Food Safety Modernization Act (FSMA)
Accredited Third-Party Certification Rule

FSMA: Accredited Third-Party Certification Rule

The Accredited Third-Party Certification Rule creates a voluntary certification system for foreign food entities under the Food Modernization Act (FSMA). It establishes requirements and procedures for accreditation bodies to be recognized by the FDA. Once recognized, those accreditation bodies can certify auditors.

The Rule regulates third-party auditors that food and beverage industry members may use. In effect since 2016, it enables importers to access expedited review through the Voluntary Qualified Importer Program (VQIP) and complete food safety audits as ordered by the FDA.

This rule is related to the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Rule.

How the Rule achieves its goal

Accrediting bodies must follow International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) standards, with FDA oversight ensuring compliance. These requirements achieve international consistency for auditors.

Food safety audits

The FDA can require certifications for specific imported foods when necessary to protect public health. Certification bodies, or third-party auditors, can perform two kinds of food safety audits:

Consultative audits determine if a foreign entity is in compliance with industry standards and U.S. food safety requirements.
Regulatory audits determine whether a facility complies with FDA regulations and the Food, Drug, and Cosmetics (FD&C) Act’s food safety requirements.

In rare cases, the FDA appoints independent auditors for potentially harmful border shipments.

Voluntary Qualified Importer Program (VQIP)

The VQIP expedites FDA review of animal and human food imports. Approved importers receive immediate clearance for most shipments. Required examinations use smaller samples with prioritized lab results, enhancing safety while reducing delays.

Importers can apply for the VQIP via the FDA website.

Who must comply with the Rule?

The FDA can require mandatory import certification for all goods except:

Some foreign-manufactured alcoholic beverages
Some USDA-regulated poultry, egg, and meat products

Any accrediting body seeking to qualify food safety auditors for the VQIP or mandatory import certification must meet the FDA’s guidelines. Any potential auditor must, in turn, meet criteria from the FDA and a recognized accreditation body.

Non-compliance consequences for the food & beverage industry

The FDA can order mandatory import certifications for imported food products when they arrive at the border for U.S. Customs and Border Protection (CBP) inspection. The CBP keeps the imported foods in custody until they are cleared.

Importers must get an inspection or export or destroy non-compliant foods within 90 days. The CBP may collect liquidated damages from the importer’s bond if an importer does not comply.

Non-compliance consequences for accrediting bodies and auditors

Accreditation bodies maintain FDA authorization through regular self-monitoring reports, record access, and timely performance corrections. Auditors maintain accreditation by meeting performance standards, ensuring staff objectivity and competency, and providing FDA record access. Failure to comply results in no longer being recognized by the FDA for accrediting bodies and losing accreditation for auditors.

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Reason for the Rule

The FDA created the Accredited Third-Party Certification Rule as a streamlined, secure way for foreign food suppliers to get their imports approved. Under the FD&C Act, the FDA has authority to require certification for foods entering the U.S. The Rule provides a framework for this.

History

The FDA first proposed the Accredited Third-Party Certification Rule in 2013 and established it in late 2015. It began accepting applications and recognized its first accrediting body in 2018. More recently, the FDA determined food auditing safety standards and established VQIP guidelines.

Timeline

January 2011: FSMA becomes law, establishing foreign food auditing provisions.
July 2013: The FDA publishes the Accredited Third-Party Certification proposed rule.
November 2015: The FDA finalizes the rule and establishes the voluntary program for third-party certification bodies.
December 2016: The FDA issues Model Accreditation Standards, outlining audit requirements and auditor qualifications to clear up confusion about the Rule.
January 2018: The FDA recognizes the first accreditation board for the Rule
October 2020: The FDA launches a voluntary pilot program for evaluating third-party food safety standards
July 2023: As a result of the voluntary pilot program, the FDA determines four third-party food safety auditing standards that align with FSMA
November 2024: The FDA issues new guidance for the VQIP.

In the news

Updated February 2025