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Regarding the National Bioengineered Food Disclosure Standard (USDA)
The Difference from Japan's GMO labeling system and points to note when exporting

The implementation date of the National Bioengineered Food Disclosure Standard is January 2020 and it is about five months away until January 2022 when this is becoming mandatory. Some of you who have exported food products must have taken action. I assume there are many business operators considering exporting products to the U.S. in the future, so I would like to take this opportunity to summarize the differences from the Japanese system and points to note.

Main Points

  • Bioengineered Foods (BE foods) refer to genetically modified foods.
  • Foods containing detectable modified genetic materials are subject to labeling (except the unintentional presence of up to 5% for each ingredient)
  • A label for a bioengineered food must bear a disclosure indicating that the food is "Bioengineered Food" or "contains Bioengineered Food Ingredients".

What is a BE food?

According to the USDA, BE foods are defined as foods that contain genetic material that has been modified through certain laboratory techniques and for which the modification could not be obtained through conventional breeding or found in nature. USDA has published the following list to provide business operators with information on whether the ingredients are subject to disclosure under the Standard.

  • 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)
  • Sugarbeet

Even if a food is not included on the List, business operators whose records show that the food is bioengineered must make appropriate disclosure of that food.

Information disclosure method

A label for a bioengineered food must indicate the food is a "bioengineered food" or "contains a bioengineered food ingredient" on the information panel or the principal display panel of containers and packaging. There are mainly four disclosure options, "text", "symbol", "electronic or digital link" such as QR codes, and/or text message that must include the statement "Text [command word] to [number] for bioengineered food information. When used, the number must immediately send a response to the consumer’s mobile device with the bioengineered food disclosure." (Small food manufacturers may make the disclosure using a telephone number or URL.) The below is quoted from "What is a Bioengineered Food?" (pdf).

How will bioengineered food be labeled?

Quote: What is a Bioengineered Food? (pdf)

The Difference from Japan's GMO labeling system

Business operators who are planning to export food products to the U.S. need to know the difference between both country’s systems. I organized the difference as follows.

  the National Bioengineered Food Disclosure Standard (USA) GMO labeling system (Japan)
Foods subject to the standard 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), Sugarbeet, and Processed food made with the ingredients derived from bioengineered sources above. The other foods with records that show that the food they are selling is bioengineered. The following eight agricultural products, Soybean, Corn, Potato, Rapeseed (Canola), Cottonseed, Alfalfa, Sugarbeet, Papaya, and 33 processed foods containing these ingredients.
The standard for weight ratio of regulated ingredients - Mandatory labeling requirements are imposed for "main ingredients (ranked within the top three constituents in terms of the ratio of weight they occupy, and the (respective) weight ratios of which account for 5% or more of the total)".
Exemptions to the disclosure requirement Highly refined foods with undetectable modified genetic materials (sugar and oil, etc.). Foods of which DNA or protein is undetectable (except for agricultural products and their processed products of which conventional counterpart with respect to composition, nutritional value, etc. are markedly different). Foods of which ingredient does not fall under "the main ingredients".
Types of mandatory labeling
  • "Bioengineered food"
  • "Contains a bioengineered food ingredient"
  • "Genetically modified"
  • "Not segregated from GM product"
  • "XXX high oleic acid, genetically modified"
Types of voluntary labeling
  • "Derived from bioengineering"
  • "Ingredient(s) derived from a bioengineered source"
  • "Not genetically modified"
    (However, this statement will be limited to the cases where no recombination gene is detected from April 2023.)
Labeling methods Text, symbol, digital or electronic link, and/or text message that must include the statement "Text [command word] to [number] for bioengineered food information" must be indicated on containers and packaging. Text indication on containers and packaging.
The threshold level for the unintentional presence of material 5% 5% (The case where separate production and distribution management is appropriately implemented)
Exempted foods Foods containing meat, poultry, or egg product ranked within the top two constituents in terms of the ratio of weight they occupy. Incidental additives that are present in food at an insignificant level and do not have any technical or functional effect in the food (21 CFR 101.100(a)(3)). Food served in a restaurant or similar retail food establishment and food produced by very small food manufacturers. Additives.
Food served in retail food establishments (Food Labeling Standards).

As mentioned above, the following three points of the U.S standard in particular are very different from the Japanese system.

  1. No standard for weight ratio of ingredients
    (Even for ingredients that are not ranked within the top three constituents in terms of the ratio of weight they occupy, and the (respective) weight ratios of which account for less than 5% of the total, they are subject to labeling if a recombinant gene is detected.)
  2. There is no standard similar to "separate production and distribution management" *1
    (The "may be " labeling such as "Not segregated" cannot be used.")
  3. There is no standard for "Not genetically modified" labeling. *2
    (There is a view that the certification of food under USDA's National Organic Program shall be considered sufficient to make claims about "not bioengineered" or "non-GMO" or another similar claim.)

*1 For foods exported to Japan, "separate production and distribution management" and "safety assessment" need to be confirmed.
*2 Japan’s "not genetically modified" labeling has been tightened to the case of "not detected". (April 2023)

In addition, there is a standard for representation in a foreign language in the U.S. If you wish to leave Japanese labeling on containers and packaging of your products, it is advisable to pay attention when these systems are revised.

Reference Websites and Decision Tool

The tool on the USDA site is designed to provide an overview of the major requirements for determining what foods must be disclosed as bioengineered foods. If you proceed to answer each question with YES/NO, the following question appears and you will know on the spot whether the ingredient is subject to labeling or not.

Is this a bioengineered food?

Quote: Decision Tool – Do I need to make a bioengineered food disclosure?

In the case where the target ingredients (on the BE food list) are used, the first step will be to confirm whether they are detected and after that to consider "how to disclose the information". The implementation date of the Standard is January 1, 2020, and the mandatory compliance date is January 1, 2022, so if you are considering exporting your products to the U.S, we recommend checking the schedule carefully.

July 2021