Background and Statement of the Problem: Method Development, Validation, Verification, and Acceptance to Strengthen Public Trust in Environmental Data

Plenary Session
Oral Presentation

Prepared by J. Morgan
Pace Analytical Services, LLC, 7210 Franklin Road, Lebanon, TN, 37090, United States


Contact Information: [email protected]; 615-347-5418


ABSTRACT

For more than 50 years, some EPA program offices have relied on the idea that if the Agency writes, validates, and approves a highly detailed method, data quality will follow. Experience has shown, however, that this approach does not always achieve the intended result. By the time the method development and approval process is complete, the underlying technology may have already advanced. Even the most detailed method can leave room for interpretation, and errors can still occur, particularly in laboratories that may not have the necessary expertise or experience.

Like a well-written recipe, an analytical method can provide strong direction, but it cannot by itself guarantee a successful outcome. Historically, EPA water programs have used a process in which the Agency reviews supporting information, such as the method and validation data, proposes nationwide approval in the Federal Register, solicits and evaluates public comments, and then publishes a final rule. Even under favorable circumstances, this process can take three to five years. As a result, some innovative technologies may face significant delays or may never receive approval. The speed of technology drives the need to rethink the approach and therefore advance our ability to provide better information for the future of environmental health and decisions. Examples will be shared.