One of FDA’s biggest challenges as it rolls out new regulations to implement the Food Safety Modernization Act will be outreach and education so every impacted business will know what’s expected under the new, prevention-based regulatory approach. As part of its outreach efforts, FDA posted a presentation on its website on August 19, titled Proposed Rules to Help Ensure the Safety of Imported Food, in which it describes the elements of the Proposed Regulations for Foreign Supplier Verification Programs (FSVPs) and the Proposed Rule for Accreditation of Third-Party Auditors.
The agency explains that the new, integrated approach to imports will include the FSVP and the voluntary qualified importer program (VQIP). But it will also include mandatory certification, and enhancements to the existing prior notice system. In addition, the agency wants to help build the capacity of foreign governments, and to expand its own foreign offices. And it has other tools at its disposal, such as stronger enforcement authority under FSMA.
As you may know, a key principle of the import-related rules under FSMA is that the importers will be responsible for ensuring that the food they import to the U.S. complies with FDA safety standards. Unless a product has a specific exemption, the importer will be required to develop an FSVP for each food imported, with varying requirements based on the type of product, the category of importer, the hazard of the specific food, and on who will control the hazard. If there is no U.S. owner of the food at the time of entry, the importer is deemed to be the U.S. consignee. And if there is no consignee or U.S. owner at the time of entry, the importer will be the U.S. agent or representative of the foreign owner or consignee.
The proposed requirements for supplier verification are mainly based on who will control the hazards that are reasonably likely to occur.
The agency is attempting to be fair with regard to exemptions and to avoid duplication of effort by companies already covered by other preventive requirements. So, for example, products from facilities subject to FDA’s low acid canned food requirements will be exempt, but only with regard to the microbiological hazards elements of the rule. In addition, the agency proposes modified FSVP requirement for dietary supplements and for dietary supplement components.
For these and for other reasons, I believe the FSVP will be a complex regulation to implement, with many opportunities for confusion of responsibilities and roles. As a former regulator, I have sympathy with the agency as it gets deep into this huge task that will take many years to complete. I encourage you to speak up if you see elements of the proposed rules that will be unduly burdensome and to present FDA with workable regulatory solutions. Now is the opportune time.