The U.S. Food and Drug Administration (FDA) in late April announced draft guidance for the Accredited Third-Party Certification, a voluntary program within the Food Safety Modernization Act (FSMA). The guidance aims to encourage more organizations to participate in the Accredited Third-Party Certification Program (also referred to as the Third-Party Program or TPP) which would expedite regulatory approval of foreign food and beverage into the U.S.
The guidance will clarify the purpose of the TPP by providing answers to frequently asked questions relating to the requirements for prospective accreditation bodies who recognize certification auditors. These third-party certification bodies are tasked with providing consultative and regulatory audits for foreign food entities to make sure that they are in compliance with applicable U.S. food safety requirements.
The FDA anticipates that the guidance will be an impetus for additional participation in TPP by allowing more companies and organizations seeking accreditation status and more certification groups to be accredited to audit foreign food companies, a FDA spokesperson said in an email response to questions.
The FSMA, signed into law in 2011, established standards and enforcement procedures to prevent potentially harmful food from reaching U.S. consumers food safety regulations. The TPP rule was added in 2015 to help the FDA expedite the process of regulating foreign food entering the country.
The guidance provides transparency in a confusing process of food safety oversight. For foreign food or beverage companies looking to break into the U.S. market, getting an audit from a certification body can make the regulatory process run smoothly.
Although the TPP program is voluntary, it benefits the FDA as well. If there are more recognized accreditation bodies and more accredited certification entities, the FDA has less obstacles to quickly moving food and beverage brands through the regulatory process while maintaining food safety standards.
By allowing third-party entities to accredit certification bodies, the FDA created a framework for food importers to participate in the Voluntary Qualified Importer Program (VQIP), a voluntary, fee-based program that expedites review and import of human and animal foods to help importers avoid unexpected delays at the point of entry.
The FDA insists that participation in VQIP has increased every year and has retained all of its participants since its inception in 2019.
One of the eligibility criteria for participation in VQIP is that each foreign supplier of food imported must be certified under TPP.
“Increased numbers of TPP participants may make it easier for eligible entities to seek certification and for importers, including food and beverage importers, to have their foreign suppliers (eligible entities) certified under TPP for the purposes of VQIP eligibility,” an FDA spokesperson said.
The TPP draft guidance provides a framework for businesses interested in becoming accreditation bodies and provides clarity for all parties interested in participation in TPP. The guidance explains how to apply for TPP status, the requirements and scopes of recognition for accredited certification bodies under TPP, and what areas those bodies oversee in their audits of eligible food importers.
The comment period is open for 90 days in the Federal Register and the FDA will consider the comments submitted during the comment period when finalizing the guidance.
In addition to the four active accreditation bodies (American National Standards Institute, ANSI National Accreditation Board, International Accreditation Services and the National Bureau of Agricultural Commodity and Food Standards) recognized by the FDA, there are 13 active certification entities able to provide consultative and regulatory audits for food importers.