The Food Safety Modernization Act (FSMA) is like a tiger with shallow teeth but a long reach.
There are a lot of ways to get stuck fighting with one, but few ways for him to kill you.
Likewise there are a lot of ways to overlook something with your FSMA compliance strategy. However, the FDA has three primary mechanisms for enforcement when it comes to imposing direct penalties for non-compliance.
Those are:
1. Hourly re-inspection fees (~$225/hour range)
2. Product recalls
3. Suspension of facility registration
FSMA Background
Animal food need not be shown to contain contaminants to be considered adulterated.It is adulterated simply if it was prepared, packed, or held under conditions whereby it may become contaminated. Is having an inadequate food safety plan one of those conditions whereby food may become contaminated (and thus be considered adulterated)?
Direct Enforcement and Penalties
Adulterated foods are potentially subject to FDA product recalls.The FDA has authority suspend or revoke a facility’s registration; making them not able to legally offer food for sale in the United States until FDA lifts the suspension.
However, these two options are most likely reserved for adulteration that has potential to create serious adverse health consequences or death to animals or humans (SAHCODHA). So if you encounter a FSMA issue with the FDA, the consequence is likely limited to being billed hourly for re-inspection of your facility and documentation while you fix the problems that were identified.
Indirect Compliance Pressure
I don’t make a point of wrestling tigers just because the most common result is only a hospital bill. And an effective compliance strategy shouldn’t take the back seat just because the FDA’s instruments are blunt and the specifics regarding how they’ll be wielded are unclear. In fact, the primary driver of FSMA enforcement lies within the marketplace. Particularly, what buyers will or won’t tolerate from suppliers: “Is food safety something you’re taking seriously, or is your haphazard approach a potential liability for us down the road?”
1. If food safety is an afterthought for your plant, you might be much more concerned about ongoing market access than penalties from the FDA.
2. As such, the willingness or reluctance of downstream buyers to do business with you – not just the fear of ‘going to jail’ — plays a significant part of a holistic compliance strategy.
Market signals from entities in the supply chain with the most prowess will have a lead role in defining the terms of engagement.
Going Beyond Penalty Avoidance
FSMA is like life, the point isn’t only to avoid going to jail. Sure, you want to stay out of prison; but whether you operate a feed mill or manufacture distillers grains, you also want to keep your customers happy and operate your business responsibly and profitably.
Industry and consumers, not just regulators, are driving forces toward implementing a more systematized approach to animal feed safety throughout the supply chain.
How much time have you spent evaluating your FSMA compliance strategy?
Christianson CPA can provide you with solutions for FSMA compliance that simplify your strategy, reduce the total burden, and satisfy the FDA’s regulatory requirements.
