On December 21, 2018, the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) issued a final rule1 (BE Final Rule) to implement the National Bioengineered Food Disclosure Standard (NBFDS),2 which became law in July 2016. The purpose of the NBFDS and implementing regulations is to provide uniform information to consumers about bioengineered (BE) food and BE food ingredients. The BE Final Rule addresses many key concerns and questions raised by industry, especially in response to the BE Proposed Rule, which was issued in May 2018.
APPLICABILITY
The BE Final Rule creates a mandatory national labeling disclosure requirement for BE food, defined as food that contains detectable “genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques” and “for which the modification could not otherwise be obtained through conventional breeding or found in nature.”3
The BE Final Rule applies to foods that are (1) subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FDCA), or (2) subject to the labeling requirements under the Federal Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act, but only if the most predominant ingredient would independently be subject to labeling under the FDCA (e.g., carrots) or the most predominant ingredient is broth, stock, or water (or similar solution) and the second most prominent ingredient would independently be subject to labeling under the FDCA.4
Further, AMS has published a List of Bioengineered Foods (BE List) that identifies BE foods that are authorized for commercial production (and that are in legal production) somewhere in the world.5 The BE List is intended to assist regulated entities (i.e., food manufacturers, importers, and retailers that package food or sell bulk food items) in identifying those foods that may require BE disclosures. The BE List currently includes the following:
- Alfalfa
- Apple (Arctic™ varieties)
- Canola
- Corn
- Cotton
- Eggplant (BARI Bt Begun varieties)
- Papaya (ringspot virus–resistant varieties)
- Pineapple (pink flesh varieties)
- Potato
- Salmon (AquAdvantage®)
- Soybean
- Squash (summer)
- Sugarbeet
Not all BE foods and ingredients will be on the BE List. Regulated entities whose records show that a food they are selling or using is bioengineered must make appropriate disclosure of that food, even if that food is not included on the BE List. AMS will review the BE List annually and make updates as necessary.
EXEMPT FOODS AND ENTITIES
The following foods and entities are exempt from the BE Final Rule requirements:
- Very small food manufacturers (annual receipts of less than $2.5 million).6
- Food served in a restaurant or similar retail food establishment.7
- Food that has inadvertent or technically unavoidable presence of BE substances up to 5 percent per ingredient (Note: this does not include any food or ingredient with the intentional presence of BE substances).8
- Food derived from animals that were fed with BE feed.9
- All National Organic Product (NOP) certified label products (“100% Organic,” “Organic,” and “Made with Organic”) as NOP rules clearly require that no ingredient may be bioengineered.10 This exemption, however, does not apply to “products with less than 70 percent organically produced ingredients.”11
- Refined foods that are derived from BE crops and do not contain detectable modified genetic material.12 For example, refined sugar that is derived from BE sugarbeets, but does not contain detectable modified genetic material, is not required to bear the BE disclosure statement.
- Certain incidental additives present in food at an insignificant level and that do not have any technical or functional effect in the food.13
FORMS OF DISCLOSURE
Food that meets the definition of “BE food” and is not otherwise exempt must bear an appropriate BE disclosure statement. Generally, a regulated entity may choose from among the following types of on-package disclosures, any one of which will satisfy the disclosure requirement:14
- Text Disclosure: Entities may use “Bioengineered Food” or “Contains a Bioengineered Food Ingredient,”15 as applicable. The use of a “may be bioengineered” disclosure is not permitted.
- Symbol Disclosure: Entities may utilize one of the AMS-prescribed color or black-and-white symbols.16
- Electronic or Digital Link Disclosure with Phone Number: Entities may provide a link to the BE information, which must be accompanied by the instructions “Scan here for more food information” or similar language. The label must also provide an option for the consumer to access the disclosure information by calling a phone number.17
- Text Message Disclosure: Entities may provide a statement that instructs consumers on how to receive a text message with the BE disclosure information.18
There are also other disclosure options available for small food manufacturers (defined as “annual receipts of at least $2,500,000 but less than $10,000,000”) and small and very small packages.19 Disclosures must be of “sufficient size and clarity” and appear on the information panel (adjacent to the manufacturer/distributor statement), on the principal display panel (PDP), or on an alternate panel likely to be seen by a customer under ordinary shopping conditions if there is insufficient space on the information panel or the PDP.20 For bulk items, the disclosure must appear on signage or other materials (e.g., placard, sign, label, sticker, band, twist tie, etc.) that allows consumers to easily identify and understand the BE status of the food.21
VOLUNTARY BE LABELING
The BE Final Rule allows for voluntary BE labeling but in only two circumstances. First, certain entities that are exempt from the requirements of the NBFDS (i.e., very small food manufacturers, and restaurants and similar retail food establishments) may voluntarily label foods if those foods would otherwise be subject to the mandatory label disclosure.22 The form of such disclosure must be consistent with the options outlined above. Second, certain highly refined foods that do not technically meet the definition of “bioengineered food” but are derived from BE food or crops (i.e., corn syrup that has been refined such that the modified genetic material is undetectable) may voluntarily disclose that they are “derived” from bioengineering or a bioengineered source consistent with the various options provided for in the BE Final Rule.23
The BE Final Rule does not address or cover absence claims such as “Non-GMO”; such claims must be truthful and non-misleading and consistent with applicable law.
RECORDKEEPING REQUIREMENTS
If a food is on the BE List, or if a regulated entity has knowledge that a food or an ingredient is BE, the regulated entity must maintain records to demonstrate compliance with the BE Final Rule regarding that food or ingredient.24 The BE Final Rule describes, among other things, three ways in which regulated entities can use records to show that modified genetic material is not detectable in their food products. First, regulated entities can maintain records verifying that the “food is sourced from a non-bioengineered crop” or other food source, such as non-bioengineered salmon.25 Second, regulated entities can maintain records showing that “the food has been subjected to a refinement process ‘validated’” to render modified genetic material undetectable.26 Third, regulated entities can maintain “certificates of analysis or other records of testing appropriate to the specific food that confirm the absence of modified genetic material.”27
It should be noted that USDA did not intend to impose burdensome new recordkeeping requirements; rather, the agency expects regulated entities to maintain records that are “customary or reasonable” to demonstrate compliance with the BE food disclosure requirements.28 Records must be maintained for at least two years beyond the date the food or food product is sold or distributed for retail sale.29
COMPLIANCE DATES
Section 66.13 of the BE Final Rule divides compliance into two parts by setting forth both “implementation” and “compliance” dates for the NBFDS. Regulated entities, other than small food manufacturers, have an implementation date of January 1, 2020, and small food manufacturers have an implementation date of January 1, 2021. This means that regulated entities “should begin implementing the NBFDS no later than those dates by 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.”30
Most importantly, mandatory compliance begins on January 1, 2022, which is when all regulated entities must comply with the requirements of the NBFDS (i.e., foods entering commerce after this date must be labeled in compliance with the BE Final Rule).31 For regulated entities that can and would like to do so, the BE Final Rule provides for a voluntary compliance period that ends on December 31, 2021.32
VIOLATIONS
Section 66.400 of the BE Final Rule states that the failure to make a BE food disclosure as required by the NBFDS is a prohibited act. The rule creates a process for investigation and AMS action on complaints regarding possible violations.33 Specifically, AMS may investigate such complaints and conduct a records audit of the regulated entity, after which AMS will provide the results of its investigation of the regulated entity and give the option for a hearing or appeal.34 Following the hearing, AMS will make a final determination, which will be made public and considered a final agency action subject to future judicial review.35
USDA does not have the authority to issue a recall or impose civil penalties for violations of the BE Final Rule. USDA has noted, however, that states may adopt identical requirements and may impose remedies for violations of their state standards, such as monetary damages and injunctive relief.36
CONCLUSION
In the BE Final Rule, which largely mirrors the NBFDS, USDA addressed many key industry concerns and tried to strike a balance between cost and consumer access to information.
1 See Final Rule; National Bioengineered Food Disclosure Standard [Docket No. AMS-TM-17-0050], 83 Fed. Reg. 65814 (Dec. 21, 2018) (to be codified at 7 C.F.R Pt. 66), available athttps://www.federalregister.gov/documents/2018/12/21/2018-27283/national-bioengineered-food-disclosure-standard. The proposed rule can be found at 83 Fed. Reg. 19860 (May 4, 2018).
3 7 U.S.C. § 1639(1); 83 Fed. Reg. at 65871 (§ 66.1).
4 83 Fed. Reg. at 65872 (§ 66.3(b)).
6 83 Fed. Reg. at 65872 (§ 66.5(b)).
7 Id. at 65872 (§ 66.5(a)).
8 Id. (§ 66.5(c)).
9 Id. (§ 66.5(d)).
10 Id. (§ 66.5(e)).
11 Id. at 65824-65825.
12 Id. at 65816.
13 Id. at 65871 (§ 66.1).
14 Id. at 65871 (§ 66.1).
15 Id. at 65873 (§ 66.102).
17 Id. at 65874 (§ 66.106).
18 Id. (§ 66.108).
19 Id. (§§ 66.110 and 66.112).
20 Id. at 65873 (§§ 66.100(c) and (d)).
21 Id. at 65874 (§ 66.114(b)).
22 Id. at 65874-65875 (§ 66.116(a)).
23 Id. (§ 66.116(b)).
24 Id. at 65875-65876 (§ 66.302(b)).
25 Id. at 65872 (§ 66.9).
26 Id.
27 Id.
28 Id. at 65875-65876 (§ 66.302(a)(1)).
29 Id. (§ 66.302(a)(3)).
30 Id. at 65832 (§ 66.13).
31 Id.
32 Id.
33 Id. at 65876 (§§ 66.400-406).
34 Id.
35 Id.
