Date: Dec 27, 2018
On December 21, 2018, the U.S. Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) published its final rule implementing the National Bioengineered Food Disclosure Standard (NBFDS) (Public Law 114-216) mandated by Congress in 2016, which amended the Agricultural Marketing Act of 1946. See 83 Fed. Reg. 65814. This final rule follows AMS' proposed rule, which was published on May 4, 2018. See 83 Fed. Reg. 19860. The NBFDS preempted State and local genetic engineering labeling requirements and charged AMS with developing a national mandatory standard for disclosing the presence of bioengineered (BE) food. The final rule is codified at 7 C.F.R. Part 66.
This alert provides an overview of the final rule and is divided into four parts: (1) Applicability; (2) Disclosure; (3) Administrative Provisions; and (4) Compliance Dates.
In addition to food manufacturers, the final rule requires importers of food labeled for retail sale in the U.S. and some U.S. retailers to disclose foods and ingredients produced from foods that are or may be bioengineered. Under 7 C.F.R. § 66.100(a), if a retailer packages a food or sells food in a bulk container and/or display, then the retailer is responsible for ensuring that the food bears a BE food disclosure if necessary.
The most predominant ingredient of the food would independently be subject to labeling requirements under FDCA or
The most predominant ingredient of the food is broth, stock, water, or a similar solution AND the second-most predominant ingredient of the food would independently be subject to the labeling requirements under FDCA
B. "Bioengineered Food" and Detectability
"a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature; provided that such a food does not contain modified genetic material if the genetic material is not detectable pursuant to § 66.9."
Verify that the food is sourced from a non-BE crop or source;
Verify that the food has been subjected to a refinement process validated to make the modified genetic material in the food undetectable (a "validated refining process" is defined further in the regulations under 7 C.F.R. § 66.9(b)); or
Provide for testing records appropriate to the specific food that confirm the absence of modified genetic material.
"...based on the available scientific evidence, refined beet and cane sugar, high fructose corn syrup, degummed refined vegetable oils and various other refined ingredients are unlikely to require BE food disclosure because the conditions of processing serve effectively to degrade or eliminate the DNA that was initially present in the raw agricultural commodity." 83 Fed. Reg. 65814, 65834.
C. List of Bioengineered Foods
The List provides a tool to determine whether a food must bear a BE disclosure. If an entity uses a food or ingredient on the list above, or its ingredient utilizes (or is sourced from) a food/crop from the List, that entity must maintain records regarding that food or ingredient. (See Recordkeeping section below). That entity's records drive the disclosure determination. For example, if a food or food ingredient is on the List and the entity's records show that the food is a BE food (or does not indicate whether or not the food is BE), the food must bear a BE disclosure if no exemptions otherwise apply. (See Disclosure and Recordkeeping sections below.) AMS plans to maintain additional information on its website associated with the bioengineered status of the foods and crops on the List.
D. Evolving Technologies, Gene Editing
E. Yeast, Enzymes and Other Organisms
F. Factors and Conditions: Refining the Scope of Disclosure
Food served in a restaurant or similar retail food establishment. AMS modified the proposed definition of "similar retail food establishment" to include examples, such as a food truck and transportation carrier. In the preamble to the final rule, AMS clarified that salads, soups and other ready-to-eat items prepared by grocery stores are exempt from the disclosure requirements.
Very small food manufacturers (with annual receipts of less than $2.5 million).
Threshold for inadvertent or technically unavoidable presence of bioengineered substances of up to 5% for each ingredient, with no allowance for any BE presence that is intentional. Therefore, food in which any single ingredient contains more than 5% of a bioengineered substance cannot use this threshold exemption. In the preamble to the final rule, AMS acknowledges the sufficiency of the existing industry standards, which typically calculate threshold amounts as the BE content of an ingredient relative to the non-BE content of that same item or ingredient. Verification of compliance with the threshold will be done through records, not prescriptive tests or methodologies.
Food derived from an animal is prohibited from being considered a BE food solely because the animal consumed feed produced from, containing, or consisting of a BE substance.
Food certified under AMS' National Organic Program (NOP) are exempt. This exemption covers all NOP certified label categories ("100% Organic," "Organic" and "Made with Organic").
on the information panel (IP) directly adjacent to the statement identifying the name and location of the handler, distributor, packer, manufacturer, importer or any statement disclosing similar information (also known as the "signature line");
anywhere on the principal display panel (PDP); or
an alternative panel if there is insufficient space on the IP or PDP.
A. Form of Disclosure
Text: The text disclosure option allows entities to use "bioengineered food" and "contains a bioengineered food ingredient" for multi-ingredient food.
Symbol: While the proposed rule sought comment on three alternative symbols, the final rule uses a variation of one of the proposed symbols, which incorporates the word "bioengineered" and can be used in either color or black and white:
Electronic of Digital Link: The use of an electronic or digital link to disclose BE food must be accompanied by the statement "Scan here for more food information" or equivalent language. A telephone number that provides access to the BE food disclosure is required, along with the statement "Call [number] for more food information," and must be near the electronic or digital link. Additionally, the electronic or digital link must provide the bioengineering disclosure on the first product information page accessed through the link, without any marketing or promotional material. The disclose must confirm with either the text disclosure or symbol disclosure.
Text Message: As required under the NBFDS, AMS conducted a study to identify potential technological challenges that may impact whether consumers would have access to the bioengineering disclosure through electronic or digital disclosure methods. Ultimately, the Secretary concluded that consumers would not have sufficient access to the BE disclosure through electronic or digital means under ordinary shopping conditions, and as a result, the final rule provides for a text message disclosure option. If utilizing the text message option, the entity must not charge the consumer a fee to access the disclosure by text message, and the requirements involve including a statement, "text [command word] to [number] for bioengineered food information."
B. Voluntary Disclosure
III. Administrative Provisions
January 1, 2020 for regulated entities other than small food manufacturers
January 1, 2021 for small food manufacturers ("any food manufacturer with annual receipts of at least $2,500,000, but less than $10,000,000")
January 1, 2022 as the mandatory compliance date. By that date, all regulated entities must comply with the requirements of the NBFDS.
December 31, 2021 as the last day for the voluntary compliance period. The voluntary compliance date allows entities to use labels that are compliant with preempted State labeling laws during the compliance period, or they can apply stickers or ink stamp disclosures to existing labels.
Attorneys in Keller and Heckman's Food and Drug Practice are monitoring these changes and are consulting with clients to be sure they are in compliance by the dates noted above. If you have questions or need guidance contact us at email@example.com.
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