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The Standard
March 2009 - Page 4

Guidance For Validation Of Superfund Data
The US EPA has published a guidance document titled “Guidance for Labeling Externally Validated Laboratory Analytical Data for Superfund Use” (dated January 2009). This document was written specifically for the Contract Laboratory Program and its deliverables and analytical procedures. The guidance, which is applicable to chemical and radiochemical analytical data, focuses on the definition and labeling of data verification and validation efforts. The labeling of the data verification and validation is intended to be incorporated into the electronic data deliverable such that the procedures used to carry out the data verification and validation processes can be easily identified. This guidance document does not address the evaluation of sample collection or data usability of analytical data.

Five data verification and validation stages are presented and defined in the document.

Stage 1 Validation is a verification and validation based only on completeness and compliance of sample receipt condition checks.
Stage 2A Validation is a verification and validation based on completeness and compliance checks of sample receipt conditions and only sample-related QC results.
Stage 2B Validation is a verification and validation based on completeness and compliance checks of sample receipt conditions and both sample-related and instrument-related QC results.
Stage 3 Validation is a verification and validation based on completeness and compliance checks of sample receipt conditions, both sample-related and instrument-related QC results, and recalculation checks.
Stage 4 Validation is a verification and validation based on completeness and compliance checks of sample receipt conditions, both sample-related and instrument-related QC results, recalculation checks, and the review of actual instrument outputs.

Of note is that this guidance document defines analytical data verification as generally consisting of a completeness check to confirm that all data requested from the laboratory have been received and comply with the project control documents (e.g., Quality Assurance Project Plan, Work Plan). In addition, analytical data validation is defined as generally consisting of an analyte-specific and sample-specific process for evaluating compliance of the data received with methods, procedures, or contract requirements.

US EPA's Most Wanted List
arrest Environmental laws are still laws and breaking them can lead to serious fines and jail time for those who get caught. What types of people knowingly commit environmental crimes? Some of the worst are compiled on US EPA’s Most Wanted List. Mug shots and all, the website lists fugitives who are defendants charged with environmental crimes or violations of the U.S. Federal Criminal Code. These individuals have fled the court’s jurisdiction and/or the country rather than face prosecution or serve a sentence and are currently considered fugitives from justice. The colorful bunch is charged with crimes ranging from smuggling R-12 Freon^® from Mexico for sale in the US to discharging pollutants into a major US river through a secret pipe installed at a chemical facility, to dumping tons of oil-contaminated grain into the open ocean. One fugitive is responsible for illegally placing chemical oxygen generators containing hazardous substances in the cargo hold of a passenger plane; the generators, which were not properly prepared or packaged for shipping, resulted in a fire causing the plane to crash killing all 110 people on board.

Some of the fugitives are listed as potentially armed and dangerous and the US EPA advises against citizens attempting to apprehend these individuals; the website provides fugitive location forms and telephone numbers for local US EPA Criminal Investigation Division offices that should be used if a fugitive is sighted.

In 2008, the US EPA successfully apprehended two fugitives - one individual who is currently serving a sentence related to the discharge of de-icing chemicals into the Colorado River and the second constructed a subdivision development that significantly impacted a wetland area, (resulting in a 33-month jail sentence). In 2004, this individual escaped from jail and fled to Mexico but was captured in 2008 and deported to the US where he is currently facing multiple charges.

Most recently, the US EPA apprehended a former environmental consultant who had been indicted in New York on a 30-count indictment, charging mail fraud and money laundering. The indictment is seeking the forfeiture of over $5.9 million. This fugitive fled to India prior to his indictment in 2004. Following his extradition from India, the individual was taken into custody by US EPA Special Agents at JFK International Airport on February 18, 2009.

US EPA’s criminal enforcement program was established in 1982 and was granted full law enforcement authority by Congress in 1988. The program was greatly expanded with the enactment of the 1990 Pollution Prosecution Act. The US EPA criminal enforcement program has successfully prosecuted significant violations across all major environmental statutes, including data fraud cases (e.g., private laboratories submitting false environmental data to state and federal environmental agencies); indiscriminate hazardous waste dumping that resulted in serious injuries and death; industry-wide ocean dumping by cruise ships; oil spills that caused significant damage to waterways, wetlands and beaches; international smuggling of CFC refrigerants that damage the ozone layer and increase skin cancer risk; and illegal handling of hazardous substances such as pesticides and asbestos that exposed children, the poor, and other especially vulnerable groups to potentially serious illness.

US EPA Takes Position On TCE Toxicity Values
At long last, the US EPA has taken a position on trichloroethene (TCE) toxicity values for use in human health risk assessments. TCE toxicity values have been in debate since 2001 when the US EPA published a highly criticized draft health assessment for TCE. In a January 15, 2009, memo, US EPA’s Office of Solid Waste and Emergency Response (OSWER) officially stated that the draft 2001 health assessment, titled Trichloroethylene Health Risk Assessment: Synthesis and Characterization, should not be used as a source of toxicity values because draft documents are not included in US EPA’s three-tiered hierarchy of toxicity information sources. The memo encourages US EPA Regional Offices to cease using the 2001 draft toxicity values.

The recently published memo identifies the California Environmental Protection Agency (CalEPA) inhalation unit risk value of 2.0×10^-6 (μg/m3)^-1 as the currently acceptable inhalation toxicity value for assessing cancer risks. The memo also recommends the use of CalEPA’s oral cancer slope factor of 0.013 mg/kg-day for estimating cancer risks from oral exposures to TCE. For assessing non-carcinogenic inhalation exposures, the US EPA recommends two values - the New York State Department of Health’s 10 μg/m3 air criterion and the CalEPA’s 600 μg/m3 Reference Exposure Level (REL). An RfC of 40 μg/m3 was recommended in the draft 2001 health assessment document.

OSWER also identifies an indoor air concentration of 1.2 μg/m3 for TCE corresponding to a cancer risk level of 1×10^-6 as a point of departure for determining remediation goals. A concentration range of 1 μg/m3 to 120 μg/m3, corresponding to a risk range of 1×10^-6 to 1×10^-4, is considered generally acceptable by OSWER as indicated in the memo.

Vapor intrusion exposures are also addressed in the 2009 memo. OSWER suggests that for TCE and other volatile contaminants, multiple lines of evidence are necessary to adequately characterize the vapor intrusion pathway. That is, no single media data set (e.g., soil, groundwater, soil gas, indoor air, sub-slab air) can be used to fully evaluate the potential for vapor intrusion risks because of the high number of variables affecting the transport of vapors from the subsurface to indoor air and because of the confounding influence of background (indoor) sources of common contaminants.

Finally, the memo reiterates that the US EPA has not officially published the recommended toxicity values in its Integrated Risk Information System (IRIS) database and that the toxicity values may change as new information becomes available. The values identified in the 2009, however, memo should be used until IRIS is updated. It should be noted that when IRIS is updated for TCE, OSWER may review data to ensure that sites addressed under the current approach remain protective if IRIS publishes toxicity values different than those currently recommended by the US EPA in its 2009 memo.

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