FDA Takes Action Against Chemicals and Mycotoxins in Foods

While the increasing frequency and intensity of natural disasters are readily observable impacts of climate change, there also are less visible signs of emerging risks caused by the geographic changes in weather events. Among those emerging risks is the natural occurrence of chemicals and mycotoxins in food ingredients. To both protect consumers and avoid the FDA’s increased scrutiny, businesses need to increase their vigilance toward these.

Numerous studies are being conducted on the impacts of emerging risks to foods, including those on chemicals and mycotoxins:

• In August, the European Food Safety Authority (EFSA) published a report aptly titled “Emerging chemical risks in food and feed” in which the researchers identified and scored emerging issues based on climate change scenarios that are projected to occur by 2050. From this, 19 emerging chemical issues were characterized, with nine rated as most critical — with all nine related to toxins produced by microorganisms (bacteria, fungi, algae) whose growth is strongly affected by climate change.
• Another 2024 report, “Changing Climate, shifting mycotoxins,” discusses how warming temperatures are enabling the migration, introduction and increase of fungal species, including those that produce mycotoxins. The ability of some of these (such as Aspergillus flavus and Fusarium graminearum) to acclimatize and become more aggressive, combined with the weakening of certain crops due to weather changes, could make these crops more vulnerable to fungal outbreaks. Add to this the fact that mycotoxins are able to survive most food and feed processing steps, and there is significant risk to the final product. While the report accedes that many factors contribute to the rise of mycotoxins, climate is seen as the most important.

With food risk from both chemicals and mycotoxins increasing, FDA has become more active in its related assessment, monitoring and enforcement activity:

• In September, FDA held a public meeting to discuss its development of an enhanced systematic process for the post-market assessment of chemicals in food. Stating that it currently has only an “ad hoc” process for post-market assessment, the agency is working to develop a science-based, reproducible and reliable process. Chemicals would be prioritized for review based on multiple criteria but primarily focused on risk to public health. Then, depending on the complexity of information gathered and triaged, the assessment process for a particular chemical may be focused or comprehensive. While this process development did not include FDA compliance-related activities and actions that would be taken in response to a result indicating an urgent public health matter, it can be expected that FDA would be expeditious in regulation to limit or remove the chemical from the food supply.
• Also in September, FDA increased its monitoring of mycotoxins of regulatory interest in human foods to add T-2/HT-2 toxins and zearalenone; and the agency updated its testing to the use of a multi-mycotoxin method, which provides results for multiple mycotoxins in a single sample analysis. In case there’s any doubt as to the purpose of this updated program, FDA made it clear that the data will support enforcement actions, risk assessments and international activities, as well as provide information on mycotoxin incidence, extent of contamination and co-occurrence. This update should be of concern to anyone using grains in their foods, as both are produced by Fusarium molds, with T-2/HT-2 found in contaminated grains such as wheat, rye, oat and barley and zearalenone in contaminated grains such as corn, oats, wheat, sorghum and rice.

For both chemical and mycotoxin contamination protection, food businesses should take a fresh look at their hazard analysis and supply chain controls to determine if they are addressing all current hazards and to strengthen both to guard against emerging issues. Climate change is part of the global landscape, which, by all scientific accounts, will only worsen. Being proactive now can go a long way toward protecting your consumers and your brand today and in the future.