A data synthesis framework and case study supporting risk-based prioritization of additives and polymer-associated chemistries

Polymers and plastics are widely used to support a range of growing market segments and applications (e.g.,, packaging, construction, agricultural films) due to functional properties (e.g.,, durability, versatility) and cost effectiveness. With continued growing use of polymers and plastics, there is increased interest in health and environmental assessments of these materials, including chemicals associated with their production and use. Additives and polymer-associated chemistries (APAC), as individual chemicals, are subject to regulation by chemical assessment frameworks (e.g.,, U.S. TSCA, EU REACH). Finished products and articles are subject to other regulations (e.g.,, U.S. FDA Federal Food, Drug, and Cosmetic Act). Assessing risk (ie, hazard x exposure) and making risk-based decisions requires analysis of a complex, dynamic dataset. There is a need for practical screening and prioritization methods to address the large numbers and complexity of APAC. Therefore, a data synthesis framework supporting risk-based screening and prioritization of APAC is proposed to demonstrate where and how to gather, organize, and process data for downstream human health and environmental risk assessment of APAC (ie in articles). A case study was performed using the 13,186 APAC identified in the UNEP Chemicals in Plastics report to evaluate the utility of this data synthesis framework and evaluate how many APAC have sufficient publicly available data to perform downstream risk assessment. Based on application of this framework, it was determined that at a minimum Tier 1 + data are readily accessible to support risk-based screening and prioritization of most of the UNEP database APAC for human health (8,819 or 66.9%) and environmental (9,068 or 68.8%) risk assessment.