APRIL 2014

NUREG/BR-0117

NO. 14-02

MEDICAL USE OF 

BYPRODUCT MATERIAL 

PROPOSED RULE

 PAGE1

COMPLIANCE BEGINS FOR 

THE PHYSICAL PROTECTION 

OF BYPRODUCT MATERIAL 

 PAGE2

NEW MEMBERS TO THE 

ADVISORY COMMITTEE ON THE 

MEDICAL USES OF ISOTOPES

 PAGE2

FROM THE DESK OF 

THE DIRECTOR

 PAGE3

APPOINTMENT TO THE 

CERTIFICATION REVIEW 

BOARD 

 PAGE4

FUKUSHIMA LESSONS 

LEARNED

 PAGE4

SIGNIFICANT ENFORCEMENT 

ACTIONS 

 PAGE7

GENERIC COMMUNICATIONS 

ISSUED

 PAGE9

SELECTED FEDERAL 

REGISTER NOTICES

 PAGE10

ONGOING RULEMAKINGS

 PAGE10

TO OUR READERS

 PAGE12

Medical Use of 

Byproduct Material 

Proposed Rule

The U.S. Nuclear Regulatory Commission 

(NRC) has regulatory authority over the 

medical use of byproduct material. The NRC 

has issued regulations to provide for the 

radiation safety of workers, the general public, 

patients, and human research subjects when 

byproduct material is used for medical purposes. 

These regulations are contained in Title10 of the 

Code of Federal Regulations (10 CFR) Part 35, “Medical Use of Byproduct Material.”

BACKGROUND

The NRC revised Part 35 in its entirety in 2002 (67 FR 20250), and further revised the 

training and experience (T&E) requirements in 2005 (70 FR 16336). In implementing 

the current regulations, the NRC staff, stakeholders, and the Advisory Committee on 

the Medical Uses of Isotopes identified issues that need to be addressed through the 

rulemaking process. These issues will be addressed in a proposed rule.

SUMMARY

The proposed rule will address three ongoing rulemaking projects and several other 

related topics. First, this rule proposes amendments to the reporting and notification 

requirements for a medical event for permanent implant brachytherapy. Second, the 

rule proposes changes to: (1) the T&E requirements for authorized users, medical 

physicists, radiation safety officers, and nuclear pharmacists; (2) the requirements 

for measuring molybdenum contamination and reporting of failed technetium and 

rubidium generators; and (3) allow associate radiation safety officers to be named 

on a medical license and several clarifying amendments. Third, the rule proposes 

changes to address a request in a petition for rulemaking (PRM 35 20) to exempt 

certain board certified individuals from certain T&E requirements (i.e., “grandfather” 

these individuals). This exemption would allow certain board certified individuals 

to be identified on a license or permit for materials and uses that they performed 

on or before October 24, 2005, the expiration date of the former Subpart J of 

10 CFR Part 35 which contained the prior T&E requirements.

STATUS

In August 2013, the NRC staff sent the 10 CFR Part 35 proposed rule package (SECY 

13 0084, available in NRC’s Agencywide Documents Access and Management System 

Continued on page 2

OFFICE OF FEDERAL & STATE 

MATERIALS & ENVIRONMENTAL 

MANAGEMENT PROGRAMS
APRIL 2014

2

(ADAMS) Accession No. ML13178A124) to the Commission for review and approval to publish the 

proposed rule in the Federal Register for public comment. In a staff requirements memorandum 

(SRM) dated January 6, 2014, the Commission approved publication of the proposed rule, subject to 

some changes, as noted in the SRM (ADAMS Accession No. ML14007A044). 

After the NRC staff incorporates the Commission directed changes, the proposed rule will be 

published in the ederal Register for a 120 day comment period. Concurrent with the publication of 

the proposed rule, the draft guidance conforming to the proposed rulemaking will also be available 

for public comment. The NRC is anticipating publication of the proposed rule and the conforming 

draft guidance for public comment in mid May 2014.

(Contact: Neelam Bhalla, FSME, 301-415-6843, or Neelam.Bhalla@nrc.gov, or, 

Edward Lohr, FSME, 301-415-0253, Edward.Lohr@nrc.gov)

COMPLIANCE BEGINS FOR THE PHYSICAL 

PROTECTION OF BYPRODUCT MATERIAL 

On March 19, 2013, the NRC published a final rule that added a new part—Part 37, “Physical 

Protection of Category 1 and Category 2 Quantities of Radioactive Material”—to the NRC 

regulations in 10 CFR and made conforming changes to other regulations. The new requirements 

establish security requirements for the most risk significant radioactive materials, based on their 

quantities (i.e., category 1 quantities or category 2 quantities of these radioactive materials as 

determined in Appendix A, “General Provisions,” to 10 CFR Part 37). The new rule became effective 

on May 20, 2013, and required compliance by NRC licensees by March 19, 2014, one year after 

publication. The NRC issued Regulatory Issue Summary (RIS) 2014 03, “Notice of 10 CFR Part 37 

Implementation Deadline for NRC Licensees” (ADAMS Accession No. ML14052A157), to provide 

information to assist licensees in their compliance with the new requirements. Agreement States 

have until March 19, 2016, to issue compatible requirements for their licensees.

For more information on 10 CFR Part 37, please visit http://www.nrc.gov/security/byproduct/10 

cfr part 37.html. The NRC welcomes comments and questions from anyone interested in 

the new regulations and their implementation. You can use the dedicated e-mail resource 

Part37.Resource@nrc.gov to ask questions and provide comments to the NRC regarding 

10 CFR Part 37 and its implementation.

(Contact: Paul Goldberg, FSME, 301-415-7842, or Paul.Goldberg@nrc.gov)

NEW MEMBERS TO THE ADVISORY 

COMMITTEE ON THE MEDICAL USES 

OF ISOTOPES 

The Acting Director of FSME, in consultation with the Commission, has selected three 

new members to the Advisory Committee on the Medical Uses of Isotopes (ACMUI). 

The new members are Dr. Philip Alderson, Dr. Vasken Dilsizian, and Mr. Francis Costello. 

These individuals will fill the existing vacancies on the ACMUI for the positions of the 

Health Care Administrator, Nuclear Cardiologist, and Agreement State Representative, respectively. 

The appointments are for 4 years. 

2

(from left to right: Dr. Philip Alderson, 

Dr. Vasken Dilsizian, and Mr. Francis 

Costello)

Continued on page 4
APRIL 2014

3

FROM THE DESK OF 

THE DIRECTOR

OFSME understands that interacting with our external stakeholders 

is one of the cornerstones of what makes a National Materials 

Program work. Recently, I reviewed a list of our external meetings and 

conferences. I was pleasantly surprised by not only the extensive list, but 

also by the level of involvement and interactions between the States and 

the NRC. The importance of these meetings is not lost on the NRC’s 

senior leaders, as Chairman Allison M. Macfarlane, Commissioner William 

C. Ostendorff, and Deputy Executive Director of Operations (EDO) 

Michael F. Weber have participated in or are scheduled to participate in 

significant materials meetings and conferences.

The NRC continues to change and adapt to the shifting demands of 

our budgetary and regulatory framework, and FSME is no exception. 

Over the past year, FSME and the Office of Nuclear Materials Safety and 

Safeguards (NMSS) established a working group to evaluate a potential 

merge of offices. After careful consideration of the working group’s 

recommendation and additional information provided by the staff, we 

have recommended to the EDO and the Commission that NMSS 

and FSME merge. A Commission paper was prepared that included 

the reason for the proposed merger and a short discussion on the 

alternatives considered in arriving at the staff’s recommendation. Should 

the Commission approve the staff’s recommendation, we will continue 

to communicate with both internal and external stakeholders as we 

move forward with implementing the Commission’s direction. (Note: 

The staff proposed merging the two offices beginning October 1, 2014).

The regulation of radioactive materials is accomplished nationally by 

the NRC and 37 Agreement States. Since the NRC discontinues 

its authority when it enters into an agreement with a State, each 

Agreement State establishes legislations and regulations to protect public 

health and safety within its borders. To ensure that the regulations of 

radioactive material are conducted in a consistent manner nationally, each 

Agreement State’s regulations must be compatible with NRC regulations. 

Compatibility regulations require that some regulations are identical 

between the NRC and States, but it also allows the Agreement States 

flexibility with other regulations. Compatibility has been an important 

topic in FSME for the last several months—there has been discussion 

on the amount of flexibility that should be afforded the Agreement 

States due to three significant projects currently underway. Two 

significant amendments to NRC regulations with important compatibility 

implications that will impact Agreement States have been the subject 

of discussion and direction by the NRC Commission. In addition to 

10 CFR Part 35, “Medical Use of Byproduct Material,” regulations that 

cover the medical use of radioactive material, FSME is amending the 

NRC regulations for low level waste disposal (10 CFR Part 61, “Licensing 

Requirements for Land Disposal of Radioactive Waste”) where all the 

Nation’s low level waste disposal facilities are licensed and regulated 

by Agreement States. FSME staff is also preparing a Commission 

paper to propose the final version of the agency’s policy statement on 

compatibility, a process that started in 2011. In the coming months, 

the topic of compatibility and the amount of flexibility provided to 

Agreement States will continue to be an important topic in FSME. 

In March 2014, Part 37, “Physical Protection of Category 1 and Category 

2 Quantities of Radioactive Material,” became effective. This new rule 

codifies the orders that were put in place following 9/11. It is important 

to note that the rule also has some additional criteria that were gained 

from inspections and lessons learned. FSME recently issued a Regulatory 

Issue Summary (RIS 2014 03, “Notice of 10 CFR Part 37 Implementation 

Deadline for NRC Licensees”) that highlighted this rule. I encourage you 

to distribute that RIS to your staff and licensees.

Also, in March 2014, we published the revised draft of the interim staff 

guidance (ISG) on “Evaluations of Uranium Recovery Facility Surveys of 

Radon and Radon Progeny in Air and Demonstrations of Compliance 

with 10 CFR 20.1301,” for public comment. On April 2, 2014, a public 

meeting was held to discuss the revisions to the draft report and to 

solicit additional comments. Staff prepared the ISG on radon and radon 

progeny surveys and certain aspects of dose determinations for uranium 

recovery facilities to assist in evaluating compliance with the 10 CFR Part 20, 

“Standards for Protection against Radiation,” public dose limit. The new 

revision to the draft was developed with the assistance of the many 

comments provided by all of our internal and external stakeholders. I 

trust that with the revised draft, and the additional comments you 

provided, we will be able to publish a final version in the near future that 

will assist us in dealing with this issue.

Radium is another topic of interest that I’d like to highlight. Recently, the 

Hunters Point Naval Shipyard (HPS) site in San Francisco, CA, has been 

of interest to the public. The Navy is the land owner and responsible for 

the cleanup of the HPS site under the Comprehensive Environmental 

Response, Compensation, and Liability Act (CERCLA, also known as the 

Superfund Act). However, the Navy uses various civilian contractors to 

perform aspects of remediation work at this site. The NRC’s role at this 

site involves staying informed of the site’s CERCLA activities and providing 

oversight to the Navy’s contractors with NRC licenses. The NRC is 

drafting a Commission paper dealing with this topic. The paper will 

summarize the NRC’s ongoing actions for what we expect to be a couple 

dozen military sites needing actions. Additionally, just as the Agreement 

States have wrestled with radium contamination at commercial sites, the 

NRC is expending effort to identify any potential additional sites that may 

need attention in NRC States.

I look forward to seeing many of you at the Conference of Radiation 

Control Program Directors (CRCPD) annual meeting in Atlanta this year. 

Best wishes for some warmer spring weather!

Brian Holian, Acting Director
APRIL 2014

4

Dr. Alderson currently serves as Dean of the School of Medicine and as Vice President for 

Medical Affairs at Saint Louis University, located in St. Louis, MO. 

Dr. Dilsizian currently serves as Chief of the Nuclear Medicine Division (PET Cardiovascular 

Imaging) at the University of Maryland Medical Center located in Baltimore, MD. He is also 

Professor of Radiology and Medicine at the University of Maryland School of Medicine, which is 

also located in Baltimore. 

Mr. Costello is a Radiation Health Physicist with the Pennsylvania Bureau of Radiation Protection, 

located in Norristown, PA. 

The ACMUI advises the NRC on policy and technical issues that arise in the regulation of the 

medical uses of radioactive material in diagnosis and therapy. The ACMUI membership includes 

health care professionals from various disciplines who comment on changes to NRC regulations 

and guidance; evaluate certain non routine uses of radioactive material; and bring key issues to 

the attention of the NRC staff for appropriate action. Additional information about the ACMUI 

can be found at http://www.nrc.gov/about nrc/regulatory/advisory/acmui.html.

(Contact: Sophie Holiday, FSME, 301-415-7865 or Sophie.Holiday@nrc.gov)

APPOINTMENT TO THE CERTIFICATION 

REVIEW BOARD

DIn March 2014, Larry W. Camper, Director, Division of Waste Management and Environmental 

Protection of FSME, was appointed as a member of the Certification Review Board (CRB) 

for the Academy of Board Certified Environmental Professionals (ABCEP). The CRB is 

responsible for managing the ABCEP certification process. Members of the CRB represent 

many fields of professional effort (i.e., consulting, academia, private industry, government). The 

CRB is responsible for determining the qualifications of each applicant and grants or denies 

certification based upon the information provided. All CRB members are appointed by the 

ABCEP Board of Directors and must be certified by the ABCEP. As part of this process, 

Mr. Camper will serve as a member of a seven person team consisting of ABCEP certified 

professionals reviewing the credentials and application packages for individuals seeking 

certification by the ABCEP. 

Mr. Camper was certified by the ABCEP in 2012 with a specialty in environmental assessment 

and he currently serves as the Chairman of the NRC National Environmental Policy Act 

Executive Steering Committee. 

The FSME staff congratulates Mr. Larry Camper on his new appointment!!!

FUKUSHIMA LESSONS LEARNED

Background

On March 11, 2011, a 9.0 magnitude earthquake struck Japan and was followed by a 45 foot 

tsunami, resulting in extensive damage to the nuclear power reactors at the Fukushima 

Dai ichi facility.
APRIL 2014

5

What is NTTF?

Following the Fukushima accident, the Commission directed staff to establish a Near Term Task 

Force (NTTF) to conduct a systematic and methodical review of NRC processes and regulations 

to determine whether the agency should make additional improvements to its regulatory 

system, and to make recommendations to the Commission for its policy development (tasking 

memorandum dated March 23, 2011). The NTTF conducted a review of insights from the 

Fukushima accident and developed near term recommendations described in a report entitled, 

“Recommendations for Enhancing Reactor Safety in the 21st Century,” which was submitted 

to the Commission (SECY–11–0093, dated July 12, 2011). In brief, the NTTF developed 12 

overarching recommendations, limited to radiological health and safety considerations for 

nuclear power reactors. 

Recommendation 1 was the most significant overarching recommendation, which consisted 

of an overall recommendation, and four specific sub recommendations. This recommendation 

called for the establishment of a logical, systematic, and coherent regulatory framework for 

adequate protection that appropriately balances defense in depth and risk considerations.

The NTTF sub recommendations were to:

• 1.1 Draft a Commission policy statement that articulates a risk informed defense in depth 

framework. 

• 1.2 Initiate rulemaking to implement a risk informed, defense in depth framework consistent 

with the above recommended Commission policy statement. 

• 1.3 Modify the Regulatory Analysis Guidelines to more effectively implement the defense in 

depth philosophy in balance with the current emphasis on risk based guidelines. 

• 1.4 Evaluate the insights from the Individual Plant Examination (IPE), and Individual Plant 

Examination for External Event (IPEEE) efforts, to identify potential generic regulations or plant 

specific regulatory requirements. 

The remaining overarching recommendations pertain to system design for seismic and flooding 

and strengthening station blackout mitigation, vent design in boiling water reactors facilities, and 

additional aspects of emergency planning enhancements. 

What is RMRF? 

In a memorandum dated February 11, 2011, the NRC Chairman created a Risk Management 

Task Force (RMTF) headed by Commissioner George Apostolakis. The task force was chartered 

to develop a strategic vision and options for adopting a more comprehensive and holistic risk 

informed performance based regulatory approach for reactors, materials, waste, fuel cycle, and 

transportation that would continue to ensure the safe and secure use of nuclear material. In April 

2012, the RMTF issued NUREG–2150, “A Proposed Risk Management Regulatory Framework 

(RMRF).” NUREG–2150 addressed agency mission, objective, risk management goal, and a decision 

making process in consideration of RMTF findings. More importantly, NUREG–2150 proposed 

over 50 recommendations for all NRC programs or business lines. Considering FSME programs, 

a total of 11 recommendations were proposed including 5 recommendations for materials uses; 

3 recommendations for low-level waste, and 3 recommendations for uranium recovery program. 

The task force did not propose any recommendations for decommissioning.

What is the relationship between NTTF and RMRF?

The Commission linked the timeframe for developing an RMRF paper on policy statement 

within 6 months of issuing the SRM on NTTF Recommendation 1. In addition, the RMRF 

proposed framework for agency mission, objective, risk management goal, as well as 
APRIL 2014

6

several recommendations are similar to NTTF Recommendation 1 and its subrecommendations. For example, defense-in-depth concept is a common feature 

among NTTF and RMRF recommendations. 

Why and how is FSME involved in NTTF and RMRF 

activities, and what is the potential future impact on FSME 

programs/business lines? 

The NTTF Recommendation 1 and its sub recommendations apply to all NRC 

programs including FSME. Further, certain recommendations regarding safety and 

security apply to material uses and other FSME business lines. FSME is also involved 

in addressing material safety and security to ensure depth of analysis of potential 

incidents or accidents, including use of the defense-in-depth concept in equipment 

design, operational activities including human factors, as well as analysis of lessons 

learned based on NRC and international experience gained in licensing and control 

of radioactive material uses. Currently, FSME is also participating in Japan Lessons 

Learned Project Directorate (JLD) reviews, addressing lessons learned and potential 

needs for additional features to enhance safety and security. 

 With regard to RMRF, FSME staff participates in all RMRF work group (RMRF WG) 

activities focusing on development of a conceptual policy statement and addressing 

issues pertaining to FSME NUREG–1250 eleven recommendations. The FSME 

Deputy Office Director is continually involved in the RMRF Executive Steering 

Committee (ESC) meetings and discussion of implementation and stakeholder 

feedback issues. FSME staff also coordinates with Agreement States Liaison Officers 

to keep Agreement States informed of the ongoing RMRF activities, public meetings, 

and progress made on development of a policy statement. 

Updates: 

NTTF:

• FSME staff provided a summary of key activities to JLD that may be related to the 

ongoing JLD reviews such as regulations and/or regulatory guides that may need to 

be looked at in the context of JLD review activities. 

• On June 14, 2012, the NRC Chairman issued a tasking memorandum entitled, 

“Evaluating Options Proposed for a More Holistic Risk Informed, Performance 

Based Regulatory Approach.”

• NTTF WG developed a detailed paper addressing staff recommendations for 

disposition of Recommendation 1 of the NTTF (SECY–13–0132, December 6, 2013).

• NTTF WG briefed the Commission on approaches for disposition of NTTF 

Recommendation 1 (January 10, 2014).

• NTTF WG is awaiting Commission decision regarding options for disposition of 

Recommendation 1.

RMRF:

• FSME staff participated in RMRF WG meetings and contributed to development 

of a conceptual policy statement briefly addressing RMRF recommendations 

applicable to FSME business lines.
APRIL 2014

7

• RMRF developed a draft policy statement on July 12, 2013 and FSME staff provided a 

comment report (ADAMS Numbers ML13210A180 and ML13210A214) on the July 2013. 

FSME comments focused on format, content, and issues pertaining to implementation as 

applicable to its business lines. 

• RMRF WG conducted a public meeting on July 30, 2013, to discuss NUREG–2150 

recommendations and how to address such recommendations.

• RMRF conducted a meeting, open to the public, with ACRS for discussion of NUREG–2150 

recommendations, conceptual policy statement, and alternative approaches to disposition of 

NUREG–2150 recommendations.

• RMRF WG re directed its activity to develop a white paper addressing a conceptual RMRF 

policy statement and soliciting public comments. 

• On November 25, 2013, the (NRC published, “Conceptual Example of a Proposed Risk 

Management Regulatory Framework Policy Statement,” in the Federal Register (FRN) and 

requested public comments (78 FR 70354; November 25, 2013); and a white paper on the 

topic (ADAMS No. ML13273A5179).

• The original FRN provided a closing date of January 10, 2014, for the public review and 

comment period. The NRC extended the closing date for public comments until 

February 28, 2014. In addition, a public meeting on this topic was conducted on 

January 30, 2014, at NRC Headquarters in Rockville, Maryland.

• Currently, NRC staff is reviewing and addressing in detail public comments and comments 

submitted by NRC offices. 

• The timeframe for developing and submitting an RMRF policy statement to the Commission 

is six months from the date of issuance of Commission SRM on disposition of NTTF 

Recommendation 1 (see NTTF status above).

(Contact: Boby Abu Eid, FSME, 301-415-5811 or Boby.abu-Eid@nrc.gov)

SIGNIFICANT ENFORCEMENT ACTIONS

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

Canberra Industries, Inc. (EA–13–184)

On November 1, 2013, the NRC issued a Notice of Violation to Canberra Industries, Inc., 

(Canberra) for a Severity Level III violation. The violation involved the licensee’s failure to 

secure from unauthorized removal or access licensed materials that are stored in controlled 

or unrestricted areas as required by 10 CFR 20.1801, “Security of Stored Material.” Specifically, 

Canberra stored an americium 241/ beryllium source in a locked calibration room in which there 

was a pass through window to an unlocked outer room that was open and accessible. Also, the 

source was inside a shielded drum that was not secured to the floor and the motorized device 

that is used to expose the source could have been operated by unauthorized individuals through 

an unlocked switch located in the outer room.

ADCO Services, Inc. (EA–13–131)

On October 30, 2013, the NRC issued a Notice of Violation to ADCO Services, Inc., for a Severity 

Level III violation. The violation involved the failure to have an individual specifically named on the 
APRIL 2014

8

license to fulfill the duties of the radiation safety officer (RSO) as required by License 

Condition 11.A of the NRC License. Specifically, the RSO left the company on 

June 30, 2012, and the licensee did not hire a new qualified RSO. Also, the company 

did not submit an amendment request to the NRC until February 1, 2013.

Nordlund and Associates (EA–13–053)

On June 27, 2013, the NRC issued a Notice of Violation to Nordlund and Associates 

for Severity Level III violations. One of the violations involved the failure of Nordlund 

to confine possession and use of byproduct materials to the locations and purposes 

authorized by the license as required by 10 CFR 30.3(c)(2), “Activities Requiring 

License,” and 10 CFR 30.34(c), “Terms and Conditions of Licenses.” From 

August 7, 2009, to April 3, 2013, the licensee possessed four radium 226 gauges that 

were not on its NRC license and used one of these gauges for density measurements at 

a temporary job site on July 3 and 5, 2012. The licensee was not authorized to possess 

the gauges and did not submit a license amendment until February 19, 2013, which is 

more than 6 months from the waiver expiration date. The second violation involved 

the failure of the company to use a minimum of two independent physical controls that 

form tangible barriers to secure portable gauges from unauthorized removal, whenever 

portable gauges are not under the control and constant surveillance of the licensee as 

required by 10 CFR 30.34(i). Even while the radium gauges were locked within the 

shed, the company did not have a second physical barrier to prevent their removal. 

Another violation involved the failure of Nordlund to conduct operations so that the 

dose in any unrestricted area from external sources would not exceed 2 millirem in any 

one hour as required by 10 CFR 20.1301(a)(2), “Dose Limits for Individual Members 

of the Public.” Specifically, as of January 16, 2013, the licensee stored its radium gauges 

in an outdoor shed in an unrestricted area in a manner would result in a dose of 

approximately 4.5 millirem per hour external to the shed.

MEDICAL

Centro de Medicina Nuclear (EA–13–059)

On November 5, 2013, the NRC issued a Notice of Violation and Proposed Imposition 

of Civil Penalty in the amount of $7,000 to Centro de Medicina Nuclear (CDM) for 

a Severity Level III violation. The violation involved the failure of CDM to comply 

with an order issued on August 7, 2012, after CDM failed to pay the NRC licensing 

fee. Specifically, as of November 5, 2013, CDM had not submitted an answer to the 

order, paid the license fee, or submitted the required written report regarding the 

amount, condition, and status of its licensed material by August 27, 2012; or begun 

decommissioning its site by October 26, 2012.

Jackson Cardiology Associates, P.C. (EA–13–134)

On October 30, 2013, the NRC issued a Notice of Violation and Proposed Imposition 

of Civil Penalty in the amount of $3,500 to Jackson Cardiology Associates, P.C. 

(Jackson), for a Severity Level III problem involving two violations. The first violation 

involved the failure of Jackson to supply and require the use of individual monitoring 

devices by adults likely to receive a dose in excess of 10 percent of the limits in 

10 CFR 20.1201(a), “Occupational Dose Limits for Adults,” as required by 10 CFR 

20.1502(a)(1), “Conditions Requiring Individual Monitoring of External and Internal 

Occupational Dose.” The second violation involved the failure of Jackson to ensure 

that information provided to the NRC was complete and accurate in all material 
APRIL 2014

9

respects as required by 10 CFR 30.9, “Completeness and Accuracy of Information.” Specifically, 

on August 20, 2012, a nuclear medicine technologist informed an NRC inspector that dosimetry 

had been left at home although it had been misplaced at the end of June 2012. The technologist 

neglected to inform the inspector that payments were not made to the vendor to continue the 

contract nor were the services of a replacement vendor obtained. 

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 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, FSME, 301-415-5868 or Michele.Burgess@nrc.gov)

GENERIC COMMUNICATIONS ISSUED

The following are summaries of NRC generic communications issued by FSME. If any of these 

documents appears relevant to your needs and you have not received it, 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.

Information Notice

The NRC issued an Information Notice (IN) to addressees to provide significant recently 

identified information about safety, safeguards, or environmental issues. Addressees are expected 

to review the information for applicability to their facilities and consider actions, as appropriate, to 

avoid similar problems. 

On November 15, 2013, the NRC issued IN 2013–22, “Recent Licensing Submittals Containing 

Personally Identifiable Information.” The IN was issued to remind licensees to refrain 

from submitting personally identifiable information (PII) in licensing applications and other 

correspondence when the PII is not necessary to support NRC review of the submitted 

information. (Contact: Katie Wagner, FSME, 301-415-6202, or Katie.Wagner@nrc.gov)

Regulatory Issue Summary

The NRC provides a regulatory issue summary (RIS) as an informational document used to 

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

On March 13, 2014, the NRC issued RIS 2014–03, “Notice of 10 CFR Part 37 Implementation 

Deadline for NRC Licensees.” This RIS was issued to remind licensees required to implement the 

new 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 Quantities of Radioactive 

Material” that the compliance date of this rule is March 19, 2014, and to identify sources of 

reference information available to assist in compliance.

On January 10, 2014, the NRC issued RIS 2014–01, “Regulatory Requirements for Withholding of 

Proprietary Information from Public Disclosure.” This RIS was issued to inform addressees how 

to request withholding of proprietary information from public disclosure under 10 CFR 2.390(b), 

“Public Inspections, Exemptions, Requests for Withholding,” and how to submit proprietary 

information to the NRC.

(Contact: Hector Rodriguez Luccioni, FSME, 301-415-6004 or Hector.Rodriguez Luccioni@nrc.gov)
APRIL 2014

10

SELECTED FEDERAL REGISTER

NOTICES

January 16, 2014 

79 FR 2907 Consumer Product Policy Statement (Policy Statement; Revision)

Summary: The NRC is updating its policy statement on products intended for use 

by the general public (consumer products). The update reflects the NRC’s current 

approach to radiation protection, legislation that has been enacted since the policy 

was published in 1965, and subsequent approaches taken in the NRC’s regulatory 

framework for exemptions.

Contact: Shirley Xu, FSME, 301-415-7640 or Shirley.Xu@nrc.gov. 

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 and 

new site specific analyses and to 

permit the development of criteria 

for future LLRW acceptance based 

on the results of these analyses.

The rulemaking package 

(SECY–13–0075 dated 

July 18, 2013) was sent to 

the NRC Commission 

for review. The SRM was 

issued February 12, 2014. 

A revised proposed rule is 

due to SECY in 12 months 

(February 2015). 

10 CFR Part 35 – 

Medical Use of Byproduct 

Material – Medical event 

Definitions, Training and 

Experience and Clarifying 

Amendments 

The proposed rule would amend the 

reporting and notification requirements for a medical event, training 

and experience requirements, and 

changes to address a request filed in 

a petition for rulemaking.

The rulemaking package 

(SECY–13–0084, dated 

August 8, 2013 was 

sent to the NRC 

Commission for review. 

On January 6, 2014, the 

SRM was issued approving 

the proposed rule with 

some modest changes. 

The proposed and draft 

guidance will likely be 

published for public 

comment in May 2014.

FINAL RULE

10 CFR Part 71 – 

Compatibility with 

Transportation Standards

The rule would amend the transportation safety requirements in 10 CFR 

Part 71 to make changes to the NRC 

regulations for the packaging and 

transportation of radioactive material. 

The NRC published the 

proposed rule in the 

Federal Register on 

May 16, 2013 (78 FR 

28988). A final rule will 

likely be sent the Commission in September 2014.
APRIL 2014

11

DIRECT FINAL RULE

10 CFR Part 70 – 

Appendix A Direct 

Final Rule, Reportable 

Safety Events

The direct final rule and companion 

proposed rule would modify the 

event reporting requirements In Part 

70, Appendix A.

The Commission approved 

staff to move forward 

with rulemaking (COMSECY–13 –0005). The direct 

final rule and companion 

proposed rule may be 

published for public comment in October 2014.

10 CFR Part 73 – 

Safeguard Information – 

Modified Handling 

(SGI–M) Categorization 

Change for Materials 

Facilities

The direct final rule and companion 

proposed rule would remove the SGI 

M designation of the security related 

information for large irradiators, 

M&D licensees, and for any licensee 

that transports category 1 quantities 

of radioactive material or transports 

small quantities of irradiated reactor 

fuel that weighs 100 grams or less 

in net weight of irradiated fuel. The 

security related information for these 

facilities and transportation will be 

protected under the requirements 

of the new 10 CFR Part 37, 

“Physical Protection of Category 

1 and Category 2 Quantities of 

Radioactive Material.” 

The staff sent the Commission a rulemaking 

package on April 24, 2013 

(SECY–13–0045), which 

the Commission approved. 

The SRM was issued on 

August 12, 2013. 

The direct final rule and 

companion proposed 

rule will likely be published 

for public comment in 

June 2014.

PETITIONS

PRM-72-7 - NEI Petition – 

CoC Format and Content

The petition, submitted by Anthony 

Pietrangelo, on behalf of the Nuclear 

Energy Institute, requested that the NRC 

amend its 10 CFR Part 72 regulations 

to add a new rule governing spent 

nuclear fuel storage cask Certificate 

of Compliance (CoC) format and 

content, extend the applicability of 

the backfit rule to CoCs, and make 

other changes. The petitioner raised 

six issues to improve the efficiency of 

the licensing and oversight of spent 

fuel dry cask storage.

The receipt and request of 

the petition was published 

in the Federal Register on 

February 5, 2013 for 

75-days of public 

comments.

PRM 32-8 – Campco 

Petition

CampCo submitted a petition for 

rulemaking (PRM 32 8) requesting 

the NRC to amend regulations to 

allow commercial distribution of 

tritium markers.

The receipt and request of 

the petition was published 

in the Federal Register on 

July 11, 2013, for 75 days 

of public comments. 
APRIL 2014

12

POLICY STATEMENT

Tribal Policy Statement The tribal policy statement development will describe how to interact effectively with Native American tribes.The staff sent the 

Commission a Tibal Policy 

Statement in January 2014 

(SECY–14–0006). The 

policy statement will likely 

be published for public 

comment in June 2014.

PRE-RULEMAKING

10 CFR Part 20 – ICRP 

Recommendations 

The rulemaking would revise 

10 CFR Part 20.

FSME is developing technical issue papers and will 

publish for stakeholder 

comment in mid-2014. 

TO OUR READERS 

Thank you for your interest in our newsletter. In our attempt to keep the FSME News Link 

relevant, we welcome feedback on its contents. If you would like to suggest topics for the 

newsletter, please contact Vanessa Cox, FSME 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 FSME News Link and to prevent any interruption of service, please 

report e-mail address changes to Ms. Cox at FSME_Newsletter@nrc.gov.

Please send written correspondence to the following address: 

Vanessa Cox, Editor, FSME Licensee Newsletter

Office of Federal and State Materials and

Environmental Management Programs

U.S. Nuclear Regulatory Commission

Two White Flint North, Mail Stop: T 8 F42

Washington, DC 20555 0001