The Incessant Pursuit of Zero
Over the last year, thousands of products have been recalled in Europe due to the presence of ethylene oxide (EtO) or its breakdown products, particularly products containing the additive locust bean gum. The additive is commonly used as a thickener in ice cream, which has led to the global recall of tens of thousands of pounds of one ice cream brand, and a French recall of more than 100 brands. And now, the EU has added another key focus to its pursuit of EtO: pet foods.
As we discussed in a July newsletter, the EU amended its import entry regulations related to the presence of EtO in foods, increasing the frequency of identity and physical checks on locust bean gum or guar gum from India, Malaysia and Turkey. But the new regulation carried difficulties in enforcement because the EU has a regulation against the use of EtO for sterilizing purposes in food additives, but there is no quantified limit for its presence in food additives in general. Thus, enforcement challenges were raised because of the difficulty of determining if the EtO resulted from sterilization use or some other cause.
So on August 11, the EU Commission issued a regulation “to avoid those difficulties and to ensure a high level of protection of human health,” declaring that “the presence of ethylene oxide, irrespective of its origin, is not authorised for all food additives.” The new regulation sets the maximum limit for EtO residues in food additives “at the validated lowest residue concentration, which can be currently quantified and reported by routine monitoring with validated control methods” (currently not more than 0.2 mg/kg), effective September 1.
To make the matter even more challenging many regulatory authorities look for the breakdown products of EtO such as 2 Chloroethanol (2Ce), and then assume if they detect 2Ce it was because EtO was there originally. There are certainly some data to suggest that 2Ce may be present naturally in certain products, thus making the drive to zero even more difficult for the food industry.
While the U.S. does allow the use of EtO, which is the principal method of bacterial reduction in herbs and spices, there is some movement to require clear labeling of foods that are sterilized with the chemical. Additionally, the U.S. is dealing with a zero tolerance environment of its own, such as the low to no tolerances being advocated or set for PFAS and heavy metals.
Just as with EtO, one of the greatest challenges is that while the elements can be toxic at high levels or prolonged exposure, all are present in the environment and can result from multiple sources, making zero tolerance fundamentally unattainable. It is for this reason that the industry needs to take steps to limit these chemicals and heavy metals as much as possible in foods. But, as we’ve stated in past articles, while the elements should be identified as potential hazards, the associated risk (and regulatory levels) should consider dose and relative exposure, not just presence.
Unfortunately, basing regulation on presence or consumer-perceived risk, rather than actual risk, is not new. The ability to detect at levels lower than the ability to prevent has been an ongoing issue in the food industry, and the closer that detection gets to zero, the greater the challenge for food producers. The recall and disposal of such food – deemed adulterated without actual risk – also has sustainability implications in relation to potentially massive food waste and unnecessary disposal to landfills.
Given all this, a key strategy for the food industry to consider is that of conducting an in-depth risk analysis of the real impact on public health – the level at which any real risk exists. Once determined, the food industry would have to act on anything which equals or exceed that level. But if there is negligible risk, then there would need to be better communication with and education of the public – and regulatory bodies. This is particularly apparent when considering the recent comment of USDA Deputy Under Secretary for Food Safety Sandra Eskin who said (in relation to setting Salmonella levels in breaded stuffed raw chicken products), “If we require it, the testing industry will create it.” That may be, but it circles the issue right back around to the ability to detect being lower than the ability to prevent.
Unfortunately, when it comes to EtO, regulatory agencies have decided to apply a simple solution to a very complex problem, and as usual that creates a lot of challenges for the food industry. This is certainly a topic that the food industry needs to create even more robust risk assessment than are currently available in order to at least try to get regulatory agencies to adopt a more balanced and attainable strategy.