On February 3, 2020, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published a notice requesting comments and feedback on its draft instructions on testing methods under the National Bioengineered Food Disclosure Standard (Standard). According to the Standard, which became effective in 2019, with a mandatory compliance date of January 1, 2022, foods that do not contain bioengineered (BE) material do not require label disclosure. USDA’s definition of BE food (7 CFR 66.1) states that food does not contain modified genetic material if the genetic material is not detectable. Therefore, detectability testing for BE materials in foods plays a key role for stakeholders to determine labeling compliance. Given its importance, USDA AMS has drafted instructions on acceptable testing methodology to be used to satisfy the requirement that the food does not contain detectable BE material. Detectability testing must meet the following standard:

• Laboratory quality assurance must ensure the validity and reliability of test results;
• Analytical method selection, validation, and verification must ensure that the testing method used is appropriate and that the laboratory can successfully perform the testing;
• The demonstration of testing validity must ensure consistent, accurate analytical performance; and
• Method performance specifications must ensure that analytical tests are sufficiently sensitive for the purposes of the detectability requirements of this part.

Comments on USDA AMS’s draft instructions must be submitted on or prior to March 4, 2020.

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