Reminder: Upcoming FSIS Webinar on Public Health Regulations 

On October 7, 2021, FSIS will host a webinar from 2:00 - 3:00 p.m. ET, to provide an overview of the Public Health Regulations (PHRs) for fiscal year 2022. PHRs are used to recommend establishments for a Public Health Risk Evaluation (PHRE) and to provide early warning alerts to prevent a future loss of process control. This overview will include the process for selecting PHRs as well as answer commonly asked questions.

Please submit questions for the webinar to fsis@usda.gov by October 4, 2021. On the day of the event, please use this link to join the webinar.

Reminder: Upcoming Deadlines for Inspection of Egg Product Exports to the U.S. 

On September 7, 2021, FSIS published a Federal Register notice describing upcoming deadlines to submit equivalence documentation for countries that currently export or wish to export egg substitutes and/or freeze-dried egg products to the U.S. According to the October 2020 final rule on egg product inspection regulations, FSIS will begin enforcing its regulation of these products on October 30, 2023. For this reason, countries that already export or wish to export these products to the U.S. must undergo an equivalence determination by FSIS. The notice describes the following deadlines:

• Phase 1: Notify FSIS of intention to export egg substitutes and freeze-dried egg products to the United States by October 30, 2021.
• Phase 2: Submit a complete self-reporting tool (SRT), including supporting documentation, that demonstrates how a country’s egg products inspection system achieves an equivalent level of public health protection to FSIS’ inspection system by April 30, 2022.
• Phase 3: Receive a determination by FSIS that the SRT submission and supporting documentation demonstrates that the country maintains an equivalent documented egg products inspection system to FSIS’ inspection system by October 30, 2023.

Additionally, countries that currently maintain egg product inspection systems equivalent to that of FSIS (i.e., Canada and the Netherlands) and wish to continue as well as countries that begin exporting egg substitutes and/or freeze-dried egg products to the U.S. after October 30, 2023, must submit an updated certified establishment list by October 1, 2023, that includes establishments producing those products.

Reminder: FSIS Seeks Comments on the Labeling of Meat and Poultry Products Derived from Animal Cells 

On September 2, 2021, FSIS announced an advance notice of proposed rulemaking (ANPR) to solicit comments and information regarding the labeling of meat and poultry products made using cultured cells derived from animals under FSIS jurisdiction. FSIS will use these comments to inform future regulatory requirements for the labeling of such food products.

In 2019 USDA and the Food and Drug Administration (FDA) announced a formal agreement to jointly oversee the production of human food products made using animal cell culture technology to ensure that such products brought to market are safe, unadulterated and truthfully labeled. Under the agreement, FDA will oversee cell collection, growth, and differentiation of cells. FDA will transfer oversight at the cell harvest stage to FSIS. FSIS will then oversee the cell harvest, processing, packaging, and labeling of products. FDA and FSIS also agreed to develop joint principles for the labeling of products made using cell culture technology under their respective labeling jurisdictions. Seafood, other than Siluriformes fish, falls under FDA’s jurisdiction, whereas meat, including Siluriformes fish, and poultry are under FSIS’ jurisdiction.

FSIS has received numerous comments on the topic in response to a 2018 joint public meeting with FDA and regarding two petitions for rulemaking (from the United States Cattlemen's Association and Harvard Law School Animal Law and Policy Clinic). The Agency now seeks additional comments on specific topics that will inform rulemaking related to statutory and regulatory requirements for the labeling of these meat and poultry products. Topics include consumer expectations about the labeling of these products, especially considering the nutritional composition and organoleptic qualities (taste, color, odor, or texture) of the products; names for these products that would be neither false nor misleading; economic data; and any consumer research related to labeling nomenclature for products made using animal cell culture technology. Should any labels be submitted before the Agency completes its rulemaking, FSIS acknowledges in the ANPR how they would be generally evaluated.

Other than labeling regulations for this product, FSIS does not intend to issue any new food safety regulations for the cell-cultured food products under its jurisdiction. Current FSIS regulations requiring sanitation and Hazard Analysis and Critical Control Point (HACCP) systems are immediately applicable and sufficient to ensure the safety of products cultured from the cells of livestock and poultry.

The 60-day comment period on the ANPR closes on November 2, 2021. To view the ANPR and information on how to comment or submit information, please visit the FSIS website.  

Policy Update

FSIS notices and directives on public health and regulatory issues are available on the FSIS Policy webpage. The following policy updates were recently issued:

FSIS Notice 39-21 - FSIS Vehicle Telematics Implementation Phase-in

FSIS Notice 40-21 - Proof of Vaccination Survey

FSIS Notice 41-21 - New Sanitation Requirements in Egg Products Plants Going into Effect

Export Requirements Update

The Library of Export Requirements has been updated for products for the following:

• Australia 

Complete information can be found at the FSIS Import & Export Library.