Constituent Update - December 3, 2021
FSIS Seeking Proposals for Pilot Projects to Control Salmonella in Poultry Slaughter and Processing Establishments
FSIS is inviting poultry slaughter and processing establishments to submit proposals for pilot projects that will test different control strategies for Salmonella contamination in poultry products. Pilot projects will last for a defined period of time, during which establishments will experiment with new or existing pathogen control and measurement strategies and share data collected during the pilots with FSIS. The data will be analyzed by FSIS to determine whether it supports changes to FSIS’ existing Salmonella control strategies.
On October 19, 2021, USDA announced that FSIS would be mobilizing a stronger and more comprehensive effort to reduce Salmonella illnesses associated with poultry products. A key component of this effort is identifying ways to incentivize use of preharvest controls to reduce Salmonella contamination coming into the slaughterhouse. In November 2021, FSIS held roundtable listening sessions with industry and consumer groups to answer questions about establishment pilot projects. FSIS is providing the following information on how establishments interested in participating in a pilot can submit a pilot proposal.
Who can submit a proposal?
FSIS will consider proposals from all active poultry establishments (or parent corporations) that produce raw products subject to FSIS’ Salmonella performance standards, regardless of the establishment’s Salmonella performance standard category in order to encourage all establishments to explore alternative approaches that will reduce Salmonella illnesses in consumers. Key partners such as breeders, live animal producers, and allied businesses (i.e., consultants, testing or intervention technology developers) are encouraged to assist in these projects, but the proposals must be received from poultry establishments under FSIS jurisdiction and authority.
What proposals would be of most interest to FSIS?
Proposals should consider new or existing control and measurement strategies for controlling Salmonella, before and/or after harvesting of live birds. Importantly, the proposal must describe: (1) how the strategy will be applied and monitored by the establishment; and (2) how the impact will be measured by the establishment.
Proposals may include evaluating strategies to reduce Salmonella in live birds or raw poultry products subject to the performance standards (chicken and turkey carcasses, chicken parts and comminuted chicken and turkey). These strategies may include testing/diversion, vaccination, prebiotics, probiotics, antimicrobials, phage, biosecurity, housing, density, environmental monitoring, litter, feed, and breeding. FSIS would also be interested in proposals to evaluate tracing of birds or flocks from preharvest to processing or communicating information about preharvest controls to processors that purchase raw poultry from slaughter facilities. Additionally, FSIS is interested in pilots that focus on alternative approaches to standard setting (e.g. performance or products standards) based on serotypes of public health concern, quantification, or genetic virulence factors. FSIS is not setting a limit on the duration of a pilot but is interested in short-term as well as longer-term pilots.
What information should be included in the proposal?
General: Title, participating establishment number(s), point(s) of contact, study duration.
Statement of Purpose: Include a detailed description of the pilot strategy, along with the rationale, objectives, and scientific/technical support.
Experimental Design: Provide detailed information about the general approach, including: the nature of the treatments, mode of application, operational parameters, number and name of participating establishment(s), and study time frame.
Monitoring and Evaluation: Describe how the strategy will be monitored and verified including measurable operating parameters, monitoring frequency, and sampling methods (including the method for mitigating carryover of antimicrobial residue). Include templates for collecting and sharing data. Describe procedures for records maintenance and availability.
Terms of Participation: Describe the conditions under which the establishment would agree to collaborate with FSIS, including data sharing, possibly through a third-party. Depending on the nature of the pilot, FSIS may provide alternatives to its Salmonella categorization and posting of establishments that agree to participate in a pilot. However, FSIS will continue to evaluate whether establishments meet the existing standards and take action at establishments that do not meet these standards. While FSIS may decide not to post categories of establishments participating in pilots; rather, FSIS may identify such establishments as pilot participants on the FSIS website. Alternatively, if establishments use FSIS’ Salmonella sampling and testing methods, FSIS may use establishment data to assess whether they meet the performance standards. The agency will develop an agreement that specifies the terms that establishments and FSIS will adhere to throughout the duration of the pilot. The parties reserve the right to suspend or cancel the pilot at any time.
How do I submit a proposed pilot?
Interested establishments can submit a proposal through the askFSIS New Technology queue (askFSIS | Food Safety and Inspection Service (usda.gov)) using the subject line: “Pilot Proposal”. FSIS will log the request into its New Technology Monitoring System and issue a formal letter. An FSIS technical review team will evaluate the proposal and will follow up with questions if needed.
Can I discuss my idea for a pilot with FSIS before I submit a proposal?
Yes. Please request a meeting using Salmonella@usda.gov
USDA Invests $32 Million to Strengthen U.S. Food Supply Chain
On November 22, 2021, USDA Secretary Tom Vilsack announced the investment of $32 million in grants awarded to 167 meat and poultry slaughter and processing facilities to support expanded capacity and efficiency through the Meat and Poultry Inspection Readiness Grant (MPIRG) program.
With this grant funding, meat and poultry processing businesses can cover the costs for improvements such as expanding existing facilities, modernizing processing equipment, and meeting packaging, labeling, and food safety requirements needed to achieve a federal Grant of Inspection under the Federal Meat Inspection Act or the Poultry Products Inspection Act, or to operate under a state’s Cooperative Interstate Shipment program.
In June 2021, USDA announced the availability of $55.2 million in MPIRG funding, accepting applications for a competitive grant award process which resulted in today’s awards.
Remaining funds will be made available through a forthcoming Request for Applications.
Click here to learn more about MPIRG and see the list of awards.
FSIS Posts Next Set of Establishment-Specific Datasets
In the October 8, 2021 Constituent Update, FSIS announced that it was reviewing public comments on Livestock Humane Handling and Poultry Good Commercial Practices inspection task datasets and would announce the revised date for their publication in a future Constituent Update. After reviewing the public comments received, FSIS: (1) added key descriptions from the data documentation files to the top of the web page containing the dataset files to improve customer experience, (2) added the date when the data were pulled to enhance transparency, and (3) removed extraneous columns.
Consistent with the public posting of other establishment-specific datasets, the datasets will be divided into two files: Current and Archived. The Current dataset represent a fiscal year-to-date and will be updated quarterly (at minimum, 1 quarter of data up to 4 quarters of data). The Archived dataset will capture the previous fiscal year data once the new fiscal year starts and will be updated annually. As this is the first time the Livestock Humane Handling and Poultry Good Commercial Practices inspection tasks datasets will be posted, there will only be a single dataset for each task (i.e., current), and it will only include data from Fiscal Year 2021 Quarter 3 (FY2021 Q3). This data was posted on December 3.
The initial Livestock Humane Handling and Poultry Good Commercial Practices inspection task datasets can be found on the FSIS website here. Information regarding verified regulations and Memoranda of Interview and Noncompliance Records associated with the tasks are included in the data documentation. Any personally identifiable or confidential commercial information has been redacted.
Subsequent postings will follow the regular posting schedule for establishment-specific datasets, in which new datasets are typically released the first Friday of the next quarter with a quarter lag, meaning data for FY2021 Q4 are planned to be released on January 7, 2022, data for FY2022 Q1 are planned to be released on April 1, 2022, and so forth.
FSIS to Host Field Service Laboratory Virtual Open House
FSIS will host a virtual field service laboratory open house on December 13, 2021, from 11:00 a.m. to 3:00 p.m. ET. The open house will present laboratory basics and include specific topics based on recent feedback and frequent questions received by the FSIS laboratories.
The event topics will include:
- An overview of the laboratory system, quality assurance, and accreditation
- FSIS’ FY 2022 sampling plan and how FSIS collects, records, and reports out laboratory data and results
- The process for field inspection staff scheduling sample collection tasks in PHIS for laboratory analysis and how FSIS receives and logs those samples into our laboratory database
- Microbiology methods for Salmonella and canned goods
- An overview of the material transfer agreement process to obtain FSIS isolates in support of food safety research
- Chemistry methods for aminoglycosides and metals
The topics will be presented through a combination of live demonstrations and presentations. Interested participants must pre-register by following this link. Participants will then receive an e-mail with the link to the event.
Tips for Faster Label Approval Process
Labels are currently taking about 5-7 business days to evaluate.
TIP: When applying for temporary label approval, clearly indicate the specific reasons. Submit one temporary approval application for multiple labels, if appropriate.
Temporary label approvals may be granted for labels that bear certain deficiencies. In the Label Submission and Approval System (LSAS), the specific reasons should be described in the free text box in the “Temporary” section of the “Label Approval” menu or in a separate attachment. Label applications submitted via paper application (FSIS Form 7234-1) must include the reasons on the “Continuation Sheet” (page 4) or in an attached document.
The reasons should be as specific as possible. For example, in the case of a formulation change resulting in a non-compliant ingredients statement, simply stating that the “formula has changed” or that there are “minor changes to the order of predominance” does not provide enough information for FSIS to evaluate the request for temporary label approval. In this case, the temporary label application should note the specific ingredients in the product that were not originally listed in the label and/or note the change of ingredients in the order of predominance and where they should be listed in the ingredients statement. FSIS recommends displaying the new formula and the old formula (or current non-compliant ingredients statement) side by side with the impacted ingredients highlighted.
When the same labeling deficiency impacts multiple products and, therefore, multiple labels, the establishment may submit one label in the temporary label application and reference all the products impacted (rather than submitting one application for each product impacted). An example would the change in order of predominance of ingredients in a purchased soy sauce impacting the sublisting of the soy sauce on multiple product labels.
The following information is often missing from temporary label applications, resulting in returned applications with requests for additional information:
- Addressing the four criteria for temporary label approval described in 9 CFR 412.1(f)(1)(i-iv)
- Noting if the changes impact nutrition information on the label. When ingredients have changed, the application should note if the nutrition information on the label is impacted and, if so, which values have changed and provide the new values.
- Providing the number of impacted labels on hand, information about the prior label approval, and the amount of time requested to use the non-compliant labels. This information should be completed in the “Label Approval” section of LSAS after selecting “Temporary” as the label approval type, or by completing all of the fields in Box 6b of FSIS Form 7234-1.
Please note that temporary approvals are granted for a maximum of 180 days. However, the amount of time requested should only be as long as needed. For example, if the temporary approval is requested for a one-time-only use of existing labels on a batch of product with a formulation error, the request would be much shorter than the length of time requested for a change resulting from a long-term change in the formula of an ingredient (e.g., soy sauce).
For assistance when applying for a temporary label approval in LSAS please see the “Approval Information” section in the User Guide for Industry Users beginning on page 119.
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 57-21 - Update to USDA Sample Seals for Submission to FSIS Laboratories
FSIS Directive 3900.1 - Temporary Duty Travel
FSIS Directive 7000.2 - Experimental and Sample Products Policy - Revision 1
FSIS Directive 8010.2 - Investigative Methodology - Revision 6
Export Requirements Update
The Library of Export Requirements has been updated for products for the following:
- Singapore
- Japan
- Taiwan
- Jamaica
- Cuba
- Australia
- Ukraine
Complete information can be found at the FSIS Import & Export Library.