Third-Party Certification Modernization Act

Summary#

This bill amends the Federal Food, Drug, and Cosmetic Act to expand the FDA's accredited third-party certification program for food safety. It updates definitions to say eligible entities can be domestic or foreign facilities that choose to be audited by accredited third-party auditors. It expands the meaning of a "regulatory audit" and removes limits on how third-party food and facility certifications can be used.

The bill requires the Secretary to set up a system to recognize accreditation bodies that accredit third-party auditors within 2 years. It directs the FDA to use third-party certifications when deciding whether imported foods meet import requirements, whether a facility qualifies for the voluntary qualified importer program, and permits using certification results to analyze risks and prioritize inspections and other regulatory activities. The bill also adds a record item for inspections to note whether a facility holds a certification aligned with FDA preventive controls regulations.

What it means for you#

  • Domestic and foreign food facilities can choose to be audited by accredited third-party auditors and seek food or facility certifications.
  • Importers may have third-party food certifications used by FDA to determine whether foods meet import requirements.
  • Facilities with certifications may be evaluated for the voluntary qualified importer program.
  • FDA may consider third-party audit results when prioritizing inspections and other regulatory work.
  • The FDA must create a recognition system for accreditation bodies within two years.

Expenses#

No publicly available information on estimated costs, appropriations, or funding levels is included in the bill text. The bill does require the Secretary to establish a recognition system for accreditation bodies within two years, but the text does not provide cost estimates or funding sources.

Proponents' View#

No publicly available information in the bill text about proponents' statements or arguments for the bill.

Opponents' View#

No publicly available information in the bill text about opponents' statements or arguments against the bill.