Nevertheless, regulated entities must still be able to establish that their products do not contain detectable amounts of modified genetic material. To do so, they must maintain records that verify: 1) the food was made from a non-BE food; or, 2) the food was refined using a process validated to render the modified genetic material undetectable; or, 3) the absence of detectable modified genetic material (i.e., test results). Acceptable types of 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 BE form.
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Generally, regulated entities have four options for disclosing the presence of BE ingredients in their products: 1) a USDA-approved symbol; 2) on-package text; 3) electronic or digital disclosure; or, 4) a text message disclosure (all described in greater detail below). The 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 consumers under ordinary shopping conditions.
The use of a USDA-approved symbol is one form of BE food disclosure regulated entities may use to designate BE foods. AMS initially proposed three alternative symbols (with variations), all designed to disclose a food’s BE status in a non-disparaging manner. Ultimately, AMS adopted the two symbols at right.
For regulated entities that do not wish to utilize the symbol, there are other permissible means of designating BE foods. One is on-package text. For foods (e.g., raw agricultural commodities or ingredients produced therefrom), the required text disclosure is “Bioengineered Food.” For multi-ingredient foods that contain both BE and non-BE ingredients, the required text disclosure is “contains a bioengineered food ingredient.”
Disclosure of BE ingredients may be also made through an electronic or digital disclosure. Such disclosures must include instructions to “scan here for more food information” or similar language. Alternatively, regulated entities can use a text message disclosure, stating, “Text [command word] to [number] for bioengineered food information.”
In terms of placement, the disclosure may be placed anywhere on the principal display panel or on the information panel adjacent to the statement identifying the name and location of the manufacturer/distributor. If there is insufficient space on these panels, then on any other panel likely to be seen by a consumer under ordinary shopping conditions.
Small food manufacturers have additional options, such as directing consumers to call or visit a website for more food information. This requires an accompanying phone number and/or website URL. Disclosure on small and very small packages may use an abbreviated disclosure.
AMS affirmatively decided against prescribing specific type sizes for different disclosure options because, given the enormous breadth and variety of available packaging options, prescriptive requirements were deemed too difficult to implement.
Every regulated entity subject to mandatory BE disclosure must maintain customary or reasonable records that establish compliance. Records may be kept in any format (hard copy or electronic) and may be stored at any business location. Examples of such 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.
AMS maintains a list of BE foods on its website. Foods on the list must be disclosed unless records are available to demonstrate they are not BE. Restaurants and similar retail food establishments, as well as very small food manufacturers (< $2.5 million in annual receipts) are exempted from the rule. The purpose of the BE foods list is to provide a straightforward method of determining whether a food requires a BE disclosure. For products that contain a food on the list, regulated entities would either make a disclosure consistent with the National Bioengineered Food Disclosure Standard or not disclose if they believe the food is not required to have a BE disclosure.
This Final Rule becomes effective on Feb. 19, 2019 and must be implemented by Jan. 1, 2020, except for small food manufacturers, whose implementation date is Jan. 1, 2021. The mandatory compliance date is Jan. 1, 2022. Regulated entities may voluntarily comply with the Final Rule until Dec. 31, 2021. All food manufacturers must comply by Jan. 1, 2022.