Attachment_A_-_OLE_Kits_SOO_Final_August_2026.pdf

National Oceanic Atmospheric Administration (NOAA) National Marine Fisheries Service (NMFS)

Office of Law Enforcement (OLE)

Statement of Objectives (SOO)

1. Background:

NOAA's National Marine Fisheries Service (NMFS) is responsible for the stewardship of the nation's living marine resources and their habitats. NMFS Office of Law Enforcement (OLE) is responsible for the enforcement of federal laws and international treaties relative to marine fisheries, including the inspection of seafood imports at the Nation’s largest ports and investigation of seafood fraud and unlawful international trade.

The United States (U.S.) is the largest importer of seafood in the world by value, importing between $25-$30 billion annually. Combatting illegal trade and detection of seafood fraud is critical to prevent illegal products from entering U.S. commerce and creating unfair competition for America’s native seafood industry. Identification of species is an important component in regulating the international trade in marine fisheries products. Imports of various seafood products which are not readily identifiable, such as fish filets, fish products, derivatives, etc.

present challenges for enforcement to confirm species identification and legality of seafood imports.

2. Scope:

This SOO outlines requirements to research, develop, and field deploy rapid, genetic-based test kits to accurately identify the species of imported seafood. Seafood mislabeling and substitution represent a significant economic and public health threat, unfairly undercutting domestic U.S.

producers and compromise consumer trust. By leveraging cutting-edge molecular diagnostics, OLE can establish a robust, efficient, and science-driven enforcement capacity at U.S. ports of entry, thereby protecting the integrity of the U.S. seafood market.

In Fiscal Year 24 the United States imported more than 762 million kilograms of shrimp, valued at more than $6 billion, via 56,019 individual shipments. OLE has no capability to rapidly test to determine whether shrimp shipments are properly labeled as either farm-raised or wild caught.

The Seafood Import Monitoring Program (SIMP) identified tuna as one of the most non-compliant imported species of relevance to the program, often lacking chain of custody documents, legal origin or vessel information. Tuna is often subject to seafood fraud, mislabeling and trafficking due to its value and limited quotas. The requirement herein is to develop and validate a reliable, fast, accurate assay for white shrimp (Litopaneaeus vannamei) and various tuna species. Additional optional work will address other species.

3. Performance Objectives:

OLE needs to develop highly accurate, field-deployable species identification technology to support real-time decision-making aimed at intercepting mislabeled and illegal seafood products, thereby safeguarding the competitiveness of American seafood. Emerging technology includes the use of assays to perform rapid, targeted detection of species-specific DNA sequences, without the need for specialized equipment, pipetting, or refrigeration. Test results are made easily visually interpretable through a colorimetric reaction test strip, analogous to home tests for COVID19. The resulting assays provide accurate information on species identity within approximately 30 minutes without using complex laboratory equipment, enabling point-of-need verification of seafood products.

The kits will use a rapid field-ready genetic identification platform (i.e., CRISPR or similar) developed primarily for fish and seafood species identification, to create the test strips for the kits. The tests kits should be shelf stable at ambient temperatures for a minimum of three months, and all kits should include the necessary materials, reagents or small equipment needed to process samples, from collection of a sample to preparing the samples for the test, to . The final developed test for the target species of interest should validate exclusion of closely related species, or other species that are expected as substitutes in seafood trade. This contract will use the COVID-like genome technology portion of the identification processes in the form of test kits. This technology uses genetic technology similar to what is desired.

The firm-fixed price contract will ultimately produce test kits which incorporate the testing strips for specific species. OLE officers at multiple locations across the United States will use the kits and strips to conduct multiple tests at a single site in a day. Future kits and strips may then be purchased for a fixed price per kit and/or associated testing strips, with possible volume discounts.

3.1.Shrimp Research & Development

● Stage 1: Sequence analysis for Pacific white shrimp (Litopenaeus vannamei) to evaluate and identify assays for identification in the context of genetic assay design.

● Stage 2: Develop an appropriate rapid field-ready genetic identification assay, with laminar flow detection, for Pacific white shrimp (L. vannamei) for application on test strips

3.2.Tuna Species Research & Development

● Stage 2: Develop an appropriate genetic identification assay, with laminar flow detection, from an existing, developed genetic sequence which satisfies Stage 1 requirements, provided at the time of award for subsequent application on test strips, for four (4) tuna species, including: Atlantic bluefin (Thunnus thynnus), bigeye (Thunnus obsesus), yellowfin (Thunnus alabacares) and either Pacific bluefin or albacore sp, which will be determined at the time of the award.

3.3.Shrimp and Tuna Development to Production

● Stage 3: Field Optimization: Develop a multi-species field kit for OLE Officers to deploy system test strips in the field and convert development to production, initially producing 1,000 test strips (200 for each of the five species above, single-use) and a minimum of 12 Test (field) kits will include the test strips for multiple species, as well as all associated equipment and materials/supplies (e.g., PPE, instruction pamphlet, heating device, consumables) for deployment in the field for species identification of shrimp and tuna species, as described above. Intermittent delivery dates of test strips may be required, depending on shelf life. Portable kit design will determine the final number, depending on reusable components. Vendor is to travel to at least one port for field operation and limited demonstration or training to OLE Agents in the field.

3.4.Additional Species Research & Development (Stages 1 through 3)

● OLE may require the contractor to finalize sequence analysis for new species and other similar species to evaluate and identify assays for species identification in the context of a genetic assay design. The contractor will be required to develop an appropriate assay and convert development to production of test strips (single-use) and field kits (multi-use) with intermittent delivery dates, in the same quantities described in 3.3.

● Species prioritized as high risk for seafood fraud and trafficking, in alignment with the aims of Executive Order 14276, Restoring America’s Seafood Competitiveness, which directs the U.S. Government to leverage new technology to combat Illegal, Unreported, and Unregulated (IUU) Fishing and eliminate unfair trade practices:

○ Northern Red Snapper (Lutjanus campechanus) - Origin (Mexico vs. U.S.)

○ Shrimp (Litopenaeus vannamei) - Farmed vs. wild species claims

○ Scallop (Placopecten magellanicus) - Seafood Fraud - U.S. vs. Foreign species

○ Red King Crab (Paralithodes camtschaticus) - Seafood Fraud – Russian Origin

○ Blue Crab (Callinectes sapidus) - Seafood Fraud – U.S. vs South America/Asia

Origin

○ Squid (Nototodarus sloanii) & (Todarodes pacificus) - Seafood Fraud

○ Totoaba (Totoaba macdonaldi) - Trafficking Endangered Species (swimbladders)

○ Toothfish (Dissostichus eleginoides) & (Dissostichus mawsoni) - Seafood Fraud

○ American eel (Anguilla rostrata) - Origin (Caribbean vs. Northern Hem) -

Trafficking

○ Red & Black Grouper (Epinephelus morio) & (Mycteroperca bonaci) -

Trafficking

3.5. Full-Scale Production & Delivery (Firm-Fixed-Price Unit Prices (must include all equipment/materials/supplies for the strips/kits))

● Throughout the period of performance of the full contract, OLE requires additional deliveries of test strips and field kits for any of the species developed under the contract with the lead time negotiable, but less than the Stage 3 requirements. Intermittent delivery dates will be required throughout the life of the contract in the contiguous United States, Alaska, and Hawaii. The additional quantities are anticipated to be a minimum of 2,000 strips per year. Kit requirements will depend on final design, with the expectation that 12 kits, or their internal components, per 1,000 strips may be required.

● It is the intent of OLE to be able to compete this requirement (strips and kits) in the future.

3.6.Deliverables

● The contractor shall submit completed sequence analysis (raw data and alignment files), assay development (detailed notes on assay development, quality control and quality assurance steps followed), and laboratory validation results (detailed notes on lab validation, including complete species list and results evaluated), to the NOAA/NMFS Conservation Biology Division, Marine Forensic Laboratory, Northwest Fisheries Science Center (MFL) for review and approval when each stage of development is completed. Review and approval by NOAA will occur within 1 month of receipt of the information. Point of Contact to be provided upon award of contract.

● The contractor shall provide field tests to the MFL for independent laboratory testing and validation. Independent testing will occur within 2 months of receipt of the field tests.

● The contractor shall assist and/or participate in piloting the developed technology during planned port operations in Newark, NJ and/or Long Beach, CA deploying the technology during the Field Optimization. These ports will be determined at a later date. Piloting will include field demonstrations and hands-on training to OLE or MFL personnel, collection of validation samples for the Marine Forensic Lab, and assistance with interpretation of test results.

4. Place of Performance

Work will be conducted off-site at the contractor’s facility.

5. Period of Performance:

5.1.Shrimp and Tuna: (Anticipated to commence on September 30, 2026)

○ Research & Development

■ Stage 1 - Completed up to nine (9) months after award

■ Stage 2 - Completed up to six (6) months after Stage 1 completion

○ Development to Production

■ Stage 3 - Completed up to nine (9) months after Stage 2 completion

5.2.Additional Species: The Government anticipates performance will be from September 30, 2028 - September 29, 2030 with timeframes similar to those referenced for shrimp and tuna. The Government will exercise optional work contingent on need, availability of funds, and performance quality.

5.3.Full-Scale Production and Delivery: The Government anticipates ordering additional test strips and field kits for any species from September 30, 2028 - September 29, 2033. The Government may exercise option periods contingent on need, availability of funds, and performance quality.

6. Operating Constraints

7. Government Furnished Property and Resources

The Government will not furnish any property or resources to the contractor in support of the contract.

8. Intellectual Property Rights:

All deliverables and data are the property of the U.S. Government. All documents, analyses, files (digital or other), reports, notes and photos are to be used only by contractor personnel assigned to this contract. Copies of documents, files and other data are not to be disseminated to anyone outside of OLE or to any other contractor personnel without explicit release from the Government.

9. Packaging, Packing, and Shipping Instructions

The contractor shall ensure that all items are preserved, packaged, packed, and marked in accordance with best commercial practices to meet the packing requirements of the carrier and to ensure safe and timely delivery at the intended destination. Shipping term is FOB Destination.

10.Inspection and Acceptance Criteria

Inspection and acceptance will be in accordance with RFO FAR Clause 52.212-4. The Contracting Officer or the duly authorized representative will accept supplies and services to be provided under the contract.

11.Other Pertinent Information or Special Considerations

11.1. Contractor Travel: The Government anticipates that domestic travel will be required for certain positions for Stage 3: Field Optimization as authorized by the Contracting Officer’s Representative (COR) and Project Lead. The contractor shall identify, forecast, and manage travel requests. All travel must be approved by the COR and Project Lead at least 10 business days in advance of the travel requirement. The contractor shall maintain a travel log of all approved trips and include all estimated/vouchered costs, which may be reviewed by the COR and Project Lead as needed. During performance, travel costs are reimbursed in accordance with RFO FAR 31.205-46 and Federal Travel Regulations, subject to the COR’s approval. Any travel conducted without prior coordination with the COR and Project Lead will be done at the contractor’s own risk and expense. The Government will reimburse the contractor in accordance with RFO Clause 52.212-4 Alt I.

All travel requests being sent for COR and Project Lead approval shall include the following items:

● Purpose of the Travel;

● Tentative Travel Dates;

● Method of Travel (e.g., Private vehicle, Government Owned Vehicle, airplane, etc.) & cost for that method, and

● baggage expense, if applicable;

● Duration of Travel;

● Departure Location and Arrival Location;

● Per diem expenses per day;

● Lodging Expenses per day, if applicable;

● Lodging Taxes per day, if applicable;

● Distance from Office or Home to Airport or Other Transportation Facility, if applicable;

● Parking costs per day at the Airport, if applicable;

● Method of Transportation at Arrival Destination (e.g. – Subway/Metro, Bus, Taxi, Rental Car} with projected costs, if applicable); and

● Quantity and Cost of Fuel for a Rental Car, if applicable.

The following policies are the Government’s interpretation of reasonable. Travel costs will be verified with the local Government travel agency.

● Commercial Airline tickets purchased will be:

o Lowest non-penalty coach fare available which satisfies the schedule

(except for immediate departure).

o Reserved/purchased as far in advance as possible to make maximum use of discounts.

● Airport parking will be paid for at the long-term parking rate or cheapest available rate, whichever is less.

● Rental vehicles are authorized as follows:

o For 3 or less people - not to exceed the cost of the least expensive compact size.

o For 4 or 5 people - not to exceed the cost of the least expensive mid-size car/station wagon.

o For 6 or more people, or for carrying equipment, samples, etc. - the least expensive of a van, or combination of compact, mid-size/station wagon, and van.

● Travel for 12 hours or less: No per diem (including meals) will be paid when the official travel is 12 hours or less within the continental United States (CONUS).

● Local travel within a 50-mile radius from the contractor’s facility is considered the cost of doing business and will not be reimbursed. This includes travel, subsistence, and associated labor charges for travel time. Travel performed for personal convenience and daily travel to and from work at the contractor’s facility will not be reimbursed. Travel, subsistence, and associated labor charges for travel time for travel beyond a 50-mile radius of the contractor’s facility are authorized on a case-by-case basis and must be pre-approved by the COR.

11.2. Shipping Charges: The Government will reimburse applicable shipping charges in accordance with RFO Clause 52.212-4 Alt I.

11.3. Training Requirements

The following training is currently required to be completed under the contract.

Completion certificates must be submitted to the COR no later than three (3) business days after the start of the contract or completion of courses. The COR may authorize additional training that is necessary for the contract or mandated by NOAA.

11.4. Insurance Requirements:

11.5. Kick-Off Meeting/Periodic Meetings

The contractor shall attend a contract kick-off meeting with the Contracting Officer, COR, and Project Lead within seven (7) calendar days after the date of award, or another date/time specified by the COR/Project Lead. The purpose of the meeting is to set the standards of performance, discuss technical, management, personnel and security topics, place of performance, communication channels, required government training, travel authorization and reporting procedures, and task management requirements and invoicing details. The kick off meeting will be held via teleconference (i.e. Google Meet). The contractor is responsible for developing and providing to NOAA an agenda and/or any briefing slides, if applicable.

The Contracting Officer, COR, Project Lead, and other government personnel, as appropriate, may meet periodically or on an ad hoc basis with the contractor to discuss work under the contract or review the contractor's performance. At performance specific meetings, the Contracting Officer will apprise the contractor of how the Government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. All meetings shall be at no additional cost to the Government. A summary of the meetings shall be provided within seven (7) business days of the meeting when requested by the Contracting Officer, COR or Project Lead.

11.6. Evaluation of Contractor Performance

11.6.1.The value of this contract requires that the contractor be registered in the

Contractor Performance Assessment and Reporting System (CPARS) located at https://www.cpars.gov/. Registration within 30 days of contract award is required.

# Training Course Name Contractor Personnel Applicability 1 NOAA Cyber Security Awareness Training (CSAT) All contractors completed annually 2 NOAA Safety Training All contractors requiring routine physical access to and/or working on-site at a Government facility 3 Sexual Assault/Sexual Harassment Prevention and

Response Training IAW NAM 1330-52.222-70(b)(6) All contractors, contractor-provided annually

4 Records Management 101 All contractors completed annually

5 DOC Understanding AI: Capabilities, Risks, and Responsible Use

All contractors completed annually

NOAA requires use of the CPARS modules as the secure, confidential, information management tool to facilitate the performance evaluation process for this contract.

11.6.2.The Contracting Officer will evaluate interim contractor performance on at least an annual basis and final contractor performance upon contract completion using the process and criteria in CPARS. Subcontractor information may be included for evaluation areas where the subcontractor actions have significantly influenced the prime contractor’s performance, if applicable. Evaluations of contractor performance will be provided to the contractor as soon as practicable after completion of the evaluation. The contractors will be given up to 60 days after receipt of the evaluation to submit comments, rebutting statements, or additional information. Copies of the evaluations, contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used by Federal agencies to support future award decisions.

11.6.3.Resolving Disagreements between the Government and Contractor: The ultimate conclusion on the performance evaluation is a decision of the contracting agency.

Copies of the evaluation, contractor response(s), and review comments, if any, will be retained as part of the evaluation.

11.7. Quality Assurance

11.7.1.The incentive for all deliverables and services is positive past performance documented on the Contractor Performance Assessment Report (CPAR) and potential exercise of optional work and delivery periods (e.g. Additional Species Research & Development). Disincentives for negative performance include any contractual remedies available pursuant to RFO FAR 52.212-4(b).

11.7.2.The Government will evaluate the Contractor’s performance under this contract.

Government personnel will record all surveillance observations. When an observation indicates defective performance, the COR may require the Project Lead or designated representative at the site to initial the observation. The initialing of the observation does not necessarily constitute concurrence with the observation, only acknowledgement that the individual has been made aware of the defective performance. Such surveillance will be done according to standard inspection procedures or other contract provisions. Any action taken by the Contracting Officer as a result of surveillance will be in accordance with the terms of the contract.

11.7.3.The COR is the responsible point of contact for quality assurance. If an assistant or alternate COR is designated by the Contracting Officer, a separate letter shall be provided to the contractor indicating that individual’s authority.

11.7.4. The Project Lead will assist the COR in performance of formal contract surveillance and reports to the COR. The Project Lead has no authority to allow the contractor to deviate from contract requirements, direct or interfere with the methods of performance by the contractor, or provide technical direction to any of the contractor’s personnel unless methods being used are unsafe or compromise security.