SBIR-STTR Award

Many scientific investigations have shown that polycarbonate (PC) plastics leach bisphenol- A (BPA), one of many hundreds of chemicals having estrogenic activity (EA) or anti-EA used to manufacture PC and other plastic products. Chemicals having EA or anti-EA 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. These adverse effects sometimes occur at very low (picomolar to nanomolar) concentrations, especially on fetal or developing mammals (including humans). PC plastics are hard and clear and often used to make baby bottles or water bottles and other products that contain foodstuffs. PPi's data show that no EA-Free PC substitute is currently commercially available, including those marketed as BPA and/or phthalate free. In order to meet this commercial and health-related need, Plastipure (PPi) is submitting a Phase I SBIR grant to confirm that it is feasible to develop resins that do not release chemicals having EA or anti-EA (EA-Free) and that directly substitute for PC resins that have many advantageous characteristics, e.g., hard, clear, microwavable and resistant to UV light and moisture. PPi also 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 micrewave radiation. PPi will use very sensitive, reproducible and accurate in vitro assays to confirm that no chemicals having detectable EA are released from these resins or plastic products. Once these Phase I feasibility studies are successfully completed, PPi should have the only known hard and clear replacement for PC plastics that do not leach BPA, phthalates, or any other chemicals having EA. PPi's EA-Free substitutes for PC resins would then be licensed to plastic manufacturers who would then produce EA-free consumer products, such as food containers and baby bottles. Alternatively, PPi may subcontract to have some such products manufactured under its own label. Given the increasing concern of individuals for their and their children's well-being and PPi's requests from large and small retail firms, EA-free plastic products should have high commercial potential.

Public Health Relevance:
Many scientific investigations have shown that polycarbonate (PC) plastics leach bisphenol-A (BPA), one of many hundreds of chemicals having estrogenic activity (EA) or anti-EA used to manufacture PC and other plastic products. Chemicals having EA or anti-EA 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. These adverse effects sometimes occur at very low (picomolar to nanomolar) concentrations, especially on fetal or developing mammals (including humans). Given such adverse effects of chemicals having EA and anti-EA on mammals (including humans), there is high scientific, societal, and commercial merit for PPi to develop EA-/Anti-EA-Free plastic resins and products that are direct substitutes for PC resins and products, especially water bottles, food containers and baby products.

Thesaurus Terms:
0-6 Weeks Old; 4,4' Isopropylidinediphenol; Actinic Rays; Adverse Effects; Advertising; Aggression; Aggressive Behavior; Australia; Behavioral; Biological; Canada; Carbonates; Carbonic Dichloride; Cell Growth In Number; Cell Multiplication; Cell Proliferation; Cellular Proliferation; Characteristics; Chemicals; China; Client; Cyclic Olefins; Cycloalkanes; Cycloparaffins; Data; Diet; Drug Formulations; Electromagnetic, Microwave; Endocrine; Endocrine Disrupter; Endocrine Disrupting Chemicals; Endocrine Disruptors; Endocrine Disrupting Agent; Endocrine Disruption; Estrogenic Agents; Estrogenic Compounds; Estrogens; Ethene Homopolymers; Ethylene Homopolymers; Ethylene Polymers; Evaluation; Exhibits; Exposure To; Feasibility Studies; Food Container; Formulation; Formulations, Drug; Goals; Government; Grant; Gray; Gray Unit Of Radiation Dose; Health; Heat Stress; Heat Stress Disorders; Heat Stress Syndromes; Hormonal; Human; Human, General; Hydrogen Oxide; Individual; Infant, Newborn; Investigation; Japan; Label; Left; Legal Patent; Letters; Licensing; Mcf-7; Mcf-7 Cell; Mcf7; Mcf7 Cell; Mainland China; Mammalia; Mammals; Mammals, General; Man (Taxonomy); Man, Modern; Manufacturer; Manufacturer Name; Marketing; Measures; Methods; Microwaves; Molecular Weight; National Institute Of Environmental Health Sciences; Newborn Infant; Newborns; Organism-Level Process; Organismal Process; Ovarian; Patents; Persons; Phase; Phosgene; Physiologic Processes; Physiological Processes; Plant Resins; Plastics; Polyethylenes; Polymers; Polypropylenes; Pressure; Pressure- Physical Agent; Propene Polymers; Propylene Polymers; Publishing; Radiation; Reporting; Resins, Plant; Resistance; Robotics; Sbir; Sbirs (R43/44); Small Business Innovation Research; Small Business Innovation Research Grant; Solutions; Sperm Count; Sperm Count Procedure; Sperm Numbers; Stress; Sun/Ultra-Violet Rays; Testing; Therapeutic Estrogen; Toy; Treatment Side Effects; Uv Radiation; Ultraviolet Rays; Validation; Water; Base; Bisphenol A; Cancer Type; Catalyst; Chemical Release; Child Well Being; Commercial Application; Commercialization; Consumer Product; Copolymer; Diphenylolpropane; Endocrine Disrupting; Endocrine Disrupting Compound; Estrogenic Activity; Experience; Fetal; Flexibility; In Vitro Assay; Manufacturing Process; Meetings; Microwave Electromagnetic Radiation; Microwave Radiation; Monomer; Newborn Human (0-6 Weeks); Phthalates; Physical Property; Polycarbonate; Polycarbonate Plastic; Pressure; Public Health Relevance; Ray (Radiation); Resin; Resistant; Side Effect; Social; Therapy Adverse Effect; Treatment Adverse Effect; Ultraviolet; Ultraviolet Light; Ultraviolet Radiation

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 EA or 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 at very 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-layered plastics, 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 Statement:


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 abnormal brain 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.

Project Terms:
Acids; Adolescent; Adverse effects; Advertising; Aggressive behavior; Attention; base; Behavioral; Beverages; Biological Assay; bisphenol A; Brain; cancer type; Characteristics; chemical release; Chemicals; Cognitive; Complex Mixtures; consumer product; Data; Development; Disease; Dose; Drug Formulations; Emotions; Endocrine Disruptors; estrogenic activity; Estrogens; Exhibits; Exposure to; Family; fetal; flexibility; Food; Food Packaging; Freezing; Functional disorder; Glycols; Grant; Health; Heat Stress Disorders; Human; in vitro Assay; in vivo; Infant; Ingestion; Injection of therapeutic agent; Interagency Coordinating Committee on the Validation of Alternative Methods; Juice; Learning Disabilities; Legal patent; Link; Malignant Neoplasms; Mammals; Marketing; MCF7 cell; Measures; Mechanics; meetings; Methods; microwave electromagnetic radiation; Molds; monomer; Motivation; novel; Obesity; Oils; Ovarian; oxidation; Oxygen; Paper; Pathology; Peer Review; Phase; phthalates; physical process; Physiological Processes; Plant Resins; Plastics; polycarbonate; polycarbonate plastic; Polyethylene Terephthalates; Polyethylenes; Polymers; Polypropylenes; Polystyrenes; prevent; Property; prostate enlargement; Puberty; public health medicine (field); public health relevance; Publications; Publishing; Reporting; Resistance; Risk; Scientist; Sex Orientation; Small Business Innovation Research Grant; soft drink; Sperm Count Procedure; Stress; Sunlight; Testing; Thick; Ultraviolet Rays; Water; xenoestrogen