Baby bottles that release no chemicals having estrogenic activity

描述（由申请人提供）：在这个快速通道申请中，PlastiPure （PPi）提出快速和完全开发商业化的无EA婴儿奶瓶，以解决一个重要的公共卫生问题：婴儿摄入具有雌激素活性的化学物质（EA）或从婴儿奶瓶的多个组件中抗EA浸出，包括奶瓶，抗压装置，乳头，密封环等。许多科学研究表明，含有EA或抗EA的化学物质会对许多生物过程产生重大的不利健康影响，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。这些不利的健康影响有时发生在极低（pM-nM）浓度下，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）在nM-<M浓度的硬聚碳酸酯（PC）塑料中具有EA和浸出物，对胎儿或幼年哺乳动物有不利的健康影响。PPi的研究表明，几乎所有的塑料，包括不含双酚a的塑料和所有塑料婴儿奶瓶的大部分成分，释放出的其他化学物质的EA含量通常高于PC塑料。PPi将使用其独特的专利材料和制造工艺生产婴儿奶瓶，其组成部分不释放任何具有EA或反EA的化学物质，即即使暴露在常用压力下（紫外线，微波，湿热）也不含EA。在第一阶段，PPi将确认初步数据，即开发无ea有机硅来制造婴儿奶瓶的无ea奶嘴是可行的。在第二阶段，PPi将确认它拥有无EA树脂来制造无EA婴儿奶瓶的所有其他组件，包括PC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无EA，无论是作为新瓶还是在重复测试周期模拟延长使用后。PPi的无ea奶瓶将在行业中独具特色，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。因为它已经开发了大部分材料，所以PPi处于独特的地位，可以立即开始工作，并在两年半内将先进技术，更安全的产品放在零售货架上。作为突破性产品，无ea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整体安全的认识。这些婴儿奶瓶的成功将使PPi能够将更安全的无ea塑料引入广泛的食品包装和消费品，大大提高整体消费品的安全性。使用PPi独有的无ea专利塑料材料和加工方法，直接生产无ea婴儿奶瓶，果断完成NIEHS（和PPi）“减轻人类疾病和残疾负担”的使命。

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".