FULLY APPROVED_Justification to limit competition - FAR 13 SingleSource or BNJ.pdf

United States Department of Agriculture Limited Source/Brand Name Justification

FAR 13.106-1(b)(1) – Simplified Acquisitions Control No. (if applicable) ______________________

1. Identification of the agency and the contracting activity.

United States Department of Agriculture - Agricultural Research Service (USDA-ARS) Northeast Area Acquisitions and Personal Property/Fleet

2. Description of supply or service required to meet the agency’s needs.

The USDA-ARS Eastern Regional Research Center requires a contract for ELISA allergen test kits.

Allergen testing is a key component for proposed research in ice cream waste streams. This research will require large amounts of testing over the course of the project and use up test kits for six different allergens at unpredictable speeds. When some kits run out, more need to be able to be acquired in a timely manner so as not to hinder ongoing research.

3. The rationale or circumstances for limiting competition.

The Veratox ELISA test kits from Neogen are required for the following technical reasons:

a) The material on which we are working, waste ice cream, has many additives in unpredictable amounts (such as chocolate) that have been known to interfere in allergen testing. We have already conducted verification trials with Neogen to verify that their kits can accurately handle the product and have concluded that they can. No other company has conducted such testing on waste ice cream.

b) Veratox from Neogen comes with antigen sample wells already installed into the plates, which cuts down significantly on the time required to run the tests and limits the amount of technical expertise needed to run the tests, which is critical for our proposed work which is already labor intensive.

c) Different companies require the purchasing of unique specialized equipment to go with the allergen tests of specific companies, and we have already purchased the equipment necessary to use the Veratox technology from Neogen.

d) Allergen detection limits depend on the allergen, but most allergen types in Veratox kits are detectable from 2.5-25ppm, with many detecting as low as 1 ppm of sample. This is a broad range of detection that suits the nature of our sample’s unknown composition. In addition, all allergen types we are testing meet this standard with Veratox from Neogen. Other competing brands have detection ranges that vary significantly between allergens and are often much more narrow than the one from Veratox Neogen.

f) Many allergen testing products are not quantifiable at all and are only qualitative. For our purposes, we need quantifiable results.

4. A description of the market research conducted and the results or a statement of the reason market research was not conducted.

Market research was conducted to identify nitrogen/protein analyzers capable of meeting our specific research requirements for analyzing challenging ice cream waste samples. We examined literature, product specifications, technical comparisons, and incorporated our direct experience with the following systems:

a) AllerTox from Hygiena

b) SensiSpec Elisa

c) AgraQuant RomerLabs

d) Veratox Neogen

Please see separate model comparison table generated in the market research process

While all tests utilize the Elisa test method, the market research revealed only the Veratox Neogen had all of the following characteristics:

- Large range of concentrations quantifiable, >20ppm

- Has kits for all allergens required for our research

- Has consistent range of quantification

- Has verified efficacy with waste ice cream

5. Estimated price, including all options, if applicable.

The amount of test kits required for the project is only an estimate, however the number of kits currently believed to be necessary is around 100 kits total. At a cost of $796 each, the approximate cost is estimated to be around $80,000

6. Recommended source(s).

Neogen 620 Lesher Place Lansing, MI 48912 USA

800.234.5333 (USA)

Certifications

Supporting data that is the responsibility of technical or requirements personnel and which form the basis for this justification are accurate and complete to the best of my knowledge.

Dr. Benjamin Plumier

Research Chemical Engineer

The information contained in this justification is accurate and complete to the best of my knowledge and belief and in accordance with Federal Acquisition Regulation 13.106-1(b)(1), I hereby determine the circumstances described above deem only one source, or limited sources, reasonably available and competition is precluded for the reasons indicated in this document.

Insert Name of Contracting Officer Contracting Officer

Notes and Guidance. Delete these Notes prior to finalizing document for signature

For acquisitions greater than the micro-purchase threshold but less than the Simplified Acquisition Threshold (SAT) the Contracting Officer may solicit from one source only if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand name, etc.). Contracting Officers must document the rationale for soliciting from a single source, including brand name in accordance with FAR 13.106- 1(b)(1)(i) and FAR 13.106-3(b)(3)(i).

Program personnel are advised to work with contracting personnel early on in order to promote and provide for full and open competition to the maximum extent practicable. In circumstances permitting other than full and open competition, program personnel shall provide necessary information to contracting personnel to support and document the circumstances limiting competition through the use of this form

Advance planning. Contracting without providing for full and open competition shall not be justified on the basis of (1) a lack of advance planning by the requiring activity or (2) concerns related to the amount of funds available to the agency or activity for the acquisition of supplies or services.

Brand Name. Items peculiar to one manufacturer can be a particular brand name, product, or feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer. Brand name specifications shall not be used unless the particular brand name, product or feature is essential to the Government’s requirements and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the Agency’s needs.

Posting. When an acquisition contains brand name specifications, the Contracting Officer shall include the justification required by FAR 13.106-1(b) or 13.501 with the solicitation when synopsizing in the GPE (actions exceeding $25,000) or displaying in a public place (actions exceeding $15,000 but not expected to exceed $25,000), as required by FAR 5.102(1)(6).

Screening. Before posting the justification, in accordance with FAR 6.305(e) and 24.202, the Contracting Officer is responsible to redact any information that is exempt from disclosure under Freedom of Information Act or information proprietary to the contractor.

Signatures. After review and completion by the Program Office and Contracting Officer, the Word document shall be converted to an Adobe PDF file and routed for electronic signatures. Signature blocks shall include dates.

https://www.acquisition.gov/far/part-13#FAR_13_106_1 https://www.acquisition.gov/far/part-13#FAR_13_501