Attachment 3 - Brand Name Justification.pdf

United States Department of Agriculture Item Peculiar to One Manufacturer

Over the Simplified Acquisition Threshold Identification Number: 123A9426Q0015

Rev. 3/10/26

In accordance with the Federal Acquisition Regulation (FAR)16.507-6 (b), the following justification documents the exception to fair opportunity.

(1) Mission Area and Contracting Activity.

Requisition Number: 1162446

Requesting Activity Agency: FSIS-OPHS

Contracting Activity: FSIS-OM-PcMB

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

This justification authorizes and approves the solicitation of a brand-name, firm-fixed price, indefinite-delivery, indefinite quantity (IDIQ) for the procurement of supplies and reagents to perform residue analysis for the Western Lab, Midwestern Lab, and Eastern Lab. This program is essential to check for veterinary drug, pesticide, and contaminant chemical residues within the nation’s food supply. The new contract will continue to provide the critical resources needed to maintain and enhance the performance for this required process.

The sole manufacture is:

UCT, LLC

2731 Bartram Rd Bristol, PA 19007

UEI: VMZ1Z4D2EL22

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

This contract will provide supplies and reagents to perform residue analysis using solid phase extraction columns, QUECHERS salt kits, and QUECHERS salt packages used for the chromatographic separation of analytical compounds by chromatography/mass spectrometry/mass spectrometry for all FSIS laboratories. The primary objective of this contract is to ensure the provision of these essential supplies. These supplies play a crucial role to check for veterinary drug, pesticide, and contaminant chemical residues within the nation’s food supply. The solid phase extraction columns, QUECHERS salt kits, and QUECHERS salt packages are used for extraction clean-up of samples. The columns separate out impurities from extracts based on molecular characteristics such as hydrophobicity and ionic interactions.

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 $855,000 as shown below:

Over the Simplified Acquisition Threshold Identification Number: 123A9426Q0014

Rev. 3/10/26

Period Fiscal Year Estimated Total

BASE FY26 $140,000

Option 1 FY27 $140,000 Option 2 FY28 $150,000 Option 3 FY29 $170,000 Option 4 FY30 $170,000 Subtotal $770,000

Evaluation of FAR 52.217-9 $85,000 Grand Total $855,000

(4) Identify the exception to fair opportunity.

The statutory authority supporting the placement of an order or establishment of an Indefinite Delivery/ Indefinite Quantity (IDIQ) that exceeds the micro-purchase threshold on a brand name basis is: FAR 16.507-7 - Items Peculiar to One Manufacturer.

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

The solid phase extraction columns, QUECHERS salt kits, and QUECHERS salt packages from UCT, LLC are the only items compatible with the guidelines and standards set forth in FSIS' Chemistry Laboratory Guidebook (CLG). These standards provide guidelines to check for veterinary drug, pesticide, and contaminant chemical residues within the nation’s food supply. UCT is the sole manufacturer that offers the specific proprietary components and integrated capabilities necessary to ensure compatibility, performance continuity, and compliance with existing USDA/FSIS operational standards.

UCT’s systems incorporate proprietary design features, materials, and performance specifications that cannot be replicated, substituted, or modified by alternative sources. These features are essential because they interface directly with the Government’s current equipment baseline, preserves the functionality of previously procured systems.

Market research confirmed that although other manufacturers provide similar product categories, none offer the required combination of technical attributes, proprietary interfaces, or compatibility features. Competing products were determined to lack one or more of the following essential capabilities:

operations;

• Access to proprietary design specifications necessary for safe and accurate integration;

• Calibration, performance, or material characteristics that meet FSIS’s validated baseline;

• Ability to maintain continuity with historical data, performance outputs, or quality controls developed using UCT equipment;

Substitution with another manufacturer’s product would require significant re-engineering, create discontinuity in operational outputs, and jeopardize the integrity of existing systems and datasets.

This would result in additional costs to the Government, extended deployment timelines, and unacceptable risk to ongoing FSIS mission operations.

Because the Government’s operational environment depends on retaining full compatibility, continuity, and reliability with UCT’s proprietary components and performance characteristics, no alternative manufacturer can meet the agency’s minimum needs. Therefore, restricting competition

(6) A determination by the Contracting Officer that the order represents a fair and reasonable price.

The Contracting Officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable based on a thorough comparison of submitted quotations from the solicited Request for Quotes (RFQ).

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

Additional facts supporting use of other than full and open competition include the Government’s need to maintain continuity of analytical methodology and standardization determined by 9 CFR

416.3 and further supplemented by FSIS Residue Directives 10800.1, 10800.2, and 10800.3, and the FSIS Chemistry Laboratory Guidebook (CLG). These laws, policies, and guidelines mandate that each analytical method utilize the specific equipment and materials identified in the method in order to ensure consistent performance, data comparability, and adherence to validated analytical procedures. Because many FSIS residue and contaminant detection methods are validated using alidation, disrupt method integrity, and jeopardize regulatory testing accuracy. The CLG emphasizes that while FSIS does not explicitly endorse any commercial product, the equipment listed within each method is required to meet performance expectations, facilitate training, and support nationwide consistency across FSIS laboratories. In addition, FSIS regulatory requirements, including 9 CFR 416.3, require that laboratory equipment be designed to ensure proper sanitation and inspection access—standards UCT products have already been demonstrated to meet within FSIS laboratory environments. Because UCT components interface directly with existing validated produ factors provide strong support for limiting competition and acquiring UCT products under the authority for items peculiar to one manufacturer.

The laboratory is responsible for ensuring accuracy and compliance to veterinary drug, pesticide, and contaminant chemical residue checks within our nation's food supply. Without these kits, the laboratory risks compromising sample throughput, delaying verification activities, and undermining public health protections.

For these reasons, continuity of analytical performance, interoperability with existing instruments, and the need to safeguard long-term national datasets support the decision to restrict competition and use the cited authority.

(8) A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition of the supplies or services required.

To foster competition for future acquisitions and reduce reliance on brand-specific features, the agency continues to take several actions to eliminate barriers that contribute to the need for an exception to fair opportunity. The agency will assess opportunities to transition validated Chemistry extraction materials, column t interchange meetings, to identify alternative suppliers capable of meeting FSIS performance requirements and to understand emerging technologies that may support future competitive sourcing.

without compromising ongoing mission operations. These activities may include pilot studies, method equivalency assessments, and collaborative testing among FSIS laboratories to determine consistency with historical results. Collectively, these actions are intended to expand the potential competition to the maximum extent practicable for subsequent acquisitions.