1. One Part of Ensuring Benzene NESHAP Compliance – Auditing the Analytical Provider TCEQ Environmental Trade Fair & Conference May 5, 2015 Presented by Rock J. Vitale, CEAC Technical Director of Chemistry/Principal Support from Kristin M. Gordon, PE Houston Office Director, All4 Inc. 1

2. CAAA of 1970  Clean Air Act Amendments (CAAA) of 1970  Established National Ambient Air Quality Standards (NAAQS)  Authorized Establishment of New Source Performance Standards (NSPS)  NSPS stem from NAAQS 2

3. CAAA of 1970 (Cont.)  Clean Air Act Amendments (CAAA) of 1970  Required US EPA to identify and list all air pollutants (not already identified as criteria pollutants) that “may reasonably be anticipated to result in an increase in mortality or an increase in serious irreversible or incapacitating reversible illness.”  National Emission Standards for Hazardous Air Pollutants (NESHAPs) resulted from this mandate 3

4. NESHAPs – Part 61  Emission Standards established by the US EPA  CAAA 1970 didn’t provide US EPA with much enforcement authority along with the establishment of the NESHAP  CAAA 1970 hazardous air pollutant (HAP) program based on risk to human health (i.e., risk-based standards).  Difficult to establish these standards because of the uncertainty in assessing health risk.  40 CFR Part 61  Apply to specific compounds emitted from specific processes  Asbestos, Benzene, Beryllium, Inorganic Arsenic, Mercury, Radionuclides, and Vinyl chloride 4

5. NESHAPs – Part 61  Subpart J: Equipment Leaks of Benzene (fugitive emission sources)  Subpart Y: Benzene Storage Vessel Emissions  Subpart BB: Benzene Transfer Operations Emissions  Subpart FF: Benzene Waste Operations Emissions 5

6. CAAA of 1990  Revamped pre-existing system of HAP control  Moved to control technology based standards which apply to specific categories of stationary sources  40 CFR Part 63  Apply to specific source categories that are considered area sources or major sources of the 188 listed HAP  Maximum Achievable Control Technology (MACT) and Generally Available Control Technologies (GACT) 6

7. HAPs  There were originally 189 listed HAP, currently 188.  Most HAP are VOCs.  Changes are made all of the time to the list of HAP.  US EPA is required to review the list of HAP periodically and add new substances that “present, or may present, through inhalation or other routes of exposure, a threat of adverse human health effects.” 7

8. MACT – Part 63  Maximum Achievable Control Technology  Residual Risk Component  Every 8 years, US EPA is required to review existing MACT standards  40 CFR Part 63  http://www.epa.gov/ttn/atw/mactfnlalph.html http://www.epa.gov/ttn/atw/mactfnlalph.html 8

9. Consent Decree  Agreement between Company and US EPA  May cover multiple facilities under a parent company  Traditionally based on noncompliance with a standard(s)  Also a mechanism to enforce compliance with a MACT(s)  Significant number of industries Impacted 9

10. Consent Decree  Consent Decrees Often Require  Air Permitting of Affected Sources  Installation of Air Pollution Control Equipment  Emissions Testing and/or Continuous Emissions Monitoring (CEMS)  Air Monitoring: Meteorological and Ambient Pollutant  Wastewater Monitoring  Laboratory Audits  Initial Audit  Continuing Audits 10

11. Laboratory Auditing Process  Prior to the On-Site Audit  Pre-Audit Logistics  Arrange Date of Audit  Coordinate Audit Team  Agree on Audit Scope  Assess Interest in Sponsor Participation 11 Pre- Audit Logistics WhenWhoWhatCost

12. Laboratory Auditing Process  Pre-Audit Request for Documents  Quality Assurance Manual  Analytical SOPs  Support SOPs  Resumes of Technical and Managerial Personnel  Current Instrumentation  Organizational Chart  MDL Summaries for Analyses of Interest  Internal and External Audits & CARs  Current VOA PE Study Results & CARs 12

13. Laboratory Auditing Process  Pre-Audit Questionnaire  Organization & Personnel  Analytical Instrumentation  Calibration Sources and Standards  Laboratory Information Management  Information Technology  Data Reduction and Reporting 13

14. Laboratory Auditing Process  On-Site Audit  Opening Meeting  Introductions  Confirm Schedule and Agenda  Discuss Potential Concerns or Issues  Laboratory Assessment and Interviews  Sample Receiving and Storage  Sample Receiving and Triage  Documentation  Sample Handling and Storage 14

15. Laboratory Auditing Process  Laboratory Assessment and Interviews  Bottleware  Cleanliness  Traceability  Shipping Documentation  Analytical  Calibration  Analytical Sequence  Review and Reporting of Data  Traceability of Standards and Reagents 15

16. Laboratory Auditing Process  Review of Records  Metrology, Training – Ethics  Review of Proficiency  PE Study Results, Demonstrations of Capability  Review of Quality Systems and IT  Data Archive and Backup, Security  Review of External Sample Handling  Shipment from Service Center  Review of 40 CFR Requirements  NESHAP Requirements 16

17. Laboratory Auditing Process  Review of Data Packages  Calculations, QA/QC Summaries, Completeness  Raw Calibration and Instrument Data  Closing Meeting/Debrief  Agreement and Consensus on Findings  Plan/Schedule for Audit Closure  Closing Questions for Auditor and Client/Sponsor 17

18. Laboratory Auditing Process  Post-Audit  Drafting of Findings and Comments  Draft Report Issued for Factual Review  Report Consensus and Finalization  Laboratory Issues Corrective Action Plan (CAP)  Auditor Adequacy Assessment of Laboratory’s CAP 18

19. Common Findings and Implications on Data Quality  Findings vs. Suggestions vs. Comments  Snapshot of Current Practices  Severity of Findings 19

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21. Sample Receipt and Storage  Samples Allowed to Warm up to > 6  C During Triage  No Specific Documented Plan to Evaluate and Maintain Sample Temperature During Triage  Chain-of-Custody Issues  Storage Blank Issues  Temperature of Sample Storage Units 21

22. Sample Bottleware  Sample Bottleware and Preservative Traceability  Documented Cleanliness of Bottles and Preservatives  Retention of Certificates of Analysis 22

23. Sample Disposal  Solvent Waste  Confidential Client Information in Municipal Dumpsters 23

24. Sample Analysis and Reporting  Traceability of Standards and Reagents  Labeling of Standards and Reagents  Proper Documentation of Unpreserved Samples Analyzed after 14 days  Number of Quantitation Ions  Standard Storage/Expiration Issues 24

25. Documentation and Quality Systems  SOPs Inconsistent with Laboratory Practices  SOPs Inconsistent with Method Requirements  Logbooks not Controlled Documents  Inconsistent Logbook Reviews  Support Equipment with Expired Calibrations  Incomplete Data Packages 25

26. Internal Audits  Internal Audits not Scheduled Consistently  Document Review Past Due  Follow-up on Findings  Incomplete Root Cause Analysis  Ineffective Corrective Actions 26

27. Training  Training Records Incomplete  Demonstration of Capability Data Not Compiled and Evaluated 27

28. Other  Working Thermometer Calibration Factor Calculations  Excessively Wide DOC Limits for Volatiles  Ethics and Data Integrity Issues 28

29. Technical Specification Manual  NELAC Issues  Passed Down to States to Implement  Ambiguities  Audits Differ State by State  Technical Specification Manual  Part of an Overall Laboratory Management Strategy  Consistency Across All Laboratories  Resolves Ambiguities  Consistent Audit Requirements  Consistent Data Deliverables 29

30. Opportunities  Many BWON audits are required annually  Many opportunities for industrials to share audit cost  Ask me about those opportunities 30

31. Contact 31 Environmental Standards, Inc. “Setting the Standards for Innovative Environmental Solutions” Headquarters 1140 Valley Forge Road | PO Box 810 | Valley Forge, PA 19482 | 610.935.5577 Virginia 1208 East Market Street | Charlottesville, VA 22902 | 434.293.4039 Tennessee 8331 East Walker Springs Lane, Suite 402 | Knoxville, TN 37923 | 865.376.7590 Texas 2000 S. Dairy Ashford Road, Suite 450 | Houston, TX 77077 | 281.752.9782 New Mexico PO Box 29432 | Santa Fe, NM 87592 | 505.660.8521 Illinois PO Box 62 | Geneva, IL 60134 | 630.262.3979 www.envstd.com | solutions@envstd.com All4 Inc. An Environmental Consulting Firm Specializing in Air Quality. www.all4inc.com kgordon@all4inc.com | 281.937.7553 Philadelphia | Atlanta | Houston