Call them GMOs or BEs … non-“natural” foods are getting new regulations. On January 4, 2016, Congress passed an act requiring USDA to establish a national regulatory standard for the disclosure of food that is or may be bioengineered (BE). On May 3, 2018, USDA AMS published the National Bioengineered Food Disclosure Standard proposed rule(pdf), inviting public comment. As proposed, the rule would require that foods labelled for retail sale disclose information about BE food and ingredients to provide a mandatory uniform national standard for disclosure of information to consumers. The proposed rule would also require, and enable federal collection, of new recordkeeping. For many of the proposed requirements, AMS includes options for which it directly requests public comment. As proposed, food bioengineering would refer to 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. With this, however, AMS asks if the rule should include definitions for “found in nature” and “conventional breeding,” and if so, what these should be. The definitions of these, and BE food itself, are important because they would be used to determine what foods would be required to bear a BE disclosure moving forward, when new technologies may emerge. Based on its definition of BE food, AMS has proposed two lists, both of which would be included in the standard and maintained on its website: BE foods that are commercially available in the U.S. with a high adoption rate including (with percentages of how much is currently bioengineered): highly adopted canola (90%); corn, field (92%); cotton (93%); soybean (94%); sugar beet (100%). BE foods that are commercially available in the U.S. that are not highly adopted including apple, non-browning cultivars corn, sweet papaya potato squash, summer varieties Only foods or products on either of those lists or made from foods on either of the lists would be subject to disclosure under the rule, but the disclosure requirements do vary, primarily in that a “may” disclosure is allowed for list 2 but not for list 1. (See the Text disclosure section below.) While these lists are not long, the foods made from them can be extensive. As an example, AMS noted that any foods made from or containing ingredients made from field corn are likely to contain BE corn and would, thus, be subject to disclosure, such as corn starch, cornmeal, corn syrup, grits, corn chips, corn tortillas, corn cereal, etc. The two lists would be reviewed and revised annually for which interested parties could recommend additions to and subtractions from with supporting data. Other aspects of the lists on which AMS solicits comment are whether the proposed cutoff of 85% adoption rate is appropriate for identifying foods on the list of highly adopted BE foods, as well as the potential impact and associated burdens of maintaining separate lists for high and non-high adoption BE foods. The rule also proposes, and seeks comment on: Incidental Additives. Ingredients exempt from labeling would be exempt from disclosure, unless the incidental additive would require disclosure pursuant to other FDCA labeling requirements. Undetectable Recombinant DNA. Food products for which it can be demonstrated that modified genetic material cannot be detected would be exempt. Records would need to show that food subjected to a specific process has been tested for that purpose by a laboratory accredited under ISO/ICE 17025:2017 standards using methodology validated according to Codex Alimentarius guidelines. Other exemptions would include: Food served in a food service establishment. Very small food manufacturers (with annual receipts of less than $2,500,000). Food derived from an animal if based solely on the fact that the animal consumed feed produced from, containing, or consisting of a bioengineered substance. Foods with amounts of BE substance below an established threshold level (on which AMS is seeking comment). Food Certified Organic under the National Organic Program. Disclosure. The propsed rule includes options for disclosure of BE food and ingredients on packaging 1. Text. Legible under ordinary shopping conditions: Use of the statements “Bioengineered food” or “Contains a bioengineered food ingredient” for foods/ingredients on the list of BE foods with a high adoption rate. These could not bear a “may” disclosure. Use of “Bioengineered food,” “May be bioengineered food,” “Contains a bioengineered food ingredient,” or “May contain a bioengineered food ingredient” for foods on the list of BE foods commercially available, but not highly adopted, in the United States. 2. Symbols. AMS proposes three options designed to communicate the bioengineered status of a food in a way that would not disparage biotechnology or suggest BE food is more or less safe than non-BE food. 3. Electronic or digital link with the statement: “Scan anywhere on package for more food information,” “Scan icon for more food information,” or equivalent language. The link must provide the bioengineering disclosure on the first product information page without any marketing or promotional material. 4. Small food manufacturers (with less than $10 million in annual receipts but $2,500,000 or more in annual receipts) could use a phone number noting that it provides access to information and an Internet website address. 5. Small and Very Small Packages could use and electronic or digital link with the statement “Scan for info” and/or phone number with “Text for info.” 6. Foods Sold in Bulk Containers. Retailers would be responsible for disclosure compliance using the above text, symbol, electronic or digital link, or (if applicable) text on signage or other materials (stickers, bindings, etc.) on or near the bulk item Voluntary disclosure could be used for foods not on either of the two BE lists. However, to minimize consumer confusion, the disclosure must comply with the above requirements for text, symbol, digital or electronic link, or text message disclosure, as applicable. Recordkeeping and Enforcement. Those defined as responsible for disclosure under the proposed rule would have to maintain records to demonstrate compliance: If making affirmative disclosures for BE food on either list of BE foods, records would only need to show that the product contains a food or food ingredient on one of the lists. If choosing not to disclose that foods are or may be bioengineered, additional records may be needed to substantiate non-disclosure. If offering for foods from either list for retail sale without disclosure, records must verify the foods are not bioengineered. AMS is authorized to enforce compliance with the standard through records audits and examinations, hearings, and public disclosure of these results, but it does not have authority to recall any food on the basis of whether the food bears a disclosure that it is bioengineered. Public comment on the rule is due by July 03, 2018. The final rule would become effective 60 days after its publication in the Federal Register, with a compliance date of January 1, 2020, and (January 1, 2021, for small food manufacturers) to align with FDA’s extension on compliance with the nutrition labelling rule. Read the AMS’ full proposed rule at National Bioengineered Food Disclosure Standard proposed rule (or the pre-publication pdf). About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
