Analytical Test Method Requirements: An Enforcement Perspective
Oral Presentation
Prepared by J. Morgan
USEPA, OECA, Office of Criminal Enforcement, Forensics and Training, USEPA Headquarters - WJC Building South, 1200 Pennsylvania Ave., N.W., Mail Code: 2232A, Washington, DC, 20004, United States
Contact Information: morgan.james@epa.gov; 202-564-7684
ABSTRACT
The Clean Water Act (CWA) and the Safe Drinking Water Act (SDWA) created national regulatory programs administered by the Environmental Protection Agency (EPA or Agency) and the Agency in turn may authorize states to administer these programs. In implementing these regulatory programs the Agency has developed mandatory procedures for sampling and analysis of waters receiving pollutant discharges as well as analytical methods to assess drinking water sources. These procedures are found at 40 CFR Part 136 (CWA) and 40 CFR Part 141 (SDWA). These test methods apply to both federally-run programs and to states that administer CWA and SDWA programs and are mandatory for use and reporting requirements under the respective statutes. Further, states may not authorize variances from or approve alternative test methods unless the EPA Regional Alternate Test Procedure (ATP) Coordinator has granted approval for such alternatives.
The CWA and SDWA rely upon self-reporting to assure compliance with permit limits and other requirements. The system’s integrity relies upon honest reporting of analytical results by the regulated community and their laboratories. Intentionally falsified or fraudulent data could potentially have serious implications for human health and the environment and undermines the self-reporting system and the public’s trust in EPA. For these reasons lab fraud and unethical laboratory practices are considered serious matters subject to civil or criminal liability.
From time to time, EPA’s Office of Enforcement and Compliance Assurance (OECA) receives reports about laboratories falsifying sample analysis, using improper test methods, modifying a test method without approval, falsifying test methods, and/or failing to report that an unapproved test method has been used for compliance purposes. Engaging in such practices places the individuals and laboratories at risk of civil or criminal prosecution. In fact, knowingly reporting fraudulent data to regulatory authorities can potentially result in criminal charges under Title 18 of the United States Code. Such charges include mail fraud, wire fraud, and false statements, all of which can result in significant financial penalties and potential incarceration.
Over the past few years, EPA’s Office of Criminal Enforcement, Forensics and Training (OCEFT) has investigated and, together with state agencies and the Department of Justice, prosecuted laboratories and/or individuals for lab fraud and unethical laboratory practices. This presentation will discuss some of the laboratory practices that OECA has learned about that may be worthy of civil or criminal prosecution and will also present selected case examples of labs and individuals who have had enforcement actions taken against them.
Oral Presentation
Prepared by J. Morgan
USEPA, OECA, Office of Criminal Enforcement, Forensics and Training, USEPA Headquarters - WJC Building South, 1200 Pennsylvania Ave., N.W., Mail Code: 2232A, Washington, DC, 20004, United States
Contact Information: morgan.james@epa.gov; 202-564-7684
ABSTRACT
The Clean Water Act (CWA) and the Safe Drinking Water Act (SDWA) created national regulatory programs administered by the Environmental Protection Agency (EPA or Agency) and the Agency in turn may authorize states to administer these programs. In implementing these regulatory programs the Agency has developed mandatory procedures for sampling and analysis of waters receiving pollutant discharges as well as analytical methods to assess drinking water sources. These procedures are found at 40 CFR Part 136 (CWA) and 40 CFR Part 141 (SDWA). These test methods apply to both federally-run programs and to states that administer CWA and SDWA programs and are mandatory for use and reporting requirements under the respective statutes. Further, states may not authorize variances from or approve alternative test methods unless the EPA Regional Alternate Test Procedure (ATP) Coordinator has granted approval for such alternatives.
The CWA and SDWA rely upon self-reporting to assure compliance with permit limits and other requirements. The system’s integrity relies upon honest reporting of analytical results by the regulated community and their laboratories. Intentionally falsified or fraudulent data could potentially have serious implications for human health and the environment and undermines the self-reporting system and the public’s trust in EPA. For these reasons lab fraud and unethical laboratory practices are considered serious matters subject to civil or criminal liability.
From time to time, EPA’s Office of Enforcement and Compliance Assurance (OECA) receives reports about laboratories falsifying sample analysis, using improper test methods, modifying a test method without approval, falsifying test methods, and/or failing to report that an unapproved test method has been used for compliance purposes. Engaging in such practices places the individuals and laboratories at risk of civil or criminal prosecution. In fact, knowingly reporting fraudulent data to regulatory authorities can potentially result in criminal charges under Title 18 of the United States Code. Such charges include mail fraud, wire fraud, and false statements, all of which can result in significant financial penalties and potential incarceration.
Over the past few years, EPA’s Office of Criminal Enforcement, Forensics and Training (OCEFT) has investigated and, together with state agencies and the Department of Justice, prosecuted laboratories and/or individuals for lab fraud and unethical laboratory practices. This presentation will discuss some of the laboratory practices that OECA has learned about that may be worthy of civil or criminal prosecution and will also present selected case examples of labs and individuals who have had enforcement actions taken against them.
