This Small Business Innovation Research (SBIR) Phase I project will confirm the feasibility of developing flexible packaging that does not leach chemicals having estrogenic or anti-estrogenic activity (EA), while maintaining all the fit-for-use properties of conventional flexible plastic packaging having EA. Hundreds of studies have shown that exogenous chemicals having EA can cause many adverse health effects (including reproductive dysfunctions, learning disabilities, birth defects, and increased rates of cancers). PlastiPure's data show that nearly all plastic products leach chemicals having easily detectable EA at concentrations having known adverse health effects. PlastiPure is developing proprietary materials and processes to fabricate EA-free flexible films and bags that are cost- and performance-competitive with conventional packaging having EA. This project is innovative because no other firm has shown that it is feasible to develop the polymer-based materials and processes needed to produce EA-free flexible films and bags for use in medical, food, and beverage packaging.
The broader/commercial impacts of this research is the widespread commercialization of EA-free flexible film products. In the past few years, a rapid market switch from PC containing BPA-based plastics to BPA-free plastic products has shown that consumers apply market pressure to ensure that safer products are commercially available. Almost all BPA-free plastic products on the market today leach many chemicals having easily detectable EA, often at levels higher than the original BPA-based product. The funding of this NSF SBIR grant will help facilitate a comprehensive reduction of risks to public health and reduced environmental impact from chemicals having EA.
This Small Business Innovation Research (SBIR) Phase I project successfully confirmed the feasibility of developing flexible packaging that does not leach chemicals having detectable levels of EA** (estrogenic or anti-estrogenic activity), while maintaining all the fit-for-use properties of conventional flexible plastic packaging that leaches chemicals having EA**. Hundreds of studies have shown that exogenous chemicals having EA** can cause many adverse health effects (including reproductive dysfunctions, learning disabilities, birth defects, and increased rates of cancers), with infants, children, and adolescents being particularly at risk. In this grant, PlastiPure, Inc. confirmed that it has formulated resins and blends suitable to produce four types of flexible polyolefin films suitable for use in food or beverage packaging applications, all of which do not leach chemicals having detectable levels of EA** into food and beverage simulants (ethanol and saline). To confirm that the EA-free** (free of leachable chemicals having EA**) films have the same fitness-for-use as conventional food packaging films, PlastiPure formulated and compounded EA-free** resins to successfully produce films from these resins using standard cast-film processes. The physical properties of these EA-free** films (tensile strength at yield, tensile strength at break, and ultimate elongation) were determined to be comparable to commercially-available films of a similar thickness that had been shown to leach chemicals having detectable levels of EA**. These films were extracted using food and beverage simulants according to FDA migration protocols. The EA** of the extract solutions was quantified using a reliable and sensitive in vitro assay where human breast cancer cells (MCF7) that either proliferate in the presence of estrogenic chemicals, or inhibit proliferation in the presence of anti-estrogenic chemicals. Prototype films produced from resins formulated by PlastiPure were exposed to common-use stresses associated with consumer packaging (UV light, microwaving, and thermal cycling). After exposure to common-use stresses, the films were extracted with the same food simulants. These extracts were also found to not leach chemicals having detectable levels of EA**. Besides the single layer films produced in this work, multilayer EA-free** films can also be produced to achieve performance properties that are driven by market requirements, such as the ability to be boiled or hot-filled, for oxygen and water impermeability, and for heat sealability. The broader/commercial impacts of this research are the widespread commercialization of EA-free** flexible film products suitable for use in food and beverage packaging. In the past few years, a rapid market switch from bisphenol A (BPA)-containing polycarbonate plastics to BPA-free plastic products has shown that consumers apply market pressure to ensure that safer products are commercially available. However, BPA is not the only chemical leaching from plastic packaging that can have EA**. PlastiPure has shown that over 90% of tested commercial plastic food packaging leaches chemicals having detectable levels of estrogenic activity. PlastiPure anticipates that once consumers are aware of the overall issue of EA** in plastic products, they will demand that manufacturers and retailers provide products that are comprehensively free of all chemicals with EA**. This strategy is much more efficient than going through a slow, chemical-by-chemical replacement strategy. The preliminary data from this Phase I grant confirmed the feasibility to make EA-free** flexible plastic packaging with physical properties comparable to conventional flexible plastic packaging that leaches chemicals having EA**.
