Under the FSMA, contamination will bring consequences. The FDA is ramping up inspections, testing swabs against a national database of foodborne illness outbreaks, and promising criminal prosecutions. The presence of a strain of listeria or salmonella that has sickened consumers will now trigger a Department of Justice investigation--even if no specific violations are found at the plant.
The new law also extends criminal liability all the way up the corporate ladder. Managers who sign off on inadequate preventive controls will be held accountable if food is contaminated, as will the CEO’s whose complacency led to pathogens on the processing floor. Ignorance of the contamination is no defense--anyone who contributed to unsanitary conditions could be looking at $250,000 in fines and up to a year in prison.1 Prepare for inspections now, and find problems before the FDA does.
High and Low Risk
The frequency of inspections will depend on whether your facility is classified as high or low-risk. Plants with a history of violations are more likely to be considered “high risk”, as will plants producing foods that have a propensity for harboring pathogens, like luncheon meats or queso. The FDA anticipates approximately ¼ of the nation’s food production plants will qualify as high risk.
The high risk group will see inspections stepped up to at least once every 3 years. Low risk producers will not necessarily see more frequent inspections, but the law expands the FDA’s power to review records on demand.2
Once an investigation has been initiated, regulators will have virtually unlimited access to your records.3 Whereas the agency previously could only review records for specific products suspected of contamination, the FSMA lets inspectors look into any product they “reasonably believe” may be at risk. This includes “industry-wide” risks, meaning that a plant with no known issues could have to show its records if it uses the same procedures or equipment as its competitors4.
Practice Your Presentation
When preparing for a visit from the FDA, practice makes perfect. Mock inspection drills can help the real test go smoothly. In addition to verifying that your facility is in compliance with regulations, a mock inspection will be an opportunity to practice the presentation of your food safety plan and related records. A mock inspection will prepare your Qualified Individual to justify the facility’s preventive control measures, and ensure that critical staff members are available and able to demonstrate the plan’s implementation.
Stick to the Plan
Implementing your food safety plan is only the first step in preventive controls. The FDA will also be scrutinizing your verification and validation measures. Not only do your records need to verify that the plan has been followed, but the logbooks should also be routinely audited by a Qualified Auditor. Recordkeeping inconsistencies can be grounds for civil sanctions, even if the inspector finds no actual violations on the production floor.5 6 7
Your plan must be kept current, with documentation of all corrective actions. Any changes to procedures or equipment require an immediate hazard analysis and subsequent revision of the plan. Your preventive controls need to accurately reflect every stage of storage, production, packaging, and labeling.8 9
Test Before Trouble
The FDA will also be expanding on-site sampling. Inspectors will take product samples, swab equipment and utensils, and may even test the floors, drains, and walls of preparation areas. If pathogens are detected, the FDA has the authority to initiate a recall or even revoke a facility’s registration, effectively shutting down production. And if a sample is determined to be a genetic match with a case of foodborne illness in the CDC’s nationwide PULSENET database, a criminal investigation will result, regardless the facility’s conformance to cGMP’s or the thoroughness of its preventive controls.
Preemptive tests may be the only way to find problems before the FDA. Environmental testing by a qualified lab is a small expense compared to the disruption that would follow a positive result during inspection.10
FDA inspections will be more frequent and more rigorous under the FSMA, and facilities must in a constant state of readiness. But with the right combination of personnel, preparation, and preventive controls, you can be confident when the inspectors visit.
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