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Nan Thomey How Regulatory Knowledge Can Improve Customer Service

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1980s Mantra

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21 st Century Fast Good Cheap Pick all Three

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What is Good? Data of Known Quality Compliant with TNI Standard Compliant with Regulatory Requirements Fulfills Client Data Quality Objectives Minimizes laboratorys liability

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Why Data of Known Quality? Terms such as high quality are undefinable or esoteric High Quality is a sales term, not a technical definition Known quality is a measureable achievement Not all data are created equal Not all data uses require the same levels of sensitivity, precision, and accuracy If the quality of data is known, it should prevent improper use Properly identifying data quality can reduce laboratorys liability if used improperly

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Customer Service Generating data of known quality does not necessarily fulfill the customers goal We can qualify data with a G for garbage Data quality is known But data is unusable for its intended purpose Regulatory Knowledge and Data Quality Objectives are tools to ensure the data of known quality is also usable for its intended purpose

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Biggest Obstacles to Customer Service Failure to identify purpose of data collection activity Customer doesnt give the information Project manager forgets to ask Assumptions are made Client is actually using data for more than one purpose Client decides after the fact to use the data for a different purpose than originally provided

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Major Federal Regulations and How We Tend to View Them Clean Water Act (CWA) Wastewater Compliance Safe Drinking Water Act (SDWA) Drinking Water Resource Conservation and Recovery Act (RCRA) Hazardous Waste Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) - Superfund Clean Air Act (CAA) Air Quality Toxic Substances Control Act (TSCA) Product Manufacturing and Distribution

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Major Regulations Seems simple,#Amirite? Not so fast Multiple and complex subtitles State primacy delegation County and Local Regulations add-on Multiple subtitles within each regulation expand scope into many subcategories and creates overlap between multiple program areas

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Significance to Analytical Lab? Regulatory requirements specify extensive requirements for engineering, management, documentation, recordkeeping, etc. In reality, the sampling and analysis requirements specified are just the tippy toe of the iceberg Environmental professionals at manufacturing plants and engineering firms include the smartest people I have ever met Is it fair to say that environmental professionals at client sites are rarely analytical chemists? Environmental protection creates immense value to corporations through risk and liability reduction But has anybody figured out how to show that value on a balance sheet to shareholders as an asset?

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What Kind of Analytical Information is Buried in the Encyclopedia of Regulations? Allowed Methods Compounds to be Analyzed Preservation, compositing and sample management Lower level of measurement required (expressed in many different ways: MDL, MAL, MRL, PQL, etc. etc. Requirements for Audit Samples Type of Sample Grab or Composite Sampling frequency Instructions for preparation of composite Regulatory limits

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Benefits of Regulatory Knowledge Assist the client in deciphering analytical requirements Assist the client in making sure their sampling and analytical protocol fulfill regulatory requirements Help find solutions to problems

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Methods Clean Water Act methods approved for NPDES monitoring and fulfilling discharge permit requirements Clean Air Act methods for stack emissions testing, fugitive emissions, Total VOC emissions from wastewater and storage tanks Texas State Regulations methods for compliance with TAC 115 Multiple methods are approved. Lab can help client choose best method for their matrix and data quality objectives

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Compounds to be Analyzed Clean Water Act List of Priority Pollutants RCRA Appendix VIII, Appendix IX, Comparable Fuels Standards, Injection Wells, TRI reports, CERCLA CLP list; but also site specific CAA Hazardous Air Pollutants, comprehensive list CAA Industry specific list of regulated compounds for MACT compliance TRPP Site specific constituents of concern; broad spectrum analyses

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Preservation and Sample Management CWA lists specific preservation requirements, holding times, and may indicate grab or composite sampling. Describes how composites are to be prepared for volatile compounds in permits CAA depending on subtitle will specify frequency of sampling for compositing (every X hours); may specify number of sampling days and how to average results MACT has broad terms minimize loss of volatiles during all sample collection and handling Use of chillers for sample collection to reduce loss of volatiles

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Lower Level of Measurement May be Specified Affects whether client can use zero for NDs in averaging in NPDES or MACT Comparable Fuels standards sets ND at specified levels as compliance limits Inconsistent Terminology causes

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Requirement of Audit Samples Primarily under Clean Air Act Some CAA provisions may specify performing field spikes But pay close attention to Quality Assurance Project Plans

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Type of Samples Grab or composite? How is composite to be prepared? Over what time period is the composite to be collected? How to obtain a representative sample?

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Sampling Frequency How often do samples need to be collected to demonstrate compliance? Do samples even need to be collected, or can process knowledge be used?

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Regulatory and Compliance Limits Regulation may specify specific numerical limit Examples: RCRA waste characteristics, universal treatment standards, land disposal restrictions CAA may specify specific limits in MACT based on industry type Regulation may just specify a complex calculation to determine compliance limit Wastewater permits will specify daily max and monthly average Total VOCs may define whether a source is a wastewater TRPP PCLs depend on size of affected area and usage

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Data Quality Objectives Basis for defining good data Must incorporate regulatory requirements previously mentioned Include precision, accuracy, representativeness, comparability Nobody can afford or deliver zero uncertainty

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Problems with DQOs Far too frequently, the DQO process is performed backwards Lab is contacted and asked what are your MDLs, MQLs, precision, accuracy Lab limits are adopted Does not necessarily address risk of decision making Are not universal across all ranges

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Example of DQO Importance TCLP Benzene limit is 5 mg/L Result is 4.75 Laboratory QC limits for MS/MSD is 80-120%, 15% RPD In this batch, MS recoveries were 85%, and 95% What would you do?

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What Would You Do? Collect more samples? Make sure Matrix spike was performed on that sample? Classify as hazardous because risk associated with improper disposal far exceeds any other cost? Hey, the number is