In December 2018, the Agricultural Marketing Service (AMS) published the final National Bioengineered Food Disclosure Standard (Final Rule). Although mostly straightforward, the rule does contain some nuance and complexity, which regulated entities should become familiar with before the Final Rule takes effect.
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In short, the Final Rule requires food manufacturers, importers, and retailers who package and label food for retail sale or sell bulk food items (regulated entities) to disclose the presence of bioengineered (BE) ingredients in their products. Importers and domestic entities are subject to the same disclosure and compliance requirements.
The Final Rule has been met with mixed reviews. By and large, industry advocates have responded favorably to it. The Food Marketing Institute, for instance, lauded the Final Rule as a consistent and transparent way to provide important information to consumers regarding products containing BE ingredients.
The Final Rule is not without critics, however. They charge that the rule is deeply flawed, lacks transparency, and will likely further confuse consumers. The Organic Trade Association issued a statement expressing its deep disappointment with the new rule. The Center for Science in the Public Interest expressed concern about the potential for consumer confusion.
More broadly, critics are especially unhappy with the lack of reference to genetically modified organisms (GMO) and genetic engineering in the disclosure requirements. They argue that the term “bioengineered” is misleading. AMS, ostensibly in response to critics, wrote that it had considered a variety of terms, “but ultimately determined that bioengineering and bioengineered food accurately reflected the scope of disclosure and the products and potential technology at issue.” Moreover, AMS was concerned that using terms such as “genetic engineering” or “genetically modified organisms” would conflict with preemption provisions.
Like almost any regulations that govern highly interpretive and controversial subject matters, it is nearly impossible to achieve consensus agreement. As for the final BE Food Disclosure Rule, there are compelling arguments on both sides. It remains to be seen whether future changes will be warranted, or what types of amendments may eventually be enacted. For now, and for better or worse, we have a Final Rule.
What Is Bioengineered Food?
Predictably, given the controversy surrounding bioengineering, much debate has centered around how to define what is (or is not) a BE food. The Final Rule adopts the statutory definition of “bioengineered food” as codified in the Amended Agricultural Marketing Act of 1946. Thus, BE foods are those foods containing genetic material that has been modified through in vitro recombinant DNA techniques, and for which the modification could not otherwise be obtained naturally or through conventional breeding. It should be noted that foods for which the presence of modified genetic material is due to incidental additives are not considered BE.
Even within the relatively technical definition adopted in the Final Rule, significant points of contention remain. For instance, there are two countervailing viewpoints regarding whether highly refined foods and ingredients should be exempted from BE disclosure requirements. One view, favored by many in the food industry, holds that highly refined products should be exempt because the definition expressly requires the presence of “genetic material,” and genetic material is removed from highly refined foods in the course of the refinement process.
Another view, counter to the first, is that the definition of “bioengineering” ought to include highly refined products because highly refined products that are derived from genetically modified foods contain modified genetic material prior to processing and may still contain modified genetic material—albeit at undetectable levels—after processing.
After thorough deliberation (the rule’s draft documents included significant written discussion on this topic), AMS has elected to adopt the first view. Though we understand and acknowledge both positions, we believe AMS made the right choice. Just from a practical standpoint, it would be virtually impossible to determine whether a product containing no detectable genetic material was derived from modified genetic material. In any event, foods that do not contain detectable amounts of modified genetic material are exempt from BE disclosure requirements under the Final Rule.