Toxicity of Resin 3-D Printing Emissions: Phase 1

The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to Department of Orthopaedics, School of Medicine West Virginia University (WVU). for Procurement of the measurement of toxicity associated with resin 3-D printing emissions. Resin 3-D printing, also known as vat photopolymerization (VP) will be evaluated. Specifically, the vendor shall: a)  determine the dose–response relationship of pulmonary inflammation and systemic toxicity induced by VP printing emissions in mice and b) determine the sensitization potential following inhalation exposure to VP printing emissions in mice. Dr. Li’s research at the School of Medicine, West Virginia University (WVU), focuses on nanoparticle toxicity, immunotherapy, nanomedicine, advanced materials, and biomedical engineering. He has been well funded by NIH and other federal agencies and has recently collaborated with NIOSH scientists. This procurement research project aligns closely with his expertise. The WVU School of Medicine campus is adjacent to the NIOSH Morgantown campus which is a critical fact that supports sole source procurement. The proposed inhalation toxicology studies require 1) unique training, 2) unique exposure system, and 3) rapid transfer of samples with limited stability to NIOSH Morgantown. Specifically, NIOSH staff will need to provide the vendor with training on how to perform some experimental steps via in-person training. It is not feasible for NIOSH staff to travel to perform this training for a vendor outside the local area. A NIOSH designed and built exposure generation system is required to perform the experiments. The size, weight, and intricate properties of this system prevent it from being shipped so a local vendor must be used to permit transfer of the equipment for the study period. Additionally, the specialized exposure generation system can require frequent coordination, monitoring, and, when necessary, immediate technical adjustments by NIOSH staff so the vendor must be local. Finally, the vendor will collect biological specimens for NIOSH to analyze. These samples are extremely sensitive and a local vendor ensures the prompt transfer and processing of biological specimens at NIOSH, thereby preserving sample quality and ensuring reliable study results. For these reasons, vendor proximity is essential to the efficient and successful performance of the contract. Market research was conducted to identify potential offerors capable of performing the required animal inhalation exposure studies. This effort included reviewing academic institutions, contract research organizations (CROs), and other research entities with expertise in inhalation toxicology, nanoparticle exposure, and animal studies. Publicly available information, institutional websites, and prior collaborations were evaluated to assess technical capabilities, facilities, and relevant experience. Consideration of vendors with demonstrated expertise in pulmonary toxicology, advanced materials, and immunological assessments. Particular attention was given to identifying facilities with the capability to conduct specialized inhalation exposure studies and handle hazardous emissions. Through this process, it was determined that while several institutions possess general animal research capabilities, they do not meet the combined requirements of technical expertise and close geographic proximity to the NIOSH Morgantown campus. Proximity was identified as a critical operational factor necessary to support real-time coordination, equipment oversight, and timely transfer and processing of biological samples.