On July 8, the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) published in the Federal Register its notice on the issuance of final guidance to assist regulated entities in complying with the National Bioengineered (BE) Food Disclosure Standard (Standard). AMS previously announced the publication of these guidances on its website. The guidances concern Guidance to Ensure Acceptable Validation of a Refining Process, a frequently asked question (FAQ) document regarding this validation guidance, Guidance on Testing Methods, and an FAQ document pertaining to the testing method guidance.
Under the Standard, regulated entities must make a BE food disclosure if they are using a food on the AMS List of BE Foods (the List), or a food produced from an item on the List unless they maintain records to demonstrate that modified genetic material is not detectable. If regulated entities do not maintain the required records and do not want to create them, they must make a BE food disclosure.
The regulated entity has three option to demonstrate that modified genetic material is not detectable:
- maintain records that demonstrate the food is sourced from a non-bioengineered variety of the crop or source;
- validate (and keep records) that the refining process removes the modified genetic material, so it is not detectable; or
- maintain testing records that demonstrate genetic material is not detectable.
The published guidances address options 2 and 3.
Validation of the refining process carries certain benefits. Once a refinement process has been validated, no further testing is required unless there is a change in the refining process. The regulated entity must maintain validation data and records that demonstrate that the validated refining process has been used. A refining process needs to be validated only once and may be applicable to multiple facilities and manufacturers. That said, the validated refining process must be verified continually. Verification focusses on monitoring steps in the refining process that are key to removal of the genetic material.
AMS notes that the regulated entity is responsible for ensuring that the refining process removes the modified genetic material to below detectable levels. Neither the regulations nor AMS specify a threshold of minimal detection for rDNA. Over time, testing methods may evolve and become more sensitive, detecting increasingly smaller levels of genetic material. However, this should not be interpreted as requiring continual adjustment of the refining process because the level of detection is moving target. In the FAQ, AMS states that once a regulated entity has determined that the genetic material is not detectable, the validation is complete. The regulated entity has no obligation to determine if a more sensitive method shows presence of rDNA.
The alternative way to demonstrate that modified genetic material is not detectable is by testing to demonstrate the absence of modified genetic material. When using this option, the regulated entity must keep records, such as certificates of analysis, showing that each batch or lot of a food or ingredient was tested and does not contain detectable modified genetic material. USDA does not recommend a specific test, but the test must be fit for purpose. In the FAQ on testing methods, AMS recommends referencing the International Organization for Standardization (ISO) International Standard Foodstuffs – Methods of analysis for detection of genetically modified organisms and derived products – General requirements and definitions; Codex Alimentarius Commission document CAC/GL 74-2010 Guidelines on Performance Criteria and Validation of Methods for Detection, Identification and Quantification of Specific DNA Sequences and Specific Proteins in Foods; or AOAC Official Methods of Analysis.
AMS reminds regulated entities (and others) that compliance with the Standard is based on recordkeeping and AMS will look at a regulated entity’s records to determine whether they complied with the disclosure requirements of the Standard.
This concludes AMS’s planned work on BE labeling. Regulated entities should (in theory at least) have the information they might need to handle BE labeling questions, and Hyman Phelps & McNamara is available if you need assistance or have further questions.