The implementation date for the disclosure obligations triggered by the USDA's final rule establishing a national standard for the disclosure of bioengineered ingredients in certain food products is January 1, 2020 for regulated entities other than small manufacturers (the implementation date for small manufacturers is January 1, 2021). The implementation date is a deadline by which regulated entities should begin implementing the standard by identifying the foods that will need to bear a disclosure, the records necessary to meet the recordkeeping requirements, and the type of disclosure that the entity will use on its products. The final rule, published on December 21, 2018, includes a list of the "bioengineered" ingredients that can trigger disclosure obligations, and provides additional direction to manufacturers and others as to how they must disclose bioengineered foods.
The USDA's rule, which is referred to as the National Bioengineered Food Disclosure Standard (the "Standard"), was promulgated pursuant to the 2016 National Bioengineered Food Disclosure Standard Act (the "Act") enacted in July 2016. The Act preempted the GMO labeling regimes of several states, including Vermont. You can read more about the background of the Act and the actions undertaken by the USDA prior to the release of its final rule here and here.
List of "Bioengineered" Foods
The USDA's Standard requires disclosure for certain food products that are "bioengineered" (or "BE") or that contain BE ingredients. The final regulations define BE food to mean 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." Food is separately defined in the regulations and includes certain exemptions.
Notably, the definition of BE food does not include food in which modified genetic material is not detectable. The regulations separately define when modified genetic material is not detectable. The definition of BE food also excludes incidental additives as described in 21 C.F.R. § 101.100(a)(3).
As part of the Standard, the USDA has established a list of commercially available bioengineered foods: alfalfa, apple (Artic" 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 sugarbeet. The list is intended to aid regulated entities considering whether they need to make a BE disclosure. However, it is not intended to be exhaustive. Indeed, the USDA notes that new bioengineered products continue to be developed. The USDA will review the list annually and make updates through the normal rulemaking process, as needed.
Entities subject to the disclosure requirements, except for manufacturers with annual receipts of less than $2.5 million, must make appropriate disclosures for BE foods not on the USDA's list if the entity has actual knowledge that the food it is selling is bioengineered. "Actual knowledge" is not defined in the regulations.
On its website, the USDA provides specific guidance about the bioengineered foods and whether use of that food as an ingredient will trigger any disclosure obligations, depending on the prevalence of that bioengineered food in U.S. and global crops. For example, bioengineered corn is so prevalent that, according to the USDA, "corn grain moving in global commerce" and corn that comes from certain countries, including the United States, "should be presumed to be BE corn" requiring a disclosure, absent an exemption. The USDA notes, however, that "[t]here is no commercial production of BE popcorn. All popcorn can be presumed to be non-BE."
Except for certain exemptions (more on that below), if a food product is a bioengineered food or contains a bioengineered ingredient, regulated entities will be required to include a disclosure on the label of that food product. The Standard allows regulated entities to choose from four disclosure options for non-exempt foods: a text disclosure, a symbol disclosure, an electronic link disclosure, or a text message disclosure.
If a regulated entity chooses to use a text disclosure on a food label, it must read "bioengineered food" or "contains bioengineered ingredients," as appropriate. For a symbol disclosure, manufacturers must utilize a symbol stating that the product is "bioengineered." Although food manufacturers are not required to disclose the fact that ingredients in a particular food were derived from bioengineered foods if the modified genetic material is no longer detectable in that product, the USDA also provides an additional symbol for regulated entities who voluntarily choose to disclose the fact that their product was derived from bioengineering.
For the electronic link disclosure option, regulated entities may include a link on food packaging that can be scanned by a smartphone, at which point the user's smartphone will open a website containing the required disclosures. The electronic disclosure link must be accompanied by a text statement that reads "Scan here for food information" and a telephone number that consumers can call for information. The USDA's Standard also requires that either the text disclosure or symbol disclosure described above be displayed on the first screen a consumer sees after scanning the electronic link.
For the text message disclosure option, the food product label must include the statement "Text [command word] to [number] for bioengineered food information." When a consumer texts the word chosen by the manufacturer to the number, the consumer must immediately receive a text message containing the appropriate bioengineered food disclosure.
Exemptions from the Labeling Requirements
The Standard exempts a number of foods and entities from the labeling requirements. Exempted foods include animal products (e.g., meat or eggs) from animals that consumed feed containing GMO ingredients; food certified as organic under the USDA's National Organic Program; and food served in restaurants or similar retail food establishments, including cafeterias, food stands, and bars.
The Standard also includes an exemption for products that have an inadvertent or "technically unavoidable presence" of a bioengineered food, as long as that presence amounts to five percent or less of the ingredients that make up that food product. The USDA defines "technically unavoidable" as a situation where bioengineered food unintentionally remains during the reasonable and customary practices used to separate bioengineered and non-bioengineered foods. For example, a small amount of bioengineered corn remaining in a harvesting combine despite a reasonable effort to remove all bioengineered corn from the combine before harvesting the non-bioengineered corn could qualify as "technically unavoidable." The threshold is intended to allow for coexistence among BE and non-BE crops.
The Standard further exempts small food manufacturers whose annual receipts total less than $2.5 million. However, these small food manufacturers and other exempt entities, such as restaurants, can voluntarily comply with the Standard if they so choose.
The USDA requires that all regulated entities comply with the Standard beginning on January 1, 2022. Regulated entities can voluntarily comply with the Standard until December 31, 2021.
The Act authorizes the USDA to enforce compliance with the Standard only through records audits and examinations, hearings and public disclosure of the summary of the results of audits, examinations, and similar activities. However, the USDA advises in the Federal Register that states may adopt standards identical to the USDA Standard, and impose remedies for violations of the state standard, such as monetary damages and injunctive relief.
Like other new or substantially modified labeling schemes, regulated entities may be required to devote substantial time and resources to developing and implementing an effective compliance strategy and plan. Compliance strategies and plans will likely need to involve evaluation of products, consideration of alternative methods of compliance available under the regulations, and coordination with others in the company's chain of distribution, including review and potential update of commercial contracts.
Strategies and plans will also likely not be "one-size-fits-all." For instance, some entities may transition conventional products to organic, to take advantage of the exemption in the Standard for food certified under the National Organic Program.
Moreover, "over-disclosing," i.e., simply placing a disclosure on every product regardless of whether it is required, is likely not an option for regulated entities. The regulations state that, absent certain exceptions, a label shall not bear a disclosure that a food is a bioengineered food or contains a bioengineered food ingredient if the records maintained by the company demonstrate that the food is not a bioengineered food or does not contain a bioengineered food ingredient.
Failure to develop and execute an appropriate compliance strategy and plan is not without risk. While the Standard's provisions for USDA enforcement are relatively limited, at least some states will likely seek to adopt their own identical standards but with additional remedies for violations. Moreover, consumer class action plaintiffs' attorneys and competitors may also attempt to sue regulated entities based on violations under state laws, and may use the USDA's central publication of violations as a resource.
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