ML21022A078

Viewgraphs Entitled, Us NRC: Function, Framework, Alternative Technologies

ML21022A078
Person / Time
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
Shared Package
ML21021A360	List: ML21022A078 ML21022A079 ML21036A091
References
Download: ML21022A078 (18)

Text

United States Nuclear Regulatory Commission:

Function, Framework, Alternative Technologies Margaret Cervera Source Management and Protection Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Materials Safety and Safeguards

Topics

• Introduction to the Nuclear Regulatory Commission

• Agreement States

• Statements of Policy

• The rulemaking process(es)

• Risk-based or risk-informed

• Sources of information:

• Regulatory basis/assessment

• Safety-Security integration - the requirements

• Alternative technologies 2

Introduction to the Nuclear Regulatory Commission License and regulate the Nations civilian use of radioactive*

materials to ensure adequate protection of the public health and safety, promote the common defense and security, and to protect the environment.

~19,300 total specific licenses in the US civilian sector for use of radioactive material

• ~2,800 regulated by the NRC

• ~16,500 regulated by Agreement States

~31,000 total general license device holders

• radioactive includes byproduct, source, and nuclear materials 3

Statements of Policy Commission's general attitude or opinion on a topic

• provide a clear understanding of their expectations of how the regulated community should act in specific circumstances

• to explain clearly how the Commission and the NRC intends to conduct itself 4

The overall rulemaking process:

5

Rulemaking 6

Risk-based vs. Risk-informed What can go wrong? How likely is it? What would be the consequences?

High Probability, High Consequence. Low Probability, High Consequence.

An expedition to Mount Everest has a A skydiving accident, in which the high probability of serious parachute fails to open, can also have consequences, such as a fatal fall or severe consequences (including frozen extremities. As a result, the fatality). However, the risk is overall risk is considered to be very acceptable to many people because high. using the proper safety precautions can adequately reduce the High Probability, Low Consequence. probability of an accident. As a result, A unicyclist has a relatively high probability of the overall risk is considered to be falling. However, the consequences of such an moderate.

accident are relatively minor. The unicyclist usually lands on his or her feet or, at worst, takes a tumble. Thus, even though the probability of falling is high, the consequences are so minor that the overall risk is low.

7

Risk-based vs. Risk-informed What can go wrong? How likely is it? What are the potential consequences?

Category 1 & 2

?

and what should/can we do to prevent it?

A. Reasonable assurance of adequate Category 3 protection B. Absolute protection (zero risk) 8

What information comes in:

• Intelligence - domestic and international

• Official reports - suspicious and actual

• Studies and reports:

• Other US agencies

• NAS

• International partners (IAEA)

• Operating experience - domestic and international

• related events

• Petitions for rulemaking

• Commission direction / legislation 9

NRCs Graded Approach - 3 groups Specific

• All other radioactive and nuclear materials

• 10 CFR Part 19 Notices, instructions and reports to workers: inspection and investigations

• 10 CFR Part 20 Standards for protection against radiation General

• 10 CFR Part 21 Reporting of defects and 10 CFR Part 31 noncompliance

• Devices for detecting, measuring, gauging,

• Other applicable regulations producing light, producing an ionized atmosphere

• Inherent safety via engineering design Exempt

• Loss, theft, damage, and/or malfunction must be reported 10 CFR 30.14 - 30.22

• Cannot be abandoned

• Low concentrations of radioactive material used

• Limited scenarios for transfer, including for by the public, such as smoke detectors, marine disposal, from initial user to other compasses, watch hands, static eliminators

• No appreciable safety or security impact, therefore no requirements for users 10

NRCs Graded Approach - within the Specific License Additional explicit physical Additional control measures protection measures for specific to modalities of use. radioactive material quantities All radioactive and nuclear material Part 32: manufacture or distribute category 2 (roughly the same as that is neither exempt nor held Part 33: broad scope activities the Code of Conduct on the Safety under the general license. Part 34: industrial radiography and Security of Radioactive Includes all industrial, medical, Part 35: medical Sources) research, calibration, Part 36: panoramic irradiator manufacturing, distribution, and Part 39: well logging Enhanced physical protection accelerator-produced uses of [10 CFR Part 37]

material.

Minimum 2 independent physical Modality-based [various parts]

barriers for portable gauges Basic performance-based control measures for safety and security

[10 CFR Part 20 & 10 CFR Part 30]

11

Selected Regulations - 10 CFR Part 19 Notices, instructions and reports to workers: inspection and investigation 20 Standards for protection against radiation 21 Reporting of defects and noncompliance 32 Specific domestic licenses to manufacture or transfer certain items containing byproduct material 33 Specific domestic licenses of broad scope for byproduct material 34 Licenses for industrial radiography and radiation safety requirements for industrial radiographic operations 35 Medical use of byproduct material 36 Licenses and radiation safety requirements for irradiators 37 Physical protection of category 1 and 2 quantities of radioactive material 39 Licenses and radiation safety requirements for well logging 40 Domestic licensing of source material 61 Licensing requirements for the packaging and land disposal of radioactive waste 70 Domestic licensing of special nuclear material 71 Packaging and transportation of radioactive material 12

• Occupational and Example 1:

public exposure 10 CFR Part

• Management systems and 10 CFR Part control

• Secure material from 30: specific license oversight

• Material receipt, shipment, radiopharmacy 20: safety & unauthorized access accountability security when in use or storage Inspection focus areas:

• Security and control of material

• Maintain shielding of

• Manufacturing QA and QC material 10 CFR Part 32: M&D

• Registered/licensed as a medical facility

• Comprehensive safety through Federal or measures State authority

• Radiation dosimetry

• Radiation instrumentation 10 CFR Part

• Knowledgeable and

• Proper packaging 71:

• Licensed pharmacist trained staff transport

• Appropriate 10 CFR

• Additional training labeling/placarding 35.55: ANP and experience as

• Internal management nuclear pharmacist systems and oversight Image: CentraMed Radiopharmacy 13

• T&R personnel

• Security plans and Example 2: panoramic

• Occupational and public 10 CFR Part 20: safety exposure control

• Secure material from 10 CFR 37:

procedures

• Detect, assess, respond to all unauthorized access irradiator

& security unauthorized access when enhanced (performance based) Inspection focus areas:

in use or storage security

• Report suspicious activities

• Detect, assess, respond to

• Security and control of removal of material from material the security zone (prescriptive)

• Maintain shielding of material

• Comprehensive safety measures 10 CFR

• Management systems and

• Radiation dosimetry Part 30: oversight

• Facility shielding and specific

• Material receipt,

• Radiation instrumentation 10 CFR Part 36:

access control license shipment, accountability

• Knowledgeable and

• Attendance during irradiators operation trained staff

• Internal management systems and oversight 14

Non-isotopic Technologies Remember:

• NRC mission is to license and regulate the Nations civilian use of radioactive and nuclear materials to ensure adequate protection of the public health and safety, promote the common defense and security, and to protect the environment

• NRC authority is limited to radioactive and nuclear materials - no authority over machine generators of radiation

• NRC does not regulate the sectors (medical, research, energy, construction, )

• NRC, to maintain objectivity and independence, does not promote any technology or influence business decisions 15

Alternative Technologies Relevant activities:

2005 Energy Policy Act established the Radiation Source Protection &

Security Task Force - alternative technologies, both non-isotopic and lower activity, are included 2008 NAS Radiation Source Use and Replacement 2011 Policy of the U.S. Nuclear Regulatory Commission on the Protection of Cesium-137 Chloride Sources 2016 GARS Transitioning from High-activity Radioactive Sources to Non-radioisotopic (Alternative) Technologies 2019 Non-radioisotopic Alternative Technologies White Paper 16

Conclusion

• All licensed radioactive material has security requirements commensurate with the associated risk posed by radiation

• Graded approach allows the NRC and Agreement States to ensure consistent adequate protection while enabling beneficial uses of radioactive materials across the United States

• Fully integrating safety and physical protection measures allows licensees to develop custom programs that complement their specific needs and meet all regulatory requirements - including those of other authorities 17

THANK YOU NRC Public Website NRC Radioactive (www.nrc.gov) NRC 10 CFR Part 37 Materials Security