In 2016, U.S. Congress passed the National Bioengineered Food Disclosure Law. This law required the United States Department of Agriculture (USDA) to issue a set of rules on the mandatory disclosure of bioengineered foods. In 2018, USDA published its final rule on implementing this new standard.
This rule will require that most food products intended for human consumption in the United States disclose if they contain or may contain any bioengineered ingredients. Here, we will review the requirements, applicability, and future compliance dates.
What products are required to have the new labeling?
The new disclosure requirement applies to food intended for human consumption. Pet food and animal feed are not covered. The definition of food in this case includes articles used for food or drink and articles used for components of food and drink. This includes raw agricultural commodities such as fruits or vegetables as well. The rule also covers processed food items (soups, cereals, etc.), dietary supplements, processing aids, and enzymes.
Any food item that is subject to the U.S. Food and Drug Administration’s labeling rules is also subject to the Bioengineered Disclosure Standard. Most alcoholic beverages are exempt unless they are regulated by FDA, which includes wine with less than 7% alcohol by volume, or beer brewed without malted barley or hops.
Meat, poultry, or egg products are exempt from the Bioengineered Disclosure Standard unless they are an ingredient in a food product where the most predominant ingredient is subject to FDA labeling regulations. If the predominant ingredient is broth, stock, water, or a similar solution then the second-most predominant ingredient is what determines if the product must disclose bioengineered ingredients. For example, if a canned stew lists stock, carrots, and pork as its ingredients in descending order of prevalence, the product would have to disclose if there are any bioengineered foods present because processed carrots are subject to FDA labeling regulations.
What is a bioengineered food?
USDA’s rule defines bioengineering in regards to food as a food “that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and for which the modification could not otherwise be obtained through conventional breeding or found in nature”. This definition excludes foods where modified genetic material is not detectable; in which case facilities must keep records that verify the genetically modified material is not detectable.
Highly refined ingredients are not subject to the disclosure requirements. This is because the conditions of processing effectively degrade the DNA that was initially present in the raw commodity. This makes the genetically modified material undetectable. Facilities must maintain records to prove their highly refined ingredients have undetectable levels of genetically modified material.
USDA provides a list of commonly bioengineered products for those who may be unsure whether their product contains bioengineered ingredients or not.
The following are exempt from the disclosure standard:
- Food served in a restaurant or similar retail food establishment
- Very small food manufacturers (make less than $2.5 million in annual food sales)
- Inadvertent or technically unavoidable presence of bioengineered substances of up to 5% of each ingredient (no allowances for any bioengineered presence that is intentional)
- Food derived from an animal that was fed with bioengineered products
- Foods certified as Organic
It is the responsibility of the manufacturer, importers, and certain retailers to put the bioengineering disclosure on the product. For food that is packaged prior to being received by the retailer, it is the responsibility of the manufacturer or importer. For retailers that package the food, it is their responsibility.
The implementation date for covered facilities that make more than $10,000,000 in annual food sales is January 1, 2020. For facilities that make less than $10,000,000 in annual food sales, the implementation date is January 1, 2021. USDA recommends all applicable products have the disclosure by this time. The rule states that starting January 1, 2022, compliance will be mandatory for facilities of all sizes and failure to comply can result in enforcement action.
Registrar Corp is a private company that assists businesses in complying with FDA regulations. Our labeling specialists can help develop or review your label for compliance with FDA and USDA requirements. For more information, call us at +1-757-224-0177 or chat with a Regulatory Specialist 24 hours a day at www.registrarcorp.com/livehelp.