Updated information is available regarding the National Bioengineered Food Disclosure Standard.
Will each facility be required to validate a process for highly refined ingredients? Or will facilities that use the same processes be able to rely on results from a process that has already been validated?
Answer: The requirements for a validated refining process are explained at 7 CFR 66.9(b). Those requirements state that, among other things, once a refining process has been validated to render modified genetical material in a food undetectable, additional testing is not necessary to confirm the absence of detectable modified genetic material in food subsequently refined through that process, provided that no significant changes are made to the validated process and provided that records are maintained to demonstrate that the refining process has been validated and that the validated refining process is followed. As required by the regulation, validation refers to the process, not the facility in which the process occurs. As such, once a process is validated under the Standard and all recordkeeping requirements are followed, that validated process does not need to be revalidated when completed in a different facility.
Will AMS maintain a list of validated refining processes?
Answer: No, AMS will not be maintaining a list of validated refining processes. Given the proprietary nature of food production, AMS believes that regulated entities are in the best position to determine whether the processes they use make modified genetic material undetectable.
For purposes of the threshold, what types of records are required to show that the presence of a bioengineered substance is inadvertent or technically unavoidable? If a food manufacturer has specification sheets that require ingredient suppliers to provide inputs with less than or equal to 0.9% BE substance, can they assume that such presence is inadvertent or technically unavoidable?
Answer: At 7 CFR 66.5(c), the Standard exempts from disclosure a food in which no ingredient intentionally contains a bioengineered substance, with an allowance for inadvertent or technically unavoidable bioengineered presence of up to five percent for each ingredient. Any intentional use of a bioengineered food or bioengineered food ingredient requires disclosure.
If a regulated entity’s records indicate they have sourced a non-bioengineered ingredient and they have taken reasonable precautions to keep bioengineered and non-bioengineered ingredients separate, then AMS may presume that any bioengineered presence below five percent is inadvertent or technically unavoidable. A record that indicates an ingredient has less than or equal to 0.9 percent BE presence, without more, is insufficient because the amount up to or equal to 0.9 percent may have been intentionally included. A record that indicates an ingredient was sourced from a non-bioengineered crop, reasonable precautions have been taken to keep that non-bioengineered crop and ingredient separate from bioengineered crops and ingredients, and that any presence of a bioengineered substance is less than or equal to 0.9 would be sufficient to demonstrate compliance with the exemption at 7 CFR 66.5(c).
Added to Disclosure and Voluntary Disclosure
We are in the process of revising our labels and I was trying to find more information on the disclosure statements. Is there a minimum font size for any of the disclosure options?
Answer: Disclosure requirements, such as the size of disclosure, are explained at 7 CFR 66.100. At 7 CFR 66.100(c), it states that the required 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 the consumer under ordinary shopping conditions. Given the variation in package sizes and multiple disclosure options, AMS has not prescribed specific size requirements for the disclosure. Any disclosure that is “of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions” is acceptable.
Added to Compliance and Enforcement
Is AMS going to ask grain handlers to produce records indicating that a certain shipment of grain is or is not bioengineered?
Answer: The Standard defines regulated entities at 7 CFR 66.1 as the food manufacturer, importer, or retailer that is responsible for making a bioengineered food disclosure. For purposes of compliance and enforcement, AMS will be looking to the records maintained by these entities. Nothing in the Standard requires entities other than these regulated entities to maintain records to demonstrate compliance with the Standard. As such, unless a grain handler also meets the definition of a regulated entity, the Standard does not include any recordkeeping requirements or mandate any particular disclosure requirements for a grain handler. Any such requirements are governed by private contracts with entities throughout the food supply chain.
In order to make compliance easier throughout the food supply chain, AMS did include a List of Bioengineered Foods at 7 CFR 66.6. For foods on this list, including soybeans, there is a presumption that all foods, and foods derived from such foods, are bioengineered foods unless a regulated entity has records to demonstrate they are non-bioengineered. As such, there is no requirement to maintain records that affirmatively show a food on the list, or a food produced from a food on the list, is a bioengineered food.
Do we need to maintain records on all apples, or just that we do not carry Arctic varieties? Would an attestation be a sufficient record?
Answer: The Standard at 7 CFR 66.302 requires all regulated entities to maintain records that are customary and reasonable to demonstrate compliance with the disclosure requirements of the law. If your records indicate that you have an Arctic variety apple, then you must make a disclosure unless you have other records to demonstrate it is not a bioengineered food. If your records do not indicate that you have an Arctic variety apple, then you do not need to make a disclosure unless you have actual knowledge that the apple is bioengineered. In many instances, the records you likely already keep that indicate what variety of apple you are selling will be sufficient to demonstrate whether you are selling an Arctic variety apple. Should you choose to keep a record such as an attestation that you are not selling certain varieties of apples then that record would also be sufficient to demonstrate compliance with the Standard.
Our company produces products for retail sale, but also produces products for foodservice and other items sold as ingredients to other food manufacturers for further processing. Do only those foods sold at the retail level need the BE disclosure? Or must a disclosure be made throughout the supply chain?
Answer: As explained at 7 CFR 66.3, the Standard applies to food subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act. From this general applicability, there are several exceptions listed at 7 CFR 66.5, including an exemption for very small food manufacturers and restaurants and similar retail food establishments.
For purposes of compliance, AMS intends to enforce the Standard only at the retail level. Because the Standard is designed to give consumers more information about their food, enforcement should be limited to ensuring proper disclosure at the retail level where consumers are making their buying decisions. While AMS intends to limit enforcement to the retail level, it reiterates that all regulated entities must maintain customary or reasonable records to demonstrate compliance with the Standard, as required by 7 CFR 66.302.
For more information visit: https://www.ams.usda.gov/rules-regulations/be