70RSAT22RFI000003 - PICS RFI - RFI - 20211210.pdf

PIID: 70RSAT22RFI000003

RFI ATTACHMENT

SCIENTIFIC, TECHNICAL AND ENGINEERING SUPPORT FOR PIADC

DECONTAMINATION AND CLOSURE

Background

Since 1954, the Plum Island Animal Disease Center (PIADC), located on Plum Island, New York, has been operated by the Federal Government for the purposes of agricultural research, training and diagnostics involving transboundary (foreign) animal diseases threatening U.S. agricultural production systems. In 2003, in accordance with the Homeland Security Act, ownership of PIADC was transferred from the U.S.

Department of Agriculture (USDA) to the Department of Homeland Security (DHS), including the “assets and liabilities of the Center” (6USC190). The mission of PIADC is being transferred to the National Bio and Agro-Defense Facility (NBAF), which is currently under construction in Manhattan, Kansas.

Pursuant to the Consolidated Security, Disaster Assistance, and Continuing Appropriation Act of 2009, Congress directed DHS to sell Plum Island (through the GSA) given the decision to transition the scientific mission to the NBAF (P.L. 110-329 - Section 540). Ultimately, as part of the Consolidated Appropriations Act, 2021, which was enacted in December 2021, the prior sale requirement was repealed and revised to ensure that the Plum Island property “be disposed of as a single consolidated asset” by GSA (P.L. 116-260 – Division FF Title V Section 501).

To prepare the island for cessation of government activities, the DHS Plum Island Closure and Support (PICS) program will ensure closure of the Plum Island property in a manner that reduces risks to an acceptable regulatory level for release to any public entity. The PICS program defines requirements for the island’s end-state to satisfy applicable related laws and regulations and will oversee the execution of the activities necessary for its closure and conveyance.

Due to the nature of scientific activities conducted at PIADC during its operation, it is necessary for the PICS program to collaborate with the New York Department of Environmental Conservation (NYSDEC) and the USDA Division of Agricultural Select Agents and Toxins (DASAT) regarding the end-state determination of decontamination for the facility and island, prior to its conveyance by GSA.

Purpose

The PICS program involves a broad scope of activities; however, the purpose of this RFI is to assess available capabilities to provide services to support strategic and technical aspects of the biological decontamination process for the facility. As such, responders should have demonstrable, relevant expertise and experience to support various scientific, technical and engineering tasks related to initial through terminal biological decontamination of a large-scale biocontainment facility. The scope of the anticipated activity will entail conceptual and strategic planning spanning regulatory, scientific, engineering, and other disciplines. Specific tasks may include, but are not limited to:

• planning/executing scientific activities for decontamination method testing and evaluation (T&E), to include analyses involving various technologies, sampling approaches, monitoring methods, among others;

• translating results of method T&E into plans for terminal facility decontamination;

• delivery of engineering planning, engineering design, and logistics to support implementation of facility decontamination methods and/or independent third-party review of such developed products;

• integration of scientific, engineering and other technical data in order to produce a comprehensive facility decontamination plan;

• operation of an on-island mobile laboratory for provision of independent third-party verification/validation testing of biological and chemical indicators (SCBIs, spore strips, integrators); and

• development of documentation of verification/validation results for review by regulatory bodies.

NOTE: The subject activities of this RFI do not entail the performance of the primary operations and maintenance functions or physical execution of decontamination activities for the biocontainment buildings at Plum Island.

Each activity will be accomplished while working collaboratively with additional PICS federal and contracted personnel, both onsite and offsite. These will primarily include DHS personnel at PIADC and may include others at ONL headquarters, contractors performing the primary operations and maintenance function at the facility, and additional contracted personnel providing various additional technical services.

Therefore, responders should be able to demonstrate the ability to coordinate effectively with multiple, diverse parties.

DHS is exclusively seeking responses from entities that have engaged in strategic planning, execution, and oversight/quality assurance of the execution of biological decontamination and closure activities at the facility level.

Requested Information

DHS requests that responders to this RFI include the following information and answer the following questions detailed below in Sections 1 through 4.

SECTION 1 – General Information

• Name and Address of Firm/Organization

• Business Size of Firm/Organization

• Primary Contact

• Email Address

• Socio-economic status of Firm/Organization (using NAICS Code 541620)

• Dunn and Bradstreet number for Firm/Organization

• Is your firm/organization registered with the System for Award Management (SAM) at http://www.sam.gov? If, yes, please also include SAM Unique Entity Identifier (UEI).

• An overview of your firm/organization’s technical capabilities to perform scientific, technical and engineering services in support of strategic planning, execution, and oversight/quality assurance of the execution of biological decontamination at the facility scale.

• Interested parties may also provide information describing technical experience that is similar to the activities that are described in the RFI, in both scope and complexity.

• A brief description of the qualifications of responder personnel that would be available to assist with the described scope should also be provided.

• A description of any indefinite delivery vehicles, i.e. indefinite-delivery contracts, blanket purchase agreements, and/or Government-wide Acquisition Contracts, etc., your firm/organization holds, including the administering Federal agency, which would cover the scope of services described in this RFI.

SECTION 2 – Technical Approach/Recommendation – Analytical Testing and Sampling Support

The PICS program requires support to provide technical and senior level staffing to perform all aspects of operating a mobile laboratory to support independent third-party verification/validation testing for facility decontamination processes. This will include a range of services, from developing procedures through receiving, processing and reporting on samples to maintaining a clean and safe work environment.

It is envisioned that the laboratory will perform biological and chemical indicator processing (SCBIs, spore strips, integrators), as part of analytical testing for validation of terminal decontamination processes. This will include, but is not limited to:

maintenance of samples, autoclave operation, maintaining a safe work environment, and documenting all results and activities. In addition, and as part of compliance processes, this may include preparation and shipment of samples to an offsite third-party laboratory (depending on the required analyses).

DHS also sees the need for a separate review of sampling locations, quantities, or any other analytical requirements that may be identified that the on-island mobile laboratory cannot support. For this reason, the ability to coordinate testing involving an offsite laboratory is also required.

Use of offsite laboratories will require collaboration with DHS personnel and the New York State Department of Environmental Conservation (NYSDEC) to ensure that the chosen laboratories are acceptable and meet their requirements for sample verification, and quality and data management.

http://www.sam.gov/

DHS requests that responders develop responses to the following points, based on the scenario and conditions described above. Specifically, please describe your company/firm’s experience and knowledge, as well as recent, analogous examples of support services provided for the following:

• Laboratory staffing to ensure proper day-to-day operation covering test development, execution of test procedures and documentation of results, as well as senior level staffing to oversee test development, execution, and accuracy of results.

• Routine operations of a BSL-2 operational space, including execution of plans and methods to meet existing facility programs and safety protocols.

• Contracting and managing third-party performers (laboratories) to provide:

(1) additional analytical support as needed and (2) independent verification of biological and chemical indicator testing/analysis of biological decontamination and laboratory decommissioning processes.

• Collaboration with Federal agencies and State regulatory departments to select third-party performers (laboratories) and sampling/analysis methodologies to meet verification and analytical requirements.

SECTION 3 – Technical Approach/Recommendations - Decontamination

Development of a terminal biological decontamination plan for the PIADC facility poses several unique challenges. In accordance with the scope of the PIADC scientific mission, the biocontainment buildings at Plum Island have been used for decades to house large livestock, laboratory animals, and biological select agents (Buildings 101 and 257), and also to support ancillary functions, such as waste processing (Buildings 102 and 111). The primary focus of these scientific activities involved the use of pathogens that are ranked as Tier 1 by the Division of Select Agents and Toxins (DSAT), and as such, pose a severe threat to U.S. animal health and the economy.

During its operation, which continues at present, the facility has been used to enable the safe study of a range of high-consequence agricultural pathogens, and study of the pathogens in their host species, in its multiple biosafety level (BSL)-3, ABSL-3, and BSL-3 Ag spaces. For example, most of its current scientific repertoire involves studies of foot and mouth disease virus (FMDV), African swine fever virus (ASFV) and classical swine fever virus (CSFV). In addition, other agricultural pathogens have been utilized/encountered at the facility through the USDA Animal and Plant Health Inspection Service (APHIS) diagnostic and teaching programs, also housed at PIADC.

Though FMDV, ASFV and CSFV are not considered threats to public health, there are a number of microorganisms commonly associated with livestock that can cause disease in humans, so the presence of such pathogens at the facility due to the historical use of livestock, may also need to be considered.

By statute, PIADC is the only location in the U.S. where manipulation of live foot-and-mouth disease virus (FMDV) may occur (21USC113a), until the Secretary of Agriculture determines it is appropriate to transfer that capacity to the successor facility.

Accordingly, the terminal decontamination and closure of PIADC will represent the first of its kind for a facility with a history of handling FMDV in the U.S. Therefore, it is necessary that the decontamination plan for PIADC be both scientifically defensible, and also represent best available practices drawn from multiple disciplines. This is necessary given the expected degree of scrutiny that the plan is likely to receive.

Presently, it is anticipated that the aforementioned components of the PIADC facility, i.e., Buildings 101, 102, 111 and 257, will be included as part of the terminal decontamination plan. The plan may expand to address additional facility spaces, as it is developed.

Beyond the hazards posed by the aforementioned pathogens, there are additional sources of risk associated with aging buildings and operating facilities, such as the presence of asbestos, lead paint, confined spaces, residual chemicals, thermal hazards, and sanitary waste. Accordingly, PIADC biocontainment facilities must be thoroughly decontaminated and decommissioned prior to closure and conveyance, in a manner that is compliant with applicable Federal, State and industry standards.

The rationale for selection of technologies and processes to be used as part of the terminal decontamination plan also poses a challenge. Though a spectrum of technologies is available for biological decontamination in clinical, industrial and academic research settings, current, scientifically controlled demonstrations to confirm their efficacy may be warranted, particularly for a decontamination project of this type.

Similarly, companion mechanisms to enable sampling and to validate the efficacy of selected decontamination practices may need to be developed and tested, under controlled conditions, to provide the necessary assurances to enable regulatory approval. Lastly, sampling methodologies also warrant consideration, to include sample type(s) collected, number, and placement.

To achieve these objectives, it may be necessary to develop and perform a series of applied scientific studies, conducted with the level of rigor necessary to withstand regulatory scrutiny, to yield publications in peer-reviewed journals, and to address anticipated interest from the general public. The outcome of these analyses should be used to justify the chosen approach to terminal decontamination (to include sampling and process monitoring mechanisms) and will also need to be articulated as part of interactions with regulatory authorities. The findings must then be translated into practices to be used by the executing contractor. Concurrently, engineering services will be needed to sequence the approach to sampling, decontaminating and monitoring the efficacy of these processes, and to support logistical aspects such as how to partition the facility while maintaining both necessary utilities and optimal conditions for decontamination effectiveness.

DHS requests that responders develop responses to the following points, based on the scenario and conditions described above. Specifically, please describe your

• Development of a comprehensive terminal decontamination plan for a large scale biocontainment facility, including engagement with various regulatory, management, and scientific authorities/stakeholders.

• Selection of technologies for use as part of terminal decontamination, sampling processes, and process monitoring mechanisms. If applicable, please include brief discussion of details regarding scientific approaches involved and experiments performed to justify selected decontamination approaches.

• Coordination of the aforementioned activities with multiple, diverse parties (as discussed in this RFI)

• Strategic planning, execution and/or oversight of execution of biological decontamination (and closure activities) for a large-scale biocontainment facility.

SECTION 4 – Technical Approach/Recommendation – Integration/Engineering/Logistics

As described in Section 3, the PICS program may need to evaluate and select technologies and processes to be used as part of the terminal decontamination. As the results of applied scientific studies become available, it will be necessary to review the information and determine what, if any, facility modifications are required to implement the indicated methods. If these methods become recommended, then detailed engineering will be required to (1) integrate these practices into the facility decontamination plan, and (2) to establish the modifications, costs, schedule and logistics to expediently implement the necessary changes.

Integration of new methods into the facility plan will require collaboration between scientific subject matter experts, the PICS program, the facility and regulators.

This process requires a thorough understanding of the current facility infrastructure, and includes, but is not limited to, HVAC systems to provide the necessary temperature and humidity requirements, and room/hallway configuration to support decontamination.

To support this effort, the PICS program envisions senior level engineering capabilities across multiple disciplines (program management, mechanical, electrical, structural) to translate scientific recommendations into the plans, drawings, specifications, estimates, and schedules necessary to implement the methods. In addition, DHS anticipates that during decontamination, facility modifications or engineering improvements may be indicated that would make the decontamination process less expensive, safer, or assist with meeting schedule constraints.

DHS requests that responders develop responses to the following points, based on the scenario and conditions described above. Specifically, please describe your

• Development of engineering and logistical requirements/designs/plans to support identification and implementation of required facility modifications. This may include preparation of presentations, reports and other deliverables to demonstrate the need for previous facility modifications; developing design basis, scope of work, plan, estimates and logistics for implementation of these facility modifications; and providing engineering oversight during modifications to ensure identified requirements are met.

• Integration of the specialties and disciplines, described in this RFI, in order to achieve a cohesive and comprehensive decontamination strategy.

In addition, please provide,

• Your organization/firm’s familiarity with the PIADC site/building layout, regulatory constraints and biological safety requirements.

• And, whether your company/firm would intend to submit a proposal (IF DHS ISSUES AN RFP) to provide services to DHS consistent with those described in this RFI, considering your company/firm’s capabilities, experience and current resources. Note that DHS estimates the services described in this RFI will require an approximate 8 year commitment with a level of effort of $1.5-$2M per year.