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Anatomy of an Enforcement Action by the U.S. Nuclear Regulatory Commission

Anatomy of an Enforcement Action by the U.S. Nuclear Regulatory Commission. Susan B. Smith Associate University Counsel Temple University June 21, 2001. The Big Picture. NRC Jurisdiction. Research Basic Science Diagnostic / Therapeutic Activities Nuclear Medicine; Radiation Oncology EH&S

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Anatomy of an Enforcement Action by the U.S. Nuclear Regulatory Commission

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  1. Anatomy of an Enforcement Action by the U.S. Nuclear Regulatory Commission Susan B. SmithAssociate University CounselTemple University June 21, 2001

  2. The Big Picture

  3. NRC Jurisdiction • Research • Basic Science • Diagnostic / Therapeutic Activities • Nuclear Medicine; Radiation Oncology • EH&S • Ordering; Storage; Disposal • Overlapping jurisdiction w/EPA, DOL, OSHA, DEP

  4. Soup to Nuts • Incident occurs; • Investigation ensues; • “Predecisional Enforcement Conference” is held; then • Official action is imposed.

  5. An Incident Occurs

  6. Triggering an Investigation • Improper handling, storage, disposal • Medical misadministration • Falsification • Wrongdoing • Discrimination / retaliation

  7. Reducing Possibility of Investigation • Create policies • Provide training, education • Make RSO accessible • Conduct Audits • self-identify problems

  8. Knowing Your Investigators • Not trained physicists or clinicians • Educate the investigators • Academic institution v. nuclear reactor • Union environment • Tenure / property rights

  9. Involving Counsel • Multiple representation • Conflicts between clients • Outside counsel

  10. The Investigation Ensues

  11. Living Through the Investigation (I) • Notify insurance company • Provide training • Responding to document requests • to subpoena or not to subpoena • be alert to state law • creating documents (e.g., org. charts)

  12. Living Through the Investigation (II) • Witness Interviews • Preparation before interview • Counsel’s presence at interview • Request for polygraphs

  13. Reviewing OI Findings • Ask to see full report • Ask whether criminal referral issued • Consider submitting response

  14. The Predecisional Enforcement Conference

  15. Particulars of the Conference • Purpose: To provide info. to assist NRC in determining enforcement action. • Goal -- to reach understanding of: • facts, root causes, missed opportunities; • corrective actions taken or planned; and • significance of issues; need for comprehensive corrective action.

  16. Attending the Conference • Who will attend? • from NRC • from institution • from other agencies

  17. Presenting at the Conference • Setting the tone • combative v. righteously indignant v. statesmanlike v. apologetic v. submissive • Who Presents? • Script presentation • consider exhibits, multimedia • What to Present? • Identify source of problem • Corrective actions

  18. Advocating at the Conference • Non-cited Violation (NCV) • Administrative Action: letter of reprimand, demand for info., notice of deviation, notice of nonconformance. • Notice of Violation (NOV) • Civil Penalty (CP) • Order: to modify, suspend, or revoke license; to cease and desist; etc.

  19. After the Conference • Follow-up, as appropriate • Respond to action imposed • Take institutional action • personnel action • Contest action

  20. Securing the Institution

  21. Responding Internally • Effect all promised corrective action • Effect culture change, if appropriate • senior administration • faculty / staff • Control internal damage

  22. Questions & Answers

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