If your business imports food products into the United States, you’ve got new rules to follow!
The U.S. Food and Drug Administration’s (FDA) Foreign Supplier Verification Programs (FSVP) final rule outlines the activities importers should perform to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards, and the final rule on Accredited Third-Party Certification creates an FDA-approved and regulated accreditation program for third-party food and safety auditors who can provide certifications. The first compliance dates for these began in May 2017.
Are you in compliance? Do you even know the rules? Food importers will be impacted the most by this new rule because they must verify that all the food they import, unless it qualifies for an exemption, meets U.S. safety standards. Domestic food importers and exporters must now comply with a much more complicated process involving hazard analysis, environmental monitoring requirements, and validation of preventive controls.
If you work in the food industry in any manner — as a food producer, shipper, carrier, processor, food safety certified auditor, food company CEO, VP or director level personnel, internal food safety and quality team member, food testing labs and quality personnel, Current Good Manufacturing Practices (CGMP) specialist, or operations personnel — these rules affect you!
Where It All Began
On November 10, 2015, the FDA published the final rules for the FSVP and third-party accreditation programs under the Food Safety Modernization Act (FSMA). In November 2016, it prepared guidance documents that extended the requirements previously published under the final rules for CGMP hazard analysis and risk-based preventive controls for human and animal food.
The FDA’s FSMA rules are based on the idea that risk can be reduced through preventive approaches that may not have been widely understood or followed in the food industry. The final FSVP and Accredited Third-Party Certification rules rely heavily on new rules for Hazard Analysis and Risk-Based Preventive Controls (HARPC), environmental monitoring, and validation of preventive controls.
It’s critical to understand how the FDA has interwoven the FSMA into a more compact and focused set of final rules than the proposed rules might have led us to believe.
Resistance Is Futile
Regardless of your ability to understand these new rules, the implementation period has begun. The implications of these newly published FSMA rules go far beyond what their titles imply. More importantly, the Accredited Third-Party Certification rules need to be understood by all food industry personnel because earlier established food safety standards and audits will be changing to accommodate the new rules.
For example, in order to evaluate food risk and supplier performance, you need to understand how the basic rule requirements give you more control over suppliers – but also make you responsible for taking corrective actions if you find something is amiss with a supplier.
Protect Your Company: Knowledge Is Power
Compliance doesn’t come together overnight. You’ll need to prepare your business to comply with changing food safety and quality standards and audits. Transportation food safety expert Dr. John Ryan reviews these key rules in an audio conference for ProfEdOnDemand, “The Impact of New Foreign Supplier Verification and Third Party Accreditation Rules on Your Food Business.” John reviews earlier final rules and provides a summary of the final FSVP and Accredited Third-Party Certification rules. He also outlines the steps to bring your internal food safety systems up to date, and reviews the requirements for accreditation and certification bodies. You’ll understand FSVP and third party accreditation reporting requirements so you can protect your company from a conflict of interest.