Understanding the Risk
You may have recently heard this story about a girl who tragically died from an allergic response to peanut allergen – from something her boyfriend consumed. It was a shock to her family. Food allergies are a very serious matter and can often take people by surprise.
The risk becomes even greater when the consumer has no way of knowing that the allergen is present. That was the case in a recent spate of recalls beginning in December 2014, and ending mid-year 2015, in which cumin powder had become contaminated with peanut protein. The cause? It wasn’t a mistaken ingredient addition during processing, or poor sanitation between products. There was an intentional addition of peanut shell to the cumin prior to grinding. The motivation? To make more money by increasing the overall volume of product which could be sold.
Sadly, similar scenarios occur regularly across the globe. Food products are intentionally contaminated, largely with financial motivation but potentially also for more nefarious reasons, and in many cases they go undetected. If not detected these events can make a recall necessary, and can potentially destroy a business’s reputation, as well as exacting a very large financial cost. In the case above with the cumin the contamination was apparent due to consumers’ allergic response, but if not for that it may have never been noticed.
Intentional adulteration has been an area of concern for the food industry for years, but it’s only recently that standards have begun being applied across the industry with a specific focus on this subject and standardized expectations. Below we’ll discuss what these standards look like and give you some practical tips to manage this risk for your operation.
FDA’s New Rule
This is the first time that the FDA has made a “food defense plan” mandatory.
The FDA recently issued the 6th and final Food Safety Modernization Act (FSMA) rule, referred to in shorthand as the “Intentional Adulteration Rule” but formally called the “FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration”. This is the first time that the FDA has made a “food defense plan” mandatory. The rule is specifically written to address intentional adulteration which is aimed at causing broad-scale harm to public health, and that includes terrorist acts aimed at the food supply.
In terms of scope, no specific hazards or foods are given particular focus by this rule, but rather it is aimed at larger operations with certain processes which may be higher risk for intentional adulteration with intent to do harm. It exempts very small businesses, as well as holding of food (for instance warehousing) except in liquid storage tanks, processing of packaged foods which are not re-opened, and farm activities, as well as a few other minor exceptions.
The rule takes an approach which integrates well with existing HACCP-based structures. It requires that a vulnerability assessment be conducted, to include factors such as the severity of impact of an activity, the degree of physical access to product, and likelihood or potential that contamination attempts might be successful. The rule also requires mitigation strategies to be implemented including monitoring, corrective actions, and verification, as well as records and training of personnel (sounds like the HACCP approach doesn’t it?).
GFSI (Global Food Safety Initiative) Considerations
Edition 7 of the BRC Food standard, which was published in January 2015, included a section dedicated to “Product Authenticity”. Additions are expected in other GFSI standards as well, including the upcoming release of the SQF standard.
Section 5.4 of the BRC Food standard addresses concerns related to intentional adulteration, whether it impacts food safety or quality criteria.
What Should I Do?
Generally, risks of adulteration will appear in two places: your ingredients may bear a higher risk of adulteration, or there may be areas of your operation or supply chain where products can be accessed and tampered with.
Assess and Document.
Generally, risks of adulteration will appear in two places: your ingredients may bear a higher risk of adulteration, or there may be areas of your operation or supply chain where products can be accessed and tampered with. You can use a tool like the FDA’s Food Defense Plan Builder, as well as documenting a vulnerability assessment using the HACCP approach.
Do your homework.
If you use a variety of ingredients you’ll also need to conduct an assessment of the specific ingredients you use. One of the best tools for this is the web site www.foodfraud.org which is published by the USP; they also publish the “Food Chemical Codex” which we highly recommend for any operation which uses a variety of flavorings or ingredients. You can also do research using FDA’s food recalls archive, and Europe’s RASFF web site.
Document and train.
As with any food safety exercise, in order for your food defense / product authenticity program to be effective, it needs to be formally established and agreed upon by the food safety team, as well as thoroughly documented. This helps ensure consistent execution, and also acts as a communication tool and proof to regulators or auditors of what your company is doing. Training your team is also critical, so they are aware of risk factors and how your program works. If you think about it, employees are one of your best food defense tools – they’re your company’s constant eyes and ears in your facility. They may be the first to notice if something is “off.” Help them understand what signs to look for, and what actions to take should an issue arise. Of course, if you would like to have your team trained we can provide that service for you.
The final step in any food safety program is to verify that the program is working as intended, as well as to verify or validate its effectiveness. This can be done, in this case, through internal audits, third party audits, and site exercises. A crisis management exercise is already mandated by GFSI programs, why not choose a scenario which helps to test and verify that your staff know how to properly respond should product be tampered with?
We understand that when it comes to food safety, these days expectations are steadily increasing, with customers and regulators constantly “raising the bar.” We provide articles like this one in the hope that it will help your company meet or exceed expectations you’re facing. And of course if you need further assistance please contact us and we will do our best to help!