Animal feed facilities are also subject to the preventive controls mandate but will be addressed in a separate but similar rule that takes into account some differences in how preventive controls would work in human and animal feed facilities.
Farms that grow fresh produce also must take a preventive approach, but, because of the nature of these operations, the preventive controls will be different from those in facilities that manufacture food. The produce safety rule will set science- and risk-based standards for the safe production and harvesting of fruits and vegetables, addressing such areas as water quality, employee hygiene, soil amendments, and animal intrusion in growing fields.
The challenge is to devise rules that target the practices most likely to introduce hazards and that are flexible enough to be feasible and effective across the great diversity of crops, hazards, practices and growing conditions in the produce sector. This is not easy to do, so we look forward to robust comments on the proposed rule.
The law’s new import requirements are closely tied to the preventive controls and produce safety requirements and call for a fundamental paradigm shift. Rather than placing primary reliance on FDA inspectors detecting and correcting problems at the port of entry, FSMA makes importers accountable for verifying, in a manner transparent to FDA, that the food they import has been produced in accordance with U.S. standards, or under modern preventive controls that provide the same level of public health protection. In short, importers must manage their supply chains to ensure the safety of imported foods.
This new import paradigm is grounded in public-private collaboration. FDA sets safety standards and will provide a certain level of oversight through a continuing presence at the border and a stronger presence overseas. But much of the assurance that imported food safety standards are being met will come from the importer carrying out what FSMA calls a Foreign Supplier Verification Program. The fourth rule FDA is working on will lay out how importers can meet this new requirement.
Having preventive control requirements apply to both domestic and imported products is, of course, essential for food safety and for consumer confidence in today’s global marketplace, and it will require real collaboration between government and industry to achieve that goal.