Food Industry Regulatory Update December 23, 2022

In This Week’s Edition:

Best Practices for Convening a GRAS Panel; Guidance for Industry; Availability
Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern
2023 Rate Changes for the Basetime, Overtime, Holiday, Laboratory Services, and Export Application Fees
FDA CORE Outbreak Investigation Status Update
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
FDA Warning Letters

Best Practices for Convening a GRAS Panel; Guidance for Industry; Availability

FDA is announcing the availability of a final guidance for industry entitled “Best Practices for Convening a GRAS Panel.” This guidance document is intended for any person who is responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act when that person convenes a panel of experts to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food.

Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern

FDA is announcing the availability of a draft guidance for industry #152 entitled “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” This draft guidance informs stakeholders about FDA’s current method for evaluating potential microbiological effects of antimicrobial new animal drugs on bacteria of human health concern as part of the new animal drug application process.

2023 Rate Changes for the Basetime, Overtime, Holiday, Laboratory Services, and Export Application Fees

FSIS is announcing the 2023 rates it will charge meat and poultry establishments, egg products plants, and importers and exporters for providing voluntary, overtime, and holiday inspection and identification, certification, and laboratory services. Additionally, FSIS is announcing that there will be no changes to the fee FSIS assesses to exporters that choose to apply for export certificates electronically through the export component of the Agency’s Public Health Information System. The 2023 basetime ($67.12), overtime ($82.80), holiday ($98.44), and laboratory services rates ($87.36) will be applied on January 1, 2023.

FDA CORE Outbreak Investigation Status Update

This week’s updates are:

No new updates

CORE Investigation Table

FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.

FDA Import Alerts

The latest FDA import alerts include adulteration of honey, cheese due to microbiological contamination, foods due to heavy metal contamination, and more.