Proposed Rules. Notification of availability

Agency: Food and Drug Administration, HHS
Action: Notification of availability
Citation: FR Doc. 2020-09169 · Docket No. FDA-2020-D-1304 · 21 CFR 1

Summary

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled “Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency.” Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices. The guidance communicates the Agency's intention not to enforce certain requirements for the onsite monitoring activities and certificates for the currently recognized accreditation bodies (ABs) and accredited third-party certification bodies (CBs) in the Accredited Third-Party Certification Program for human and animal food in certain circumstances. Because travel restrictions and advisories related to COVID-19 may impact the ability of recognized ABs and accredited CBs to conduct onsite activities, this guidance provides temporary flexibility so that recognized ABs can maintain the accreditations of their CBs, and so that already-issued certifications need not lapse, in certain circumstances.

Dates

The announcement of the guidance is published in the Federal Register on April 30, 2020.

Supplementary Information

I. Background We are announcing the availability of a guidance for industry entitled “Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency.” This policy relates to the circumstances that gave rise to the public health emergency related to COVID-19 declared by the Department of Health and Human Services. Given this public health emergency this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices. The guidance represents the current thinking of FDA on this topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. This guidance document concerns certain requirements for the recognized ABs and accredited CBs in the Accredited Third-Party Certification Program that was established in 21 CFR part 1, subpart M, as part of our implementation of the FDA Food Safety Modernization Act (Pub. L. 111-353). The Accredited Third-Party Certification Program regulation ( https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-accredited-third-party-certification ) requires recognized ABs to monitor the performance of the CB(s) they accredited. While some of the monitoring activities can be conducted remotely, some of the activities must be conducted onsite. The Accredited Third-Party Certification Program regulation also requires that accredited CBs can issue certificates for a term only up to 12 months. Due to the impact of the travel restrictions and advisories related to COVID-19, this guidance provides flexibility to the recognized ABs and accredited CBs in the Accredited Third-Party Certification Program for certain requirements related to the onsite monitoring activities and certificates that have already been issued, in certain circumstances. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved FDA collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in in part 1, subpart M, have been approved under OMB control number 0910-0750. III. Electronic Access Persons with access to the internet may obtain the guidance at https://www.fda.gov/FoodGuidances, https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19 or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: April 24, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-09169 Filed 4-29-20; 8:45 am]