One Part of Ensuring Benzene NESHAP Compliance – Auditing the Analytical Provider TCEQ Environmental Trade Fair & Conference May 5, 2015 Presented by Rock.

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

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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

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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

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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

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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

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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

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Training

Training Records Incomplete

Demonstration of Capability Data Not Compiled and Evaluated

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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

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Opportunities

Many BWON audits are required annually Many opportunities for industrials to share audit cost

Ask me about those opportunities

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Contact

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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