EPA's Alternate Test Procedure Program: The Process to get Alternate Methods or New Methods Approved for Compliance Monitoring under the Clean Water Act (CWA)

Collaborative Efforts to Improve Environmental Monitoring
Oral Presentation

Prepared by , R. Ghei

Contact Information: yildiz.chambers@gdit.com; 703.485.4265


ABSTRACT

Currently, there are a number of methods approved for compliance monitoring under the Clean Water Act (CWA) including EPA, vendor, and voluntary consensus body (e.g., Standard Methods for the Examination of Water and Wastewater) methods. However, laboratories and vendors may want to be able to use other methods for compliance monitoring that are not currently approved under the Code of Federal Regulations (CFR), 40 CFR Parts 136 and 503. To address this need EPA has established an alternate test procedure (ATP) program to allow stakeholders to apply to have their methods approved under 40 CFR Parts 136 and 503.

Under the ATP program, a laboratory or vendor (applicant) may apply for approval of an ATP or new method to be used as an alternate to an EPA-approved method. The applicant is generally responsible for characterizing method performance of its proposed alternate test procedure or new method either by conducting a side-by-side comparison study (most common) or a quality control (QC) acceptance criteria study prior to receiving approval from the ATP program.

The ATP process begins with the development of a detailed study plan calling out the methods to be evaluated (e.g., alternate procedure and reference method), the matrix or matrices (e.g., ambient waters, biosolids), and verification procedures. Stakeholders should become familiar with the ATP protocol (EPA-821-B-10-001) prior to developing the study plan. After EPA has approved the study plan the study can move forward. The side-side comparison study should be conducted by a single-laboratory and include matrix samples from 10 diverse geographical areas throughout the country. The QC criteria should include a minimum of three laboratories that have demonstrated acceptable performance using the EPA-reference method.

Once the study is completed, the applicant will analyze the data to determine if their alternate test procedure or new method performed similar or better than the EPA-reference method for at least 80% of the matrices evaluated during the study. This is demonstrated by recovery, precision, and false positive and false negative rates. Upon completion, all raw data, statistical analyses, and final report are submitted to EPA for review. Generally, if EPA concurs with the results, the alternate test procedure or new method would be approved and promulgated in their next rule making effort.