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New Requirement for Labeling Bioengineered Food: Key Deadlines for 2021 and Beyond

May 27, 2021

As restrictions lift and customers begin to crowd stores once more, businesses that make, brand, or sell food might want to ask themselves: Are we ready for mandatory compliance with retail food labeling regulations beginning January 1, 2022?

Not sure what I am talking about? Well, back in 2016, Congress amended the Agricultural Marketing Act, and directed the U.S. Department of Agriculture (USDA) to establish a national mandatory standard for disclosing foods that are, or may be, bioengineered (BE). The National Bioengineered Food Disclosure Standard (NBFDS or the Standard) was published in 2018, but until the end of 2021, compliance is strictly voluntary. That is no longer the case beginning on New Year’s Day 2022. So, for businesses and corporate counsel out there, here are questions you might want to ask yourself over the next few months.

Am I a business dealing in food for human consumption?

If so, then the Standard might apply to you. But, before looking at how BE food is characterized, perhaps it is easiest to first ask: Is my business even the type covered by the Standard? Except for a couple of narrow exceptions, the Standard applies to food manufacturers, importers, and retailers. Specifically, it can apply to all packaged and bulk-type retail sale items, and to any business along the chain of manufacture. For example, grocery stores, convenience shops, and even gas stations might either brand third-party products with their own label or offer bulk stand-type food for customers, so they should be aware of these new rules.

However, the regulations lack some clarity on who exactly is considered a “regulated entity” when it defines them as ‘‘the food manufacturer, importer, or retailer that is responsible for making bioengineered food disclosures under § 66.100(a).’’ The regulations generally look to align responsibility for labeling with the requirements of other mandatory food labeling laws and regulations, including those administered by FDA and USDA Food Safety and Inspection Service. The definitions are a bit circular, but the Standard does provide some examples.

Accordingly, if a food is packaged prior to receipt by a retailer, either the food manufacturer or the importer is responsible for ensuring that the food label bears a BE food disclosure. And if a retailer packages a food or sells food in a bulk container and/or display, then the retailer is responsible. Notably, restaurants and similar retail food establishments and very small food manufacturers (less than $2.5 million of “annual receipts”) are entirely exempt.

OK, but what the heck are bioengineered foods anyway?

So, you are saying to yourself, OK, I deal in food for human consumption, and I might be the type of entity covered … but what the heck are bioengineered foods anyway? Well, as a trained geneticist and Doctor of Molecular Microbiology and Immunology, I can tell you there is a simple scientific definition of BE food … it is food … that has been bioengineered. Sorry, I could not pass up the opportunity for bad science humor (shout out to my mom for the bad joke gene). Unfortunately, in the case of the Standard, this is quite a complicated question, without a simple answer.

The NBFDS defines BE foods as those with detectible levels of recombinant genetic material, where modification could not otherwise be obtained through conventional breeding or found in nature. This is a broad, and again somewhat confusing, definition, so the NBFDS also provides consumers and regulated entities a starting point by providing lists of foods that have bioengineered varieties. The lists are not meant to be comprehensive, but a running guide that the USDA periodically updates. You can check them out at Notably, even if the food is not explicitly on the list, regulated entities whose records show that a food they are selling is bioengineered must make appropriate disclosures.

Can I be excused from dinner?

Yet again, there are shades to one of the most relevant questions: Which foods in fact require disclosure? Briefly, it is both 1) foods that are subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act (FDCA), and 2) foods that are subject to the labeling requirements under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act — but in the second case, only if the predominant ingredient would be independently subject to labeling under the FDCA, or the predominant ingredient is broth, stock, water or a similar solution and the second-most predominant ingredient would independently be subject to labeling under the FDCA.

As you might expect, there are nuances and a few workarounds. For instance, the NBFDS “prohibits food derived from an animal to be considered a BE food solely because the animal consumed feed produced from, containing, or consisting of a bioengineered substance. 7 U.S.C. 1639b(b)(2)(A).” Hence, for our purposes, it is perhaps more effective to look at what are NOT considered BE foods for the purposes of the new labeling requirements.

If your BE ingredient(s) is only an Incidental Additive, then the entire product is not considered BE, and the regulations do not apply to that product. Also, if your product has a BE ingredient, but the modified genetic material is Not Detectable, then that product is not required to be BE labeled. But what does that mean? Well, modified genetic material is not detectable if, as defined by the Standard:

  • Records verify the food is made from a non-bioengineered food. For example, “certification of food under USDA’s National Organic Program (7 CFR part 205) shall be considered sufficient to make claims about the absence of bioengineering in the food”;
  • Records verify the food has been refined using a process validated to render the modified genetic material undetectable; or
  • Testing records for specific foods confirm the absence of detectable modified genetic material.

Don’t Panic!

So, if you are still reading, then unfortunately you might be a regulated entity with a BE product that requires labeling under the Standard. But do not despair! As discussed, there are some exceptions to the types of food and the types of entities subject to the NBFDS. In fact, there are even some simpler labeling requirements depending on package size and/or manufacturer size. Some even avoid using the term “bioengineered” at all!

Plus, even if your company is required to abide by these new BE labeling regulations of the NBFDS, the compliance requirements (mainly labeling, but also importantly record keeping) are not overly onerous given the extensive record keeping that is usually a standard part of modern businesses. And among the options for labeling is the simple inclusion of an authorized USDA BE symbol on your packages or bulk item displays:

For further information or to determine the requirement in your specific situation, please consult with counsel, the USDA BE section, and the NBFDS.

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