A05 SSJ Exceeding the SAT 06172025gdb3_Animal Species.pdf

United States Department of Agriculture

Sole Source (Including Brand Name) Justification exceeding

Simplified Procedures for Certain Commercial Items (FAR 13.5)

Control No. (if applicable) ______________________

1. Identification of the agency and the contracting activity.

1a. Requesting Activity Agency:

USDA, FSIS, Office of Public Health Science (OPHS)

1400 Independence Avenue, SW

Washington, DC 20250

1b. Contracting Activity:

USDA, FSIS, Office of Management (OM)

Procurement Management Branch (PcMB)

5601 Sunnyside Avenue, Maildrop 5230

Beltsville, MD 20705-5230

2. The nature and/or description of the action being approved.

USDA FSIS proposes to enter into a sole source firm fixed price IDIQ contract with bioMérieux using the simplified procedures for certain commercial items under Federal Acquisition Regulation

(FAR) Part 13.5.

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

The purpose of this contract is to allow purchasing of GENE-UP PRO animal species ID kits for the detection of multiple animal species from food samples for the Food Safety Inspection Service

(FSIS). Individual kits will be purchased to detect the following animal and poultry species:

Canine, feline, bovine, chicken, ovine, equine, porcine, turkey, caprine, deer, elk, duck, and rabbit species. For operational effectiveness, the kits need to be compatible with the GENE-UP® PCR platform. This device is already established in the field service laboratories.

FSIS field service Eastern Laboratory ensure that laboratory analytical services are performed in support of the Agency’s statutorily mandated food safety inspection tasks. The laboratory is responsible for ensuring accuracy and compliance to species labeling requirements to enforce 9

CFR 319, Standards of Identity or Composition. Additionally, they must be able to detect cat and dog muscle tissue per the 2019 Farm Bill.

It is anticipated that this contract will be one base year and four option years, estimating

$695,000.00 for the total contract value.

Base Year: $130,000.00

Option Year 1: $130,000.00

Option Year 2: $140,000.00

Option Year 3: $145,000.00

Option Year 4: $150,000.00

Total: $695,000.00

4. The statutory authority permitting other than full and open competition.

41 U.S.C § 1901 - Simplified Acquisition Procedures up to $7.5 million, as authorized by FAR

13.500(a) and implemented by FAR 13.501(a).

5. Supporting rationale demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

For operational effectiveness, the animal species ID kits need to be compatible with the GENE-

UP® PCR platform. This is a device already established in the field service laboratories.

Market research has shown that the only known available vendor that is able to provide the necessary testing kits with the specificity and sensitive required is bioMérieux. Additionally, this system is already validated for use and would not cause an interruption in statutorily mandated food safety inspection tasks. Failure to have these kits could result in the lapse of mandated food safety inspections and possibly putting the ability for Americans to purchase and consume safe food at risk by introducing falsely labelled imported products.

BioMérieux has the ability and well-established infrastructure to get the required kits to the laboratories. Additionally, bioMérieux is the only authorized reseller of the required product. The requested kits work on the already established technology (the GENE-UP® PCR platform) within the lab, lowering the overall cost burden.

6. A description of efforts made to ensure offers are solicited from as many potential sources as is practicable.

Market Research has been done extensively to find alternative solutions. Only one other vendor, ThermoFisher, has a product that can provide all animal species needed, but their product requires the use of different machine that is not already established at the labs. The ThermoFisher system requires a heavy upfront equipment cost to function, and then further requires large amounts of consumables due to the high-throughput nature of its system. If FSIS used that system, much of the kit would go to waste since it is built to run hundreds of samples at one time, and FSIS only tests 5-

10 samples per week. This would lead to a waste of taxpayer funds as the technology requires a specific amount of consumables whether 1 or 96 samples are run at a time. The bioMérieux test works as a simple Polymerase Chain Reaction (PCR) test using equipment already obtained by

FSIS.

Market research is conducted in a continual basis as having more than one vendor for all of the supply items is ideal. However, the market has shown that is not possible. The government will continue to encourage vendors to enter the market for these products. This effort is critical to get on contract due to national security. Ideally, this contract will run for one base year with four additional option years, and advances in these technologies can be revisited before each option year is exercised.

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

Proposed prices will be determined fair and reasonable on the basis of comparison of the proposed price with prices found reasonable on previous purchases and through current price lists.

ThermoFisher would require a different device at an additional cost of an estimated $200,000 to the

Government. The cost of the kits is also higher at an estimated $350.00 when compared to bioMérieux at an estimated $300.00.

8. 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 through internet catalog and website searches for product availability, phone calls with vendors to see what their capabilities were, and direct quotes were received. No other vendor besides bioMérieux was able to provide the kits compatible with the

GENE-UP® PCR platform, along with their pricing.

ThermoFisher did provide animal ID test kits with pricing, but the kits were not compatible with the technology already established at the labs.

9. Any other facts supporting the use of other than full and open competition.

There are no additional facts for supporting the use of other than full and open competition.

10. A listing of the sources, if any, that expressed a written interest in the acquisition.

bioMérieux

ThermoFisher

11. A statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated.

The Government will continue to search for other alternatives in the future that may satisfy the time sensitive and laboratory requirements needed for the Agency’s statutorily mandated food safety inspection tasks.

Certifications & Approvals

Supporting data which form the basis for and included in this justification are certified accurate and complete.

Hannah Anderson Martinez

Microbiology Staff Officer

The information contained in this Justification for Other Than Full and Open Competition is certified accurate and complete to the best of my knowledge and belief.

Monika Masei

Contracting Officer

Additional Reviews & Approvals

Advocate for competition for the procuring activity (if over $750,000). I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief.

Therefore, unless additional approvals are required as prescribed below, as advocate for competition for the procuring activity/MASCO, I hereby approve this justification.

Insert Name of the Procuring Activity Competition Advocate/MASCO

Title:

Procuring Activity Advocate for Competition