO) Criteria Policy

2006 Abnormal Occurrence (AO) Criteria 

Policy

2013 ACMUI AO Criteria 

Recommendations on 2006 AO Policy

2015 Proposed AO Criteria Policy 

changes versus 2006 AO Criteria Policy

2015 ACMUI AO Criteria 

Recommendations on 2015 Proposed AO 

Criteria Policy - deletions noted by 

strikeout and additions by bold text

I. For All Licensees No change All Licensees 2 No change

FN added 2 Medical patients are excluded from 

consideration under this criterion and 

these criteria do not apply to medical 

events defined in § 35.3045 of Title 10 of 

the Code of Federal Regulations (10 

CFR), which are considered in AO 

Criteria III.C, ‘‘Events involving the 

Medical Use of Radioactive Materials in 

Patients or Human Research Subjects.’’

2 Medical patients and human research 

subjects are excluded from consideration 

under this criterion and these criteria do 

not apply to medical events defined in § 

35.3045 and § 35.3047 of Title 10 of the 

Code of Federal Regulations (10 CFR), 

which are considered in AO Criteria 

III.C, ‘‘Events involving the Medical Use 

of Radioactive Materials in Patients or 

Human Research Subjects.’’

A. No change No change No change

2. No change No change No change

4. These criteria do not apply to events 

included in criteria III.C. involving 

medical administrations using byproduct 

material to patients or human research 

subjects.

[withdraw 2013 recommendation as it is 

addressed by the recommended wording 

of FN2]

Human Exposure to Radiation from 

Licensed Material

Any unintended radiation exposure 

to any minor (an individual less 

than 18 years of age) resulting in 

an annual TEDE of 50 mSv (5 

rem) or more, or to an 

embryo/fetus resulting in a dose 

equivalent of 50 mSv (5 rem) or 

more.
Appendix Table

Comparison of Portions of the Abnormal Occurrence (AO) Criteria Policy

2006 Abnormal Occurrence (AO) Criteria 

Policy

2013 ACMUI AO Criteria 

Recommendations on 2006 AO Policy

2015 Proposed AO Criteria Policy 

changes versus 2006 AO Criteria Policy

2015 ACMUI AO Criteria 

Recommendations on 2015 Proposed AO 

Criteria Policy - deletions noted by 

strikeout and additions by bold text

III. No change No change No change

A. No change Events Involving Design, Analysis, 

Construction, Testing, Operation, 

Transport, Use, or Disposal

No change

2. No change No change No change

3. No change No change No change

4. No change No change No change

Events at Facilities Other Than Nuclear 

Power Plants and All Transportation Events

Events Involving Design, Analysis, 

Construction, Testing, Operation, 

Transport, Use, or Disposal of 

Licensed Facilities or Regulated 

Materials

A major deficiency in design, 

construction, control, or operation 

having significant safety 

implications that require 

immediate remedial action.

A serious safety-significant 

deficiency in management or 

procedural controls.

A series of events (in which the 

individual events are not of major 

importance), recurring incidents, 

or incidents with implications for 

similar facilities (generic 

incidents) that raise a major safety 

concern.
Appendix Table

Comparison of Portions of the Abnormal Occurrence (AO) Criteria Policy

2006 Abnormal Occurrence (AO) Criteria 

Policy

2013 ACMUI AO Criteria 

Recommendations on 2006 AO Policy

2015 Proposed AO Criteria Policy 

changes versus 2006 AO Criteria Policy

2015 ACMUI AO Criteria 

Recommendations on 2015 Proposed AO 

Criteria Policy - deletions noted by 

strikeout and additions by bold text

C. For Events Involving Patients or Human 

Research Subjects

Events Involving the Medical Use of 

Radioactive Materials in Patients or 

Human Research Subjects 16

Events Involving the Medical Use of 

RadioactiveByproduct Materials in 

Patients or Human Research Subjects16

FN added 16 Criteria III.A.2, III.A.3, and III.A.4 

also apply to medical licensees.

[agree with addition of FN16]

1. Results in a dose that is Medical event involving a patient or 

human research subject that, as 

determined by a consultant physician(s) 

deemed qualified by NRC or an 

Agreement State, results in one or more 

of the following:

A medical event, as defined in 10 CFR 

35.3045, which results in a dose that:

An medical event, as defined in 10 CFR 

35.3045 or 35.3047, which results in a 

dose that, unintended permanent 

functional damage to an organ or a 

physiological system as determined by an 

independent physicianFN deemed 

qualified by the NRC or an Agreement 

State.

FN added FNIndependent physician is defined as a 

physician not on the licensee's staff and 

who was not involved in the care of the 

patient or human research subject 

involved in the event.

a. Unintended or unexpected permanent 

functional damage to an organ.

Is equal to or greater than 1 Gray (Gy) 

(100 rad) to a major portion of the bone 

marrow or to the lens of the eye; or equal 

or greater than 2.5 Gy (250 rad) to the 

gonads; or

Is equal to or greater than 1 Gray (Gy) 

(100 rad) to a major portion of the bone 

marrow or to the lens of the eye; or equal 

or greater than 2.5 Gy (250 rad) to the 

gonads; or

b. Unintended or unexpected permanent 

functional damage to a physiological 

system.

exceeds, by 10 Gy (1,000 rad), the 

expected dose to any other organ or 

tissue from the administration defined in 

the written directive; and

exceeds, by 10 Gy (1,000 rad), the 

expected dose to any other organ or 

tissue from the administration defined in 

the written directive; and 

For Medical Licensees - A medical 

event that:

Equal to or greater than 1 gray 

(Gy) (100 rad) to a major 

portion of the bone marrow or 

to the lens of the eye; or equal 

or greater than 2.5 Gy (250 

rad) to the gonads; or

Equal to or greater than 10 Gy 

(1,000 rad) to any other organ 

or tissue; and
Appendix Table

Comparison of Portions of the Abnormal Occurrence (AO) Criteria Policy

2006 Abnormal Occurrence (AO) Criteria 

Policy

2013 ACMUI AO Criteria 

Recommendations on 2006 AO Policy

2015 Proposed AO Criteria Policy 

changes versus 2006 AO Criteria Policy

2015 ACMUI AO Criteria 

Recommendations on 2015 Proposed AO 

Criteria Policy - deletions noted by 

strikeout and additions by bold text

c. A significant unexpected adverse health 

effect.

d. Death.

2. Represents either Notification under 10 CFR 35.3047 of an 

event involving an unintended dose to an 

embryo/fetus or a nursing child that 

results in a significant adverse health 

impact to the embryo/fetus or child, as 

determined by a consultant physician(s) 

deemed qualified by NRC or an 

Agreement State.

A medical event, as defined in 10 CFR 

35.3045, which involves:

A medical event, as defined in 10 CFR 

35.3045, which involves:

a. [delete 2.a. with recommended change in 

2.]

No change A dose or dosage that is at least 50 

percent greater than that prescribed, or

b. [delete 2.b. with recommended change in 

2.]

No change A prescribed dose or dosage that

(i) Uses the wrong 

radiopharmaceutical or 

unsealed byproduct 

material; or

[delete 2.b. (i) with recommended change 

in 2.]

No change Uses the wrong radiopharmaceutical or 

unsealed byproduct material; or

(ii) Is delivered by the wrong 

route of administration; or

[delete 2.b. (ii) with recommended 

change in 2.]

No change Is delivered by the wrong route of 

administration; or

(iii) Is delivered to the wrong 

treatment site; or

[delete 2.b. (iii) with recommended 

change in 2.]

No change Is delivered to the wrong treatment site; 

or

(iv) Is delivered by the wrong 

treatment mode; or

[delete 2.b. (iv) with recommended 

change in 2.]

No change Is delivered by the wrong treatment 

mode; or

(v) Is from a leaking source 

or sources; or

[delete 2.b. (v) with recommended 

change in 2.]

No change Is from a leaking source or sources; or

A prescribed dose or dosage 

that

A dose or dosage that is at least 

50 percent greater than that 

prescribed, or
Appendix Table

Comparison of Portions of the Abnormal Occurrence (AO) Criteria Policy

2006 Abnormal Occurrence (AO) Criteria 

Policy

2013 ACMUI AO Criteria 

Recommendations on 2006 AO Policy

2015 Proposed AO Criteria Policy 

changes versus 2006 AO Criteria Policy

2015 ACMUI AO Criteria 

Recommendations on 2015 Proposed AO 

Criteria Policy - deletions noted by 

strikeout and additions by bold text

(vi) Is delivered to the wrong 

individual or human 

research subject.

[delete 2.b. (vi) with recommended 

change in 2.]

No change Is delivered to the wrong individual or 

human research subject.
Appendix Table

Comparison of Portions of the Abnormal Occurrence (AO) Criteria Policy

2006 Abnormal Occurrence (AO) Criteria 

Policy

2013 ACMUI AO Criteria 

Recommendations on 2006 AO Policy

2015 Proposed AO Criteria Policy 

changes versus 2006 AO Criteria Policy

2015 ACMUI AO Criteria 

Recommendations on 2015 Proposed AO 

Criteria Policy - deletions noted by 

strikeout and additions by bold text

IV. Other Events of Interest No change Appendix B: Other Events of Interest No change

No change This appendix discusses other events of 

interest that do not meet the AO criteria 

in Appendix A. The Commission may 

determine that events, other than AOs, 

may be of interest to Congress and the 

public and should be included in an 

appendix to the AO report as ‘‘Other 

Events of Interest.’’ Such events may 

include, but are not necessarily limited 

to, events that do not meet the AO 

criteria but that have been perceived by 

Congress or the public to be of high 

health and safety significance, have 

received significant media coverage, or 

have caused the NRC to increase its 

attention to or oversight of a program 

area, or a group of similar events that 

have resulted in licensed materials 

entering the public domain in an 

uncontrolled manner.

The Commission may determine that events No change

other than AOs may be of interest to 

Congress and the public and should be 

included in an appendix to the AO report as 

“Other Events of Interest.” Such events may 

include, but are not necessarily limited to, 

events that do not meet the AO criteria but 

that have been perceived by Congress or the 

public to be of high health and safety 

significance, have received significant 

media coverage, or have caused the NRC to 

increase its attention to or oversight of a 

program area, or a group of similar events 

that have resulted in licensed materials 

entering the public domain in an 

uncontrolled manner.