September 19, 2016 marked the day when larger businesses must comply with new standards set forth by the FDA’s Food Safety Modernization Act (FSMA). The first year of compliance will affect the larger businesses, generally those with 500 or more employees.
Under FSMA, the FDA now can suspend facility registrations and has the authority to require expanded record-keeping. The enforcement penalties for noncompliance are severe. Failure to comply with the rules may result in significant civil and strict-liability criminal penalties, which means that responsible persons can be guilty of a crime without negligence or knowledge of a violation.
One of the new standards, the Preventive Controls rule, requires facilities to develop written food safety plans that includes a risk-based assessment to identify hazards where preventive controls are necessary to significantly minimize or prevent hazards for any food that is manufactured, processed, packed or held at the facility. The written food safety plan must also include procedures for monitoring, corrective actions and verification of each preventive control.
The preventive controls rules were the first two of seven foundational FSMA rules to become final starting in September 2015.
Under this rule, the FDA will request to see your food safety plan, and then follow the request with an on-site physical inspection of your facility. With the supply chain program requirements fast approaching, as soon as March 2017 for some facilities, now is the time to reconfirm that your food safety plan is in full compliance with the Preventive Controls rule.
FSMA promises to introduce a new era in food safety by focusing on preventing food safety risks rather than on responding to crises after they happen.
As with all new regulations, questions remain about FDA’s expectations in the coming years, as well as how those uncertainties may impact business operations. As implementation nears, it is important to examine these challenges and understand key considerations regarding likely implementation challenges and potential enforcement risks.