§ 66.9 Detectability.

(a) Recordkeeping requirements. Modified genetic material is not detectable if, pursuant to the recordkeeping requirements of § 66.302, the entity responsible for making a BE food disclosure maintains: (1) Records to verify that the food is sourced from a non-bioengineered crop or source; or (2) Records to verify that the food has been subjected to a refinement process validated to make the modified genetic material in the food undetectable; or (3) Certificates of analysis or other records of testing appropriate to the specific food that confirm the absence of modified genetic material. (b) Validated refining process. (1) Analytical testing that meets the standards described in paragraph (c) of this section must be used to validate that a refining process renders modified genetic material in a food undetectable. (2) Once a refining process has been so validated, additional testing is not necessary to confirm the absence of detectable modified genetic material in food subsequently refined through that process, provided that no significant changes are made to the validated process and provided that records are maintained to demonstrate that the refining process has been validated and that the validated refining process is followed. (c) Standards of performance for detectability testing. Analytical testing for purposes of detecting the presence of modified genetic material in refined foods pursuant to paragraph (a) of this section shall meet the following standard: (1) Laboratory quality assurance must ensure the validity and reliability of test results; (2) Analytical method selection, validation, and verification must ensure that the testing method used is appropriate (fit for purpose) and that the laboratory can successfully perform the testing; (3) The demonstration of testing validity must ensure consistent accurate analytical performance; and (4) Method performance specifications must ensure analytical tests are sufficiently sensitive for the purposes of the detectability requirements of this part.