According to FDA, approximately one in six Americans experiences a foodborne illness each year, with about 128,000 of those cases resulting in hospitalization. Nearly 3,000 people die each year from foodborne diseases, which most frequently include older adults, young children, and individuals with compromised immune systems.
Signed into law in 2011, the Food Safety Modernization Act (FSMA) enables FDA to better protect public health by strengthening food safety and increasing focus on food safety prevention rather than just reacting to problems. The law and the rules that followed were designed to put more accountability on food and ingredients producers to understand and control the risks associated with the foods they make or import into the U.S. from other suppliers. Under the rule, imported foods must be assured of food safety compliance equivalent to that of foods produced in the U.S.
Finalized in November 2015, FDA’s Accredited Third-Party Certification Program was created to ensure increased safety of imported food products. Third-party certification bodies can become accredited to perform FDA regulatory audits and issue certificates to facilities outside the U.S. The certificate is required for eligibility to supply products to an importer participating in the Voluntary Qualified Importer Program (VQIP) and for FDA-mandated import certification. An importer verifying supplier food safety may also use this certification audit to comply with the supplier verification activity requirements of the Foreign Supplier Verification Program (FSVP) rule of FSMA.
The supplier’s scope of certification is determined by the product and process employed in manufacturing and production of the food—preventive controls for human food, the produce safety rule, seafood HACCP, or juice HACCP. The audit also verifies compliance with any additional applicable food safety regulations that apply for sites exempt from the preventive controls rules for food, such as thermally processed low-acid canned foods, acidified foods, and others. The regulations regarding sanitary transport also apply for those activities under the control of the certified site.
The Accredited Third-Party Certification Program was created to:
- Establish eligibility for participation in VQIP, which offers expedited review and entry of food at the U.S. border;
- Assist food importers in identifying and addressing potential safety issues before food reaches the U.S.; and
- Help ensure imported foods are produced in accordance with the same safety standards required of U.S. foods.
Foreign Supplier Verification Program
Under FSMA, importers are responsible for ensuring the safety of food products they bring into the U.S. for distribution and sale for public consumption. FSVP requires importers to verify that food imported into the U.S. is not adulterated or misbranded with respect to allergen labeling and it complies with U.S. product safety standards.
Food hazards can be biological, chemical, or physical and can be intentionally or unintentionally introduced. Importers must conduct a documented review of the imported food, as well as the supplier’s performance, every three years. The importers must identify and evaluate reasonably foreseeable hazards for each type of food imported to determine whether there are any that require control and, if so, document them. The hazards evaluated must also include an assessment of vulnerability of the materials or products to food fraud, or to economically motivated adulteration.
Importers are responsible for determining the appropriate activity to verify that any identified hazards have been controlled. The verification activity most appropriate is dependent on many factors, including the nature of the hazard and the severity of the risk associated with failure to control it, any additional processing the food may receive further along in the value chain that may reduce the hazard or its severity, and the intended consumer market for the food. Appropriate verification activity by a qualified individual may include annual onsite audits of the supplier’s facility, sampling, and testing, and a review of relevant food safety records is a requirement.