In an earlier post, we explored food allergy labeling laws and why many food products include “may contain” statements. To better understand the extent to which these foods may in fact contain allergens, we’re going closer to the source: food manufacturers.
On nearly all matters concerning food safety, including allergen control, FDA-regulated food manufacturers follow the Food Safety Modernization Act (FSMA).
Signed into law in 2011, FSMA introduced significant reforms to the nation’s food safety laws. For the first time, food manufacturers were required to develop and maintain a written “food safety plan.” FSMA also gave the FDA discretionary authority to approve or reject these food safety plans, giving auditors considerable interpretive power over which food safety plans would pass muster.
In 2015, the FDA published a final rule on Preventive Controls for Human Foods. This regulation is one of the key parts of FSMA and mandates that companies perform a Hazard Analysis and develop Risk-Based Preventive Controls (often referred to as “HARPC”). The regulation requires manufacturers to identify and implement controls for any “reasonably foreseeable” food safety hazard–which includes the top eight most common allergens (tree nuts, peanuts, shellfish, finfish, soy, milk, egg, and wheat). Accordingly, if any of these allergens could end up in the final food product, manufacturers must implement preventive controls, defined as “written procedures the facility must have and implement to control allergen cross-contact.” Notably, allergen testing is currently discretionary, not required.
So how tough are these food safety plans on food allergens?
According to food safety expert Dr. Scott Brooks, pretty tough. “While FSMA is not prescriptive, food safety plans must stand up to scrutiny from FDA inspectors. The FDA has published industry guidance to help ensure FSMA compliance, and those in the industry know that it’s important to follow the FDA’s guidance documents.” While not finalized, the FDA draft guidance document on HARPC advises implementing controls to prevent cross-contact, and other measures including product sequencing and sanitation controls.
Most larger companies invest considerable resources into food allergen management, according to food safety expert Dr. Bert Popping. Indeed, “large manufacturers often test foods for trace allergens and have allergen management controls in place.” Dr. Popping notes however that “a number of typically small and medium-sized companies have no allergen management in place, and accordingly will often issue precautionary statements like ‘may contain’ for legal reasons, without performing any risk assessment.”
Further guidance on HARPC will be important for advancing safety measures around allergen control at food manufacturers. Until then, we may have to settle for “may.”
- Abi and the Allergy Amulet Team
This piece was written by the Allergy Amulet team and reviewed by Dr. Bert Popping and Dr. Scott Brooks for accuracy.
Dr. Bert Popping is the managing director of FOCOS, a food consulting group based in Germany. Dr. Popping has over 20 years of experience in the food industry, and has authored over 50 publications on topics including food authenticity, food analysis, validation, and regulatory assessments.
Dr. Scott Brooks is a food safety consultant and founder of River Run Consulting. He is the former Senior VP of Quality & Food Safety, Scientific and Regulatory Affairs at Kraft Foods, and prior to that was the VP of Global Food Safety, Scientific & Regulatory Affairs, and Quality Policy at PepsiCo.