The USDA issued its final rule for the National Bioengineered Food Disclosure Standard (NBFDS) today, to be published in the Federal Register on December 21, 2018. The Non-GMO Project is disappointed by the content of the final rule, which jeopardizes GMO transparency for Americans. The NBFDS demonstrates that only the Non-GMO Project provides the transparent labeling consumers have been demanding for more than 20 years.
In its current form, categorical exemptions prevent this law from delivering the meaningful protections Americans deserve. Highly processed ingredients, many products of new genetic engineering techniques such as CRISPR and TALEN, and many meat and dairy products will not require disclosure. Animal feed is not covered by this law; meat, eggs, and dairy from animals fed a GMO diet will not require a disclosure. Overall, many products containing GMOs will not be labeled, meaning that the absence of a bioengineered (BE) disclosure does not mean a product is non-GMO. In light of these developments, the Non-GMO Project will continue to listen to consumers and provide North America’s most rigorous label for GMO avoidance.
Despite these shortcomings, the law will permit voluntary non-GMO claims such as Non-GMO Project Verified. The final law explicitly states that Non-GMO Project participants are not expected to incur costs in association with this law according to a previously conducted regulatory impact analysis. This further suggests that Non-GMO Project Product Verification Program materials fulfill the necessary requirements to avoid disclosure.
The Non-GMO Project was founded on the simple idea that everyone has the right to know what is in their food and we are committed to helping every shopper make that right a reality. Based on the final rule released today, Non-GMO Project Verified will remain the most trustworthy and accessible way for consumers to avoid GMOs. The USDA’s final rule is not good enough and we believe consumers deserve better—the Non-GMO Project is committed to providing transparent labeling and meaningful non-GMO choices to all Americans.
Frequently Asked Questions
What is the National Bioengineered Food Disclosure Standard (NBFDS)?
The NBFDS is a federal rule published on December 21, 2018 that requires mandatory disclosure of genetically engineered ingredients in certain foods. The rule uses a very narrow definition of “bioengineered,” which exempts many ingredients that consumers widely consider to be GMOs. For example, under the rule, a cooking oil made from GMO canola is not considered “bioengineered,” and is therefore exempt from labeling, simply because the finished product isn’t testable.
How is the NBFDS perceived by the public?
Consumer groups have largely rejected the rule as insufficiently meaningful and transparent. Commonly cited concerns include the narrow definition of bioengineered food, the allowance of inaccessible disclosure methods (such as QR codes), and the use of opaque terminology.
Are Non-GMO Project Verified Products automatically exempt from the NBFDS?
While Non-GMO Project Verified products are not automatically exempt, the Non-GMO Project is confident that Verified products will meet and exceed the requirements for compliance with the NBFDS. In its commentary on the final rule, Agricultural Marketing Service (AMS) states that “USDA has tried to minimize the impact the NBFDS will have on...voluntary absence claims.”
Will the NBFDS generate expenses for my Non-GMO Project Verified products?
The final rule explicitly states that Non-GMO Project participants are not expected to incur costs in association with this law according to a previously conducted regulatory impact analysis. Thus, it appears that the rule has been drafted with the intention that documentation related to Non-GMO Project Product Verification will fulfill the necessary requirements to avoid disclosure.
How do I tell if the NBFDS applies to my products?
Applicability rules are very complicated, especially for products that contain meat or eggs. Please review sections B and C under Applicability for full details.
- Examples of products the NBFDS applies to: Human food, chewing gum, vitamins and supplements, some wine and beer, and enzymes.
- Examples of products the NBFDS does not apply to: Meat, eggs, multi-ingredient food with meat or egg as the first ingredient, prepared food, pet food, animal feed, GMO-derived products without intact DNA, untestable GMOs, distilled spirits, some wine and beer, and non-food items.
Will products of new genetic engineering techniques such as CRISPR or TALEN require a disclosure?
The NBFDS limits its definition of bioengineering to recombinant techniques that result in detectable modified material in the finished food. It appears unlikely that products of techniques like gene editing would be subject to disclosure under NBFDS, but the final rule is not explicitly clear.
Is there an exemption for my small food manufacturing business?
Very small food manufacturers, defined as those with annual receipts of less than $2.5 million, are exempt from the NBFDS. Such manufacturers may choose to make a voluntary disclosure if desired.
What is the penalty for failing to comply with the NBFDS?
The NBFDS does not provide for civil penalties such as fines. If a problem is discovered during an audit, regulated entities have the opportunity to have a hearing. The AMS can publish the results of an audit after such a hearing.
Will the Non-GMO Project help my brand demonstrate compliance to the AMS?
Individual brands will be responsible for submitting documentation to AMS if they are audited. It appears that the law has been drafted with the intention that documentation related to Non-GMO Project Product Verification materials will fulfill the necessary requirements to avoid disclosure.
If one of my products has a BE disclosure and another is Non-GMO Project Verified, can I advertise them together?
This is currently permitted as long as the Non-GMO Project Verified mark is only used in association with Verified products and/or the advertisement contains a disclaimer as to which product(s) are Non-GMO Project Verified. As a reminder, all marketing materials utilizing our trademarks must be sent to our marketing department for review and approval. If the advertisement needs to be altered in any way, our marketing team will let you know.
Can I write “Non-BE” or “Not bioengineered” on my Non-GMO Project Verified products?
No, this type of language is not permitted on Non-GMO Project Verified products or related marketing materials. The NBFDS states “the focus of the NBFDS is on BE claims and not on absence claims.” Non-GMO Project participants do not need to make claims using the AMS' confusing language because their Verified products already communicate a higher-level commitment to GMO transparency. The Non-GMO Project Verified mark means a product is compliant with North America’s most trusted and rigorous Standard for GMO avoidance—a significantly more meaningful designation than “non-BE” or similar.
When do my products need to be in compliance with the NBFDS?
Implementation begins January 1, 2020; some companies will choose to start using a BE disclosure at this time. Mandatory compliance takes effect on January 1, 2022. All applicable food products must bear a bioengineered disclosure by this date.
Why should I remain in the Non-GMO Project Product Verification Program if the United States government is labeling bioengineered ingredients?
Non-GMO Project Verified remains the most technically rigorous and the most trusted label for GMO avoidance. The USDA’s law does not cover most refined ingredients, products of new genetic engineering techniques, meat products, pet food, animal feed, or personal care items. The consumers who care about true ingredient transparency will continue to look for the Non-GMO Project Verified seal.
According to Michael Hansen, Senior Scientist at Consumer Reports, “The overwhelming majority of consumers want genetically engineered food to be clearly labeled, but this rule fails to give consumers the information they deserve. Consumers can, however, rely on labels such as ‘Non-GMO Project Verified’ which will tell them if a food does not contain GMO ingredients.”
We are grateful for your commitment to providing consumers with the highest quality third-party verification for non-GMO food and products. Together, we will keep working to provide consumers with a meaningful way to know what is in their food.
GENERAL INFORMATION
The potato has been added to the High-Risk list of the Non-GMO Project Standard. The Non-GMO Project considers crops and inputs to be “High-Risk” when there is a high likelihood of GMO contamination in the conventional and non-GMO supply chain.
The Non-GMO Project uses a risk matrix to determine the Standard’s High-Risk list. The risk matrix focuses on key criteria, including the number of acres planted, commercial availability, the presence in the supply chain, usage, and its potential use in human food and/or as animal feed. These and other criteria each have an identified risk value within the matrix. As Monitored GMO crops/inputs become more available, they are entered into the matrix; when their total risk score reaches a predetermined threshold, they are recommended for addition to the High-Risk list. The GMO potato has now met this threshold.
What varieties of GMO potato are known to be in the U.S. marketplace?
On the market since 2015, the GMO potato was developed by J.R. Simplot. Currently, GMO potatoes are being marketed under the Simplot Innate brand, found under the trademark White Russet. This variety features multiple traits, including non-browning and the production of lower levels of acrylamide.
In addition to fresh, whole potatoes, what types of products could be affected?
Frozen potato products (e.g., frozen french fries), prepared food that includes potato as an ingredient (e.g., pot pies), foods that contain potato starch as a thickening agent (e.g., sauces, puddings), and certain gluten-free foods that use potato flour in their formulation may all be affected by the move of the potato to the High-Risk list.
How often do new crops/inputs get added to the Non-GMO Project’s High-Risk list?
To date, changes to the High-Risk list have been rare. Alfalfa was moved to the High-Risk list in 2011 and that is the only time since the first version of the Non-GMO Project Standard was published in 2007 that a new crop has been added to the High-Risk list. That said, new product development in the biotechnology industry is accelerating. At the same time that potato is being moved to the High-Risk list, a new variety of untestable RNAi soy is also being added.
COMPLIANCE REQUIREMENTS
What is the significance of the potato being moved from the Monitored-Risk to the High-Risk list? How does the High-Risk compliance pathway differ?
Inputs on the Monitored-Risk list are those for which GMO versions are in the research and development stage, for which GMO versions have been developed but are not widely commercially available, or for which known genetically modified organism contamination has occurred. Crops on the Monitored-Risk list are evaluated as other Low-Risk inputs and do not require testing. Once a crop has been moved to the High-Risk list, it is subject to testing requirements, or confirmation of compliance by affidavit if the crop is currently not yet testable.
What does the compliance pathway look like for the potato on the High-Risk list?
The GMO potato available in the U.S. today is currently not testable, meaning that no point in the production chain exists at which one can distinguish between a non-GMO potato and a GMO potato using publicly commercially available tests according to the requirements laid out in Section V.B. and Section V.C. of the Non-GMO Project Standard. An affidavit stating that any such non-testable High-Risk input is not the product of genetic modification is required to establish compliance with the Standard. However, the industry is rapidly developing new testing methodologies, and thus compliance pathways for these not-yet-testable crops may change.
What are the affidavit requirements?
Participants will need to provide affidavits confirming the non-GMO status of all potatoes and/or potato derivatives used in Verified Products prior to initial Verification and at each annual renewal thereafter. The affidavit is a standard document created by the Non-GMO Project (available from the Project’s Technical Administrators) that will need to be signed at a critical control point(s) by an individual who has sufficient knowledge of the Participant’s supply chain and understands the Project’s definitions of Biotechnology and Non-GMO. There may be more than one critical control point or individual within a supply chain who will meet these requirements, and the Project’s Technical Administrator will evaluate the appropriateness of the signatory selected.
My products are already Verified. How long do I have to come into compliance?
Adding crops to the High-Risk list is considered a Special Revision to the Standard, provisions for which are covered in the Terms of Reference. Verified participants will have six months or until their next product renewal to come into compliance, whichever is longer. For products that are not yet verified, the new requirements are immediate.
How does this impact the status of backstock and product Verified prior to the move of the potato to the High-Risk list?
Finished, Verified products that contain potatoes and/or potato derivatives will remain Verified. Participants may use existing inventory of potatoes and/or potato derivatives for six months, or until their next product renewal, whichever is longer, without providing affidavits. Any inventory of potatoes and/or potato derivatives that have not been used within this transition period, and any potatoes and/or potato derivatives purchased thereafter for use in Verified products, must be proven compliant via affidavit in order to continue to be used in Verified Products.
Will potatoes be eligible for a Country-of-Origin (COO) Downgrade?
Yes. Similar to all other crops on the High-Risk list, the potato will be eligible for COO downgrades dependent on the GMO regulatory framework and cultivation and import practices of each individual country. This compliance pathway is available for high-risk crops that are sourced from countries where genetically engineered versions of that crop are not grown. For more information on applying for a COO downgrade process, please see this FAQ.
INFORMATION FOR RETAILERS
We have a product policy requiring products with GMO risk ingredients to either be Non-GMO Project Verified or certified organic. Do we now need to start screening for all potato products as having GMO Risk?
Yes, given the current pace of commercialization of the Simplot Innate White Russet, potato inputs should now be treated as high-risk for GMO contamination. Retailers with additional questions about how to apply this in practice may contact our Verification team.
How can I help get the word out so that brands have the information they need to protect against this risk?
The Non-GMO Project is applying a comprehensive communications strategy to alert the industry about this news, including targeted emails, personal follow up communications to leading brands, and engagement with distributors and trade media. Retailers can help by sharing our press release with their vendor lists. Any questions from vendors may be referred to our Verification team; press inquiries may be sent to our Communications team.
It has come to the Non-GMO Project’s attention that a producer of soy and soybean oil (Calyxt) is entering into contracts to sell a new high-oleic acid soybean variety developed with the gene editing technique TALEN. Though this TALEN soy variety does not contain transgenes in the finished product, it was developed using biotechnology and is therefore a GMO. Products made with this soy are not eligible for Verification under the Non-GMO Project Standard. The Project will be ensuring compliance through legally-binding affidavits.
The Project's definition of GMO aligns with the one used by Codex Alimentarius, which is the most authoritative international definition for biotechnology. This definition encompasses new techniques such as gene-editing and aligns with a recent ruling by the highest court in the European Union that the products of such techniques are GMOs and are subject to the EU GMO Directive.
As products of biotechnology continue to enter the market at an accelerated rate and with virtually no regulation, the Non-GMO Project will continue to lead the way in addressing the supply chain risks from new GMOs and preserving non-GMO choices for the public.
Non-GMO Project addresses supply chain risks caused by new techniques like CRISPR and RNAi
Contact: Kristin Wheeler
Phone: 360.255.7704 x131
Email: press@nongmoproject.org
BELLINGHAM, WA—October 31—The potato has been added to the High-Risk list of the Non-GMO Project Standard because a GMO potato variety is now “widely commercially available” in the United States. To determine when a crop needs to be moved from the Monitored-Risk list to the High-Risk list, the Project uses an established set of criteria related to the likelihood of GMO contamination in the conventional and non-GMO supply chain. As a result of today’s move, products made with potato will now be subject to extra scrutiny before they can become Non-GMO Project Verified.
On the market since 2015, the GMO potato developed by J.R. Simplot has been engineered through a method of gene silencing called RNA interference (RNAi). This genetic engineering technique results in a potato that hides the symptoms of blackspot bruising. Currently, GMO potatoes are being marketed under the Simplot Innate brand, found under the trademark White Russet.
“Browning is nature’s most visible way of letting you know a product is rotting. GMOs that use RNAi to mask the signs of bruising could lead consumers to unknowingly ingest an unhealthy, toxic product,” says Megan Westgate, executive director of the Non-GMO Project.
The Non-GMO Project also announced today that a new variety of soy, produced with a type of gene editing called TALEN, has been added to its High-Risk list. Developments in biotechnology are happening so fast that the Non-GMO Project now has two full-time research staff dedicated to monitoring.
“The supply chain risks we’re now seeing from new GMOs are unprecedented in the decade we’ve been verifying products,” according to Westgate. “Not only are new GE techniques being used, but in some cases biotechnology companies are using unscientific arguments to deceive the public into thinking their products are non-GMO.”
The Non-GMO Project holds a firm position that anything produced with genetic engineering, like RNAi, TALEN or CRISPR, is a GMO. Although unpopular with biotechnology companies, this position aligns with a July 2018 ruling from the Court of Justice of the European Union, which determined that these new GMOs are subject to regulation under the EU’s GMO Directive.
“Our research team continually monitors approximately 250 companies involved in genetic engineering—not only how the techniques are evolving, but also what specific products are being created and how they are impacting the supply chain,” said Westgate.
The Non-GMO Project is committed to ensuring that everyone has the information needed to make an informed choice in order to avoid all types of GMOs. As the gold standard for shoppers looking to avoid GMOs, the Non-GMO Project will continue to lead the way in addressing the risks posed by new GMOs.
###
For more information view the Frequently Asked Questions.
ABOUT THE NON-GMO PROJECT
The Non-GMO Project is a nonprofit organization committed to preserving and building sources of non-GMO products, educating consumers, and providing verified non-GMO choices.
The Non-GMO Project seal has been compliant with FSIS standards since June 2013.
The USDA’s Food Safety and Inspection Service (FSIS) has announced new compliance guidance on “how companies can make label or labeling claims concerning the fact that bioengineered or genetically modified (GM) ingredients or animal feed were not used in the production of meat, poultry, or egg products.”
For brands seeking the Butterfly seal or those who already have Verified products, this new guidance does not impact Non-GMO Project Verification. The Non-GMO Project seal was first approved by FSIS in 2013, and that approval remains in effect.
The Non-GMO Project Standard's requirements remain the most rigorous in the world, and we will continue working to preserve and build a non-GMO food supply, educate consumers and provide Verified Non-GMO choices.
To date, consumer demand has driven more than 1,000 meat, egg and poultry products to meet the highest standard in the industry and achieve Non-GMO Project Verification. Shoppers’ trust in the Butterfly seal has pushed annual sales of Non-GMO Project Verified products to over $19 billion.
The new compliance guide takes effect immediately, but the USDA will hear comments via the Federal Register for sixty days. We will follow up soon with suggestions for comments.