A05_Part 12 Over SAT Brand Name JA_Redacted.pdf

United States Department of Agriculture Justification to Restrict Competition

Identification Number: 1164424

Rev. 11/6/2025

In accordance with the Revolutionary Federal Acquisition Regulation (FAR) 12.102 (b), the following justification documents the decision to restrict competition for this acquisition.

(1) Mission Area and Contracting Activity.

The United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS), Office of Management Procurement Branch (OM-PcMB), proposes to enter into a contract on a basis other than full and open competition.

(2) Nature and/or description of the action being approved.

This J&A authorizes and approves the award of a brand name, firm-fixed price, indefinite-delivery, indefinite quantity (IDIQ) for the procurement of sterile bags and sponges in support of the Field Service Laboratories (FSL) performing regulatory testing of meat, poultry and egg products for the presence of food borne pathogens and sanitary indicator organisms. This testing is essential to protect consumers by ensuring that meat, poultry, Siluriformes fish, and processed egg products are safe. The new contract will continue to provide the critical resources needed to maintain performance of this regulatory testing.

These services are commercial in nature and will be procured utilizing the procedures listed in FAR Part 12 and FAR Part 15.

The suggested contractor is:

World Bioproducts LLC 17280 Woodinville Redmond Rd NE Ste B81 Woodinville, WA 98072

UEI: QW8GWSJ275L5

(3) A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The agency requires sterile whirl‑top sampling bags and sponge samplers meeting strict FSIS laboratory specifications. These supplies must be manufactured from co‑extruded low‑density and linear low‑density virgin polyethylene and incorporate a continuous perimeter seal to prevent leakage.

Each product must be sterilized and accompanied by a certificate of analysis verifying sterility, lot number, appearance, expiration date, and other required production details. The bags must be clearly labeled and possess at least one year of remaining shelf life upon receipt. They must tolerate temperatures up to 82°C and withstand freezing to any temperature, including cryogenic levels.

The filters incorporated in the required filter bags must consist of a 330‑micron perforated third polyethylene layer sealed securely into the perimeter of the bag. This specialized filter design ensures the separation of solids from liquids during sample preparation and enables clean pipetting of homogenized samples. The filter layer must contain perforations measuring approximately 0.33 mm in diameter, arranged at densities documented in manufacturer specifications, and allow samples to be placed on either side of the filter while maintaining reliable flow characteristics.

All required sampling bags must be available in the precise sizes and configurations specified in the Statement of Work, including plain wire‑close bags, gusseted write‑on bags, filter bags, perforated‑top blender bags, sponge sampler bags moistened with either buffered peptone water or D/E neutralizing broth, and sterile poultry templates. Shipments must be made to the FSIS Eastern, Western, and Midwestern laboratories.

It is anticipated that one (1) IDIQ contract consisting of one (1) one-year base period and four (4) one-year option periods will be awarded. The estimated total for the base year plus all options is $875,000.00 as shown below:

Period Fiscal Year Total

BASE FY26 $ 175,000.00

Option 1 FY27 $ 175,000.00 Option 2 FY28 $ 175,000.00 Option 3 FY29 $ 175,000.00 Option 4 FY30 $ 175,000.00 Subtotal $ 875,000.00

Evaluation of FAR 52.217-9 $ 87,500.00 Grand Total $ 962,500.00

(4) Identify the statutory authority permitting other than full and open competition.

The statutory authority permitting other than full and open competition is FAR 6.103-1 (d), Brand Name.

(5) Demonstrate that the proposed contractor's unique qualifications or the nature of the acquisition requires using the authority cited.

FSIS laboratory methods rely on sampling equipment that has been validated through long‑standing use, including the Whirl‑Pak®‑type sterile bags referenced in USDA and FSIS procedural guides. The FSIS Directive 10250.1 outlines the use of sterile sampling equipment, including Whirl‑Pak® bags, in the Salmonella and Campylobacter verification programs for raw poultry products. It prescribes aseptic techniques, the use of specific bag types and sizes (e.g., 24‑oz. gusseted Whirl‑Pak®), precise sealing methods, sample collection schedules, and chain-of-custody protocols. In addition, the FSIS Microbiology Laboratory Guidebook MLG 41.05 provides explicit use-case instructions for Campylobacter enrichment, specifying sterile containment for carrying samples through the incubation and analysis phases in FSIS field service labs. These guidelines are embedded in FSIS regulatory manuals and training aids to ensure standardization of sample collection, handling, and transport across national lab operations.

Whirl‑Pak® products, distributed by World Bioproducts, incorporate unique technical features such as full‑page 330‑micron integrated filters, continuous perimeter seals, Tyvek® pull tabs, wire closures compatible with aseptic handling, and the ability to withstand defined thermal tolerances. These features correspond directly with FSIS’s sampling and enrichment procedures, which depend on consistent product performance to maintain regulatory method integrity. Alternative products identified through GSA Advantage, SAM.gov searches, and major distributors failed to meet all required specifications in the exact sizes, configurations, and performance characteristics needed for FSIS’s national laboratory system.

In addition, FSIS guidance documents, including ground poultry sampling instructions and Campylobacter enrichment flow charts, specifically reference Whirl‑Pak® bags and sponges as part of the validated workflow. Substituting other products would require extensive laboratory method validation and retraining which would introduce unacceptable risk to regulatory testing operations.

(6) Provide a description of efforts made to ensure that offers are solicited from as many potential sources as possible, including whether a notice was or will be publicized as required by Part 5 and, if not, which exception under Part 5 applies.

An effort to solicit offers was completed through a recently competed a full and open competition on April 17, 2026. This solicitation was cancelled upon discovering the Statement of Work and the evaluation factors listed in the Request for (RFQ) were not substantial enough to produce an award.

Three (3) responses were received from Future Gladness LLC, World Bioproducts LLC, and Xenturis LLC before the RFQ was cancelled on July 30, 2026 after FSIS determined additional technical requirements must be added to ensure alignment with sampling instructions issued to the field. A revised solicitation is planned for re‑posting in FY26. Demonstrated is a robust attempt to engage multiple potential sources and confirm that only limited vendors are capable of supplying products that meet FSIS’s full technical specification set.

Although similar sterile sampling bags were identified, none of the reviewed sources could supply the full range of sizes, features, and U.S.‑manufactured products specified in the Statement of Work. In compliance with FAR posting requirements, the brand‑name justification will be published with the solicitation on SAM.gov.

(7) A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer has determined the anticipated cost to the Government of the supplies covered by this J&A will be fair and reasonable based on a thorough comparison of historical pricing data from the prior contract and the development of an Independent Government Cost Estimate (IGCE) using current market rates.

(8) A description of the market research conducted, and the results or a statement of the reason

Market Research was not conducted.

Market research conducted on February 24, 2026 included a review of mandatory sources, USDA‑wide contracts, commercial marketplaces, distributor catalogs, and prior acquisition history.

World Bioproducts LLC was the only company to respond to solicitations prior to this year. This year an RFQ posted on April 1, 2026, and further expanded the market research effort. The lack of clear information received helped the Government clarify the specifications needed for this requirement.

Clarification exchanges demonstrated that many vendors lacked the ability to meet FSIS’s technical requirements in their entirety. Xenturis LLC failed to respond to required clarifications, and World Bioproducts LLC confirmed that it could not provide two of the required items and omitted country‑of‑origin information for several others. Future Gladness LLC provided the only completed quote package, but multiple follow‑up technical clarification exchanges revealed that FSIS could not determine technical acceptability. Ultimately, the RFQ was cancelled on July 30, 2026 after FSIS identified additional technical requirements needed to align the procurement with field sampling instructions. According to the cancellation notice, the Government intends to reissue a revised solicitation during FY26. This RFQ cycle confirmed that although multiple vendors seek to compete, the technical capabilities required for FSIS’s sterile sampling program remain highly specialized and not broadly met in the commercial marketplace.

These results indicated that while other sterile bags exist, none meet all FSIS requirements in terms of material composition, sterility verification, filter performance, temperature tolerance, write‑on capability, sizing, and Made‑in‑USA compliance. Manufacturer documentation confirms Whirl‑Pak® compliance with USDA, Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Hazard Analysis Critical Control Point (HACCP) standards. Under FDA regulations, 21 CFR 211 Subpart G and 21 CFR 610.12, packaging and closure systems for drug and biologic products must adhere to documented quality procedures, sterility validation, material compatibility, and retention of labeled specifications. Whirl‑Pak® bags comply with these by providing post‑manufacturing sterilization, material clarity, strength, sterility certificates, and testing protocols for acceptance. EPA quality assurance practices for environmental and field sample collection emphasize controlled handling, secure containment, proper labeling, and documented chain-of-custody to maintain sample integrity through transport and analysis. Lastly, HACCP-based food safety program requirements necessitate sampling systems that are sterile, leak‑proof, traceable, and reliable under diverse conditions.

FSIS procedural documentation further validates the brand’s integration into existing sampling and enrichment workflows.

(9) Any other facts supporting use of other than full and open competition, such as:

Switching to another brand would require extensive method verification across all FSIS laboratories, potentially delaying critical regulatory testing. The existing sampling protocols use Whirl‑Pak® bags explicitly, demonstrating an established performance dependency. Additionally, FSIS requires U.S.

manufactured products, and Whirl‑Pak® meets this criterion while providing traceable sterility documentation and robust quality assurance controls.

(10) A listing of the sources, if any, that expressed an interest in the acquisition in writing.

The previous solicitation produced expressions of interest from three vendors: Future Gladness LLC, World Bioproducts LLC, and Xenturis LLC. Future Gladness LLC submitted the only fully completed quote package but ultimately failed to provide sufficient technical information to demonstrate acceptability. World Bioproducts LLC submitted a quote but could not provide two required items.

Xenturis LLC failed to respond to Government clarification requests and was therefore not considered further. These results confirm that while industry interest exists, only vendors with direct ties to the specific manufacturer of required sterile sampling products demonstrate compatibility with FSIS’s operational needs.

Other large distributors list selected Whirl‑Pak® SKUs within their catalog. No other vendor has demonstrated the ability to meet all specifications as a manufacturer.

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition of the supplies or services required.

FSIS will continue performing regular market research, encouraging industry engagement, and evaluating emerging products for possible future competition. The agency will explore developing performance‑based specifications that may reduce brand specificity while ensuring laboratory method integrity. FSIS will also consider phased validation approaches to broaden industry participation, although significant barriers remain due to specialized sampling requirements. FAR posting requirements will be followed for transparency.

(12) Certifications & Approvals

Technical / Requirements Personnel Certification I certify this requirement meets the Government’s minimum need and that the supporting data, which forms a basis for this justification, is complete and accurate.

Name Date Title

Contracting Officer’s Certification I certify that the data supporting the recommended use of other than full and open competition accurate and complete to the best of my knowledge and belief.

Karen Petty Date Contracting Officer