The Food Safety Modernization Act (FSMA) is making significant changes in the industry, with allergen controls and revised good manufacturing practices (GMPs) being among these sweeping changes. These elements were once best practices or suggestions, but now, GMPs in place for allergen control is required under FSMA.
When we talk about allergens within the FSMA framework, we’re talking about the Preventive Controls Rule, and more specifically, HARPC (Hazard Analysis and Risk-Based Preventive Controls).
HARPC, however, is not amending or changing the idea of allergens. There are still the “Big 8” allergens requiring certain labeling via the Food Allergen Labeling and Consumer Protection Act of 2004, which focused on the declaration of controlled allergens, and are still in place.
FSMA and Undeclared Allergens
What FSMA is changing is how to manage allergens in the production of finished products, and how companies manage undeclared allergens. For example, you could mix up packaging for two products you produce, one with peanuts and one without, thus creating an issue with undeclared allergens.
Another example occurs when you have cross-contact (FDA uses cross-contact in the rules but has the same meaning as cross-contamination). Like in the example above, if you have the two products running at different times, you need to make sure that cross-contact doesn’t occur.
Since undeclared allergens have become the leading cause for recalls, undeclared allergen control has changed in a significant way with FSMA in the HARPC portion of the Preventive Controls Rule.
One of the ways FSMA is doing this is through the idea that food allergens are a hazard. In the HARPC portion of the Preventive Controls Rule, you have to identify hazards that are reasonably likely to occur and develop controls to mitigate the possibility of these hazards from materializing. This is one of the ways HARPC has shifted allergen control.
Additionally, cross-contact is now a consideration when drafting your food safety plan within the HARPC rule. You have to make sure you’re talking about why or why not allergen cross-contact is not included or would be included in certain areas of your food safety plan. But this not just an issue for your operation, it’s also a question for your suppliers as well.
If you’re bringing in an ingredient that could potentially have an allergen associated with it or has the potential to be cross-contaminated, you want to make sure this is addressed in your supplier’s food safety plans as well. You need to know your suppliers are controlling the hazard in their facilities so that when it comes time to use their ingredient, you’re just as confident that there aren’t cross-contact issues.
An interesting way TraceGains helps with this particular issue is with our Allergen Analysis Dashboard, which comes with the Supplier Management module. The out-of-the-box dashboard allows you to filter for allergens by supplier, item, or across all items and/or across all suppliers.
Allergens and GMPs
Perhaps one of the biggest ways HARPC has changed allergen control is through the GMP revisions. Elements that were once recommendations before are now required GMPs under the HARPC rule.
There are about 26-28 allergen controls that are identified in the GMP revisions. Basically controls within every stage you could imagine. There are controls for cross-contact with handling, storage, and use, to controls for cross-contact with sanitation practices—ensuring proper cleaning procedures are in place for when changes in the production run occur.
Every step in the operations chain, from receiving ingredients to incorporating those ingredients to labeling the final product, has a GMP step somewhere along the line.
Additionally, the labeling control is unique in that it addresses a common issue within the industry when it comes to mislabeling. Undeclared allergens due to mislabeling are a large reason for recalls. This is now part of the GMP requirements.
As mentioned above, there is a really significant shift in focus when it comes to allergens. FDA is looking at undeclared allergens in a brand new way and no longer treating them as a recommendation. You need to make sure you’re documenting and following an operating procedure that ensures your allergens are declared properly when a product leaves your facility.