Conferences canceled. Movie theaters shuttered. Temperature checks at work - it’s obvious these are unprecedented times. Companies are racing to accommodate and anticipate new consumer needs and a new reality. The United States Food and Drug Administration (FDA) is no different. In light of the pandemic and shifting safety concerns, the FDA has issued three temporary policies to guide companies.
1 - Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency: This guidance provides the Accredited Third-Party Certification Program’s currently-recognized accreditation bodies (ABs) and accredited certification bodies (CBs) flexibility. In certain circumstances, this guidance offers flexibility around the requirement that ABs monitor the performance of CBs with onsite observations, as well as the requirement that certificates be issued for only a one-year term for those already-issued certifications granted under the Accredited Third-Party Certification Program.
2 - Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: This guidance announces flexibility in the eligibility criteria for the qualified exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule) (21 CFR Part 112) due to disruptions to the supply chain for the duration of the COVID-19 pandemic.
3 - Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: This guidance offers details around the specific cases under which the FDA will not enforce onsite audit requirements. It details that when circumstances allow for it to be safe to do so, receiving facilities and FSVP importers should attempt to resume onsite audits quickly and should revise their food safety plans and FSVP to include new details.
The FDA implemented all three guidances without public comment because it determined that prior public participation for the guidances was not “feasible or appropriate.” Additionally, all three guidances are merely that - guidance. Meaning the FDA intends these as recommendations and are not legally enforceable. Take these guidances seriously, as they will protect your workforce, suppliers, customers, and brand.
Our on demand webinar offers more clarity around the temporary FSVP policy. James Chu, FSVP Lead Instructor and Supplier Quality Manager at John B. Sanfilippo & Son, Inc., shares expert insight on how to comply with temporary FSVP policy updates, including how to verify suppliers remotely and how your company should prepare in the event of a remote FDA inspection. You can watch it here.