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December 20, 2024
Note: FSIS will be publishing the next Constituent Update on Friday, January 3, 2025, due to the holiday season.
FSIS Announces Stronger Measures to Protect the Public from Listeria monocytogenes
On December 17, 2024, FSIS announced several new steps to strengthen the agency’s oversight of food processing facilities it regulates and ensure safe food. These steps reflect the agency’s continual effort to protect public health through science-based regulation, strong enforcement, and advancement of its prevention-first approach to eliminating foodborne illness.
Over the past several months, Listeria monocytogenes has been linked to foodborne illness outbreaks and large-scale recalls of ready-to-eat meat and poultry products, causing the agency to review its processes closely. While the agency’s review continues, FSIS announced a number of improvements and initiatives that can be implemented quickly. These actions are intended to strengthen FSIS’ inspection and oversight by enhancing its ability to proactively identify and respond to the types of systemic problems that could lead to outbreaks.
The changes FSIS announced fall into three categories: enhancing its science-based approach to mitigate foodborne pathogens, with a key focus on Listeria monocytogenes; improving training and tools for its inspection workforce; and evolving its oversight of regulated facilities, with an emphasis on data review and state inspection agreements.
Directives and Notices related to these measures were posted to our website.
For more information, please read the full press release.
FSIS Enhances Detection Capability for Listeria and Issues Instructions to FSIS Personnel for Responding to Results
FSIS has enhanced its Listeria testing method to incorporate detection of non-Lm Listeria spp. in addition to L. monocytogenes. This enhancement will improve insight into the effectiveness of an establishment’s sanitation program during the production of ready-to-eat (RTE) meat, poultry, and egg products and decrease the results reporting time for most routine samples. FSIS will implement this new method on January 17, 2025. Under this new method, FSIS will adopt a single 24-hour Listeria sample enrichment step, a Listeria spp. rapid screening kit, and selective media that will streamline the laboratory identification of non-Lm Listeria spp. and L. monocytogenes. These changes will allow establishments to receive negative results within one day after a sample is received by FSIS, in most cases. This change is an important enhancement that will allow FSIS and establishments to respond to positive findings quickly and shows how FSIS continues to implement the latest testing methods to further food safety. The “Notice of Change” page included at the front of each revised or new Microbiology Laboratory Guidebook (MLG) chapter provides an overview of the changes made throughout the document. Further details can be found in the MLG.
FSIS has also issued FSIS notice 50-24 that provides instructions to inspectors concerning the new testing. This notice explains that the samples that inspectors collect for RTE products (including domestic and imported meat, poultry, and egg products), food contact surfaces (FCSs), and non-food contact surfaces (NFCS) will be analyzed for both L. monocytogenes as well as other Listeria spp. FSIS is not making any changes to how it analyzes these products for Salmonella. Therefore, FSIS will continue to test these RTE products for Salmonella and will not test FCSs or NFCS for Salmonella (except FCS and NFCS samples collected during Salmonella Intensified Verification Testing).
Results for non-Lm Listeria spp. and L. monocytogenes will be reported at the same time. Establishments will receive all results by email. When RTE product samples, food contact, or environmental, non-food contact samples collected are positive for non-Lm Listeria spp. but negative for Lm and Salmonella, the product can move into commerce although establishments must take corrective actions. The FSIS notice discussed above provides that FSIS inspectors will inform establishments of this requirement. Positive sampling results in these RTE products indicate that the establishment’s sanitation program is ineffective at preventing conditions where Lm contamination may occur and may have failed to prevent direct contamination of product resulting in adulteration. Conditions that allow Listeria spp. other than Lm to inhabit and thrive in various sites in a production facility, such as on floors, in drains, or in standing water, are the same conditions that allow Lm to occupy and thrive in those sites. In addition, if sanitation and employee hygiene practices allow Listeria spp. other than Lm to cross-contaminate processing equipment, gloves or aprons of employees, and product, those same practices may allow Lm contamination.
FSIS notice 50-24 provides that FSIS inspection program personnel will verify corrective actions are taken by establishments in response to positive non-Lm Listeria spp. findings in RTE product samples, food contact, and environmental, non-food contact samples. FSIS inspection program personnel will also discuss with supervisory personnel to determine if additional follow up is needed (for example, if the District Office should assign a Food Safety Assessment, intensified sampling, or recommend enforcement actions) considering trends in FSIS sampling results over time, such as recurring non-Lm Listeria spp. positives and other information such as Sanitation Standard Operating Procedure and Sanitation Performance Standard noncompliance and establishment test results.
Today, FSIS announced that it is soliciting nominations for membership to the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). NACMCF is the advisory committee charged with providing impartial scientific advice and recommendations to FSIS and other government agencies on microbiological and public health issues relative to the safety of the U.S. food supply. FSIS expects to appoint 30 committee members in 2025, whose work will include reviewing FSIS’ regulatory approach to Listeria monocytogenes.
FSIS is seeking nominations from individuals with knowledge and expertise in microbiology, risk assessment, epidemiology, public health, food science and other relevant disciplines to obtain the scientific perspective, expertise, experience and point-of-view of all stakeholders. Nominees affiliated with consumer groups are not required to have a scientific background. Persons in academia, industry, state and local government officials, public health organizations, and industry and consumer organizations are invited to submit nominations. Self-nominations are welcomed.
The food safety programs of FSIS and the U.S. Department of Health and Human Services (HHS) Food and Drug Administration (FDA) are strengthened through NACMCF recommendations. The programs of other federal agencies concerned with food safety, including the Department of HHS Centers for Disease Control and Prevention, the Department of Commerce, National Marine Fisheries Service, and the Department of Defense (DoD), Veterinary Services also benefit from NACMCF work.
The committee is currently addressing Cronobacter spp. in powdered infant formula for the Food and Drug Administration and the benefits of genomic characterization of pathogens for FSIS. In addition to focusing on Listeria monocytogenes, FSIS anticipates that the 2025-2027 term committee may also explore food safety strategies for aged raw milk cheeses. We especially encourage the nomination of candidates with expertise in these specific areas.
NACMCF nominations must be accompanied by a cover letter addressed to the Secretary of Agriculture. Submissions must include a resume or curriculum vitae and a completed USDA Advisory Committee Membership Background Information form AD-755.
All nomination packages must be received by February 18, 2025. Nomination packages should be sent by email to NACMCF@usda.gov, or mailed to: The Honorable Thomas Vilsack, Secretary, U.S. Department of Agriculture, 1400 Independence Avenue SW, Room 1128 South Building, Attn: Kristal Southern, Designated Federal Officer, FSIS\OPHS\National Advisory Committee on Microbiological Criteria for Foods, Washington, DC 20250.
Individuals who have questions about their nomination package can contact Kristal Southern by email at NACMCF@usda.gov or by telephone at 202-937-4162.
For more information on how to apply, visit the Federal Register notice. More information about NACMCF is available on the FSIS webpage.
FSIS and Agricultural Research Service (ARS) have published the results of the exploratory sampling program that assessed whether antibiotic residues are detected in cattle intended for product with a raised without antibiotics (RWA) claim.
The article, “Antibiotic Residues in Cattle Reported to be Raised Without Antibiotics,” was published in the Journal of Agricultural and Food Chemistry, a peer reviewed journal that focuses on the chemistry and biochemistry of agriculture and food. The exploratory study found at least one antibiotic residue in samples from 37 of the 189 animals (20%) identified as raised without antibiotics.
FSIS previously discussed this study in the Federal Register that announced the availability of updated animal raising claims guidance.
As announced on July 29, 2024, FSIS issued a comprehensive proposed rule and determination to more effectively reduce Salmonella contamination and illnesses associated with raw poultry products. On October 11, 2024, FSIS announced that the comment period for the proposed rule and determination extended until January 17, 2025.
FSIS invites interested persons to submit comments on this document and wants to ensure that individuals have the detailed instructions necessary to submit a comment online. Commenters have multiple channels to submit their comments, including online through the Federal eRulemaking Portal, by mail, or Hand- or courier-delivered submittals.
To submit an online comment through the Federal eRulemaking Portal, follow these instructions:
- Go to the Federal eRulemaking Portal at https://www.regulations.gov, for access to the rulemaking docket.
- Click on the search bar, type in the phrase, “Salmonella Framework for Raw Poultry Products,” and then click “Search.”
- Click on the proposed rule titled, “Salmonella Framework for Raw Poultry Products.”
- Click the “Comment” button found on the left side of this page.
- On the “Write a Comment” webpage, a list of tips for submitting comments can be reached by clicking on the “Commenter's Checklist” link.
- Commenters are not required to submit their email address along with their comment and can submit comments anonymously if preferred.
- If an email is provided, commenters can opt to receive email confirmation of submission and a tracking number. However, if you choose to identify as anonymous, the option to receive an email confirmation will not be displayed.
- Commenters may also choose from three options in order to identify themselves as:
- an individual, meaning yourself or another person whom you represent with their consent;
- an organization, such as a company, organization, or government agency; or
- anonymous, to mean a person who does not want their name associated with the comment.
- Lastly, ensure that the CAPTCHA test below the identity selection section has been completed. Then, you may click “Submit Comment.”
It is important to note that commenters should not submit personally identifiable information through this form. Any personally identifiable information (e.g., name, address, phone number) included in the comment form or in an attachment may be publicly disclosed in a docket or on the internet.
If you require assistance submitting a comment, please email the Regulations.gov Help Desk at regulationshelpdesk@gsa.gov or call 1-866-498-2945.
As noted in the November 15, 2024, Constituent Update, FSIS is providing additional updates as Public Health Information System (PHIS) export implementation with Mexico continues.
FSIS has increased the processing capacity of PHIS and made additional information-technology (IT) improvements to ensure the system is working as efficiently as possible for exporters and foreign government users. FSIS is also planning additional enhancements to further improve users’ experience. FSIS continues to seek user feedback on system performance at PHISTechnicalQA@usda.gov.
To export to Mexico and other countries that require additional FSIS certification of an establishment, the establishment profile information in PHIS needs to match the listing on the country’s eligible establishment list for the appropriate country. If the establishment information on the country listing and export application and certificate do not exactly match, a shipment may be rejected by Mexico. The establishment profile information in PHIS is the data source for the Meat, Poultry, and Egg Product Inspection (MPI) directory. Establishment information can be viewed by searching the FSIS Inspected Establishment Listings of the MPI directory.
Establishments can correct the information on the Mexico establishment list posted on the U.S. Establishment by Country page by submitting a new 9080-3 and can ask the Inspector in Charge (IIC) to correct the PHIS establishment profile information; however, some establishment profile updates may require the establishment to submit an updated FSIS Form 5200-2, Application for Federal Inspection or FSIS Form 5200-6, Application/Approval for Voluntary Reimbursable Inspection Service.
When a new 9080-3 is submitted, only the information on that 9080-3 will be listed. A new 9080-3 overwrites the existing entry, so exporters should only submit complete 9080-3 applications that cover all products they intend to export to Mexico. Exporting establishments should not produce or ship product to Mexico until Mexico has accepted and included the establishment on its eligible establishment list, and the approval is reflected in the Export Library.
Mexico’s certification system that generates the Mexico approved plant list excludes the “M” (for meat) and “V” (for voluntary) prefixes for FSIS establishment numbers. Even if the M or V are listed on the 9080-3, they will be removed on Mexico’s approved plant list. When exporting product to Mexico, the export applicant should select the establishment number in the PHIS application dropdown menu that matches exactly with the number listed on the country’s approved list and does not include the “M” for meat product inspection or the “V” for voluntary inspection.
Of note, PHIS-generated, digitally signed PDF certificates are NOT the same as the electronic certification (eCert) process and are NOT transmitted directly to the foreign country’s system as eCert data. As stated in the Mexico Export Library, Mexico requires that a paper version of the PHIS-generated, digitally signed 9060-5 certificate, including the watermark “Approved Certificate – Available for Validation in PHIS” accompanies each consignment.
Granting appropriate access to export applications is a useful tool to facilitate exports to Mexico, and any country in PHIS. Export applicants can grant access to the individual export application in PHIS to other industry users who may need to edit or manage the applications within PHIS by using the PHIS “Access Control.” option. Only the original applicant, users the applicant gave access control, or corporate administrators associated with the exporting establishment can view (read only) or edit (read-write) that application, depending on the permission assigned in the “Access Control” option. Additional industry users cannot be granted access once FSIS IPP have started to review the application (i.e., FSIS personnel have opened and saved the task). To allow for greater access to the application once FSIS IPP have started the review process, it is recommended that the export applicant assign more than one industry user to view, edit, and access (read, write, and add others to access control) the application prior to submission.
“Access control” is an option on the left navigation menu, and a person or company name may be entered. An individual who has access to PHIS and the export applicant role and has been assigned read-write permission in that application’s Access Control option will be able to view and update the application if necessary.
Exporters may find these references useful as PHIS implementation with Mexico continues to proceed:
i. General Export Guidance;
ii. PHIS Resources;
iii. PHIS Help tutorials;
iv. Mexico Export Library; and
v. PHIS Industry User Guide
Today, FSIS updated the individual establishment Salmonella performance standard category information for raw poultry carcasses, raw chicken parts, and comminuted poultry products on the Salmonella Verification Testing Program Monthly Posting page on the FSIS website. Additionally, FSIS will post the aggregate sampling results showing the number of establishments in categories 1, 2, or 3 for establishments producing young poultry carcasses, raw chicken parts, or not ready-to-eat (NRTE) comminuted poultry products at the location linked above.
Today, FSIS updated the Import Presented Refused and Import Refusal Reason datasets on the Import and Export Data page. The Import Presented Refused dataset will include lot-level information for import volume along with import refusal data at the lot-level. The Import Refusal Reason is provided as a secondary dataset, providing each refusal reason as its own row to facilitate analysis.
The Import Presented Refused and Import Refusal Reason datasets are updated monthly and will be posted the third Friday of each month, with data broken out by fiscal year (FY), starting with data from FY 2014 (starting on October 1, 2013) through the most recent FY. These datasets are released in an open, non-proprietary comma-separated values (CSV) format. Instructions on how to open csv files using Excel are available on the FSIS website in the “Comma Separated Values Guide” section.
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:
Policy Update
FSIS notices and directives on public health and regulatory issues are available on the FSIS Policy webpage. The following policy update was recently issued:
FSIS Notice 50-24 - Testing for Non-Listeria Monocytogenes Listeria Species
FSIS Notice 49-24 - FSIS RTE Inspection Fundamentals Training
FSIS Notice 48-24 - Public Health Information System Physical Plant Modification Profile Questionnaire and Ready-To-Eat Questionnaire Task
FSIS Directive 5100.1 - Food Safety Assessment Methodology - Revision 6
FSIS Directive 5720.4 - Talmadge-Aiken Cooperative Inspection
Export Requirements Update
The Library of Export Requirements has been updated for products for the following:
- Kiribati
- Egypt
- Mexico
- Taiwan
- Uruguay
- Myanmar
- Benin
- Azerbaijan
- North Macedonia
- Japan
- Cuba
- Jamaica
- European Union
- Canada
- Vietnam
Complete information can be found at the FSIS Import & Export Library.
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