Attachment 1 Sole Source.pdf

United States Department of Agriculture Only One Source Able to Provide the Products, Services, or Solutions

Under the Simplified Acquisition Threshold Identification Number: 1169663

Rev. 10/29/25

In accordance with the Revolutionary Federal Acquisition Regulation (FAR) Federal Acquisition Regulation (FAR) 8.401 and General Services Administration Regulation (GSAR) 538.7104-3 (a), the following documents the decision to restrict competition for this acquisition.

(1) Mission Area and Contracting Activity.

Requisition Number: 169063

Requesting Activity Agency: USDA AMS

Contracting Activity: Equipment Purchase

(2) Estimated Value

Period Fiscal Year Total One time purchase FY26

Grand Total

(3) Brief Description of Supplies or Services

The acquisition involves purchase and installation of two CEM Oracle 6 fat and moisture analyzers. One instrument will be installed at the National Science Laboratory, Gastonia, North Carolina and the other at the National Science Laboratory, Blakely GA. This scientific equipment is used for the determination of moisture and fat content in food sample using the American Association of Analytical Chemists (AOAC) method 2008.06 “Moisture and fat in meats. Microwave and nuclear magnetic resonance analysis”. It is widely used in analytical chemistry and food laboratories. This method is specifically required by NSL clients.

(4) Suggested Source

The suggested contractor is:

GERSTEL, Inc.

701 Digital Drive, Suite J Linthicum, MD 21090 410-247-5885 POC sales@gerstelus.com, www. Gerstelus.com

UEI:

(5) Justification for Restricting Competition and the Basis for that Decision.

A. The Gerstel Freestyle Immuno Affinity Column Sample Preparation Robotic System qualifies as a sole source procurement because it is the only instrument worldwide that provides the combination of features in an automated robotic sample preparation and cleanup system for the analysis of aflatoxin in peanuts and peanut products. Gerstel Freestyle Immuno Affinity Column Sample Preparation Robotic System has specialized robotic handling systems that are customized to the specific procedure and equipment currently being manually used in the laboratory.

mailto:sales@gerstelus.com http://www/

Under the Simplified Acquisition Threshold Identification Number: 1169663

No other instrument manufacturer can provide the customization and support needed to successfully prepare samples automatically.

Current laboratory procedures and quality assurance factors have already been established for the manual procedures currently being used. This instrument mimics those procedures robotically.

Due to its unique combination of:

• aflatoxin-focused robotic design,

• peanut-validated immunoaffinity columns,

• fully automated extract-to-HPLC workflow

• demonstrated high sensitivity and reproducibility for aflatoxins in peanuts

The Gerstel FREESTYLE Immunoaffinity Column Sample Preparation Robotic System constitutes a sole source solution for our required application.

B. Describe market research conducted and the results or the reason why no market research was conducted.

Market research was conducted to verify the availability of comparable instruments, starting with the

Other systems do exist that can perform similar to the GERSTEL system specified. However, they do not off a solution that is purpose built has validated workflows for peanuts and peanut products and does not rely on a third-party robot. The combination of these factors are what set the system apparat from other robots that can perform the steps but have not already been configured and tested to do so successfully in a manner that meets the needs of the laboratory.

Examination of similar instruments

Waters AflaTest WB or JASCO AFLAKING

Has validated peanut workflows, but require integration with a general-purpose robot to achieve full automation. Not a turnkey solution.

JASCO AFLAKING IAC

Requires a third-party robot. Not a turnkey solution

Tecan/Hamilton/Gilson SPE robots require custom method development and is not purpose built for aflatoxin.

Under the Simplified Acquisition Threshold Identification Number: 1169663

Certifications & Approvals

(1) 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.

Digitally signed by MICHAEL MILLER Date: 2026.06.08 11:09:25 -04'00'

Name Michael D. Miller Title Supervisory Chemist

(2) 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. I hereby approve this justification.

Name Contracting Officer

MICHAEL MILLER