Constituent Update - November 20, 2020
FSIS, FDA, and CDC Post Outbreak Data
FSIS investigates outbreaks of foodborne illness, commonly referred to as food poisoning in collaboration with public health partners, including the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), USDA’s Animal and Plant Health Inspection Service (APHIS), and state and local health and agriculture departments. In an effort to improve outbreak investigations communications and transparency with the public, starting on Wednesday, November 18, 2020, FSIS, FDA, and CDC began publishing information on all active foodborne illness investigations..
Publicly sharing information on active investigations will increase awareness for consumer and industry stakeholders, which will help mitigate surprises, and improve internal and interagency coordination.
Foodborne illness investigations are multi-faceted, multidisciplinary undertakings that involve collecting and analyzing data from a variety of sources. Epidemiologic, laboratory, and environmental evidence help guide the short-term outbreak response activities and long-term preventive actions of public health organizations working to minimize or prevent further illness.
FSIS is sharing information on active outbreak investigations to increase transparency about the work that FSIS does to investigate and respond to foodborne outbreaks.
Consumer awareness may help consumers protect their families from foodborne illness. If you believe you may have been exposed to contaminated meat, poultry, or egg products and become ill, first consult your healthcare provider, and then please contact FSIS to provide public health officials with timely information regarding what you ate.
FSIS will be updating this table weekly.
- For information on outbreaks investigated by CDC and FDA, please see the CDC outbreaks table and the FDA outbreaks table.
FSIS to Host Midwestern Laboratory Open House
FSIS plans to host a virtual open house at the Midwestern Laboratory in St. Louis, Mo. on December 14, 2020, from 8:00 a.m. – 1:00 p.m. CT. The open house will offer an inside look at the sample analysis process from beginning to end. The event will provide an overview of what happens to a sample from the time it is delivered to an FSIS lab to the time the sample result is reported. Attendees will receive an introductory presentation about the lab system followed by a virtual visit to sample receiving and other stations within the lab to learn how samples are processed and analyzed for microbial pathogens and chemical residues. Unique sampling projects or analyses to the Midwestern Laboratory include the FSIS National Antimicrobial Resistance Monitoring System (NARMS) Program testing of lymph nodes, Inspector Generated Sampling Program known as KIS™ (kidney inhibition swab testing) for chemical residues, such as Ceftiofur, Penicillin, and Polyfluorinated Alkyl Substances (PFAS).
Participants must pre-register. Please go to https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/meetings-archive/upcoming-meetings/meeting-registration-ophs-open-house-midwestern to register. A confirmation email with additional logistics will be provided to attendees prior to the open house session.
Tips for Faster Label Approval Process
Labels are currently taking about 5-7 business days to evaluate.
TIP: Establishments should only use the FSIS email address LSAS@usda.gov for technical and enrollment questions about the Label Submission and Approval System (LSAS). Other inquiries should be directed to either LSAS Messages or AskFSIS as appropriate.
FSIS established the email address LSAS@usda.gov to assist users with LSAS technical questions, such questions on uploading supporting documents as part of a label application or questions on the LSAS enrollment process. FSIS has noticed a recent increase in the volume of questions LSAS users submit to this email address in error, resulting in a reduced response time as staff must reroute the questions to the appropriate staff. For additional information about using the LSAS Messages function, please see the “Application Messages” section on page 55 in the User Guide for Industry Users.
Note: Questions about the USDA eAuthentication process should be submitted to the eAuthentication Service Desk at eAuthHelpDesk@ftc.usda.gov.
FSIS’ online question and answer portal, askFSIS, is the most effective way to submit questions about labeling regulations, standards, policies, and questions about a specific label that has been approved, approved as modified, or returned. Alternatively, establishments may use the LSAS Messages function to communicate with FSIS personnel regarding issues for a label application that has not been reviewed or approved. The LSAS Messages function is also a useful means for submitters to ask questions about label applications recently returned by FSIS. To log in to askFSIS or to create an account in askFSIS for the first time, please visit AskFSIS
FSIS will continue to provide updates regarding label turnaround time, as well as suggestions to assist industry to streamline label submissions in its Constituent Update.
New Flexibilities for Establishments Working with New Antimicrobial Interventions
As described in the February 2016 Federal Register (81 FR 7285) entitled “New Performance Standards for Salmonella and Campylobacter in Not-Ready-to-Eat Comminuted Chicken and Turkey Products and Raw Chicken Parts and Changes to Related Agency Verification Procedures,” FSIS performs routine verification sampling of raw poultry products in order to assess process control in all establishments subject to performance standards. Providing sampling flexibility around an establishment’s newly implemented interventions will allow for increased innovations in food safety by ensuring that the different intervention does not impact the establishment’s overall performance.
If an establishment wants to request that its product not be subject to FSIS testing related to Salmonella performance standards while the establishment begins using, for the first time, an intervention that has already been approved in FSIS Directive 7120.1: Safe and Suitable Ingredients used in the Production of Meat, Poultry, and Egg Products, it may submit a request to FSIS following the procedures below. FSIS will then review and approve the request if the establishment meets the criteria.
FSIS requires poultry slaughter establishments to develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens and fecal contamination throughout the entire slaughter and dressing operation (9 CFR 381.65(g)). FSIS recommends establishments support and validate the most effective interventions for their HACCP systems and is interested in which interventions are most effective. FSIS understands some establishments may be reluctant to use new interventions that could initially affect their ability to meet applicable Salmonella performance standards because establishments may need to gain experience using the intervention before they have success in addressing the pathogen. Therefore, for establishments that follow the procedures and meet the criteria below, FSIS will temporarily stop Salmonella testing related to the standards for a limited period of time (i.e., maximum of 4 weeks) in applicable product(s) subject to new interventions. FSIS will allow no more than one trial period every 52 weeks.
FSIS will not test for Salmonella under the performance standards when an establishment starts using new interventions under the following conditions and FSIS has approved the request:
- The establishment will have to conduct sampling and testing for Salmonella using FSIS’s sampling and testing methods.
- The establishment will have to share its results with FSIS during the trial (e.g., during the weekly meeting with inspectors) and the final results will be submitted at the end of the trial period. FSIS will provide specific details on these submissions in the approval letter.
- The establishment will have to collect a sufficient number of samples to demonstrate process control and demonstrate, with statistical confidence, if the new intervention effectively addresses pathogens, including Salmonella.
- Based on its test results, the establishment will have to take corrective actions if it does not meet FSIS’s pathogen reduction performance standards or it observes a trend of increasing Salmonella levels.
Requests for the new testing initiative should describe what the intervention testing is intended to accomplish, as well as the expected beneficial effects. Additionally, requests should provide support for how the establishment will meet the conditions outlined in the above bulleted list, as well as information about the parameters of the proposed intervention. FSIS will focus its review of the request on how the establishment will ensure it maintains process control for pathogens, such as Salmonella, when it starts using new antimicrobial interventions. FSIS will also focus on how the use of the new intervention would lead to better process control. The request should include a protocol that addresses experimentation, implementation, and evaluation. The protocol is to minimally contain the following:
- Statement of Purpose: The submission should include a detailed description of what the new intervention testing is intended to accomplish, along with the rationale and objectives of the proposed trial. If enhanced food safety is the purpose, the statement of purpose should identify the particular area of concern: e.g., pathogenic microorganisms in raw poultry. In all cases, the practical outcome to be measured must be clearly defined.
- Experimental Design: The submission should include detailed information about the general approach, including: the nature of the treatments, how they are to be applied, number and name of participating establishment, and time frame of the study. This section should also include the method(s) of use describing how the intervention will be used including application types and operational parameters (e.g., concentration, pH, pressure, contact/dwell time, etc.).
- Monitoring and Evaluation: The submission should describe how the technology will be monitored and verified, to include tests, analysis (proposed statistical methods), parameters to be monitored and the frequency of monitoring. The protocol should address sample collection methods to ensure mitigation of antimicrobial agent carryover, records maintenance, and records availability.
FSIS will log the request into its New Technology Monitoring System from which a formal letter will be issued, outlining the timeline and criteria the establishment will need to meet during the trial period. FSIS will need requesters to submit the request and all supporting materials at least 30 days prior to the proposed date they plan to start using the new intervention, under the conditions described above.
While conducting the intervention testing, establishments must maintain all records, including the scientific supporting documentation, in accordance with (9 CFR 417.5). For the duration of the use of the intervention the establishment must implement the intervention within the same ranges and operational parameters listed in their documentation (e.g., research or experimental protocols). The establishment needs to demonstrate that the intervention is achieving the intended result and may do so by documenting in-plant observations, measurements, microbiological test results, or other information.
If FSIS grants an establishment’s request, but the establishment subsequently does not adhere to the requirements set forth in the formal letter, FSIS will resume normally scheduled sampling.
FSIS will also be announcing and seeking comments on these new flexibilities in a forthcoming Federal Register notice.
 FSIS currently only samples poultry slaughter and processing establishments under a performance standard. This program only applies to establishments being sampled under a performance standard.
 The collection of information needed to meet the criteria is authorized by OMB under Control Number 0583-0156, “Modernization of Poultry Slaughter Inspection.”
 The collection of submissions for these requests is authorized by OMB under Control Number 0583-0127, “Procedures for the Notification of New Technology and Requests for Waivers.”
PHIS Export Module Billing Enhancement
The Food Safety and Inspection Service (FSIS) is improving its billing system for electronic applications for export certificates in the Agency’s Public Health Information System (PHIS) export module. FSIS regulations published in 2016 provide that FSIS charges a fee to exporters that apply for export certificates electronically through the export component of the PHIS.
Starting December 6, 2020, FSIS will begin collecting billing information from users with the export broker role. Following this data collection phase, fees for export certificate applications submitted by users with the export broker role will be charged to that user. Fees for applications submitted by users with the export applicant role will continue to be charged to the establishment associated with the export applicant. FSIS expects the data collection phase to continue into January 2021. FSIS will provide advance notice of the specific date prior to implementing the change in billing in a future Constituent Update.
FSIS notices and directives on public health and regulatory issues are available at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations. The following policy update was recently issued:
FSIS Notice 60-20 - Restoration of Forfeited Annual Leave
Export Requirements Update
The Library of Export Requirements has been updated for products for the following countries:
- New Caledonia