National Bioengineered Food Disclosure : What Israeli Companies Need to Know

In the age of big data, there is no shortage of information while often conflicting, on any given topic. One of those topics is food. Much has changed over the recent decades regarding our understanding of food and its nutrient value, the effect of the quality of soil and water on our food, weather and herbicide and pesticide. Grocery shopping nowadays involves making many educated decisions. For every research crowning the new trendy super food, there is at least one contradicting it all. Shop for Organic? Natural? Plant-based protein? And yes, the elephant in the room -food that has been genetically modified. While some argue against such food, others, disagree. For each, their own, however the consumers’ right to know in the U.S. and make their own decision will soon be a tad easier.

More than 50 countries, including among others England, France, India, New Zealand and Australia, have adopted rules for regulating and marking bioengineered food. In July 2016 the National Bioengineered Food Disclosure Law was enacted in the U.S. In December 2018, U.S. Secretary of Agriculture Sonny Perdue announced the National Bioengineered Food Disclosure Standard (NBFDS). The NBFDS defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature.

The implementation date of the NBFDS is around the corner – January 1, 2020, except for small food manufacturers, whose implementation date is January 1, 2021. The mandatory compliance date is January 2, 2022. Regulated entities may voluntarily comply before that time and may use existing labels.

Who must comply?

Food manufacturers, importers and retailers who package and label food for retail sale; or sell bulk food items

The NBFDS does not apply to restaurants, restaurant-like retail food establishments such as cafeterias and food trucks, or very small food manufacturers that have annual receipts of less than $2.5 million. The NBFDS applies to all food subject to Federal Food, Drug, and Cosmetic Act (FDCA) labeling requirements (including raw produce, seafood, dietary supplements, most prepared foods, snacks, desserts, chewing gum, and drinks); or food subject to the labeling requirements of the Federal Meat Inspection Act, Poultry Products Inspection Act, or Egg Products Inspection Act if the most predominant ingredient of the food would independently be subject to the labeling requirements under the FDCA, or if the most predominant ingredient of the food is broth, stock, water, or a similar product and the second-most predominant ingredient would be subject to the FDCA labeling requirements (for example, stews and soups).

Alcoholic beverages that are not subject to the Federal Alcohol Administration Act (e.g., wines with less than 7% alcohol by volume and beers brewed without malted barley and hops) are subject to the NBFDS. Otherwise, alcoholic beverages are not subject to the NBFDS. 

What foods are considered bioengineered foods?

Bioengineered foods are those that contain genetic material that has been modified through in vitro rDNA techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature. For example: Alfalfa; Apple (Arctic varieties); Canola; Corn; Eggplant (BARI Bt Begun varieties); Pineapple (Pink flesh varieties); Potato; Salmon (AquAdvantage®); Soybean; Squash (summer); Sugarbeet and more. However, a NBFDS regulated entity must disclose a food as bioengineered when it has records showing the food is bioengineered, even if it is not on the list.

Exemptions:

For the NBFDS to apply certain threshold has to be met. For example, NBFDS does not apply to incidental additives, or to foods that contain 5% or less bioengineered ingredient.  The NBFDS does not apply to animals fed bioengineered feed. And, food certified under the National Organic Program is expressly exempted from disclosure because the National Organic Program regulations already do not allow bioengineered ingredients in these products.

How must bioengineered foods be labeled?

There are specific guidelines for disclosing bioengineered ingredients. For example, the disclosure location must be conspicuous:

  • Information panel adjacent to the manufacturer/distributor information
  • Principal display panel
  • If there is insufficient space on either the information panel or the principal display panel, then disclosure may be made on any other panel likely to be seen by a consumer under ordinary shopping conditions.

The information must also be available to everybody:

  • On-package text has to be clear
  • Use one of the below symbols:

  • Electronic or digital disclosure: QR code may be used to direct consumers to a website that contains information about bioengineered ingredients.
  • Food manufacturers, importers, and retailers can provide a number that consumers can text message for information.

Voluntary Disclosure

Companies that wish to make voluntary disclosures may do so if they are an entity that is exempt; or for foods that do not contain detectable modified genetic material but are derived from bioengineering.

What are the record keeping requirements?

Everyone subject to mandatory bioengineered food disclosure is required to keep sufficient records to establish compliance with the standard. A regulated entity must keep customary or reasonable records that would be generated in the course of normal business – no new records or forms are required. Regulated entities may also determine which records to maintain, provided they are sufficient to demonstrate compliance. The records may be in any format (hard copy or electronic), and  may be stored at any business location.

What does enforcement look like?

Failure to make a bioengineered food disclosure as required by the NBFDS is prohibited. Complaints about possible violations of the NBFDS will be made to the Agriculture Marketing Service (AMS). AMS will conduct a records audit, if appropriate. And, the regulated entity will be notified about the results of the audit or investigation and provided an opportunity to appeal. Summary of results will be posted on AMS website.

Israeli companies manufacturing and importing food to the U.S. will have to make sure they are in compliance with the new regulations. The Israel Public Health Protection Law, (Food) of 2015, regulates the rights and obligations of all factors involved in production, import and sale of food in Israel. In December 2017, the Israeli parliament’s Labor, Welfare and Health Committee approved new regulations, Regulations for the Protection of Public Health (Food) (Nutritional Labeling) 2017, requiring front of pack labeling for most prepackaged food products.  According to the new regulations that will enter into effect on January 2020, the nutritional value of prepackaged food will be made accessible and clear by the usage of symbols for the high content of sodium, sugar or saturated fatty acids. While Israeli crops for the most part, are not bioengineered, there is a vast research conducted in Israel on genetically engineering of crops. There is however, usage of certain imported bioengineered ingredients in the food production industry in Israel such as corn, soy and canola. While not yet enacted, the mandatory labeling of bioengineered food regulation in Israel is in its final phase of deliberation as well. Either way, for Israeli food companies that the U.S. is one of their main target markets, compliance with the Israeli regulation, European or any other country’s will still require making sure they meet the U.S. disclosure requirements.

About the Author
Meital Stavinsky is a Miami and Washington D.C. attorney, member of Holland & Knight's Public Policy & Regulation Group and Co-Chair of the firm's Israel Practice. Meital focuses her practice on business, public policy and regulation, with a particular emphasis on Israeli emerging and advanced technologies companies in the areas of AgriTech, FoodTech, CleanTech and Advanced Transpiration Technologies. Meital assists Israeli companies seeking to enter the U.S. market and expand their operations in the U.S. She has successfully advocated on behalf of leading innovative Israeli AgriTech companies in raising their profile and advancing their goals before the U.S. Congress and key U.S. federal agencies, most recently in connection with the 2018 Farm Bill.
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