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

PA21-259、PHS 2021-2 NIH、CDC 和 FDA 小型企业创新研究补助金申请综合征集（母版 SBIR [R43/R44] 临床

• 批准号: 10601913
• 负责人: William Compel
• 金额: $ 20万
• 依托单位: AEMS CORP.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10601913
• 关键词: PA21; 259; PHS; 2021; Omnibus

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.

项目概要 我们提出的努力解决因病原菌存活不足而引起的食源性疾病 消毒过程。由于行业对新鲜豆芽的依赖，新鲜豆芽是一种已知的食源性疾病载体。 芽苗种子消毒过程不充分。 FDA 承认他们推荐的氯基 (Cl) 治疗不足以消除细菌病原体4，欢迎新疗法的开发5。 该 SBIR 的目标是开发并商业化一种基于 AEMS Corp. 的专有技术称为代理交付矩阵 (ADM)。我们的消毒 ADM 有意 完全由公认安全 (GRAS) 成分组成，以便符合快速通道要求 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 环保有机豆芽生产的新时代，降低豆芽相关疾病的发生率 食源性疾病，节省种植者的时间和金钱，提高工人的安全，并推广健康食品 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标证明我们的治疗可以有效替代氯治疗。 在目标 1 期间，我们将验证 ADM 是一种有效的新方法，可提供能够杀死细菌的 GRAS 消毒剂 大肠杆菌。我们将在整个 I 期中使用致病性大肠杆菌 O157:H7 的临床分离株，而不是 替代细菌可以真实地验证我们的治疗效果。组合屏幕将产生 用于芽苗种子消毒的消毒 ADM 材料库。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的模拟工业生长条件下对芽苗菜种子进行消毒。因为几乎所有的发芽案例 相关的食源性疾病源于未正确消毒的受感染种子，我们将在现实生活中进行练习 故意用大肠杆菌 O157:H7 感染苜蓿种子后发芽的场景，以测试卫生效果。 我们还将评估发芽率和芽苗产量，以评估我们的处理对芽苗质量的影响。目的 2 施加现实条件来准确反映豆芽的工业生产，以促进我们的采用 技术并获得商业利益。 芽苗菜种子消毒不充分将继续危及食品供应的安全和保障，直到 采用新的治疗方法。 SBIR一期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 技术扩展到其他种衣和食品加工 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展 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来促进食品供应的完整性。