Monday February 08, 2021
CPSC Floats Draft Updated Guidance on Cruelty-Free Testing
CPSC staff's January 27 draft guidance describes eight areas the agency will consider in evaluating non-animal testing methods for ensuring compliance with the Federal Hazardous Substances Act (FHSA). Such methods are known as "new approach methods" (NAMs) or – in combination with existing animal data – "integrated approaches to testing and assessment" (IATA). CPSC would seek comments for 75 days under a draft Federal Register notice awaiting commission approval at the PSL deadline.
The guide also included an optional outline for use when submitting methods for agency evaluation. The eight areas –most getting a paragraph or two of overview in the draft guide (bit.ly/3apIr6S) – address peer review, validation studies (more below), procedures and protocols, end points, applicability, risk assessment data, use limits, and description of the method's adherence to the reduce/refine/replace concept for alternatives to animal testing.
The second area – validation studies – gets more attention with breakout paragraphs on full validation, partial validation, cross validation, cross/inter-laboratory validation, selectivity, accuracy, precision, quality control, sensitivity, reproducibility, stability, and robustness.
The guide would replace one from 2012, built around the policies of the Interagency Coordinating Committee for the Validation of Alternative Methods, (ICCVAM), on which CPSC participated. The briefing package explained:
"Because ICCVAM no longer formally validates test methods, to assist stakeholders, including the public, manufacturers, test method developers, and test laboratories, in determining what test methods are deemed reliable for determining compliance with the labeling requirements under the FHSA, CPSC staff drafted proposed guidance clarifying staff’s informational requirements and process for evaluating NAMs and IATAs."