Thank you, everyone, for joining us today for this webinar on GEMs in the National
Bioengineered Food Disclosure Standard, which requires regulated entities to
disclose information about bioengineered food and ingredients. My name's Alex Fischer, and I serve
as a presidential management fellow at the food disclosure and labeling division of the USDA.
The standard is implemented and enforced by the food disclosure and labeling division
within the agricultural marketing services of 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.
We also strive to provide excellent customer service to our stakeholders.
The goal of this presentation is to provide an overview of the standard and discuss how GEMs are
regulated. As we move through the presentation, please keep in mind that I'm very interested in
answering any questions that you may have regarding the standard. However, I'm unable
to answer live questions. So, please send any additional questions to befooddisclosure@USDA.gov.
This presentation will cover who is regulated by the standard,
what foods are considered bioengineered, how bioengineered foods must be labeled,
recordkeeping requirements for regulated entities, and enforcement.
So, the standard identifies three different groups as regulated entities. These regulated entities
are responsible for complying with the standard. The first type of regulated entity is a food
manufacturer, which includes anyone who packages food for human consumption and retail sale. The
second type of regulated entity is an importer. Importers are defined by U.S. Customs and Border
Protection and include anyone who imports food for retail sale into the United States.
The final category of regulated entity is retailers who either package and label food
for retail sale or sell bulk food items. 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. The standard exempts certain types of businesses
from having to comply with the regulations. These exempted entities include restaurants
and similar retail food establishments and very small food manufacturers. 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, as well
as other food enterprises located within retail establishments that provide ready to eat foods.
Very small food manufacturers are also not required to comply with the standard.
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.
We now move to what foods are considered bioengineered and are therefore subject to
the standard. 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.
Foods that do not contain detectable modified genetic material are not bioengineered foods.
The definition also allows for certain factors and conditions that may cause a food to not be
considered a bioengineered food, which at this time includes incidental additives.
AMS created this list of bioengineered foods to help regulated entities determine if their
food is bioengineered. AMS reviews and considers updates to the list annually.
The list includes all bioengineered foods that are legally produced and authorized for commercial
production somewhere in the world. Foods on or ingredients made from foods on this list
must be disclosed as a bioengineered food if the records show that the food
is bioengineered or do not indicate the bioengineered status of the food.
AMS recognizes that, while this list captures all crops and animals that are legally produced and
authorized for commercial production somewhere in the world, there may be other products
produced in labs or controlled environments, such as genetically engineered microbes.
If a regulated entity is using a food that is not on this list, but they have actual knowledge that
the food they are using is bioengineered, then they must make a bioengineered food disclosure.
Bioengineered food is a term defined in the standard, which requires food manufacturers,
retailers, and importers to disclose the presence of bioengineered foods
and bioengineered food ingredients. The definition can be found at 7 CFR 66.1. Among other things,
the phrase describes food that contains genetic material that has been modified through certain
plant breeding techniques and that could not otherwise be obtained through conventional
breeding or found in nature. GEMs is a standard term that includes enzymes, yeast, microbes,
etcetera that are made in a controlled environment.
AMS did not include on the list of bioengineered foods enzymes, yeas,
and other similar GEMs produced in controlled environments. Such substances do not categorically
meet the definition of a bioengineered food because they may qualify as incidental additives
with no technical or functional effect in the food, or they do not contain detectable
modified genetic material.Categorical inclusion of such substances on the list of bioengineer
foods would create confusion and complicate regulated entities' efforts to comply with the
standard's disclosure requirement. Regulated entities must determine whether recordkeeping
and ultimately disclosure of those substances are required on a case-by-case basis.
The definition of a bioengineered food also excludes foods subject to certain factors or
conditions. The standard currently includes one factor or condition, which is incidental
additives. Incidental additives are defined by the Food and Drug Administration, but generally are
foods that are used in insignificant amounts and have no technical or functional effect.
When used in accordance with FDA regulations, incidental additives do not need to be included
on the ingredient list. Similarly, AMS has determined that incidental additives are
not bioengineered foods, and when used in conformance with FDA regulations,
do not by themselves require a bioengineered food disclosure.
For foods not on the AMS list of bioengineered foods like enzymes, yeasts,
and other microorganisms, if a regulated entity's records demonstrate they have actual knowledge
that they are using a bioengineered version of the food, then they must make a disclosure.
Actual knowledge that a food is bioengineered means that you have knowledge that there is
detectable modified genetic material. If a food contains a genetically engineered microbe or
is made using a genetically-engineered microbe, there are several types of records that will show
that it does or does not contain detectable modified genetic material, and therefore,
that food or ingredient is not a bioengineered food. There are two options to show that modified
genetic material is not detectable, and therefore, your food or ingredient is not bioengineered.
Those options are to maintain records that verify the food has been refined using a process
validated to render the modified genetic material undetectable or verify the absence
of detectable modified genetic material through testing of the specific food.
The standard includes three categories of foods that are exempt.
First, the threshold exemption allows a certain amount of a bioengineered substance in a food
without requiring a bioengineered food disclosure. The standard allows each ingredient to contain up
to 5% of a bioengineered substance so long as it is inadvertent or technically unavoidable.
Any intentional use of a bioengineered food or ingredient requires disclosure. The second
exemption is for foods that come from an animal that is fed bioengineered feed. Foods derived
from an animal that is fed bioengineered feed are not bioengineered foods as a result of
that animal being fed bioengineered feed. The last exemption is for organic foods. Foods and
ingredients that are certified under the National Organic Program do not require disclosure.
Now that we know what foods require disclosure, we move to how that disclosure is made.
There are four different options available to all regulated entities for packages of
any size for disclosure. Those four options are
on-package text, symbol, electronic or digital disclosure, or a text message.
The standard allows for two different types of voluntary disclosure. First, entities that are
exempt, such as very small food manufacturers and restaurants or similar retail food establishments,
may voluntarily make bioengineered food disclosures. Second, regulated entities
may make voluntary disclosures for foods that are derived from foods produced through bioengineering
but do not contain detectable modified genetic material. For this type of voluntary disclosure,
entities may use any of the available disclosure options. However, the text must be written as
derived from bioengineering or ingredients derived from a bioengineered source. For disclosure by
symbol, this symbol must be used. The symbol can be printed in color or in black and white.
Now that we know how disclosures are made,
let's move on to what types of records must be kept to demonstrate compliance with the standard.
The disclosure provisions of the standard are driven by recordkeeping.
When a regulated entity uses a food on the list of bioengineered foods and decides not to make
a bioengineered food disclosure, the records must verify that the food is not bioengineered or does
not contain detectable modified genetic material pursuant to 7 CFR 66.9. When a regulated entity
makes a disclosure of foods on the list, records would simply identify the food or ingredient.
Each regulated entity may determine what types of business records to maintain
in order to demonstrate that they are in compliance with the standard.
Examples of possible records that may be useful in showing compliance include invoices,
bills of lading, inventory records, supply chain records, country of origin records,
process verifications, organic certifications, and laboratory test results.
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.
The compliance date is January 1st, 2022, and that is the date by when all bioengineered food
entering the stream of commerce must be labeled in compliance with the standard.
Regulated entities may voluntarily comply before that time and may continue to use
labels that were in compliance with state laws that are now preempted until January 1st, 2022.
Food entering commerce after the mandatory compliance date must comply with the standard.
Food is considered to have entered commerce the day on which it is labeled for retail sale.
Any stamp, sticker, or inkjet that uses one of the allowed disclosure options
and that is in compliance with the requirements concerning placement of such disclosures under
7 CFR 66.100(d) is sufficient to comply with the law. The sticker or printing cannot cover
any other mandatory labeling such as the nutrition facts.
Next, we will answer a couple of questions relating to GEMs and the standard.
First, "Is documentation required to verify the BE status of enzymes, yeasts,
and other microorganisms?" As required by 7 CFR 66.109, if a regulated entity has actual
knowledge that a food is bioengineered or contains a bioengineered food ingredient, it must make an
appropriate disclosure. For foods not on the AMS list of bioengineered foods like enzymes, yeasts,
and other microorganisms, if a regulated entity's records demonstrate they have actual knowledge
that they are using a bioengineered version of these foods, then they must make a disclosure.
The second question. "I'm using a genetically engineered microbe in my food product and have
not included the GEM on the ingredient list. Do I need to label my product BE?"
The definition of a bioengineered food at 7 CFR 66.1 excludes incidental additives that
are present in a food at an insignificant level and that do not have any technical or
functional effect in the food as described in 21 CFR 101.100(a)(3). Incidental additives when
used in accordance with this definition are not required to be included on the ingredient list.
If the ingredient you are using is considered an incidental additive,
as defined in 21 CFR 101.100(a)(3), then it is not a bioengineered food.
Finally, "Our product is made from a recombinant enzyme and there is less
than 5% of the DNA left in the final product. Do we need to label our product as bioengineered?"
The threshold exemption at 7 CFR 66.5(c) only applies when the presence of a
bioengineered substance is inadvertent or technically unavoidable and below the 5%
for each ingredient. This exemption is designed to recognize the realities of the supply chain and
acknowledge that BE and non-BE food ingredients are often grown and harvested, transported,
and processed in close proximity to one another. Any intentional use of a BE substance requires a
disclosure regardless of the percentage that food or ingredient represents in the finished product.
Given the proprietary nature of food production, companies are in the best position to determine on
a case-by-case basis whether their products are subject to labeling under the standard.
If you have any further questions, you may submit them through our email inbox,
befooddisclosure@usda.gov. Thank you.