Friday July 26, 2013, FDA released the long-awaited proposed rule for the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP). Under the proposed rule, FSVP requires U.S. importers to develop and implement a plan to verify that their foreign suppliers and their food comply with the Food, Drug, and Cosmetic Act (FDCA). To emphasize the significance of these new rules, FDA stated in a press conference Friday that if a U.S. importer fails to satisfy all the provisions of FSVP, the importer’s food shipments will be refused entry to the United States.
Have we got your attention?
Now, for those already in the food safety world, such requirements are nothing new – a fact that FDA stressed when proposing these rules. In FDA’s words: “the principle of hazard assessment is well accepted and understood throughout the international food safety community.”
What FDA fails to acknowledge, however, is that importers have typically not been part of the “international food safety community.” In reality, importers have been focused on U.S. Customs and Border Protection issues and navigating the logistics of international trade. While they were concerned about food safety, the burden of compliance was on the manufacturer. As proposed, FSVP will change this and require importers to develop new skills: food safety detective work.
Under the proposed rule, importers must become detectives (like FDA investigators) because FSVP mandates that they:
- Assess their foreign suppliers’ history of compliance with a wide array of food safety regulations,
- Conduct a hazard analysis for each food it imports and determine the possible risks associated with those foods, and
- Determine if each of its foreign suppliers has not only documented effective safety controls, but, in some cases, observe the manufacturing process to ensure the safety plans are being implemented properly.
These requirements make it clear that complying with FSVP will not be as easy as FDA may want it to appear. Food importers will need to either 1) obtain extensive training and experience in foods safety (only a “qualified individual” can perform the legally-required tasks), or 2) hire expensive third-party experts to conduct this work for them. Either option carries a high cost.
Over the next few days we will be providing in-depth analysis of the proposed FSVP rules. One thing is already clear, however: the proposed rules represent a huge increase in the expertise importers must bring to bear for each and every food they import. Essentially, importers must now become specialists in food hazards, something they have never had to do before. Experience teaches us that all such undertakings are always expensive. Despite what FDA is saying, FSVP will be no different.
