SPRING 2013

NUREG/BR-0117

NO. 13-01

LICENSING DECISION 

FOR RADIUM-223 

DICHLORIDE

 PAGE 1

UPDATE ON 

REVISIONS TO 

THE RADIATION 

PROTECTION 

REGULATIONS

 PAGE 2

FROM THE 

DESK OF THE 

DIRECTOR

 PAGE 3

THE NRC’S 

AGREEMENT STATE 

PROGRAM VERSUS 

STATE LIAISON 

OFFICER PROGRAM

 PAGE 4

POSTINVESTIGATION 

ALTERNATIVE 

DISPUTE 

RESOLUTION

 PAGE 6

DECOMMISSIONING 

WORKSHOP

 PAGE 7

SIGNIFICANT 

ENFORCEMENT 

ACTIONS 

 PAGE 8

SELECTED FEDERAL 

REGISTER NOTICES 

 PAGE 9

TO OUR READERS 

 PAGE 9

Licensing Decision 

for Radium-223 

Dichloride

Radium-223 dichloride (radium 223) is currently an 

investigational radiopharmaceutical undergoing clinical trials in 

the United States. The U.S. Food and Drug Administration 

has not approved the use of the substance. Algeta ASA 

(Algeta), a Norwegian drug maker, is developing radium-223 

and has plans to make it available for commercial use, pending 

approval, under a global agreement with Bayer Pharma AG 

(Bayer). The intended use for radium-223 is for the treatment 

of skeletal metastases in advanced castration-resistant prostate 

cancer. Radium-223 naturally self-targets bone metastases by 

virtue of its properties as a calcium-mimic and kills tumor cells 

by highly localized short-range alpha irradiation. Radium-223 

has the potential to be the first therapeutic radiopharmaceutical 

administered primarily for its alpha emissions. Therefore, the 

U.S. Nuclear Regulatory Commission (NRC) staff carefully reviewed 

the radiation safety aspects of the medical use of radium-223 to 

determine if the radiopharmaceutical should be licensed under 

Title 10 Code of Federal Regulations (10 CFR) Part 35, Subpart E, 

“Unsealed Byproduct Material–Written Directive Required,” 

or 10 CFR Part 35, Subpart K, “Other Medical Uses of 

Byproduct Material or Radiation from Byproduct Material.” On 

November 20, 2012, the Advisory Committee on the Medical 

Uses of Isotopes (ACMUI) submitted a report to the NRC to 

recommend the medical use of radium-223 to be regulated 

under 10 CFR Part 35, Subpart E. For NRC consideration, Bayer 

submitted data, which included responses to questions from the 

NRC staff.

In addition to the ACMUI report and data supplied by Bayer, the 

NRC staff reviewed technical information obtained during meetings 

and other correspondences with Bayer and Algeta representatives. 

The NRC staff learned that unit dosages of radium-223 will be 

shipped to clinical trial sites from Algeta’s manufacturing facility in 

Norway. Bayer indicated that in the future multidosage vials may 

be shipped to the United States for commercial distribution to 

medical use licensees. The current methods of distribution preclude 

the need for medical use end users to manipulate radium-223. 

Continued on page 2

OFFICE OF FEDERAL & STATE 

MATERIALS & ENVIRONMENTAL 

MANAGEMENT PROGRAMS
SPRING 2013

2

Before reaching a licensing decision, the NRC staff also discussed and evaluated issues related to such 

matters as activity measurements, contamination surveys, long-lived contaminants, radon volatility, 

patient release criteria, training, available dosimetry information, and administrative procedures.

Based on available information, the NRC staff agreed with the ACMUI recommendation and 

determined that licensing under 10 CFR Part 35, Subpart E is appropriate because the medical 

use of radium-223 is similar to other commonly used beta and photon-emitting therapeutic 

radiopharmaceuticals. The staff also has determined that under current regulations, physicians authorized 

under 10 CFR 35.390, “Training for Use of Unsealed Byproduct Material for which a Written Directive Is 

Required,” or 10 CFR 35.396, “Training for the Parenteral Administration of Unsealed Byproduct Material 

Requiring a Written Directive,” can be authorized for the medical use of radium-223.

If the NRC becomes aware of future developments related to the production, distribution, or medical 

use of radium-223 that may negatively impact radiation safety, then the NRC staff may evaluate the 

information and provide a revised decision. 

(Contact: Ashley Cockerham, FSME, 240-888-7129 or Ashley.Cockerham@nrc.gov)

UPDATE ON REVISIONS TO THE 

RADIATION PROTECTION REGULATIONS 

The NRC staff is continuing the process of engaging stakeholders during the development of the 

regulatory basis for possible revisions to the NRC’s radiation protection regulations contained 

in 10 CFR Part 20, “Standards for Protection against Radiation,” and other parts of the NRC 

regulations, as appropriate and where scientifically justified, to increase alignment with international 

recommendations. The Commission is seeking to explore implications of greater alignment with the 

International Commission on Radiological Protection (ICRP) Publication 103. Given that the NRC 

regulations provide adequate protection, the discussion has been focused on discerning the benefits 

and burdens associated with revising the radiation protection regulatory framework.

After engaging a wide range of stakeholders on potential issues associated with changes to the 

radiation protection regulations in light of the 2007 ICRP recommendations, the NRC staff provided 

a set of policy and technical recommendations to the Commission on April 25, 2012, SECY-12-0064. 

In response to those recommendations, the Commission issued the staff requirements memorandum 

(SRM) on December 17, 2012, in SRM-SECY-12-0064, directing the staff to:

• Develop a regulatory basis for revisions to NRC’s radiation protection regulations to align 

10 CFR Part 20; 10 CFR Part 50, “Domestic Licensing of Production and Utilization Facilities,” 

Appendix I “Numerical Guides for Design Objectives and Limiting Conditions for Operation to 

Meet the Criterion ‘As Low as is Reasonably Achievable’ for Radioactive Material in Light-WaterCooled Nuclear Power Reactor Effluents; and other portions of the regulations with the most 

recent methodology and terminology for dose assessment.

• Revise as low as is reasonably achievable (ALARA) guidance for those licensees that could 

benefit from more effective implementation.

• Continue discussions with stakeholders regarding possible changes to the dose limit for the lens 

of the eye.

• Continue discussions with stakeholders regarding possible reduction of the dose limit to the 

embryo or fetus of a declared pregnant worker to 100 mrem (1mSv).

2 continued on page 4
SPRING 2013

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FROM THE DESK OF 

THE DIRECTOR

One of the unique things about FSME is that our regulatory 

program encompasses a broad range of issues and 

programmatic responsibilities from nuclear material safety and 

security to the Agreement State program, decommissioning, 

low-level waste, uranium recovery, rulemaking, Tribal interactions, 

and many other radioactive materials-related issues. During the 

2012-2013 fiscal year, several Commission briefings have or will 

focus on many of FSME’s areas of interest. 

FSME kicked off the fiscal year with our business line briefing. 

What is a business line, you ask? Recently, the NRC has 

moved from budgeting resources solely by office to a more 

collaborative business line model in which all budgetary 

interfaces associated with a specific regulatory area are linked. 

Under this model, FSME is the lead for two business lines: 

(1) Nuclear Materials Users and (2) Decommissioning and 

Low-Level Waste. Last October, FSME, along with our business 

line partners in the Offices of Nuclear Regulatory Research, 

Nuclear Security and Incident Response, General Counsel, 

and the regions, led a Commission briefing that provided a 

strategic programmatic overview of our two business lines. The 

overview included the expected priorities, near- and longerterm projections and trends, and emerging focus areas for each 

business line. We will give this briefing to the Commission on 

an annual basis.

In December 2012, the Advisory Committee on Reactor 

Safeguards (ACRS) held its annual Commission briefing. The 

ACRS commented on two topics that could be of interest 

to our licensees: (1) the revision of 10 CFR Part 20 for 

conformance with the 2007 International Commission on 

Radiological Protection (ICRP) recommendations, and (2) the 

economic consequences associated with the unintended release 

of licensed nuclear material to the environment. The ACRS 

letters on these topics appear in the Agencywide Documents 

Access and Management System (ADAMS) under Accession 

Nos. ML12289A915 and ML12317A004, respectively.

In January 2013, the Commission held a briefing on public 

participation in NRC’s regulatory decisionmaking. This 

Commission briefing discussed several topics of interest to 

FSME’s stakeholders, Federal partners, and the Tribal Nations, 

including the effectiveness of Webstreaming, teleconferencing, 

and other tools, 10 CFR 2.206, “Requests for Actions under 

the Subpart,” petitions for enforcement action process, the 

rulemaking petition process, and the NRC’s interactions with 

States and Tribes. Clearly, the Commission wants to actively 

engage the public and licensees to hear various viewpoints as 

part of its decisonmaking. 

In February 2013, FSME conducted a briefing on uranium 

recovery, which included a diverse external panel with 

representatives from the U.S. Environmental Protection Agency, 

Department of the Interior, U.S. Geological Survey, Wyoming 

Department of Environmental Quality, Oglala Sioux Tribe, 

National Mining Association, and Natural Resources Defense 

Council. In April 2013, the Organization of Agreement States 

and the Conference of Radiation Control Program Directors 

will take their seats before the Commission. We also are 

actively planning the NRC’s annual Agency Action Review 

Meeting; during which NRC senior managers meet to discuss 

NRC licensee performance and evaluate the process used by 

the agency to ensure the operational safety performance of 

licensees. 

Although the Commission agenda for the rest of 2013 is not 

yet finalized, the current draft includes a number of other 

FSME-related topics. Many of the briefings may include external 

stakeholders, including licensee representatives. Whether you 

hold an NRC or Agreement State license, I am certain that 

one or more Commission meetings have, or will, cover a topic 

of interest to you. Besides Commission meetings, the FSME 

staff is very willing to set up public meetings and support 

courtesy “drop-in” visits when you are in the area. We want 

to hear from you! If you missed a Commission meeting that 

is of interest, the transcript and meeting materials (dating back 

to 1996!) are posted on the NRC public Web site. Until next 

time...

Mark Satorius, Director
SPRING 2013

4 continued on page 5

• Continue discussions with stakeholders on alternative approaches to improve individual 

protection and reduce future exposures to workers at, or near, the current dose limits, to 

address concerns about the cumulative risk incurred through exposures over multiple years.

• Improve reporting of occupational exposure by the NRC and Agreement State materials 

licensees and some medical occupations into the NRC Radiation Exposure Information and 

Reporting System.

The Commission disapproved the following:

•The staff’s recommendation to develop a regulatory basis to reduce the occupational total 

effective dose equivalent limit from 5 rem (50 mSv) per year to 2 rem (20 mSv) per year.

•The elimination of traditional units of exposure from the NRC regulations. Both traditional and 

international units should be maintained.

As the regulatory basis is developed, the NRC staff will coordinate and conduct extensive 

discussions with other Federal and State government partners; the regulated community; and the 

public on the policy issues described above. The NRC staff looks forward to hearing from you 

during this period of regulatory basis development. The planned completion date for the regulatory 

basis is December 2015.

More information on the revisions to the NRC’s radiation protection regulations and guidance can be 

accessed at http://www.nrc.gov/about-nrc/regulatory/rulemaking/potential-rulemaking/opt-revise.html.

(Contact: Cindy Flannery, FSME, 301-415-0223 or Cindy.Flannery@nrc.gov)

THE NRC’S AGREEMENT STATE 

PROGRAM VERSUS STATE LIAISON 

OFFICER PROGRAM

Below are some facts about essential and collaborative NRC programs, the Agreement State 

(AS) Program and the State Liaison Officer (SLO) Program. 

Agreement State Program State Liaison Officer Program

Section 274 of the Atomic Energy Act (AEA) 

of 1954, as amended, provides for a special 

Federal-State regulatory framework for 

the control of byproduct, source and small 

quantities of special nuclear material. 

Section 274 of the AEA of 1954, as amended, 

recognized that State governments have 

an interest in nuclear energy activities 

and directed the Commission to establish 

programs for cooperation with the States.

By signing an agreement with a State, the 

NRC relinquishes its authority over byproduct 

materials (radioisotopes); source materials 

(uranium and thorium); and certain quantities 

of special nuclear materials, as long as the State 

program is adequate to protect public health 

and safety and compatible with the NRC’s 

program.

The NRC’s responsibility is to license and 

regulate the nation's civilian use of byproduct, 

source, and special nuclear material. The 

NRC’s regulatory areas cover reactors, 

materials, and wastes. The States are 

responsible for informing and protecting 

citizens in the event of an emergency. 
SPRING 2013

5

Agreement State Program State Liaison Officer Program

The AS Program was established with the 

passage of the 1959 amendment to the AEA. 

On March 26, 1962, the first agreement was 

signed with Kentucky.

In 1976, the SLO Program was established, 

as a result of recommendations from several 

State organizations, including the National 

Governors Association.

The NRC has entered into agreements with 

37 states. Presently, these 37 Agreement 

States regulate approximately 20,000 

radioactive material licensees.

Each State Governor appoints an individual to 

serve as the SLO, and that person functions as 

the primary communication channel between 

the State and the NRC. There are 51 SLOs 

in total, one for each of the States plus the 

Commonwealth of Puerto Rico.

The NRC’s Regional State Agreements 

Officers (RSAOs) were created in each region 

with materials program responsibilities to 

serve as the primary contact between the 

NRC and Agreement States.

The NRC’s RSAOs are the main points of 

contact for the SLOs, and they maintain 

regular communications with their State 

counterparts.

Under the AS Program, the NRC provides 

assistance to those States interested in 274b 

Agreements, conducts training courses and 

workshops, evaluates technical licensing and 

inspection issues from Agreement States, 

evaluates State rule changes, and provides early 

and substantive involvement of the States in 

NRC rulemaking and other regulatory efforts.

The SLO Program covers all NRC’s program 

areas of interest to the States. The NRC 

strives to establish cooperation relationships 

with the SLOs and keep them appropriately 

informed and engaged on relevant NRC 

activities.

FSME’s Agreement State Program Branch has 

the overall responsibility for the AS Program 

including the management of the Integrated 

Materials Performance Evaluation Program 

(IMPEP).

FSME’s Intergovernmental Liaison Branch has 

the overall responsibility for the SLO Program 

and has many resources available to serve the 

entire agency.

Under Section 274 of the AEA of 1954, as 

amended, the NRC retains authority for 

ensuring that AS Program provides adequate 

protection of public health and safety. As such, 

the NRC established and implements IMPEP to 

evaluate the NRC’s materials and AS Program 

and determine its adequacy to protect public 

health and safety and its compatibility.

The NRC and the States have complementary 

responsibilities for protecting public health 

and safety and the environment. The NRC 

respects States’ interest in nuclear energy 

activities and views cooperative relationships 

with States to be essential in accomplishing the 

agency’s mission.

For information about the AS Program, please 

visit: http://nrc-tp.ornl.gov/rulemaking.html 

or contact: Duncan White, Branch Chief, 

Agreement State Programs Branch, 

301-415-2598 or Duncan.White@nrc.gov.

For more information about the SLO Program, 

please visit: http://www.nrc.gov/aboutnrc/state-tribal/fst-liaison.html or contact: 

June Cai, Senior Liaison Project Manager, 

Intergovernmental Liaison Branch, 

301-1415-5192 or June.Cai@nrc.gov.
SPRING 2013

6

POST-INVESTIGATION ALTERNATIVE 

DISPUTE RESOLUTION

The NRC’s alternative dispute resolution (ADR) program is expanding the scope 

of post-investigation ADR for a 1-year pilot period. For purposes of discussing this 

expansion, it is necessary to distinguish between early ADR and post-investigation 

ADR. In early ADR, a licensee or contractor engages in mediation with its employee; 

whereas, in post-investigation ADR, the NRC engages in mediation with the subject of 

a potential enforcement action.

The scope of the current post-investigation ADR program is limited to discrimination 

and other wrongdoing cases after the NRC’s Office of Investigations has completed 

an investigation that concludes that discrimination or other wrongdoing occurred. The 

ADR pilot program will expand the scope of post-investigation ADR to include all 

escalated nonwillful (traditional) enforcement cases with proposed civil penalties. The 

pilot program will not include violations associated with findings assessed through the 

Reactor Oversight Program (ROP). 

Since its implementation, the staff has evaluated the NRC’s use of ADR in its 

enforcement program and found it to be effective, timely, and generally positively 

viewed by both internal and external stakeholders. The NRC’s use of ADR has 

resulted in opportunities for improving public safety by including broader and more 

comprehensive corrective actions in the resultant agreements than might have been 

achieved through the traditional enforcement process. 

A December 16, 2010 tasking memorandum, “ADR Implementation and Assessment” 

(ADAMS Accession No. ML12030A228), raised the question of whether to 

expand the ADR program. In response to this memorandum, the NRC published a 

Federal Register notice (FRN), (76 FR 64124; October 17, 2011), to solicit views on 

various aspects of the ADR program, including whether it should be expanded. On 

November 8, 2011, the NRC staff held a public meeting during which both internal 

and external stakeholders expressed support for the expansion of the ADR program 

to the extent possible. 

In the November 28, 2012, SECY-12-0121, “Status Update, Tasks Related to Alternative 

Dispute Resolution in the Allegation and Enforcement Programs,” the staff informed 

the Commission of its intent to expand the post-investigation ADR program. The staff 

offered the expansion as an option for escalated nonwillful (traditional) enforcement 

cases with proposed civil penalties for a 1-year pilot period. The FRN on the pilot 

program should be published in March 2013.

(Contact: Maria Schwartz, OE, 301-415-1888 or Maria.Schwartz@nrc.gov)
SPRING 2013

7

DECOMMISSIONING WORKSHOP

The FSME Reactor Decommissioning Branch and the International Atomic Energy Agency 

(IAEA) Decommissioning and Remediation Unit held a Research Reactor Decommissioning 

Demonstration (R2D2) Project Workshop on December 3-7, 2012 in Buffalo, NY. The R2D2 

Project is an ongoing IAEA program to assist developing countries in decommissioning shutdown 

research reactor facilities. The workshop was entitled “Workshop on Project Management – 

Decommissioning Dismantling,” and was hosted by the State University of New York at Buffalo 

(UB) at its Buffalo Materials Research Center (BMRC). 

Participants from 10 countries–Argentina, Brazil, Egypt, Indonesia, Libya, Malaysia, the Philippines, 

Romania, Serbia, and Vietnam–attended the 5-day workshop. The participants were employed by 

regulatory agencies and reactors in their countries.

The workshop included technical presentations on the U.S. research reactor (RR) 

decommissioning process, the current status of the UB RR decommissioning, case studies on 

six U.S. RR decommissioning projects, and IAEA decommissioning standards and activities. 

Additionally, Mark Roberts, Senior Inspector from NRC Region I, made a presentation on the 

decommissioning research reactor inspection process.

The week’s activities included practical exercises at the BMRC facility that allowed participants to 

observe actual decommissioning work, such as the following: 

• dismantling and demolishing of a former electronics room

• dismantling of a ventilation rabbit hood

• performing radiological characterization surveys

• removing and dismantling of reactor pool components 

The participants provided oral presentations on their observations of the practical activities.

On the subject of project management, participants held a significant discussion on the roles and 

responsibilities of the regulator, operator or licensee, and the decommissioning contractor. The 

discussion focused on the responsibility for safety and compliance with requirements, stop work 

authority, contracting instruments and decommissioning costs and schedules.

Finally, the participants were able to attend and observe a public meeting sponsored by the 

university to discuss BMRC decommissioning. UB staff members presented the decommissioning 

plan, NRC and NY State regulatory approval processes, oversight and inspection, the final release 

of the site for unrestricted use and the license termination process. Their presentation included an 

overview of the decommissioning activities, demolition and schedule. Participants observed the 

interactions with the public including an extensive question and answer session. 

The R2D2 workshop concluded with very positive feedback from participants and university hosts. 

(Contact: Theodore Smith, FSME, 301-415-6727 or Theodore.Smith@nrc.gov)
SPRING 2013

8

SIGNIFICANT ENFORCEMENT 

ACTIONS

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

Department of the Army (EA-12-014)

On April 5, 2012, the NRC issued a Notice of Violation to the Department of the 

Army (Army), for a Severity Level III violation. The violation involved the Army’s failure 

to provide a radiation monitor that was equipped with personnel access door locks 

to prevent access to the radiation room of the panoramic irradiator at the Redstone 

Arsenal facility, when radiation levels were high, as required by 10 CFR 36.23(c), 

“Access Control.” Specifically, from September 24, 1996 to February 17, 2012, the 

Army’s radiation room personnel access door was not integrated with the radiation 

monitor to prevent the door from opening when radiation levels were high.

Cambridge Isotope Laboratories, Inc., Andover, MA (EA-12-177)

On October 31, 2012, the NRC issued a Severity Level III Notice of Violation (NOV) 

to Cambridge Isotope Laboratories, Inc. (CIL). The violations involved CIL’s failure 

to adhere to the regulations in 10 CFR 110.20, “General License Information,” and 

10 CFR 110.24, “General License for the Export of Deuterium.” Between 2007 and 

2011, CIL did not file an application with the Commission for specific export licenses 

to export deuterium, a material subject to NRC licensing jurisdiction in accordance 

with 10 CFR 110.9, “List of Nuclear Material under NRC Export Licensing Authority,” 

when exporting this material in excess of the quantities covered by the general license 

requirements of 10 CFR 110.24. During this time, CIL exported deuterium in: 

(1) excess of the 200 kilogram (kg)/year limit set by 10 CFR 110.24(a) to China and 

Japan in the years 2010 and 2011, and (2) excess of the 5 kg/year limit set by 

10 CFR 110.24(b) to restricted destinations per 10 CFR 110.29, “Restricted 

Destinations,” of India and Israel, in the years 2007-2011, without applying for and 

obtaining NRC specific licenses.

Detector Electronics Corporation, Minneapolis, MN (EA-12-181)

On October 19, 2012, the NRC issued a Notice of Violation to Detector Electronics 

Corporation for a Severity Level III violation. The violation involved the failure to 

obtain a specific authorization to export byproduct material to Iraq, an embargoed 

country, as required by 10 CFR 110.20(a), “General License Information;” 

10 CFR 110.23(a), “General License for the Export of Byproduct Material;” 

10 CFR 110.5, “Licensing Requirements;“ and 10 CFR 110.28, “Embargoed Destinations.” 

Specifically, on April 20, 2007, September 25, 2009, December 21, 2010, and 

June 24, 2011, the licensee exported flame detectors with electron tubes containing 

krypton-85 to Iraq, an embargoed destination, and did not have a required specific 

authorization to export byproduct material to Iraq.

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)
SPRING 2013

9

SELECTED FEDERAL REGISTER NOTICES

January 8, 2013 

78 FR 1155, Low-Level Waste Disposal, (Proposed Rule - Regulatory basis and preliminary rule 

language; second request for comment; correction)

Contact: Andrew Carrera, FSME, 301-415-1078 or Andrew.Carrera@nrc.gov

TO OUR READERS 

In our attempt to keep the FSME Licensee 

Newsletter relevant, we welcome feedback on 

the contents of the newsletter. If you would like 

to suggest topics, please contact Vanessa Cox, of 

the FSME Rulemaking and Project Management 

Branch by phone at 301-415-8342 or by 

e-mail at Vanessa.Cox@nrc.gov. In addition, to 

ensure proper delivery of the FSME Licensee 

Newsletter and to prevent any interruption of 

service, please report any 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