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This commentary presents a scientific basis for managing as one chemical class the thousands of chemicals known as PFAS (per- and polyfluoroalkyl substances). The class includes perfluoroalkyl acids, perfluoroalkylether acids, and their precursors; fluoropolymers and perfluoropolyethers; and other PFAS. The basis for the class approach is presented in relation to their physicochemical, environmental, and toxicological properties. Specifically, the high persistence, accumulation potential, and/or hazards (known and potential) of PFAS studied to date warrant treating all PFAS as a single class. Examples are provided of how some PFAS are being regulated and how some businesses are avoiding all PFAS in their products and purchasing decisions. We conclude with options for how governments and industry can apply the class-based approach, emphasizing the importance of eliminating non-essential uses of PFAS, and further developing safer alternatives and methods to remove existing PFAS from the environment., Environmental Science & Technology Letters, 7 (8), ISSN:2328-8930

Food packaging is of high societal value because it conserves and protects food, makes food transportable and conveys information to consumers. It is also relevant for marketing, which is of economic significance. Other types of food contact articles, such as storage containers, processing equipment and filling lines, are also important for food production and food supply. Food contact articles are made up of one or multiple different food contact materials and consist of food contact chemicals. However, food contact chemicals transfer from all types of food contact materials and articles into food and, consequently, are taken up by humans. Here we highlight topics of concern based on scientific findings showing that food contact materials and articles are a relevant exposure pathway for known hazardous substances as well as for a plethora of toxicologically uncharacterized chemicals, both intentionally and non-intentionally added. We describe areas of certainty, like the fact that chemicals migrate from food contact articles into food, and uncertainty, for example unidentified chemicals migrating into food. Current safety assessment of food contact chemicals is ineffective at protecting human health. In addition, society is striving for waste reduction with a focus on food packaging. As a result, solutions are being developed toward reuse, recycling or alternative (non-plastic) materials. However, the critical aspect of chemical safety is often ignored. Developing solutions for improving the safety of food contact chemicals and for tackling the circular economy must include current scientific knowledge. This cannot be done in isolation but must include all relevant experts and stakeholders. Therefore, we provide an overview of areas of concern and related activities that will improve the safety of food contact articles and support a circular economy. Our aim is to initiate a broader discussion involving scientists with relevant expertise but not currently working on food contact materials, and decision makers and influencers addressing single-use food packaging due to environmental concerns. Ultimately, we aim to support science-based decision making in the interest of improving public health. Notably, reducing exposure to hazardous food contact chemicals contributes to the prevention of associated chronic diseases in the human population.

Human exposure to endocrine-disrupting chemicals (EDCs) may increase risk for chronic disease. Diet is a significant source of EDC exposure, yet healthy diets recommended for chronic disease prevention have not been thoroughly examined for associations with EDC exposure. Using data from the National Health and Nutrition Examination Survey 2013-2016, we examined associations of dietary patterns with exposure to non-persistent EDCs potentially consumed through diet. EDCs were measured in spot urine samples. Diet was assessed using 24-h recalls. Multivariable linear regression was used to examine associations of three healthy diet scores [Healthy Eating Index (HEI), relative Mediterranean Diet (rMED), and Dietary Approaches to Stop Hypertension] and fast-food consumption with EDCs. In fully adjusted models, no diet was associated with exposure to the bisphenols, phthalates, or polycyclic aromatic hydrocarbons examined. A 1-point increase in rMED (of 18 possible points) was associated with 2.7% (95% CI: 1.7%, 3.8%) greater urinary nitrate. A 10-point increase in HEI (of 100 possible points) was associated with 5.3% (95% CI: 2.8%, 7.9%) greater nitrate and 6.8% (95% CI: 4.5%, 9.2%) greater perchlorate. Because perchlorate and nitrate can disrupt thyroid hormone production, we conducted an exploratory analysis to examine whether these chemicals mediate an association between diet and thyroid hormones. A 10-point increase in HEI was associated with 0.6% reduced serum total thyroxine (95% CI: 1.7%, 0.5%) among all adults, with 57.5% of the effect explained by perchlorate. Nitrate mediated an association of rMED with modestly reduced total triiodothyronine among females. Most EDCs examined had no association with the diets evaluated, indicating that recommended healthy diets were not protective against EDC exposures. As observed with two thyroid antagonists, some recommended diets may increase EDC exposures and related adverse health outcomes. Additional work should identify effective food production and processing practices to reduce dietary exposures to potentially harmful EDCs.

Copyright © 2020 The Authors. Food contact materials (FCMs) are used to make food contact articles (FCAs) that come into contact with food and beverages during, e.g., processing, storing, packaging, or consumption. FCMs/FCAs can cause chemical contamination of food when migration of their chemical constituents (known as food contact chemicals, FCCs) occurs. Some FCCs are known to be hazardous. However, the total extent of exposure to FCCs, as well as their health and environmental effects, remain unknown, because information on chemical structures, use patterns, migration potential, and health effects of FCCs is often absent or scattered across multiple sources. Therefore, we initiated a research project to systematically collect, analyze, and publicly share information on FCCs. As a first step, we compiled a database of intentionally added food contact chemicals (FCCdb), presented here. The FCCdb lists 12′285 substances that could possibly be used worldwide to make FCMs/FCAs, identified based on 67 FCC lists from publicly available sources, such as regulatory lists and industry inventories. We further explored FCCdb chemicals’ hazards using several authoritative sources of hazard information, including (i) classifications for health and environmental hazards under the globally harmonized system for classification and labeling of chemicals (GHS), (ii) the identification of chemicals of concern due to endocrine disruption or persistence related hazards, and (iii) the inclusion on selected EU- or US-relevant regulatory lists of hazardous chemicals. This analysis prioritized 608 hazardous FCCs for further assessment and substitution in FCMs/FCAs. Evaluation based on non-authoritative, predictive hazard data (e.g., by in silico modeling or literature analysis) highlighted an additional 1411 FCCdb substances that could thus present similar levels of concern, but have not been officially classified so far. Lastly, for over a quarter of all FCCdb chemicals no hazard information could be found in the sources consulted, revealing a significant data gap and research need. MAVA Foundation; Valery Foundation

This is a preprint of a manuscript "Impacts of food contact chemicals on human health: scientific consensus statement," submitted to Environmental Healthon June 7, 2019. Abstract Food packaging, as the most eminent type of food contact article, is of high societal use because it conserves and protects food, makes food transportable and conveys important information to consumers. It is also very relevant for marketing, which is of economic significance. Other types of food contact articles, such as storage containers, processing equipment and filling lines, are also important for modern food production and food supply. Food contact articles are made up of one or multiple different food contact materials and consist of food contact chemicals.Food contact chemicals transfer from all types of food contact materials and articles into food and, consequently, into humans. Here we summarize the scientific data and findings showing that food contact materials and articles are a relevant exposure pathway for known hazardous substances as well as for a plethora of toxicologically uncharacterized chemicals, both intentionally and non-intentionally added in food packaging. We describe areas of certainty, like the fact that chemicals migrate from food contact articles into food, and uncertainty, for example concerning the presence of unidentified migrating chemicals. In addition, we provide recommendations for research and policy, for example the testing of finished food packaging for chemical hazards.Our aim is to support science-based decision making in the interest of improving public health.Notably, reducing exposure to hazardous food contact chemicals contributes to the prevention of associated chronic diseases in the human population.

Tetramethyl bisphenol F (TMBPF) has been shown to impart unique physical properties critical for high performance of epoxy can coatings without the estrogenic activity concerns associated with other bisphenols. To further characterize the toxicological profile of TMBPF, additional endocrine-related endpoints including in vitro aromatase inhibition and steroidogenesis assays, and in vivo androgen agonism/antagonism were performed. Systemic toxicity was also assessed by a repeat dose 90-day dietary toxicity study followed by 28-day recovery period. TMBPF did not inhibit aromatase activity, and induced estradiol and testosterone at highest non-cytotoxic concentrations (10 μM) in the steroidogenesis assay. In the Hershberger assay, TMBPF showed no androgenic activity at any dose and equivocal anti-androgenic activity at the highest dose (1000 mg/kg-bw/d). In a 90-day dietary toxicity study with 28-day recovery period, observations including changes in clinical pathology, absolute and relative organ weights, and microscopic findings are discussed. In this current study, the no observed adverse effect level was considered to be 750 mg/kg-bw/d for female rats and 1000 mg/kg-bw/d for male rats with no biologically significant changes to endocrine endpoints at any dose level. Our findings provide further evidence that TMBPF is a low-toxicity substance with a toxicology profile distinct from some other bisphenols.

Global plastics production has reached 380 million metric tons in 2015, with around 40% used for packaging. Plastic packaging is diverse and made of multiple polymers and numerous additives, along with other components, such as adhesives or coatings. Further, packaging can contain residues from substances used during manufacturing, such as solvents, along with non-intentionally added substances (NIAS), such as impurities, oligomers, or degradation products. To characterize risks from chemicals potentially released during manufacturing, use, disposal, and/or recycling of packaging, comprehensive information on all chemicals involved is needed. Here, we present a database of Chemicals associated with Plastic Packaging (CPPdb), which includes chemicals used during manufacturing and/or present in final packaging articles. The CPPdb lists 906 chemicals likely associated with plastic packaging and 3377 substances that are possibly associated. Of the 906 chemicals likely associated with plastic packaging, 63 rank highest for human health hazards and 68 for environmental hazards according to the harmonized hazard classifications assigned by the European Chemicals Agency within the Classification, Labeling and Packaging (CLP) regulation implementing the United Nations’ Globally Harmonized System (GHS). Further, 7 of the 906 substances are classified in the European Union as persistent, bioaccumulative, and toxic (PBT), or very persistent, very bioaccumulative (vPvB), and 15 as endocrine disrupting chemicals (EDC). Thirty-four of the 906 chemicals are also recognized as EDC or potential EDC in the recent EDC report by the United Nations Environment Programme. The identified hazardous chemicals are used in plastics as monomers, intermediates, solvents, surfactants, plasticizers, stabilizers, biocides, flame retardants, accelerators, and colorants, among other functions. Our work was challenged by a lack of transparency and incompleteness of publicly available information on both the use and toxicity of numerous substances. The most hazardous chemicals identified here should be assessed in detail as potential candidates for substitution.

Consumer concerns about exposure to substances found in food contact materials with estrogenic activity (EA) have created substantial demand for alternatives. We assessed the potential EA of both a new bisphenol monomer used to synthesize polymeric coatings for metal food-contact applications and the nonintentionally added substances (NIAS) that may migrate into food. We evaluated tetramethyl bisphenol F (TMBPF) using in vitro and in vivo assays. We extracted the polymeric coating using food simulants ethanol (50% v/v) and acetic acid (3% w/v) and measured migration using tandem liquid chromatography (LC)/mass spectrometry (MS) and LC time-of-flight MS for TMBPF and NIAS, respectively. We also tested migrants for EA using the E-SCREEN assay. TMBPF did not show estrogenic activity in the uterotrophic assay and did not alter puberty in male and female rats or mammary gland development in female rats. Neither TMBPF nor the migrants from the final polymeric coating increased proliferation of estrogen-sensitive MCF7 cells. TMBPF did not show estrogen-agonist or antagonist activity in the estrogen receptor-transactivation assay. TMBPF migration was below the 0.2 parts per billion detection limit. Our findings provide compelling evidence for the absence of EA by TMBPF and the polymeric coating derived from it and that human exposure to TMBPF would be negligible.

Perchlorate is an endocrine-disrupting chemical that interferes with the normal functioning of the thyroid gland. Maternal thyroid dysfunction during gestation may alter fetal brain development. Perchlorate contamination is widespread: it is present in the body of all Americans tested and the majority of foods tested. The main sources of food contamination appear to be hypochlorite bleach, a disinfectant and sanitizer, that when poorly managed quickly degrades to perchlorate and perchlorate-laden plastic food packaging for dry food or localized contamination from manufacturing or processing of the chemical. Eliminating perchlorate from food packaging and improving bleach management, such as reducing concentration and storage time and temperature, would result in reduced perchlorate contamination of food and water.

Global plastics production has reached 380 million metric tons in 2015, with around 40% used for packaging. Plastic packaging is diverse and made of multiple polymers and numerous additives, along with other components, such as adhesives or coatings. Further, packaging can contain residues from substances used during manufacturing, such as solvents, along with non-intentionally added substances (NIAS), such as impurities, oligomers, or degradation products. To characterize risks from chemicals potentially released during manufacturing, use, disposal, and/or recycling of packaging, comprehensive information on all chemicals involved is needed. Here, we present a database of Chemicals associated with Plastic Packaging (CPPdb), which includes chemicals used during manufacturing and/or present in final packaging articles. The CPPdb lists 906 chemicals likely associated with plastic packaging and 3377 substances that are possibly associated. Of the 906 chemicals likely associated with plastic packaging, 63 rank highest for human health hazards and 68 for environmental hazards according to the harmonized hazard classifications assigned by the European Chemicals Agency within the Classification, Labeling and Packaging (CLP) regulation implementing the United Nations’ Globally Harmonized System (GHS). Further, 7 of the 906 substances are classified in the European Union as persistent, bioaccumulative, and toxic (PBT), or very persistent, very bioaccumulative (vPvB), and 15 as endocrine disrupting chemicals (EDC). Thirty-four of the 906 chemicals are also recognized as EDC or potential EDC in the recent EDC report by the United Nations Environment Programme. The identified hazardous chemicals are used in plastics as monomers, intermediates, solvents, surfactants, plasticizers, stabilizers, biocides, flame retardants, accelerators, and colorants, among other functions. Our work was challenged by a lack of transparency and incompleteness of publicly available information on both the use and toxicity of numerous substances. The most hazardous chemicals identified here should be assessed in detail as potential candidates for substitution.

44. Zhang X, Cook KK, Hilakivi-Clarke L. Lifetime genistein alters mammary tumors’ response to anti-estrogen tamoxifen treatment by affecting immune function in rats. Presented at: Annual Meeting of the American Association of Cancer Research (abstract 904). April 19, 2015. http://www. abstractsonline.com/Plan/ViewAbstract.aspx?mID1⁄43682& sKey1⁄45c372efb-ca04-41ea-8c64-852c1ea4d8bf&cKey1⁄4 4b9b4b58-c9eb-40eb-9ac8-8f6d479ab8a9&mKey1⁄4 19573a54-ae8f-4e00-9c23-bd6d62268424. Accessed June 5, 2015.

Background: Food contact articles (FCAs) are manufactured from food contact materials (FCMs) that include plastics, paper, metal, glass, and printing inks. Chemicals can migrate from FCAs into food during storage, processing, and transportation. Food contact materials’ safety is evaluated using chemical risk assessment (RA). Several challenges to the RA of FCAs exist. Objectives: We review regulatory requirements for RA of FCMs in the United States and Europe, identify gaps in RA, and highlight opportunities for improving the protection of public health. We intend to initiate a discussion in the wider scientific community to enhance the safety of food contact articles. Discussion: Based on our evaluation of the evidence, we conclude that current regulations are insufficient for addressing chemical exposures from FCAs. RA currently focuses on monomers and additives used in the manufacture of products, but it does not cover all substances formed in the production processes. Several factors hamper effective RA for many FCMs, including a lack of information on chemical identity, inadequate assessment of hazardous properties, and missing exposure data. Companies make decisions about the safety of some food contact chemicals (FCCs) without review by public authorities. Some chemical migration limits cannot be enforced because analytical standards are unavailable. Conclusion: We think that exposures to hazardous substances migrating from FCAs require more attention. We recommend a) limiting the number and types of chemicals authorized for manufacture and b) developing novel approaches for assessing the safety of chemicals in FCAs, including unidentified chemicals that form during or after production. ISSN:1552-9924 ISSN:0091-6765

The American diet is dramatically different today than in 1958, when Congress passed the Food Additives Amendment. Innovations in processing, preserving, and packaging have made food more affordable and convenient but added thousands of new chemicals to our diet. More than 10,000 additives are allowed in food, but most have not been tested, and their long-term, chronic effects have rarely been studied. The regulatory system has fallen short of being fully implemented and has been weakened by decades of limited resources. A legal loophole allows new chemicals in food without notice to or review by the Food and Drug Administration, and the outdated safety assessment process fails to adequately address public health concerns. The result is that consumers bear the burden of deciding what is safe to eat, with limited information to do so. Without robust review of the safety of chemicals in food, there is little insight into the extent to which they may be contributing to chronic diseases.

Food additives play important roles in modern food manufacturing including adding color and flavor and extending shelf-life as well as improving processing, storing and transportation of food. This review examines a number of issues that have recently been raised in food additives safety assessments including the concepts of adverse and cumulative effects and whether the current testing approaches are adequately evaluating health outcomes of concern. We include recommendations for how food safety evaluations could be improved including- 1) adopting methods to comply with the statutory requirement to include cumulative effects of chemicals in the diet to the safety assessment of additives, 2) the inclusion of more sensitive endpoints in hazard assessments that better represent human health outcomes, 3) the use of systematic review methods to improve regulatory decision making, and 4) the use of improved screening methods to prioritize chemical evaluations.

The American diet has changed dramatically since 1958, when Congress gave the United States Food and Drug Administration (FDA) the authority to ensure the safety of chemicals in food. Since then, thousands of chemicals have entered the food system. Yet their long-term, chronic effects have been woefully understudied, their health risks inadequately assessed. The FDA has been sluggish in considering scientific knowledge about the impact of exposures-particularly at low levels and during susceptible developmental stages. The agency's failure to adequately account for the risks of perchlorate-a well-characterized endocrine-disrupting chemical-to vulnerable populations is representative of systemic problems plaguing the regulation of chemicals in food. Today, we are faced with a regulatory system that, weakened by decades of limited resources, has fallen short of fully enforcing its mandates. The FDA's inability to effectively manage the safety of hundreds of chemicals is putting our children's health at risk.