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New “Bioengineered” Labeling Rule Will Cause Further Confusion

January 8, 2019

Final label design for bioengineered (aka, genetically modified organisms or GMO) food products (center) with preliminary designs (background). Graphic credit: NSAC.
Final label design for bioengineered (aka, genetically modified organisms or GMO) food products (center) with preliminary designs (background). Graphic credit: NSAC.

The new year may seem off to a sluggish start with the partial government shutdown stalling programs and delaying implementation of the 2018 Farm Bill, but there is some new news out there. At the end of 2018, the United States Department of Agriculture’s (USDA) Agricultural Marketing Service’s (AMS) highly anticipated “GMO” labeling rule was officially morphed into a “bioengineered” labeling rule , and now that rule is finalized.

The National Sustainable Agriculture Coalition (NSAC) advocated for a final rule on the National Bioengineered Food Disclosure Standard that would uphold the integrity of labeling claims and increase marketplace transparency. Unfortunately, the final rule for a National Bioengineered Food Disclosure Standard fails to provide an accurate and transparent message about which foods contain genetic engineering or genetically modified organisms (GMOs).


Under the finalized rule, most bioengineered food will be required to comply with its disclosure requirements. Bioengineered food is defined in the final rule as: all food that contains detectable genetic material modified by in vitro recombinant deoxyribonucleic acid (rDNA) techniques and that could not have been modified through conventional breeding or found in nature. There are exemptions for certain bioengineered products as well, which are outlined in the following section.

Crops subject to the final rule include: alfalfa, apple (ArcticTM varieties), canola, corn, cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus- resistant varieties), pineapple (pink flesh varieties), potato, salmon (AquAdvantage®), soybean, squash (summer), and sugarbeet. AMS will review this list and consider any updates on an annual basis.  

The final rule also applies to food products regulated by the Food and Drug Administration (FDA) under the Food Drug and Cosmetic Act. For more information on which products are regulated by FDA and which are regulated by USDA, see NSAC’s post: “Making Sense of the GMO Labeling Proposed Rule”.

Compliance Details

Understandably, both producers and consumers are likely to have a lot of questions about this rule, and who/what it covers. A few key questions, and answers, are laid out below:

Q: Who should prepare to comply with this rule?

A: Regulated entities include food manufacturers, importers, and some retailers with annual sales of at least $2.5 million.  

Q: What bioengineered products must include a disclosure?

A: A bioengineered disclosure must be placed on all bioengineered food products that are packaged or sold in bulk for retail sale by a regulated entity.

Q: What do regulated entities have to disclose?

A: All regulated entities must disclose on a food label that the food is bioengineered or contains a bioengineered food ingredient. The disclosure can be made by either:

  1. A text disclosure stating the product is a “Bioengineered Food(s)” if it is a raw agricultural commodity or a product with all bioengineered ingredients or “Contains Bioengineered Food(s)” if the product contains one or more, but not all, bioengineered food ingredients; 
  2. The approved symbol disclosure, which is available here;
  3. An electronic or digital disclosure that is accompanied by a statement similar to “Scan here for more food information” and a telephone number that allows customers to receive the same information if they call at any time; or
  4.  A text message disclosure stating “Text [command word] to [number] for bioengineered food information;” the number must send an immediate response to the consumer.

For small and very small packages of less than 40 square inches, the electronic disclosure can simply state “scan for info” (excluding the phone number) or “text for info” (including the phone number). If packages are less than 12 square inches, utilizing existing Uniform Resource Locators for a website or telephone number are also acceptable if the package provides the required bioengineered food disclosure.

For small food manufacturers, which are manufacturers with annuals sales between $2.5 and $10 million, the disclosure can be the statement “call here for more food information” or “visit [website url] for more food information.” For small food manufacturers, small and very small packages can simply state “call for info” next to a phone number.

Q: Where should the disclosure go?

A: All regulated entities must put a bioengineered disclosure on their bioengineered retail food products that are packaged or sold in bulk. The disclosure can be placed on the:

  1. Information panel (the label to the right on the front label panel on a product, as seen by a consumer directly facing the product) adjacent to the name and location of the packer, manufacturer, importer, handler, or similar information;
  2. Principal display panel or the front label panel; or
  3. If there is insufficient space on the information panel and the principal display panel, on another panel where a consumer in a typical shopping situation would be likely to see it.  

The disclosure’s size and display must be large enough to appear prominently on the food package and readable by consumers in a typical shopping situation.

For products sold in bulk containers (e.g., display case, bin, barrel) the disclosure should be on a sign, label, sticker, twist tie, or other method to allow consumers to locate and understand the disclosure.

Q: What kind of record keeping is required?

A: Paper or electronic records that prove compliance with the disclosure standard must be kept for at least two years. There are several acceptable records, including, for example, a label with the disclosure standard or records that a non-bioengineered crop was used. AMS can request to review these records.

Q: What’s the deadline for compliance?

A: All regulated entities must comply with the final rule by January 1, 2022. Regulated entities can voluntarily comply with the requirements until December 31, 2021. Voluntary bioengineered disclosures may use labels that already meet the requirements of the preempted state GMO labeling laws, or stickers or ink stamps may be applied to already existing labels with the appropriate bioengineered disclosure.

Exemptions & Exceptions

Not all bioengineered or genetically modified products on the market will have a disclosure, as the rule contains several exemptions and exceptions. The following food products are exempt from the final rule, even if they contain modified genetic material:

  • Food produced with bioengineering that is sold by a very small food manufacturer with annual sales of less than $2.5 million.
  • Food served in restaurants, food trucks, trains, airplanes, delicatessens and in similar establishments.
  • Food products that contain an unavoidable or accidental presence of a bioengineered substance of up to five percent per each ingredient in the final product. In contrast, if a manufacturer producing a non-bioengineered product purposely uses a bioengineered ingredient because they run out of a non-bioengineered ingredient, the product is not exempt and would require a bioengineered disclosure.  
  • Food from animal products fed a bioengineered substance – if there are no other ingredients in the final product that contain modified genetic material.
  • Any food certified under the National Organic Program, which already prohibits genetically modified ingredients.

Two additional exemptions based on the definition of bioengineered include:

  • Food that was modified through bioengineering but does not contain detectable genetic material. A regulated entity must keep records proving the bioengineered food’s refinement process renders the modified genetic material undetectable or verifying a test proves the food is absent of modified genetic material.
  • Bioengineered food present at an insignificant level and without any functional effect on the food product.

No food can be labeled as “bioengineered” if the label does not meet the requirements of this rule. Nonregulated entities can voluntarily disclose their product is bioengineered, so long as it is disclosed in the same manner required by the rule. Products like soybean oil created from GMO soybeans, which is excluded from the final rule because it went through a refinement process rendering the modified genetic material undetectable, can still include a voluntary disclosure that the product or ingredients were “derived from bioengineering.”

Products could still be labeled as “not genetically engineered” (or a similar claim), so long as it is in compliance with other federal labeling laws.

Access and Enforcement Issues

Given the degree to which the labeling under the final rule vary, some consumers may not be able to access the bioengineered disclosure standard information at all. Depending on the type of disclosure required, a cellphone, scanning device, or the internet would be necessary for a consumer to access digital bioengineered disclosure information. This standard disenfranchises customers without access to these services or devices, and generally increases the difficulty of finding important information about food products.

The final rule also neglects to include a strong enforcement mechanism. AMS did not adopt NSAC’s suggestion to develop and implement audits on a regular basis and to publicize the results of those audits in a timely manner. Instead, AMS is relying on consumers to do the investigating for them.

AMS will accept written complaints of any violations of the final rule by mail or on the AMS website. The agency will then determine if there are reasonable grounds to initiate an investigation, and if so, will request records from that regulated entity. AMS will make any investigation results public.  

Unclear Information, Blurred Guidelines

There are a number of shortcomings in the final rule, including the use of the term “bioengineered,” which replaces the more commonly used terms “GMO” or “genetically engineered.” While AMS’s Information for Consumers attempts to educate consumers about the new term, switching from commonly recognized terms to a new, largely unknown phrase requires more than just an online information page. We urge AMS to develop a robust consumer education campaign around the meaning of “bioengineered” to help consumers and producers familiarize themselves with the new term.

NSAC has also encouraged AMS to expand the definition of bioengineered to include all genetic editing techniques, including CRISPR and RNAi. Unfortunately, AMS failed to clearly require a disclosure for food using any type of genetic editing technique, not solely rDNA.

AMS’s decision to exclude some genetically engineered products from the final rule is also disappointing. Bioengineered oil and sugar products refined to the point where modified genetic material is not detected, for example, are excluded. This type of rulemaking fails to adequately inform consumers about what genetic editing techniques were used to create products. Under this final rule, the disclosure will not inform consumers when certain ingredients are made from GMO crops, like soybean oil made from GMO soybeans. 

The final rule also exempts products that contain up to five percent of any unintentional and unavoidable or inadvertent bioengineered substance, even though the industry standard for products that contain inadvertent or technically unavoidable genetically engineered material is 0.9 percent per ingredient.

Confusion Ahead

When it comes to the new bioengineered disclosure symbol, transparency advocates have little to smile about – despite the fact that AMS was eventually pressured to remove version of the label that incorporated symbols in the shape of a literal smiling face. The final choice for the bioengineered disclosure symbol still lacks impartiality; displaying sunshine and a cheery farm landscape signals to the consumer that the product in question is “good”, “healthy”, or has other positive attributes.

Although it is clear that AMS has failed to create a value-neutral symbol, we are pleased that at least the final version of the symbol includes the actual term “bioengineered”; previous version had simply used the letters “BE.”

NSAC also applauds AMS for removing the option for “not highly adopted” bioengineered products to use ambiguous terms like “may contain” or “may be” bioengineered. NSAC advocated for the removal of these terms in our comment to the proposed rule, and are pleased that the text disclosure option does not include them.

Finally, we are also encouraged that AMS adopted our recommendation to clarify that food certified under the National Organic Program would be exempt from the final rule requirements.

Despite a few key positives, however, this final rule is likely to leave consumers even more confused than before about what’s in their food. NSAC urges AMS to continue working toward greater transparency and clarity in federal food labels, and hopes that they will take additional steps toward ensuring consumers understand the limited scope of the bioengineered disclosure standard final rule as soon as possible.

Categories: General Interest

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