In February’s “FSMA Friday and Regulatory Update” webinar, Eric Edmunds, JD, of The Acheson Group (TAG) discussed the National Bioengineered Food Disclosure Standard Final Rule published by USDA Agricultural Marketing Service (ARS) in late December 2018. While rules generally take effect 60 days after publication, ARS recognized that companies need time to identify the foods that need to include the disclosure as being bioengineered (BE) or derived from bioengineered foods. Additionally, it is not about a food safety issue; it is to provide transparency for consumers. So, it included three dates: Implementation – by January 1, 2020 food companies should have identified food products needing the disclosure (January 1, 2021 for small food manufacturers – those with annual receipts less than $2.5 million). Voluntary compliance – Because there are companies that want to disclose BE inclusion, they can use voluntary disclosure methods, such as labels already printed, stickers, etc., until December 31, 2021. Mandatory compliance – On January 1, 2022 all BE foods must be labeled according to the standard. The standard includes a definition of Bioengineered Food as “a food that contains detectable 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 found in nature.” USDA-ARS chose to focus on the final food product rather than the process used to develop the food or ingredient in order to have a standard that will not need amendments as new technologies are developed. This differs from the European definition which does address specific scientific methods. USDA-ARS included a list of BE foods which are known to be available on the market as a starting point for food companies: alfafa, apple (ArcticTM 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. Although some are not produced in U.S. (e.g., the eggplant varieties and salmon), all are included because imports must bear the disclosure as well; ARS plans to update the list annually, but just because a food is not on the list not doesn’t mean it’s not bioengineered. Although the standard was developed by USDA, it primarily addresses FDA foods. Thus, foods that must be disclosed are: Any food subject to the FD&C labeling requirements that is bioengineered or contains a bioengineered ingredient. Foods subject to the Federal Meat Inspection Act, Poultry Product Inspection Act, or the Egg Products Inspection Act only if: (1) the predominant ingredient is subject to the FD&C or (2) the predominant ingredient is broth, stock water, or similar solution and second-most predominant ingredient is subject to the FD&C (e.g., chicken noodle soup that has more noodles than chicken). Disclosure must be made on the principle display panel or next to manufacturer/distributor on the information panel. In rare cases, it can be put elsewhere if there is not space for it there. Disclosure is to be made through packaging text; one of two symbols included in the standard (shown above); through an electronic or digital link (e.g., “Scan here for more food information” which must be accompanied by a phone number); or through a text option, e.g., “Text [command word] to [number] for bioengineered food information.” The electronic and text options must be accessible 24/7 and provide the same information. Studies are being conducted to ensure these are adequate ways to inform customers. USDA-ARS includes a variety of ways that companies can demonstrate whether or not a food is bioengineered, which include: Recordkeeping of the source of food or refinement process. Validation of the refining process through analytical testing standards or continuous testing. Utilizing standards of performance for detectability testing through designated laboratory quality assurance and reliability of consistent of analysis and sensitivity. There are some exemptions to the rule. These include restaurants and similar retail establishments and very small food manufacturers. Also, food is not considered BE if it has no intentionally added bioengineered (BE) ingredients (inadvertent or technically allowance for up to 5% of each ingredient); if the food is derived from an animal when animal has consumed BE feed; or if it is certified under the National Organic Program. Enforcement will be through document review. AMS can make request for records, for which the business will have 5 business days to provide records. It can visit the facility, for which it will provide three business days’ notice. Additionally, any interested person may file a written statement or complaint with AMS, for which AMS will determine if reasonable grounds exist for investigation. 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
