THE STANDARD – DECEMBER 2014
If you were to visit the website of Appalachian Laboratories, Inc., you would see a link to a 2007 Certificate of Excellence. If you were to search Google for “Appalachian Laboratories, Inc.” today, you would see such titles as, “Lab official admits faking coal water quality reports,” “State environmental board to decide if lab can stay open,” and “DEP to require new mine water samples because of lab controversy.”
John W. Shelton, Field Supervisor, admitted to a charge of conspiracy to violate the federal Clean Water Act (CWA) in October. Assistant US Attorney Blaire Malkin alleged that Mr. Shelton began the fraud when he was hired in 2008, and that he continued through his employment which ended in July 2013. Mr. Shelton implicated other laboratory employees, including the laboratory manager John Brewer. Court records show Mr. Shelton and other laboratory employees “falsified and rendered inaccurate” water samples by diluting them or replacing them with water they knew to be in compliance with permit standards and not keeping water samples temperature preserved as required.
One may ask “why?” The charging document alleges, “The objects of the conspiracy were to increase the profitability of Appalachian by avoiding certain costs associated with full compliance with the CWA and to maintain and increase its revenue by providing its customers and the agencies regulating those customers with reports purporting to show that those customers were operating their sites in compliance with the CWA and thereby allow those customers to avoid fines and other costs associated with bringing their operations into compliance with the CWA and thus encourage and maintain for Appalachian the patronage of those customers.”
Sadly, the quality and defensibility of analytical data are often unknown and as is the case with Appalachian Laboratories, frequently called into question. Five years of compliance samples are now suspect. Based on a lending institution’s May 2014 survey of 20 environmental consultants, cost, not quality, was reported as the number one driver of laboratory selection. This behavior in the market presents a very real risk to any industry relying on analytical data to make business decisions and defend its practices. In addition, and as proven in the Appalachian Laboratories case, an often-ignored factor affecting environmental data quality is the manner in which samples are handled in the field.
As of the writing of this article, Appalachian Laboratories remains certified by the West Virginia Department of Environmental Protection (WVDEP). The WVDEP performed an on-site audit of Appalachian Laboratories in May 2013; the laboratory scored 98.5 out of 100. One may ask; how this is possible and what can the industry do to protect against laboratory fraud? A strong laboratory and sampling consultant quality assurance (QA) program is the key to managing this risk.
QA program services offered by Environmental Standards, Inc. include assistance in laboratory selection, third party laboratory audits, data validation, conducting double-blind performance evaluation programs, designing client-dedicated analytical technical specifications, sampling consultant selection, consultant evaluations, quality assurance of sample and field data collection via client dedicated SOPs, field audits, and training.
Perfluorinated chemicals (PFCs) are man-made, super chemicals. PFCs have unique properties due to the incredible strength of the carbon-fluorine bond. PFCs have been widely used since 1950 due to their resistance to heat, friction, moisture, oil, and other chemicals. Aerospace, alternative energy, automotive, construction, electronics, military, petrochemical, and other industries rely on the use of PFCs. PFCs are utilized in the production of many everyday consumer products including nonstick cookware, food packaging, cosmetics, furniture, clothing, and carpeting. Fluorochemical-based surfactants in aqueous film-forming foams (AFFFs) block oxygen from feeding fuel fires and prevent the release of flammable fuel vapors. PFCs may be present in various goods as a by-product of manufacturing, as an impurity, or as the product itself.
PFCs have become ubiquitous in the environment because of their stability and wide-spread use. PFCs have been detected in water, soil, air, wildlife, and humans throughout the world. Perfluorinated alkyl acids (PFAAs), especially perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA), are the most commonly discussed PFCs in scientific literature and by regulators. PFOS and PFOA were included on the 2009 final contaminant candidate list three for consideration under the Safe Drinking Water Act and six PFAAs are currently being monitored under the Unregulated Contaminant Monitoring Rule. Additional regulatory notification rules and other proposed rulemaking has been made by US EPA under Toxic Substances Control Act (TSCA) based on the 2009 long-chain PFC action plan. Long-chain (with carbon chain lengths of eight or greater) PFAAs are bioaccumulative in wildlife and humans and considered toxic to laboratory animals and wildlife, producing reproductive, developmental, and systemic effects in laboratory tests. PFAAs may enter the environment through industrial release (e.g., via effluent, emission, and/or landfill), consumer product use and disposal, application of AFFFs in firefighting and training, and the degradation of larger compounds and polymers that contain a perfluoroalkyl functional group.
Environmental Standards, Inc. personnel have observed an increase in the frequency regulators request PFAA analyses since 1999, when we were first asked to help in the development of an analytical procedure for the analysis of PFOA by a Fortune 100 client. A handful of commercial laboratories responded to the need for PFAA analysis and developed their own varied, proprietary methodologies. The US EPA has since introduced an analytical method for drinking water (US EPA 537) and the number of laboratories offering PFAA analysis has been growing. Various procedural differences amongst these laboratories can lead to data quality and comparability issues. Environmental Standards, Inc. personnel have observed differences through auditing and data validation activities of many of the laboratories offering PFAA analysis. Although the laboratories generally use the same instrumentation (LC/MS/MS), there can be significant differences in sample preparation and introduction to the instrument as well as differences in calibration and quantitation techniques. Examples include the strict avoidance of glass versus the use of glass fiber filters, use of materials that may contain PFCs in the laboratory, differences in the parent/daughter transitions monitored, presence or absence of branched isomers in addition to linear isomers in standards, evaluation for branched isomers, and the number and types of isotopes used. Contact Principal Chemist David R. Blye or Senior Technical Chemist Meg A. Michell at 610.935.5577 to discuss how Environmental Standards can assist you with PFAA analysis needs.
Chevron Appalachia is the first company to be certified by the Center for Sustainable Shale Development (CSSD). The CSSD is a non-profit organization serving as a center of excellence for shale gas development. It represents a unique collaboration bringing together diverse stakeholders such as the Environmental Defense Fund, Clean Air Task Force, Pennsylvania Environmental Council, Chevron, Shell, EQT Corporation, and Consol Energy. Focusing on the Appalachian Basin, the Center’s mission is to help ensure environmentally safe resource development through innovative practices, performance standards, and third-party certification.
Achieving CSSD certification requires that a company meet 15 performance standards that are protective of the air quality, water resources, and climate. These standards are intended to set a bar above and beyond both State and Federal government regulation to demonstrate responsible stewardship. In April of 2014, Chevron applied for certification and successfully underwent an independent review conducted by an outside Auditor. The certification is valid for two years. President of Chevron’s Appalachia business unit, Nigel Hearne is quoted as saying that “progress can best be achieved through collaboration – not conflict.” CSSD standards reinforce Chevron’s own focus on environmental standards and culture of responsible development. Standards of performance include limitations on flaring, use of green completions, reduced engine emissions, emissions controls on storage tanks, maximizing water recycling, development of groundwater protection plans, closed loop drilling, well casing design, groundwater monitoring, wastewater disposal, impoundment integrity, and reduced toxicity fracturing fluid.
Chevron is at the vanguard as companies move beyond compliance towards a social license to operate. This trend is driven not only by the public, but investors as well. Exxon recently released a report that outlines for shareholders how the company addresses risks associated with unconventional gas development. A coalition of investment firms and institutional investors spearheaded by Boston Common Asset Management with nearly $1 trillion in assets has been advocating for transparency to assist investors in making informed decisions. Environmental Standards, Inc. continues to work with the industry playing an important role in ensuring sound science and effective information management to support commitments to both compliance and stewardship.
Potential Environmental Standards clients may be hesitant at first to enlist us to handle what they see as a big project, but our current customers tell us that we have proven time and again that sometimes it pays to hire David instead of Goliath. Here are five reasons why a smaller-sized environmental company is, more frequently than ever, bringing in business that used to go to the ENR 200 firms.
1. The Professionals Doing the Work
Large firms may have an overall numbers advantage over their smaller counterparts, but only a handful of people will be handling any given project. It’s the quality of the specific people who will be working on your project that matters. Clients need to remember that they are not hiring 700 or 800 people; you’re hiring a small team of experienced professionals that, in the case of a small firm, happen to be subject matter experts that are part of a smaller shop. If you have more than four or five people on any given project, it usually means you are overstaffing.
2. Cost Savings and Flexibility
We can be generally both cheaper and more nimble than big behemoths, and those traits can be enough to make our bigger clients consider giving the work to us. Without being boxed in by a traditional cost structure, smaller firms have the freedom to get creative and show clients that we are able to adjust to their needs. Small companies can offer more flexible, creative, or aggressive billing arrangements than larger firms that have fixed hourly rates, big contract requirements, and who are often more concerned with meeting monthly billing or income requirements. Ultimately, it’s up to us to show the client that saving money and gaining flexibility is worth taking a risk and moving away from a bigger firm.
3. Every Project Counts
A smaller firm with a limited track record of handling large projects can still show it has the skills to rumble with the major players by getting the job done. It’s critical we perform at a high level even when there may not be an obvious pot of gold waiting at the end of the project. We have to dot every ‘i’ and cross every ‘t’ in a way that builds a good reputation. We will get a reputation, for better or for worse. People will talk. And we may not even know when we take a project that we’ve hooked a big one. For instance, while we might have done a laboratory audit for $3,000, we find that the same client can hand us a $1 million project right behind it. We pick up clients in different ways, we may even pick them up being on the other side of the table in an environmental matter. We’re working on a transaction or a piece of a project, and we become noticed.
4. Although Small, We’re Noticed
Nothing works better than continued success. Our clients and competitors notice when we consistently beat an agency at its own game and with that reputation comes opportunity. It is far from easy, and most can’t get there, but there are enough talented people here that are worthy of being retained to bring home the big results and they do so time after time.
5. We Know When to Jump In (or Not)
Smaller firms also have to be careful to choose their spots carefully. We only get one chance to make a first impression with a potential client. We have our own set of skills and it’s best for us to wait until we find a project that’s a good fit. We understand our strengths and weaknesses and if our firm doesn’t fit the project, we don’t pursue it.
A smaller firm needs to remember that clients often associate big firms with comfort and credibility, and perceive a risk in going with a smaller company; many of our professionals have a big company background and extensive project experience on large projects. We have the references to prove it.
Pharmaceutical companies typically handle current Good Manufacturing Practices (cGMP) deficiencies internally with the assumption that these technical and operational issues pose relatively little risk of civil liability or criminal enforcement. However, with the US Department of Justice’s hightened focus on cGMP violations as a potential basis for criminal and civil liability, companies are being increasingly penalized as the result of cGMP violations. In fiscal year 2013, this trend was confirmed when the federal government recovered approximately $4 billion in criminal fines and civil settlements related to health care fraud, a substantial portion of which came from pharmaceutical and medical device companies1.
The US Food and Drug Administration (FDA) issued over 5,000 Form 483 observations which are used by the FDA to document and communicate concerns during an inspection, and 43 warning letters to drug or medical device manufacturers with regards to cGMP deficiencies in fiscal year 2013 alone. Six of these letters were specifically concerned with data integrity issues, a number that continues to increase, as 5 warning letters questioning data integrity were already issued by June of this year. The third most frequent cause for a delayed FDA submission is poor data integrity, which can potentially cost pharmaceutical companies $11,000 per day in lost sales if the submission is eventually declined.
While data integrity is expected when submitting an FDA application for scientific review and approval (e.g., IND, NDA, ANDA, BLA), the FDA has acknowledged that this is an emerging issue; specifically the sophistication of which electronic records are being manipulated. Data that lack integrity are unreliable and damage the assurance and confidence in a drug’s safety, efficacy, and quality, but most importantly, data integrity issues can lead to situations that render the product as being adulterated, breaking the trust of consumers and severely impacting business. In order to ensure data integrity, pharmaceutical companies must take a more comprehensive approach towards data review and increase the amount of time and money put into training of inspectors. However, the lack of hands-on experience with instrument software, coupled with a lack of an in-depth understanding of the analytical technique, makes this a very lengthy and expensive process. Unless the company calls on a quality assurance firm for assistance, it must be willing to invest time and money into raw data validation, and more in-depth laboratory audits in order to confirm that the information presented in electronic records is accurate and conforms to regulatory standards.
The team at Vitale Scientific Associates, LLC (VSA) has years of experience reviewing and validating data packages related to all phases of pharmaceutical development, from pre-clinical through Phase I-IV data packages, to ensure our clients’ data are suitable for their intended purpose and will withstand rigorous regulatory scrutiny. Our team of expert analytical chemists and biologists provides efficient and time-sensitive solutions for technical or quality assurance needs. For more information, contact Principal Chemist David Thal or Senior Quality Assurance Chemist Evan Ogburn at 865-376-7590.
1The Department of Justice, Office of Public Affairs, 01/09/2014.
Food fraud is a growing problem and many common foods can be subject to fraudulent activities, from unintentional mislabeling to malicious adulteration. A variety of analytical, molecular, and even forensic microscopy techniques can be used to determine if companies are claiming that a food is something other than what it is by illegally cutting a primary ingredient with something less expensive and/or more toxic. Three popular foods that have been subject to rampant abuse are olive oil, fish, and honey.
One study found that 69 percent of imported olive oil labeled “extra virgin” did not meet, in organoleptic testing (taste and smell characteristics reported by trained experts), the standard. Olive oil is commonly cut with other less expensive oils like sunflower seed or soybean oil. Worse yet, vegetable oil cut with beta carotene (to disguise the flavor) and chlorophyll (to enhance coloring) can be passed off as olive oil. Detecting adulterated olive oil can be difficult, but laboratories can use a variety of analytical chemistry methods to detect fraud. Nuclear magnetic resonance has been used successfully and individual triglycerides can be analyzed using capillary gas chromatography with flame ionization detection. Alternatively, olive oil pigments can be assessed for authenticity using near ultraviolet-visable absorption spectra based on four oil pigments: utein, pheophytin-a, pheophytin-b, and β-carotene. This process is inexpensive and can be processed in a matter of minutes.
- 100% of the sushi bars tested sold mislabeled fish
- Tilefish, on the FDA’s do-not-eat list because of its high mercury content, was substituted for red snapper and halibut in a small market
- 94% of the “white tuna” was not tuna at all, but escolar, a snake mackerel that has a toxin with purgative effects on people who eat more than a small amount of the fish
- 58% of the 81 retail outlets sampled sold mislabeled fish (three in five)
The US Food and Drug Administration is attempting to combat fish species substitution with new DNA-sequencing equipment in many of its major laboratories across the country. The agency is using DNA barcoding, which is a molecular technique that uses a short marker in an organism’s DNA for phylogenetic characterization using a library of bar codes for species. This technique has been successfully employed to assess whether a given fish filet actually belongs to a particular species.
Food Safety News reported that most of the honey sold in stores is not actually honey. In fact, more than three-fourths of the honey sold in US grocery stores has been adulterated. Instead, manufacturers are generating sweet-tasting syrups out of cane sugar, corn syrup, or a dozen other sweetening agents, which is much more inexpensive than getting honey directly from bees. The only way to tell definitively whether honey is natural is to microscopically measure the pollen in honey. Most of the honey sold in the US, however, has had the pollen filtered out.
Environmental Standards, Inc. is pleased to announce that we are a certified EarthSoft Business Partner. EarthSoft partners with consultants who can provide implementation and custom services for EQuIS™ software products. When you work with a certified EarthSoft Business Partner, you can be certain that they have the EQuIS licenses and skills necessary, supported by EarthSoft’s industry leading EQuIS software.
In late June, EarthSoft announced plans for a large-scale deployment of its EQuIS environmental data management software solutions for the US Department of Energy’s (US DOE’s) Office of Legacy Management; migration of environmental data for more than 90 facilities from in-house Oracle systems into EQuIS is anticipated.
The DOE purchased EQuIS Enterprise 6 Gold, 15 licenses of EQuIS Professional, unlimited Distribution Licenses of EQuIS Data Processor (EDP) and EQuIS Data Gathering Engine (EDGE), and significant services for a phased implementation beginning later this year across their portfolio of sites such as Rocky Flats, Fernald/Mound, Weldon Springs, and other facilities. Many of the services will be provided by Environmental Standards.
The decision to migrate to EQuIS was made upon successful conclusion of an extensive pilot evaluation conducted collaboratively in 2013 by the DOE and another contractor.
EQuIS Enterprise 6 provides the US DOE with an extremely robust high-volume commercial environmental data management system specifically configured for comprehensive task management, data checking and loading (EDP), data validation, loading and storage from dataloggers (EQuIS Live), field data collection using EDGE, and flexible reporting and visualization including the Esri web API.
The DOE project is just one of many EQuIS implementations completed by Environmental Standards.
During the summer and fall of 2014, Environmental Standards attended the Pennsylvania Department of Environmental Protection’s (PA DEP’s) annual regulatory update meetings sponsored by PA DEP and the Society for Women Environmental Professionals. The meetings were held at PA DEP’s southeast regional office in Norristown and the central office in Harrisburg.
The discussions were primarily focused on the proposed revisions to Chapter 250 and new draft technical guidance. The proposed rulemaking was published in the Pennsylvania Bulletin on May 17, 2014. Public comments were due on June 17, 2014, and the anticipated promulgation of the revisions is anticipated in early 2015. Notable changes to Chapter 250 include:
- There will be more flexibility in documentation of public notices regarding Notices of Intent to Remediate (NIRs) and reports. In the past, a certified mail receipt and notarized public notice were required.
- Report fees will be waived for resubmission of a report due to minor deficiencies. In the past, a report resubmission required new fee submittal.
- New carcinogenic equations have been developed for trichloroethylene (TCE) since TCE is now classified as a mutagen.
- Revisions to the medium-specific concentrations (MSCs) were proposed due to the following: new toxicological information from the United States Environmental Protection Agency (US EPA); some new substances have been added; and the US EPA has changed the average body weight of an adult from 70 to 80 kilograms.
- It is also worth noting that US EPA’s Office of Solid Waste and Emergency Response (OSWER) has recently updated many other exposure factors. The updates include: average water ingestion has been changed from 2 liters per day to 2.5 liters per day; and the residential exposure duration has been changed from 30 years to 26 years. Unfortunately, these changes will not be reflected in the new PA DEP MSCs due to the timing of the PA DEP release in relation to the US EPA updates.
- Emphasis was also placed on the synergy and ongoing need for cooperation between the Waterways and Wetlands Program (storm water) and the Environmental Cleanup Program. The objectives of both programs need to be taken into consideration when designing the cleanup and redevelopment of environmentally challenged sites. For example, it is not prudent to infiltrate storm water in an area of soil or groundwater contamination.
The meeting also provided information on proposed updates to the technical guidance documents for light non-aqueous liquids (LNAPL) and vapor intrusion (VI). The LNAPL guidance document addresses Act 2 and underground storage tank corrective action sites, and provides guidance on: determining extent and volume, LNAPL removal, assessing exposure pathways, and managing remaining LNAPL. The current VI guidance has not been updated since 2004, and applies to the Statewide Health Standard only. Site-specific guidance for VI has yet to be written. The proposed revision to the VI guidance includes current and future buildings, assessment options, petroleum exclusion distances, and other assessment and mitigation options.
Earlier this year, the US EPA and the US Army Corps of Engineering (USACE) jointly issued a proposed rulemaking that would redefine the term “waters of the United States” under the Clean Water Act (CWA), and in turn, redefine the scope of the federal agencies’ regulatory authority under the CWA and revise regulations that have been in place for more than 25 years. These revisions are proposed in light of 2001 and 2006 Supreme Court rulings that interpreted the regulatory scope of the CWA.
The effect of the US EPA and USACE proposal will expand jurisdiction and assert new regulatory authority over non-navigable waters, seasonal flows, wetlands, seeps, intermittent streams and wetlands, isolated ponds, isolated marshes, flood plains, and additional waters with no direct connection to navigable waterways. These waters have not been previously regulated under the CWA. The proposed rule also excludes specified waters from the definition of “waters of the United States.” The listed waters and features would not be jurisdictional even if included within the categories that are considered jurisdictional. The excluded waters include waste treatment systems, prior converted cropland, artificially irrigated areas that would revert to upland should application of irrigation water to the area cease, ditches that are excavated wholly in uplands and have less than perennial flow, and ditches that do not contribute flow to traditional navigable waters.
These changes have caused many individuals to express concern that the proposed rule will greatly expand the reach of the CWA beyond what Congress intended. From the inception of the CWA, the US EPA and USACE have applied a very broad interpretation of “waters of the United States.” However, if the proposed rule goes into effect, it will be entitled to much greater weight in the courts with the informal agencies’ policy interpretations than it is currently, and the power of the US EPA and USACE to assert CWA jurisdiction could increase significantly. Our country’s farmers have great concerns – under the proposed rule change, groundwater streams, gullies, and erosion channels, which are all prominent features on farms, would now be included under the proposal. The proposed change could potentially cause farmers difficulty because they would be required to obtain additional permits to comply with the CWA.
The proposed rule will result in more permitting requirements, environmental impact analyses, mitigation requirements, and lawsuits. The impact will be felt by the entire regulated community and average Americans, including landowners and small businesses that are unable to absorb the additional cost.
If you would like to know more about how these proposed changes could impact your business please contact us at 610-935-5577.