Although the risk of allergen cross contact is well understood, the recent addition of sesame to FDA’s “big nine” list of Major Food Allergens requires a renewed focus on preventive allergen controls and validated/verified food allergen testing methods to detect contamination and mislabeling.
Despite this attention, allergen control continues to be a major problem for the food and supplement industries. Why? System failures at every link in the chain.
EAS independent consultant and food safety expert, Steven Gendel, Ph.D, has 25 years FDA experience (most recently as FDA’s Food Allergen Coordinator) and nearly 10 years of industry experience with preventive allergen controls. He shares his thoughts on tackling the increasingly complex world of allergen cross contact and allergen controls in this Q&A.
Q: What is the biggest problem with allergen cross contact today?
Gendel: The fact that we continue to see so many allergen-related food recalls shows that industry is still having problems designing and implementing effective allergen controls. Allergen control is not like pathogen control because you can’t remove the hazard at a critical control point once an undeclared allergen is in the supply chain.
Q: What is the FASTER Act of 2021 and how do I ensure compliance?
Gendel: FASTER stands for the “Food Allergy Safety, Treatment, Education, and Research Act”.
This law has several parts, the most impactful one for food manufacturers being the addition of sesame to the list of Major Food Allergens. Once the law takes effect on Jan. 1, 2023, food manufacturers will need to control sesame and sesame-derived ingredients the same way they do for the other Major Food Allergens. This includes making sure labels are updated as needed, sesame is considered in facility risk evaluations, sanitation validations are updated as needed, and potential cross-contact is controlled.
Q: What is one of the first steps to controlling allergen cross-contact and ensuring compliance with Preventative Controls for Human Food (PCHF) rules outlined in the Food Safety Modernization Act (FSMA)?
Gendel: The first step is to have effective GMPs in place. It is important that we don’t lose sight of how important these are.
The next step is to be sure that facilities know what allergens are coming in, where they are stored, and where they are being used. All of this feeds into the process of doing a hazard evaluation that identifies where cross-contact and mislabeling are possible.
Q: How is a Preventive Controls Program (PCP) developed?
Gendel: As a broad description, the development of a Preventive Controls Program involves the following:
- Determining what can go wrong
- Identifying controls that prevent those things from happening
- Designing ways to monitor the preventive measures
- Planning what to do if a control fails or is not implemented properly
- Developing a recordkeeping system to document what actually happens
- The last step is to implement all these processes and controls
Q: In today’s global world, how should manufacturers deal with supply chain challenges and their effects on allergen cross contact and allergen controls?
Gendel: Unfortunately, there are no simple answers to this problem. The biggest challenge is to be sure that you know your whole supply chain. Every step in the chain, including during transport, is an opportunity for something to go wrong, for allergen cross contact to occur or for misidentification. As we are seeing, supply chains can change suddenly and in unexpected ways.
In addition, allergen labeling-and-control regulations are not the same in all countries and are subject to change. This means that manufacturers cannot rely on history or past relationships alone to ensure allergen control.
The best things that a manufacturer can do is the following:
- Regularly test incoming ingredients
- Monitor information from regulatory agencies around the world for news about newly identified problems
- Support efforts to increase supply chain transparency
If you have questions about how this affects your company, contact EAS Consulting Group, a Certified Group company, and we’ll be glad to help.