Nan Thomey How Regulatory Knowledge Can Improve Customer
Service
Slide 2
1980s Mantra
Slide 3
21 st Century Fast Good Cheap Pick all Three
Slide 4
What is Good? Data of Known Quality Compliant with TNI Standard
Compliant with Regulatory Requirements Fulfills Client Data Quality
Objectives Minimizes laboratorys liability
Slide 5
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
Slide 6
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
Slide 7
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
Slide 8
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
Slide 9
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
Slide 12
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
Slide 13
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
Slide 16
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?
Slide 20
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
Slide 22
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
Slide 23
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?
Slide 24
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