Who is covered by the Standard?
- Food Manufacturers, Importers, and Retailers who package and label food for retail sale or sell bulk food items.
- Exceptions: Restaurants and similar retail food establishments, and very small food manufacturers (<$2,500,000 annual receipts).
What foods require disclosure?
- Foods that are subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act (FDCA).
- Foods that are subject to the labeling requirements under the Federal Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act, only if:
- The predominant ingredient would independently be subject to labeling under the FDCA, or
- The predominant ingredient is broth, stock, water or similar solution and the second most predominant ingredient would independently be subject to labeling under the FDCA.
What are bioengineered foods?
- A food that contains genetic material that has been modified through in vitro rDNA techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.
- Foods in which the modified genetic material is not detectable are not bioengineered foods.
- Foods subject to certain factors and conditions are not bioengineered foods (i.e. incidental additives).
How is “Detectability” determined?
- Modified genetic material is not detectable if:
- Records verify the food is made from a non-bioengineered food,
- Records verify the food has been refined using a process validated to render the modified genetic material undetectable, or
- Testing records for specific foods confirm the absence of detectable modified genetic material.
- Records may include, among others, supply chain records, organic certification, or documentation that the ingredient is sourced from a country that does not allow production of that specific ingredient in a bioengineered form.
Is there a list of Bioengineered Foods?
- AMS maintains a List of bioengineered foods on its website. Foods on the List must be disclosed unless records are available to demonstrate they are not bioengineered.
How must disclosures be made?
- Disclosure may be made on:
- The information panel adjacent to the manufacturer/distributor information
- The principal display panel
- If there is insufficient space on either of those panels, then on any other panel likely to be seen by a consumer under ordinary shopping conditions
- There are four options for making disclosure:
- On-package text, e.g. “Bioengineered Food,” or “Contains a Bioengineered Food Ingredient.”
- USDA approved symbol <include symbol>
- Electronic or digital disclosure – must include instructions to “Scan here for more food information” or similar language, and include a phone number
- Text message disclosure – “Text [command word] to [number] for bioengineered food information.
- Small Food Manufacturers may use any of the four disclosure options, or may direct the consumer to “Call for more food information” or visit a website for more food information. Such disclosure requires an accompanying phone number and/or website URL.
- Disclosure on small packages may be made using shortened versions of the required statements.
- Disclosure on very small packages may be made using an existing URL.
How is disclosure made on foods sold in bulk containers?
- Retailers are responsible for disclosure.
- Disclosure can be made using any of the four standard options.
- Disclosure must be placed on signage or other material on or near the bulk food items.
Can an entity make voluntary disclosures?
- Entities that are otherwise exempt from disclosure may disclose using any of the options available to regulated entities.
- In limited circumstances, certain foods that do not meet the definition of “bioengineered food” but are derived from bioengineered crops or food may be disclosed. If using the symbol for such disclosures, you must use the following USDA approved symbol <insert symbol>
What records must be maintained?
- Everyone subject to mandatory disclosure must maintain records that are customary or reasonable to establish compliance.
- Records may be kept in any format (hard copy or electronic) and may be stored at any business location.
- Examples of possible records include: invoices, bills of lading, supply chain records, country of origin records, process verifications, organic certifications, and lab test results.
- Records must be maintained for two years after the food is sold or shipped.
- USDA may request records, in which case records need to be produced within five business days.
What happens in cases of noncompliance?
- Failure to make a required disclosure is prohibited.
- Complaints of possible violations may be made to AMS.
- AMS may investigate and conduct a records audit.
- Results of the audit or investigation will be shared with the regulated entity and are appealable.
- Following any appeal, AMS makes a final determination and posts the summary of the results to the AMS website.
For more information on bioengineered foods, visit the USDA Agricultural Marketing Service website.