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.
A qualified individual is someone hired on a full-time basis or sought through an external resource to help you:
- Document and implement the hazard analysis, verification activities, and corrective actions;
- Conduct performance evaluation of foreign suppliers;
- Approve suppliers;
- Reevaluate FSVP and documentation;
- Perform on-site supplier verification activities; and
- Maintain up-to-date records.
Certification audits conducted according to the program may be used to satisfy the onsite audit activity requirement for supplier verification. Supplier certificates must be maintained as records to demonstrate compliance with FSVP.
When the FDA Third-Party Accredited Certification is used to satisfy FSVP requirements, it provides the opportunity to reduce audit burden and conserves human and financial resources related to repetitive or redundant customer audits. The audit against the applicable FDA regulations for the product scope may be conducted in conjunction with a current certification program, such as a Global Food Safety Initiative (GFSI) benchmarked food safety program, to ensure any gaps between the existing program and the FDA requirements are fully evaluated.
Voluntary Qualified Importer Program
VQIP, a voluntary fee-based program, provides expedited review and import entry of food brought into the U.S. for participating importers. Participating importers benefit from increased speed and predictability at U.S. points-of-entry. Consumers benefit from increased safety and security of imported foods.
VQIP suppliers must be certified by a certification body accredited under the FDA Third-Party Accredited Certification Program. A supplier site may choose to have a third-party consultative audit prior to the certification audit to help the site prepare. Consultative audits are not available from accredited certification bodies and may not be used for certification.
VQIP benefits for importers include:
- Quicker, easier market entry for imported goods;
- Limited examination and sampling;
- FDA sampling at importer’s preferred location; and
- Faster test results.
FDA High-Risk Import Certification
FDA may determine a foreign supplier or food product is high risk and mandate import certification (IC) by a Certification Body accredited under the FDA Third-Party Accredited Certification Program. FDA does not maintain a register or list of high-risk products, but may designate this status in the event of an ongoing food safety incident, as a result of field sampling, or in response to elevated risk to food safety due to geopolitical or natural events.
If FDA designates a product as high risk requiring import certification, the supplier would be notified by FDA and the site would choose the accredited certification body to perform the certification in order to qualify for import. The imported product must be accompanied by the certificate and be listed by the certification body on its public listing of certified sites.
Regardless of the reason for the certification, foreign suppliers and importers should remember:
- All accredited certification audits for VQIP suppliers and FDA high-risk imports are unannounced;
- FDA may mandate an import certification for high-risk products as a condition of import, unrelated to VQIP or FSVP;
- If a supplier undertakes a VQIP or IC audit by an accredited certifier, its audit information is shared with FDA, and it is listed publicly for its certification status and authorized products for import;
- Audit information for VQIP suppliers and FDA IC imports is subject to public disclosure under the Freedom of Information Act;
- If a VQIP or IC supplier is involved in a recall, the certification is immediately suspended pending further investigation;
- If a certification body observes a critical food safety hazard at the certified site, FDA is immediately notified, the certification audit is stopped, and certification is suspended;
- Importers and suppliers must maintain clean food safety records for the three years immediately preceding certification; and
- Mixed loads of certified and non-certified products for VQIP imports will be detained in order to separate the load.
Accreditation and Certification Process
FDA authorized independent accreditation bodies to assess the program integrity for those certification bodies that have applied for and achieved accreditation under this program. The certification bodies currently accredited are listed on the FDA website as well as with the accreditation bodies (ANSI, ANAB, IAS, etc.).
Accreditation of certification bodies, such as NSF International, under the FDA Third-Party Accredited Certification Program requires that the certification body establish a system for managing the certification process integrity, demonstrate auditor and personnel competence, training and qualifications, and maintain records of certification activities.
The audit duration and cost are variable depending on the scope and complexity of the requested audit, and are determined by the requirements of the accredited certification body. Typically the full process from application to certification decision requires three to four months to complete. The certification process is similar to third-party food safety certification programs in several ways, including:
- Application and contract review;
- Determination of scope and assignment of auditor;
- Document and records review;
- Resolution of any non-conformance from document review;
- Certification audit;
- Technical review for accuracy and quality of report;
- Non-conformance corrective action and closure; and
- Certification decision and report issued within 45 days of audit.
Following a positive certification decision, the certificate is valid for 12 months. In cases where the product is seasonal, the certificate is valid only for the audited season of production. Additional audits are required for multiple seasons within the annual production cycle.
Broad adoption of this newly available and flexible solution will help to reduce audit fatigue on the part of the manufacturers and suppliers engaging in supplier verification activity to comply with FSMA. The scope of the audit can be broad to service the full range of production at a supplier site or limited to only a narrow scope of product or process. It recognizes the robust structures in place established through GFSI while also covering the gap for FDA-specific compliance verification.
Whether the audit is conducted at the supplier for eligibility for VQIP, as FDA import certification, or as an FSVP verification activity, the audit against FDA regulations provides a consistent standard of equivalent compliance, regardless of the origin of the food.
Allen is the associate managing director of Supply Chain Food Safety Operations at NSF International. Reach her at firstname.lastname@example.org.