Statement of Objectives - Request for Information STEC Media.pdf

US Department of Agriculture (USDA)

Statement of Objectives

Contents Project Title

1.0 Purpose

2.0 Scope

3.0 Background

4.0 Performance Objectives

4.1 Company Overview and Capability Summary

4.2 Technical Capabilities

4.3 Validation, Data, & Supporting Evidence

5. Deliverables

Project Title Commercial Products used to Grow and Isolate Shiga toxin-producing Escherichia coli (STEC) in Food

1.0 Purpose

The purpose of the Statement of Objectives (SOO) is to gather information on commercially available STEC colony isolation procedures that increase the likelihood of identifying and isolating a variety of STEC in raw beef or other food products, regardless of serogroup, from a mixed population. FSIS seeks to understand the level of granularity in STEC confirmation protocols, including selective media that do not rely on STEC serogroup.

2.0 Scope

The USDA Food Safety and Inspection Service (FSIS) Laboratory System continually incorporates new approaches to our laboratory testing and data analytics workflows to increase efficiencies in our food safety system. For example, FSIS laboratories incorporated an additional screening test for the STEC laboratory method which provides high confidence that the stx and eae genes are in the same cell, thereby increasing the likelihood that a screen positive result leads to a confirmed positive. The Agency is data driven and is considering what approaches can move us to better risk-based regulatory controls.

3.0 Background

FSIS is the public health, regulatory agency within the USDA responsible for inspecting establishments producing meat, poultry, and egg products and verifying that these products are safe, wholesome, and properly labeled. FSIS employs approximately 7,500 people, including inspection personnel working in 7,100 federally inspected establishments, scientists and staff in three FSIS laboratories, and investigators nationwide. The high throughput FSIS laboratories operate 365 days a year, analyzing hundreds of product samples each day to identify potential hazards and threats to the food supply. During Fiscal Year 2025, FSIS analyzed more than 109,000 meat, poultry and pasteurized eggs samples submitted by inspectors, which produced more than12,900 bacterial isolates and generated more than 2.2 million individual test results. FSIS annually tests more than 20,000 raw beef samples, including domestic and imported raw ground beef, ground beef components, bench trim, and beef manufacturing trim for the presence of the “top seven” STEC serogroups (O26, O45, O103, O111, O121, O145, O157). The current methodology and isolation procedures can be found online in Microbiology Laboratory Guidebook (MLG) 5C. Media and reagents can be found in MLG 1.

4.0 Performance Objectives

4.1 Company Overview and Capability Summary

• Provide a brief overview of the vendor's portfolio of media that can be used to support STEC testing that allows laboratory personnel to select and/or isolate STEC colonies and/or stx/eae carrying strains regardless of serogroup (even those outside of the U.S. top seven

STEC).

https://www.fsis.usda.gov/sites/default/files/media_file/documents/MLG-5C.04.pdf https://www.fsis.usda.gov/sites/default/files/media_file/documents/MLG-5C.04.pdf https://www.fsis.usda.gov/sites/default/files/media_file/documents/MLG-Appendix-1.14.pdf

4.2 Technical Capabilities

• Describe relevant methods, workflows, media and/or technology platforms.

• Is the product compatible with meat-based microbiology testing methods and samples?

o If yes, list all compatible matrices and sample types.

• Does the media and/or isolation method provide distinguishing characteristics that allow analysts to select STEC regardless of serogroup from a mixed population environment?

o If yes, describe those characteristics.

• Describe performance characteristics (e.g., sensitivity, specificity, robustness).

• Describe operational requirements (equipment, training, method turn-around/incubation time and temperature, throughput, environmental requirements).

• Provide cost options on a per plate and batch basis (include batch yield). List and identify any ancillary and proprietary supplies or reagents. Include anticipated shipping surcharges as a separate line item.

4.3 Validation, Data, & Supporting Evidence

• Does your company have third-party validation by recognized independent organizations (i.e., AOAC, AFNOR, MicroVal, NordVal) for the isolation procedure?

o If yes, provide supporting documentation.

• Is there available validation data, internal/external studies, regulatory certifications?

o If yes, provide supporting documentation.

• If applicable, list data formats and reporting structures for any identification and isolation procedures.

5. Deliverables Respond to each item concisely and in plain language. You may also include links to online materials or interactive presentations. Submissions should include the following:

• The name of the individual(s) and/or organization responding.

• A brief description of the responding individual(s) or organization's mission and/or areas of expertise.

• A point of contact for questions or other follow-up on your response.

By responding to the SOO, each participant (individual, team, or legal entity) warrants that they are the sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original (or is an improved version of an existing work that the participant has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which participant is aware.

By responding to the SOO, each participant (individual, team, or legal entity) consents to the contents of their submission being made available to all Federal agencies and their employees on an internal-to-government website accessible only to agency staff persons.

Participants will not be required to transfer their intellectual property rights to the USDA, but participants must grant to the Federal Government a nonexclusive license to apply, share, and use the materials that are included in the submission. To participate in the SOO, each participant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of participant rights to the Federal Government. Interested parties who respond to this SOO may be contacted for follow-on questions or discussion.

5. Deliverables