Will FSVP Shed Light on Food Safety or Keep it in the Dark?

If, however, a food product under Option 1 is subject to a hazard for which there is not a reasonable probability that exposure will cause adverse health consequences or death, the requirements are far less stringent. In these circumstances, the importer will have the ability to choose for itself which verification procedure from a list proposed by FDA it will use. These less stringent verification procedures include periodic onsite auditing; periodic lot-by-lot sampling and testing of the food; periodic review of the foreign supplier’s food safety records; and any other procedures which, in the discretion of the importer, are deemed “appropriate.”

Under Option 2, regardless of the level of risk associated with a food product, an importer will be able to establish compliance by merely selecting one of the less stringent verification procedures outlined above. Thus, the real difference between Option 1 and Option 2 is that, with respect to food products that carry a reasonable likelihood of causing adverse health consequences or death, under Option 2 there is no auditing requirement. Instead, importers simply could choose to periodically review the supplier’s food safety records, to periodically test the supplier’s products, or to follow any other verification procedures the importer deems “appropriate.”

Life or Death Decisions?

In light of the differences between options, how could choosing one or the other really be a matter of life or death? The answer really depends upon whether the question is viewed through the lenses of foreign product suppliers, importers, or consumers.

From the perspective of foreign food product suppliers, Option 2 may be interpreted as the only real option. Under Option 2, importers could demonstrate compliance, regardless of the capabilities or qualifications of the foreign supplier, by “periodically” testing incoming products or selecting one of the other less stringent procedures (or, I guess, by simply making up one of its own). If Option 1 were selected, however, a large number of existing foreign food product suppliers would likely be forced out of business.

This is because many foreign suppliers, in order to export to the U.S., would be forced to pass a physical audit demanding them to demonstrate actual compliance with each of the requirements of the Food Safety Modernization Act (FSMA), including the requirement that they develop and implement a science-based written preventative control program. Foreign suppliers would also be required, in order to pass that audit, to comply in other respects as well, demonstrating they have adequate prerequisite programs, equipment, and facilities. Because many foreign suppliers would be unable to satisfy the proposed auditing requirements, they would also be unable to export foods to the U.S. Thus, from the perspective of many foreign food product suppliers, the choices being proposed by FDA raise literal questions of life and death.

From the standpoint of the importer, the answer is less clear. On the one hand, the audit requirements should be welcome from the standpoint of sophisticated companies. Requiring audits of all foreign suppliers of high risk foods will enhance incentives for foreign suppliers to upgrade their food safety systems, will ensure the increased safety of all high-risk foods, will promote the application of uniform standards applicable to all foreign suppliers, and will level the competitive playing field for all importers. On the other hand, the cost of foreign food product imports will likely increase (at least in the short-term) as companies work to achieve compliance, and importers will likely be burdened with increased regulatory costs as they themselves work to ensure their foreign suppliers are FSMA compliant and being properly audited by qualified individuals. Bottom line is everyone wins, but foreign imports become a bit more costly.