11 March 2016
FDA Expected to Increase Foreign Facility Inspections in the Years Ahead
The Food and Drug Administration has identified several steps it plans to take over the next year or two to further implement provisions of the Food Safety Modernization Act. President Obama’s fiscal year 2017 budget request includes US$14 million for new import safety systems, with a priority on implementing the foreign supplier verification programme rule. This rule makes importers responsible for ensuring that the foods they bring in from other countries are produced in a manner that is consistent with U.S. food safety standards. The FDA states that it will use its FY 2017 funding to hire staff to perform FSVP inspections and provide training, technical assistance and outreach. The agency will also expand its overseas presence to increase and better target its inspections of foreign food facilities and to work with and assist foreign governments to ensure the safety of food before it is exported to the United States.
The last two of seven FSMA final rules, on sanitary transportation and intentional adulteration, are due to be sent to the Federal Register on 31 March and 31 May, respectively. The sanitary transportation rule is designed to prevent the physical, chemical or biological contamination of human and animal food during transportation by motor or rail vehicles through practices such as improperly refrigerating food, inadequately cleaning vehicles between loads and failing to properly protect food during transportation. This rule is generally expected to apply to shippers, receivers and carriers who transport food in the U.S. by motor or rail vehicle as well as persons outside the U.S. (e.g., exporters) who ship food to the U.S. in an international freight container by ocean-going vessel or in an air freight container. Failure to comply could result in food shipments being refused entry into the United States.
The intentional adulteration rule is expected to require the largest food businesses in the United States and abroad to take steps to prevent facilities from being the target of intentional attempts to contaminate the food supply, including developing a written food defence plan, implementing strategies to address vulnerabilities, and establishing monitoring procedures and corrective actions. With some exceptions, this rule will likely apply to both domestic and foreign facilities that manufacture, process, pack or hold food and are required to register as a food facility.