Q. What happens if a regulated entity does not comply with the Standard?
- It is a violation of the Standard for a regulated entity to knowingly fail to make a bioengineered food disclosure in accordance with the requirements of the Standard.
- If anybody suspects a violation may have occurred, they can file a written complaint with the AMS Administrator by mail or on the AMS website. The Administrator will determine whether reasonable grounds exist for an investigation of the complaint, and if so, request records from the entity responsible for disclosure. Based on those records, AMS will make its findings available to the regulated entity and provide them with an opportunity for a hearing. After the hearing, and once AMS has finalized its findings, AMS will make public a summary of the results of the investigation.
- USDA does not have the authority to issue a recall or impose civil penalties for violations of the Standard.
- After the Standard is implemented, States may adopt identical requirements and States may impose remedies for violations of their standards, such as monetary damages and injunctive relief.
Questions Added 5/24/2019
Q. Is AMS going to ask grain handlers to produce records indicating that a certain shipment of grain is or is not bioengineered?
- 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.
Q. 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?
- 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.
Q. 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?
- 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.
Question Added 09/24/19
Q. Is documentation required for every single ingredient we use? Or for products that are already going to require disclosure, can we stop after we have enough information to determine which disclosure option to use?
- The Standard at 7 CFR 66.302 requires regulated entities to maintain records that are customary or reasonable to demonstrate compliance with the disclosure requirements of the law. If your records indicate that you are using a food on the AMS List of Bioengineered foods, or a food produced from a food on the List, then you must make a disclosure unless you have other records to demonstrate it is not a bioengineered food.
- Where a disclosure is made, any record, including the ingredient list or a product specification sheet that lists the ingredient, would be sufficient to demonstrate compliance with the law.
- The Standard does not include an affirmative requirement to identify the BE status of all ingredients.