Compliance-cartoonIn 2013, the U.S. imported 19% of its overall food supply, says the US Food & Drug Administration (FDA). This included 80% of its seafood, about 52% of its fresh fruit, and 22% of its fresh vegetable supplies. Understandably, the Food Safety Modernization Act (FSMA) contains specific provisions to ensure that US importers conform to the new food safety requirements being put in place for domestic producers. They include:

Laboratory accreditation for food analyses: The law charges the FDA with establishing a program to ensure that food is tested by laboratories accredited by bodies that conform to FDA requirements. These accreditation bodies may also accredit laboratories that operate outside the United States using the same accreditation standards that are applied to domestic laboratories.

Voluntary qualified importer program: The law requires the FDA to establish a program that provides expedited review and importation for designated foods where the importers volunteer and qualify for this program. Qualifying factors are to include the known safety risks of the food being imported, the importer’s compliance record, compliance record of the foreign supplier, and the capability of the exporting country to comply with US food safety standards.

Power to inspect foreign food facilities: The law empowers the FDA to enter into arrangements with foreign governments to inspect foreign facilities registered with the FDA. The FDA is further empowered to refuse entry into the U.S. of foods where the agency has been refused permission to inspect the relevant facility(s).

Building capacity of foreign governments with respect to food safety: The law allows the FDA to provide support aimed at expanding the technical, scientific, and regulatory food safety capacity of foreign governments and those food industries from which foods are exported to the United States.

Accreditation of third-party auditors: The law empowers the FDA to establish a system for the recognition of bodies that accredit foreign entities as third-party auditors able to conduct food safety audits to certify that eligible entities meet US food safety requirements.

Foreign Supplier Verification Program: The law requires that importers perform risk-based verification activities of their foreign suppliers to ensure that the food being imported complies with the new food safety requirements. The law defines an “importer” as the owner or consignee of the food at the time it enters the United States. HACCP-compliant seafood, juice, and low-acid canned food facilities are exempted from these new requirements.

Rules to implement these last two programs have been made final and take effect in January, 2016:

Foreign Supplier Verification Programs (FSVP) Rule: Within 18 months, affected importers must establish and put in place for each product and each foreign supplier written procedures to:

  1. verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the FSMA’s preventive controls or produce safety regulations;
  2. ensure that their foreign supplier’s food is not adulterated or mislabeled; and
  3. identify and evaluate the known or reasonably foreseeable hazards for each type of food it imports to determine if there are any hazards requiring a control and implement such controls.

In sum, the Foreign Supplier Verification Programs (FSVP) Rule requires importers to “. . . assume greater responsibility to verify that the foods they import into the United States meet the same safety standards required of domestic producers.” (FDA senior policy advisor)

The Final Rule on Accredited Third Party Certification establishes a program to accredit third-party certification bodies, also known as auditors, to conduct food safety audits and to certify foreign facilities and the foods they produce.

Information about other FDA action to enact the FSMA is available here.

If you/your company serves as the importer of record for food products entering the United States, contact us for more information on the FDA’s new rules and for support with developing your FSMA compliance program.