National Bioengineered Food Disclosure Standard rules publish May 4: Ties to patent protection and gene editing

by McKee, Voorhees & Sease, P.L.C.

McKee, Voorhees & Sease, P.L.C.

National Bioengineered Food Disclosure Standard rules publish May 4: Ties to patent protection and gene editing

In 2016 Congress passed an amendment to the Agricultural Marketing Act of 1946 to establish a national bioengineered food disclosure standard. This law was an important milestone in establishing transparency for consumers, ensuring labeling certainty for innovators developing new products, and preventing proliferation of independent state-by-state disclosure laws which would make food packaging unworkable from a compliance perspective. Congress specified that implementing rules must be finalized by July 29, 2018 – a rapidly approaching deadline.

USDA will post their proposed rule to the Federal Register on May 4, 2018 and will be seeking public comments for 60 days thereafter.

The question of what will be labeled begins with specifying that the product must be “food” and must be “bioengineered”.

What is food?

In the National Bioengineered Food Disclosure Standard, Food is defined as: A food [(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” (per 21 U.S.C. 321(f))] that is intended for human consumption. (7 U.S.C. 1639(2).)

So, yes to that wine from Sonoma County, a green smoothie, and even the beloved frosted brown sugar cinnamon Pop-Tart. No to KeyGene’s patented guinea pig, at least in the States.

What is “bioengineering"?

The amended Act defines “bioengineering” as referring to a food “(A) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature.” 7 U.S.C. 1639(1).

Details on each of these components of the definition are to be determined, and the USDA is seeking public comment on this definition including whether, for example, highly refined products such as sugars and oils would contain any modified genetic material.

Interestingly, USDA anticipates that in applying the “found in nature” component of the definition of “bioengineered”, they will consider whether a modification has intellectual property protection and was able to meet the patentability criteria of 35 U.S.C. 101, which excludes products of nature from patent protection.

Based on recent U.S. Supreme Court decisions, the U.S. Patent and Trademark Office issued updated guidance to examiners outlining the criteria to determine when inventions are products of nature are therefore not patentable subject matter under 35 U.S.C. 101. See for example, U.S. Patent and Trademark Office’s 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 FR 74618, 74622-24 (Dec. 16, 2014), and the more recent Memorandum from Deputy Commissioner for Patent Examination Policy to Patent Examining Corps titled “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant's Response to a Subject Matter Eligibility Rejection” (May 4, 2016) (

USDA states that “AMS believes that there are similarities in how a product of nature is interpreted for purposes of patent eligibility and how a modification could be found in nature, for purposes of determining whether a modification is bioengineered” (

This is another example illustrating the importance of tying intellectual property and regulatory strategies together, as IP and regulatory agencies review and consider each other’s regulations and product-specific documents during the commercialization lifecycle from discovery through post-launch.

Where does that leave products of gene editing?

For products produced by site-directed mutagenesis such as CRISPRs where technology is simply used to “text edit” an existing gene to change a “typo”, there is no recombinant DNA technique such as a plasmid insertion involved. Therefore based on the literal text of the definition, this would not qualify as “bioengineering” as outlined in the Act.

However, as the definition undergoes public comment and the final rules are drafted and implemented, it will become clear whether implementing guidelines expressly exclude products of gene editing or if it will be considered on a case by case basis dependent on the technology as implemented. Issues include whether “recombinant DNA techniques” may include the use of an HDR template and/or guide RNA, and whether products who have met the threshold of patentability under 35 USC 101 by arguing they are not found in nature, even though similar products exist in nature, end up as “bioengineered” in the final rules.

If gene edited products are indeed expressly excluded, does this mean that each state can draft and implement separate legislation regarding labeling for gene edited food products?

This topic was addressed through a section directed to federal preemption, mentioned without discussion in the published rule, noting simply that “Subtitle F addresses Federal preemption of State and local genetic engineering labeling requirements”. Subtitle F, below, uses the phrase “genetic engineering” distinct and presumably broader than the strictly defined “bioengineering”, but final interpretation is yet to be determined (7 U.S.C. 1639i).

FEDERAL PREEMPTION.—No State or a political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food or seed in interstate commerce any requirement relating to the labeling of whether a food (including food served in a restaurant or similar establishment) or seed is genetically engineered (which shall include such other similar terms as determined by the Secretary of Agriculture) or was developed or produced using genetic engineering, including any requirement for claims that a food or seed is or contains an ingredient that was developed or produced using genetic engineering.

Further complicating factors include the tie in to the Organic Foods Production Act of 1990 (7 U.S.C. 6501 et seq.), international labeling laws, requirements for importers, and situations where FDA may have voluntary or mandatory labeling requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA).

What will the label look like?

The draft rule proposes options for use of logo and information placement depending on product type and package size, utilizing symbols that display “BE” (bioengineered). There is also allowance for use of an electronic link such as a QR code as proposed by GMA, if accompanied by a telephone number.

What happens next?

These next few months are an opportunity to provide public comment, advocate with members of Congress, and consider implications on both IP and regulatory strategy for relevant products in development. Stay tuned for further details during the public comment period.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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