Federal food safety regulation now marches to a new drummer. Preventing, not reacting, is the new paradigm set by the Food Safety Modernization Act (FSMA). Being rolled out over two years, the 2011 law is the first major revamp of food safety laws since the 1930s.
While some provisions are already in effect, the Food and Drug Administration (FDA) continues to lag behind in its rulemaking schedule. FSMA is already a complex law, with effective dates that vary by provision. The fits and starts of the rulemaking process add to the confusion being confronted by the coffee and other industries.
Some of the changes are big — like mandatory recalls, importer accountability for food safety, and presumptive liability for reasonably foreseeable risks. Other provisions include expanded authority for administrative detention, increased records retention and access requirements, and more frequent facility inspections.
In general terms, the FSMA approach targets identifiable entry points of contamination. It assesses the likelihood and level of risk and erects regulatory “firewalls” against those risks. Procedurally, the statute grants enhanced powers to the FDA and assigns new responsibilities to those along the supply chain.
For the FDA, there’s more authority to monitor and address potential vulnerabilities at various steps along the supply chain. For example, the FDA gets new jurisdiction over food manufacturing and holding practices. For those along the supply chain, FSMA heightens standards of accountability and traceability to ensure a safe and unbroken chain of custody. Companies that pack, receive or hold foods are on the legal hook for contaminated goods since they “knew or should have known” of problem conditions.
Here are FSMA’s key provisions:
1. The FDA has the authority to recall food on a mandatory basis. Previously, the FDA could simply issue its recommendation for voluntary recalls.
2. Importers are held legally responsible for the safety of the foods they import under a high standard of there being a “reasonable probability of serious health effects.” Prior to FSMA, importers could pass food through without an obligation to inspect the food for safety risks.
3. Importers are also required to verify that imported food and food ingredients are produced in accordance with U.S. standards.
4. Companies that simply pack, receive or hold foods will also be presumptively liable for any contamination of the foods they handle under a slightly lower standard that they “knew or should have known” of problem conditions.
5. The FDA’s Administrative Detention powers are expanded, and the agency can now order food detained under a lower standard of having “reason to believe that such article is misbranded or adulterated.” The prior, lower standard was “credible evidence or information indicating that an item presents a threat of serious health consequences.”
6. Food producers and manufacturers must engage Preventive Controls, having conducted hazard analyses of reasonably foreseeable hazards, including acts of terrorism.
7. Records must be kept to trace food’s chain of custody to isolate potential contamination sources.
8. The FDA has wider authority to gain emergency access to records.
9. All import shipments must be pre-announced and accompanied by proper documentation
10. Prior notice is required for shipments that have been rejected by another country for health reasons.
11. The FDA can require more frequent inspections of domestic and foreign facilities, as well as periodic re-inspections.
12. The FDA has the power to “de-register” a facility under a standard of “reasonable probability of serious health consequences.”
13. The FDA funds FSMA enforcement through a schedule of fees for facility inspections.
14. Qualified companies can subscribe to a “fast lane” clearance system for imports known as the Foreign Supplier Verification Program (FSVP).
15. Legal protection is accorded to whistleblowers against discrimination or retaliation
Where Do Things Stand?
Most of the above FSMA provisions are already in effect. While enforcement is not yet uniform or certain, it is still legally required that companies comply.
However, there are two notable exceptions – Preventive Controls and the FSVP. As the FDA continues to reach out for public comment on specific regulations, the agency has confirmed that it will not enforce preventive controls provisions until those regulations are in place and there has been ample time for implementation. Also on hold is the FSVP, pending further regulatory work on logistics of verifying foreign suppliers’ risk-based safety measures.
The FDA is three-fourths of the way to the end of its two-year mandate to complete rulemaking to implement FSMA. However, with deadlines pushed back as well as FDA funding issues, it’s likely that the process will be delayed beyond year end. As the process continues to unfold, NCA will keep the industry informed. Watch Serving Coffee, the NCA website, and other NCA publications and communications.