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FSMA Final Rule on Accredited Third-Party Certification

Finalized: November 2015

The FDA’s Food Safety Modernization Act (FSMA) introduced a rule in November 2015 establishing the Accredited Third-Party Certification Program. This voluntary program allows third-party certification bodies—also known as third-party auditors—to be accredited to conduct food safety audits and issue certifications for foreign food facilities producing food for humans and animals.

The primary goal? To ensure that only competent, impartial, and qualified third-party auditors operate within the U.S. import system, helping safeguard the food supply from risks and improving international accountability.

Why This Matters

Under FSMA, certified audits by accredited third-party auditors can be used in two critical ways:

  1. Eligibility for VQIP: Certifications can help importers qualify for the Voluntary Qualified Importer Program (VQIP), which provides faster FDA review and entry of food imports.
  2. FDA-Mandated Certification: In specific situations, the FDA may require a certification before a food can be imported—especially if there’s concern about potential health risks.

Key Elements of the Program

  1. Scope of the Rule

This rule outlines:

  • How accreditation bodies can be recognized by the FDA.
  • How third-party certification bodies can become accredited.
  • Requirements such as legal authority, technical competency, conflict-of-interest protections, recordkeeping, and quality assurance.

To support consistency with international standards, the program allows the use of documentation aligned with ISO/IEC standards (global benchmarks set by the International Organization for Standardization and the International Electrotechnical Commission).

Note: If no suitable accreditation body is recognized within two years, the FDA may directly accredit third-party certification bodies.

The FDA retains the authority to monitor, revoke, or withdraw accreditation if standards are not met.

  1. Responsibilities of FDA-Recognized Accreditation Bodies

Accreditation bodies, which may include foreign government agencies or private entities, must:

  • Assess and accredit third-party certification bodies, including observing audits during the review process.
  • Regularly monitor and audit the certification bodies they accredit.
  • Notify the FDA of any changes in accreditation status.
  • Submit reports and maintain records accessible to the FDA.
  • Continuously evaluate and improve their own operations.
  1. Requirements for Accredited Third-Party Certification Bodies

Once accredited, third-party auditors are held to strict standards. They must:

  • Conduct unannounced audits of food facilities.
  • Immediately notify the FDA if a serious public health risk is discovered.
  • Ensure their audit teams are qualified and impartial.
  • Confirm that facilities have effectively corrected any identified deficiencies.
  • Keep complete records available for FDA inspection.
  • Monitor and improve their own performance.

There are two types of audits:

  • Consultative Audits: Pre-certification assessments, intended for internal facility improvement. These also review compliance with industry best practices.
  • Regulatory Audits: Formal inspections that determine whether a facility qualifies for certification. Only these can be used for VQIP or required import certification.

Who Can Be a Third-Party Auditor?
Accreditation is open to both foreign government entities and private sector auditors.

Supporting FDA Guidance and Actions

  • Model Accreditation Standards (Dec 2016): Provides guidance on education, experience, and qualifications for third-party auditors and their agents.
  • VQIP Guidance (Nov 2016): Explains how certified importers can benefit from streamlined import procedures—helping FDA focus resources on higher-risk imports.
  • User Fee Rule (Dec 2016): Sets annual fees for participation in the program to cover FDA costs.
  • First Accreditation (Jan 2018): ANSI-ASQ National Accreditation Board was announced as the first recognized accreditation body.
  • FAQs Guidance (Apr 2022): Draft guidance published to answer common industry questions about the program.

Exemptions

Some products and producers are not subject to mandatory import certification under this rule, including:

  • Certain alcoholic beverages made by foreign facilities under specific conditions.
  • Meat, poultry, and egg products regulated by the U.S. Department of Agriculture (USDA) at the time of import.

Implementation Timeline

  • June 2017: FDA launched an application portal for organizations seeking to become recognized accreditation bodies.
  • Third-party certification bodies may apply for accreditation once recognized accreditation bodies are actively accepting applications.

This program represents a major step forward in food import safety—allowing the FDA to better manage risks and giving trusted importers the opportunity to benefit from faster entry processes. For food businesses abroad, earning certification through an accredited third-party can open doors to the U.S. market while building consumer trust through verified safety practices.

Source: United States Food and Drug Administration (FDA)

Reach out to Fresh Group Food Safety And Quality Consulting for any inquiries related to food quality and safety.