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 我们建议的工作是解决由致病菌存活不足引起的食源性疾病。 消毒过程。鲜芽是已知的食源性疾病的媒介，因为工业依赖于 对萌芽种子的消毒工艺不足。FDA承认他们推荐的氯基 (CL)治疗不能充分消除细菌病原体4，并欢迎开发新的治疗方法。 本发明的目的是开发和商业化一种新型的有机发芽种子杀菌剂，该杀菌剂以一种 AEMS公司的专有技术称为代理交付矩阵(ADM)。我们的消毒ADM是故意的 完全由公认的安全(GRAS)成分组成，以符合快速通道 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 环境友好型有机豆芽生产的新时代，降低与豆芽相关的发病率 食源性疾病，为种植者节省时间和金钱，提高工人安全，促进健康食品 消费者和生产者所期望的芽菜的好处。 我们将通过两个主要目标证明我们的治疗可以有效地替代氯治疗。 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GRAS的消毒剂 大肠埃希菌。我们将在整个第一阶段使用致病性大肠杆菌O157：H7的临床分离株，而不是 一种替代细菌，以现实地验证我们治疗的效果。组合屏幕将产生一个 萌芽种子消毒ADM材料文库。最有效的ADM将在目标2中进行研究 在加州大学戴维斯分校模拟工业生长条件下对萌芽种子进行消毒。因为几乎所有的发芽病例- 相关食源性疾病源于受感染的种子没有经过适当的卫生处理，我们将在现实生活中 故意用O157：H7大肠杆菌感染紫花苜蓿种子后发芽的情况，以测试卫生效果。 我们还将评估发芽率和发芽产量，以评估我们的处理对发芽质量的影响。目标 2施加现实条件，以准确反映芽苗的工业化生产，以促进采用我们的 技术和获得商业利益。 对萌芽种子进行不适当的卫生处理将继续危及食品供应的安全和保障，直到 采用了一种新的治疗方法。SBIR第一期项目的成功完成将带来一种新的生产方式 芽菜对人类食用更安全。ADM技术在其他种衣剂和食品加工中的推广 设施表面将提高其他食品的安全性。未来的研究和开发将延长 ADM平台在人类健康和食品安全方面的其他应用。资金将确保食品和食品的安全 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.