Attachment 3 Buy American Act APPROVED Waiver Solicitation Number 1232SA26Q0217.pdf

From: noreply.mia@madeinamerica.gov <noreply.mia@madeinamerica.gov> Sent: Monday, April 27, 2026 12:40 PM To: Jordan, Monte - REE-ARS <monte.jordan@usda.gov> Cc: Jordan, Monte - REE-ARS <monte.jordan@usda.gov>;

MBX.OMB.MIAwaivers@omb.eop.gov Subject: 1232SA26Q0217 Email Made in America Office Procurement Waiver Reviewed_04.27.2026

Procurement Waiver

Your Procurement waiver has been reviewed.

Please check the status of your waiver by visiting the Made in America website.

Email MBX.OMB.MIAwaivers@omb.eop.gov if you have questions or need assistance.

From: Emmons, Lara J. EOP/OMB <Lara.J.Emmons@omb.eop.gov> Sent: Monday, April 27, 2026 12:40 PM To: Jordan, Monte - REE-ARS <monte.jordan@usda.gov> Cc: Watson, Crandall - OCP, DC <crandall.watson@usda.gov> Subject: 1232SA26Q0217 Email Lara Emmons APPROVAL BAA waiver_04.27.2026

Greetings, This email is to inform you that the Buy American Act waiver regarding your acquisition has been deemed consistent with policy / has received the required approval.

Thanks, Lara Emmons, Procurement Analyst Made In America Office | Office of Management and Budget Executive Office of the President 202-881-4207

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REVIEWED

12 bioreactor 2-liter autoclavable glass vessels and required parts that must be compatible with Sartorius Biostat-B Bioreactor Control Units.

Waiver type - Procurement: Nonavailability

Agency: Department of Agriculture • Product Service Code (PSC) : 6640 | Last Modified:

04/27/2026

Procurement Summary USDA, ARS, MWA, National Center for Aquacultural Utilization Research (NCAUR), Bioenergy Research Unit (BRU), Peoria, Illinois location requires 12 bioreactor vessels and required parts that must be compatible with Sartorius Biostat-B Bioreactor Control Units. The following features requested. 1) Compatibility with our current Biostat-B Twin MO bioreactor control units. 2) Compatibility with our current Biostat benchtop bioreactor vessels including stirring mechanism and water-based temperature control. 3) Compatibility with current jacketed water-based temperature control system for vessels. a. Connections for double wall UniVessel Glass b. Needs to be able to connect to control unit water lines c. Includes hose kit to connect vessel to Control Unit temperature control. 4) Stainless steel head plate with following ports/connections a. Ports available must include 19 mm, 12 mm, and 6 mm options, accommodating various sensor and accessory needs. i. Temperature probe ii. Oxygens sensor iii. pH sensor iv. Acid/base/anti-foam and feed additions v. Anti-foam Sensor

vi. Water chilled condenser vii. Aeration Sparge 5) Stainless steel stirrer shaft with direct coupling to Biostat-B Twin MO bioreactor control unit motor. 6) Inner dimensions: Diameter = 130mm, Height = 240mm a. The fermentation vessels must be compatible with the Bioreactor control units at stated in item 1, but also must be appropriately sized to dimensions listed in item 6 to maintatin continuity of conditions for experimental design in relation to 20 years of historic data produced with similarly sized fermentation vessels. How can we improve this site?

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Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

Yes

OMB Determination Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted 04/20/2026

Procurement Instrument Identifier (PIID) N/A

Solicitation ID N/A

Procurement Stage Pre-solicitation

Waiver Coverage Individual Waiver

United States Department of Agriculture Made in America Nonavailability Waiver

Determination & Findings (D&F)

Rev. 11/5/25

DETERMINATION & FINDINGS

In accordance with Federal Acquisition Regulation (FAR) 25.103 (b)(2), the following information is provided to justify the purchase of items that are not manufactured in the United States in sufficient and reasonably available commercial quantities of a satisfactory quality to meet the requirements of this acquisition.

FINDINGS

1. Agency and Contracting Activity

a. Mission Area: USDA, ARS, National Center for Agricultural Utilization Research, Bioenergy Research Unit (BRU), Peoria, IL.

b. Contracting Activity Office: Contracting Operations Branch/Acquisition and Property Division.

c. Funding Office: National Center for Agricultural Utilization Research, Peoria, IL.

Procurement Instrument Identifier: IAS requisition #1162866, Solicitation #1232SA26Q0217

2. Nature and/or Description of End Item(s)

a. NAICS: 334516

b. PSC: 6640

c. Procurement Stage: Pre-Solicitation

d. Country(ies) of Origin and U.S. Content: Germany

a. Waiver Title: 12 bioreactor 2-liter autoclavable glass vessels that must be compatible with Sartorius Biostat-B Bioreactor control units

b. Summary of Procurement: USDA-ARS-MWA-NCAUR-BER requires 12 bioreactor vessels that must be compatible with Sartorius Biostat-B Bioreactor control units.

c. Period of Performance: 04/01/2026 – 05/18/2026

d. Is this product being used in multiple locations? No. USDA, ARS, National Center for Agricultural Utilization Research, Bioenergy Research Unit (BRU), Peoria, IL.

e. Estimated value of product being waived: $69,000.00.

Determination & Findings (D&F)

3. Market Research Market research was conducted by both the program office and contracting activity office. Program office researched vendor, Satorius Stedim North America, Inc. website to obtain the specifications required for compatible vessels for Sartorius Biostat B bioreactor systems. Sartorius bioreactor vessels are only sold through Sartorius Stedim North America, Inc.

An internet search was conducted by the Program Office end-user to verify the availability of comparable bioreactor vessels compatible with Sartorius Biostat-B control units from other vendors.

This included analyzing product specifications, consulting with peer institutions.

Market research findings of seven vendors researched and contacted by the Program Office are listed below.

Vendor One - Contacted through email communication for possible alternative to Sartorius bioreactor vessels. Vendor responded that bioreactors vessels from their company were not compatible with Sartorius bioreactor control units.

Vendor Two – Ratio of height/inner diameter is 2; specified ratio is 1.4 – not compatible.

Vendor Three – Reactor vessels are single use only, specification is autoclavable – not compatible.

Vendor Four – 2L vessel is not double walled and has no connection for control unit water lines – not compatible.

Vendor Five – Smallest vessel is 50L, specified working volume is 0.4L to 2 – not compatible.

Vendor Six – Complete vessel with headplate and stand is single walled. Jacketed glass only version is compatible with Broadley James and Applikon controllers only. Requested vessel must be compatible with Sartorius Bioreactor controller – not compatible.

Vendor Seven – Hyperform glass bioreactors. No 2L vessel is available – not compatible.

The responses and findings confirmed that no other bioreactor vessels compatible with Sartorius Biostat-B Bioreactor control units met the required compatibility and performance criteria. Market research did not identify a compatible product made in America.

Market research was performed by the contracting activity office by performing research of previous/prior orders through the Federal Procurement Data System - Next Generation (FPDS-NG) site for Sartorius comparable or compatible bioreactor vessels. No comparable or compatible product orders were found that are made in America. Additional market research was performed by the contracting activity office by researching Sartorius bioreactor vessels in Contract Opportunities on SAM.gov website. Only opportunities identified for compatible bioreactor vessels were procurements awarded to vendor, Sartorius Stedim North America, Inc.

a. Was a Sources Sought or Request for Information Issued? Yes

b. If a Sources Sought or Request for Information was issued, identify where it was published and for how long. If one was not published, please explain why: Sources Sought Announcement was posted to Contract Opportunities on SAM.gov from 03/19/2026 to 03/23/2026.

c. Market Research Description: The contracting activity office performed market research by searching the Federal Procurement Data System – Next Generation (FPDS- NG) site using product description “bioreactor vessels” and by searching using vendor name “Sartorius” for previous/prior orders. No previous/prior orders identified on the

Determination & Findings (D&F)

FPDS-NG site that were made in America. Additional market research was carried out through Contract Opportunities on SAM.gov website. This search was completed choosing Combined Synopsis/Solicitation as Notice Type and Award Notice Type to retrieve prior solicitation or award postings. Product description “bioreactor vessels” was also used as in search field to narrow search for prior solicitation or award postings.

Opportunities identified were procurements awarded to vendor, Sartorius, with no comparable or compatible opportunities found that are made in America.

4. Competition

a. Do you plan to compete this opportunity? No.

b. If no, describe why competition isn’t anticipated. The bioreactor fermentation vessels requesting to be purchased must be compatible with the Sartorius Bioreactor control unit that is currently in use at the Bioenergy Research Unit (BRU), Peoria, IL location. Sartorius bioreactor vessels are only sold through Sartorius Stedim North America. Market research did not identify a comparable product made in America. The acquisition of the bioreactor vessels must be restricted to Sartorius Stedim North America, Inc.

5. Buy American Provisions

c. Did/Will the solicitation include one of the standard Buy American Act provisions announcing the agency’s intention to provide a price preference for domestic end products and/or construction material? Yes

d. If no, provide a reason for not including the price preference:

e. In the event that a U.S. made end product was offered, but would be rejected for reasons other than price, please explain the rationale for exclusion (i.e., qualitative, past performance rationale). N/A.

6. Waiver Information The USDA, ARS, MWA, BRU, Peoria, IL location program office is requesting delivery of the 12 bioreactor vessels within 60 days from vendor, Sartorius Stedim North America, Inc. The bioreactor vessels must be appropriately sized to allow comparison to historic data produced with similarly sized fermentation vessels. Compatibility with current Sartorius Biostat-B Bioreactor control units is required for use and continuity of conditions for experimental design. Procurement of the Sartorius bioreactor fermentation vessels is vital in the ongoing research at the Bioenergy Research Unit (BRU), Peoria, IL location. Sartorius bioreactor vessels and replacement parts have been purchased in the past. Market research did not identify a compatible product made in America.

a. Waiver Coverage: Individual Waiver

b. If this is a multi-procurement waiver, provide an explanation for the basis of the multi-procurement waiver assessment: N/A.

Determination & Findings (D&F)

c. Waiver Rationale: The acquisition of the 12 bioreactor vessels must be restricted to Sartorius Stedim North America, Inc. The bioreactor vessels must be compatible with the Sartorius Bioreactor control unit that is currently in use at the USDA, ARS, MWA, Bioenergy Research Unit (BRU), Peoria, IL location. The bioreactor vessels from Sartorius Stedim North America, Inc. will allow comparison to historic data produced with similar sized bioreactor vessels. Compatibility with current Sartorius Biostat-B control units is required for use and continuity of conditions for experimental design in the ongoing research being conducted at the Bioenergy Research Unit (BRU), Peoria, IL location. Sartorius bioreactor vessels are only sold through Sartorius. Market research did not identify a comparable product made in America.

d. Anticipated Mission Impact if there is no waiver: The USDA, ARS, MWA, Bioenergy Research Unit (BRU), Peoria, IL location conducts a broad-based program of microbial, biochemical, genetic, and fermentation engineering research that is international in scope and importance addressing national research needs for new environmentally acceptable agricultural practices and value-added products. The requested procurement of the Sartorius bioreactor vessels is required for the use and continuity of conditions for experimental design. Not being able to procure the 12 bioreactor vessels will result in the loss of comparing historic data produced with similar sized bioreactor vessels that are currently being used with the Sartorius Biostat-B control units. This would also affect the overall mission of the Bioenergy Research Unit (BRU) research program of developing bioproducts and bioprocesses for conversion of agricultural commodities into biofuels and chemicals, enzymes, and polymers.

e. Expected Maximum Duration of the Proposed Waiver: Instant Delivery Only.

Public Comment Link: The requested waiver will be available for public to view on the Made in America website.

Determination & Findings (D&F)

Rev. 11/5/25

DETERMINATION

Based on the it has been determined that determination that an article, material, or supply is not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities of a satisfactory quality to meet this requirement. Therefore, this waiver is justified in accordance with Federal Acquisition Regulation (FAR) 25.103 (b)(2).

Submitted by:

Name of Program or Technical Personnel Title of Program/Technical Personnel

The information contained in this D&F is accurate and complete to the best of my knowledge and belief and in accordance with the Federal Acquisition Regulation.

Monte Jordan

Digitally signed by Monte Jordan Date: 2026.04.01 10:29:37 -05'00'

Name of Contracting Officer Contracting Officer

Additional Reviews & Approvals

Chief of the Contracting Office (COCO) (between $15,000 and $25,000). I have reviewed this D&F and find it to be accurate and complete to the best of my knowledge and belief. I hereby approve this justification.

Digitally signed by MICHAEL BARNES Date: 2026.04.02 13:22:59 -04'00'

Name of COCO Chief of the Contracting Office

USDA Head of Contracting Activity (HCA) (greater than $25,000). I have reviewed this D&F and find it to be accurate and complete to the best of my knowledge and belief. I hereby approve this justification.

USDA, Head of Contracting Activity

MICHAEL BARNES

CRANDALL WATSON

Digitally signed by CRANDALL

WATSON

Date: 2026.04.15 15:51:18 -04'00'