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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
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
2 Topics
* Introduction to the Nuclear Regulatory Commission
* Introduction to the Nuclear Regulatory Commission
* Agreement States
* Agreement States
Line 28: Line 28:
* Regulatory basis/assessment
* Regulatory basis/assessment
* Safety-Security integration - the requirements
* Safety-Security integration - the requirements
* Alternative technologies 2
* Alternative technologies


Introduction to the Nuclear Regulatory Commission License and regulate the Nations civilian use of radioactive*
3
~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 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.
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
*radioactive includes byproduct, source, and nuclear materials Introduction to the Nuclear Regulatory Commission
    * ~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
4 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
* 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
* to explain clearly how the Commission and the NRC intends to conduct itself


The overall rulemaking process:
5 The overall rulemaking process:
5


Rulemaking 6
6 Rulemaking


Risk-based vs. Risk-informed What can go wrong?                     How likely is it?       What would be the consequences?
7 Risk-based vs. Risk-informed What can go wrong?
High Probability, High Consequence.                                    Low Probability, High Consequence.
How likely is it?
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.
What would be the consequences?
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.
High Probability, High Consequence.
7
An expedition to Mount Everest has a high probability of serious consequences, such as a fatal fall or frozen extremities. As a result, the overall risk is considered to be very high.
Low Probability, High Consequence.
A skydiving accident, in which the parachute fails to open, can also have severe consequences (including fatality). However, the risk is acceptable to many people because using the proper safety precautions can adequately reduce the probability of an accident. As a result, the overall risk is considered to be moderate.
High Probability, Low Consequence.
A unicyclist has a relatively high probability of falling. However, the consequences of such an 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.


Risk-based vs. Risk-informed What can go wrong?      How likely is it? What are the potential consequences?
8 Risk-based vs. Risk-informed What are the potential consequences?
Category 1 & 2
Category 1 & 2 Category 3
                                                            ?
?
and what should/can we do to prevent it?
and what should/can we do to prevent it?
A. Reasonable assurance of adequate Category 3 protection B. Absolute protection (zero risk) 8
A. Reasonable assurance of adequate protection B. Absolute protection (zero risk)
What can go wrong?
How likely is it?


What information comes in:
9 What information comes in:
* Intelligence - domestic and international
* Intelligence - domestic and international
* Official reports - suspicious and actual
* Official reports - suspicious and actual
Line 69: Line 74:
* related events
* related events
* Petitions for rulemaking
* Petitions for rulemaking
* Commission direction / legislation 9
* Commission direction / legislation


NRCs Graded Approach - 3 groups Specific
10 NRCs Graded Approach - 3 groups Exempt 10 CFR 30.14 - 30.22
* Low concentrations of radioactive material used by the public, such as smoke detectors, marine compasses, watch hands, static eliminators
* No appreciable safety or security impact, therefore no requirements for users General 10 CFR Part 31
* Devices for detecting, measuring, gauging, producing light, producing an ionized atmosphere
* Inherent safety via engineering design
* Loss, theft, damage, and/or malfunction must be reported
* Cannot be abandoned
* Limited scenarios for transfer, including for disposal, from initial user to other Specific
* All other radioactive and nuclear materials
* All other radioactive and nuclear materials
* 10 CFR Part 19 Notices, instructions and reports to workers: inspection and investigations
* 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 20 Standards for protection against radiation
* 10 CFR Part 21 Reporting of defects and 10 CFR Part 31                                      noncompliance
* 10 CFR Part 21 Reporting of defects and noncompliance
* Devices for detecting, measuring, gauging,
* Other applicable regulations
* 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]
11 Basic performance-based control measures for safety and security
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]
[10 CFR Part 20 & 10 CFR Part 30]
11
All radioactive and nuclear material that is neither exempt nor held under the general license.
Includes all industrial, medical, research, calibration, manufacturing, distribution, and accelerator-produced uses of material.
Minimum 2 independent physical barriers for portable gauges Modality-based [various parts]
Additional control measures specific to modalities of use.
Part 32: manufacture or distribute Part 33: broad scope activities Part 34: industrial radiography Part 35: medical Part 36: panoramic irradiator Part 39: well logging Enhanced physical protection
[10 CFR Part 37]
Additional explicit physical protection measures for radioactive material quantities category 2 (roughly the same as the Code of Conduct on the Safety and Security of Radioactive Sources)
NRCs Graded Approach - within the Specific License


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
12 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
* Occupational and Example 1:
 
public exposure        10 CFR Part
13 Example 1:
* Management systems and 10 CFR Part control
radiopharmacy 10 CFR Part 20: safety &
* Secure material from 30: specific license oversight
security
* Material receipt, shipment, radiopharmacy 20: safety &     unauthorized access                  accountability security        when in use or storage Inspection focus areas:
*Occupational and public exposure control
*Secure material from unauthorized access when in use or storage 10 CFR Part 30: specific license
*Management systems and oversight
*Material receipt, shipment, accountability 10 CFR Part 32: M&D
*Manufacturing QA and QC
*Registered/licensed as a medical facility through Federal or State authority 10 CFR 35.55: ANP
*Licensed pharmacist
*Additional training and experience as nuclear pharmacist 10 CFR Part 71:
transport
*Proper packaging
*Appropriate labeling/placarding Image: CentraMed Radiopharmacy Inspection focus areas:
* Security and control of material
* Security and control of material
* Maintain shielding of
* Maintain shielding of material
* Manufacturing QA and QC                  material 10 CFR Part 32: M&D
* Comprehensive safety measures
* Registered/licensed as a medical facility
* Comprehensive safety through Federal or      measures State authority
* Radiation dosimetry
* Radiation dosimetry
* Radiation instrumentation 10 CFR Part
* Radiation instrumentation
* Knowledgeable and
* Knowledgeable and trained staff
* Proper packaging 71:
* Internal management systems and oversight
* Licensed pharmacist                          trained staff transport
 
* Appropriate                10 CFR
14 Example 2: panoramic irradiator 10 CFR Part 20: safety  
* Additional training labeling/placarding      35.55: ANP and experience as
& security
* Internal management nuclear pharmacist systems and oversight Image: CentraMed Radiopharmacy 13
*Occupational and public exposure control
* T&R personnel
*Secure material from unauthorized access when in use or storage 10 CFR Part 30:
* Security plans and Example 2: panoramic
specific license
* Occupational and public 10 CFR Part 20: safety exposure control
*Management systems and oversight
* Secure material from         10 CFR 37:
*Material receipt, shipment, accountability 10 CFR Part 36:
procedures
irradiators
* Detect, assess, respond to all unauthorized access irradiator
*Facility shielding and access control
& security        unauthorized access when      enhanced      (performance based)         Inspection focus areas:
*Attendance during operation 10 CFR 37:
in use or storage security
enhanced security
* Report suspicious activities
*T&R personnel
* Detect, assess, respond to
*Security plans and procedures
* Security and control of removal of material from       material the security zone (prescriptive)
*Detect, assess, respond to all unauthorized access (performance based)
*Report suspicious activities
*Detect, assess, respond to removal of material from the security zone (prescriptive)
Inspection focus areas:
* Security and control of material
* Maintain shielding of material
* Maintain shielding of material
* Comprehensive safety measures 10 CFR
* Comprehensive safety measures
* Management systems and
* Radiation dosimetry
* Radiation dosimetry Part 30:      oversight
* Radiation instrumentation
* Facility shielding and    specific
* Knowledgeable and trained staff
* Material receipt,
* Internal management systems and oversight
* 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:
15 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 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 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 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
* NRC, to maintain objectivity and independence, does not promote any technology or influence business decisions


Alternative Technologies Relevant activities:
16 Alternative Technologies Relevant activities:2005Atomic Energy Act established the Radia tion Source Protection &
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
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
17 Conclusion
* All licensed radioactive material has security requirements commensurate with the associated risk posed by radiation
* 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
* 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
* 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


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

Latest revision as of 12:26, 29 November 2024

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:
References
Download: ML21022A078 (18)
v • d • e


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

2 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

3

~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 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.

  • radioactive includes byproduct, source, and nuclear materials Introduction to the Nuclear Regulatory Commission

4 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

5 The overall rulemaking process:

6 Rulemaking

7 Risk-based vs. Risk-informed What can go wrong?

How likely is it?

What would be the consequences?

High Probability, High Consequence.

An expedition to Mount Everest has a high probability of serious consequences, such as a fatal fall or frozen extremities. As a result, the overall risk is considered to be very high.

Low Probability, High Consequence.

A skydiving accident, in which the parachute fails to open, can also have severe consequences (including fatality). However, the risk is acceptable to many people because using the proper safety precautions can adequately reduce the probability of an accident. As a result, the overall risk is considered to be moderate.

High Probability, Low Consequence.

A unicyclist has a relatively high probability of falling. However, the consequences of such an 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.

8 Risk-based vs. Risk-informed What are the potential consequences?

Category 1 & 2 Category 3

?

and what should/can we do to prevent it?

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

What can go wrong?

How likely is it?

9 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

10 NRCs Graded Approach - 3 groups Exempt 10 CFR 30.14 - 30.22

  • Low concentrations of radioactive material used by the public, such as smoke detectors, marine compasses, watch hands, static eliminators
  • No appreciable safety or security impact, therefore no requirements for users General 10 CFR Part 31
  • Devices for detecting, measuring, gauging, producing light, producing an ionized atmosphere
  • Inherent safety via engineering design
  • Loss, theft, damage, and/or malfunction must be reported
  • Cannot be abandoned
  • Limited scenarios for transfer, including for disposal, from initial user to other 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
  • 10 CFR Part 21 Reporting of defects and noncompliance
  • Other applicable regulations

11 Basic performance-based control measures for safety and security

[10 CFR Part 20 & 10 CFR Part 30]

All radioactive and nuclear material that is neither exempt nor held under the general license.

Includes all industrial, medical, research, calibration, manufacturing, distribution, and accelerator-produced uses of material.

Minimum 2 independent physical barriers for portable gauges Modality-based [various parts]

Additional control measures specific to modalities of use.

Part 32: manufacture or distribute Part 33: broad scope activities Part 34: industrial radiography Part 35: medical Part 36: panoramic irradiator Part 39: well logging Enhanced physical protection

[10 CFR Part 37]

Additional explicit physical protection measures for radioactive material quantities category 2 (roughly the same as the Code of Conduct on the Safety and Security of Radioactive Sources)

NRCs Graded Approach - within the Specific License

12 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

13 Example 1:

radiopharmacy 10 CFR Part 20: safety &

security

  • Occupational and public exposure control
  • Secure material from unauthorized access when in use or storage 10 CFR Part 30: specific license
  • Management systems and oversight
  • Material receipt, shipment, accountability 10 CFR Part 32: M&D
  • Manufacturing QA and QC
  • Registered/licensed as a medical facility through Federal or State authority 10 CFR 35.55: ANP
  • Licensed pharmacist
  • Additional training and experience as nuclear pharmacist 10 CFR Part 71:

transport

  • Proper packaging
  • Appropriate labeling/placarding Image: CentraMed Radiopharmacy Inspection focus areas:
  • Security and control of material
  • Maintain shielding of material
  • Comprehensive safety measures
  • Radiation dosimetry
  • Radiation instrumentation
  • Knowledgeable and trained staff
  • Internal management systems and oversight

14 Example 2: panoramic irradiator 10 CFR Part 20: safety

& security

  • Occupational and public exposure control
  • Secure material from unauthorized access when in use or storage 10 CFR Part 30:

specific license

  • Management systems and oversight
  • Material receipt, shipment, accountability 10 CFR Part 36:

irradiators

  • Facility shielding and access control
  • Attendance during operation 10 CFR 37:

enhanced security

  • T&R personnel
  • Security plans and procedures
  • Detect, assess, respond to all unauthorized access (performance based)
  • Report suspicious activities
  • Detect, assess, respond to removal of material from the security zone (prescriptive)

Inspection focus areas:

  • Security and control of material
  • Maintain shielding of material
  • Comprehensive safety measures
  • Radiation dosimetry
  • Radiation instrumentation
  • Knowledgeable and trained staff
  • Internal management systems and oversight

15 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

16 Alternative Technologies Relevant activities:2005Atomic Energy Act established the Radia tion 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

17 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

THANK YOU NRC Public Website (www.nrc.gov)

NRC 10 CFR Part 37 NRC Radioactive Materials Security

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