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Biotech Blog: The Final National Bioengineered Food Disclosure Standard

By CSPI Biotechnology Director Greg Jaffe

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In July 2016, President Obama signed the National Bioengineered Food Disclosure Law (NBFDL), requiring food manufacturers to disclose the presence of bioengineered foods and ingredients. That law required the U.S. Department of Agriculture to finalize regulations for the law’s implementation by its two-year anniversary. On May 4, 2018, USDA proposed regulations and subsequently received more than 14,000 comments from the public. USDA issued the final rule on December 21, 2018. This article identifies some of the important issues raised in the public comments on the proposed rule, and describes USDA’s final decisions on those issues.

Background on the NBFDL

The NBFDL defines “bioengineered” to mean any food “(a) that contains genetic material that has been modified through in vitro recombinant DNA techniques; and (b) for which the modification could not otherwise be obtained through conventional breeding or not found in nature.”

Under the NBFDL, a food manufacturer can choose among three different options to disclose foods or ingredients that are bioengineered:

  • Use text on the product’s package, as specified by the USDA;
  • Include a symbol, developed by the USDA, on the package; or
  • Add an electronic or digital link (such as a QR code, bar code, or SmartLabel) on the package that leads to a website with the required information.

It also identifies exemptions from the disclosure requirements, such as food served in restaurants or similar establishments and food products from “very small food manufacturers.” As with any law, the devil is in the details. That’s why it’s important to dig into the USDA regulations.

Issue 1: What Term to Use—Bioengineered, Genetically Engineered, Genetically Modified, and/or GMO?

What term should be used to describe a product or ingredient that was produced from a bioengineered organism? In the NBFDL, Congress used “bioengineered,” but gave the USDA the discretion to allow other “similar” terms. In its proposed rule, the USDA stated that it considered alternative phrases, but tentatively decided only to allow “bioengineered.” That decision was supported by trade associations representing different parts of the food industry (e.g., the Grocery Manufacturers Association, Food Marketing Institute, American Soybean Association, and American Farm Bureau Federation). Some comments pointed out that all crops have been “genetically modified” from their ancestors or that “GMO” can be misinterpreted by consumers who think that a live “organism” is part of the food.

In the final rule, the USDA did not change its position and only allowed the term “bioengineered.”

Many organizations and food companies (including organic producers), however, urged the USDA to allow the use of other terms, specifically “genetically engineered,” “genetically modified,” and/or “GMO.” Some (Campbell’s Soup, for example) argued that “GMO” is the most familiar and preferred term for consumers. Others (including Stonyfield) argued that there should be consistency among government programs and that “GMO” is used in the USDA’s National Organic Standards Program. Still others (like the Environmental Working Group) argued that “bioengineering” is a term associated with the medical field, not food. CSPI argued that the term “genetically engineered” should be allowed since it is scientifically accurate.

In the final rule, the USDA did not change its position and only allowed the term “bioengineered.” The USDA “determined that bioengineering and bioengineered food accurately reflected the scope of the disclosure and the products and potential technology at issue,” and that using additional terms might cause marketplace confusion. The final rule also requires the food manufacturer only use either “bioengineered” or “contains bioengineered ingredients,” and prohibits the food manufacture from identifying the specific ingredients that came from a bioengineered crop. Finally, USDA stated that it would engage in outreach and education on the new disclosure term.

Issue 2: What Symbol to Use

The NBFDL gives food manufacturers the option of disclosing bioengineered foods using a symbol instead of text on the package. The USDA proposed three options for the public to comment on:

As expected, reactions varied tremendously. A large majority of the food industry preferred the first symbol. But, many commenters disliked all three symbols because they portrayed GMOs in too positive a light. Some described the second and third symbols as a “smiling sun” and a “winking face.” 

The USDA’s proposal also asked the public whether the symbols should incorporate the word “bioengineered” in addition to just the letters “BE.” In a poll by the International Food Information Council, only 23% of consumers said that the symbol alone was the right amount of information, but when the term “bioengineered” was added to the symbol, 65% of consumers thought the symbol had the right amount of information.

In the final rule, USDA picked the symbol that was the least objectionable (the one on the left, above, and the symbol CSPI supported as the best of the three options). The department was persuaded, at least in part, by the IFIC poll that putting the word “bioengineered” in the symbol gave consumers the right amount of information; they got rid of “BE” and replaced it with the word “bioengineered.” The final symbol, which has both color and black and white options, is below.

Issue 3: Whether to Disclose Highly Refined Ingredients and Products

Probably the most controversial issue in the rulemaking process was whether highly refined ingredients should require disclosure. Highly refined ingredients produced from an engineered crop, such as sugar or corn oil, do not contain any bioengineered material (i.e., DNA or protein) and are biologically and chemically identical to the same ingredient made from a non-bioengineered crop. Should such products be disclosed? The stakes are high. Different stakeholders have estimated that anywhere from 18% to 78% fewer food products would bear disclosures if highly refined ingredients did not merit disclosure.

The USDA proposed two options, perhaps because the food industry itself was divided. The first option, which was generally supported by farmers and developers of genetically engineered seeds, was that highly refined ingredients should not be disclosed. Those groups argued that highly refined ingredients are not “bioengineered” because there is strong scientific evidence that they don’t contain any detectable DNA or protein from the bioengineered organism. Some countries with mandatory GMO labeling, including Thailand, Japan, New Zealand, Australia, and Indonesia, exempt highly refined ingredients for that reason.

The second option was that highly refined ingredients should be disclosed. That position was supported by many consumer and environmental groups, members of the organic industry, food companies, and food retailers. Those proponents made several different arguments, including: 

  • Scientific evidence suggests that highly refined ingredients do contain genetic material, even if it is not readily detectible;
  • According to some members of Congress, the Federal statute was meant to cover highly refined ingredients and to cover more products than the state laws the Federal statute replaces (which did apply to those ingredients);
  • Consumers expect to know if an ingredient came from a bioengineered crop even if it is highly refined;
  • To be transparent, many food companies will disclose highly refined ingredients voluntarily, which could lead to consumer confusion if the disclosures aren’t required for all products;
  • Inclusion of highly refined ingredients will be less disruptive to trade, since at least 38 countries with GMO labeling regulations mandate labeling of those ingredients—including major trading partners like the European Union, the United Kingdom, and Brazil.

CSPI supported disclosure of highly refined ingredients, but proposed that the disclosure language should specify when ingredients are “derived from bioengineered crops but do not contain bioengineered materials.”

The USDA decided that only products that contain ingredients with detectable modified genetic material must be disclosed.

In the final rule, option one was the winner. The USDA decided that only products that contain ingredients with detectable modified genetic material must be disclosed, and that refined products originating from a bioengineered crop but without engineered DNA present are not themselves “bioengineered food.” USDA set forth three methods for showing that an ingredient does not have modified genetic material: (1) records verifying the source of the ingredient was a non-bioengineered food crop; (2) testing records showing that the refinement process for an ingredient would render modified genetic material undetectable; or (3) testing records for the specific food confirming the absence of modified genetic material.

The final rule does allow food manufacturers to voluntarily disclose that a refined food originated from a bioengineered food. The USDA gives the example of disclosing that the corn syrup in a carbonated beverage originated from bioengineered corn. Under the final rule, the voluntary refined-product disclosure can state “derived from bioengineering” or “ingredient(s) derived from a bioengineered source,” and the word “ingredient” can be replaced with the specific crop or food ingredient (contrary to the mandatory “bioengineered” disclosure, which does not permit a label to identify the specific bioengineered ingredients in a food). The voluntary disclosure also can be made using the symbols below. It is anticipated that many food manufacturers will make a voluntary disclosure to be transparent, or to provide information that they believe their consumers want to know.

Issue 4: Whether to Include Gene-Edited Agricultural Products

Should only traditional genetically engineered organisms (i.e. “transgenic” plants or animals, where a foreign gene has been added) be disclosed? Or should disclosure requirements also include products that contain ingredients produced through newer gene-editing techniques (e.g., using techniques such as CRISPR, where DNA changes can be made within a species without introducing foreign DNA)? The question arises because “bioengineering” means any food “(a) that contains genetic material that has been modified through in vitro recombinant DNA techniques; and (b) for which the modification could not otherwise be obtained through conventional breeding or not found in nature.” Yet the statute leaves undefined “conventional breeding” and “found in nature.” How those terms are defined could determine whether gene editing techniques trigger disclosure requirements.

In its comments to USDA, the food industry mostly agreed that gene-edited products should not require disclosure. Industry leaders argued that “conventional breeding” should be defined as methods that take advantage of the existing potential genetic variability of an organism. They argued that if a gene-edited product could have been produced through conventional breeding, such as chemical mutagenesis, then it should not be subject to disclosure. Similarly, the industry contended that “found in nature” should be broadly defined to include all types of genetic modification—such as deletions, insertions, substitutions, and duplications—provided they are not produced using foreign DNA.

USDA will determine on a case-by-case basis whether disclosure will be required for gene edited products.

On the other hand, some consumer and environmental groups, and some members of the food industry (primarily those involved with organic products), asked the USDA to include gene-edited products in the labeling requirement. They relied on statements by Sen. Debbie Stabenow (the ranking member of the Senate Agriculture Committee) that the law was meant to include gene-edited products, as well as a letter that the USDA’s general counsel wrote when the law was passed that said the USDA has legal authority to include gene-edited products. They also argued that defining “bioengineering” broadly is consistent with international agreements, whose definitions of GMOs, they argue, include gene-edited products.

In the final rule, the USDA punted on whether gene edited products will require mandatory disclosure. It also did not establish definitions for “conventional breeding” or “found in nature.” Instead, the USDA stated that when it periodically updates the List of Bioengineered Foods, it will determine on a case-by-case basis whether disclosure will be required based on: (1) the characteristics of the food, and (2) whether it meets the definition of a “bioengineered food.” Based on USDA’s decision on “highly refined ingredients,” it is almost certain that that unless a gene-edited product has detectable modified genetic material, there will be no mandatory disclosure.

Issue 5: When Mandatory Disclosure Will Be Enforced and What Will Happen to Violators

The proposed rule stated that food manufacturers would need to disclose the presence of bioengineered foods and ingredients by January 1, 2020, which also is the date by which foods must carry the updated Nutrition Facts label. Commenters provided a spectrum of views on that proposal. Those who wanted an all-encompassing disclosure rule generally also wanted food manufacturers to comply no later than the USDA’s proposed date. But many food manufacturers asked for more time. For example, Danone and the Food Marketing Institute asked for two years from the publication of the final rule; Walmart asked for three years.

In the final rule, the USDA set an initial implementation date of January 1, 2020 when manufacturers can begin disclosure, but stated that the required compliance date is January 1, 2022. The USDA said that if it becomes aware of a potential violation after the compliance date, it will investigate, make its findings available to the regulated entity, and provide for a hearing. The USDA will then make public a summary of the results of its investigation. However, the USDA stated that it has no authority to issue a recall or impose a civil penalty. Those remedies could be imposed by a state, but only if the state adopts requirements identical to the federal standard.

Final Thoughts

At over 60 pages in the Federal Register, the final rule and the USDA’s explanation are full of hundreds of details that will need to be implemented by food manufacturers before the new labeling regime comes into full effect. Whether the disclosed information ultimately provides consumers with the information they seek in a digestible form, or whether it further confuses them, remains to be seen. However, it can be predicted that the required disclosure will be less clear than it would have been if USDA had adopted CSPI’s recommendations: first, to allow the term “genetic engineering,” (rather than only “bioengineering”) and second, to require the disclosure of highly refined ingredients (rather than making it voluntary).

Contact Info: 

Contact Jeff Cronin (jcronin[at]cspinet.org) or Richard Adcock (radcock[at]cspinet.org).