1. nuclearsafety.gc.ca Joint Congress on Medical Imaging and Radiation Sciences May 28, 2015 e-Doc 4724278 CNSC Administrative Monetary Penalties Overview

2. 2 Canadian Nuclear Safety Commission Jean-Claude Poirier Senior Project Officer Internal Quality Management Division Canadian Nuclear Safety Commission

3. 3 What are AMPs? Monetary penalties imposed by the CNSC for violations of a regulatory requirement –Only violations listed in the AMPs Regulations are subject to an AMP AMPs are: –Not criminal –One of several CNSC enforcement tools

4. 4 Canadian Nuclear Safety Commission History of AMPs Became popular in Canada in the 1990s Today: 53+ Federal Acts in Canada contain provisions for AMPs Most provincial legislation also have AMPs Common regulatory practice in U.S.A., Germany, UK and other countries Purpose of AMPs: compliance and deterrence

5. 5 Canadian Nuclear Safety Commission Authority for AMPs (1) Canadian Legislative basis –Nuclear Safety and Control Act (NSCA) sections 65.01 through 65.21 June 2012 –Administrative Monetary Penalties Regulations July 2013

6. 6 Canadian Nuclear Safety Commission Authority for AMPs (2) AMPs legislation highlights: –the rules surrounding violations –designating CNSC staff who can issue an AMP –designating CNSC staff who will conduct reviews –the process and rules concerning a “Review” –maximum penalty for a violation $25K for an individual $100K for a corporation

7. 7 Canadian Nuclear Safety Commission Authority for AMPs (3) The Regulations: Section 1: Definition Section 2: Designation of what constitutes a violation Section 3: Classification of the violations Three categories: A, B and C Section 4: Penalties Ranges Section 5: Criteria to be used for determining the amount of the penalty Section 6: Service of documents Section 7: Coming into force

8. 8 Canadian Nuclear Safety Commission Authority for AMPs (4) The CNSC can currently issue AMP penalties for violations to any of the provisions listed in the AMP Regulations Schedule. These include specific violations to the Nuclear Safety and Control Act 1.General Nuclear Safety and Control Regulations 2.Radiation Protection Regulations 3.Class I Nuclear Facilities Regulations 4.Class II Nuclear Facilities and Prescribed Equipment Regulations 5.Uranium Mines and Mills Regulations 6.Nuclear Substances and Radiation Devices Regulations 7.Packaging and Transport of Nuclear Substances Regulations 8.Nuclear Security Regulations 9.Nuclear Non-Proliferation Import and Export Control Regulations

9. 9 Canadian Nuclear Safety Commission Achieve higher levels of compliance, and reduce risk to the health and safety and security of Canadians and their environment. Provide CNSC with a more comprehensive and effective compliance and enforcement regime. Serve as a credible deterrent. Goals of AMPs

10. 10 Canadian Nuclear Safety Commission Monitor Identify Correct Verify Enforcement Failure of self-correction Restore self-correction Execution of Regulatory Powers Corrective Action Program Non-compliance Violation Compliance Vs Enforcement

11. 11 Canadian Nuclear Safety Commission Who do AMPs target?

12. 12 Canadian Nuclear Safety Commission Considering AMPs 1.Compliance is not obtained using either regular interaction or written notices 2.There is a history of repeat non-compliance 3.Non-compliance is intentional or a result of negligence 4.Harm is caused or would likely occur because of the non-compliance 5.Non-compliance is motivated by competitive or economic benefit 6.There is unreasonable risk to health, safety or the environment (likely in conjunction with an order)

13. 13 Canadian Nuclear Safety Commission CNSC AMP Program Rigorous Approval Process: Inspectors recommend AMPs Director endorse all AMPs Internal Quality Management Division reviews all AMPs (Quality Check) Director General makes final decision

14. 14 Canadian Nuclear Safety Commission Penalty Calculation Penalty amounts are affected by: The category of violation (A, B, C) Who committed the violation (Individual or Corporation) Considering 7 determining factors

15. 15 Canadian Nuclear Safety Commission Categories Violations are classified into three broad categories, based on regulatory significance: Category A (low regulatory significance) Category B (medium regulatory significance) Category C (high regulatory significance)

16. 16 Canadian Nuclear Safety Commission Penalty Ranges Ranges for Individuals Category A: $300 - $3,000 Category B: $300 - $10,000 Category C: $300 - $25,000 Ranges for Corporations Category A: $1,000 - $12,000 Category B: $1,000 - $40,000 Category C: $1,000 - $100,000 Category for each violation is stated in column 3 of the AMP Regulation Schedule

17. 17 Canadian Nuclear Safety Commission The Schedule Sample from the regulations

18. 18 Canadian Nuclear Safety Commission Determining Factors FactorDescriptionScale Factors 1 to 4 represent the regulatory significance of the scoring. The higher the score; the greater the penalty amount 1Compliance history  Compliance history of the person who has committed the violation 0 to +5 2Intention or negligence  Degree of intent or negligence on the part of the person 0 to +5 3Actual or potential harm  Harm that resulted or could have resulted from the violation 0 to +5 4Competitive or economic benefit  Whether the person derived any competitive or economic benefit from the violation 0 to +5 Factors 5 to 7 allow for the penalty amount to be decreased based on the assistance of the violator. 5Efforts to mitigate or reverse effects  Whether the person made reasonable efforts to mitigate or reverse the violation’s effects -2 to +3 6Assistance to Commission  Whether the person provided all reasonable assistance to the Commission -2 to +3 7Attention of Commission  Whether the person brought the violation to the attention of the Commission -2 to +3 total factor score (maximum score is 29)

19. 19 Canadian Nuclear Safety Commission Review process Anyone receiving an AMP can request a review within 30 days –Facts of violation –Amount of penalty Review is done by the Commission Commission issues record of decision

20. 20 Canadian Nuclear Safety Commission Web Posting AMPs are posted on CNSC website –Amount –Summary of violation –Regulatory requirement Notice of Violation is posted Posting happens after phone call to licensee

21. 21 Canadian Nuclear Safety Commission AMPs Program Described REGDOC 3.5.2 For more Information on: –Enforcement options –Penalty calculation –Notice of Violation –Review process –Recovery of penalties –Public disclosure

22. 22 Canadian Nuclear Safety Commission AMPs Issued to date CNSC has issued 15 AMPs since 2013 2 in 2013 9 in 2014 4 in 2015 All Regulatory Actions are posted on the CNSC website at: http://www.nuclearsafety.gc.ca/eng/acts-and-regulations/regulatory- action/index.cfm

23. 23 Canadian Nuclear Safety Commission Regulatory Toolbox AMPs Order Licensing action Decertification Warning GN 12(2) request Written Notice Increase Scrutiny Prosecute New!

24. 24 Canadian Nuclear Safety Commission Questions Thank You For Your Attention!

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