Search results for: bioengineered

  • USDA recently published its 2026 Unified Agenda, which includes an August 2026 target date for a Notice of Proposed Rulemaking (NPRM) to revise the bioengineered (BE) foods disclosure regulations and address the deficiencies identified by the Ninth Circuit, which held that the absence of detectable modified genetic material is not legally equivalent to a food not containing such material, and invalidated the rule’s detectability exemption as well as its digital and text-message disclosure provisions.
  • The 2016 National Bioengineered Food Disclosure Standard introduced federal disclosure requirements for BE foods, requiring manufacturers to disclose foods that contain BE ingredients.  In December 2018, the USDA published its final regulations, which added a detectability exemption and text-message option. The detectability exemption excluded certain foods from the definition of a BE food if “the genetic material is not detectable,” and USDA added an additional disclosure option of text messaging to “provide additional and comparable methods” to access the BE disclosure. The original requirements only offered three disclosure options: on-label text, symbol, and electronic / digital link. Manufacturers used quick response (QR) codes when using the electronic or digital link disclosure options, and the other two options required a symbol designed by the U.S. Department of Food and Agriculture (USDA) and an on-label text of “bioengineered food” or “contains bioengineered food ingredients.”
  • In July 2020, consumer advocacy groups and organic food retailers sued USDA, arguing that the rule improperly exempted many highly refined foods from disclosure and allowed companies to rely on QR codes and other digital disclosures that were not readily accessible to consumers.
  • As we previously reported, the district court upheld most of the rule in 2022, but in October 2025, the Ninth Circuit invalidated the detectability exemption and the digital and text-message disclosure provisions, while upholding USDA’s use of the term “bioengineered.” The court found that the detectability provision was inconsistent with the statute because the absence of detectable modified genetic material was not equivalent to the food not containing such material.
  • Now, both parties have submitted briefs regarding the appropriate timing for vacatur of the invalidated provisions, with plaintiffs arguing for a January 1, 2028, compliance date, and USDA seeking to delay vacatur of the digital and text-message disclosure provisions until January 1, 2029. While the district court has not yet ruled, both parties agreed on a January 1, 2028, vacatur date (requires PACER login) for the detectability provision.
  • Keller and Heckman will continue to monitor developments regarding bioengineered food disclosure standards.

  • The Ninth Circuit has reversed (Law360 subscription required) a district court ruling exempting highly refined foods from the definition of a “bioengineered food.” As we previously blogged, in 2022, the U.S. District Court for the Northern District of California dismissed a challenge by natural and organic grocers and advocacy organizations against USDA’s Agricultural Marketing Service’s (AMS) final regulations implementing mandatory uniform national bioengineered (BE) food disclosure standards for human food.
  • On appeal, the Ninth Circuit agreed with the plaintiffs that AMS’s current rule allowing exemptions if manufacturers conclude the BE ingredients are not “detectable” is not “legally equivalent to saying the food does not  ‘contain’ such material.” Specifically, the court considered what it means to “contain” modified genetic material, determining that a food is considered BE “if it actually has modified genetic material within it.” Thus, the court rejected AMS’s “flawed legal premise that the non-detectability of a substance under the regulation was equivalent to its non-presence.”
  • The court did, however, disagree with the plaintiffs’ contention that AMS lacks any discretionary authority to adopt a detectability exception for highly processed foods made from BE ingredients. Under the statute, the agency is required to determine “the amounts of a bioengineered substance that may be present in food, as appropriate, in order for the food to be a bioengineered food.” Thus, the agency could, for example, adopt a particular limit of detection as fixing the “amount” of a BE substance that may be potentially present, and a showing that the substance cannot be detected within that limit would mean the food does not qualify as BE. According to the court, while that food would otherwise meet the broad statutory definition of BE, “it would not count as a ‘bioengineered’ food under the regulatory standard only because it was excluded under a limit-of-detection-based standard promulgated under the Act.
  • The court remanded the case to the district court with instructions to grant summary judgment to the plaintiffs, remand the regulations to AMS, and determine, after receiving input from the parties, whether any provisions of the regulations should be vacated.
  • The court also affirmed the district court’s decision that AMS was not arbitrary and capricious in requiring the term “bioengineered” in disclosures and reversed the district court’s decision to deny vacatur of disclosure format rules.
  • Keller and Heckman will continue to monitor any developments related to BE foods and labeling.
  • USDA’s Agriculture Marketing Service (AMS) recently solicited public information about possible amendments to the electronic or digital link option for disclosing a bioengineered food. 
  • By way of background, the National Bioengineered (BE) Food Disclosure Standard regulations (BE regulations) currently provide that a BE disclosure may be made by on-package text, on-package symbol, electronic or digital link, or text message. 7 CFR 66.100(b).
  • However, as we have previously reported, in September 2022, a district court held that USDA had exceeded its statutory authority in authorizing the text message option as a standalone means of disclosure. The law which the BE regulations implement (7 USC 1639 et seq.) instructed USDA to provide “additional and comparable” options to the electronic or digital link if it determined that consumers would not have sufficient access to the BE disclosure. However, the Court determined that the text message was not an “additional” option and did nothing to cure the issues which USDA identified with the digital or electronic link disclosure. Accordingly, the Court ordered USDA to reconsider both the text message and electronic or digital link disclosure methods, although both remain in place pending the reconsideration. 
  • Pursuant to the Court order, last month USDA requested public input on the effectiveness and usage of the electronic or digital link disclosure, potential “additional and comparable options,” and other questions related to the BE disclosure methods more generally. The detailed questions can be found in 89 Fed. Reg. 25187 (Apr. 10, 2024). Comments are due by June 10, 2024.
  • On November 29, 2023, USDA’s Agricultural Marketing Service (AMS) published a final rule updating the National Bioengineered Food Disclosure Standard’s (the Standard) List of Bioengineered (BE) Foods (the List) by adding “sugarcane (Bt insect-resistant varieties)” and amending “squash (summer)” to “squash (summer, coat protein-mediated virus-resistant varieties).”
  • AMS is required to review the List on an annual basis. We have previously blogged about earlier versions of these proposed updates to the List (in the form of a request for comments and a proposed rule) and the final form of these updates includes more precise descriptions which is intended to capture only BE foods.
  • The presence a food ingredient on the List (or an ingredient derived from one on the List) in a food establishes a presumption that the food is a BE food requiring a BE disclosure. If a food is on the List, but is not a BE food, then records must be kept rebutting the presumption of its BE status. However, conversely, a food may be a BE food even if it is not on the List, and in all cases a BE disclosure is required if a regulated entity has actual knowledge that a food is BE.
  • The effective date of this final rule is December 29, 2023, but per the Standard, regulated entities have 18 months from the effective date to comply.

 Judge Backs Most Of GMO Labeling Rule, Bans QR Codes (subscription to Law360 required)

  • The National Bioengineered Food Disclosure Standard Law of 2016 (discussed here) amended the Agricultural Marketing Act of 1946 to require the U.S. Department of Agriculture (USDA) to develop mandatory uniform national bioengineered (BE) food disclosure standards for human food.  The law provides three options for a BE disclosure: text, a USDA-created symbol, or electronic or digital link (i.e., a Quick Response (QR) code that directs scanners to online information).  For QR codes, however, the law directs USDA to conduct a consumer accessibility study and, if necessary, to provide additional and comparable options to access the BE disclosure.  As reported here, the mandated Study of Electronic or Digital Link Disclosure identified significant challenges that may impact whether consumers can access the BE food disclosure through electronic or digital links.  In December 2018, USDA’s Agricultural Marketing Service (AMS) published final regulations that include text messaging as a fourth option for providing BE information with improved consumer access.
  • On September 14, 2022, a judge in the U.S. District Court for the Northern District of California ruled on a motion for summary judgement that was filed by natural and organic grocers and advocacy organizations challenging the BE disclosure standard and the implementing regulations promulgated by AMS.  Most of the challenges to the National Bioengineered Food Disclosure Standard (NBFDS) were dismissed, including a challenge of the rule’s use of the word “bioengineered” instead of more familiar terms such as “genetically engineered” or “genetically modified organism,” and a challenge to the rule’s exclusion of highly refined foods that do not contain detectable amounts of modified genetic material.  Summary judgement was granted to the plaintiffs, however, on an Administrative Procedure Act (APA) challenge to the electronic or digital link provisions of the NBFDS.  The court found that by leaving the QR code disclosure method as a standalone option (after USDA’s study revealed significant access problems) and adding a fourth disclosure option that regulated entities can select instead of the electronic disclosure method fails to comply with Congress’s express direction to “provide additional and comparable options to access the bioengineering disclosure.”
  • At USDA’s urging, the text message disclosure decision was remanded without vacatur so that the food industry and consumer access to BE disclosures will not be disrupted while USDA revisits this provision of the NBFDS.  According to the Center for Food Safety website, CFS and the other plaintiffs will consider appealing the court’s decision to uphold other provisions of the NBFDS.
  •  As covered on this blog, on July 24, 2020, the Agricultural Marketing Service (AMS) of the United States Department of Agriculture (USDA) recommended the addition of a new crop, ‘‘Sugarcane (insect-resistant),’’ to the List of Bioengineered Foods (the List).  AMS also recommended amending the existing listing for “squash (summer)” to “squash (summer, virus-resistant),” and sought information about bioengineered (BE) versions of cowpea and rice.  As of January 1, 2022, the date when all regulated entities were required to comply with the National Bioengineered Food Disclosure Standard (NBFDS; discussed here), the use of a listed food or ingredient produced from an item on the List would require a BE food disclosure unless a regulated entity has records demonstrating that the food or ingredient they are using is not BE.  When a crop is not on the List (as is currently the case for sugarcane), a BE disclosure is required only if the entity has actual knowledge that a food or food ingredient that it uses is BE.
  • On July 21, 2022, AMS announced a proposed rule that would update the List to add “sugarcane (Bt insect-resistant varieties)” and amend “squash (summer)” to “squash (summer, mosaic virus-resistant varieties).”  Both proposed listings would contain more precise language than previously recommended.  AMS noted in the July 22, 2022 Federal Register notice of the proposed rule that it did not receive any comments on cowpea or rice and is not proposing any action related to those two crops at this time, and addressed comments opposed to the previously recommended updates on sugarcane or wanting additional changes to the amendment for squash (summer) as follows:
    • On a comment acknowledging that BE sugarcane is authorized in Brazil, but arguing that sugarcane (Bt insect-resistant varieties) should not be added to the List because the BE sugarcane is in production in Brazil primarily for seedling bulk up, and not for human consumption, AMS found that sugarcane (Bt insect-resistant varieties) could be used for human food and requested data or evidence that would support or refute the conclusion that seedling bulk up is the only current use for sugarcane (Bt insect-resistant varieties).
    • In answer to a comment that BE sugarcane produced in Brazil is unlikely to end up in the United States, AMS noted that the List reflects production of BE foods on a global level and does not consider whether such foods are likely to end up in the U.S.
    • As for comments that sugar produced from BE sugarcane is not a BE food because it is highly refined and does not contain detectable modified genetic material, AMS noted that the BE presumption established by listing applies here because the BE sugarcane meets the only two applicable criteria for inclusion (i.e., it is authorized for commercial production and currently in legal commercial production somewhere in the world), and that the presumption could potentially be rebutted, and the associated BE disclosure requirement could be avoided, by demonstrating that modified genetic material is not detectable in sugar.
    • AMS declined to add a trade name to the more specific listing for “squash (summer, mosaic virus-resistant varieties),” in response to comments suggesting this would help distinguish BE versions from their non-BE counterparts, because there is more than one variety of squash (summer) that meets the listing criteria and it is an AMS policy to list crops generically where there is more than one BE variety being marketed.
  • As we noted previously when AMS recommended adding ‘‘Sugarcane (insect-resistant)’’ to the List, the addition of “Sugarcane (Bt insect-resistant varieties)” may complicate the strategy of regulated entities wishing to alleviate NBFDS burdens by avoiding “Sugarbeet,” which is currently listed generically based on availability of more than one BE version.  Comments on the proposed rule are due by September 20, 2022.

 

 

  • A December 21, 2018 final rule by the Agricultural Marketing Service (AMS) of the United States Department of Agriculture (USDA) established the National Bioengineered Food Disclosure Standard (NBFDS), as discussed here.  The NBFDS regulations include a List of Bioengineered Foods (the List) that AMS has determined are currently in legal production somewhere in the world.  Items on the List are presumed to potentially require a bioengineered (BE) food disclosure unless records demonstrate the item used is not bioengineered.  A BE food disclosure may be required for a food that is not on the List only if the regulated entity has actual knowledge that it is bioengineered.
  • On July 24, 2020, AMS took action to update the List by recommending the addition of a new crop, ‘‘Sugarcane (insect-resistant),’’ based on the determination that in 2018, Brazil approved commercial production of BE sugarcane developed to resist borer infestations using recombinant DNA technology and in the 2018/2019 crop year, approximately 4,000 hectares were planted for commercial production.  Additionally, in keeping with a policy of including a modifier when only one BE trait is available, AMS has proposed to include the modifier “(insect-resistant)” for an already listed crop, “Squash (summer).”
  • The addition of ‘‘Sugarcane (insect-resistant)’’ to the List may complicate the strategy of regulated entities wishing to alleviate NBFDS burdens by avoiding “Sugarbeet,” which is currently listed generically based on availability of more than one BE version.  Comments on the proposed updates to the List are due by August 24, 2020.  The mandatory date for compliance with the NBFDS is January 1, 2022.
  • The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) announced today that it is soliciting comments on its draft instructions for validation of refining processes under the National Bioengineered Food Disclosure Standard rule (“the rule”). As previously covered on this blog, the rule was published on December 21, 2018, and requires entities to disclose any food that is or may be bioengineered.
  • Importantly, the rule’s definition of “bioengineered food” excludes foods where modified genetic material is not detectable and includes provisions for how regulated entities can use records to demonstrate that modified genetic material is not detectable, which would remove those foods from the requirement to disclose. Specifically, certain refining processes may render modified genetic material in a food undetectable, provided that the refining process is validated.
  • To ensure acceptable validation of refining processes, AMS has indicated that it will publish instructions to industry at https://www.ams.usda.gov/rules-regulations/be. We will continue to monitor the status of these instructions and will provide an update when they are published.
  • USDA’s Agricultural Marketing Service (AMS), which promulgated the National Bioengineered (BE) Food Disclosure Standard, has announced additional responses to its Frequently Asked Questions (FAQs).   A total of five new FAQs have been published, one of which confirms that BE labeling information need not be provided online or in catalogs (i.e., disclosure on the label itself is sufficient).
  • AMS also released a Disclosure Determination Tool, which walks users through a series of questions and advises whether the food requires BE labeling.
  • The implementation date of the disclosure standard is January 1, 2020, except for small food manufacturers, which have until January 1, 2021.  The mandatory compliance date is January 1, 2022.
  • After much anticipation, the Agricultural Marketing Service (AMS) has released the final rule establishing the national mandatory bioengineered (BE) food disclosure standard. The rule is scheduled to be published on December 21, 2018 in the Federal Register. As previously reported on this blog, the proposed rule was published on May 4, 2018 and approximately 14,000 comments were received by the end of the comment period. The final rule includes a number of significant provisions related to applicability, disclosure requirements, administrative provisions, and compliance dates.
  • Keller and Heckman will release a comprehensive client alert on the final rule within the week, so while this blog cannot cover all areas of the final rule, below are some of the issues of interest:
    • Highly refined ingredients, detectability, and voluntary disclosure: the rule’s definition of “bioengineered food” specifically excludes foods where modified genetic material is not detectable and includes provisions for how regulated entities can use records to demonstrate that modified genetic material is not detectable, which would remove those foods from the requirement to disclose. However, if an entity wishes to disclose a food made with ingredients derived from a BE source, where the genetic material does not have detectable modified genetic material, the rule allows for entities to make a voluntary disclosure, creating a voluntary “derived from bioengineering” disclosure.
    • List of Bioengineered Foods: the final rule adopts one single “List of Bioengineered Foods” to identify the crops or foods that are bioengineered to help regulated entities determine whether a food must bear a BE disclosure. Canola, corn, soybean, and sugarbeet, among others, are included. Updates to the List will be done through rulemaking on an annual basis.
    • Exemptions from disclosure, including a threshold allowance and incidental additives: the final rule adopts a 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. Moreover, the final rule also exempts incidental additives that are present in food at an insignificant level and do not have any technical or functional effect in the food.
    • 4 disclosure options: In addition to the text (“bioengineered food” or “contains a bioengineered food ingredient”), symbol, and electronic disclosure, USDA adopted an additional text message disclosure option. The chosen symbol is one of the symbols USDA filed with the U.S. Patent and Trademark Office after the comment period ended for the proposed rule
    • Implementation and compliance dates: the final rule establishes implementation dates of January 1, 2020 for entities other than small food manufacturers and January 1, 2021 for small food manufacturers; entities are to begin implementing the standard no later than those dates. The final rule also establishes a mandatory compliance date, January 1, 2022, for all regulated entities, and a voluntary compliance period, where entities can use labels compliant with preempted State labeling laws, which ends on December 31, 2021.
  • In addition to the client alert, Keller and Heckman is planning to present a webinar on the final rule in the coming weeks. Stay tuned!

The Daily Intake is taking a holiday hiatus and will return on January 2, 2019.  We wish you a joyous holiday season and a happy new year.