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USDA AMS Solicits Comments on Draft Instructions for Testing Methods to Confirm the Absence of Detectable Modified Genetic Material

  • As previously covered on this blog, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) implements the National Bioengineered Food Disclosure Standard (the Standard).  On January 1, 2022, which is the mandatory compliance date for the rule, regulated entities must disclose whether food offered for retail sale is bioengineered (BE) or uses BE food ingredients.  The regulatory definition of “bioengineered food” excludes foods where modified genetic material is not detectable and USDA’s regulations discuss “detectability” at 7 CFR 66.9.  In the issuing the final rule, USDA AMS indicated it would provide further instructions on two of the provisions by which a regulated entity can determine that modified genetic material is not detectable: (1) acceptable testing methodology and (2) validating a refining process.  As we reported, USDA AMS released draft instructions for validation of refining processes on December 17, 2019.  Today, USDA AMS released for comment its draft instructions regarding acceptable testing methodology.

  • The draft instructions for acceptable testing methodology describe factors to consider when selecting a test method that is fit for the purpose of demonstrating that a food does not contain detectable modified genetic material.  The draft instructions state that entities should use validated methods accepted by international bodies (e.g., International Organization for Standardization (ISO) and Codex Alimentarius Commission (Codex)) and/or validate their own methods.  The following international standards are referenced:  ISO 24276 Foodstuffs -Methods of analysis for detection of genetically modified organisms and derived products- General requirements and definitions, ISO 21571 Nucleic Acid Extraction, ISO 21569 Qualitative Nucleic Acid Analysis, ISO 21570 Quantitative Nucleic Acid Analysis, and Codex 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.  Additionally, the instructions address DNA-based methods (e.g., polymerase chain reaction (PCR) methods both qualitative and quantitative are noted as being “acceptable”), emerging technologies, and other methods, as well as general considerations in selecting a laboratory and record keeping requirements.

  • Comments on the new draft instructions are due by March 4, 2020.  After USDA reviews the comments received they will publish final instructions on testing methods on their website.  

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...