Allergens and GMO: What is Happening in Control Programs?—Part 2

Need to Know
- Only 28 percent of surveyed food safety and quality professionals reported having a GMO control program, and 15.9 percent conducted analytical GMO testing
- GMO control programs primarily rely on supplier approval, documentation, traceability, segregation, and risk assessment rather than routine plant-level testing
- GMO testing volumes are expected to remain flat or experience modest growth through 2030, with demand concentrated in claim-sensitive and export-oriented supply chains
- Improved traceability could shift GMO testing toward targeted, lot-specific verification, supporting claim substantiation, supplier management, and corrective actions
Welcome to Part 2 of our series on the allergen and GMO control and testing programs used by food processors. In Part 1, we saw how allergen control programs are nearly universal in food plants, and analytical testing to support those programs is common but more limited in volume than might be expected. Here, we will focus on GMO (Genetically Modified Organism, or bioengineered) programs, which follow a different model. We will also examine specific in-plant control programs and testing for GMO as less common elements of a food safety plan.
For many food companies, GMO testing is not a daily food safety activity. It is a targeted verification tool used when an ingredient specification, customer requirements, export market, organic program, non-GMO claim, or bioengineered food disclosure question creates a need for greater certainty.
These distinctions matter. GMO testing is often discussed alongside microbiological, allergen, chemical, and authenticity testing because the same laboratories may perform the work. However, the business and food safety cases are very different. In most instances, GMO testing does not determine whether food is safe to consume, but instead determines whether a product, ingredient, or supply chain meets a defined identity, labeling, buyer, regulatory, or market-access requirement.
GMO Control Programs Rely on Supplier Verification
In our survey this past June, we posed questions to a very relevant group of food safety and quality professionals, of which 29.4 percent worked in food safety, 27.5 percent worked in QA/QC, and approximately one-third worked in laboratory, regulatory/legal, corporate management, or related functions. Roughly two-thirds were located in the U.S., and the sample represented processors of prepared foods, ingredients, flavors, baked goods, dairy products, meat and poultry, grains, and a range of other food categories.
Of this group, only 28 percent reported having a GMO control program, and just 15.9 percent indicated that they conduct analytical testing for GMO. This indicates that GMO control is not based on plant-level testing programs as would be the case for allergens or microbiology, but more accurately characterized as a specialized assurance function, activated where commodity risk and commercial stakes justify the effort.
Our survey responses also make clear that most GMO control activities occur before an ingredient even arrives at the plant. Respondents most often identified supplier approval, raw material approval, risk assessment, traceability, commercial specifications, labeling, documentation, segregation, and audits as the most effective elements of their programs. One respondent said their GMO status was "Identified at time of purchase, labeled, and segregated in the racks." Another cited "approved suppliers" as the basis for their raw material control, and another said their control program was basic since "…no GMO products are handled at our facility."
The most common areas of concern in the survey were related to corn, soy, sugar and sugar beet-derived ingredients, dextrose, and herbicide-tolerant crops. Several respondents identified concerns involving "Roundup ready" soybeans, pest-resistant crops, biodiversity contamination, shared storage, and commodity commingling. This is not surprising, as industry data shows that by physical production volume measured by acreage planted, maize/corn is the largest GMO-relevant commodity, followed by soybeans, sugar beet, canola/rapeseed, cottonseed, alfalfa, and small volumes of potato, papaya, squash, and specific varieties of apples.
Looking for quick answers on food safety topics?
Try Ask FSM, our new smart AI search tool.
Ask FSM →
These responses reflect the real operational environment. Corn and soy move through complex commodity chains involving farms, elevators, railcars, terminals, processors, distributors, and ingredient manufacturers. A non-GMO or identity-preserved claim can be easily undermined by cross-pollination, commingling during storage or transportation, changes in raw material sourcing, incomplete supplier documentation, or a supplier's own failure to maintain adequate segregation.
GMO Sampling and Testing Methods
Because of this supply chain complexity, the GMO testing that does occur in food production generally begins at the ingredient level—not on environmental surfaces, production equipment, or end products, as might be the case for the other analytes mentioned (e.g., allergens and microbiological contaminants). Companies collect samples to verify the status of a defined lot, supplier shipment, or identity-preserved stream. Typical collection points include sites of bulk commodity deliveries, including trucks, railcars, containers, barges, and totes, grain elevators, silos, warehouses, and other storage points where the risk of commingling exists. Other sites include ingredient receiving areas for flour, meals, soy protein, corn derivatives, starches, sugars, dextrose, or other crop-derived materials in supplier facilities. These tests are conducted before shipment, when the supplier is responsible for demonstrating conformance to a specification.
The reason for the test should determine the sampling plan. A test used to qualify a supplier may focus on initial lots and periodic verification. A test used to support a non-GMO claim may require a defined frequency linked to commodity risk, supplier history, volume, and the consequences of a failure. A test used to investigate commingling may require targeted, statistically defensible composite samples from the suspected lot or storage location.
The most common analytical methodologies used are PCR or qPCR. PCR-based methods can screen for common genetic elements, identify specific events, and in some cases quantify the relative amount of genetically modified material. Rapid screening kits, including lateral flow tests and ELISA immunoassays, are also used but in limited volumes at the plant level, and these kits are not considered as a replacement for a well-designed molecular testing regimen. Our survey reflected this use, with only a few respondents reporting the use of screening kits or GMO-specific lateral flow and ELISA tests. The most commonly used method was outsourcing to commercial labs who use qPCR.
Outlook for the GMO Testing Market, 2027–2030
Over the next three years, the GMO testing market is likely to show flat to low-single-digit growth. The market has some potential to expand as demand for substantiation for non-GMO, organic, identity-preserved, private-label, and export-oriented supply chains continue to grow. At the same time, however, there are few drivers for universal finished product testing or other plant-level analytical testing, and such applications are unlikely to become standard practice.
For established North American food and ingredient testing, the most defensible base case is flat to low-single-digit annual growth in sample volume from 2027–2030. Revenue may rise somewhat faster, perhaps as high as the mid-single digits, as laboratories capture more complex work and adjacent services involving event-specific analysis, difficult matrices, fast turnaround, export documentation, and claim substantiation. Growth above that level is more likely to occur in seed, GMO trait, feed, and global trade-compliance applications than in routine finished food testing (Figure 1). There may be more pressure for continued higher levels of testing in Europe as EU rules mandate traceability through the production and distribution chain for GMO-derived products, including the ability to identify the supplier and buyer.
It is also important to recognize that the market for the supply of diagnostic tests is mature, saturated, and dominated by a small number of competitors. Because of this competitive structure, these few competitors will be constrained in their price increases, further limiting the value growth of the market.
These market issues will have little impact on food processing companies, as the industry's largest challenge is not analytical detection technology but rather supply chain control. In our survey, respondents cited vendor reliance, traders, supplier documentation, shared storage, incoming materials, raw material changes, cross-contamination, and lack of onsite verification as the most difficult issues. The market will favor preventive supply chain controls over any broad use of analytical surveillance.
How Food Traceability Requirements Could Reshape GMO Testing
One pending development that may impact the market for GMO testing is the growing requirements for food traceability.
The U.S. Food and Drug Administration's (FDA's) Final Food Traceability Rule under FSMA Section 204(d) requires certain businesses handling foods on the Food Traceability List to maintain Key Data Elements linked to Critical Tracking Events. While the rule is aimed principally at rapid outbreak response and does not target GMO identity, its concepts—lot codes, receiving records, transformation records, shipping records, and traceability plan governance—are directly transferable to GMO-sensitive supply chains.
Traceability requirements in the EU represent the more stringent end of the continuum. For example, the EU framework also requires labeling for foods produced from GMOs even when GMO-derived DNA or protein is no longer detectable [generally, the labeling threshold is 0.9 percent for an authorized GMO presence, as per Regulation (EC) No 1829/2003].
For firms in North American or other world regions that supply Europe or other traceability-sensitive markets, more robust traceability can potentially increase demand for GMO testing because it provides the infrastructure needed to apply analytical results to specific shipments, lots, and commercial decisions.
More likely, however, is the expectation that these greater traceability requirements are more likely to reshape GMO testing more than they expand it. The principal effect will be to move testing from a general verification activity toward a lot-specific, risk-based supply chain control. When an ingredient's supplier, origin, shipment, receiving record, storage location, and finished product use are digitally linked, a GMO result becomes more actionable: it can support release of a defined lot, trigger targeted supplier corrective action, or identify the precise finished products affected by a discrepancy.
Improved traceability should move testing upstream, nearer to the point where material identity is clearest and corrective actions are least expensive. It will also change the value of testing at different sampling points by defining the highest-value sampling points:
- Point of supplier or processor
- Before shipment of a claim-sensitive commodity
- Before the point of receipt, linked to a defined truck, railcar, container, tote, or bulk lot
- At storage transfer points, especially elevators, silos, terminals, and warehouses where commingling is possible
- Before blending, milling, extraction, or other transformations that dilute the result or reduce DNA detectability
- After a documented supplier, origin, formulation, or processing change.
Better traceability will also expose lower-value testing points including:
- Finished product testing with no clear link back to the input lot
- Testing of highly refined oils, sugars, syrups, or other DNA-poor matrices as the only proof of source identity
- Testing after materials from multiple lots have been blended, unless the program's purpose is to assess the blend itself.
An effective traceability system does not eliminate the need for laboratory testing. It allows a business to use its spending more efficiently, focusing on those points where the result can meaningfully support product release, supplier management, claim substantiation, and corrective action.
For commercial laboratories, the most attractive work will be less about commodity screening alone and more about interpretation, difficult matrices, event-specific analysis, quantification, claim substantiation, method validation, rapid turnaround, and defensible reporting. The central question is not simply whether modified genetic material is present, but whether a company can credibly demonstrate that its product meets the applicable claims, contractual obligations, regulatory requirements, or market expectations. This may drive more labs to offer more adjacent services such as software packages and consulting services, rather than more sophisticated analytical techniques.
The Future of GMO Control and Testing
In the coming years, GMO control programs at food processing facilities are expected to remain largely unchanged, with only modest adjustments. GMO test applications and test volumes are likely to remain flat. The use and value of testing may shift as improved traceability and greater scrutiny of supplier records make lot-specific verification, confirmatory analysis, and export- or claim-related testing more consequential. The market opportunity, therefore, is not simply more tests; it is better-targeted tests linked to defined lots and credible supplier documentation, which provide for timely decisions about claim substantiation and corrective actions. Better traceability tools and software packages may lead market growth more than any analytical technologies.









