TNI Looking for Laboratories to Help Update the Quality Control Acceptance Criteria in Methods 608.3, 624.1, and 625.1

Date Posted: 11-25-2019

On September 27, 2017, three (3) new EPA methods were approved – 608.3, 624.1 and 625.1. These are updates of methods developed in the 1970s. While the technology has changed a lot since then, the method performance data and Quality Control criteria in these new methods are what existed at the time of their validation, and likely do not represent what is now achievable.

As the EPA stated in the preamble to the final rule published on August 28:

Although EPA received comments about updating the QC acceptance criteria, EPA did not adopt such changes because EPA lacks data from a multi-laboratory validation study from which to develop such criteria. 

In response to concerns expressed by TNI members about these methods, TNI contacted several other organizations that had expressed similar concerns and proposed a partnership which includes TNI, the Water Environment Federation (WEF), the Association of Public Health Laboratories (APHL), and the American Council of Independent Laboratories (ACIL). We have discussed with these organizations the potential for providing data that could be used by EPA to update the old QC acceptance criteria. In a letter to EPA on January 26, 2018, we noted that our organizations represent a significant number of the commercial, state and municipal laboratories that will be using these updated methods in the future. We stated that we would very much appreciate the opportunity to collaborate with the Agency and its staff in addressing this important issue.

In response to the letter, EPA expressed interest in pursuing this project with the partner organizations. EPA has noted that this is a secondary data collection effort and no “new” (primary) data are being generated. EPA requested the partners develop a Study Plan for secondary data collection that would outline what data deliverables will be required and what data review will take place.  
In order to ensure representative datasets are used to update the QC criteria, we are attempting to provide EPA with data from a representative cross section of the laboratory community: large commercial laboratory chains, small independent laboratories, and publicly-owned treatment works (POTW) laboratories.

Later this year, all laboratories accredited for these methods will be asked to volunteer to participate in this project. Data collection would not begin until 2020. If your laboratory is interested in participating in this effort, please complete this form: https://nelac-institute.org/content/submit-qcdemo.php.  This early indication of interest is not binding on your laboratory. There will be an opportunity to review the Study Plan before a final commitment is made. This is a unique opportunity for laboratories across all sectors to work with EPA to solve a common concern.