On May 4, the U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) issued a proposed rule to implement the National Bioengineered Food Disclosure Standard (Bioengineered Food Standard). Congress passed the bioengineered food standard in 2016 to impose mandatory disclosures notifying consumers of products produced with genetic engineering. In passing the legislation, Congress introduced a new term that will become part of the common lexicon of the food industry: “bioengineered.”

Under the standard, certain human food manufacturers, retailers and importers will be required to notify consumers that a food is either bioengineered (BE) or contains BE contents. The bioengineered food standard will affect products regulated by the Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA); however, Congress provided exemptions that will permit a substantial proportion of FSIS-inspected products to avoid BE labeling requirements. Under the standard, BE labeling would be required only in the following circumstances: (1) in cases in which meat (FMIA), poultry (PPIA) or egg products (EPIA) are not the predominant ingredient; or (2) in cases in which water, broth or stock are the predominant ingredient, but the second-most predominant ingredient is not meat, poultry or egg products. There is one exception to the general exemption for most meat, poultry and egg products. If the animal products are produced through genetic engineering, they would be deemed “bioengineered.” But no such products are commercially available.

The proposed rule is AMS’ effort to meet Congress’ instructions for implementing rules. When it passed the bioengineered food standard, Congress left AMS substantial leeway to determine how to best implement the law. Some of the major highlights of the proposed rule include:

• Defining bioengineered: One of the toughest jobs Congress delegated to AMS was defining what constitutes “bioengineered.” The language provided by Congress defined “bioengineered” as ingredients containing “genetic material … modified through in vitro recombinant DNA techniques” or “for which the modification could not be otherwise obtained through conventional breeding or found in nature.”  

This poses a major choice for AMS. Several highly processed products such as sugar and oils such as soybean do not contain detectible amounts of genetic material. A narrow interpretation of bioengineered would result in many foods produced with genetically engineered ingredients avoiding disclosure, whereas most pro-labeling proponents would prefer AMS to define ingredients as BE regardless of whether genetic material remains in the final product. Rather than select one approach, AMS is requesting public comments on two options: (1) highly processed foods cannot be labeled because they do not contain detectible genetic material that is BE or (2) highly processed foods that contained BE genetic material prior to processing must be labeled.

Effect of Animal Feed: Products derived from animals (meat, milk, poultry, eggs) will not be considered BE solely because the animal consumed feed containing BE ingredients.

Exemptions: The following foods are exempt from disclosure: (1)foods served in restaurants, institutions and other food service establishments; (2) food manufactured by very small manufacturers (less than $2.5 million in receipts); (3) food certified organic under the National Organic Program.

Disclosure options: Manufacturers, retailers and importers will be responsible for ensuring that products are properly labeled. AMS proposes several options including: (1) text disclosure (e.g., “bioengineered food,” “may contain a bioengineered food”); (2) symbol disclosure — AMS has proposed several symbol icons to indicate BE content in lieu of a text disclosure; (3) electronic or digital link disclosure — the proposed rule would allow the option of providing a website or QR code that would link consumers to info on BE content in the food; and (4) text message disclosure — the proposed rule would allow consumers to text a number to receive a text message indicating the BE status of the food. Small manufacturers also would have the option to provide a phone number or website for consumers to call.

Compliance dates: Unless an exception applies, manufacturers, retailers and importers must comply by Jan. 1, 2020. Small food manufactures must comply by Jan. 1, 2021. Under the proposed rule, a small food manufacturer is a manufacturer with less than $10 million but more than $2.5 million in annual receipts. 

AMS is accepting public comments on the proposed rule until July 3, 2018. The bioengineered food standard requires that AMS promulgate a final rule by July 28, 2018. It is likely that AMS will miss the deadline. NP