The long awaited GMO labeling proposed rule is finally out for public comment. As you may recall from prior posts, Congress had previously directed the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) to set up a national disclosure standard for “bioengineered” (aka genetically modified “GMO” or genetically engineered “GE” ) foods by July 29, 2018.

The recently issued proposed rule lays out AMS’ current thinking on the issue. In several important instances, however, the only thing that’s clear is how much remains to be resolved in the few weeks between when the comment period ends and the rule is supposed to be finalized. Below, we provide an analysis of some of the major sticking points in the proposal, including areas on which the National Sustainable Agriculture Coalition (NSAC) plans to focus our comments.

AMS is accepting public comments on the proposed rule through July 3. You can submit comments here.

Who Must Disclose?

The law requires all foods covered by to the Federal Drug Administration’s (FDA) regulatory authority under the Food, Drug, and Cosmetics (FD&C) Act that are or may be “bioengineered” to be labeled. FDA’s regulatory authority includes raw produce, seafood, dietary supplements, and most prepared foods. Meat, poultry, and shell egg products are regulated by USDA, not FDA, and are only subject to the labeling requirements if they are part of a multi-ingredient food and the most predominant ingredient of the food would be subject independently to the FD&C Act labeling requirements. The same is true for multi-ingredient foods where the predominant ingredient is water, broth, or stock, and the second most predominant ingredient is independently covered by the FD&C Act.

In practical terms, this means that, for example, a package of beef jerky where the first ingredient was beef and the second or third was high fructose corn syrup would not be subject to disclosure. In the second case, a can of soup where the ingredients were listed as “broth, carrots, chicken…” would be subject to disclosure, whereas a can of soup that first listed broth, then chicken, and then carrots would not.

There are other limitations on the scope of who must disclose based on the definition of “bioengineered,” the amount of GE material present in the product, and the definition of small and very small businesses. In the case of small and very small businesses, these operations are eligible for modified requirements or are altogether exempt from the labeling requirements, respectively. AMS has not finalized definitions or standards for any of the aforementioned issues or groups, however, and each one presents substantial issues.

Who Must Disclose: Bioengineered

The definition of “bioengineered” remains unchanged in the proposed rule as applied to food. According to the GMO Disclosure law, bioengineered food is food that:

• contains genetic material that has been modified through in vitro recombinant [DNA] techniques; and
• the modification could not otherwise be obtained through conventional breeding or found in nature.

The main issue with this definition is that it leaves open a question as to whether highly refined products from GE crops, such as sugar or high fructose corn syrup, fit the definition and would therefore trigger disclosure. AMS has not weighed in on this issue, but is inviting public comment on it. AMS is also looking for input on how to address the definitions of “conventional breeding” and “found in nature.”

It should be noted that AMS is only considering requiring disclosure of “bioengineering” – a term that is not widely used, and certainly nowhere near as commonly understood as GMO or GE. That issue is addressed more in the section below. In this post, we will continue to use the terms GMO or GE instead of bioengineered, because the former are more widely understood.

In an effort to simply the concept, AMS is proposing to establish two lists of GMO foods: (1) a list of GMO foods that are commercially available in the US with a “high adoption rate” (85% or more) and (2) a list of GMO foods that are commercially available in the US but not “highly adopted” (less than 85%). A product would only be subject to disclosure if it appeared on one of those lists, or contained ingredients from either list, and AMS would maintain the lists and review and revise them annually.

Currently, AMS includes canola, field corn, cotton, soybeans, and sugar beets on the first (high adoption) list, and non-browning apples, sweet corn, papaya, potato, and summer squash on the second list. AMS has further proposed that products containing foods from the first list would have to bear a “contains bioengineered ingredients” label, and products containing foods from the second list would carry a “may contain” label.

AMS is requesting comments about the lists (their composition, cutoffs, the process for reviewing and revising them), as well as how the agency should approach issues like incidental additives, like enzymes, and food where the GM material cannot be detected (ex., refined sugar).

Who Must Disclose: Thresholds

In the authorizing statute, Congress gave USDA the authority to determine whether there could be GE material in a food product up to a certain threshold without triggering the requirement to disclose, which could limit the scope of products subject to the labeling requirement.

In the proposed rule, AMS requests comment on three options for a threshold; products containing GE material up to that cutoff would be exempt from having to disclose. The options listed below begin with the the most comprehensive application of the labeling requirement and end with the option that would exempt the greatest number of products from disclosure:

• Products that contain ingredients with GE material that is “inadvertent or technically unavoidable,” and does not exceed 0.9 percent of the weight of the specific ingredient.
• Products that contain ingredients with GE material that is “inadvertent or technically unavoidable” and is no more than 5 percent of the weight of the specific ingredient.
• Food that contains ingredients with GE material that does not exceed 5 percent of the total weight of the food item in its final form.

Note that the third option does not specify that the GE materials be there inadvertently, nor does it look at the percentage of the ingredient that is GE. AMS considers “inadvertent or technically unavoidable” to mean that there is some trace amount of a GE substance present due to cross-contamination of GE and non-GE foods in the supply chain (or, in AMS’s terms: “coexistence”). Under the third option, the manufacturer could knowingly use ingredients with GE material so long as the total amount of GE material in the whole food item does not exceed 5 percent.

Who Must Disclose: Very Small Manufacturer Exemption

The law exempts food served in restaurants and similar retail establishments like cafeterias from disclosure. It also exempts very small food manufacturers, though it leaves it up to AMS to define “very small.” AMS is proposing to define a “very small” manufacturer as having less than $2.5 million in sales, estimating that this cutoff will exempt 74 percent of food manufacturers, 4 percent of products, and 1 percent of sales. They are looking for feedback on this definition, including whether they should consider the cutoff to be $500,000 or $5 million instead.

Small manufactures are given additional time to comply and more flexible labeling requirements. AMS is defining a “small” manufacturer as having between $2.5 million and $10 million in sales, and estimates that this cutoff would cover 12 percent of food manufacturers and 4 percent of products.

Under these definitions, 86 percent of small and very small food manufacturers (producing 8 percent of products) would either be completely exempt from the disclosure requirement, or would have additional time to comply with less strict labeling requirements.

Who Must Disclose: Exemption for Products from Animals Fed GE Feed

As a reminder, the law exempts from disclosure products that contain ingredients from animals fed GE feed, if that would be the only ingredient triggering disclosure. The proposed rule maintains this exemption, and gives the example of eggs used in a baked good. If the chicken that produced the eggs was given feed consisting of GE corn and soybeans, the baked good would not be subject to the labeling requirement solely for that reason. If, however, the baked good contained those eggs and also contained high fructose corn syrup or sugar from GE beets, then the disclosure requirement would apply.

What Does Disclosure Look Like?

AMS is proposing four options for disclosure: on-package text, on-package symbol, digital or electronic link, or text message. As noted above, AMS is proposing to only use the term “bioengineered” or “BE,” despite the widespread recognition and common usage of terms like “genetically modified” and “genetically engineered.” Disclosure parameters for each of the options being considered are as follows:

1. Text: For text disclosure, the text required depends on whether the product or ingredients fall on the above-mentioned lists. For “highly adopted” products, the text disclosure would state “bioengineered food” or “contains a bioengineered food ingredient.” For products on the low adoption list, the text would state “may be bioengineered” or “may contain a [BE] food ingredient.”
2. Symbol: AMS is proposing three different symbol options, with four variations for each one. You can see all the symbols here, and some symbols are included in the graphic above. It is highly questionable as to whether two of the three could be considered “neutral” given their close resemblance to smiley-face emoticons.
3. Digital/Electronic: If a manufacturer selects this option, the link must include text that says something like: “scan here for more information” as well as a telephone number and text that say “call for more food information.” The first page that the link opens to must include the disclosure (either text or symbol) and can’t contain any marketing material. There are measures to prohibit against digital disclosure being used to collect or sell any personal identifying information about consumers, but there is not much additional detail as to how the QR code should be positioned so as to be clear to consumers, nor does it offer any comparable options for shoppers without cellphones.
4. Text message: This additional option is likely a result of a study that was required by Congress to determine the feasibility of QR codes as a disclosure method. This approach would include text on the package that says something like “text this number for more food information” and then receive the disclosure via text.

It seems quite likely that, should AMS finalize these four options, the most commonly selected option by companies that produce GE foods would be #3. Not only does this option keep any identifying information off the actual package label that might steer a consumer away, it also requires consumers to take an additional step to determine whether a product contains GMOs. Interestingly, the report that Congress required AMS to undertake on QR codes found that although the majority of Americans (77 percent) own smartphones, 85 percent experienced technical challenges using apps for scanning digital links – a troubling statistic given the likely industry reliance on this option.

How will the standard be enforced?

While failure to disclose is prohibited by law, Congress did not give AMS the authority to enforce the labeling requirement through recall authority or other stricter measures. AMS is therefore establishing record keeping requirements as an enforcement tool, but is otherwise limited in its enforcement and public disclosure capabilities. FDA’s enforcement authority under the FD&C Act does provide some backstop for product labeling claims that are false or misleading.

NSAC’s Take

NSAC believes that product labeling claims must be made and upheld with integrity. We assess the integrity of a particular claim using several key criteria, including: simplicity of meaning; transparency of process; accountability; stakeholder engagement; independence; fairness/equity; and value. We are continuing to evaluate this proposal against those criteria, and will be developing additional comments for the docket. We will provide additional information to the public as our analysis unfolds.

For more information on the process that led to the enactment of the law requiring mandatory disclosure, read our earlier blogs on the subject.