PA21-259, PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical

项目摘要 我们提出的努力解决食源性疾病引起的致病菌存活不足 消毒过程。新鲜的豆芽是一种已知的食源性疾病的载体，因为行业依赖于一种 消毒发芽种子的过程不充分。FDA承认他们推荐的氯基 (Cl)治疗不足以消除细菌病原体4，并欢迎开发新的治疗方法。 该SBIR的目标是开发和商业化一种新型的有机芽苗菜种子消毒剂， AEMS公司的专有技术称为代理交付矩阵（ADM）。我们的消毒ADM故意 完全由公认安全（GRAS）成分组成，以适应快速通道 FDA批准，并确保食品，工人和环境安全。采用我们的消毒ADM可以促进 一个环保的有机芽苗菜生产的新时代，降低芽苗菜相关的发病率 食源性疾病，节省种植者的时间和金钱，提高工人的安全，并促进健康食品 消费者和生产者所期望的豆芽的好处。 我们将通过两个主要目的证明我们的治疗可以有效替代Cl治疗。 在目标1期间，我们将验证ADM作为一种有效的新方法来提供能够杀死 大肠埃希菌我们将使用致病性E.大肠杆菌O 157：H7而不是 一种替代细菌来实际验证我们的治疗效果组合屏幕将产生一个 用于发芽种子消毒的消毒ADM材料库。目标2将研究最有效的ADM 在加州大学戴维斯分校的模拟工业生长条件下消毒发芽种子。因为几乎所有的豆芽- 相关食源性疾病源于受感染的种子，是不适当的消毒，我们将行使现实生活中的 在用E. coli O 157：H7进行消毒效果检测。 我们还将评估发芽率和芽产量，以评估我们的处理对芽质量的影响。目的 2施加现实的条件，以准确地反映芽苗菜的工业化生产，以促进采用我们的 技术和获得商业利益。 对芽苗菜种子的消毒不充分将继续危及食品供应的安全， 采用新的处理方法。SBIR第一阶段项目的成功完成将带来一种新的生产方式， 豆芽对人类食用更安全ADM技术在其他种子包衣和食品加工中的应用 设施表面将提高其他食品的安全性。未来的研究和开发将扩大 ADM平台在人类健康和食品安全方面的其他应用。资金将确保食品安全， 通过减少食源性疾病的发生率，促进食品供应的完整性。

Project Summary Our proposed effort addresses foodborne illness caused by pathogenic bacteria surviving inadequate sanitization processes. Fresh sprouts are a known vehicle of foodborne illness due to industry reliance on an insufficient process for disinfecting sprout seeds. The FDA acknowledges their recommended chlorine-based (Cl) treatment inadequately eliminates bacterial pathogens4 and welcomes the development of new treatments.5 The objective of this SBIR is to develop and commercialize a novel organic sprout seed sanitizer based on an AEMS Corp. proprietary technology called an Agent Delivery Matrix (ADM). Our sanitizing ADM are intentionally composed entirely of Generally Recognized As Safe (GRAS) ingredients in order to be amenable with fast-track FDA approval and to ensure food, worker, and environmental safety. Adoption of our sanitizing ADM could foster a new era of environmentally friendly organic sprout production that lowers the incidence of sprout-related foodborne illness, saves the grower time and money, enhances worker safety, and promotes the health-food benefits of sprouts desired by consumers and producers. We will demonstrate our treatment can be an effective replacement of Cl treatment through two primary Aims. During Aim 1, we will validate ADM as an effective new approach to deliver GRAS sanitizers capable of killing Escherichia coli. We will use a clinical isolate of the pathogenic E. coli O157:H7 throughout Phase I instead of a surrogate bacterium to realistically validate the efficacy of our treatment. Combinatorial screens will yield a library of sanitizing ADM materials for sprout seed sanitization. The most effective ADM will be studied in Aim 2 to sanitize sprout seeds in simulated industrial growing conditions at UC Davis. Since nearly all cases of sprout- related foodborne illness originate from infected seed that is improperly sanitized, we will exercise a real-life scenario for sprouting after intentionally infecting alfalfa seeds with E. coli O157:H7 to test for sanitation efficacy. We will also evaluate germination rate and sprout yield to evaluate our treatment’s effects on sprout quality. Aim 2 imposes realistic conditions to accurately reflect industrial production of sprouts to facilitate adoption of our technology and garner commercial interest. Inadequate sanitization of sprout seeds will continue to jeopardize the safety and security of the food supply until a new treatment is adopted. Successful completion of this SBIR Phase I project will lead to a new way to produce sprouts safer for human consumption. Extension of ADM technology to other seed coatings and food processing facility surfaces will improve the safety of other food products. Future research and development will extend the ADM platform to other applications in human health and food safety. Funding will ensure the safety of food and promote the integrity of the food supply by reducing the incidence of foodborne illness.