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On December 21, 2018, the Agricultural Marketing Service (AMS) published the Final Rulemaking for the National Bioengineered Food Disclosure Standard. Food products with or containing food ingredients with modified genetic material shall include at least one of the following four bioengineered (BE) label disclaimers: Text disclaimer; Symbol; Electronic or digital link disclaimer; or Text message disclaimer. Product labels shall include a BE disclaimer effective January 1, 2022.
The Bioengineered (BE) Food Labeling Disclosure Standard applies to food or food ingredients that contain genetic material modified through in vitro rDNA techniques, where the modification could not have otherwise been obtained through conventional breeding or otherwise found in nature. Food or food ingredients that do not contain genetic material – e.g., genetic material is not detectable – are not considered bioengineered food.
The BE disclosure requirements encompass food and food ingredients that falls under the:
• Federal Food, Drug, and Cosmetic Act (FDCA) or
• Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act – only if:
o The most predominant ingredient of the food would independently be subject to the labeling requirements under the FDCA or
o The most predominant ingredient of the food is broth, stock, water or a similar solution and the second-most predominant ingredient of the food would independently be subject to the FDCA labeling requirements
This includes, food products intended for human consumption, dietary supplements, and chewing gum, but does not include pet food or animal feed. It applies to packaged food as well as raw agricultural products and food sold in bulk containers.
The USDA compiled a list of bioengineered foods to help ease the burden on regulated entities; they intend to update and maintain the list, as needed, on an annual basis. Food that is or contains a food ingredient from the List of Bioengineered foods below are required to label their product and maintain records indicating that the food is derived from BE substances.
List of Bioengineered Foods
|• Alfalfa||• Pineapple (pink flesh varieties)|
|• Apple (Arctic™ varieties)||• Potato|
|• Canola||• Salmon (AquAdvantage®)|
|• Corn||• Soybean|
|• Cotton||• Squash (summer)|
|• Eggplant (BARI Bt Begun varieties)||• Sugar beet|
|• Papaya (ringspot virus resistant varieties)|
The USDA provided four possible labeling options:
1) A text disclosure, using one of the following statements, as appropriate:
“Bioengineered food”, “Bioengineered foods”,
“Contains a bioengineered food ingredient”, or
“Contains bioengineered food ingredients”
2) A symbol disclosure, using the symbol pictured to the right in color or in black and white
Note: It is not permissible to modify the symbol or used the abbreviation “BE”
3) An electronic or digital link disclosure, such as a QR code, with the statement, “Scan here for more food information” along with a phone number and the statement
“Call [1-000-000-0000] for more food information.
The landing page for the electronic or digital link shall only include either the text disclosure or the symbol disclosure; it may not have any marketing or promotional material.
4) Text message disclosure, using the statement,
“Text [command word] to [number] for bioengineered food information”
The text message response shall utilize the same format as the text disclosure. The text message may not include promotional or marketing information.
Note: For both the electronic or digital link disclosure and the text message disclosure, the responsible entity may not collect, analyze, or sell any data. If data needs to be collected to provide the BE disclosure, the information shall be deleted immediately.
Entities that are not required to have a bioengineered disclosure on their products, such as a restaurant or similar establishment, and very small food manufacturers with annual receipts of less than $2.5 million, may voluntarily comply with the above four labeling options.
Since the disclosure standard only applies to products that have detectable amounts of modified genetic material, refined products that do not have detectable amounts of DNA may not require BE labeling, even if the source ingredient may have been from a bioengineered crop. However, regulated entities may voluntarily list a BE disclosure on certain foods derived from bioengineering, but with no detectable DNA, using one of the four methods below:
1) The label may list the statement, “Derived from bioengineering” or “Ingredient(s) derived from a bioengineered source”, otherwise following all the same requirements as a product required to have a BE disclosure
Note: Specific crop(s) or food ingredient(s) may replace the word “ingredient(s)”
2) The label may use the “Derived from bioengineering” symbol pictured to the right in color or black and white
3) The label may have an electronic or digital link disclosure in a similar manner as products required to have a bioengineered disclosure, except using the derived from bioengineering text disclosure or symbol
4) The label may have a text message disclosure in the same manner as products that are required to have a bioengineered disclosure, using the derived from bioengineering statement
The BE disclosure shall be on the information panel next to the name and place of business or on the Principal Display Panel (PDP), or if there is insufficient space on either of those panels, elsewhere on the packaging where the consumer is likely to see the statement under ordinary shopping conditions.
There are additional labeling options for small food manufacturers with annual receipts more than $2.5 million, but less than $10 million and small and very small food packages.
The implementation date is January 1, 2020, except for small food manufacturers who will have until January 1, 2021 to comply with the regulations.
• Small food manufacturers are those with annual receipts of at least $2.5 million, but less than $10 million
Responsible parties may ‘voluntarily’ comply until December 31, 2021 to go through any backlog of labels before they must utilize the bioengineered food labeling disclosure on any products labeled on or after January 1, 2022
• Between January 1, 2020 and December 31, 2021, labels may utilize the preempted State labeling requirements for genetic engineering. In addition, before the mandatory compliance date of January 1, 2022, old labels may use stickers or stamps to add the BE disclosure
When there is an update to the List of Bioengineered Foods that would affect a product, regulated entities will have 18 months after the effective date to update labeling.
In July 2016, congress enacted the National Bioengineered Food Disclosure Standard, a federal law that preempted existing state laws, mandating that food products containing modified genetic material have a Bioengineered food labeling statement.
Click to view more information from the USDA website:
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