Baby bottles that release no chemicals having estrogenic activity

描述(由申请人提供)：在这项快速通道申请中，PlattiPure(PPI)建议为商业化快速完全开发一种不含EA的婴儿奶瓶，以解决一个重要的公共健康问题：婴儿摄入具有雌激素活性(EA)或抗EA渗出的化学物质，包括奶瓶、镇静装置、乳头、密封圈等。许多科学研究表明，含有EA或抗EA的化学物质可对许多生物过程产生重大不利健康影响，如精子数量和功能、前列腺大小、子宫和卵巢功能、青春期时间、肥胖、学习能力和某些类型的癌症。这些有害的健康影响有时在非常低的(PM-NM)浓度下发生，特别是对胎儿或发育中的哺乳动物(包括人类)。许多科学研究还表明，双酚A(BPA)具有EA，并从坚硬而透明的聚碳酸酯(PC)塑料中浸出，浓度为NM-lt；M；M，对胎儿或幼年哺乳动物的健康产生不利影响。PPI的研究表明，几乎所有塑料，包括不含BPA的塑料和所有塑料婴儿奶瓶的大多数成分，释放出的其他化学物质的EA水平往往高于PC塑料。PPI将使用其独特的专利材料和制造工艺来生产婴儿奶瓶，其组成部分不会释放任何含有EA或抗EA的化学物质，即即使暴露在常用压力(紫外线、微波、湿热)下也不释放EA。在第一阶段，PPI将确认初步数据，即开发不含EA的有机硅来生产用于婴儿奶瓶的不含EA的乳头是可行的。在第二阶段，PPI将确认它拥有不含EA的树脂，以制造不含EA的婴儿奶瓶的所有其他成分，包括PC奶瓶的硬质和透明树脂替代品，满足或超过适合使用的测试，并保持不含EA，无论是作为新奶瓶还是在模拟延长使用的重复测试周期后。PPI的不含EA的婴儿奶瓶将在行业中独一无二，并为我们最脆弱的人群：胎儿、婴儿和青少年提供显著的健康益处。由于已经开发了大部分材料，PPI处于独特的地位，可以立即开始工作，并在21年半内将先进技术、更安全的产品放到零售货架上。作为突破性产品，不含EA的婴儿奶瓶将实现快速的市场渗透，并提高消费者对塑料产品总体安全的认识。这些婴儿奶瓶的成功将使PPI能够将更安全的不含EA的塑料引入广泛的食品包装和消费品中，极大地提高整体消费品的安全性。使用PPI独特的、获得专利的不含EA的塑料材料和加工方法，直接和果断地生产不含EA的婴儿奶瓶，履行NIEHS(和PPI)“减轻人类疾病和残疾负担”的使命。 公共卫生相关性：PlattiPure(PPI)正在解决一个公共卫生问题[婴儿使用塑料奶瓶摄入的具有雌激素或抗雌激素活性(EA或抗EA)的化学物质的释放]，方法是使用其独特的专利材料和方法生产不释放含有EA或抗EA的化学物质的婴儿奶瓶。含有EA或抗EA的化学物质，即使在非常低的剂量下对胚胎哺乳动物也会对许多行为和生理过程产生显著的不利影响，如精子计数、子宫和卵巢功能、攻击行为和某些类型的癌症。不含EA的婴儿奶瓶果断地履行了PPI和NIEHS的使命，即“减轻人类疾病和残疾的负担”。

DESCRIPTION (provided by applicant): In this Fast-Track application, PlastiPure (PPi) proposes to rapidly and completely develop for commercialization an EA-Free baby bottle to address an important public health problem: ingestion by infants of chemicals having estrogenic activity (EA) or anti-EA leaching from multiple components of baby bottles, including the bottle, anticolic devices, nipple, sealing rings, etc. Many scientific studies have shown that chemicals having EA or anti-EA can have significant adverse health effects on many biological processes such as sperm number and function, prostate size, uterine and ovarian functions, time to puberty, obesity, learning abilities, and some types of cancers. These adverse health effects sometimes occur at very low (pM-nM) concentrations, especially on fetal or developing mammals (including humans). Many scientific studies have also shown that bisphenol A (BPA) has EA and leaches from hard and clear polycarbonate (PC) plastics at nM-<M concentrations that have adverse health effects on fetal or juvenile mammals. PPi's studies show that almost all plastics, including BPA-free plastics and most components of all plastic baby bottles, release other chemicals having EA often at levels higher than PC plastics. PPi will use its unique and patented materials and manufacturing processes to produce baby bottles whose component parts do not release any chemical having EA or anti-EA, i.e., are EA-Free even when exposed to common-use stresses (UV light, microwaves, moist heat). In Phase I, PPi will confirm preliminary data that that it is feasible to develop EA-Free silicones to manufacture EA-Free nipples for baby bottles. In Phase II, PPi will confirm that it has EA-Free resins to make all other components of EA- Free baby bottles, including hard and clear resin substitutes for PC bottles, that meet or exceed fit-for-use tests and remain EA-Free, both as new bottles and after repeated test cycles simulating extended use. PPi's EA-Free baby bottles will be unique in the industry and provide significant health benefits to our most vulnerable populations: fetus, infants and juveniles. Because it has already developed most of the materials, PPi is uniquely positioned to begin work immediately and put advanced-technology, safer products on retail shelves within 21/2 years. As breakout products, EA-Free baby bottles will achieve rapid market penetration and raise consumer awareness about the safety of plastic products in general. The success of these baby bottles will allow PPi to introduce safer EA-Free plastics into a broad range of food packaging and consumer goods, greatly increasing overall consumer product safety. Using PPi's unique and patented EA-Free plastic materials and processing methods to produce EA-Free baby bottles directly and decisively fulfill NIEHS' (and PPi's) mission to "reduce the burden of human illness and disability." PUBLIC HEALTH RELEVANCE: PlastiPure (PPi) is addressing a public health problem [release of chemicals having estrogenic or anti-estrogenic activity (EA or anti-EA) ingested by infants using plastic baby bottles] by using its unique and patented materials and methods to produce baby bottles that do not release chemicals having EA or anti-EA. Chemicals having EA or anti- EA, even at very low dosages on fetal mammals, can have significant adverse effects on many behavioral and physiological processes such as sperm counts, uterine and ovarian functions, aggressive behaviors, and some types of cancers. EA-Free baby bottles decisively fulfill PPi's and NIEHS' mission of "reducing the burden of human illness and disability".