Center for Veterinary Biologics and FSIS Announce Interest in Salmonella Vaccines for Poultry

The Animal and Plant Health Inspection Service’s Center for Veterinary Biologics (CVB) has published Notice No. 24-15, Salmonella Vaccines and USDA Food Safety and Inspection Service’s Framework to Reduce Salmonella Illnesses Attributable to Poultry to inform veterinary biologics manufacturers of FSIS’ interest in Salmonella vaccines for poultry. As part of the Salmonella Framework for Raw Poultry Products, FSIS has proposed serotypes of public health significance for raw chicken carcasses, chicken parts, and comminuted chicken (Enteritidis, Typhimurium, and I,4,[5],12:I:-); and for raw comminuted turkey (Hadar, Typhimurium, and Muenchen). FSIS also noted that Salmonella Infantis remains a serotype of considerable concern in terms of potential severity of illness and antimicrobial resistance and has requested comment on the possible inclusion of Infantis as a serotype of public health significance. FSIS is interested in learning about and engaging in discussions with veterinary biologics manufacturers on vaccination technologies, especially modified-live vaccines targeting FSIS’ proposed serotypes of public health concern or their associated serogroups.

CVB regulates the licensing of veterinary biologics, including products for animal pathogens, such as Salmonella, that are also considered food safety risks. CVB has published previous notices describing the jurisdictional issues where food safety is an additional consideration beyond an animal health claim, including Notice 05-07, Biologics for Reduction of Colonization and/or Shedding in Animals and Notice 12-09, Licensing of Vaccines as Preharvest Food Safety Interventions.

As a reminder, FSIS extended the comment period for the Salmonella Framework for Raw Poultry Products proposed rule and determination until January 17, 2025. Written comments may be submitted online via the federal eRulemaking portal, available at www.regulations.gov; by mail sent to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Washington, DC 20250-3700, or by hand or courier delivery to 1400 Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, Washington, DC 20250-3700. All items submitted must include the agency name and docket number FSIS-2023-0028.

FSIS to Consider Additional Import Inspection Establishment Applications

All shipments of meat, poultry, or egg products must be reinspected by FSIS at an official import inspection establishment after meeting U.S. Customs and Border Protection and Animal and Plant Health Inspection Service requirements. All facilities intending to operate as official import inspection establishments must apply for a Federal Grant of Inspection (GOI) (9 CFR 304.1).

Since 1990, FSIS has limited GOIs for official import inspection establishments to facilities within 50 miles of conventional ports of entry, generally located around the country’s perimeter in consideration of food defense and security issues, as well as inspection resource constraints. 

However, more recently, FSIS’ security and food defense concerns have been addressed by advances in international trade data systems, the implementation of the agency’s Public Health Information System (PHIS) electronic import component, import prior notification requirements (9 CFR 327.5, 381.198, 557.5, and 590.920), and the agency’s ability to track import shipments when they arrive in the U.S. Therefore, FSIS has decided that going forward, it will not deny GOIs based exclusively on the 50-mile criterion.

To provide more flexibilities to importers and domestic establishments, FSIS will consider, on a case-by-case basis, GOIs for official import inspection establishments outside the 50-mile geographic radius of a U.S. land or sea port of entry. In reviewing GOI applications for import inspection establishments, FSIS will consider factors such as: 1) the availability of inspection program personnel to staff the establishment; 2) the expected volume of product; and 3) the hours the establishment would be operating to determine whether FSIS should issue the GOI.

While FSIS wants to provide more flexibility to import businesses, this flexibility must be balanced against the agency’s existing inspection resources. FSIS will assess the factors listed above to ensure that potential official import inspection establishments have a consistent work schedule that would provide for the efficient and effective use of FSIS import inspection personnel as outlined in 9 CFR 307.4(d)(1) and (2).

Please visit the FSIS website for more information on how to apply for a GOI.

IFSAC Releases 2022 Annual Report on the Sources of Foodborne Illness

The Interagency Food Safety Analytics Collaboration’s (IFSAC) newest annual report, “Foodborne illness source attribution estimates for Salmonella, Escherichia coli O157, and Listeria monocytogenes – United States, 2022” is now available.

IFSAC is a collaboration between FSIS, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). The group was established in 2011 to improve coordination of federal food safety analytic efforts and address cross-cutting priorities for food safety data collection, analysis, and use.

IFSAC analyzes foodborne illness outbreak data for priority pathogens and specific foods and food categories that are responsible for foodborne illnesses in the United States. The data are analyzed by calendar year and released in annual reports as part of ongoing efforts to understand sources of foodborne illness in the United States. CDC estimates that, together, these priority pathogens — Salmonella, Escherichia coli O157, Campylobacter, and Listeria monocytogenes — cause nearly 2 million cases of foodborne illnesses in the U.S. each year.

Attribution estimates for Campylobacter are again not presented in this year’s report. Evidence suggests the sources of Campylobacter outbreaks likely differ considerably from the sources of non-outbreak-associated illnesses caused by this pathogen. IFSAC is exploring alternative approaches for estimating the sources of Campylobacter illnesses.

The updated estimates, combined with other data, can help shape agencies’ priorities and inform the creation of targeted interventions that may help reduce foodborne illnesses caused by these pathogens. These estimates also inform stakeholders and improve our ability to assess whether prevention measures are working.

 For more information, visit IFSAC projects or email IFSAC@fda.hhs.gov.

FSIS to Update Multi-Residue Chemistry Methods

FSIS is improving two chemical residue methods used for the quantitative analysis of chemical residues and for aminoglycosides screening. 

The FSIS laboratory system is implementing an enhanced version of the quantitative and confirmation method for veterinary drug residue analysis (Quantitation and Confirmation of Animal Drug Residues by High-Resolution, Accurate-Mass Liquid Chromatography Mass Spectrometry (HRAM LC-MS); CLG-MRQ1). This enhanced version expands the capability of CLG-MRQ to analyze veterinary drugs with established tolerances in target tissues of bovines. The first version of CLG-MRQ1 included veterinary drug quantitation for bovine muscle. However, to further increase the capability of the method to other target tissues, the method has been expanded to include quantitative analysis of several chemical residues in bovine kidney and liver. Additionally, mass spectrometric criteria were added to simultaneously quantitate the amount of and confirm the presence of veterinary drugs in bovine muscle, kidney, and liver.

The FSIS laboratory system is also implementing an updated method version for screening aminoglycosides (Screening for Aminoglycosides by UHPLC-MS-MS; CLG-AMG4). The updated version clarifies preparation procedures for solutions and standards to include expiration dates and storage conditions. Format revisions that are similar to previously published method updates have also been made to the updated method.

The updated methods will be posted no later than January 13, 2025, on the Chemistry Laboratory Guidebook page of the FSIS website. Please direct questions regarding specific elements of any method to AskFSIS.

Available for Public Comment

FSIS seeks public comments on proposed rules and notices, which are viewable on the FSIS Federal Register & Rulemaking webpage. FSIS is currently seeking comments on the following:

• Until December 27, 2024: Uniform Compliance Date for Food Labeling Regulations (2024)
• Until January 17, 2025: Salmonella Framework for Raw Poultry Products
• Until February 3, 2025: Food Date Labeling

Export Requirements Update

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

• Taiwan
• Kazakhstan
• North Macedonia
• Singapore
• Cuba
• Ukraine
• Canada
• Curacao
• Chile
• Jamaica
• Dominican Republic
• Iraq
• Japan
• Mexico
• Turkey
• Azerbaijan

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