On December 20, 2018, the Agricultural Marketing Service announced the availability of its long-awaited final rule implementing the national mandatory bioengineered (BE) food disclosure standard (NBFDS). The history of the law and rule was discussed in our post on the proposed rule.
In the proposed rule, AMS requested input on, among other things, the definition of BE (e.g., should it include genetic editing) the definition of BE foods (should it include highly refined foods that contain no DNA), the proposed logo to use on BE foods, other electronic means of disclosure, and a possible threshold below which no disclosure statement would be required. Not surprisingly, AMS received many comments and the final rule is 63 pages long. Some “highlights” include:
- Use of the term “bioengineered:” AMS maintained the designation BE rather than GMO
- Definition of bioengineering: In the proposed rule, AMS discussed the reach of the definition and queried whether bioengineering should cover procedures such as gene-editing. Ultimately, AMS did not deviate from the statutory definition.
- Definition of bioengineered food: AMS limited the definition to foods that do contain modified genetic material; highly refined foods that do not contain detectable modified genetic material do not need to be labeled with a disclosure statement. For example, even though sugar beets may be a bioengineered food, the refined sugar derived from these sugar beets is not subject to the disclosure requirement. This definition (which is consistent with the statute) greatly limits the number of foods that would require a BE disclosure statement.
- Although the rule does not require a BE disclosure statement on foods that contain no detectable modified genetic material, it allows voluntary labeling of such products, which may be labeled as “derived from bioengineering.” The rule does not provide for a “may contain” disclosure; if the food is not derived from a BE food, it may not be labeled with a BE disclosure statement.
- The rule allows for inadvertent or technically unavoidable BE presence of up to five percent. AMS did not set a threshold for foods that intentionally contain a BE substance, but if the BE ingredient qualifies as an incidental additive (as defined in 21 C.F.R. § 101.100(a)(3)) a BE disclosure statement is not required.
- List of BE foods: AMS has decided to maintain one list (not two, as considered in the proposed rule) of BE foods that could potentially be offered for sale in the United States. This list includes foods that are not (yet) commercially available in the United States, such as BE salmon. This list is subject to annual review (and update). The rule provides a mechanism for public input into updates to the list, including rulemaking as necessary, as well as consultation with other government agencies.
The list of BE foods establishes a presumption about what foods might require BE disclosure statement. However, it does not “absolve regulated entities from the requirement to disclose the BE status of food and food ingredients produced with foods not on the list when the regulated entities have actual knowledge that such foods or food.”
- Forms of disclosure:
- On-package text, e.g. “Bioengineered Food,” or “Contains a Bioengineered Food Ingredient” whichever is applicable.
- Symbol: AMS developed a modified version of one of the proposed symbols; it uses the word bioengineered instead of BE. The symbol may be in color or in black and white. The Agency has provided links to various formats for the symbol options (“AMS believes the modified symbol is an appropriate, nondisparaging way to communicate the information” required by the law).
- Despite comments against the use of an electronic or digital link disclosure, the final regulation allows use such disclosures. As explained by AMS, the law requires that AMS provides this option. The link must be accompanied by instructions to “Scan here for more food information” or similar language, and the label must provide an option for the consumer to access the disclosure by calling a phone number.
- A text message disclosure – “Text [command word] to [number] for bioengineered food information.”
Additional disclosure options are available for small entities and for small packages.
Retailers that sell bulk/non-packaged foods are responsible for providing the disclosure and may use any of the four standard disclosure options.
- Enforcement: Failure to make a required disclosure is prohibited. The rule sets forth a process for investigation and AMS action on complaints reporting possible violations. Pursuant to this process, AMS may investigate such complaints and conduct a records audit of the regulated entity. AMS will share the results of its investigation with the regulated entity and provide the option for a hearing/appeal. Following the hearing, AMS makes a final determination. This determination will be made public and is considered a final agency action (e. subject to challenge in court). The rule does not set forth specific civil penalties, recalls, or other enforcement mechanisms.
The rule will be effective on Feb. 19, 2019. AMS has set an “implementation date,” “a voluntary compliance date,” and “a mandatory compliance date.” The “implementation date,” (Jan. 1, 2020 for all but small entities, and Jan. 1, 2021 for small entities) is described as the date by which the regulated entities should begin “identifying the foods that will need to bear a BE disclosure, the records necessary to meet the recordkeeping requirements, and the type of BE disclosure they will use on their products.” The “voluntary compliance date,” (ending on Dec. 31, 2021) is described as the last date on which companies are not mandated to comply, whereas the “mandatory compliance date,” (January 1, 2022) is the date by which all regulated entities (including small entities) must comply with the new regulation. In other words, from now through Dec. 31, 2021, regulated entities may voluntarily comply with the regulations. “Very small” food manufacturers, defined as manufacturers with annual receipts below $2,500,000, are exempt from the mandatory BE labeling requirements.
AMS has created a page containing frequently asked questions and a fact sheet. AMS plans to provide additional outreach and education to inform regulated entities and the public about the new disclosure terms.