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.
Nevertheless, regulated entities must still be able to establish that their products do not contain detectable amounts of modified genetic material. To do so, they must maintain records that verify: 1) the food was made from a non-BE food; or, 2) the food was refined using a process validated to render the modified genetic material undetectable; or, 3) the absence of detectable modified genetic material (i.e., test results). Acceptable types of records may include, among others, supply chain records, organic certification, or documentation that the ingredient is sourced from a country that does not allow production of that specific ingredient in a BE form.
Generally, regulated entities have four options for disclosing the presence of BE ingredients in their products: 1) a USDA-approved symbol; 2) on-package text; 3) electronic or digital disclosure; or, 4) a text message disclosure (all described in greater detail below). The disclosure must be of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by consumers under ordinary shopping conditions.
The use of a USDA-approved symbol is one form of BE food disclosure regulated entities may use to designate BE foods. AMS initially proposed three alternative symbols (with variations), all designed to disclose a food’s BE status in a non-disparaging manner. Ultimately, AMS adopted the two symbols at right.
For regulated entities that do not wish to utilize the symbol, there are other permissible means of designating BE foods. One is on-package text. For foods (e.g., raw agricultural commodities or ingredients produced therefrom), the required text disclosure is “Bioengineered Food.” For multi-ingredient foods that contain both BE and non-BE ingredients, the required text disclosure is “contains a bioengineered food ingredient.”
Disclosure of BE ingredients may be also made through an electronic or digital disclosure. Such disclosures must include instructions to “scan here for more food information” or similar language. Alternatively, regulated entities can use a text message disclosure, stating, “Text [command word] to [number] for bioengineered food information.”
In terms of placement, the disclosure may be placed anywhere on the principal display panel or on the information panel adjacent to the statement identifying the name and location of the manufacturer/distributor. If there is insufficient space on these panels, then on any other panel likely to be seen by a consumer under ordinary shopping conditions.
Small food manufacturers have additional options, such as directing consumers to call or visit a website for more food information. This requires an accompanying phone number and/or website URL. Disclosure on small and very small packages may use an abbreviated disclosure.
AMS affirmatively decided against prescribing specific type sizes for different disclosure options because, given the enormous breadth and variety of available packaging options, prescriptive requirements were deemed too difficult to implement.
Every regulated entity subject to mandatory BE disclosure must maintain customary or reasonable records that establish compliance. Records may be kept in any format (hard copy or electronic) and may be stored at any business location. Examples of such records include invoices, bills of lading, supply chain records, country of origin records, process verifications, organic certifications, and lab test results. Records must be maintained for two years after the food is sold or shipped. USDA may request records, in which case records need to be produced within five business days.
AMS maintains a list of BE foods on its website. Foods on the list must be disclosed unless records are available to demonstrate they are not BE. Restaurants and similar retail food establishments, as well as very small food manufacturers (< $2.5 million in annual receipts) are exempted from the rule. The purpose of the BE foods list is to provide a straightforward method of determining whether a food requires a BE disclosure. For products that contain a food on the list, regulated entities would either make a disclosure consistent with the National Bioengineered Food Disclosure Standard or not disclose if they believe the food is not required to have a BE disclosure.
This Final Rule becomes effective on Feb. 19, 2019 and must be implemented by Jan. 1, 2020, except for small food manufacturers, whose implementation date is Jan. 1, 2021. The mandatory compliance date is Jan. 1, 2022. Regulated entities may voluntarily comply with the Final Rule until Dec. 31, 2021. All food manufacturers must comply by Jan. 1, 2022.
The proposed compliance date of Jan. 1, 2020, is intended to align with FDA’s proposed rule to extend the compliance dates for the changes to the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales.
Failure to comply with the BE food disclosure requirements is prohibited, but the consequences are relatively feeble. The AMS enforcement authority is limited to enforcing compliance through records audits and examinations, hearings, and public disclosure of the results of audits, examinations, and hearings. The Final Rule does not authorize civil penalties or recall authority for violations.
During the rule-making process, some argued that accountability is a key aspect of a meaningful labeling claim, and that rigorous enforcement provisions were necessary to effectuate the rule. AMS asserted that the enforcement process, which again includes a complaint process, investigations, audits, hearings of limited scope, and resulting notifications to both regulated entity and the public, sufficiently meets the requisite enforcement needs.
Time will tell whether and how these regulations may need to be altered, added to, refined, or repealed. While the Final Rule will not be perfect for every consumer every time, we am pleased that the Final Rule, whatever its faults, will provide consumers with additional information from which to answer that age-old question: To BE or not to BE.
Stevens, a food industry attorney, is a founding member of Food Industry Counsel, LLC. Reach him at email@example.com. Chappelle is also a food industry lawyer and consultant at the same organization. Reach him at firstname.lastname@example.org.