FDA Issues Temporary Policy Regarding Certain Accredited Third-Party Certification Program Requirements During COVID-19
Wednesday, April 29, 2020

FSMA established the Accredited Third-Party Certification Program, which is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies have the authority to accredit third-party “certification bodies,” otherwise known as third-party auditors. In turn, the certification bodies (1) conduct consultative and/or regulatory food safety audits and (2) issue certifications to eligible entities that produce food for humans and animals.

On April 22, FDA issued a temporary policy guidance document to address current challenges in conducting Accredited Third-Party Certification Program-related onsite monitoring activities during the COVID-19 public health crisis. The guidance provides currently-recognized accreditation bodies (ABs) and accredited certification bodies (CBs) flexibility so that ABs can maintain the accreditations of CBs, and already-issued certifications need not lapse where certain safeguards are in place.

The guidance document provides flexibility specifically with regard to the following:

For ABs monitoring accredited CBs, FDA does not intend to enforce the requirement that recognized ABs must conduct onsite observations of regulatory audits and visit the CBs headquarters within 1 year after accreditation and every 2 years thereafter. The FDA provides this flexibility when the AB determines that it is impracticable to conduct the observations or visit the headquarters due to government travel restrictions or advisories related to COVID-19, and the AB conducts annual comprehensive assessments of a CBs performance in accordance with 21 CFR 1.621(a).

For already-issued certificates under the Program, FDA does not intend to enforce the requirement that the CBs issue certificates for a term only up to 12 months when the CB determines that it is impracticable to conduct regulatory audits due to government travel restrictions or advisories related to COVID-19, among other requirements.

According to the guidance, ABs should resume onsite observations and visits within a reasonable period of time after it becomes practicable to do so.

 

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