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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
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
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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
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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
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
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)
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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.”
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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
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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
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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
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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
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Pre-Audit
Logistics
When
Who
What
Cost
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
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Laboratory Auditing Process
Pre-Audit Questionnaire Organization & Personnel Analytical Instrumentation Calibration Sources and
Standards Laboratory Information
Management Information Technology Data Reduction and Reporting
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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
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
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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
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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
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
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Common Findings and Implications on Data Quality
Findings vs. Suggestions vs. Comments Snapshot of Current Practices Severity of Findings
19
20
Sample Receipt and Storage
Samples Allowed to Warm up to > 6C 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
Sample Bottleware
Sample Bottleware and Preservative Traceability
Documented Cleanliness of Bottles and Preservatives
Retention of Certificates of Analysis
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Sample Disposal
Solvent Waste Confidential Client Information in Municipal
Dumpsters
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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
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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
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Internal Audits
Internal Audits not Scheduled Consistently Document Review Past Due Follow-up on Findings Incomplete Root Cause Analysis Ineffective Corrective Actions
26
Training
Training Records Incomplete
Demonstration of Capability Data Not Compiled and Evaluated
27
Other
Working Thermometer Calibration Factor Calculations
Excessively Wide DOC Limits for Volatiles Ethics and Data Integrity Issues
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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
Opportunities
Many BWON audits are required annually Many opportunities for industrials to share audit cost
Ask me about those opportunities
30
Contact
31
Environmental Standards, Inc.“Setting the Standards for Innovative Environmental Solutions”
Headquarters 1140 Valley Forge Road | PO Box 810 | Valley Forge, PA 19482 | 610.935.5577Virginia 1208 East Market Street | Charlottesville, VA 22902 | 434.293.4039
Tennessee 8331 East Walker Springs Lane, Suite 402 | Knoxville, TN 37923 | 865.376.7590Texas 2000 S. Dairy Ashford Road, Suite 450 | Houston, TX 77077 | 281.752.9782
New Mexico PO Box 29432 | Santa Fe, NM 87592 | 505.660.8521Illinois PO Box 62 | Geneva, IL 60134 | 630.262.3979
www.envstd.com | [email protected]
All4 Inc.An Environmental Consulting Firm Specializing in Air Quality.
[email protected] | 281.937.7553
Philadelphia | Atlanta | Houston
