PURPOSE OF MEDICAL 

EVENT REPORTING

The U.S. Nuclear 

Regulatory Commission 

(NRC) regulations aim 

to ensure radioactive 

materials are used safely 

in medical diagnosis, 

therapy and research. 

The rules exist to ensure 

the safety of medical 

workers, the public, and 

patients, and to protect 

the environment. 

The term “medical event” 

may sound alarming when it applies to nuclear medicine and radiation therapy, 

but it rarely means that a patient has been harmed. Rather, a medical event 

refers to a potential problem with how a medical facility administered radioactive 

materials or radiation from radioactive materials. The provisions in Title 10 of 

the Code of Federal Regulations (10 CFR) 35.3045, “Report and Notification of a 

Medical Event,” identifies the requirements for reporting a medical event. 

The purpose of medical event reporting is to allow the NRC to follow up on 

incidents and determine if other licensees might be making the same or similar 

mistakes, or experiencing the same or similar challenges. When staff members 

identify similarities in the problems reported from multiple facilities, they can 

provide, with the help of the agency’s Agreement State partners, information 

that could help prevent additional similar incidents. The NRC requires reporting, 

because a medical event indicates that there were problems administering the 

radioactive material or radiation in accordance with the physician’s (authorized 

user’s) directions (prescription). The NRC analyzes each medical event to see if 

further action is needed. A medical event may not result in a violation, but the 

failure to report a medical event is a violation.

The physician also needs to analyze the event to determine if a patient is actually 

harmed, whether from too high a dose or inadequate treatment when a dose 

is too low. In some cases, the NRC may ask a medical consultant (physician) to 

independently assess the medical consequences to the patient.

In summary, NRC regulations require that licensees report instances in which 

mistakes were made in the administration of radiation or radioactive materials 

that meet the criteria in 10 CFR 35.3045. Medical events may not result in 

SPRING 2016

NUREG/BR–0117

NO. 16-02

PURPOSE OF MEDICAL 

EVENT REPORTING

PAGE 1

ANNUAL USERS 

TRAINING MEETING

PAGE 2

INTERNATIONAL 

SAFEGUARDS 

REPORTING 

REQUIREMENTS

PAGE 2

SIGNIFICANT 

ENFORCEMENT 

ACTIONS 

PAGE 4

GENERIC 

COMMUNICATIONS 

ISSUED 

PAGE 7

SELECTED FEDERAL 

REGISTER NOTICES

PAGE 9

ONGOING 

RULEMAKINGS

PAGE 10

TO OUR READERS

PAGE 13

OFFICE OF NUCLEAR MATERIAL 

SAFETY AND SAFEGUARDS
SPRING 2016

2

violations, but not reporting them is a violation. The purpose of these regulations is to allow 

the NRC and the Agreement States to gather data, look for trends and communicate with the 

medical facilities that the agencies regulate to prevent, when possible, similar problems from 

being repeated.

(Contact: Said Daibes, NMSS, 301–415–6863 or Said.Daibes@nrc.gov)

ANNUAL USERS TRAINING MEETING 

The Nuclear Materials Management and Safeguards System (NMMSS) 2016 

Annual Users Training Meeting will be May 9–12, 2016, in New Orleans, LA. 

This 4-day event offers unique learning and networking opportunities for the 

NRC licensees and the U.S. Department of Energy (DOE)/ National Nuclear 

Security Administration, along with other Federal agencies and contractor 

organizations involved in management of nuclear materials. A limited block 

of rooms has been reserved at the government per diem rate of $122 per 

night on a first-come, first-served basis for the nights of May 8–12, 2016. 

Please register for the training event as well as review the draft agenda and 

reserve your hotel accommodations at http://108.31.8.56/nmmss2016/. 

There is no registration fee to participate in this valuable training opportunity. 

A training certificate will be provided. 

(Contact: Mirabelle Shoemaker, NRC NMMSS Project Manager, 301–415–7363 or 

Mirabelle.Shoemaker@nrc.gov)

INTERNATIONAL SAFEGUARDS 

REPORTING REQUIREMENTS 

The U.S. Government has negotiated and brought into force agreements with 

the International Atomic Energy Agency (IAEA) related to the implementation of 

international safeguards in the United States and its territories in the Caribbean. 

Under the safeguards agreements, a nuclear facility is a reactor, a fuel cycle 

installation, or any other type of installation possessing more than 1 effective 

kilogram of nuclear material. One aspect of these agreements is a requirement for 

the United States to report information to the IAEA. This information includes an 

eligible facilities list, design information questionnaires, material accounting reports, 

information on imports and exports of source and special nuclear materials, and 

information activities related to nuclear fuel cycles. The International Safeguards 

Team of the Material Control and Accounting Branch (MCAB) in the Division 

of Fuel Cycle Safety, Safeguards, and Environmental Review is responsible for ensuring that 

accurate and complete information is collected regarding the installations licensed by the NRC 

and Agreement States and is properly reported. The NRC also responds to the IAEA, through 

the U.S. Department of State, to resolve any questions on information received by the IAEA 

concerning installations licensed by the NRC or Agreement States. 

The U.S. and IAEA Safeguards Agreement requires the United States. to provide the IAEA a 

list (eligible facilities list) of all U.S. nuclear facilities that do not have activities of direct national 

security significance. The IAEA may select any facility on that list for (a) reporting, design 
SPRING 2016

3

information verification, and inspection, or (b) reporting and design information 

verification only. Since the agreements entered into force, nine NRC–licensed 

nuclear facilities have been selected for inspections (however, none is currently 

being inspected) and four (three fuel fabrication facilities and one enrichment 

facility) are currently selected for reporting and design information verification. The 

NRC’s portion of the eligible facilities list has 269 facilities. DOE facilities are also 

on the list, and one is currently selected from the list for inspection. 

When the IAEA selects a facility for inspection from the list, the United States is 

required to prepare and submit to the IAEA a design information questionnaire for 

the facility. This document follows a prescribed format and provides the IAEA with 

information necessary for the IAEA to design an effective international safeguards 

approach for the facility and to understand the accuracy and precision of the 

reported material accounting data. After the receipt of the design information questionnaire, the 

IAEA will typically confirm the accuracy of the information stated in the questionnaire through a 

design information verification site visit. After the site visit, the design information questionnaire 

will typically be changed to add or revise information to address the IAEA’s questions. As facility 

design or operations change, the IAEA requires that the design information questionnaire for 

a facility be updated. MCAB staff is currently working with the four selected facilities to make 

sure that their responsible facility staff members are aware of the requirement and are updating 

the design information questionnaires to reflect the current facility status. During 2015, the 

IAEA conducted a design information verification visit at the Louisiana Enrichment Services gas 

centrifuge enrichment plant in Eunice, NM.

When the IAEA selects a facility from the eligible facilities list, the United States is also required 

to submit an initial inventory declaration for the facility regarding all source and special nuclear 

material at the facility, and to subsequently report all inventory changes that occur. Annually, the 

United States is also required to submit a physical inventory list for the facility and to submit a 

material balance report that assesses all of the inventory changes for the year and compares that 

book inventory value with the value obtained from the physical inventory taking. The reporting 

of inventory changes occurs monthly. 

The United States is also required to report to the IAEA all U.S. imports and exports of source 

and special nuclear material. These reports are necessary for the IAEA to establish matches for 

import and export reports generated in other countries. Where the IAEA cannot match a U.S. 

import or export with an export or import of another country, MCAB works with the IAEA and 

other Federal agencies to resolve the issue. On average, the U.S. makes 26,000 nuclear material 

accounting reports to the IAEA annually. These reports are made through the U.S. Nuclear 

Materials Management and Safeguards System, which is jointly funded and managed by the NRC 

and DOE.

The United States also negotiated and brought into force the Protocol Additional to the US 

IAEA Safeguards Agreement (Additional Protocol) in 2009. The Additional Protocol requires 

the United States to report on certain activities related to the nuclear fuel cycle. These activities 

include, among others: research and development, manufacturing of nuclear-related equipment, 

imports and exports of such equipment, uranium and thorium mining, storage of uranium 

and thorium ore concentrates, activities on the sites of nuclear facilities, and nuclear fuel cycle 

development plans. On average, the NRC makes 200 declarations (quarterly and annually) per 

year. The primary annual information collection and reporting occurs in the first 2 months of 

each year.

(Contact: Bruce Moran, NMSS, 301–415–7269 or Bruce.Moran@nrc.gov)
SPRING 2016

4

SIGNIFICANT ENFORCEMENT ACTIONS

The NRC issued significant actions for failure to comply with a regulation.

Northern States Power Company (Monticello Nuclear Generating 

Plant, Unit 1) (EA-14-193)

On December 21, 2015, the NRC issued a Confirmatory Order to Northern States Power 

Company, Minnesota (licensee) to formalize commitments made as a result of an Alternative 

Dispute Resolution mediation session. The licensee made the commitments as part of a 

settlement agreement with the NRC regarding apparent violations of NRC requirements. The 

agreement resolves the licensee’s failure to ensure nondestructive examinations (NDE) on 

spent fuel dry shielded canisters (DSC) that were performed in accordance with procedural 

requirements. The agreement also resolves the falsification of records when recording the NDE 

results, contrary to the requirements of the following:

• 10 CFR 72.158, “Control of Special Processes” 

• 10 CFR 72.11, “Completeness and Accuracy of Information”

• paragraph (c) of 10 CFR 72.154, “Control of Purchased Material, Equipment, and Services” 

The licensee agreed to a number of corrective actions, including: (1) restore compliance 

for all affected DSCs, (2) revise applicable procedures, (3) present at an industry forum, (4) 

submit an article to an industry publication, and (5) assess the effectiveness of improvements. 

In consideration of these commitments, the NRC agreed to refrain from issuing a Notice of 

Violation and a proposed imposition of a Civil Penalty.

JOMA Shop, LLC (EA-15-196) 

On December 21, 2015, the NRC issued a Notice of Violation to JOMA Shop (JOMA) for a 

Severity Level III problem for two related violations. The violations involved JOMA’s transfer of 

watches containing byproduct material without an NRC license as required by paragraph 

(a) of 10 CFR 30.3, “Activities Requiring License,” and an import of byproduct material into 

United States without having the required license for possession of the byproduct material as 

required by 10 CFR 110.5, “Licensing Requirements.” Specifically, beginning on or around 

May 2013, JOMA initially transferred (distributed/sold), 7,617 tritium watches to persons without 

obtaining a specific license authorizing such transfers and before April 2012. JOMA imported 

these watches without having a possession license issued by the State of New York, without first 

obtaining a specific import license from the NRC, and without obtaining a license to distribute 

the watches from the NRC.

ECS Mid-Atlantic, LLC (EA-15-148) 

On December 14, 2015, the NRC issued a Notice of Violation to ECS Mid-Atlantic, LLC 

(ECS), for a Severity Level-III violation. The violation involved ECS’s failure to control and 

maintain constant surveillance or failure to use two independent physical controls that form 

tangible barriers to secure a portable gauge from unauthorized removal as required by 

10 CFR 20.1802, “Control of Material Not in Storage,” and paragraph (i) of 10 CFR 30.34, 

“Terms and Conditions of Licenses.” Specifically, on June 8, 2015, a portable gauge was left 

unattended and uncontrolled at a job site at the U.S. Naval Academy, and it was not secured 

with any physical controls that form tangible barriers to secure it from unauthorized removal.
SPRING 2016

5

CTI and Associates, Inc. (EA-15-157) 

On November 23, 2015, the NRC issued a Notice of Violation to CTI and Associates, Inc., for a 

Severity Level III violation of both 10 CFR 20.1801, “Security of Stored Material,” and paragraph 

(i) of 10 CFR 30.34, Terms and Conditions of Licenses.” The violation involved CTI’s failure 

to secure licensed material in a portable gauge from unauthorized removal or access, with a 

minimum of two independent physical controls that form tangible barriers, while the gauge was 

stored in a controlled or unrestricted area and not under the control and constant surveillance 

of the licensee. Specifically, the licensee left an unattended gauge inside an unlocked shipping 

container that was accessible to the public.

Testing Engineers & Consultants, Inc. (EA-15-141) 

On October 23, 2015, the NRC issued a Notice of Violation to Testing Engineers & Consultants 

(TEC) Inc., for a Severity Level III violation. The violation involved TEC’s failure to use a 

minimum of two independent physical controls that form tangible barriers to secure portable 

gauges from unauthorized removal when the portable gauges were not under the control and 

constant surveillance of the licensee, as required by paragraph (i) of 10 CFR 30.34, Terms and 

Conditions of Llicenses.” Specifically, from 2011 until June 19, 2015, during off-duty hours, nonlicensee building tenants had access to the storage room’s locked door, which resulted in a only 

single physical barrier securing the gauges from unauthorized removal.

Cal Testing Services, Inc. (EA-15-117) 

On October 9, 2015, the NRC issued a Notice of Violation to Cal Testing Services (CTS), Inc., 

for a Severity Level III violation. The violation involved CTS’s failure to ensure each individual 

who acts as a radiographer or a radiographer’s assistant wears a direct reading dosimeter, 

an operating alarm rate meter, and a personnel dosimeter at all times during radiographic 

operations as required by paragraph (a) of 10 CFR 34.47, “Personnel Monitoring.” Specifically, 

on March 20, 2015, a radiographer’s assistant wore an inoperable alarm rate meter while 

performing radiographic operations.

MEDICAL

McLaren Medical Center Bay Region (EA-15-111)

On August 27, 2015, the NRC issued a Notice of Violation to McLaren Medical Center Bay 

Region (McLaren) for a Severity Level III violation. The violation involved McLaren’s failure to 

develop, implement, and maintain written procedures to provide high confidence that each 

administration is in accordance with the written directive as required by paragraph (a) of 

10 CFR 35.41, “Procedures for Administrations Requiring a Written Directive.” Specifically, as 

of February 6, 2015, the licensee failed to include specific steps in its procedure for verifying 

the catheter position to ensure the administration was in accordance with the written directive. 

As a result, a medical event occurred because the patient received an unintended dose of 

approximately 2.6 gray (260 rad) to the skin of the right thigh.
SPRING 2016

6

INDIVIDUALS

Mr. Larry Yeates (IA-15-029)

On December 28, 2015, the NRC issued a Notice of Violation to Mr. Larry Yeates for Severity 

Level III violations of paragraphs (a)(1) and (a)(2) of 10 CFR Part 72.12, “Deliberate Misconduct.” 

These violations involved the deliberate failures of Mr. Yeates to ensure that liquid penetrant 

nondestructive tests, a special process, were conducted in accordance with the Monticello Nuclear 

Generating Plant procedure. Specifically, from September 5, 2013 through October 17, 2013, 

Mr. Yeates deliberately failed to comply with procedure steps involving the developing time 

before the final interpretation of 38 welds on the six separate spent fuel storage dry shielded 

canisters that he examined. Additionally, Mr. Yeates failed to accurately record the nondestructive 

evaluation results. The information was not accurate, because the developer dwell times were 

over-reported.

Mr. Mickey Lovell (IA-15-028)

On December 28, 2015, the NRC issued a Notice of Violation to Mr. Mickey Lovell for 

Severity Level III violations of paragraphs (a)(1) and (a)(2) of 10 CFR Part 72.12, “Deliberate 

Misconduct.” These violations involved Mr. Lovell’s deliberate failures to ensure that liquid 

penetrant nondestructive tests, a special process, were conducted in accordance with the 

Monticello Nuclear Generating Plant procedure. Specifically, from September 5, 2013 

through October 17, 2013, Mr. Lovell deliberately failed to comply with procedural steps 

involving the developing time before the final interpretation of 28 welds on the six separate 

spent fuel storage dry shielded canisters he examined. Additionally, Mr. Lovell failed to 

accurately record the nondestructive evaluation results. The information was not accurate, 

because the developer dwell times were over-reported.

Mr. Mawuena Gnamavo (IA-15-061)

On October 30, 2015, the NRC issued a Notice of Violation to Mr. Mawuena Gnamavo for 

a Severity Level IV violation of paragraph (b)(2) of 10 CFR 71.8, “Deliberate Misconduct.” 

The violation involved Mr. Gnamavo’s deliberate misconduct, which caused his employer, 

Columbiana Hi-Tech (CHT), a certificate holder, to be in violation of paragraph (a) of 

10 CFR 71.7, “Completeness and Accuracy of Information,” requirement for knowingly 

submitting inaccurate quality and nondestructive examination inspector training and 

experience documents to CHT. Specifically, shortly after Mr. Gnamavo’s initial hire date 

of January 30, 2012, he provided falsified documents to CHT, consisting of a letter of 

recommendation and a training certificate. CHT used these documents as part of the basis 

to certify Mr. Gnamavo as a qualified inspector in both visual examination and dye penetrant 

examination. Mr. Gnamavo then inspected and approved important safety welds on 10 CFR 

Part 71, “Packing and Transportation of Radioactive Material,” and 10 CFR Part 72, “Licensing 

Requirements for the Independent Storage of Spent Nuclear Fuel High-Level Radioactive 

Waste, and Reactor-Related Greater than Class C Waste,” equipment and components 

without the required qualifications.

Dr. Bradley D. Bastow (IA-14-039)

On August 4, 2015, the NRC issued a Confirmatory Order to Dr. Bradley D. Bastow, 

radiation safety officer (RSO) for Cardiology II, P.C. The Order prohibits Dr. Bastow from 

serving as an RSO, including an assistant or associate RSO, while in NRC jurisdiction, until 

he demonstrates his completion of specific trainings and commits to comply with regulatory 

requirements. The NRC identified violations that were attributable to Dr. Bastow’s activities 

as the RSO. For example, the violations involved Dr. Bastow’s failure to repair or replace 
SPRING 2016

7

radiation detection instrumentation and to ensure that the instrumentation was calibrated and 

operable. He also failed to shadow a radiation safety officer and to maintain complete and 

accurate documents. The violations continued to indicate that Dr. Bastow was not adequately 

fulfilling his duties as the RSO. This Order does not prevent Dr. Bastow from serving as an 

authorized user.

Information about the NRC’s enforcement program can be accessed at http://www.nrc.gov/

about-nrc/regulatory/enforcement/current.html. Documents related to cases can be accessed 

through Agencywide Documents Access and Management System (ADAMS) at http://www.

nrc.gov/reading-rm/adams.html. Help in using ADAMS is available by contacting the NRC 

Public Document Room staff at 301–415–4737 or 1–800–397–4209 or by sending an e mail 

to PDR.Resource@nrc.gov.

(Contact: Michele Burgess, NMSS, 301–415–5868 or Michele.Burgess@nrc.gov)

GENERIC COMMUNICATIONS ISSUED 

The following items summarize NRC generic communications issued by NMSS. If any of 

these documents appear relevant to your needs and you have not received a copy, please call 

one of the technical contacts listed below. The Web address for the NRC library of generic 

communications is http://www.nrc.gov/reading-rm/doc-collections/gen-comm. 

REGULATORY ISSUE SUMMARIES

The NRC provides regulatory issue summaries (RIS) as informational documents used to 

communicate with the nuclear industry on a broad spectrum of matters. 

On November 12, 2015, the NRC issued RIS-15-13, “Seismic Stability Analysis Methodologies 

for Spent Fuel Dry Cask” (ADAMS Accession No. ML13353A710). The agency issued the RIS to 

share information regarding acceptable seismic stability analysis methodologies with addressees to 

determine seismic stability of spent fuel dry cask loading stack-up configurations. 

On December 4, 2015, the NRC issued RIS-15-15, “Information Regarding a Specific 

Exemption in the Requirements for the Physical Protection on Category 1 and Category 2 

Quantities of Radioactive Material” (ADAMS Accession No. ML15092A432). The agency 

issued the RIS to provide addressees with information regarding the guidance in NUREG-2155, 

Revision 1, “Implementation Guidance for 10 CFR Part 37, ‘Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material,’” and in the questions and answers concerning the 

application of 10 CFR Part 37 to licensees with 10 CFR Part 73, “Physical Protection of Plants and 

Materials,” security plans, which can be found on the NRC’s public Web site at http://www.nrc.

gov/security/byproduct/10-cfr-part-37.html. Specifically, paragraph (b) of 10 CFR 37.11, 

“Specific exemptions,” states, 

Any licensee’s NRC-licensed activities are exempt from the requirements of subparts B and C of 

this part to the extent that its activities are included in a security plan required by part 73 of this 

chapter. 

This RIS is being issued to provide information on the activities that should be included within 

the licensee’s security plan relative to this specific exemption from the requirements 

of Subparts B and C of 10 CFR Part 37. 

On December 23, 2015, the NRC issued RIS-15-17, “Review and Submission of Updates to Final 

Safety Analysis Reports, Emergency Preparedness Documents, and Fire Protection Documents” 
SPRING 2016

8

(ADAMS Accession No. ML15321A400). The agency issued the RIS to remind licensees of the 

review and submission requirements of 10 CFR 2.390, “Public Inspections, Exemptions, Requests 

for Withholding,” regarding information that may be withheld from public disclosure, as well as 

to recommend that the updates to final safety analysis reports (FSARs) required by paragraph 

(e) of 10 CFR 50.71, “Maintenance of Records, Making of Reports,” be made electronically 

on a total FSAR replacement basis, as described in paragraph (b)(6) of 10 CFR 50.4, “Written 

Communications.“ This RIS does not transmit or imply any new or changed requirements or staff 

positions, or require any specific action or written response. However, licensee review of FSAR 

updates and emergency preparedness and fire protection documents for physical protection 

information or Safeguards Information to be withheld from public disclosure, and submission 

of updates electronically on a total FSAR replacement basis, will enable the agency to more 

efficiently and effectively carry out its regulatory functions in an open and transparent manner.

On December 14, 2015, the NRC issued RIS-15-18, “Sodium Iodide-131 (I-131) Patient 

Release Information Collection” (ADAMS Accession No. ML15321A391). The agency issued 

the RIS to all NRC medical use licensees and NRC Master Materials License (MML) medical 

use permittees administering sodium iodine I-131 to patients under a written directive to 

inform physicians, licensees, and permittees of an opportunity to voluntarily submit information 

requested in the NRC’s November 16, 2015, Federal Register notice (FR) information request 

titled, “Sodium Iodide-131 (I-131) Patient Release Information Collection” (80 FR 70843). No 

specific action or any written response is required. The RIS is provided to the NRC MMLs for 

their information and for distribution to their appropriate medical use permittees. The NRC 

is providing this RIS to the Agreement States for their information and for distribution to their 

licensees, as appropriate.

On December 21, 2015, the NRC issued RIS-15-19, “Decommissioning Timeliness Rule 

Implementation and Associated Regulatory Relief” (ADAMS Accession No. ML15321A391). 

The agency issued the RIS to achieve the following: 

• Provide clarity to licensees on the Decommissioning Timeliness Rule’s (DTR’s) requirements 

to notify the NRC to begin and complete decommissioning after certain criteria are met. 

• Highlight opportunities for licensees to request alternatives to the DTR’s requirements.

• Remind licensees that there are situations where they can request an alternative to the DTR’s 

timeliness requirements for both beginning and completing decommissioning if adequately 

justified.

• Clarify when the DTR applies to licensees whose only location of use are temporary job sites. 

• Clarify when the NRC considers that the licensee has transitioned from an “operational” to a 

“decommissioning” status. 

This RIS informs licensees of requirements regarding the DTR under the following:

• 10 CFR Part 30, “Rules of General Applicability to Domestic Licensing of Byproduct Material” 

• 10 CFR Part 40, “Domestic Licensing of Source Material”

• 10 CFR Part 70, “Domestic Licensing of Special Nuclear Material”

• 10 CFR Part 72, “Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, 

High-Level Radioactive Waste, and Reactor- Related Greater than Class C Waste” 
SPRING 2016

9

This RIS is supplemental guidance for decommissioning and does not contradict information 

presented in Administrative Letter 96-05, Revision 1, “Compliance with the Rule, ‘Timeliness in 

Decommissioning of Material Facilities’” (Agencywide Documents Access and Management System 

(ADAMS) Accession No. ML081570203) or NUREG-1757, Volume 3, Revision 1, “Consolidated 

Decommissioning Guidance: Financial Assurance, Recordkeeping, and Timeliness, Final Report” 

(ADAMS Accession No. ML12048A683). This RIS does not apply to power reactors that have 

specific regulations concerning decommissioning (e.g., 10 CFR 50.82, “Termination of License,” and 

10 CFR 50.83, “Release of Part of a Power Reactor Facility or Site for Unrestricted use”). This RIS 

requires no action or written response beyond that already required by regulations. The NRC 

is providing this RIS to the Agreement States for their information and for distribution to their 

licensees, as appropriate.

SELECTED FEDERAL REGISTER NOTICES

January 27, 2016 

Federal Register (FR) notice 81 FR 4680, “Draft NUREG/CR-7209, A Compendium of Spent Fuel 

Transportation Package Response Analyses to Severe Fire Accident Scenarios” (Draft NUREG/CR; 

Request for Comment) 

Summary: The NRC is issuing for public comment draft NUREG/CR-7209, “A Compendium 

of Spent Fuel Transportation Package Response Analyses to Severe Fire Accident Scenarios.” 

This report summarizes studies of rail and truck transport accidents involving fires, relative to 

regulatory requirements for shipment of commercial spent nuclear fuel (SNF). Comments 

were due by March 28, 2016. 

(Contact: Jimmy Chang, NMSS, 301–415–7427 or Jimmy.Chang@nrc.gov)

October 28, 2015 

FR notice 80 FR 66056, “Strata Energy, Inc.” (Temporary Exemption)

Summary: The NRC is issuing a temporary exemption from certain NRC financial assurance 

requirements to Strata Energy, Inc. (Strata), in response to its annual financial assurance update 

for its Ross In-Situ Recovery (ISR) project. Issuance of this temporary exemption will not 

remove the requirement for Strata to provide adequate financial assurance through an approved 

mechanism, but will allow the NRC staff to further evaluate whether the State of Wyoming’s 

separate account provision for financial assurance instruments it holds is consistent with the 

NRC’s requirement for a standby trust agreement.

(Contact: John L. Saxton, NMSS, 301–415–0697 or John.Saxton@nrc.gov)
SPRING 2016

10

ONGOING RULEMAKINGS

RULEMAKING DESCRIPTION STATUS

PROPOSED RULES

10 CFR Part 61, 

“Low–Level 

Radioactive Waste 

(LLRW) Disposal”

The proposed rule would revise 

10 CFR Part 61 to require LLRW 

disposal licensees and license 

applicants to conduct updated site 

specific analyses and to permit 

the development of criteria for 

future LLRW acceptance based 

on the results of these analyses.

The NRC published the proposed 

rule and notice of availability of the 

draft guidance in the Federal Register

(80 FR 16082 and 80 FR 15930) 

on March 26, 2015. The comment 

period was extended until and 

closed on September 21, 2015. The 

comments received are under NRC 

review. The final rule package is due 

to the Commission in May 2016. 

10 CFR Parts 30 

and 32, “Items 

Containing Byproduct 

Material Incidental 

to Production 

(formerly Polymer 

(Polycarbonate or 

Polyester) Track 

Etched (PCTE) 

Membranes)”

The proposed rulemaking would 

amend requirements for tracketched membranes that have 

been irradiated with mixed 

fission products as part of the 

membrane production process. 

The proposed rulemaking 

would also accommodate the 

licensing and distribution of 

other irradiated products (e.g. 

gemstones) without the need 

for a specific exemption for each 

distributor.

The NRC is currently drafting the 

regulatory basis for the rulemaking 

and expects to release it for public 

comment in December 2016. 

10 CFR Part 73, 

“Enhanced Security 

of Special Nuclear 

Material”

The proposed rule would update 

security regulations, including 

portions of 10 CFR Part 73, 

relating to physical protection of 

special nuclear material at NRC 

licensed facilities and in transit.

On February 3, 2015, the Office 

of Nuclear Security and Incident 

Response (NSIR) submitted a user 

need request (ADAMS Accession 

No. ML14317A037) to NMSS to 

initiate a rulemaking to update 

the security regulations within 

10 CFR Part 73. NMSS accepted 

the regulatory basis (ADAMS 

Accession No. ML14321A007) on 

February 25, 2015. On April 22, 2015, 

the NRC published the final 

regulatory basis in the Federal Register

(80 FR 22434). A working group 

was formed and is working on the 

proposed rule.
SPRING 2016

11

10 CFR Part 73, 

“Cyber Security at 

Fuel Cycle Facilities”

The proposed rulemaking would 

revise 10 CFR Part 73 to add 

new cyber security requirements 

for Fuel Cycle Facilities.

On September 4, 2015, the NRC 

published the draft regulatory basis 

and asked for comments in the Federal 

Register (80 FR 53478). The working 

group is reviewing the comments.

FINAL RULE

10 CFR Part 35, 

“Medical Use of 

Byproduct Material 

– Medical Event 

Definitions, Training 

and Experience 

and Clarifying 

Amendments” 

The rule would amend the 

reporting and notification 

requirements for medical events 

for permanent brachytherapy, 

amend training and experience 

requirements to remove 

attestation requirements for 

certain individuals, make changes 

as requested in PRM-35-20, 

petition for rulemaking, and 

clarifying amendments.

The NRC published the proposed 

rule and draft guidance in the Federal 

Register (79 FR 42224) for public 

comments. The comment period 

closed November 18, 2014. The 

NRC received 48 comment letters, 

each containing numerous individual 

comments. The comments are 

posted at http://www.regulations.gov 

under Docket ID NRC-2008-0175. 

On October 8, 2014, the NRC held 

a public meeting to promote better 

understanding of the proposed 

amendments. The comments 

received are under NRC review. 

The final rule package is due to 

the Commission in Spring/early 

Summer 2016.

10 CFR Part 74, 

“Material Control and 

Accounting of Special 

Nuclear Material”

This rule would revise and 

consolidate the current 

Material Control and Accounting 

(MC&A) requirements into 

10 CFR Part 74, and would 

clarify and strengthen the MC&A 

requirements, in part, by removing 

existing exemptions in the item 

control provisions.

Staff is resolving the public 

comments and preparing the final 

package for the rulemaking. The 

final rule package is due to the 

Commission in November 2016. 
SPRING 2016

12

PETITIONS

PRM-72-6, “Petition 

for Rulemaking (PRM72-6), C-10 Research 

and Education 

Foundation, Inc.”

The petitioner submitted 12 

requests for the NRC to amend 

its regulations concerning dry cask 

safety, security, transferability, and 

longevity. In a Federal Register

notice dated October 16, 2012, 

the NRC denied nine of the 

petitioner’s 12 requests (Requests 

1, 2, 3, 5-8, 10 & 12), accepted for 

consideration Request 11 as part 

of the ongoing independent spent 

fuel storage installation (ISFSI) 

security rulemaking effort 

(RIN 3150-AI78; Docket ID 

NRC-2009-558), and reserved 

two requests for future 

rulemaking determination 

(Requests 4 and 9).

The package was sent to the Office 

of the Executive Director for 

Operation for their review in 

March 2016. 

PRM-28, PRM-29 

and PRM-30, “Linear 

No-Threshold Model 

and Standards for 

Projection Against 

Radiation”

The NRC received three petitions 

for rulemaking (PRM) requesting 

that the NRC amend its 

“Standards for Protection against 

Radiation” regulations and change 

the basis of those regulations 

from the Linear No-Threshold 

(LNT) model of radiation 

protection to the radiation 

hormesis model.

On June 23, 2015, the NRC 

published in the Federal Register, 

80 FR 35870, the receipt of the 

Petition For Rulemaking; Notice 

of Docketing and requested 

public comment on three PRMs, 

PRM-20-28, PRM-20-29, and 

PRM-20-30. The public comment 

period was September 8, 2015. 

But on August 21, 2015, the NRC 

published in the Federal Register, 

80 FR 50804, the receipt of the 

Petition for rulemaking; notice 

of docketing and extension of 

comment period. The NRC 

extended the public comment 

period until November 19, 2015, to 

allow more time for members of 

the public to develop and submit 

their comments. Staff is examining 

the issues raised in the PRMs to 

determine whether they should be 

considered in rulemaking.
SPRING 2016

13

POLICY STATEMENT

Tribal Policy Statement The Tribal Policy Statement 

development will describe the 

Commission’s policy for consulting 

and coordination with Native 

American tribes.

The proposed Tribal Policy 

Statement was published in the 

Federal Register (79 FR 71136) on 

December 1, 2014, and the public 

comment period closed on 

May 31, 2015. Staff is in the 

process of reviewing comments.

PRE-RULEMAKING

10 CFR Part 20, 

“Standards for 

Protection against 

Radiation, International 

Commission 

on Radiological 

Protection (ICRP) 

Recommendations” 

The rulemaking would 

incorporate recommendations 

from the ICRP to revise 

10 CFR Part 20.

The NRC published an advance 

notice of proposed rulemaking in 

the Federal Register (79 FR 43284) 

on July 25, 2014, and the public 

comment period closed on 

June 22, 2015. Staff is reviewing 

comments.

TO OUR READERS 

Thank you for your interest in our newsletter. In our attempt to keep the NMSS licensee 

newsletter—The NMSS News Link—relevant, we welcome feedback on its contents. 

If you would like to suggest topics for the newsletter, please contact Vanessa Cox, NMSS 

Rulemaking and Project Management Branch, by telephone at 301–415–8342 or by e–mail at 

Vanessa.Cox@nrc.gov. In addition, to ensure proper delivery of The NMSS News Link and to 

prevent any interruption of service, please report e–mail address changes to Ms. Cox. 

Please send written correspondence to the following address:

Vanessa Cox, Editor, NMSS Licensee Newsletter

Office of Nuclear Material Safety and Safeguards

U.S. Nuclear Regulatory Commission

Two White Flint North, Mail Stop: T-8-D36

Washington, DC 20555–0001
SPRING 2016

14
SPRING 2016

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NUREG/BR-0117 No.16-02

March 2016