Note: This is the second installment in a three-part series. Part I can be found here; Part III will appear on April 25th.

The National Bioengineered Food Disclosure Standard is now the law of the land. From a consumer’s perspective, there are now federal regulations requiring food products containing bioengineered/GMO ingredients to disclose this on their packaging. From an industry perspective, the potential implications, impact, and costs could be significant. Mandatory disclosure could play out in a number of ways.  There are, however, numerous paths to exemption.

On one side of the GMO debate are proponents of transparency and consumer rights. On the other side are those primarily concerned with technical details, feasibility, and industry impact. s for the regulations, there is clearly a lot of bark. But is it backed with any bite?

In Part I, we address the nuts and bolts of the Standard. Here in Part II, we will explore some of the larger implications, potential impact, and paths to exemption.

New Definition: The statutory definition is new.

A food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.

This conceptualization allows for the inclusion of new events and markers (for example replacing 35S as a critical piece of many GMO constructs in the never-ending shell game of detectability  and also leaves the door open for the future inclusion of gene editing, CRISPR, etc (currently excluded in U.S. regulations but recently defined and regulated as bioengineered by the European Union). Perhaps towards this end, “conventional breeding,” and “found in nature” are not defined but instead left intentionally ambiguous.

Scope and Focus: The law does not focus on non-GMO claims. That more or less follows the same path it does now… at least for now. Rather, the NBFDS is all about disclosing to consumers that a product contains/may contain detectable bioengineered ingredients.

Also, there is no presumed health risk of consuming BE foods as long as they have been approved for human consumption by the FDA. Whether you agree or disagree, the agencies are harmonized. If it’s approved, it’s approved, and that’s that.  I hasten to add here that the recent verdict ordering Monsanto to pay $289 million in a lawsuit connecting glyphosate to non-Hodgkins lymphoma reminds us that scrutiny is paid not just to crops that are bioengineered for pesticide resistance but include the pesticides themselves.

All in all, the NBFDS is not so much about transparency as it is about technical feasibility and cold, hard reality. To paraphrase AMS, the law is concerned more with the products of bioengineering technology rather than with biotechnology itself. Interestingly, this puts the USDA at odds with the Non-GMO Project which prioritizes transparency and verification down through the entire supply chain.  

Thresholds: The regulations establish a strict presumption as well as two different thresholds. Again, there’s a lot of bark, but how much bite?  

  • Presumption: If a product or ingredient contains any of the commodities on the Bioengineered Foods List in any form, that product or ingredient is presumed to be bioengineered and must bear disclosure unless it can be exempted.  
  • Threshold #1: Allows for inadvertent, unintentional, or otherwise technically unavoidable BE/GMO content up to 5% per ingredient. This is a huge number relative to the E.U. limit of 0.9% (the global standard). Once more, this is quite different from the Non-GMO Project’s emphasis on the entire supply chain being managed to minimize the risk of foreign material and/or cross-contamination.  
  • Threshold #2: At the same time, the law is extremely strict regarding the intentional inclusion of BE/GMO in food products. It establishes a zero-tolerance threshold for a product or ingredient that knowingly contains a bioengineered input. If there is any intentional inclusion of bioengineered inputs, the product must bear disclosure unless it can be exempted. This is significant because it far exceeds the EU/global standard threshold of 0.9% or below.  Indeed, any country importing into the United States has to comply with our new standards.

Exemptions: The law is not without its critics, particularly when it comes to exemptions.  As much as it seeks to mandate disclosure, the NBFDS also allows for numerous paths to exemption. This is why I wonder whether the regulations are more bark than bite.

Exclusions include:

  • Pet Food
  • Animal Feed: If an animal consumes BE feed, it is not considered BE nor are its products (this is a huge variance from Non-GMO Project requirements)
  • Generally, those products governed under the Meat, Poultry, or Egg Acts (unless they are not the most prominent ingredient)
  • Restaurants, food trucks, cafeterias, etc.
  • Certified Organic: Products containing 70%+ organic ingredients is the only certification that provides automatic exemption. Other “verified” seals do not automatically qualify for exemption
  • Process formally verified and approved by USDA AMS to remove all DNA from BE sources
  • Very Small Business with annual receipts <$2.5MM.

Most Notable Exemptions: It all boils down to the DNA. If a product has no detectable BE DNA, that product is exempt no matter what the original source. This is particularly important for refined/processed products such as corn syrup and canola oil. The regulations are only concerned with the presence of BE DNA in the product itself not in the source of the product.  

Accordingly, the path of least resistance for exemption is Real-Time PCR testing. Because if the product contains no detectable BE DNA, that product is exempt. Test to verify. Test to document.

Bark or Bite?: Proponents of transparency and consumer choice tend to feel the NBFDS doesn’t go far enough and is toothless without more serious repercussions. Here is what AMS has established. I leave it to you to decide.

  • Compliance is mandatory. Records must be kept for up to two years.
  • Because approved BE traits/events have been deemed safe for human consumption by the FDA, there are no recall mechanisms in the legislation.
  • AMS does not intend to test final food products to determine compliance with the rule
  • In the event of a complaint or other reasonable cause, USDA may initiate an on-site audit with three days notice. Results will be posted to a public website open to all including consumer advocacy groups and potential litigants.
  • Individual states have the right to establish financial penalties provided these policies meet certain criteria.

As is often the case, good laws require good intentions. Looking at the NBFDS, I feel there is a genuine belief in the principle of disclosure and respect for consumer choice. At the same time, I feel the law is at odds with itself.  Most notably, the emphasis on the finished product rather than what went into making it suggests a certain circumnavigation of the entire transparency issue itself.

A good negotiation leaves both sides feeling a little dissatisfied. It’s a give and take, and what is taken requires something of similar value to be given in return. I feel this way about the NBFDS. It seems to me the biggest change comes up front. Companies large and small need to assess the potential impact, establish new regulatory and quality platforms for compliance, and create implementation programs.  

Understanding how the National Bioengineered Food Disclosure Standard might impact your business is not an option, it’s a necessity. So is testing as a core facet of your overall risk-mitigation platform. Contact us for a free impact assessment and summary of the Mérieux NutriSciences’ GMO Surveillance, Verification, and Risk-Mitigation Program.

Meet the Author

Todd E. Napolitano, MA, PhD
Business Development Manager, Technical Sales, Mérieux NutriSciences

Todd E. Napolitano is the Director of Business Development and Program Manager for Mérieux NutriSciences’ GMO Services division.  Todd has a broad background in analytical services in food, materials, and environmental sciences. He hails from Scarsdale, NY, and currently resides in Haddonfield, NJ with his two children.

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