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FSMA is a hot topic and the internet is constantly flooded with explanations, tips, and a lot of discussion. But what is missing from the discussion? Here are 5 things that have been overlooked in the headlines and the compliance frenzy:
1. Who has the upper hand?
Although FSMA affects food suppliers as a whole, the requirements set some ahead of others at the get-go. A study put forward by Oxford Academic conducted a case study of the North American fresh-tomato industry to analyze the discrepancy that has emerged. In summary, they found that importers that must comply with FSMA will be hard-pressed to match the competition of those based locally. Additionally, large growers that previously adopted GAPs won’t face the costly demands that those operating on a smaller scale will deal with. So although FSMA compliance is demanding for all involved in food production, it inherently will dictate varying levels of competition for large, small-scale, and foreign food companies.
2. The “Hidden Teeth” of FSMA are more severe than you might think.
There are a great many reasons that compliance with FSMA is necessary, but there is one that some are calling the “hidden teeth” of FSMA. It is familiar information — that much responsibility has been shifted to food processors as they are now liable for every step from the farm to the table. The implications aren’t mentioned as frequently, however, and they are astounding. If any sickness or death occurs as a result of food they release, Senior Executives may face extensive criminal charges. Also known as the Park Doctrine, this legal aspect of FSMA is an undeniable incentive for executives and managers to approach compliance as a matter of grave significance.
(RELATED: Shine a light on your supply chain with a FREE FOOD SUPPLIER ASSESSMENT.)
3. Tiering is vital for plan development.
Under FSMA, new implementations are emerging along with requirements and many don’t know where to start. A hazard analysis is necessary, but where does it lead? There isn’t much talk surrounding arguably one of the most important aspects of preparing for FSMA. That is categorizing and tiering suppliers based on risk. This tiering process that divides suppliers into a high, moderate, or low risk category serves as the foundation for both corrective and verification actions. An initial hazard analysis determines where most of the risk lies.
A useful tool to use with this method is FDAzilla, a resource that tracks past and present compliance with the FDA to identify risk levels. By comparing the risk of all the suppliers under a particular processor, it can be clear where to focus compliance efforts.
4. Without good leadership, compliance is close to impossible.
Many large companies that have already dealt with FSMA have found success by instilling a culture of food safety within their company. Brian Perry of Bay Valley Foods LLC claimed, “[food safety culture] is probably the most important piece of how FSMA readiness is demonstrated” (qtd here). Every individual within the system should be concerned with food safety and work towards eliminating hazards. To achieve this outlook across a company is impossible, however, without the right people — specifically, without the right leader. A leader that is attentive to the issues within the company and makes every effort to correct them will set a valuable example for what is expected from the other employees.
A dedication to food safety isn’t the only thing modeled by company leadership. Transparency is key and leaders that keep an open door with the FDA foster transparency throughout the rest of their company. One leader that has enacted this strategy is Dan Herzog (Gonella), who explained, “We’ve contacted our FDA offices, we’ve learned their names, we know they’re coming” (qtd here).
5. FSMA instantly expanded job opportunities in food safety.
The current conversation is centered around the impact of FSMA on food processing companies, yet there is another facet to its reach that is largely unreported. Becoming compliant often entails hiring more professionals. When this is multiplied by food companies across the nation, the demand for auditors, consultants, and FSMA qualified individuals is amplified. For those that already fit these requirements, it means that they have just struck it big. For others, it means that there may be viable work opportunities in this field.
Knowledge of every facet of FSMA will set companies apart whether they are large, small, or anywhere in between. A complete understanding of the impact that FSMA will have is still emerging, but keeping up with the conversation will be instrumental in reaching compliance.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at [email protected].
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