FDA Law Blog: FSIS Now Allows Use of the Term GMO in “Negative Claims”

FDA Law Blog: FSIS Now Allows Use of the Term GMO in “Negative Claims”

FSIS Now Allows Use of the Term GMO in “Negative Claims” Posted: 26 Aug 2016 08:33 AM PDT By Riëtte van Laack – On August 24, 2016, the Food Safety Inspection Service (FSIS) of the U.S. Department of Agriculture announced the availability of its compliance guidance regarding “Statements That Bioengineered or Genetically Modified (GM) Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg Products.”  Although the title may suggest otherwise, the main change in FSIS policy is that the Agency will now allow the terms “GMO” and “genetically modified organism” when making claims for non-use of genetically modified or bioengineered ingredients (FSIS refers to such claims as negative claims).  Before the issuance of this guidance, FSIS did not allow these terms in the labeling for such products, except if the name of the third-party certifying organization contained these terms (e.g., “Non-GMO project”). As we reported previously, FDA also had indicated that it frowns on the term “GMO” because, according to FDA, it is scientifically inaccurate. However, FDA could not prevent such use.  Because FSIS, unlike FDA, approves labels for meat, poultry and processed egg products, FSIS could actually prevent the use of the term “GMO” on those products. The recently enacted National Bioengineered Food Disclosure Standard includes a statement essentially defining non-GMO as not-bioengineered: “‘not bioengineered,’ ‘non-GMO,’ or any other similar claim describing the absence of bioengineering.”  Therefore, FSIS has decided that it no longer will object to use of the term GMO and, going forward, will allow the use of the term non-GMO in negative claims regarding the absence of genetically modified ingredients or animal feed. The guidance is effective immediately. FSIS will begin approving negative claims that contain the terms “genetically modified organism” or “GMO” for meat, poultry and egg products that do not contain bioengineered ingredients or that are derived from animals that do not consume bioengineered feed.  In evaluating such claims, FSIS will use the definition of “bioengineering” from the new law, i.e., a food (A) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature.”  The requirements for a third party certification that the product is indeed non-GMO and related requirements (including the requirement to identify the third party’s website on the label and in labeling) remain the same.  For products that qualify for an “organic” claim under the National Organic Program, establishments need not provide FSIS with additional documentation for approval of negative claims.  In accordance with the new law, FSIS will not require additional documentation for non-GMO claims in labeling of products that qualify for an organic claim under the National Organic Program. Comments on the guidance must be received by October 24, 2016.  AMS is responsible for the implementation of the National Bioengineered Food Disclosure Standard. So far AMS has established a webpage for tracking progress on its implementation of the new law.