Third-Party Certification and Inspection Modernization Act of 2026

Summary

Amends the Federal Food, Drug, and Cosmetic Act to broaden the FDA’s accredited third‑party auditor certification program. The changes allow domestic facilities and entities to be eligible, expand how third‑party audit results and certifications may be used (including for import eligibility and a voluntary importer program), permit FDA to consider certifications when setting inspection priorities, and make technical and conforming edits to existing program deadlines and references. The bill does not appropriate new funds or change tax law; it changes definitions, cross‑references, and one new factor FDA may use when targeting inspections, and it clarifies a two‑year recognition deadline for accreditation bodies.

• Allows domestic facilities registered with FDA to be eligible for accredited third‑party certification, not just foreign facilities.
• Expands the definition of regulatory audits so results can determine multiple types of certifications, including facility certifications for a voluntary importer program.
• Removes the requirement that third‑party certifications only accompany import shipments and authorizes their use for specified regulatory purposes.
• Adds a new inspection targeting factor permitting FDA to consider whether a facility holds an FDA‑aligned third‑party food safety certification.
• Clarifies and preserves a two‑year recognition deadline for accreditation bodies that oversee third‑party auditors.
• Does not appropriate new funds or change tax law; it primarily revises statutory definitions and FDA authorities.
• Could increase the role and demand for third‑party auditors and accreditation bodies across domestic and international supply chains.
• May shift FDA inspection prioritization and risk analyses by allowing certifications to be considered when scheduling inspections.