USCG’s Office of Operating and Environmental Standards (CG-OES) has released a policy letter describing the process for submitting viability testing methods to the Coast Guard and explains the information needed to evaluate a testing method.
Requirement for Minimum Precision and Accuracy
SCG’s initial position in the draft policy letter stated that viability testing methods would need to include statistical data demonstrating a stated minimum for precision and accuracy data.
In response to comments, USCG deleted references to such standards in the final policy letter and clarified the requirement to state that information on method risk and uncertainty, including precision and accuracy, is important to consider as part of the best available science assessment, but that there are no criteria for specific values to be met.
Requirement for Specific Number and Locations of Field Tests
USCG’s initial position in the draft policy letter was that viability testing methods would need to include validation data from a specific number of tests from specific locations.
In response to comments, the Coast Guard deleted references to minimum testing requirements in the final policy letter and clarified the basis for requesting information regarding the degree to which methods have been validated over a range of geographic locations and conditions.
Equivalency to Existing Organism Enumeration Methods in ETV Protocol as a Requirement for Viability Testing Method
The Coast Guard significantly modified what was written in the draft policy letter regarding equivalency with several testing method parameters in the ETV Protocol.
In the draft policy letter, the Coast Guard stated that the existing regulation including the ETV Protocol “set the standard for rigor, documentation and transparency required of any BWMS type-approval testing protocol submitted to the Coast Guard for acceptance. BWMS type-approval testing for systems that render organisms nonviable will incorporate protocols based on viability and will be subject to the same level of rigor currently used for type-approval.”
The Coast Guard changed the final policy letter to focus on evaluating best available science, not adherence to a standard established by the ETV Protocol. The requirement for equivalency was removed from the final policy letter and the basis for the requested information is further explained in the relevant sections below
Existing Testing Method as Applied to Viability Testing
In the draft policy, the Coast Guard did not describe the use of the existing testing method to test organism viability. However, in response to comments expressing confusion on this issue, in the final policy letter the Coast Guard elaborates on the VIDA provision prohibiting the use of stains to test viability and how that relates to accepting a viability testing method for use within the existing type-approval program.