The January 1, 2022, mandatory compliance date for the National Bioengineered Food Disclosure Standard (NBFDS) is fast approaching. Unless the U.S. Department of Agriculture Agricultural Marketing Service (USDA-AMS) issues an enforcement discretion policy to give regulated entities more time to implement the requirements, foods labeled for U.S. retail sale will soon need to comply with the NBFDS regulations. 

You’ve mastered the U.S. Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act), conquered Hazard Analysis and Critical Control Points, and survived the Food Safety Modernization Act. Now, what is the NBFDS? The NBFDS and its regulations require the disclosure of bioengineered foods, or “BE foods” for short. This mandatory standard for the disclosure of BE foods was Congress’s answer to a jumble of state labeling laws for genetically modified organisms. It preempts state laws imposing GMO labeling requirements, such as Vermont’s genetic engineering labeling law, to create a uniform national standard. The mandatory BE food disclosure requirement applies to human food subject to the labeling requirements under the FD&C Act and some meat- and egg-containing products under the jurisdiction of the USDA Food Safety and Inspection Service. Food manufacturers and importers (including those that manufacture or import dietary supplements), as well as retailers that package and label food for retail sale or sell bulk food items, are all required to comply with the NBFDS. 

What does this mean for food industry professionals? While it will depend on where you are positioned along the supply chain, the NBFDS quite likely means increased record keeping, validation, and testing. The coronavirus pandemic has disrupted supply chains for many entities subject to the NBFDS. Putting compliance systems and processes into place now will save a lot of headaches at the end of the year and allow time for the inevitable curveballs. 

What Are Bioengineered Foods?

BE food is primarily defined by the NBFDS regulations as “a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.” Incidental additives and food that “does not contain modified genetic material if the genetic material is not detectable pursuant to [specific standards]” are excluded from the definition of BE food—and therefore not subject to disclosure. In a move critical for the food industry trying to determine what foods fall within the definition of a BE food, USDA-AMS has released two guidance documents concerning validation and testing for entities wishing to confirm whether a food or ingredient does not contain detectable modified genetic material. We’ll cover these in a moment. 

To more generally aid manufacturers and other covered entities, USDA-AMS has developed a list of BE foods. Many regulated entities start their NBFDS analysis by determining what products use a food or an ingredient produced from food on this list, which currently consists of the following: alfalfa, apple (Arctic® varieties), canola, corn, cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot-virus-resistant varieties), pineapple (pink-flesh varieties), potato, salmon (AquAdvantage®), soybean, squash (summer), and sugar beets. Then, if that entity uses a food or an ingredient produced from food that is on the list, its records, typically supplier documentation of the BE food status of an ingredient, will determine whether the food must bear a BE food disclosure. 

Complicating matters, the list of BE foods is not exhaustive. Even if a food is not on the list, regulated entities are required to disclose any BE foods if they have actual knowledge that the food is bioengineered per the NBFDS and the food is not otherwise exempt. Further, USDA-AMS will periodically update the list of BE foods. USDA-AMS already requested comments on its recommendations to add BE sugarcane (insect resistant) to the list, for example. 

In the regulations, there are express exemptions to the NBFDS disclosure requirement for: food served in a restaurant or similar retail food establishment, very small food manufacturers (< $2.5 million in annual receipts), a threshold for inadvertent or technically unavoidable presence of BE substances of up to 5 percent for each ingredient, and food certified under USDA-AMS’s National Organic Program. Also, food derived from an animal cannot be considered a BE food solely because the animal consumed feed produced from, containing, or consisting of a BE substance.

Using Validation and Testing to Demonstrate a Food Is Not a BE Food

Due to the definition of BE food in the NBFDS regulations, the NBFDS does not require disclosure if a processed or refined food derived from the BE ingredient does not contain any detectable modified genetic material that could be considered BE, even if that food is on the list of BE foods. What does this mean practically? When it issued the final regulations, USDA-AMS explained that refined beet sugar, high fructose corn syrup, and canola oil, for example, are unlikely to require BE food disclosure because the processing has eliminated the detectable genetic material that was initially present in the raw commodity.

Despite USDA-AMS’s statement, ultimately, it is up to regulated entities to ensure that adequate records demonstrate that modified genetic material is, in fact, undetectable in the food or ingredient. There are three ways to demonstrate modified genetic material is not detectable per the NBFDS regulations: 1) records that verify the food is sourced from a non-BE crop or source, 2) a validated process, that is, records that verify food has been subjected to a refinement process “validated” to make modified genetic material undetectable, or 3) detectability testing, that is, testing records confirming the absence of detectable modified genetic material. The regulations also set out general standards of performance that must be followed if an entity uses analytical testing. On July 2, 2020, USDA-AMS released its final guidance documents on validation of a refinement process and detectability testing. 

Validation of a refining process

As indicated above, if the entity that would be responsible for making the BE disclosure for a food maintains records showing the food has been subjected to a refinement process validated to make the modified genetic material in the food undetectable, the food is not a BE food subject to disclosure. USDA-AMS’s guidance on validation includes the following steps to validate a refinement process: 1) identify raw materials, ingredients, and product-contact materials; 2) define characteristics and the intended use of the end product; 3) define the sequence and interaction of all processing steps used to arrive at the end product; 4) identify key steps in the refinement process that may influence the end product’s characteristics and its ability to meet specified requirements; 5) assemble validation information that demonstrates the refinement process operates as intended to meet specific requirements (end-product characteristics), conducting studies as needed; 6) continually verify the refinement process is operating as validated; 7) revalidate the refinement process, as applicable, if significant changes are made to the process; and 8) maintain records of the validation and ongoing verification. 

The key takeaways regarding validation are the following:

• The identification of the key steps in the refinement process, which may include the entire process, is crucial. A key step “is any action or activity that can influence (prevent, reduce, or eliminate) the ability to meet specified requirements.” This is the step in the process that renders modified genetic material undetectable. It is also important to define the key steps by calculable parameters (e.g., time, temperature) and decision criteria (e.g., limits). This way, if minor changes do occur that do not impact the key-step parameters and criteria, regulated entities may be able to avoid revalidating an entire refinement process. 
• While end-product testing is one way to validate that a refining process used to create an ingredient renders any modified genetic material undetectable, USDA-AMS does not establish a specific threshold of minimal detection for rDNA. 
• Validation refers to the process, not the facility where the process occurs. Therefore, once a process has been validated, another manufacturer does not need to revalidate that process if it is completed in a different facility. 
• Continued verification that the refinement process is operating as validated is required. 
• Significant changes to the validated refinement process that could impact the process’s ability to meet the specified requirements will need to be revalidated. 

Detectability testing

The NBFDS regulations also provide that modified genetic material is not detectable if the entity that would be responsible for making the BE disclosure for a food maintains records of testing, such as Certificates of Analysis, that confirm the absence of modified genetic material. USDA-AMS’s guidance on testing methodology provides instructions for selecting a test method, DNA-based methods, emerging technologies and other methods, general considerations in selecting a laboratory, and record-keeping requirements. 

The key takeaways regarding testing are the following:

• When considering a test method, USDA-AMS has deemed it critical that the method be appropriate (validated) for the product/commodity being tested. Therefore, if a test method does not already exist to detect modified DNA in a particular ingredient or food, developing and validating a new method for that ingredient or commodity will probably be required. 
• USDA-AMS indicates that broad-spectrum tests may not be sufficient to detect genetic modifications, and industry may consider event-specific testing in some instances. Event-specific polymerase chain reaction testing could be burdensome for industry since some commodities, like soy and corn, have multiple commercialized events. 
• USDA-AMS does not identify a sample size requirement for testing and instead defers to a Codex Alimentarius guideline on validation criteria. In addition to determining an appropriate sample size, it will be important to consider how often testing should be conducted for a given ingredient or food.
• If there is a complaint that a BE food was not properly disclosed, USDA-AMS indicates that it will not be testing foods to determine compliance. Rather, the regulated entity’s ingredient-specific records will be the focus of its inquiry. 

Record Keeping

The record-keeping requirements of the NBFDS are critical to understand. The burden is on the regulated entity to determine, based on its records, whether a food must bear a BE food disclosure. And, as stated above, USDA-AMS does not intend to conduct its own testing to confirm compliance with the NBFDS but rather will review a company’s existing records. Critically, regulated entities must maintain records for at least 2 years beyond the date the food or food product is sold or distributed for retail sale. Per the NBFDS, these records must be kept if an entity’s food or ingredient is on the list of BE foods or the entity has actual knowledge that the food is BE. USDA-AMS provides examples of the types of records that can be used (e.g., supply chain records, bills of lading, invoices), but regulated entities can determine for themselves which of their usual business records will demonstrate compliance and should be maintained.

BE Food Disclosure Options

Once a determination is made that a food is BE and requires labeling under the NBFDS, regulated entities can choose one of four options to disclose the presence of BE food (text, symbol, electronic/digital link, or text message), each with its own specific requirements. The electronic/digital disclosure option has been the subject of some criticism, including during the comment period for the final rule, as well as of a pending lawsuit against USDA. But the regulations expressly provide that an entity may make a digital NBFDS disclosure by using a QR code, for example. 

The NBFDS also includes a voluntary disclosure option. Entities may voluntarily disclose the presence of BE foods, including certain foods that do not meet the definition of “bioengineered food” but are derived from BE crops or food on the list of BE foods. The text disclosure option for voluntary disclosure is either “derived from bioengineering” or “ingredient(s) derived from a bioengineered source,” and USDA-AMS has also created a separate symbol for voluntary disclosure. 

Risks of Noncompliance

If a regulated entity fails to make a mandatory disclosure, USDA’s enforcement authority is limited to investigations and publicizing the summary of the results of an audit or the summary of the final results of an investigation at the conclusion of the hearing for a noncompliant entity. These investigations will most likely include auditing an entity’s records if USDA-AMS determines that further investigation of a complaint is warranted. While USDA lacks the authority to recall products or issue monetary damages for a violation, there is potential litigation risk from both consumers and competitors. Although consumers cannot directly sue for a violation of the NBFDS, they may try to leverage state consumer laws. Plaintiffs have already filed lawsuits challenging “non-GMO” or “natural” product labels under state laws where courts have considered the requirements of the NBFDS. 

Conclusion

This article provides an overview of the NBFDS. As with any significant mandatory regulatory or labeling change, regulated entities should thoroughly review the NBFDS’s requirements, including, as appropriate, with their outside counsel. Here are some additional potential steps toward compliance with the NBFDS that a regulated entity can consider: 

• Itemize current and anticipated food product offerings as of January 1, 2022, for products potentially subject to the NBFDS.
• Check for NBFDS exemptions, for example, products that are certified by USDA-AMS’s National Organic Program. 
• Check ingredients against the current list of BE foods.
• Work internally or with suppliers to determine whether a processed or refined food derived from a BE food or crop does not contain any detectable modified genetic material consistent with USDA-AMS guidance, as needed.
• Separately and additionally confirm which products are known to contain BE foods.
• If there is a disclosure obligation, determine the preferred method of disclosure (text, symbol, electronic/digital link, or text message). Also consider voluntary disclosure if applicable. Update product labels as needed. 
• Finally, consider procedures to address any ingredients for which there is no clear disclosure requirement, setting up a process to monitor updates to the list of BE foods, and implementing systems to evaluate disclosure requirements for reformulations. 

Because there is so much flexibility built into the NBFDS, we expect that businesses will adapt and adjust their compliance strategy as supply chains, BE ingredient availability, and product offerings change. 

Samuel Jockel, Esq., is a senior associate in Alston & Bird’s Litigation & Trial Practice group and a member of the Food, Drug & Device/U.S. Food and Drug Administration team. Sam focuses his practice on regulatory, policy, and litigation matters related to food, beverages, cosmetics, dietary supplements, and drugs. Sam previously served as a trial attorney in USDA’s Office of the General Counsel. He was counsel for the implementation of the National Bioengineered Food Disclosure Standard, playing a key role in providing advice to senior USDA officials, drafting the proposed rulemaking, and defending the USDA in an Administrative Procedure Act challenge. 

Rachel Lowe, Esq., is a litigator who represents clients in a variety of industries, including food and beverage and retail, in class actions and other complex commercial disputes. She is a member of Alston & Bird’s Chambers-rated Food, Beverage & Agribusiness team and works hand in hand with regulatory counsel to advise industry-leading food producers, distributors, and retailers facing litigation and investigations.