The U.S. Food and Drug Administration (FDA) is expected to publish final versions of its Foreign Supplier Verification Program (FSVP) and Produce Safety rules by October 31, 2015. These are two of the major proposed rules under the Food Safety Modernization Act (FSMA). FDA published the original proposed Produce Safety rule on January 16, 2013 and the original proposed FSVP rule on July 29, 2013. FDA published revisions to both proposed rules in September 2014.
The Produce Rule will require covered farms to “take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce.” This includes, but is not limited to, actions such as following certain hygienic practices, testing and treating agricultural water sources, and identifying potentially contaminated produce and avoiding harvest of that produce. Covered farms will also need to keep records of training, testing results, treatment of seeds and beans, and other activities. Most raw agricultural commodities are covered by the rule.
The FSVP rule will require U.S. importers to “perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of domestic food producers.” Importers will be required to maintain a written hazard analysis that identifies and evaluates potential hazards for each food they import. They will also need to conduct and document risk assessments and supplier verification activities. The FSVP rule applies to most food imported or offered for import into the United States.
When determining appropriate verification activities for a certain supplier, the importer will need to consider the supplier’s FDA compliance history, such as whether the supplier is the subject of an FDA warning letter or Import Alert. Registrar Corp’s FDA Compliance Monitor allows users to monitor the FDA compliance status of any food facility around the world. Along with assisting with future FSVP compliance, the FDA Compliance Monitor helps importers avoid costly delays and detentions by notifying them of Import Alerts in advance of importing.
FDA discussed some of its plans for Produce Safety and FSVP implementation at the FSMA Public Meeting hosted last month. For both rules, FDA is working to ensure that inspections and regulation are consistent and to provide easily accessible training and support for both regulators and industry.
Registrar Corp assists food facilities with FDA compliance. For questions about FSMA rules or other FDA regulations for food and beverages, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.