FDA hosted an excellent day-long public meeting on March 21, 2016 to review the import-related elements of the new FSMA regulations. In opening remarks, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor noted that implementing import provisions is the agency’s biggest FSMA challenge.
In a March 21 FDA Voice blog, Taylor called the Foreign Supplier Verification Program (FSVP) “the ‘regulatory linchpin’ of FSMA’s historic paradigm shift for imported food from reaction at the border to accountability for prevention at the point of production.”
Section 301 of FSMA requires importers to have a foreign supplier verification program and the Importer of Record must verify that suppliers have adequate preventive controls to assure the safety of their products. It is the importer’s responsibility to determine the hazards and the best way to verify that preventive controls are being implemented.
A preventive control may not be required for some low-risk products. But this does not mean that low-risk products such as candies, cookies or crackers are exempt from FSVP, just that a hazard analysis may show no significant hazard so no special controls are required.
The FDA does not plan to create a list of high-risk products, but the agency may require special preventive controls in some circumstances.
Food exempted from FSVP requirements include juices and seafood covered by existing HACCP rules, food used for research and development, food for personal consumption, and alcoholic beverages and ingredients (when the importer uses them to make alcoholic beverages). Also exempt are foods transshipped through the U.S., foods imported for processing and export, foods originating in the U.S. that is returned, and meat, poultry and egg products regulated by the U.S. Department of Agriculture.
To the surprise of some stakeholders at the March 21 public meeting, foods imported for distribution as samples at trade shows are not exempt from FSVP requirements.
In some circumstances importers may comply with FSVP requirements if they can establish that there is a system in place to control a hazard at a subsequent stage in the distribution chain. If a hazard is controlled by an importer’s customer or other entity in the distribution system, the importer must have documentation in the form of a disclosure statement and written assurances.
The FSVP preventive control requirements are aligned with those of the FSMA preventive controls and produce rules. The goal is to produce food using the same level of public health protection and to assure that the products are not adulterated or misbranded, especially with regard to allergen labeling. Although the FSVP is not a border program, it will require identification of the importer at the point of entry.
In addition to requiring importers to implement FSVP requirements, FDA plans to conduct more foreign inspections and to work more closely with foreign governments. The agency may determine that some countries have equivalent food safety systems, which should benefit suppliers in those countries. But this will be lengthy process and will likely take years to accomplish for each country. New Zealand was the first country FDA designated as having an equivalent system. Currently, Australia, Canada — and most recently the European Commission — are being considered for this designation.
The final FSVP rule was published on Nov. 27, 2105. Because the compliance dates are aligned with those of the separate preventive controls and produce rules, importers will need to comply with whichever is the latest of the following dates:
- 18 months after the publication of the FSVP final rule;
- For the importation of food from a supplier that is subject to the preventive controls regulations for human food or animal food or the produce safety regulation, 6 months after the foreign supplier of the food is required to comply with the relevant regulations; or
- For an importer that is also subject to the supply-chain program provisions in the preventive controls regulations for human food or animal food, the date the importer, as a receiving facility, is required to comply with the supply-chain program provisions of the relevant regulation.
FDA is currently developing guidance that will give more clarity to the FSVP compliance requirements in specific circumstances, such as in the case of suppliers in countries or regions deemed to have equivalent controls. But the agency says importers should not delay in assessing their products and their suppliers with a view to achieving compliance.