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

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 Program Issues 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. Shut-off valve Off

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