CEC Research

Clancy Environmental Consultants, Inc. regularly conducts research on microbiological methods and monitoring for the USEPA. A brief history is given below.

Beginning in 1994, CEC developed and tested the protocols for preparing performance evaluation samples for Giardia and Cryptosporidium for the Information Collection Rule (ICR). The results allowed EPA to implement the laboratory quality control program to establish data quality acceptance criteria for the ICR laboratory approval program for labs seeking to participate in the ICR. After development of the sample preparation protocol, two performance evaluation studies were conducted to evaluate the performance of expert laboratories using the ICR method.

In 1995, CEC conducted a field evaluation of the ICR method for Giardia and Cryptosporidium analysis in water. CEC staff traveled to seven water utilities across the U.S. and spiked and collected samples of raw and finished drinking water. The spiked samples were sent to four expert labs for analysis. CEC collected, verified, and analyzed the data, developing the performance criteria for the method.

These two studies clearly showed the poor performance of the ICR method, which is characterized by poor sensitivity and specificity and low recoveries. CEC was quickly tasked with evaluating alternative filters for sample collection and alternative methods for sample processing in hopes of improving the overall method for the near-term, as the ICR monitoring was soon to begin. While modest improvements were made, it was clear that a new method using new technologies was needed in order to make the types of improvements that would enhance data quality.

In 1996, the USEPA tasked CEC with developing such a method. After nine months of research, Method 1622: Cryptosporidium in Water by a Filtration/IMS/FA was developed and tested, and available for use in June 1997 (Clancy, J.L. et al. 1999. USEPA Method 1622. J. Am. Water Works Assoc. 91 (9) 60-67). Shortly afterward, Giardia detection was included and a second method, Method 1623: Cryptosporidium and Giardia in Water by a Filtration/IMS/FA, was delivered. CEC conducted method detection limit (MDL) studies and developed preliminary precision and recovery specifications for the optimized methods for Cryptosporidium and Giardia. Methods 1622 and 1623 were validated in collaborative trials by the USEPA and are now the standard methods used in the U.S. and worldwide for determination of pathogenic protozoa in water.

In 1998, CEC began work on a project co-sponsored by the USEPA and the Water Environment Research Foundation (WERF) to develop specific methods for recovery and enumeration of Cryptosporidium oocysts in wastewater matrices. In 2001 and 2002, the USEPA asked CEC to analyze wastewater samples from the meat products industry for the presence of Cryptosporidium oocysts using the newly-developed methods. These wastewater methods have now been finalized and are being adopted by the USEPA as standards for wastewater (Method 1693).

In 2007, the USEPA Health and Ecological Criteria Division awarded a three year contract to Clancy Environmental for "Technical and Regulatory Support for the Development of Criteria for Water Media (Microbiology Emphasis)," Contract #EP-C-07-036. CEC is currently working on issues related to the ambient water quality criteria, microbial risk assessment, and criteria document development for enteropathogenic E. coli and adenoviruses.