Attachment 1 - Single Source Justification A_Redacted.pdf

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Notice of Intent to Award a Sole Source Award For Cobalt-60 Reload of Foss Therapy Model 484F-C Cobalt-60 Irradiator
Solicitation number
12639526Q0261
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This is a Justification to Restrict Competition document submitted by the USDA APHIS PPQ Phoenix Rearing Facility through the AAMD Acquisition Branch in Minneapolis for a non-competitive contract award under FAR 12.102(b).

The agency seeks to procure a turn-key Cobalt-60 source reload operation for a Foss Therapy Model 484F-C Cobalt Irradiator, requiring approximately 20,000 curies of Cobalt-60 to be installed at the Phoenix Rearing Facility. The irradiator is used to sterilize navel orangeworm moths for production shipments. Current operational constraints require over 8 minutes per irradiation cycle to achieve the necessary 30-kilorad dose, with more than 8 cycles needed per production run, resulting in total irradiation times exceeding 90 minutes that will increase as the radioactive material decays. The reload will enable the facility to meet the coming year's production rate and reduce processing time.

Foss Therapy Services Inc. is identified as the sole responsible source because it manufactures the irradiator model exclusively, holds proprietary designs and mechanical specifications, and possesses regulatory authorization from both the Nuclear Regulatory Commission (NRC) and California Radiologic Health Branch (CRHB) to perform maintenance and cobalt-60 source reloading work on this equipment. No other vendor possesses the required regulatory authorization, technical specifications, or manufacturer approval to safely and legally complete this work. The contracting officer determined pricing to be fair and reasonable based on historical pricing data from USA Spending and internal USDA documents, comparing the offered pricing to previous similar purchases by USDA and other departments while accounting for inflation, size, and capacity factors. This acquisition will be structured as a small business set-aside since all available businesses are registered as small businesses in the SAM database. No other sources expressed written interest in the acquisition, and no market research was conducted due to the exclusive nature of the requirement.

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United States Department of Agriculture Justification to Restrict Competition

FAR 12.102(b) Identification No. _1172541

1. Identification of the agency and the contracting activity.

Agency: USDA APHIS PPQ Phoenix Rearing Facility Contracting Activity: AAMD Acquisition Branch, Minneapolis

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

This is to secure a contract for a reload of 20,000 curies Cobalt 60 for the Model 484F-C irradiator at the Phoenix Rearing Facility (PRF).

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

The Foss Therapy 484F-C Cobalt Irradiator is used to sterilize navel orangeworm moths. At the current rate and age of our cobalt Co-60 sources, it takes over 8 minutes for each irradiation cycle to reach the required dose of 30 kilorad. Over 8 cycles are required to sterilize enough insects for the current production rate shipments. Due to this, the total irradiation time is over 90 minutes and will continue to increase as the radioactive material decays. The goal of increasing the number of sterile insects requires a shorter irradiation time. A turn-key Cobalt-60 source reload operation is needed for the Foss Therapy 484F-C Cobalt-60 Irradiator. The required amount needed to be installed is approximately 20,000 Curies of Cobalt-60. This will allow the Phoenix Rearing Facility to meet the coming year’s production rate.

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

The statutory authority permitting other than full and open competition is 41 U.S.C. 1901 and 1903 as implemented by FAR 12.102.

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

Foss Therapy Services Inc. manufactured and installed the irradiator and they are the only company qualified to perform the reload. Foss Therapy is the only company that performs this service on this model of machine.

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.

Foss Therapy Services (FTS) holds the proprietary designs, exact engineering tolerances, and mechanical blueprints for the Model 484F-C. Third-party providers do not possess the proprietary mechanical specifications necessary to align and properly configure the replacement sealed source capsules into the machine's specific multi-source holders

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

To determine fair and reasonable pricing, the USDA reviewed historical pricing data on the USA Spending website, and internal USDA documents, as available, to compare pricing offered to that previously paid. Factors such as inflation, size, and capacity were taken into consideration. From this review, USDA determines that pricing offered for this procurement is expected to be similar to previous pricing paid by USDA, and other Departments, for purchases similar in nature.

8. A description of the market research conducted, and the results or a statement of the reason Market Research was not conducted.

Because the Foss Therapy 484F‑C Cobalt irradiator is a highly specialized, shielded device manufactured exclusively by Foss Therapy Services, they are the only company authorized to perform critical maintenance tasks, including cobalt‑60 source reloading. Foss Therapy is the original manufacturer and the only entity authorized by both the Nuclear Regulatory Commission (NRC) and the California Radiologic Health Branch (CRHB) to work on the shielding and source‑related components of this irradiator model. No other vendor is verified to possess the regulatory authorization, technical specifications, or manufacturer approval necessary to safely and legally reload cobalt‑60 sources for the 484F‑C unit. Therefore, Foss Therapy Services is the only responsible source available to perform this work.

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

This acquisition will be a small business set aside as all businesses are registered as a small business in the SAM database.

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

None

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.

USDA will conduct regular market research and engage with industry to identify new irradiation sources and emerging technologies for potential use in future requirements of a similar nature.

12. Certifications & Approvals

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.

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