Allergen Smart – Preparing for FSMA Changes

Allergen Smart – Preparing for FSMA Changes


Allergen Smart - Preparing for FSMA

With the majority of recalls caused by undeclared allergens, the FDA focuses efforts of preventing cross-contact with new provisions in the Food Safety and Modernization Act (FSMA). Special thanks to Len Steed, Global Innovation Manager at AIB for contributing to this article.

The importance of food safety has a face, and a name. Debra Miller-Tossey, a grandmother of 8 and avid outdoorswoman living in Cadillac, Michigan, was diagnosed with Celiac disease in 2013. Celiac is an autoimmune response to the protein (gluten) found in grains like wheat, barley and rye, which causes the body to attack and damage the small intestine. “It was such a relief, I had been feeling sick for so long, and so worried it was cancer. It was just a relief to know it had a cause and could be managed.” Standard management of allergies and intolerances from foods such as milk, eggs, peanuts, tree nuts, soy, wheat, fish and shellfish, is often strict avoidance, as even trace amounts can cause severe and even life threatening reactions called anaphylaxis. With an estimated 15 million Americans living with food allergies, the FDA, via the FSMA, is requiring documented controls to prevent undeclared allergens. Companies that produce and distribute food and beverage products will need to review the proposed 21 CFR 117 Good Manufacturing Practices (GMP) to ensure that existing prerequisite programs and Hazard Analysis Critical Control Points (HACCP) plans are effectively implemented to prevent recalls due to GMP deficiencies allowing for operational cross-contact and mislabeling.

Preventable Recalls: Undeclared and Allergen Cross Contact
The FDA Reportable Food Registry (RFR) collects data on Class 1 Recalls which is defined as ”…a reasonable probability that an article of food will cause a Serious Adverse Health Consequences or Death in Humans and Animals termed a (SAHCODHA) event. This data was used to track preventable recalls and incident patterns to help the FDA identify risk in the food chain which includes foods imported to the USA. Each year the RFR publishes a report titled “Targeting Inspection Resources and Identifying Patterns of Adulteration”. The fourth annual 2012-2013 report cites undeclared allergens as the largest reason for recalls accounting for 44% of all recalls. Food manufacturers and distributors will need to implement preventive controls as required by Section 103 Hazard Analysis and Risk Based Preventive Controls (HARPC) and the proposed GMPs.

HARPC Preventative Controls
The current GMP’s describe the methods, equipment and control procedures required for specific food sectors to prevent unsanitary conditions. The proposed change to the GMPs in 21 CFR 117 will require that companies re-examine their existing GMPs and decide if a process step, operational program or prerequisite program must be monitored similar to a HACCP Critical Control Point due to its importance to prevent a Class 1 SACODHA event. For those companies shipping product to the USA, the HARPC and proposed GMP requirement will be applicable under an additional FSMA rule called the Foreign Supplier Verification Program (FSVP). The final rule for HARPC and FSVP will be issued in August 30 2015 and October 31, 2015 respectively so the time to act is now.

For more information on how the FDA FSMA rules will affect your organization, the AIB has published an excellent resource, available here: http://www.columbianlogistics.com/AIB-FSMA-Ready

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