The clock is ticking! With the FDA’s FSMA 204 compliance deadline rapidly approaching, many in the food and beverage industry are understandably seeking clarity. We’ve been listening to your concerns and want to address some of the most common misconceptions we’ve encountered.
Let’s cut through the noise and set the record straight on these crucial regulations.
Myth #1: Paper Records Are Good Enough
Fact: While the FDA doesn’t mandate that all records must be digital, relying solely on paper is a recipe for non-compliance with Rule 204. This rule explicitly requires electronic, sortable spreadsheets to be provided within 24 hours of an FDA request.
Embracing digital recordkeeping isn’t just about ticking a box; it’s the practical and efficient pathway to meeting these requirements.
Myth #2: If I’m Already FSMA Compliant, I Don’t Need to Worry About Rule 204
Fact: Don’t let a false sense of security lull you into inaction. FSMA Rule 204 introduces a new layer of more stringent recordkeeping demands that are distinct from general FSMA compliance. Even if you’ve diligently adhered to previous FSMA regulations, Rule 204 brings specific requirements around Key Data Elements (KDEs) and Critical Tracking Events (CTEs).
You’ll likely need to re-evaluate and adjust your current processes to meet these enhanced traceability standards.
Myth #3: Small Farms and Businesses Are Exempt
Fact: While there are some exemptions, particularly for very small farms with under $25,000 in food sales, the blanket statement that all small businesses are exempt is inaccurate. Many smaller operations will still fall under the purview of Rule 204 depending on their size, the specific type of operation they run, and crucially, the types of foods they handle.
Don’t assume – verify whether the regulations apply to your specific circumstances.
More Myths Busted: Ensuring Clarity on FSMA 204
We’re not done yet! Here are a few more common myths we want to clear up:
You must require all your suppliers to send their data via the same method.
Fact: Flexibility is key! Your suppliers can utilize the systems and tools that best suit their operations, as long as these methods enable you to effectively capture, store, and share the required Key Data Elements (KDEs).
FSMA requires all food facilities to have a specific type of traceability system.
Fact: Rule 204 focuses on the outcomes – the ability to track and trace – rather than mandating a particular system. Each entity is responsible for complying with the aspects of the rule relevant to the Critical Tracking Events (CTEs) they perform. The FDA encourages voluntary adoption of best practices across the industry.
Every case leaving a distribution center must be scanned.
Fact: The primary goal of FSMA 204 is to trace products back to their origin efficiently, not to track every single individual case throughout the supply chain.
FSMA 204 applies to all food products.
Fact: This rule has a specific scope. FSMA Rule 204 applies only to foods listed on the Food Traceability List (FTL), which currently includes items like fresh leafy greens, tomatoes, certain cheeses, shell eggs, and nut butters. Not every food manufacturer or distributor is affected.
FSMA 204 only applies to manufacturers.
Fact: Traceability is a shared responsibility. The rule impacts the entire supply chain involved with FTL foods, including growers, packers, shippers, distributors, and retailers. Everyone in the chain has a role to play in ensuring traceability.
FSMA 204 is just a suggestion, not a requirement.
Fact: Let’s be clear – this is a federal regulation. Compliance is mandatory, and the FDA has the authority to take enforcement actions against those who fail to comply.
FSMA 204 only applies to U.S.-based companies.
Fact: The reach of FSMA 204 extends beyond U.S. borders. Foreign suppliers who export FTL foods into the U.S. are also required to comply, meaning importers have a crucial role in ensuring their international suppliers meet the necessary standards.
Ready to Achieve Compliance with Confidence?
Navigating these new regulations can feel overwhelming, but you don’t have to tackle it alone. ParityFactory is an integrated WMS and MES system designed for the food and beverage industry that can help you confidently meet these new FDA requirements.
Gain peace of mind knowing you have an audit-ready system in place. Schedule a demo today.