January 31, 2019

USDA Delivers Final Rule on Bioengineered Food Labeling

USDA Delivers Final Rule on Bioengineered Food Labeling

The U.S. Department of Agriculture (USDA) Agricultural Marketing Service has published a final rule regarding the labeling of “bioengineered” food in the United States.

The rule would give producers several options—text, symbol, electronic or digital link, and/or text message—for informing consumers when a product includes genetically modified material. Importantly, the rule does not apply to products from animals that have consumed bioengineered feed.

The final rule supports the bipartisan National Bioengineered Food Disclosure Standard, S.764, which was signed into law in 2016. The USDA was asked by Congress to step in and write the rules for disclosure, with the goal of informing consumers while minimizing compliance costs for producers.

Compliance with the rule will be mandatory as of Jan. 1, 2022.

What the Rule Means for Animal Products

At the most basic level, the standard for disclosure applies to bioengineered foods, which Congress has defined as: ‘‘(A) that contains genetic material that 11 has been modified through in vitro recombinant 12 deoxyribonucleic acid (DNA) techniques; and 13 ‘‘(B) for which the modification could not 14 otherwise be obtained through conventional 15 breeding or found in nature.”

Importantly, the standard defines food as products intended for human consumption, which means the disclosure doesn’t apply to animal feed or to products made from animals given bioengineered feedstuffs. For example, the rule would not apply to milk from cows or eggs from chickens given bioengineered feed.

Products from animals treated with pharmaceuticals derived from bioengineering are also exempt, as their products would not contain genetically modified material.

The rule does apply to products from animals that have been bioengineered. Although no bioengineered animal products can be sold yet in the United States, the rule would apply to livestock such as the AquAdvantage salmon, should products from the already FDA-approved salmon be approved for import.

The USDA also emphasized that the definition of “animal” under the rule does not include yeasts or bacteria.

How Disclosure Works

The disclosure process allows for flexibility on the producer side. Producers can inform consumers via writing or a symbol on packaging, a “electronic or digital link” or text message. Small food manufacturers could alternately provide a website URL or phone number to provide the disclosure. A small food manufacturer is defined as “any food manufacturer with annual receipts of at least $2,500,000 but less than $10,000,000.”

Restaurants and “retail food establishments” are exempt from the rule. The ruling also has no bearing on labeling for the absence of bioengineered products, as labels like “Non-GMO” are voluntary and would traditionally be under FDA authority.

Industry and Consumer Groups React

From the beginning, the USDA has welcomed public guidance on the rule. Starting in June 2017, the USDA solicited public comment through an online Q&A with 30 questions. This public comment period resulted in 112,000 responses.

Now that the rule is published, Feedstuffs reports that more than 1,000 food and agriculture groups support it. These groups include the American Farm Bureau Federation, the National Milk Producers Federation, the National Corn Growers Association, the American Soybean Association, the American Sugarbeet Growers Association and the Corn Refiners Association.

As the Biotechnology Innovation Organization (BIO) told Feedstuffs, “The final rule provides a mechanism for consumers to access clear, consistent and truthful information about food in a way that does not stigmatize the role of technology in food production."

The reception has not been uniformly positive though. Some groups point out that the disclosures are a marketing tool and do not address the potential for companies to make misleading health claims associated with their bioengineered products. Others question the use of the term “bioengineered.” The Center for Science in the Public Interest (CSPI) says they support the ruling overall but would have preferred the use of the term “genetically engineered,” which they believe is better understood by consumers.

Read the full rule here

View the USDA List of Bioengineered Foods here

Read the ASAS Public Policy Statement: Biotechnology: A Tool to Enhance Sustainable Production of Animal-Sourced Foods