Risk Management Program Quality Assurance Program Plan

1. Risk Management Program Quality Assurance Program Plan David R. Taylor US EPA Region 9 Quality Assurance Office

2. Products and Services Covered by the New Quality Policy • Data and Information produced for public use • Data and information produced for internal Agency activities • Products and services produced by organizations external to EPA for EPA use

3. CIO 2106 Scope • Environmental Data and Technology • Environmental Information • Assessments • Reports • Peer Review • Scientific Research • Regulatory Development • Information Technology to support services that collect and provide access to data & information

4. R9's Quality System Umbrella Quality System Quality Management Plan QAPrP QAPjP SAP SOP

5. Quality Assurance Program Plan • Describes the QA System for an environmental program like the Clean Water Act, Clean Air Act • Program usually based on environmental regulations • Contains details like a QA Project Plan, but at a organization wide or program level

6. Risk Management Program Organizations Using, Storing or Transporting Hazardous Material must: Comply with the General Duty Clause (CAA112(r)(1)) • Identify Hazards • Design and maintain a safe facility • Follow codes, standards and other business practices • Minimize the consequences of a release

7. Risk Management Program Organizations Using, Storing or Transporting Hazardous Material must: • Implement Chemical Accident Prevention (CAA 112(r)(7)) • Do a Hazard Assessment • Develop a Prevention Program • Establish an Emergency Response Program • Prepare a Risk Management Plans

8. Risk Management Program Federal Regulations EPCRA - Emergency Planning and Community Right-to-Know Act (aka SARA Title III) Sections 302-312 CERCLA - Comprehensive Environmental Response, Compensation and Liability Act, Section 103 CAA 112(r) - Clean Air Act Section 112(r)(7), Chemical Accident Prevention Provisions and Risk Management Plans; and Section 112(r)(1) General Duty Clause (1990)

9. R9 Risk Management ProgramIssues • Hawaii Inspector needed Federal credential • No QA Documentation (except R9 QMP) • No QA Guidance available • Not an Environmental Data Collection Activity, but • Environmental Information collected

10. Risk Management Plan • Summarizes key elements of a Facility’s Risk Management Program • Submitted to the U.S. EPA and put in the Central Data Exchange (CDX) • Contains certification of accuracy and completeness • Contains a brief “Executive Summary” • Available to the public at “Reading Rooms” • Companion Emergency Response Plans available to EPA upon EPA request

11. RMP Quality System • Review of Risk Management Plans based on National Guidance ensures consistency • Training and Certification • Audits • Administrative and Enforcement Action

12. Training and Certification • Basic Inspector Training • Federal Inspection Credential • Risk Management Program Training • Confidential Business Information Training

13. Risk Management Program Audits Follow one of several checklists: • Program Level 1, 2 or 3 Checklist • Audit Checklist from “Guidance for Auditing Risk Management Plans/Programs under Clean Air Act Section 112(r)” • EPCRA/CERCLA Inspection Checklist for R9

14. RMP Audits • Has facility planned satisfactorily for incidents and releases? • Is it implementing the RMP as described? • Does plan cover all chemicals and processes subject to CAA112(r)(1) (GDC) or CAA112(r)(7) (ARR) • Does facility meet Mechanical Integrity, Process Safety and Emergency Response Requirements?

16. Off Shut-off valve

17. Conclusions • New Quality Policy will require flexibility • Existing systems must be respected • New approaches will be required by the QA Community • Documentation is key