Last year, USDA AMS published the proposed rule for labeling of bioengineered (BE) foods which, as mandated by Congress, also applies to FDA-regulated foods. So, what’s with the new FDA Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants? Is BE labeling voluntary or mandated? Besides being USDA regulation vs. FDA guidance, what’s the difference? At this point, it is voluntary by either publication since the AMS National Bioengineered Food Disclosure Standard proposed rule (NBFDS) is not yet final, and guidance is never binding. But because the AMS rule is Congressionally mandated, it will eventually become law in one form or another, and we all know that it is highly recommended that food facilities understand and follow guidances as much as is tenable in your operations. As to the differences, a careful reading of the FDA guidance reveals that its focus slants more toward proper and legal labeling of non-BE foods. In fact, it is a footnote that provides the best explanation of the differences and FDA’s reasoning for the guidance. Referring to the Congressional mandate for AMS to develop a national mandatory standard for disclosing the presence (an important word here) of bioengineered material in human food, footnote 2 states: The term “bioengineered” as defined in that law includes products that are genetically engineered (GE) and applies to human food derived from plants. It does not apply to animal food. FDA no longer has authority over voluntary labeling to indicate the presence of GE content in human foods. But FDA retains jurisdiction over labeling statements to indicate the absence of GE content in human food. FDA is reviewing this draft guidance to consider what additional or new recommendations may be needed, including claims of non-GE content, that are not covered by the NBFDS. Taking each of these individually: It does seem a bit ironic that a USDA rule applies to all foods, except animal food, when agriculture is its primary authority. Interestingly, both agencies use the term -engineered (USDA: bioengineered/FDA: genetically engineered), with FDA specifically denouncing the term genetically modified/GMO in the guidance because it “can encompass any alteration to the genetic composition of a plant, including alterations achieved through traditional hybridization or breeding techniques, that term could apply to most cultivated food crops since most food crops are the product of selective breeding.” As such, FDA encourages food manufacturers to ensure that labeling “be accurate and consistent and that the integrity and meaning of scientific terminology be preserved to help ensure clear communication in food labeling.” Acknowledging that it no longer has authority over labeling GE presence, FDA upholds that it can still regulate labeling of its absence. This is of critical importance because it is precisely that on which the guidance focuses, even specifically stating that it “encourages manufacturers to use labeling claims that state that a food product (or its ingredients, as appropriate) was not developed using bioengineering, genetic engineering, or modern biotechnology.” However, there are limitations, which we discuss below. With the Congressional mandate infringing on its authorities, FDA held to its rights to add recommendations it saw as not covered by the AMS standard. With that essentially answering, “What’s with the new guidance?” it brings us to: “What is the new guidance?” The guidance is divided into three sections: Foods not derived from GE plants, foods that are derived from GE plants, and label statement substantiation. Foods not derived from GE plants. FDA lists some examples of statements that could be used to accurately state a food is not bioengineered. It also is here that the recommendation against the term GMO is explained, both as noted above and because of the consumer confusion it can cause. However, FDA said it will not take enforcement action if the term is used, as long as it is “not otherwise false or misleading.” The agency also recommends the word “free” not be used to indicate lack of bioengineering, because of the potential challenges of substantiating a “zero” claim. FDA also state that a label is misleading if it “fails to reveal facts that are material in light of representations made or suggested in the labeling,” such as stating that one ingredient in the food was not bioengineered, if another is and this is not stated; if it states that the food or ingredients are not GE when they are incapable of being produced through genetic engineering (e.g., salt); or if it suggests or implies that it is safer, more nutritious, or otherwise different than other comparable foods because it is not GE. Foods that are derived from GE plants. Reiterating the above information on misleading statements, FDA adds that simple statements that a food was developed using bioengineering are essentially best. Additionally, the guidance reminds industry that labeling requirements that apply to foods generally also apply to GE food, and if they do have characteristics that are materially different from those of comparable foods, the label needs to disclose the material differences. This would include differences such as nutritional properties, allergen presence, ingredient composition/amount, etc. Label statement substantiation. A manufacturer claiming a food as BE or non-BE must substantiate that to be truthful and not misleading, through the documentation of handling practices and procedures, use of certified organic food, or use of validated test methods. Although, as stated, the FDA document is guidance and as such none of this is “required,” it’s advisable that the industry evaluate any current or planned BE/GE/GMO labeling statements and begin working toward compliance with the AMS standard and FDA guidance. You may also want to start purging the term GMO from your vocabulary – and that of your employee’s – altogether. It may or may not help reduce the negative perception of these products, but the fewer terms we use the simpler it will certainly be. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
