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Viewgraphs Entitled, Us NRC: Function, Framework, Alternative Technologies (Follow-up Information)
ML21022A079
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Issue date: 02/05/2021
From: Margaret Cervera
NRC/NMSS/DMSST/SMPB
To:
The National Academies of Sciences, Engineering and Medicine
Cervera M, NMSS/MSST
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Slide 1 United States Nuclear Regulatory Commission:

Function, Framework, Alternative Technologies (follow-up information)

Margaret Cervera Source Management and Protection Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Materials Safety and Safeguards Good morning. My name is Margaret Cervera and Im a health physicist and security specialist in the source management and protection branch of the US Nuclear Regulatory Commission. In January of this year I presented to the Committee about the NRCs regulatory function, protection framework, and involvement in various alternative technologies activities, and was asked back to provide some follow-up information.

Slide 2 Questions The Committee provided a list of questions for NRC that encompassed seven broad areas:

1. NRC actions in response to the 2008 NAS study
2. Cost effectiveness determination of requirements
3. The Integrated Source Management Portfolio: the National Source Tracking System (NSTS), the Web-based Licensing system (WBL), and the License Verification System (LVS)
4. Category 3 source control
5. Financial responsibility for disposition
6. Operating experience with lost, abandoned, and stolen sources
7. Regulatory authority in the transportation sector On behalf of the committee Charles and Rania provided the NRC with a list of questions that I determined encompassed seven general areas. In the interests of clarity and time I tried to keep each area to a single slide. There will be a lot of information but I think we have plenty of time. For this presentation I will stop between each slide topic and allow for discussion from the Committee.

Slide 3

1. 2008 NAS report recommendations Recommendation 2: the U.S. NRC should consider radiation sources potential to cause contamination of large areas resulting in economic and social disruption (area denial) to determine what, if any, additional security measures are needed.

Recommendation 3: the U.S. government should implement options for eliminating Category 1 and 2 cesium chloride sources from use in the United States and, to the extent possible, elsewhere. The committee suggests these options as the steps for implementation:

  • Put in place incentives for decommissioning existing sources.
  • Prohibit the export of cesium chloride sources to other countries, except for purposes of disposal in an appropriately licensed facility. Commission Policy Statements As you are likely aware the Committee made recommendations in the 2008 report. For today I was specifically asked to address two: recommendations 2 and 3. For each recommendation some additional questions were posed and I will address them as well.

Around the time that the final NAS report was issued the NRC had already issued security orders to licensees and was embarking on rulemaking to make generically applicable security requirements. Coincident and in response to recommendations made in the report, the NRC also conducted a number of activities to determine what the best path for control of particularly cesium-137, was. This included investigating the potential of alternative forms of cesium - both from a production standpoint as well as evaluating the potential risk reduction that could provide. The end result of this effort was the Policy Statement of the U.S. Nuclear Regulatory Commission on the Protection of Cesium-137 Chloride Sources published in 2011.

The development of the policy statement was a process that encompassed extensive stakeholder outreach that included solicitation of public comments and multiple public meetings around the country. This statement of policy still stands to delineate the Commissions expectations for security and safety of these sources, readiness to issue additional security requirements if justified by threat, and recognition that disposal capability for all radioactive materials is needed. The QR code will take you to the NRCs public website for all statements of policy.

Further questions posed by this committee relevant to this recommendation are Has the USNRC considered changing its categorization system of radiation sources to consider risks other than deterministic health effects, such as socioeconomic risks? AND Has the USNRC conducted security analyses of the facilities licensed to use Cat 1 and Cat 2 sources to examine factors other than potential deterministic health effects?

The short answer to both questions is yes. Multiple times since about 2003 the NRC has both acknowledged the potential socioeconomic impacts of malicious use of radioactive material as well as evaluated facility vulnerability and, as I discussed the last time I briefed the committee, continually consider the threat of malicious use in the United States, via our cooperation and coordination with the law enforcement and intelligence communities. Today, the NRC bases the safety and security framework on prevention of direct radiation effects - that is, on the prevention of deterministic health effects, extended to stochastic effects through contamination that would result in a dose of 2 rem in the first year after an event that covered an area of 1 square kilometer. Note that this assumed event does not make an area uninhabitable, and the avoidable dose is less than half of the occupational dose limit applicable to radiation workers throughout the United States, but it is the level for which relocation should be considered for a population in an area while decontamination or mitigation is conducted. For the prevention and mitigation of other consequences, such as emotional distress and economic disruption, the NRC cooperates in the wider all-hazards preparedness and response activities of the United States, that is the mission of the Department of Homeland Security.

Recommendation 3 included suggestions for specific options for the elimination of cesium-137 sources both domestically and internationally. Although neither the NRC nor the Agreement States have discontinued licensing, consistent with the Policy Statement of the U.S. Nuclear Regulatory Commission on the Protection of Cesium-137 Chloride Sources if necessary the NRC can and will issue binding additional requirements to licensees.

The NRC and Agreement States will issue a license, consistent with agency authority and mission, if an applicant can demonstrate that the material will be used safely and securely.

While applicants may be asked if they have considered non-isotopic alternatives for their application, licensing does continue. Remember, as I stated in my previous presentation to the committee, the NRC does not promote any technology - isotopic or non-isotopic - and thus does not put in place incentives either to encourage or discourage use - unless you would consider regulations to be an incentive.

Specific committee questions related to this recommendation were How many new licenses were issued the past 5 years for CsCl irradiators in the United States? AND How many cesium chloride sources have been exported over the past 5 years?

Im going to talk about the source of this data shortly, and note that I am not answering the specific question asked, but since 2015 across the US there have been 16 licenses either granted or that added discrete sources of cesium-137 at or above category 2. These licensees may or may not be new and may be using the sources for irradiation of blood/research/material, or dose calibration.

Licensees must provide advanced notification of import and export of radioactive material that meets or exceeds the thresholds in 10 CFR Part 110, Appendix P - which is the same as the table as exists in 10 CFR Part 37 for domestic security requirements - or at lower activity levels for which advanced notification is a license condition. These notifications are made to the NRCs Headquarters Operations Officers or HOO that are also the agencys emergency watch standers.

From that reporting, over the same period since 2015 there have been 23 exports of cesium.

One of them was an irradiator in 2015, the remainder were either irradiator returns to a manufacturer or devices for industrial use and thus may have been required due to other isotopes in the shipment or because of a license condition. Unless they are made due to a license condition these notifications are based upon total activity not number of discrete sources or modality of use.

Slide 4

2. Integrated Source Management Portfolio ISMP home page May 2020 cat 1: 93% cobalt-60 category 2: 85% cobalt-60 The source of much of the data that the NRC and the Agreement States maintain on licensees and radioactive sources in the United States is contained in the systems that comprise the Integrated Source Management Portfolio or ISMP. These systems are the National Source Tracking System (NSTS), the Web-Based Licensing (WBL) System and the License Verification System (LVS). The integration of these systems form a comprehensive program to support the safety and security of radioactive material.

Briefly, the individual systems that comprise the ISMP perform the following functions:

  • NSTS: is a highly secure, accessible and easy-to-use IT system that accounts for category 1 and 2 radioactive sources from the time they are manufactured or imported through the time of their disposal or export, or until they decay below category 2. All licensees, whether of the NRC or an Agreement State, must report their category 1 and 2 sources to NSTS.

Additionally, NSTS, as the national registry of the United States, contains information on discrete sources held by the Department of Energy.

  • WBL: is an up-to-date electronic repository of all licenses for possession of category 2 or greater quantities of radioactive material nationwide, a web-based license system for NRC licenses, and an avenue for Agreement States to use the same licensing and information platform as the NRC. Designed to maintain information on materials licensees, WBL supports the entry of licensing information and license images that enables the NRC and Agreement States to manage the licensing life cycle from initial application through license issuance, amendment, reporting, and termination, as well as inspection and enforcement history. WBL is capable of supporting licensing for the NRC and all Agreement States; states

choose for themselves whether to utilize WBL for licenses other than those for category 1 or 2 possession.

  • LVS: Helps ensure that only authorized licensees obtain radioactive materials in authorized amounts by brokering information stored in the WBL and NSTS. Therefore, LVS enables authorized licensees to confirm for category 1 and 2 sources that (1) a license is valid and accurate and (2) a licensee is authorized to acquire the quantities and types of radioactive materials being requested.

Together, the ISMP provides the following benefits to support the National Materials Program :

  • Make national radioactive source authorization, possession, and transaction information available to other government agencies with a role in protecting the United States from nuclear and radiological threats.
  • Provide licensees with a secure automated means to verify license information and possession authorization prior to initiating radioactive material transfers.
  • Enable the NRC to monitor the location, possession, transfer and disposal of risk significant radioactive sources throughout the Nation.
  • Improve source accountability, and alert regulators to tracking discrepancies.
  • Modernize the NRC's licensing and inspection management systems.

The committee requested information on accessing data from NSTS as well. The NRC does provide snapshots of data to other entities based upon very specific and documented technical need, a demonstrated need-to-know, and an acceptable use agreement. Examples of this are data provided to NNSA Office of Radiological Security to help support their program efforts, and data supplied to DHS FEMA to support response and mitigation efforts to prepare for severe weather like when Atlantic hurricanes threaten the US mainland or Puerto Rico. to impact Puerto Rico, south Florida, and/or the U.S. Gulf or East Coasts. For example, during hurricane On the previous slide I provided information on the estimated added numbers of licenses for cesium sources. I did not provide the number of licenses issued for new irradiators. This is because the data in NSTS is of discrete sources, not by device or use, and the data in WBL is by total possession, again not by device. Determination of the number of devices would require access to both NSTS and WBL to match up discrete sources with possession limits and authorized uses. Doing so would be very resource intensive and the NRC has determined its best to focus resources on activities that provide safety and security benefit which is accounting for the source itself, not the device. I will mention that NRC is working with NNSA to determine the numbers and trends of cesium irradiators over the past 10 years, but that data is not available yet.

Slide 5

3. Cost Effectiveness Regulations.gov Part 37 Final Rule The average licensee will have a one-time cost of approximately $23,375 and an annual cost of approximately $21,736 to fully implement the final rule. The NRC believes that the selected alternative reflected in the final rule is the least burdensome, most flexible alternative that accomplishes the NRCs regulatory objective Please provide information on the costs to the licensees for complying with security requirements posed for facilities that host Cat 1 and Cat 2 sources.

How does the NRC balance the cost of source security versus the cost of potential harm from unsecured sources?

The committee asked for specific information on the cost-benefit analysis that the NRC uses to estimate the costs of establishing and sustaining 10 CFR Part 37. As a reminder, Part 37 was preceded by a series of security orders that were issued to licensees - those orders had not gone through this process. The orders were issued quickly to ensure adequate protection of the common defense and security - since this regulatory action was necessary to assure adequate protection, NRC took that action without consideration of cost. However, in cases where regulatory action would have a benefit but is not needed for adequate protection, we do consider the cost of implementation with an aim to quantify how much added protection is provided by the proposed regulation and alternative options. For Part 37 the requirements are intended to provide reasonable assurance of preventing the theft or diversion of risk-significant radioactive material. These requirements provide the Commission with reasonable assurance that public health and safety and the common defense and security continue to be adequately protected.

In my last presentation to the committee I showed the slide on the left side, Ive included it here as a refresher, where the red circles are explicit locations for Commission direction. At any of these points, or any other time for that matter, we could be redirected or the rulemaking could be denied outright. The staff cannot revisit issues that have been adjudicated without explicit Commission permission to do so - that is, like a child asking different parents trying to get the desired answer, we cannot Commission shop to get different answers.

The 10 CFR Part 37 rulemaking process included determining whether the incremental benefit of the proposed rule, above the protection in place already from the orders was sufficient and justified by the costs to implement it. This was because the regulation was not simply codifying the orders, new requirements were added and some things changed.

For the formal rulemaking process for 10 CFR Part 37 a cost analysis was prepared as part of the regulatory analysis, and this product was available for public comment. The NRC conducted a point estimate of the costs to implement Part 37. This included estimating, for a small, medium, and large facility, how many personnel would be subject to the access authorization program, what facility modifications would be necessary, what plans and procedures would need to be developed, by whom, and how long that would take, and THE types and costs of procurements, for any activities required by the rule. Since there were orders in place prior to Part 37 these estimates were performed assuming a new facility starting from scratch as well as a facility who had already been implementing the orders and for which many costs were already committed or sunk.

The estimates considered implementation and recurring costs throughout the assumed facility licensing lifetime and utilized multipliers from the Bureau of Labor Statistics to determine personnel costs.

Beginning in 2014 the NRC process for conducting these analyses included sensitivity analysis on the point estimates in an effort to improve the cost estimates provided for rulemaking.

Other than the formal retrospective review of regulatory cost estimates conducted for nuclear facilities that specifically led to this change in how cost estimates are calculated, there is no going back and redoing estimates for past rulemaking. I mention that because while the conclusion on costs that I included here is often cited as being both too high and too low it perfectly describes the difficulty in framing the costs and the benefits of any rulemaking of any regulatory agency.

Slide 6

4. Category 3 Source Control Considerations 2003 2006 2008 2014 2016 The IAEA Data Consider Program Category Code of collection: expansion Review of 3 Source Conduct category 3 of new 10 CFR Security revision sources NSTS to Part 37 and and include Accountab DOE/NRC category 3 ility Re-RDD and 1/10 Evaluation report category 3 developed sources Program Review home page C3WG home page Can the USNRC provide information on any assessments it may have done to include cat 3 sources in the NSTS? What types of comments did the agency receive following the 2017 public meeting on the topic?

Can you comment on the challenges, including costs of requiring category 3 sources to be included in the NSTS?

What level of regulatory involvement does the NRC feel is appropriate for category 3 sources (e.g. should vendors have to confirm through regulators the license and licensee are legitimate prior to shipping a source?)

The committee asked for information on assessments performed on the possible inclusion of category 3 sources in NSTS, and for license verification prior to sales.

First I will reiterate that multiple evaluations have been conducted, beginning in 2003 with the revision of the IAEA Code of Conduct on the Safety and Security of Radioactive Sources and the development of the DOE/NRC RDD report and most recently with the work of the Category 3 Source Security and Accountability Working Group (C3WG), to determine what isotopes and at what thresholds warrant specific protection levels. Additionally, within the construct of the Radiation Source Protection and Security Task Force, it is the responsibility of the Radiation Sources Subgroup to evaluate certain indicators and make a recommendation to the Task Force agencies whether or not information exists that justifies changes to the previously published Task Force lists and thresholds.

This slide shows some activities that have occurred over the years relative to category 3 sources but Ill focus on the most recent exercises in order to answer the specific questions posed by the committee.

In 2008 the NRC considered the inclusion of category 3 sources and a subset of category 4 sources in the just-established National Source Tracking System. At that time, the stated prime basis for this was based on the inclusion of category 3 sources in the Code of Conduct that it was reasonable to include them in NSTS. It was estimated, from a one time data collection, that the inclusion would add NSTS reporting requirements to approximately 1000 licensees -

or almost double the number currently required to report to NSTS. At that time discussion also encompassed possibly Including sources at 1/10 of category 3, a subset of category 4, and this was estimated to likely double again the number of obligated licensees.

Rulemaking was conducted to include sources other than category 1 and 2. Almost all of the comment letters on the proposed rule were opposed to expanding the NSTS as proposed for the following reasons:

1) That the rule was premature and should be delayed to allow time to refine the burden estimates in the regulatory analysis using actual experience from the operational NSTS for Category 1 and 2 sources;
2) That the NSTS should be fully operational and successfully tracking Category 1 and 2 sources before the NRC adds a potentially significant number of Category 3 and Category 4 sources to the system; and
3) That there needed to be additional justification of the security risks posed by these sources before incurring additional burden of accounting for them from production to disposal.

Both the Organization of Agreement States and the Conference of Radiation Control Program Directors submitted that the final rule was premature and should be delayed. All 26 comments from States, except one, were opposed to the NSTS expansion final rule. Most of the letters cited a risk that implementing the rule would have shifted limited personnel resources away from more near-term and tangible health and safety aspects of radiation protection.

Ultimately the Commission was unable to reach a decision on the proposed rulemaking to include Category 3 sources in NSTS. Therefore, the proposed action was not approved.

In 2014 the NRC was required, via legislative mandate, to evaluate the effectiveness of the requirements of 10 CFR Part 37 and determine whether the requirements provided adequate protection. According to the legislation the evaluation needed to consider inspection results and event reports from the first two years of implementation of the requirements in 10 CFR Part 37 for NRC licensees. That report, the Program Review of 10 CFR Part 37, was issued to Congress in December 2016. To do a fulsome review though the Program Review Team expanded the evaluation beyond the two criteria specified.

In totality, the "program review" assessed nine areas related to the implementation of the rule:

  • Analysis of 10 CFR Part 37 inspection results from the first years of rule implementation;
  • Review of events from the Nuclear Material Events Database and Security Incident Database;
  • Evaluation of the 10 CFR Part 37 trustworthiness and reliability program;
  • Consideration of the definition of aggregation, especially as it applies to category 3 well logging sources;
  • Assessment of the adequacy of the materials security training program for NRC and Agreement State inspectors;
  • Evaluation of enhanced tracking and accounting of radioactive sources;
  • A comparison to identify and evaluate differences between NRC requirements and international regulations, standards, and guidance (including the IAEA and a selection of other countries);
  • Assessment of separate, independent aspects of 10 CFR Part 37 by three external independent assessment consultants; and
  • Consideration of comments, questions, and recommendations made during stakeholder outreach efforts.

During the review we considered whether the scope of 10 CFR Part 37 - that is category 1 and 2 - was appropriate given the threat, vulnerability, and consequence assessments of the time.

The assessment showed that the requirements in Part 37 are effective in ensuring the security of risk-significant radioactive materials during use, storage, and transport when implemented appropriately by licensees, while identifying a number of implementation issues due to licensees' incomplete understanding of differences between requirements in the rule and requirements in the Orders.

Most recently, the Commission directed a specific evaluation of the regulatory framework for category 3 sources. The Commission included in their direction a list of 9 tasks that the staff grouped into four main concerns. These concerns included some previous GAO observations.

List of specific tasks:

  • Evaluation of pros and cons of different methods for verification of licenses validity
  • Evaluation of pros and cons to include Category 3 sources in NSTS
  • Assessment of any additional options for addressing GAO recommendations on source accountability
  • Vulnerability assessment
  • Regulatory impact analysis of benefits and costs of any recommended changes
  • Discussion on potential actions that do not require regulatory changes and monitoring their implementation through the Integrated Materials Performance Evaluation Program (IMPEP)
  • Any other factors to help inform Commissions decision
  • Assessment of the risk of aggregation of Category 3 sources into Category 2 quantities
  • Collaboration with all affected stakeholders The four concerns were:
  • Concern 1: The ability to obtain a valid license using a fictitious company or by providing false information;
  • Concern 2: The ability to alter a valid license to obtain more or different radioactive material than authorized or to counterfeit a license to obtain radioactive materials illicitly;
  • Concern 3: The ability to accumulate or aggregate Category 3 sources to a Category 2 quantity of radioactive material requiring enhanced security; and
  • Concern 4: The limited accountability, lack of pre-licensing evaluations, and lack of routine oversight of Category 3 sources contained within generally licensed devices.

The staff made recommendations to address all the concerns, some for regulatory change some not, and all the recommendations have been submitted to the Commission. While we await Commission direction, all of the non-rulemaking activities have been completed or are continuing, and provide additional confidence that security controls are appropriate and adequate today.

Extensive stakeholder input was sought for this re-evaluation. The NRC issued a Federal Register notice with questions to elicit specific feedback, held 5 public meetings and webinars around the country and in locations convenient to specific industries including medicine and energy services to encourage participation, sent letters to affected entities to encourage feedback; published articles in periodicals; and provided presentations at meetings and conferences to increase awareness of the effort. In all the NRC received over 1,000 comments.

The majority, but certainly not all, of which opposed expansion of NSTS and LVS to include category 3 sources, stating that there was insufficient basis for or benefit to either safety or security.

A summary of the public comments binned by topic and stakeholder type is available on the NRCs public website accessible via the QR code on the slide. The summary contains information on accessing the raw comments.

A final thought on category 3 quantities of radioactive material. It may seem that because category 3 isnt included in 10 CFR Part 37 that there is no security. This is not the case at all, because the security measures exist integrated within the safety framework, and include both explicit security requirements and safety requirements that also provide a security benefit.

That is, consistent with the graded security measures described by Mr. Pacheco, Mr. Waseem, and Mr. Mansoux yesterday that are recommended by IAEA for category 3 sources, controls exist across all the requirements that a licensee must comply with, that they are inspected against, and that will be enforced. While NRC has received comments suggesting that those requirements be pulled out of existing regulations and collected into 10 CFR Part 37 or in a separate Part of regulation to make that clearer or more explicit, doing that that would not a good expenditure of resources and would yield no safety or security benefit.

Slide 7

5. Financial Responsibility for Disposition Commitments of the licensee include, but are not limited to:
  • ensuring radiation safety, security, and control of radioactive materials
  • the provision of adequate resources
  • compliance with regulations and sustaining programs to ensure that the public and workers are protected from radiation hazards Financial assurance requirements: Rulemaking proposals (2):

10 CFR 30.35 requires a fixed dollar amount 1. establish financial assurance of financial assurance or a decommissioning requirements for category 1 and category funding plan for possession of byproduct 2 disposition material with a half-life greater than 120d 2. disposal of GTCC/TRU waste in other-and at activity levels above thresholds than geologic waste facility How does the USNRC deal with financial assurance issues related to disposing of sources that lack of an avenue for permanent disposal of these sources?

During the application process for a license from the NRC or an Agreement State the applicant must sign that they both understand and acknowledge a series of commitments. Examples include that they will ensure radiation safety, security, and control of radioactive materials and will comply with regulations. Another commitment is the provision of adequate resources, including financial resources, to sustain their radiation safety and security programs. Currently, when possession limits on their license meet certain activity thresholds of radioactive material, this includes specific amounts of financial assurance and possibly a decommissioning funding plan, to ensure that disposition of radioactive material and remediation of facilities is conducted properly.

The issue is that the current financial assurance requirements are specifically for decommissioning towards license termination, and do not account for disposition of radioactive sources outside of facility decommissioning towards license termination. Thus the potential for new requirements for licensees to have some kind of financial instrument to facilitate disposal of disused sources whenever that occurs before license termination.

Therefore, today, licensees must pay for disposition out of existing funds, transfer their sources to another licensee (who could be a manufacturer or distributer), or take advantage of various programs that subsidize removal of sources from their inventory such as via the Offsite Source Recovery Program or the Source Collection and Threat Reduction program, and safely and securely store their sources in the interim.

Given that some radioactive sources cannot be disposed of within the United States the remaining option is for safe and secure storage until such time that disposal is available. The

NRC has rulemaking in process examining the potential for disposing of greater-than-class-C or GTCC - basically high activity cesium - and transuranic or TRU - plutonium or americium -

waste streams in other than a geologic waste repository. That is, opening up the potential for disposal at or deeper than the 30 m depth which is the near surface but not so deep as to be considered geologic. That rulemaking is in the very early stages.

Slide 8

6. Operating experience Figures from 2009 and 2019 Nuclear Material Events Database annual reports NMED home page Please provide an overview of the USNRCs database for lost, misplaced, and stolen radioactive sources.

What are some main conclusions about risks that one can draw from analyzing the data?

What sources are the most likely to be lost, misplaced, or stolen?

What is the process for providing information from the database to requestors? For example, could the committee receive a breakdown of number of incidents and circumstances that occurred?

Before I talk about data we keep on events, I would like to remind you, from my presentation in January, of the relevant population numbers these data come from. The NRC and Agreement States hold authority over more than 19,000 licensees, and an estimated 2 million regulated sources or devices, including more than 75,000 nationally tracked sources.

Also, a reminder that reports of any loss or theft are required at very low activity levels. For example:

Cs-137 10,000 uCi (370 MBq)

Co-60 1,000 uCi (37 Mbq)

Ir-192 1,000 uCi (37 MBq)

Am-241 1 uCi (37 kBq)

The committee asked whether specific conclusions could be drawn from these data - I would submit that while events involving mobile or portable sources and devices occur more often than events at fixed operations, overall given the total population of users, sources, and devices, that events are fairly rare and when they do occur they do not tend to result in injury to either workers or the public.

So how does this work? All reports are provided to the NRCs Headquarters Operations Officers, and go on to be published on the NRCs public website and entered into NMED which is maintained for the NRC by Idaho National Lab. NMED includes data going back to about 1990.

Annual reports from 2007 to the present are available publicly and can be accessed from the QR code and/or the image link. These reports present information on trending and analysis of all the events reported that involve radioactive material. The committee asked specifically about gaining access to events and the circumstances - that information is included in the annual reports.

The reported events are classified into categories based on event reporting requirements defined in Title 10 of the Code of Federal Regulations - that is the reporting requirements are in different parts of regulations. The categories in the annual reports are (1)

Lost/Abandoned/Stolen Material, (2) Medical, (3) Radiation Overexposure, (4) Release of Licensed Material or Contamination, (5) Leaking Sealed Source, (6) Equipment, (7)

Transportation, and (8) Other.

The majority of reports are about radioactive materials that would lie in the category 4 or category 5 range - for example, that spike in 2008 was due to a large retailer reporting missing or damaged tritium exit signs from stores around the US. But specific event information is included for events involving category 1-3 quantities of radioactive material. An important note about the data is that an event may be included in more that one category - for example a recent event where a radiography crew escaped their truck during a flash flood but the device in its overpack was recovered later much farther downstream may be reported as a LAS, EQP, and TRS for analysis purposeswe will be able to see that in the next annual report.

Other important things to understand about the data, is to be aware that well logging sources abandoned downhole are reported both as abandoned and as not recovered, and that shipments of radioactive material that are not received when expected may be reported as lost - therefore its necessary to understand that the designation of lost/abandoned/stolen isnt as simple of a designation as it may seem.

The NRC also requires, for category 1 and 2 quantities under Part 37, that licensees report suspicious activities.

Examples of suspicious activity may include, but are not limited to, the following:

  • Stated threats against the licensees facility or staff
  • Use of forged, stolen, or fabricated documents to support access control or authorization activities
  • Unusual challenges to security systems that could represent attempts to gather information on system performance or personnel or equipment response actions
  • An individual(s) conducting unapproved photographing or videotaping of licensed facilities
  • Unauthorized attempts to probe or gain access to the licensees business secrets or other sensitive information or to control systems, including the use of social engineering techniques (e.g., impersonating authorized users)
  • The unauthorized operation, manipulation, or tampering of radioactive material in quantities of concern or the unauthorized operation, manipulation, or tampering of security-related structures, systems, and components that could prevent the implementation of the licensees protective strategy Reported information is shared amongst the NRC and Agreement State officials and licensees, law enforcement and homeland security officials, and emergency response officials, allowing the community to maintain situational awareness, possibly recognize trends in suspicious activities, and depending on the report initiate other investigation or enforcement actions.

Slide 9

7. Transportation The NRC and DOT are co-regulators for the safe and secure transport of radioactive materials.

Additional coordination between DHS, NRC, and DOT for security.

The roles of the DOT and the NRC in the regulation of the transportation of radioactive materials were described in an MOU signed in 1979. The MOU NRC-DOT MOU includes development of safety standards and regulations, package review, inspection and enforcement, reporting of accidents and incidents, and information sharing.

Additional cooperation on radioactive materials transportation security is described in an MOU signed in 2015 by NRC, DOT, and DHS. The MOU NRC-DOT-DHS MOU establishes a framework to:

  • leverage mutual interests;
  • enhance communication;
  • reduce duplication of effort;
  • maximize the success of respective homeland security and civil support missions;
  • promote the standardization of approach and policy Please describe security during transportation of radioactive materials; what is the NRCs and Department of Transportations roles?

In 1979 the DOT and NRC signed a memorandum of understanding to describe and agree upon the regulatory roles of each agency. Generally, the DOT is responsible for regulating the transportation of all hazardous materials, including radioactive materials. There are 9 hazard classes of material, including Class 7 (radioactive) material). Thus, for transportation, the DOT is the lead agency, and their transportation regulations are found in 49 CFR. NRC is responsible for regulating the receipt, possession, use, and transfer of byproducts, source, and special nuclear materials. Transfer of material is usually accomplished by transporting the material.

NRC transportation regulations are found in 10 CFR Part 71. It is important to understand that NRC licensees must meet 10 CFR 71.5, which requires licensees to meet the DOT transportation regulations including for permitting for hazmat transport and development and maintenance of a transport security plan.

The security requirements of Part 37 specific to transport are in subpart D. These requirements are graded - existing safety and security requirements exist in other part of CFR, additional requirements for category 2, and then additional requirements for category 1. All requirements are consistent with DOT requirements as well.

In 2015 DOT, DHS, and NRC finalized an MOU specific to transport security. Implementation of that MOU is continuing.

IF IT COMES UP: Additionally, the NRC reviews and approves or denies package designs for fissile materials and for other radioactive materials (other than low specific activity materials) in quantities exceeding Type A limits, as defined in 10 CFR Part 71. When a material exceeds a

Type A quantity, a Type B packaging must be used. When the design of a package is approved by the NRC, the NRC issues a Certificate of Compliance for that package.

Final questions?

Slide 10 References

  • Presentation to NAS committee January 2020
  • Nuclear Regulatory Commission's Nuclear Material Events Database (NMED, includes links to annual reports spanning 2007 to current) https://nmed.inl.gov/
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