How GMO-Free is "GMO-Free"? Decoding Global Regulations, Labeling Conventions, and Testing Requirements for Genetically Modified Crops

As technologies to produce GM plants have developed, regulations that govern their cultivation, import and export have multiplied and adapted. R&D specialist Donna Houchins of Romer Labs breaks down some trends in important areas, such as labeling, and discusses how producers and traders can stay compliant amid this shifting regulatory landscape.
By Donna Houchins, Research & Development Specialist, Romer Labs®

Genetically modified crops have achieved broad popularity around the world. Corn, soybeans, cotton and canola are the most commonly commercialized GMO crops. Currently, 229 different corn traits or trait stacks, 62 cotton traits or trait stacks, and 41 different soy and canola traits or trait stacks have an approval for food, feed, or cultivation in at least one country worldwide. These approvals vary with each approving country. Many crops are planted with the intention of being exported; they may reach countries in which the approvals or labeling laws differ from that of their country of origin.
With the greatest amount of acreage devoted to GMO crop production, countries such as the USA, Brazil, Argentina, India and Canada have implemented extensive approvals for food, feed, and cultivation of many events and stacks. In contrast, much exported material may reach countries with differing approvals or labeling requirements. For example, most European Union member countries have banned the cultivation of GM crops. Only a few countries such as Spain and Portugal permit the planting of genetically modified crops. However, the European Union is the world’s leading importer of GM-crops. It receives more than 30 million tons of biotech corn and soy imports intended for livestock feed each year1. For this robust trade in GMO crops to conform to legal requirements, producers who plant and export GMOs must have a thorough knowledge of the regulations of different countries. Each country independently decides whether cultivation, import and the use in food or feed is allowed, and sets restrictions on permitted events and stacks. In addition, each country sets its own labeling laws governing when these crops are sold. Some countries allow the cultivation and import of GM crops (e.g. US), some only ban the cultivation but allow import (e.g. Austria) and some ban both cultivation and import (e.g. Russia).

Authorized vs non-authorized crops 

When a crop arrives at its destination country, it is often tested before it can be transported to its final destination. These tests may reveal GM crops that are not authorized in the receiving country but may be authorized in the country of origin. Another common scenario is that GM crops arrive in a country unknown or unapproved. 
Laws forbidding the import of a GM crop are the primary barrier to entry. In general, only approved events are allowed for import. Unauthorized events will not be allowed to enter the receiving country and will be shipped back to the country of origin, resulting in high costs for the exporter. Unauthorized events can also cause high costs due to recall within their country of origin if they reach unintended markets (for example, a crop found in food that only has approvals for feed). A regulation in force in the EU serves as an example: at the “EU Register of Authorized GMOs2,” a list of all approved, withdrawn and pending crops can be found. Exporters must consider this list when shipping to the European Union. If a crop is being shipped to Europe and it is found to contain an unapproved event, it must be shipped back to its country of origin. Other countries have similar lists and rules for import.

A brief case study: how GMO labeling requirements differ in the EU and the USA

Different labeling laws in each country represent the second barrier to GMO imports. These vary widely from country to country. The European Union has one of the strictest laws regarding GM crops. In the EU, every shipment of food and feed containing GMOs must be labeled, irrespective of the ease of detection: GMO traits are known to be difficult to detect in highly refined oils.  The threshold for unintentional or technically unavoidable contamination with GMO can be up to 0.9% per ingredient. This is an extremely important qualification; it means that a food shipment could feasibly contain 0.6% of GM corn and 0.7% of GM soy and would nevertheless not fall under the regulation of labeling, as 0.9% are allowed per ingredient. However, if two different traits of GM corn are used and one contains 0.5% and the other 0.6%, labeling would be necessary as the sum of GM corn would amount to 1.1%. 
In contrast, the USA has recently released a new labeling law, which is scheduled to take effect in January 2020 for large manufacturers and January 2021 for small ones. Prior to this, the United States had not had a nationwide labeling law. This new law states that every ingredient may contain up to 5% GMO if it was technically unavoidable and unintentional (For more about the new labeling law, see inset below). However, any intentional use of GMO ingredients must be labeled regardless of the level. Therefore, producers in the US who intend to ship to the EU will need to make sure that none of their shipments include more than 0.9% per ingredient in order not to require labeling of the products in the EU, although their own regulation would permit up to 5% of unavoidably or unintentionally added GMOs. In Brazil, the threshold is set at 1%. Japan also uses a 5% threshold. Argentina and Canada do not have any labeling laws regarding GMOs. It is incumbent upon exporters to take care that their shipments meet the labeling requirements of their destination countries and not just their home countries, as the receiving country may have more stringent labeling requirements. Recalls or shipment rejections in these situations can lead to burdensome, extra costs.

Product-based vs. process-based GMOs

Products produced by new gene editing tools such as CRISPR-Cas9 may be regulated differently in different countries. CRISPR stands for “clustered regularly interspaced short palindromic repeats”. Cas9 refers to an enzyme that uses the CRISPR sequences as a guide to recognize and cleave specific strands of DNA. This new technique has given researchers the ability to edit the genome of any organism with a high degree of precision. When used in plant breeding, the difference between the standard GMO development tools and CRISPR-Cas9 is that in the standard technologies, biolistics (the “gene gun”) or foreign bacteria (typically an Agrobacterium) are used to incorporate the gene, whereas in CRISPR-Cas9, precise genome edits are made without the use of foreign organisms. 
The results of CRISPR-Cas9 can be indistinguishable from the results of traditional plant breeding techniques, mutagenesis, or naturally occurring random mutations. This has, in turn, occasioned a debate about whether crops that are altered using CRISPR-Cas9 are considered GMOs. The definition of a “GMO” that triggers the implementation of labeling law requirements differs from country to country, and therefore, some jurisdictions consider CRISPR-Cas9 traits to be GMOs, while others do not.  For example, the legal definition of “bioengineered” in the United States is “product-based”, and defines bioengineered food as anything that contains detectable genetic material modified through laboratory techniques and whose modification can neither be found in nature nor have happened through conventional breeding. This definition is included in the new labeling law that will go into effect in 2020.
The European Union’s definition is “process based”, and defines a genetically modified organism as “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”.  Under these definitions, the United States does not consider traits emerging from CRISPR-Cas9 to be GMO, whereas the European Union does. 

Traceability

In the European Union, every batch of GMO food or feed requires tracking along every step of the supply chain. Should there be reasonable suspicion that the food or feed has been contaminated with a GM crop, traceability measures would ensure that authorities are able to track down the crop and, if necessary, withdraw it from the market. The operators must inform customers by writing if a product is genetically modified or if it contains GM-ingredients. It must include information on the unique identifier or identifiers for these GMOs and the operators must ensure that this information is passed on to those who would be next in the supply chain. Every operator must keep a record of all supply chain transactions for a period of five years. This information must identify who was previous and next in each supply chain. The EU is the only jurisdiction with these tracking requirements.

Ensuring legal conformity through GMO testing

Due to the extreme degree of variance in labeling laws and approvals around the world, testing for GMOs is key in facilitating the movement of grain from country to country.  It may also be used to meet specific quality control criteria set in place by grain producers and exporters, or to meet contract requirements from purchasers. Typical tests performed by exporters and grain handlers include lateral flow devices and ELISA test kits.  Both of these methods test for specific novel proteins that are produced by the GMO plant of interest, and may be quantitative or qualitative. These are rapid tests that are typically performed at grain handling facilities. PCR testing for the specific DNA modification of interest may also be undertaken. This is a laboratory test that may detect the promoter and terminator in the DNA inserted into the GMO plant, or may be specific to a particular event.

GMO definitions and labeling: a complex landscape 

Not only do legal requirements differ from country to country, but also the definition of what a GMO is varies drastically. The different laws show the need to test for GMOs, as they could otherwise lead to unexpectedly high costs if, for example, an exporter attempts to transfer a crop to a country in which it is not approved; usually, in such a case, the exporter would have to bear the costs of the return.. New labeling laws are being implemented in the USA and other countries are currently discussing how new plant editing techniques will be regulated. To help those in the global grain trade to adapt to the complexities in GMO regulation, a broad palette of testing options can provide clarity and reduce risk. The following article goes into greater detail about common GMO testing solutions.