PLASTIPURE, INC — Department of Health and Human Services SBIR Phase II: DESCRIPTION (provided by applicant): Many peer-reviewed publications show that Bisphenol A

Description

DESCRIPTION (provided by applicant): Many peer-reviewed publications show that Bisphenol A (BPA)-based polycarbonate (PC) and all other commonly used hard and clear (HC) plastics (e.g., polyethylene terephthalate (PET), glycol-modified polyethylene terephthalate (PETG), and polystyrene (PS)) leach endocrine disrupting chemicals that most commonly exhibit estrogenic activity (EA). BPA is only one of many hundreds of chemicals having EA or anti- EA used to manufacture HC plastic products. Chemicals having EAor anti-EA have been reported to 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. These adverse effects sometimes occur atvery low (picomolar to nanomolar) concentrations, especially on fetal or developing mammals (including humans). PlastiPure's (PPi's) data show that no consumer products or packaging made from EA-free** HC plastic are currently commercially available, including those made from PC substitutes currently advertised as BPA-free or phthalate-free. In fact, BPA-free plastics often release chemicals having more EA than do plastics made using BPA (e.g., PC plastics), especially when exposed to sunlight or other UV wavelengths. In order to meet a commercial and health-related need for plastics free of EA and anti-EA (EA-free** plastics), PPi is submitting a Phase II SBIR grant to confirm that it has developed a set of EA-free** resins that directly substitute for PC,PET, PETG, and PS resins that have many advantageous characteristics in different combinations, e.g., HC, microwavable, resistant to UV light and moisture, acid resistant, cold-tolerant (including freezing), and suitable for making thick- or thin-layeredplastics, some of which have an oxygen barrier. PPi proposes to confirm that plastic products manufactured from these EA-free** resins remain EA- free** before and after common-use stresses of heat, moisture, UV and microwave radiation. PPi will use two very sensitive, reproducible and accurate in vitro assays and an in vivo assay to confirm that no chemicals having detectable EA are released from these resins or plastic products before or after stressing. Collectively, the novel EA-free**, BPA-free, HC plastics to be developed on this Phase II grant would replace PET, PETG, and other HC beverage and food-contacting plastics in highest-volume current use that all release chemicals having EA**. Products produced from these resins represent the best commercial opportunity, and the greatest potential reduction in chemicals having EA** that are currently released from plastics and ingested by consumers world-wide. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Many peer-reviewed papers report that commonly used hard and clear (HC) plastics leach chemicals having estrogenic activity (EA) regardless of whether they have bisphenol A (BPA), such as polycarbonate (PC), or are BPA-free such as polyethylene terephthalate (PET), glycol-modified polyethylene terephthalate (PETG), and polystyrene (PS). Ingestion of chemicals having EA by mammals (including humans) have been associated with causing various disorders including uterine dysfunction, higher rates of some cancers, reduced sperm count, and abnormalbrain maturation leading to pathologies such as learning disabilities, disorders of attention, motivation, emotion, cognitive development, and changes in aggressive behavior and sexual orientation. Given such potential adverse effects of chemicals having EA, there is high scientific, societal, and commercial merit for PlastiPure to develop novel EA-Free resins and single- and multi-layer plastics to replace EA-containing PC, PET, PETG, and PS plastic packaging used currently to contain most foodstuffs.