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The Standard June 2013


In This Issue:
Another Case for Data Validation
Toxicity Testing Quality Assurance
EPA Draft Standard on Quality Systems
Growing Trends in Frack Water Management
EPA Review Board Impacts Seismicity
Sustainability Reporting: Telling Your Story
What’s In A Name?
REACH and CLP in Europe
California Proposition 65: Omnibus Consumer Product Enforcement Act
Measurement of Radionuclides
Revised Total Coliform Rule
Environmental Standards Employees Wrap Up Inaugural Bowling League

Another Case For Data Validation

In the course of a recent data validation project for an oil and gas production client, Environmental Standards’ quality assurance chemists discovered, yet again, why data validation is so important in generating accurate and defensible data.
Our chemists identified an issue during post-digestion spikes (PDS) for metals analysis.  The client’s Quality Assurance Project Plan (QAPP) indicated that a PDS should be analyzed for only those compounds that fail in the pre-digestion MS/MSD.

During validation, two metals failed acceptance limits in the MS/MSD analyses; accordingly, the analytical laboratory ran a PDS.  However, due to software limitations, the laboratory reported the full metals list in the PDS instead of just the two metals.  Because Environmental Standards’ quality assurance chemists saw the full metals list, they could see that all metals failed quality control requirements in the PDS with very high recoveries.

Because these results were so “peculiar,” the laboratory – at the request of our quality assurance chemists – looked into the results again and found a process error that resulted in the PDS being “double-spiked.”  The lesson-learned is that data validation and environmental chemistry quality assurance of your analytical laboratory is absolutely necessary – even if the laboratory is accredited.

For more information about Environmental Standards’ chemistry quality assurance services and experience, contact David R. Blye, CEAC at 610.935.5577.

Toxicity Testing Quality Assurance

This article is the second in a series of three by Senior Biologist James Markwiese, PhD, discussing the quality control and quality assurance measures for state-of-the-practice toxicity testing.  The series focuses on mechanisms to facilitate the establishment and documentation of quality procedures for toxicity testing laboratories.  The first article appeared in the March 2013 issue of The Standard.

A laboratory must actively ensure that its quality system is being properly implemented and that it is achieving the required standard of quality.  Quality control measures, such as a method-specific demonstration of bioassay capability, can provide feedback on the quality system but are not enough to ensure quality results.  Audits are designed to provide an objective and thorough evaluation of quality issues affecting a laboratory and cover the entirety of the quality system.  Routine audits of toxicity testing laboratories can detect actual or potential non-conformances before they impact data quality and can even identify possible future problems.  Where there are no problems, the audit provides a record that the quality assurance system has been thoroughly evaluated and found to be acceptable.

Toxicity Testing Quality Assurance

The quality assurance elements reviewed in a toxicity testing audit include:

  • quality documents such as quality management plans, quality assurance project plans and standard operating procedures;
  • records including technician training, Chain-of-Custody, equipment calibration such as pH, salinity and light meters, environmental conditions, toxicity test data and reports and corrective actions;
  • and methodology including test implementation and performance.

These topics can be covered in any order, but typically begin with an evaluation of documentation and records and end with method/ test performance review.

The most important, and perhaps most difficult to gauge, aspect of the latter, involves evaluating competence of laboratory personnel for routine maintenance, such as culture of test organisms.  For confidence in bioassay results, it is imperative to demonstrate that the organism is responding to the test substance and/or conditions and not some confounding factor (lack of acclimation to test conditions, disease, etc.). Validity of results can be evaluated on a test-specific basis and efforts are underway to gauge long-term performance of testing laboratories.  Although audits typically only last from one to several days, and therefore represent a narrow window for gauging year-round laboratory operations, they offer an unparalleled means for evaluating a laboratory’s implementation of its quality assurance system.

EPA Draft Standard on Quality Systems

epaIn the December 26, 2012 Federal Register, EPA’s Office of Environmental Information published an “Announcement of Availability and Comment Period for the Draft Quality Standard for Environmental Data Collection, Production, and Use by Non-EPA (External) Organizations and two associated QA Handbooks.”  This represents the Agency’s first proposed revision to its quality requirements as they relate to environmental data activities since 2006, when it reissued two documents originally published in 2001:

  • EPA QA/R-2, EPA Requirements for Quality Management Plans, and
  • EPA QA/R-5, EPA Requirements for Quality Assurance Project Plans

The Standard
The standard consists of the main body and three Annexes.  The main body lays out the minimum requirements for a quality system, with some specifics about what must be included in Quality Management Plans (QMPs) and Quality Assurance Project Plans (QAPPs).  Annex A specifies requirements for QMPs.  Annex B specifies requirements for QAPPs.  Annex C provides planning guidelines.  Annexes A and B are normative (required) and Annex C is informative (guidance).

When the Standard becomes final, Annex A will replace EPA QA/R-2 and Annex B will replace EPA QA/R-5.

The Handbooks
Simultaneous with the announcement of the availability of the Draft Standard for comment, the Agency announced availability of two draft handbooks:

  • Handbook for Developing Quality Management Plans (QMP Handbook) and
  • Handbook for Developing Quality Assurance Project Plans (QAPP Handbook).

Both Handbooks are identified as guidance documents.  Once finalized, the QAPP Handbook will replace EPA Guidance for Quality Assurance Project Plans (EPA QA/G-5) (December 2002).

What Will Change?
Since the Standard is still in Draft form, it is premature to speculate on what, if any, changes will occur in Quality requirements for projects involving the collection, production, and use of environmental data.  The Summary section of the Announcement indicates that the Draft Standard “contains no new requirements.”  However, the language of the Draft can be interpreted to impose new requirements, particularly in the areas of QAPP review, independence of Quality personnel and specific activities for which QAPPs are required.  Many of the comments submitted during the review period indicate concerns to that effect.

Further, while EPA indicates that the handbooks are “non-mandatory guidance,” Annex B of the Standard, which is mandatory, frequently references the QAPP Handbook for “specifics on satisfying requirements” in many areas.  Many commenters requested that EPA revise the proposed Standard to more clearly indicate its intent on what is a requirement and what is simply guidance.

The Federal Register announcement is available for download here.  The Draft Standard can be downloaded here.  The Docket, with links to the Handbooks and comments received on the Draft Standard can be found here.

Growing Trends in Frack Water Management

growing trends in frack water management, hydraulic fracturing

Recent news releases show that the states of Pennsylvania and Texas are working on new approaches for the management of water used in the hydraulic fracturing process (fracking).  In Pennsylvania, the Pennsylvania Department of Environmental Protection (PA DEP) published a white paper in January 2013, titled Utilization of Mine Influence Water (MIW) for Natural Gas Extraction.  The white paper identified how PA DEP intends to review proposals from oil and gas drillers on using MIW for drilling operations.  The advantage of using MIW for drilling operations is two-fold:

  1. It reduces the amount of fresh or potable water needed for fracking.
  2. It helps mitigate MIW issues across the state.

The white paper indicated that the biggest disadvantage to this approach is the concern over liability associated with moving, storing, and using contaminated water.  The white paper identified some ways to address these liability concerns.  Pennsylvania’s Environmental Good Samaritan Act provides protection from civil liability for projects involving reclamation of MIW.  Additionally, the potential use of a Consent Order and Agreement between PA DEP and the driller could be used whereby the driller would not be held liable for long term treatment obligations.  As a final option, PA DEP indicated that a General Permit may be developed covering the use of MIW in natural gas operations.  If liability concerns can be overcome, it appears that PA DEP has made a good effort at addressing environmental issues associated with MIW and fracking.

In Texas, the Texas Railroad Commission is trying to encourage recycling by amending fracking fluid recycling rules.  Under the rules adopted by the Texas Railroad Commission on March 26, 2013, Texas oil and gas operators may recycle fracking fluids on their own land (leased or owned) that is used for fracturing activities without a permit.  Additionally, the oil and gas drillers may transfer the fluids to the land of another operator for recycling without a permit.  The main provisions of amended Rule §3.8 enable on-site,
permit-free storage of fluids awaiting recycling or treated fluids in “non-commercial fluid recycling pits.”  These “non-commercial fluid recycling pits” are subject to set construction standards and have use and maintenance requirements.  The goal of these new regulations is to encourage oil and gas operators to recycle by removing regulatory hurdles.  There will also likely be an added benefit of cost savings from reduced fresh water use, and transportation and disposal fees associated with flowback water.

EPA Review Board Impacts Seismicity Reviews for Injection Well Permits

US EPA’s Environmental Appeals Board (EAB) is urging the agency to ensure its current process for permitting underground injection of wastewater adequately accounts for potential seismic risks – a measure that could bolster environmentalists’ push to force EPA to weigh seismic impacts when permitting injection of oil and gas wastewater.

In a ruling in Re: Stonehaven Energy Management, the EAB supported charges from a local landowner that US EPA failed to demonstrate that its Class II underground injection control (UIC) permit for Stonehaven Energy Management Co.’s Venango County, Pennsylvania, operation adequately considered possible seismic impacts.  US EPA’s UIC regulations require consideration of “appropriate geological data on the injection zone,” the board noted, and a map prepared by the applicant that may show “faults known or suspected.”

The EAB returned the permit to US EPA’s Region III, ruling that the Region’s record failed to show that its permitting review adequately investigated the potential for seismic impacts at the permitting site.  The EAB noted that Region III needs to “include specific findings, based upon evidence in the record, on earthquake risk and on the existence of faults and fractures in the confining zone… and make those findings available to the public for review and comment,” the EAB held.

Various environmental groups are petitioning EPA to reconsider its 1988 exemption of oil and gas wastes from regulation as a “hazardous waste” under RCRA, a move that would subject the disposal to stricter permits governing hazardous waste, where potential seismicity must be considered before a permit is issued.

Class I UIC rules for hazardous wastes require an injector to supply studies that demonstrate that the proposed permit site is free of any seismic impact risks, including that the formations are free of vertically transmissive fissures or faults, that the formation has low seismicity and low probability of earthquakes, and that the injection of wastewater will not induce earthquakes or increase the frequency of naturally occurring earthquakes.
Environmental groups have previously cited a series of earthquakes in Ohio that were supposedly “linked” to a Class II disposal well used to store wastewater from natural gas extraction operations to bolster their efforts to urge EPA to reverse its stance.

Injection wells are EPA and industry’s preferred option for managing wastewater generated during the hydraulic fracturing (i.e., fracking) process.  But while use of such wells has been widespread throughout oil and gas operations in the western United States, the geological conditions of the Northeast’s prolific Marcellus shale gas plays have constrained regulators’ ability to safely discharge wastewater to underground reservoirs.

Sustainability Reporting: Telling Your Story

Forward thinking corporations recognize the need to lead and shape discussion around sustainability and not merely react to initiatives.  Increasingly, they are demonstrating transparency, traceability, and compliance through reporting.  Sustainability reporting addresses environmental, social, and economic goals – however, environmental reporting remains a significant focus as impacts are noticeable and many efficiencies associated with quality and performance are yet to be attained.  Numerous reporting frameworks exist for communicating achievements.  The Global Reporting Initiative and AA1000 standards are widely applied to convey commitment to sustainable practices.

Sustainability Reporting
The Global Reporting Initiative (GRI, is one of numerous reporting frameworks that exists for communicating sustainability achievements.

The financial benefits from improved sustainability can be direct as in the case of waste minimization, reduction in cleanup times, pollution prevention, and lower demand for resources.  Or, they may manifest through better relations with stakeholders, reduced risks and legal costs, and greater acceptance for new and existing operations.  The mining industry is adopting a framework described as the Social License to Operate.  The industries seeing the greatest benefit in benchmarking and reporting their performance are those most heavily regulated and scrutinized by the public.  However, consumers and investors alike are beginning to gravitate towards environmentally sound practices.  The Dow Jones Sustainability Index (DJSI) evaluates the largest companies in its stock portfolio for recognition in sustainability.  Those organizations that improve their behaviors position themselves for the future.

Measuring environmental performance and setting targets are critical to organizations seeking greater productivity, profit, and stature in their industry.  Monitoring key metrics such as energy, waste, water use, and emissions is necessary.  Many face significant challenges in capturing and managing the data necessary to establish benchmarks and reliable measurements.  Poor governance resulting in multiple metric frameworks, lack of standardization, and inconsistent application across operations are cited as undermining success even where positive actions are being taken.  Identifying specific data needs, acquiring detailed data, and ensuring data quality is the foundation for managing performance and establishing credible indicators for reporting.  The costs incurred for these activities are offset through initiatives that achieve compliance and document a story of stewardship.

Applying information technology to manage environmental data and measure performance allows executives to prioritize scarce resources towards the largest outcomes at the lowest cost.  Sustainability reporting and its focus on environment has quickly become the norm for large companies and is increasingly a standard for their suppliers.
Contact Izak Maitin at 610.935.5577 or to discuss data driven solutions to the environmental aspects of sustainability reporting.

What’s In A Name?

Callaway Hex ChromeIn 2012, Callaway Golf introduced their latest line of golf balls to the public.  Among the offerings was an environmentally curiously-named golf ball called the “Callaway Hex Chrome.”  While the name is actually derived from the hexagonal shaped dimples on the ball, professionals in the environmental industry may think of Hex Chrome as the shortened name for hexavalent chromium, the toxic version of the chromium species (and of Erin Brockovich movie fame).  Depositing a Hex Chrome into a water hazard from an errant tee shot is not nearly as significant as a hexavalent chromium deposit in a body of water, but it can still spoil a good walk nonetheless.  Despite its name, the ball is on Golf Digest’s 2013 hot list.  What’s next?  Might we expect a competing Dioxin golf ball in 2013?

REACH and CLP in Europe

Guest article by ToxStrategies, Inc.

European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substancesAs the second registration deadline for the European Union (EU) regulation, Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) passes, now is a good time to take inventory of your company’s responsibilities.  REACH became effective on June 1, 2007, aimed at improving the protection of human and environmental health, promoting alternative hazard testing methods, and enhancing competition among the EU chemical industry.  REACH places the burden of proof on companies, and as such, manufacturers and importers of all chemical substances in the EU must comply with requirements to identify, manage, and communicate risks associated with their chemicals.  In addition to REACH, the Classification, Labelling, and Packaging (CLP) regulation effective in the EU in January 2009, aligned the method of classifying and labeling hazardous chemicals under REACH with the United Nations’ Globally Harmonized System (GHS).  The transition from classification and labeling under the previous Dangerous Substances and Dangerous Preparations Directives to CLP will be complete in 2015.  Under REACH and CLP, chemical companies must submit key information on substances and mixtures including minimum data on human health and environmental hazards, risk characterization, and demonstration of safe use by workers and consumers to the European Chemicals Agency (ECHA).  Once registered, ECHA conducts evaluations of the dossiers to determine compliance with minimum information requirements.  Subsequently, selected dossiers will undergo detailed evaluations by EU Member States to determine whether risks associated with exposure to the chemical are adequately managed.  In cases for which safe use cannot be demonstrated, the authorities can restrict use, or even require substitution, of hazardous substances.

To date, 32,049 registrations have been submitted and another 3,097 are expected by the May 2013 deadline set for substances manufactured or imported in the EU in quantities of 100 to >1,000 tons/year or more.  The remaining deadline of May 2018 applies to all chemicals with production volumes of 1-100 tons/year.  ToxStrategies can help your company check whether your chemical of interest has already been registered.  If registration is needed, we can assist you in joining the appropriate Scientific Information Exchange Forum (SIEF) and determine whom the Lead Registrant for your substance will be.  Exporters to the EU also need to determine if they should register using an EU-based entity known as an Only Representative.  ToxStrategies can also help get a strategy into place so you can start as soon as possible gathering information on substance identification, intrinsic properties, and uses in order to draft a Chemical Safety Report.  In addition to new registrations, companies who have previously registered substances should continue to update their registration dossiers with new data or when changes in production volume or other factors warrant submission of additional information.  Even if you are not an EU-based manufacturer, your company should take steps to determine if REACH applies to you as an importer or a downstream user.  Let our team of experts help you with your REACH needs by contacting Dr. Rayetta Henderson of ToxStrategies
(; 919-797-9938;

California Proposition 65: Omnibus Consumer Product Enforcement Act

California Proposition 65 LawThe California law known as Proposition 65, formally titled “The Safe Drinking Water and Toxic Enforcement Act of 1986,” can accurately be thought of as “Omnibus Consumer Product Enforcement Act.”  The law was enacted to improve public health by reducing exposure to toxic chemicals.  More specifically, Proposition 65 controls a growing list of chemicals and substances believed to have the potential to cause cancer, birth defects, or other reproductive adverse effects.  It is administered by the Office of Environmental Health Hazard Assessment, which is part of the California Environmental Protection Agency.  Proposition 65 requires businesses to notify Californians about significant amounts of chemicals in the products they purchase, in their homes or workplaces, or that are released into the environment.  These chemicals can include ingredients or additives in household or workplace products and foods, and can even include byproducts of chemical processes.

Since it was first published in 1987, the list has grown to include approximately 800 chemicals. For carcinogens, the toxicity of a chemical is based on no more than one excess cancer risk in 100,000 individuals exposed to that concentration of the chemical over 70 years.  For non-carcinogens, an additional 1000-fold margin of safety is applied to the more conventional benchmark for toxicity that is based on an exposure concentration shown to have no effect on humans or, more often, laboratory animals.

Once a chemical is listed, businesses have a year to comply with listing requirements, including posting warnings about toxic chemicals associated with their operations.  The warning requirement states that, “no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual.”  Suppliers of food, water, and other exposure media are required to show that a properly applied method of detection and analysis was followed, where “method of detection and analysis” means a specific analytical testing procedure appropriate for detecting a particular chemical in a particular matrix such as air, water, soil, or food that is applied for the purpose of detecting the chemical or measuring its concentration (Section 12900 ARTICLE 9. MISCELLANEOUS, 22 CCR 12900).  This vague, circular language is an insufficient basis for identifying a concrete, technically valid testing regimen.  The supplier will likely need assistance from specialists to address this requirement.

Proposition 65 has established safety thresholds, also called safe harbor numbers, for some 300 listed chemicals based on conservative exposure assumptions, leaving about 500 chemicals currently without safe harbor numbers.  If a chemical is not listed, companies using such chemicals have the onus of developing exposure information.  Here again, the supplier will need assistance from specialists versed in the finer points of exposure assessment and analytical validity.  Environmental Standards provides expertise in the evaluation of sampling and analytical methodology.  We have assisted in litigation and laboratory evaluation for Proposition 65 cases and stand ready to support our clients through this challenging process.  A copy of the current Proposition 65 list can be found here.

Measurement of Radionuclides

NORM-signThe PA DEP will be evaluating the potential association of NORM and TNORM with oil and gas activities.  Uranium and thorium natural decay chains and their progeny, including radium and radon in produced and flowback water, drilling waste, and sources of offgassing, will be evaluated.  Elevated levels of salts and minerals can cause interferences in these matrices, underscoring the need to carefully follow the field and laboratory quality assurance steps in each analysis.

Radium-226 and Radium-228 are important species that will be evaluated in this study.  Their utility as NORM/TNORM indicators stem from several factors, including the relative mobility of radium as an alkali earth element; the relatively long half-life of 226 and 228, at least from a laboratory perspective; and their redox-insensitive nature in the environment.  The methods for analysis that the PA DEP have chosen include EPA Method 903.1 and DOE Ra-04, Rev 12 for radium-226 and a method by Brooks and Blanchard for radium-228 in water.  These methods utilize barium sulfate co-precipitation and additional successive steps to remove potential interferences.  The method actually measures the radon decay progeny (alpha decay to radon-222) of radium-226 via scintillation counting.  Radium-228 on the other hand undergoes beta decay and will entail gas proportional counting of the decay product of radium-228 that is assumed to be in secular equilibrium in the laboratory.

Important components that need to be included in these methods are:

  • Back correction to the sampling time
  • Background levels and counting relative to samples
  • Yield calculation
  • Efficiency of counting
  • Comparison with gross alpha/beta and an understanding of the limits of correlating these results with the individual species

Because these results will inform future actions by the state and possibly beyond Pennsylvania, energy development and production companies would be wise to follow the development of the PA DEP radionuclide project.

In the next article, we will look at the issues with direct radon measurement in the gas phase, something hinted at by the PA DEP in their sampling and analysis plan (offgasing).  Radon measurement is not particularly difficult, but there can be difficulty with getting an accurate assessment of the numerator used to report concentration units (flux or volume).

Revised Total Coliform Rule

The Total Coliform Rule (TCR) was published by the US EPA in 1989 and went into effect in 1990.  It is the only microbial drinking water regulation that applies to all public water systems (PWSs). After considering 134 comment letters, the US EPA promulgated the Final Revised TCR on February 13, 2013; the new Rule is required to be implemented by April 1, 2016.  The Revised TCR (RTCR) includes several key provisions affecting monitoring, assessment and corrective action, seasonal systems, and public notification.

drinking water regulation

For monitoring activities, the RTCR maintains the same routine sampling structure of the TCR, but allows PWSs to transition on their existing TCR monitoring frequency based upon re-evaluation of sanitary surveys.  Additionally the RTCR reduces the number of required follow-up samples for PWSs that serve less than or equal to 1,000 people, both for the collection and analysis of repeat samples and for additional routine follow-up samples.  The RTCR, however, provides more stringent criteria that systems must achieve to qualify for a reduction in monitoring and requires small PWSs to increase monitoring if they have problems.  The RTCR defines seasonal water systems (SWSs)and requires these systems to employ start-up procedures and a sampling frequency that aligns with periods of high vulnerability.  Should any sanitary defects be found when the monitoring results indicate that the water system might be vulnerable to contamination, the RTCR requires that the SWSs investigate and correct these sanitary defects.  Additionally, the RTCR requires that SWSs conduct a Level 1 basic self-assessment or a Level 2 more detailed assessment by a qualified party, based upon the severity and frequency of the contamination issue identified.

PWSs are expected to comply with the RTCR by April 1, 2016, although some states have indicated that they may pursue earlier implementation of the Rule. The US EPA headquarters anticipates providing training to regions and states later this year and into early 2014.  Additionally, the US EPA plans to release the following Guidance Manuals over the next couple of years: Assessments and Corrective Actions, Small System Guidance, Quick Reference Guide, State Implementation Guide, and other fact sheets and templates.  To view the new RTCR, visit the US EPA website.

Environmental Standards Employees Wrap Up Inaugural Bowling League

employee bowling league

The Environmental Standards employee bowling league completed a successful inaugural season this spring.  Organized by Project Geoscientist Angela Powley, the 12-week league wrapped up with trophies awarded for:

  • Outhouse Award (most # of 111 final scores) – Mark Haslett (Geosciences)
  • Most Erratic (highest standard deviation) – Aaron Smith (Chemistry)
  • Most Improved – Heather Murdoch (Chemistry)
  • Most Enthusiastic – Megan Filipovits (Geosciences)
  • Queen Pin – Meg Harnsberger (Information Technologies)
  • King Pin – Tyrone Rodriguez (Information Technologies)
  • Highest Score of the Season – Heath Brown (Geosciences)