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. 

 

  • In a sign of progress, the Office of Management and Budget (OMB) received the U.S. Department of Agriculture’s (USDA) final rule for the National Bioengineered Food Disclosure Standard (NBFDS) on August 31, 2018 – less than two months after the comment period closed on the proposed rule for the NBFDS on July 3, 2018. As previously reported on this blog, on August 7, 2018, USDA filed an additional six bioengineered food symbols with the U.S. Patent and Trademark Office, signaling that USDA was working to finalize its final rule. The statutory deadline for completion of the final regulations was July 29, 2018.
  • As an economically significant regulatory action under Executive Order 12866, the final rule must go through the 12866 review process, which involves interagency Executive Branch review before final publication, coordinated by the Office of Information and Regulatory Affairs (OIRA) in OMB.  The period for OIRA review is limited to 90 calendar days after the date of submission, which can be extended indefinitely by the agency head or by the OMB Director for no more than 30 days.
  • However, OMB went over the 90 day limitation when USDA submitted its proposed rule for the NBFDS to OMB on December 26, 2017, and when asked about the publication date for the proposed rule in April 2018, Secretary Perdue placed responsibility for the delay of the proposed rule in part on OMB. At that time, Perdue noted that the Department requested the process be expedited but struggled to receive timely input from OMB, “we turned in our papers on time; the teachers didn’t grade them on time,” Perdue said of OMB. OMB ultimately completed their review on April 30, 2018, well over the 90-day limitation under EO 12866. If OMB sticks within the 90-calendar day review period, publication of the final rule for the NBFDS could occur by the end of November 2018.

 

 

  • The U.S. Department of Agriculture’s (USDA) proposed rule for the National Bioengineered Food Disclosure Standard (NBFDS) originally included three alternative symbols for the symbol disclosure option to label bioengineered (or, “BE”) foods:

2-A                     2-B                     2-C

USDA also included a supplemental document to the proposed rule with the color versions. The preamble to the proposed rule specifically requested comment, in part, on whether the word  “Bioengineered” should be incorporated into the design of the chosen symbol and whether the phrase “May be” should be incorporated into the design of the chosen symbols to account for “may” disclosures.

  • On August 7, 2018, USDA filed six new bioengineered food symbols with the U.S. Patent and Trademark Office, to “certify that a product…is a bioengineered food”:

  • Interestingly, two of the newly filed symbols include the text, “made with bioengineering,” which was not explicitly contemplated in the proposed rule. Further, the new filing do not utilize the “smiley faces” associated with proposed Alternatives 2-B and 2-C, which received much attention in the comments to the proposed rule. Whether USDA adopts any of the newly filed symbols remains to be seen, but nevertheless, the filings do serve as a signal of USDA’s thinking as the Department works to finalize the regulations to implement the NBFDS.

FDA Confirms Extension of Compliance Dates for Nutrition Labeling and Serving Size Rules

USDA Proposes National Bioengineered (BE) Food Disclosure Rules

  • The United States Department of Agriculture (USDA) published in the May 4, 2018 Federal Register the long awaited proposed regulations implementing the National Bioengineered Food Disclosure Standard enacted in 2016.
  • The rule would require food manufacturers and other entities that label foods for retail sale to disclose information about BE food and BE food ingredient content.  The rule would serve as a national standard for disclosure, preempting inconsistent state laws enacted over the past several years.
  • Consistent with the law, the proposed rule defines bioengineered food as containing DNA that is modified through in vitro techniques in a way that could not otherwise be obtained through conventional breeding or which is not found in nature.  However, the proposed regulations do not address the more creative biotech approaches, thresholds or exemptions that industry was anxiously awaiting.  USDA is soliciting additional comments regarding whether highly processed foods, which may have all of their DNA removed, derived from bioengineered foods should be considered bioengineered due to the possibility that trace amounts of DNA will remain.  The comment period will close in 60 days on July 3, 2018.

Keller and Heckman is closely analyzing the proposed BE food disclosure standard.  Stay tuned for our client alert which will provide a more detailed summary.

  • A class-action lawsuit filed at the end of last year alleged that Non GMO (genetically modified organism) claims on many of Gerber’s baby food products are false and misleading because the products contain ingredients derived from genetically modified crops and protein and/or dairy sources derived from cows raised on genetically modified feed.
  • The lawsuit alleges that Non GMO and similar claims (e.g., GMO free) are understood by consumers in a manner consistent with the definitions set forth by the Non GMO Project, a non-profit organization that offers a “Non GMO Project” certification which requires that the certified foods contain no genetically modified processes or inputs (e.g., animal food products derived from animals fed genetically engineered feed). Plaintiff credits the widespread use of the Non GMO Project label and the educational outreach efforts of the organization with aligning consumer expectations with the Non GMO Project Standard.
  • The case presents interesting issues because “Non GMO” has no defined regulatory meaning. Disclosure of the presence of genetically modified material in foods is regulated by USDA’s National Bioengineered Food Disclosure Standard (BE Standard), which mandates labeling of food that contains bioengineered material (the BE Standard uses the term “bioengineered” instead of GMO). However, claims regarding the absence of genetically modified material are regulated by FDA and, while FDA has issued a guidance document regarding these voluntary absence of genetically modified material claims, the document does not define what it means to be “Non GMO.” In fact, the Guidance discourages (but does not prohibit) the use of the term GMO in favor of terms such as genetically engineered and further recommends against the use of “Non GMO” and similar claims because of the potential substantiation challenges.
  • Compounding the difficulty of determining the meaning of Non GMO is the fact that the absence of a required bioengineered disclosure (under the BE Standard) does not mean that a food is necessarily “Non GMO.” For example, as at issue here, a food sourced from animals fed genetically modified/GMO feed is not required to be labeled as bioengineered under the BE Standard, but it would not meet the Non GMO Project’s definition of Non GMO. For our reporting on a legal challenge to the BE Standard, see our prior post.
  • We will monitor and report on this case and any other developments on the meaning of Non GMO and similar claims.