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FDA Seeks Public Comment for Third-party Auditor Accreditation Program

August 23, 2013

The U.S. Food and Drug Administration (FDA) is seeking public comment for its proposed rule to establish a program for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and of the foods they produce for humans and animals. The proposed rule would implement Section 307 of the FDA Food Safety Modernization Act (FSMA).

The proposed rule sets eligibility requirements for recognition as an accreditation body. An accreditation body can be a foreign government/agency or a private third-party. It must also meet standards for legal authority, competency and capacity, impartiality/objectivity, quality assurance, and records procedures.

The proposed rule also contains requirements relating to auditing and certification of foreign food facilities and food under the program and for notifying the FDA of conditions in an audited facility that could cause or contribute to a serious risk to the public health.

Importers will not generally be required to obtain certifications, but, in certain circumstances, the FDA may use certifications from accredited auditors in determining whether to admit certain imported food into the United States that the FDA has determined poses a food safety risk or in determining whether an importer is eligible to participate in a voluntary program now under development for expedited review and entry of food.