JOFOC Yuma LS UAZ-final.pdf

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TMPLT 2016.06-011

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

FDA/OAGS

b. Sponsoring organization.

CFSAN/ORS/DM

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Jennifer Gibson

ii. Mailing address: 5001 Campus Dr., College Park, MD 20740

iii. E-mail address: Jennifer.Gibson@fda.hhs.gov

iv. Telephone number: 240-402-2770

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

Yuma Valley environmental sampling and surveillance for bacterial foodborne pathogens

a. Acquisition purpose and objectives.

To support FSMA and the Produce Safety Rule there is a need to have a greater understanding of the presence, persistence, seasonality and diversity of foodborne enteric pathogens within produce productions areas such as the Yuma Valley growing region which is a large supplier of fresh leafy green vegetable to the U.S. populace. This region has been linked to outbreaks of E.coli O157 illnesses and deaths after the consumption of romaine lettuce. This work will shed light on the ecology of this pathogen and other foodborne enteric pathogens such as Salmonella, Listeria and Campylobacter within the environment and routes that these pathogens use to contaminate leafy greens before or during harvest.

b. Project background.

The 2018 romaine lettuce outbreak resulted in 210 cases from 36 states with five deaths and 27 cases of HUS. Recently, the FDA, with other federal and state partners, identified E. coli O157:H7 in water samples taken from irrigation canals in the region. This has led to many questions surrounding the incidence of E. coli O157:H7, other shiga-toxin producing E. coli, and other foodborne pathogens, such as Salmonella, Listeria monocytogenes and Campylobacter, in the farm and surrounding

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Last Modified: April 5, 2017 Page 2 of 6 environment. To this end, a more detailed longitudinal microbiological study focused on the environment should yield further clues as to the sources of microbial contamination, the prevalence and persistence of bacterial enteric foodborne pathogens in the ecosystem, temporal fluctuations over time and seasonality in the field.

This is a new contract action but related to previous funding through an IAA with USDA that was subcontracted to Dr. Rock and the University of Arizona.

224192020S for $146,600

75F40119S20095 for $125,000

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

This acquisition requires the cooperation and buy-in of the Wellton-Mohawk Irrigation and Drainage district, in order to conduct research on property owned by them. They have previously stated that they will not work on any project with FDA unless, Dr. Channah Rock and the University of Arizona is involved. Without the involvement of the irrigation district, FDA will not be able to gain access to get critical samples needed to help understand the full problem of enteric pathogen contamination of romaine lettuce in this region. The services for this contract are for the University of Arizona, and Dr. Channah Rock, to conduct environmental sampling and analysis of the region, including samples to be taken from the Irrigation District lands and canals.

In addition, Dr. Rock is highly esteemed amongst her colleagues and the scientific community for her work in water quality and food safety. She has many peer-reviewed papers and has received multiple grants by other funding agencies to conduct research similar to that described in the statement of work.

The estimated cost of the requisition is $228,000

a. Project title.

Yuma Valley environmental sampling and surveillance for bacterial foodborne pathogens

b. Project Description.

Please see the attached statement of work

Requirement type.

☒ Research & Development (R&D)

☐ R&D support services

☐ Support services (non-R&D)

☐ Supplies/equipment

☐ Information Technology (IT)

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☐ Construction

☐ Architect-Engineer (A&E) services

☐ Design-build

☐ Other: Type of action.

☒ New requirement

☐ Follow-on

☐ Other:

Proposed contract/order type.

☒ Firm-fixed-price

☐ Other fixed-price:

☐ Cost-plus-fixed-fee

☐ Other cost reimbursement:

☐ Time and materials

☐ Indefinite delivery:

☐ Other:

☐ Completion Form

☐ Term Form

Acquisition identification number.

Req# 1229273, “Yuma Valley environmental sampling and surveillance for bacterial foodborne pathogens”

c. Total estimated dollar value and performance/delivery period.

$228,000 Period of performance for 1 year from time of the award

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

☒ 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

☐ 6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim

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☒ 6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

☐ 6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

☐ 6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

☐ 6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

☐ 6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

☐ 13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C.

1901 or the authority of 41 U.S.C. 1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Channah M Rock Professor & Water Quality Specialist Dept. of Environmental Science

THE UNIVERSITY OF ARIZONA

Maricopa Agricultural Center 37860 W. Smith-Enke Rd. | Maricopa, AZ 85138 Office: 520-374-6258 | Cell: 480-628-9794 channah@cals.arizona.edu

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

This acquisition requires the cooperation and buy-in of the Wellton-Mohawk Irrigation and Drainage district, in order to conduct research on property owned by them. They have previously stated that they will not work on any project with FDA unless, Dr. Channah Rock and the University of Arizona is involved. Without the involvement of the irrigation district, FDA will not be able to gain access to get critical samples needed to help understand the full problem of enteric pathogen contamination of romaine lettuce in this region. The services for this contract are for the University of Arizona, and Dr. Channah Rock, to conduct environmental sampling and analysis of the region, including samples to be taken from the Irrigation District lands and canals.

https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%2013_5.html https://www.acquisition.gov/far/html/Subpart%2013_5.html http://uscode.house.gov/view.xhtml?req=(title:41%20section:1901%20edition:prelim) http://uscode.house.gov/view.xhtml?req=(title:41%20section:1901%20edition:prelim) http://uscode.house.gov/view.xhtml?req=(title:41%20section:1903%20edition:prelim)

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6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

Market Research included many meeting (face-to-face and teleconferences) with individuals, growers and industry groups in the Yuma Valley regions and State of Arizona, who own the land that FDA needs to be able to conduct the sampling on. During these meetings it was made abundantly clear that this work could not continue if FDA is unable to work with Dr. Channah Rock and the University of Arizona.

A notice of intent to sole source was posted on June 8, 2020 with a response date of June 23, 2020.

Any interested parties were invited to submit a capability statement. No responses were received.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Prices have been determined to be fair and reasonable by the CO through analyses of historical prices, indirect cost rate agreements and salary comparisons to similar work performed and consistency with University salary rates. Certified cost and pricing data was not necessary or required.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market Research included many meeting (face-to-face and teleconferences) with individuals, growers and industry groups in the Yuma Valley regions and State of Arizona, who own the land that FDA needs to be able to conduct the sampling on. During these meetings it was made abundantly clear that this work could not continue if FDA is unable to work with Dr. Channah Rock and the University of Arizona.

A notice of intent to sole source was posted on June 8, 2020 with a response date of June 23, 2020.

Any interested parties were invited to submit a capability statement. No responses were received

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

This work is similar to previous funding provided by FDA to USDA which was then subcontracted to Dr. Channah Rock and the University of Arizona

224192020S for $146,600

75F40119S20095 for $125,000

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

No other sources expressed an interest in this requirement. Interested parties were given a chance to respond through a Notice of Intent; FDA - Sole Source - 1229273.

https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/?q=browse/far/10

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11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

It is unknow if future acquisitions will be needed at the end of the period of performance for this contract.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Signature:____________________________________

Rebecca L. Bell COR/Requiring Activity POC

6-16-2020

Signature:____________________________________

[Enter name here.] COR/POC Immediate Supervisor

[Enter date here.]

Signature:____________________________________

[Enter name here.] Head of the Sponsoring Program Office

[Enter date here.]

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Signature:____________________________________

Richard Robinson Contracting Officer

[Enter date here.]