AMS Publishes Proposed Rule to Establish Disclosure Requirements for Bioengineered Foods
Kelley Drye Client Advisory
May 11, 2018
On May 4, 2018, the USDA’s Agricultural Marketing Service (“AMS”) published a notice of proposed rulemaking that would establish disclosure requirements for bioengineered foods under a new “National Bioengineered Food Disclosure Standard,” in accordance with the requirements of amendments to the Agricultural Marketing Act of 1946 (“AMA”) that were enacted on July 29, 2016 (Public Law 114-216, hereinafter, “AMA Amendments”).[1]  Under the AMA Amendments, AMS is required to “establish a national mandatory bioengineered food disclosure standard with respect to any bioengineered food and any food that may be bioengineered” (“the BE Disclosure Requirements”).[2] 

In addition, AMS is required to “establish such requirements and procedures as [AMS] determines necessary to carry out the standard.”[3]  The AMA Amendments also prohibit any State or political subdivision of a State from directly or indirectly establishing, imposing, or enforcing any requirement relating to the labeling of whether a food or seed is genetically engineered or was developed or produced using genetic engineering.[4]  The proposed rule would more fully define the scope of foods that are subject to the mandatory bioengineered food disclosure standard, establish requirements governing disclosures, and authorize various options for complying with the disclosure requirements.  Comments on the proposed rule will be accepted by AMS until July 3, 2018.  AMS does not intend to extend the comment period beyond this date.
This Client Advisory provides an overview of the proposed rule.

I.  Foods Subject to BE Disclosure Requirements

    A. Scope of “Bioengineered Foods”

The AMA amendments require AMS to establish a bioengineered food disclosure standard that applies with respect to “any bioengineered food and any food that may be bioengineered.”[5]  Under the proposed rule, only “bioengineered food” would be required to include a BE disclosure – subject to certain proposed exclusions and exemptions discussed below.[6]  The AMS proposed rule incorporates the statutory definition of “bioengineering” in condensed form, providing that “bioengineered food means . . . a food that contains genetic material that has been modified through in vitro recombinant . . . [DNA] techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.”[7]

Similarly, the proposed definition of “bioengineered food” incorporates the statutory definition of “food,” as well as the food exclusions from the disclosure requirements.[8]  The AMS proposed rule borrows the “food” definition provided by section 201 of the Federal Food, Drug and Cosmetic Act (“FDCA”), except that it is limited to food for human (and not animal) consumption.  Consistent with the AMA Amendments, the proposed rule further limits the scope of foods that are subject to the BE Disclosure Requirements by defining “bioengineered foods” to exclude “incidental additives” which are present in food at insignificant levels and have no technical or functional effect in the finished food.[9]

The AMS proposed rule also provides a process for the public to submit requests for identifying specific factors or conditions under which a food would be subject to the BE Disclosure Requirements.  Interested parties can submit a request or petition regarding the definition, which would then result in a rulemaking to determine if the factor or condition should be incorporated. The proposed rule provides that AMS would consider (a) whether the factor or condition is within the scope of the current definition of “bioengineered;” (b) the costs of implementing the new factor or condition; and (c) other relevant information, such as whether the factor or condition is compatible with food labeling requirements of other agencies or countries.[10] 

    B. “Bioengineered Foods” Subject to the BE Disclosure Requirements

As a general matter, foods that qualify as “bioengineered foods” are subject to BE Disclosure Requirements and must provide the mandatory BE disclosure indicating that the food is a bioengineered food or that it contains or may contain a bioengineered food ingredient on the product label.[11] Under both the statute and proposed rule, this general requirement applies to all foods that qualify as “bioengineered foods” and are subject to the labeling requirements of the FDCA—that is, FDA-regulated foods.

In contrast, the BE Disclosure Requirements have a more limited application to foods that are regulated primarily by the USDA’s Food Safety and Inspection Service (“FSIS”).  For foods that are subject to the labeling requirements of one of the three statutes administered by FSIS – specifically, the Federal Meat Inspection Act (“FMIA”), the Poultry Products Inspection Act (“PPIA”), and the Egg Products Inspection Act (“EPIA”) – the BE Disclosure Requirements apply only if:

  • The most predominant ingredient of the food would independently be subject to the labeling requirements of the FDCA (i.e., the most predominant ingredient is not a meat (including catfish), poultry, or processed egg product that would be independently subject to the FMIA, PPIA, or EPIA); or

  • The most predominant ingredient of the food is broth, stock, or water, or a similar “solution,” and the second-most predominant ingredient would independently be subject to the labeling requirements of the FDCA (i.e., is not a meat (including catfish), poultry, or processed egg product that would be subject to the FMIA, PPIA, or EPIA).

For example, an oyster chowder containing the following ingredients in order of predominance—oysters, light cream, clam juice, and potatoes—would be subject to the BE Disclosure Requirements under the first of the above two criteria because oysters, the most predominant ingredient, would independently be subject to FDCA labeling requirements. 

Under the second of the above two criteria, a beef vegetable soup containing beef broth, beef, and carrots as the three most predominant ingredients would not be subject to the BE Disclosure Requirements because the second-most predominant ingredient is beef, which would independently be subject to the labeling requirements of the FMIA—rather than the FDCA.  In contrast, a vegetable chicken soup containing chicken broth, carrots, and chicken breast meat would be subject to the BE Disclosure Requirements because the second most predominant ingredient is carrots, which would be independently subject to FDCA labeling requirements.

    C. Exemptions

The AMS proposed rule would exempt the following foods and entities from the BE Dislcosure Requirements:

  • Food that is served in a restaurant or similar retail food establishment.

  • Very small food manufacturers (those with annual receipts of less than $2.5 million).

  • Food that is from an animal that eats BE feed but that is not otherwise BE.

  • Food that has been certified under USDA’s National Organic Program.

  • Foods that contain less than a specified threshold amount of the bioengineered substance.[12]
    • AMS has proposed three potential ways of defining the specified threshold amount of bioengineered substance required for labeling and requests comment on each alternative:
      • Alternative 1-A:  “Food in which an ingredient contains a bioengineered substance that is inadvertent or technically unavoidable, and accounts for no more than five percent (5%) by weight of the specific ingredient.”

      • Alternative 1-B:  “Food in which an ingredient contains a bioengineered substance that is inadvertent or technically unavoidable, and accounts for no more than nine-tenths percent (0.9%) by weight of the specific ingredient.”

      • Alternative 1-C:  “Food in which the ingredient or ingredients that contain a bioengineered substance account for no more than five percent (5%) of the total weight of the food in final form.”[13]

II.  AMS Would Provide Exhaustive Lists of Bioengineered Foods Subject to Disclosure

Under the proposed rule, only foods listed by AMS as  bioengineered foods that are commercially available in the United States, or products with ingredients made from foods on those lists, would be subject to the BE Disclosure Requirements.   AMS explained that “the BE food lists would serve as the linchpin in determining whether a regulated entity would need to disclose a BE food.”[14]  AMS proposes to compile two lists based on whether the food has a “high adoption rate,” meaning that more than 85% of U.S. plantings of that food have bioengineered cultivars.

The AMS proposed rule identifies ten specific foods that would be subject to BE disclosure – five that exceed the 85% high adoption rate and five that fall below that rate, as shown in the table below.

High Adoption BE Food Non-High Adoption BE Food
Canola Apple
Field corn Sweet corn
Cotton Papaya
Soybean Potato
Sugar Beet Summer varieties of squash


The disclosure required varies based on whether the BE food or BE food ingredient is classified by AMS as a “high adoption” or “non-high adoption” BE food, as discussed further below.  AMS plans to review and update these two lists annually by providing a notification in the Federal Register and inviting interested parties to provide comment concerning how these lists should be updated.  If additional BE foods are added to these lists, companies will have an 18-month grace period to make any necessary labeling changes.

III.  Responsibility for Compliance with BE Disclosure Requirements

Under the AMS proposed rule, the responsibility for complying with the BE Disclosure Requirements would fall on the entity that packages the food.   If food is packaged before it is received by a retailer, then the food manufacturer or importer is responsible for compliance with the BE Disclosure Requirements.  If the retailer packages the food or sells it in bulk, then it is responsible for compliance.[15]

IV. BE Disclosure Requirements

Under the AMS proposed rule, for a food that is subject to the BE Disclosure Requirements, the mandatory BE disclosure would be required to appear on the food label in one of the following forms:

  • Text statement;

  • BE symbol;

  • Electronic or digital link that is printed on the label (e.g., QR code) with a telephone number; or

  • Instructions to receive BE information by text message.For small food manufacturers and small/very small food packages, the BE disclosure could be made in additional ways.

     A. Form and Content of BE Disclosure

The rule provides that the entity responsible for compliance with the BE Disclosure Requirements can comply with the rule by using any of the following four alternative forms of disclosure.

  • Text Statement.  The text statement required depends on whether the food is a “high adoption BE food” or a “non-high adoption BE food.” 
    • High adoption BE foods or food ingredients must state either, “Bioengineered food,” or “Contains a bioengineered food ingredient.”
    • Non-high adoption BE foods or food ingredients can state either, “Bioengineered food” or “May be bioengineered food,” or “Contains a bioengineered food ingredient,” or “May contain a bioengineered food ingredient.”
  • Symbol Disclosure.  AMS has proposed the following three different symbols as possibilities and sought comment as to which should be adopted in the final rule:

  • Electronic or Digital Link Disclosure.  The electronic or digital link disclosure would give the consumer an option to scan something such as a QR-code to identify whether the product is BE.  The proposed rule would require an accompanying text disclosure such as “Scan anywhere on package for more food information” or “Scan icon for more food information,” along with a telephone number with instructions to “Call for more food information.”  The manufacturer would not be allowed to collect, analyze, or sell any personally identifiable information about the consumer through the electronic or digital link.
  • Text Message Disclosure.  The label would provide a number for the consumer to text to receive more information about the product’s BE status, along with a disclosure, “Text [number] for more food information.”  Manufacturers would not be able to charge consumers for the text, or include any other information besides the bioengineered food disclosure in the text response.

In addition to these four alternatives, small food manufacturers (those with between $2.5 million and $10 million in annual receipts) could comply with the BE Disclosure Requirements by either: (1) disclosing a phone number with the statement, “Call for more food information”; or (2) disclosing a URL with the statement, “Visit [URL or website] for more food information.”  In both instances, the disclosure given when the consumer calls the provided number or visits the provided website must be consistent with other requirements under the rule. 

    B. Placement of BE Disclosure on Food Label

Regardless of the form of BE disclosure that is used for a food,  the proposed rule requires the disclosure to be of sufficient size and clarity to appear prominently and conspicuously on the food label, making it likely to be read and understood by the buyer under ordinary shopping conditions.[16]  For most food items, the disclosure must appear on the principal display panel (PDP) or information panel of the product label.  For labels with insufficient space to place the disclosure on the PDP or information panel, the disclosure can be placed on an alternate panel likely to be seen by a buyer under ordinary shopping conditions.

Foods sold in bulk containers are not exempt from BE Disclosure Requirements.  For those products, the disclosure must appear on signage or other material (e.g., a placard, sign or label) in a manner that allows consumers to easily identify and understand the BE status of the food.[17]

V.   Recordkeeping

The proposed rule also requires manufacturers, importers, and retailers subject to the BE Disclosure Requirements to maintain records to establish compliance.  The records must contain sufficient detail as to be readily understood and audited, and must be maintained for at least two years beyond the date the food subject to the rule was sold or distributed for retail sale. 

If an entity sells food on either list maintained by AMS and determines that the food does not need to include the BE disclosure, it would need to maintain records to support that conclusion.  For example, if a manufacturer produces soy sauce but determines that the product is not made from BE ingredients such that a disclosure is not required, the manufacturer would need to have adequate records to support that conclusion. 

VI.  Enforcement

AMS only has the authority to enforce the BE Disclosure Requirements through records audits and examinations, and public disclosure of those records and examinations.  The AMA Amendments expressly provide that AMS does not have the authority to recall foods based on the lack of a disclosure.  The AMA Amendments also provide that it is a prohibited act under the AMA to knowingly fail to make a disclosure prescribed by the BE Disclosure Requirements.

VII. Compliance Dates

The rule proposes a compliance date of January 1, 2020, to align with the FDA’s recently released rule that extends compliance dates for the rules revising requirements for Nutrition Facts and Supplement Facts.  Small food manufacturers would have until January 1, 2021, in accordance with the FDA’s final rules.
 
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For more information about this advisory, please contact:

Sarah Roller
(202) 342-8582
sroller@kelleydrye.com 

Donnelly McDowell
(202) 342-8645
dmcdowell@kelleydrye.com

Lauren Myers
(202) 342-8473
lmyers@kelleydrye.com
 
[1]               Proposed Rule, National Bioengineered Food Disclosure Standard, 87 Fed. Reg. 19,860 (May 4, 2018).
[2]               7 U.S.C. § 1639b(a)(1). 
[3]               7 U.S.C. § 1639b(a)(2).
[4]               7 U.S.C. § 1639b(e).
[5]               7 U.S.C. § 1639b(a)(1).
[6]               Proposed 7 C.F.R. § 66.3(a). 
[7]               Proposed 7 C.F.R. § 66.1; see also 7 U.S.C. § 1639(1).
[8]               U.S.C. § 1639(2).
[9]               See 21 C.F.R. § 101.100(a)(3); Proposed 7 C.F.R. §§ 66.1. 
[10]             7 C.F.R. § 66.202.
[11]             Proposed 7 C.F.R. §§ 66.100-66.108.
[12]             Proposed 7 C.F.R. § 66.5.
[13]             Proposed 7 C.F.R. § 66.5(c) (emphasis added).
[14]             83 Fed. Reg. at 19,864.
[15]             Proposed 7 C.F.R. § 66.100(a). 
[16]             Proposed 7 C.F.R. § 66.100(c)-(d). 
[17]             Proposed 7 C.F.R. § 66.114.