The proposed rule for the National Bioengineered Food Disclosure Standard (NBFDS) was recently released by the Agricultural Marketing Service (AMS). The proposed rule would require manufacturers, importers and certain retailers to disclose the presence of bioengineered (BE) foods and BE food ingredients.1 The intent behind the disclosure is to provide consumers with meaningful information related to the BE status of foods, including dietary supplements, to allow consumers to make informed decisions2 when purchasing products. However, finding a balance between delivering useful information in a way that is not confusing to consumers, while not placing an unmanageable burden on manufacturers, importers and certain retailers, may prove to be challenging. Stakeholders in the food industry will need to understand when the presence of BE foods and BE food ingredients must be disclosed on product labels and the appropriate wording of the disclosure statement.
BE Substances and BE Foods
As proposed, a BE substance is defined as “Matter that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.”1 In turn, a BE food is “a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.”1 Under the proposed rule, foods containing incidental additives, as described in 21 CFR §101.100(a)(3), would not be considered a BE food if the incidental additives are present at insignificant levels that do not have any technical or functional effect in the food.
Much debate remains surrounding the interpretation and application of the definition of a BE food, particularly as it would relate to highly refined foods and ingredients sourced from BE raw ingredients. One argument to exclude highly refined foods from the BE rule is that the manufacturing process of highly refined products reduces the BE genetic material to levels that are not detectable with current limits of detection. In this case, there may become a need to include the analysis of BE genetic material in the specifications for food ingredients. Further, there are highly refined products derived from BE crops that are genetically identical to those derived from non-BE crops after undergoing the refining process. As such, it could be argued highly refined products would not meet the definition of BE foods (that is, until the methods of detection improved).
If the definition for BE foods is not clarified in the final rule, differences in interpretation and subsequently application of the definition will inevitably lead to inconsistencies in the disclosure of BE foods and BE food ingredients on product labels, leading to consumer confusion.
“Highly Adopted” & “Not Highly Adopted” BE Foods and BE Ingredients
The AMS recognized that manufacturers and other entities may find it challenging to identify BE foods, therefore the AMS compiled two different lists: “highly adopted” and “not highly adopted” BE foods.1 As proposed, “highly adopted” BE cultivars are those with a ≥85% prevalence in relation to non-BE cultivars of the same food crop planted or produced in the United States. “Highly adopted” BE cultivars include canola, field corn, cotton, soybean and sugar beet. BE foods and food ingredients that are “not highly adopted” (<85% prevalence) include those crops that have not experienced much genetic modification such as non-browning cultivars of apples, sweet corn, papaya, potato and varieties of summer squash. The AMS intends to maintain these lists on its website and update the lists on an annual basis. Both “highly adopted” and “not highly adopted” BE food and BE food ingredients would require a BE disclosure, unless the manufacturer has records to support that the food and/or ingredient being produced is not BE.
The idea is that a food manufacturer, importer or retailer could reference these lists to readily determine the BE status of a food. However, this becomes slightly more challenging for manufacturers when determining the BE status of food derivatives. As proposed, if a food contains a derivative from any of the foods on the lists, the food would have to disclose the presence of the BE ingredient. Field corn is provided as an example, because 92% of all field corn commercially produced in the United States is BE and derivatives of field corn are found in many products, such as corn starch, cornmeal, corn syrup, grits, corn chips and corn tortillas.
Advantage of AMS Maintaining Two Lists of BE Foods
Other than the distinction between the prevalence of BE cultivars relative to non-BE cultivars, there does not seem to be great utility in the proposed exercise. With technological advances in the agricultural industry, it may become a burden for AMS to reassess the BE status of foods on a regular basis and update the lists as needed.
It could also be argued that the separate lists will only result in more complex record keeping for manufacturers, importers and retailers, as well as limited transparency for consumers. As will be discussed in more detail in the subsequent section, the proposed disclosure language differs for BE food or BE food ingredients classified as “highly adopted” as compared to “not highly adopted.”
Forms of Disclosure
The disclosure may be displayed in text or as a symbol on the product label. Alternatively, language on the label may direct consumers to an electronic or digital link (e.g, quick response codes or digital watermark technology) that displays the disclosure or a phone number that would send the disclosure to a consumer via text message.
The distinction between “highly adopted” and “not highly adopted” BE foods is important here, as the required disclosures may differ. The proposed disclosures for “highly adopted” BE foods relay a clear message to consumers. For “highly adopted” BE foods, which are raw agricultural commodities or processed foods containing only BE food ingredients, the proposed disclosure is: “Bioengineered food.” If the “high adoption” BE foods are multi-ingredient foods (containing both BE and non-BE ingredients) the proposed disclosure is: “Contains a bioengineered food ingredient.”
As for “not highly adopted” BE foods and BE foods ingredients, the disclosures introduce a level of uncertainty in regards to the BE status of foods. “May be bioengineered food” or “May contain a bioengineered food ingredient,” in addition to “Bioengineered food” or “Contains a bioengineered food ingredient” have all been proposed as acceptable disclosures for “not highly adopted” BE foods and BE foods ingredients. The inclusion of the qualifiers, “may be” or “may,” do not provide any transparency to consumers in regards to the BE status of foods. Instead they provide confusion that could otherwise be avoided if the disclosures for both “highly adopted” and “not highly adopted” BE foods were aligned.
Thresholds for Disclosing Presence of BE Foods & BE ingredients
The proposed rule includes three1 possible thresholds that could be used to determine if a BE food or BE food ingredient disclosure would be required:
Alternative 1-A) Food in which an ingredient contains a BE substance that is inadvertent or technically unavoidable, and it accounts for no more than 5% of the specific ingredient by weight, would not be subject to disclosure as a result of that one ingredient.
Alternative 1-B) Food in which an ingredient contains a BE substance that is inadvertent or technically unavoidable, and it accounts for no more than 0.9% of the specific ingredient by weight, would not be subject to disclosure as a result of that one ingredient.
Alternative 1-C) Or, foods in which the total amount of all BE substances used in the product were less than 5% would not be subject to disclosure.
The first and second proposed thresholds account for the possibility that BE and non-BE crops may be mixed as a result of the supply chain. For example, BE and non-BE crops may be sourced from the same farm or be transported and/or manufactured using shared equipment. Therefore, incidental additives at insignificant levels, which do not have a technical or functional effect in the food, would not trigger a BE disclosure. Whereas the third proposed threshold is slightly different in that it would allow for the intentional (and unintentional) addition of BE ingredients to foods, provided they do not exceed the threshold. It is anticipated that fewer products would require a BE disclosure if the third threshold alternative were implemented, which would reduce the impact that this rule could have on manufacturers and other entities. In contrast, the intent of the rule is to provide consumers with information related to the BE status of food, and a non-disclosure of any amount of intentionally added BE ingredients may not fulfill that intent.
In conclusion, some aspects of the NBFDS proposed rule may not provide the clarity necessary for consumers to make informed food purchases as well as unnecessarily burden manufacturers, importers and retailers. The AMS has not issued a statement regarding the anticipated release date for the final rule for the NBFDS, but the comment period for the proposed rule has closed. Burdock Group is committed to keeping our clients informed of future actions related to the NBFDS and looks forward to serving our clients on related matters.
National Bioengineered Food Disclosure Standard – Proposed Rule. May 4, 2018. Department of Agriculture – Agricultural Marketing Service. Federal Register Vol. 83 No. 87 Pgs. 19860-19889.
For additional information regarding “informed decision making” as related to the dietary supplement industry, please consider reading “Informed Decision Making” a Priority for Responsible Stakeholders in Dietary Supplement Industry. Burdock Group. Site visited July 6, 2018.