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FDLD-USDA: Thank you for joining us today for our webinar on the record keeping requirements of the National Bioengineered Food Disclosure Standard.

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FDLD-USDA: which requires regulated entities to disclose information about bioengineered food and ingredients, my name is Anna, and I am a Presidential Management Fellow of the research and rulemaking branch in the food disclosure and labeling division.

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FDLD-USDA: The standard is implemented and enforced by the food disclosure and labeling division within the Fair Trade Practices Program of the Agricultural Marketing Service of USDA.

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FDLD-USDA: Our mission is to ensure effective and efficient regulatory compliance throughout the food supply chain to provide consumers with accurate and transparent marketing information about their food.

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FDLD-USDA: We also strive to provide excellent customer service to our stakeholders, including providing tools to assist stakeholders to comply with the Standard as such, we hope this webinar provides you with useful information to help you comply with the standard.

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FDLD-USDA: If you haven't already please check out our online resources on our be disclosure website, which include factsheets frequently asked questions and an interactive tool that can help you determine if your product requires the disclosure.

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FDLD-USDA: While this webinar is geared specifically toward information that suppliers might need to know for generating records, we have a general overview webinar of the Standard on our website, which covers that role and more depth.

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FDLD-USDA: The goal of the webinar is to provide a detailed overview of the record keeping requirements of the Standard.

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FDLD-USDA: While this webinar is intended to be most useful for suppliers regulated entities may also find the presentation informative.

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FDLD-USDA: In addition, Shelby will answer a few frequently asked questions at the end of the presentation, please send any additional questions to befooddisclosure@usda.gov.

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FDLD-USDA: The webinar will cover who is regulated by the standard what foods are considered bioengineered who is required to maintain records and record keeping requirements for regulated entities.

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FDLD-USDA: The standard identifies, who is a regulated entity, the next few slides will discuss who is considered a regulated entity.

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FDLD-USDA: The standard identifies three different groups as regulated entities these regulated entities are responsible for complying with the Standard.

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FDLD-USDA: The first type of regulated entity is a food manufacturer, which is defined as an entity that manufacturers processes or packs human food and labels, the food or food product for retail sale.

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FDLD-USDA: The second type of regulated entity is an importer importers defined as the importer of record as defined by US Customs and Border Protection.

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FDLD-USDA: Who engages in the importation of food or food product labeled for retail sale into the United States. In the instance of a company that exports products to the US, AMS will look to the importer in order to enforce the law.

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FDLD-USDA: The third and final category of regulated entity is retailers who either package and label food for retail sale or sell bulk food items.

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FDLD-USDA: Examples of a retailer, who is responsible for bioengineered food labeling include a grocery store that sells bulk items like fresh fruits and vegetables or processed bulk items like granola and cereal.

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FDLD-USDA: The standard exempts certain types of businesses from having to comply with the regulations, these include restaurants and similar retail food establishments and very small food manufacturers.

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FDLD-USDA: A restaurant or similar retail food establishment includes full service and fast food restaurants, cafeterias, lunchrooms, food stands, food trucks, trains and airplanes, bars, taverns, and lounges.

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FDLD-USDA: very small food manufacturers are also not required to comply with the standard, although they may voluntarily comply, if they so choose.

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FDLD-USDA: very small food manufacturers are defined as those with annual receipts less than $2.5 million this amount is determined by including both food and non-food receipts.

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FDLD-USDA: To summarize, those must comply with the standard include food manufacturers, importers and retailers who package and label food or sell food items, those who are not required to comply with the Standard include restaurants and similar retail food establishments and very small food manufacturers.

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FDLD-USDA: While suppliers are not defined as regulated entities by the standard, they may also play a role in helping regulated entities comply with the requirements of the Standard.

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FDLD-USDA: In some cases, regulated entities such as retailers or manufacturers might request records from suppliers, so that they can maintain records to comply with the law.

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FDLD-USDA: Any of these requests from a regulated entity to their supplier are governed by private contracts and relationships that are not regulated by the Standard.

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FDLD-USDA: We now move to what foods are considered bioengineered foods and are therefore subject to the Standard.

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FDLD-USDA: bioengineered foods are those that contain detectable 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.

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FDLD-USDA: foods that do not contain detectable modified genetic material are not bioengineered foods, finally, the definition allows for certain factors and conditions they may cause a food to not be considered a by engineer food which at this time, includes incidental additives.

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FDLD-USDA: The standard does not apply to foods that are primarily meat, poultry, or egg products.

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FDLD-USDA: to figure out if the food is primarily meet catfish poultry or an egg product look at the first ingredient on the ingredient list if that first ingredient would individually, be subject to the Federal Meat Inspection Act.

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FDLD-USDA: The Poultry Products Inspection Act or the Egg Products Inspection Act, then the food is not subject to the Standard, this means that foods, where the first ingredient is pork, beef, sheep, or goat.

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FDLD-USDA: or chicken, turkey, or another domesticated bird, or an egg product are not subject to the Standard.

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FDLD-USDA: If the first ingredient is not individually, subject to the Federal Meat Inspection Act, 

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FDLD-USDA: The Poultry Products Inspection Act or the Egg Products Inspection Act, but that first ingredient is broth stock water or a similar solution, then look to the second ingredient.

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FDLD-USDA: When the first ingredient is breath stock water or a similar solution, and the second ingredient is subject to one of those three acts

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FDLD-USDA: meaning the second ingredient is pork, beef, sheep, goat, chicken, turkey, or another domesticated bird, or an egg product than the food is not subject to the Standard.

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FDLD-USDA: The Standard includes three categories of foods that are exempt. First, the threshold exemption allows a certain amount of a bioengineered substance into food without requiring a bioengineered food disclosure.

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FDLD-USDA: The Standard allows each ingredient to contain up to 5% of a bioengineered substance, so long as it is inadvertent are technically unavoidable.

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FDLD-USDA: Any intentional use of a bioengineered food or ingredient requires disclosure.

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FDLD-USDA: This exemption is intended to acknowledge the realities of the supply chain and recognizes that bioengineered and non-bioengineered foods may be grown and processed near one another.

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FDLD-USDA: Although individuals throughout the supply chain routinely take steps to keep bioengineered and non-bioengineered food separate.

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FDLD-USDA: The threshold exemption ensures that when appropriate steps are taken to keep bioengineered and non-bioengineered food separate a non-bioengineered food will not require disclosure simply because it was grown or processed near its bioengineered counterpart.

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FDLD-USDA: In order for the presence of a bioengineered substance to be considered inadvertent or technically unavoidable.

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FDLD-USDA: The regulated entity must use reasonable and customary practices to separate bioengineered and non-bioengineered ingredients.

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FDLD-USDA: A small amount of bioengineered corn that remained in a combine or on a processing line, after a reasonable efforts to remove all bioengineered corn.

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FDLD-USDA: would be considered inadvertent or technically unavoidable if present in an amount less than 5%.

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FDLD-USDA: Conversely, if a food manufacturer was producing a non-bioengineered cracker and ran out of one non bioengineered ingredient then decided to use a bioengineered version of that ingredient, that would be considered an intentional use and would require a bioengineered food disclosure.

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FDLD-USDA: The second exemption is for foods that come from an animal that is fed bioengineered feed.

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FDLD-USDA: food derived from an animal that is fed bioengineered feed are not bioengineered foods as a result of that animal being fed bioengineered feed.

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FDLD-USDA: For example, eggs are not considered a bioengineered food just because of chicken was fed and mix of bioengineered grains.

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FDLD-USDA: Similarly, milk from a cow fed bioengineered alfalfa is not a via engineered food as a result of the cow eating bioengineered feed.

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FDLD-USDA: Conversely, if a bioengineered animal, such as salmon is fed by engineer feed disclosure would be required, because the animal is bioengineered, but not because of what it was fed.

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FDLD-USDA: The last exemption is for organic foods and ingredients that are certified under the National Organic Program do not require disclosure.

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FDLD-USDA: AMS recognizes that the definition of bioengineered foods is complex and figuring out what foods contain detectable genetic material that has been modified through in vitro rDNA techniques.

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FDLD-USDA: may be difficult for many individuals responsible for food labeling recognizing this complexity AMS created this list of bioengineered foods to help regulated entities determine if their food is bioengineered.

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FDLD-USDA: This list includes all by engineered foods that are legally produced and authorized for commercial production somewhere in the world where feasible AMS is included the specific variety of a crop or food to make compliance and record keeping easier.

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FDLD-USDA: where only one company is making a bioengineered version of a food AMS has included the trade name on the list, this list will be reviewed on an annual basis and, if necessary.

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FDLD-USDA: updated through notice and comment rulemaking AMS recognizes that while this list captures all props and animals that are legally produced and authorized for commercial production somewhere in the world.

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FDLD-USDA: There may be other products produced in labs or controlled environments and new crops that could enter commerce before AMS updates this list.

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FDLD-USDA: If a regulated entity is using a food that is not on this list, but they have actual knowledge that the food they're using is the bioengineered food, and they must make a bioengineered food disclosure.

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FDLD-USDA: foods on or ingredients made from foods on this list must be disclosed as a bioengineered food if the record show that the food is bioengineered or do not indicate the bioengineered status of the food.

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FDLD-USDA: suppliers who supply ingredients from foods on the list may receive requests from manufacturers or retailers for records.

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FDLD-USDA: If the regulated entities records show that the food is not bioengineered then it's label will not include a bioengineered food disclosure records appropriate to show a food on this list is not bioengineered will be discussed shortly.

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FDLD-USDA: For foods on this list that include a variety or trade name disclosure is required when the regulated entities records include that variety or trade name.

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FDLD-USDA: If the records do not show the food is that specific variety or trade name, then disclosure is not required unless the regulated entity has actual knowledge that the food is bioengineered.

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FDLD-USDA: For instance, if I’m a supplier selling apples and my records do not show that the apples are Arctic apples.

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FDLD-USDA: The regulated entity does not need to make disclosure unless they have actual knowledge, the apples are bioengineered.

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FDLD-USDA: I will now pass it over to Alex Presidential Management Fellow of the research and rulemaking branch to talk about the acceptable types of records that suppliers may provide next.

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FDLD-USDA: Thanks Anna.

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FDLD-USDA: Now that we know the definition of a bioengineered food, let us move on to what types of records must be kept to demonstrate compliance with the Standard.

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FDLD-USDA: All entities, subject to the Standard must keep sufficient records to show that they are in compliance with the disclosure requirements.

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FDLD-USDA: And this requires that regulated entities keep customary and reasonable records that are generated in the normal course of business.

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FDLD-USDA: It is up to each regulated entity to determine which records to maintain to demonstrate they are in compliance these records can be kept in any format, including hardcopy or electronic copy, and maybe stored at any business location.

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FDLD-USDA: There are several additional recordkeeping requirements worth noting. The Standard requires records to be maintained for two years after the food is sold or distributed for retail sale.

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FDLD-USDA: Some records, such as those verifying a certain manufacturing process or testing may be necessary to retain for longer periods of time.

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FDLD-USDA: When USDA requests records those records need to be produced within five business days unless USDA grants an extension.

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FDLD-USDA: If onsite access is necessary, USDA will provide notice of at least three business days in advance.

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FDLD-USDA: It is also important to note the suppliers are not required to maintain records and that any requirements or requests from a regulated entity to their supplier are governed by private contracts and relationships that are not regulated by the Standard.

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FDLD-USDA: There are several different scenarios when a bioengineered disclosure is or isn't required and when a regulated entity is or isn't required to maintain records, we will discuss each of these scenarios next.

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FDLD-USDA: First, we will explore the record keeping requirements for foods that are bioengineered, have bioengineered ingredients, or have detectable modified genetic material.

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FDLD-USDA: These items meet the definition of a bioengineered food at seven CFR 66.1 they may or may not be on the AMS list of bioengineered foods.

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FDLD-USDA: Each regulated entity may determine what business records, they want to maintain in order to demonstrate that they are in compliance with the Standard.

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FDLD-USDA: Examples of possible records that may be useful in showing compliance include invoices, bills of lading

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FDLD-USDA: inventory records, supply chain records, country of origin records, process verifications, organic certifications, and laboratory test results.

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FDLD-USDA: If the ingredients you supply are made from an item on the list of bioengineered foods at 7 CFR 66.6.

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FDLD-USDA: And contain detectable modified genetic material, then they are considered bioengineered food ingredients and require bioengineered food disclosure.

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FDLD-USDA: If the ingredients you supply are not made from an item on the list, then disclosure is only required if you have actual knowledge, the ingredients or bioengineering, which would include, among other things, knowledge that they contain detectable modify genetic material.

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FDLD-USDA: Next, we will discuss the record keeping requirements for foods that are not bio engineer have no bioengineered ingredients or have no detectable modified genetic material.

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FDLD-USDA: Here are the record keeping requirements for foods that are on the list, but are not bioengineered foods and disclosure is not required.

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FDLD-USDA: However, even if the food is not bioengineered, because it is on or derived from the AMS list of bioengineered foods at 7 CFR 66.6 regulated entities are required to maintain records for these ingredients. As a supplier, you may be asked to provide these records

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FDLD-USDA: if a regulated entity is using a food on the AMS list of bioengineered foods or a food produced from an item on the list, if they do not make a bioengineered food disclosure, then they must maintain records in accordance with 7 CFR 66.9.

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FDLD-USDA: As listed at 7 CFR 66.9 these records, may be records that verify the food is sourced from a non-bioengineered crop or source.

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FDLD-USDA: Records to verify that the food has been subjected to a refining process validated to make the modified genetic material in the food undetectable or certificates of analysis or other records of testing appropriate to the specific food that confirm the absence of modify genetic material.

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FDLD-USDA: Next, we will talk about examples of records that comply with these requirements.

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FDLD-USDA: Examples of records that justify non-disclosure include organic certification documentation that the ingredient is sourced from a country that does not allow production of that specific ingredient in a bioengineered form, laboratory test results, and process verification.

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FDLD-USDA: We will discuss laboratory tests and process verifications in more detail in the following slides.

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FDLD-USDA: For highly refined foods that are produced using a food on the list, but do not contain detectable modified genetic material

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FDLD-USDA: you can maintain records that verify the food has been refined using a process validated to render the genetic material undetectable.

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FDLD-USDA: Validation is confirmed through testing and through maintenance of processing records for validation and this does not identify which specific tests must be used.

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FDLD-USDA: But does prescribe standards of performance regarding testing methodology, in general, the laboratory that does the testing is expected to use quality assurance protocols that are common to the industry to ensure the validity and reliability of the test results.

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FDLD-USDA: Once a refining process has been validated through testing in records that show modified genetic material is not detected and records or maintain that show the validated processes followed the process does not need to be tested again unless significant changes are made to the process.

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FDLD-USDA: AMS published the final guidance to ensure acceptable validation of a refining process on July 7, 2020 the guide includes eight general steps to validate a refinement process.

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FDLD-USDA: The general steps to validate a refinement process are one- identify raw materials ingredients in product contact materials. Two- define characteristics and intended use of the end product. Three- define the sequence and interaction about processing steps used to arrive at the end product.

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FDLD-USDA: Four- identify key step or steps in the refinement process that may influence the end products characteristics and its ability to meet specified requirements.

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FDLD-USDA: Five- assemble relevant validation information that demonstrates the refinement process operates as intended to meet specific specify requirements, but just end product characteristics conducting studies as needed.

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FDLD-USDA: Six- continually verify the refinement process is operating as validated. Seven- revalidated the refinement process as applicable

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FDLD-USDA: and when significant changes are made to the process, finally, the eighth step is to maintain records of the validation and ongoing verification.

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FDLD-USDA: These records, paper or electronic should demonstrate that the process has been validated and continually monitor pursuant to the standard at 7 CFR 66.9 (b)(2)

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FDLD-USDA: regularly. Regulated entity should maintain these records for as long as the validated process is in use by the entity and for at least two years beyond the date the food is sold or distributed for retail sale.

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FDLD-USDA: In the case of an audit or examination, AMS will rely on looking solely at a regulated entities records and will not be testing.

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FDLD-USDA: You can show that modified genetic material is not detectable by maintaining testing records for specific foods that confirm no modified genetic material is detectable.

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FDLD-USDA: As with the validated refining process, AMS is not identifying specific tests that must be used, but has prescribed standards of performance regarding testing methodology.

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FDLD-USDA: In general, the laboratory that does the testing is expected to use quality assurance protocols that are common to the industry to ensure the validity and reliability of test results.

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FDLD-USDA: AMS published the guidance on testing methods on July 7, 2020 and the document includes five key concepts.

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FDLD-USDA: The five key concepts address selecting a testing method when regulated entities use a third option to demonstrate that modified genetic material is undetectable.

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FDLD-USDA: Which is batch by batch and product testing. Additionally, regulated entities can use this guidance when selecting a test method for the refinement process validation option.

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FDLD-USDA: The five key concepts are one- general considerations and selecting the best method. Two- DNA based test methods. Three- emerging technologies and other methods.

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FDLD-USDA: Four- general consideration in selecting a laboratory. Five- record keeping requirements. The second key concept is about DNA based test methods. Polymerase chain reaction or PCR is the most widely used and accepted test method for determining modified genetic material in food.

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FDLD-USDA: PCR can be qualitative or quantitative and USDA does not prefer one over the other, as long as the method is fit for purpose and meets the regulatory requirements.

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FDLD-USDA: Technology such as DNA sequencing continually progresses and may become more commercially and economically accessible.

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FDLD-USDA: If these emerging technologies meet the requirements of 7 CFR 66.9 see, they would be sufficient to comply with the standard.

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FDLD-USDA: AMS will not be maintaining a list of approved or fit for purpose test methods rather entities should consult the standard at 7 CFR 66.9 seem to ensure their method is sufficient. The laboratory must comply with the standard at seven CFR 66.9 (c).

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FDLD-USDA: The guidance documents can be found on our website here under detectability testing.

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FDLD-USDA: For foods that are not on the list of bioengineered foods and do not meet the required definition of a bioengineered food at 7 CFR 66.1.

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FDLD-USDA: regulated entities are not required to maintain records for foods that are not on the list, there is no presumption that they are bioengineered

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FDLD-USDA: and regulated entities are not required to keep any additional records to prove they're not bioengineered because the foods are not currently on the list, it does not require a bioengineered food disclosure unless a regulated entity has actual knowledge, it is a bioengineered food. 

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FDLD-USDA: The mandatory compliance date is January 1, 2022 and is the date by when all bioengineered foods entering the stream of commerce, must be labeled in compliance with the standard.

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FDLD-USDA: AMS considers a food as having entered commerce on the date it is labeled for retail sale.

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FDLD-USDA: The standard does not include any mandatory requirements for foods that enter commerce prior to this date and does not limit how long such foods may remain in commerce.

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FDLD-USDA: Regulated entities may voluntarily comply before that time and may continue to use labels that were in compliance with state laws that are now preemptive until January 1, 2022.

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FDLD-USDA: This concludes the presentation portion of the webinar I'll now pass it on to Shelby, agricultural marketing specialist of the research and rulemaking branch to answer a few frequently asked questions about the record keeping requirements.

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FDLD-USDA: Thank you Alex Finally, we will share.

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FDLD-USDA: A few Frequently Asked Questions involving suppliers.

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FDLD-USDA: The first question is, I am a supplier Do I need to maintain records to comply with the standard.

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FDLD-USDA: No suppliers are not considered a regulated entity and, therefore, are not required to maintain records. All regulated entities subject to the standard must keep sufficient records to show they are in compliance with the disclosure requirements.

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FDLD-USDA: Regulated entities are defined as food manufacturers, importers or retailers that are responsible for making bioengineered food disclosures under 7 CFR 66.100 (a).

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FDLD-USDA: For purposes of enforcing the standard AMS will only be looking to regulated entities to determine compliance.

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FDLD-USDA: Any requirements or request from a regulated entity to their supplier are governed by private contracts and relationships that are not regulated by the standard.

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FDLD-USDA: The second question is. how long are regulated entities required to retain records that verify compliance with the standard.

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FDLD-USDA: The standard requires records to be maintained for two years after the food is sold or distributed for retail sale.

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FDLD-USDA: Some records, such as those verifying a certain manufacturing process or testing may be necessary to retain for longer periods of time.

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FDLD-USDA: Although suppliers are not required to maintain records regulated entities may request records from their suppliers.

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FDLD-USDA: Any requirements or request from a regulated entity to their suppliers are governed by private contracts and relationships that are not regulated by the standard.

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FDLD-USDA: The third question is, what records are sufficient to verify that a food is sourced from a non-bioengineered crop.

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FDLD-USDA: Regulated entities may maintain records to show that a food is sourced from a non-bioengineered crop.

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FDLD-USDA: These type of records may include organic certification, records that show the food is sourced from a country that does not allow production of that food in a bioengineered form or any other records that communicate similar information.

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FDLD-USDA: Examples of customary or reasonable records that could be used to demonstrate compliance with the disclosure requirements include but are not limited to:

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FDLD-USDA: Supply Chain records, bills of leading, invoices, supplier attestations, ingredient lists, contracts broker statements,

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FDLD-USDA: Country of origin records, process verifications, third party certifications, organic certifications or other records generated or maintained by the regulated entity in the normal course of business.

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FDLD-USDA: The fourth question is, I'm using a food on the AMS list of bioengineered foods. My supplier sent me a record that says non-GMO is that sufficient?

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FDLD-USDA: No, a record that says non-GMO is not sufficient to comply with the standard such a statement without more would likely not be sufficient to demonstrate the food is not a bioengineered food.

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FDLD-USDA: We have provided examples of a non-compliant and compliant record on the next slide.

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FDLD-USDA: On the left is an example of a non-compliant record that simply states non-GMO.

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FDLD-USDA: This record is incomplete and would need to include either one- a record that indicates the food is produced from a non-bioengineered crop.

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FDLD-USDA: Two- a record that indicates the food has been subjected to a refinement process validated to render modified genetic material undetectable.

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FDLD-USDA: or three- a record, such as a certificate of analysis or other testing record appropriate to a specific food that confirms the absence of detectable modified genetic material.

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FDLD-USDA: These would be batch by batch testing records to confirm each batch does not contain detectable modified genetic material.

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FDLD-USDA: Here we provided an example of a compliant record. This record includes a supplemental testing record verifying that the presence of the material is not detected.

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FDLD-USDA: This example is compliant because it includes the third option as section 66.9 (a)(3) records, such as a certificate of analysis or other testing record appropriate to a specific food that confirm the absence of detectable modified genetic material.

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FDLD-USDA: The final question is- is a supplier attestation sufficient to demonstrate compliance with the standard.

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FDLD-USDA: A supplier attestation would be a sufficient record, provided it meets the requirements at 7 CFR 66.9.

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FDLD-USDA: This concludes the frequently asked questions portion of the webinar.

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FDLD-USDA: Thank you for viewing, if you have any further questions you may submit them through our email inbox befooddisclosure@usda.gov.

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FDLD-USDA: You can download a copy of the slides, transcript and recording of previous versions of this webinar on the USDA bioengineered food disclosure website at www.ams.usda.gov/BE.

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FDLD-USDA: Our website also includes a variety of resources, such as fact sheets, FAQs, and a disclosure determination tool to help regulated entities comply with the standard we hope you found this presentation helpful and thank you very much for your time and attention.