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Oxybenzone and the Mammary Gland: Impact of an Environmental Pollutant on Health, Disease & Ethical Decision-Making
The environmental pollutant and common sunscreen compound oxybenzone is a benzophenone type UV light chemical filter used in industrial and consumer goods. This chemical widely contaminates human tissues, non-human species, and environmental matrices. In this dissertation, oxybenzone is investigated for its effects on the mouse mammary gland in the offspring following perinatal exposure; after perinatal and prepubertal exposures as a dual environmental insult during two sensitive times of development; and in adults after exposure during pregnancy & lactation as an environmental factor potentially increasing the tissue susceptibility to mammary tumors. Chapter 1 introduces the mammary gland. Chapter 2 reviews UV screening chemicals with a focus on oxybenzone. Chapter 3 summarizes methods used in this dissertation. Chapters 4 and 5 present two aspects of our studies quantifying the impact of perinatal exposure to oxybenzone on the epithelial and stromal compartments of the mammary gland. Chapter 6 evaluates the effects of exposures during two sensitive periods of development: the perinatal and prepubertal periods. Chapters 7 and 8 present a concise summary of breast cancer, its trends, its genetic and environmental causes, and findings on tumors acquired in BALB/c mice transplanted with p53-/- epithelium and exposed to oxybenzone during pregnancy and lactation. Chapter 9 takes an ethics-based approach to modern-day pollutants, including endocrine disrupting chemicals, in the process of decision-making towards sustainable environmental and human health. Finally, chapter 10 summarizes and hints on future directions for oxybenzone research. The results of this work make a case for oxybenzone’s disruption of the mammary gland’s epithelial and stromal compartments during several vulnerable periods of development. Our data also support an argument that animals genetically susceptible to breast cancer may have heightened sensitivity to environmental chemicals. Lastly, we propose six principles of environmental health that are imperative in decision-making on synthetic compounds. The data presented herein contribute to the body of evidence postulating that oxybenzone is an endocrine disruptor, and that developmental exposures to everyday synthetic chemicals used for human safety and/or convenience elicit later-in-life effects on susceptibility to chemical environmental exposures, on health and disease
Out of balance: conflicts of interest persist in food chemicals determined to be generally recognized as safe
Abstract Manufacturers of chemicals added to food are responsible for determining that the use of their products is safe. There are two major legal definitions of chemicals in food: (1) food additives which includes ingredients and chemicals indirectly entering food from packaging and processing equipment, and (2) generally recognized as safe (GRAS) substances mostly used as ingredients. The law requires food additives to undergo approval by the U.S. Food and Drug Administration (FDA) before they are sold, but it GRAS substances are exempted from pre-market approval. In 1997, FDA created a voluntary program for manufacturers to submit their chemical’s safety determination in the form of a GRAS notice to the agency. Manufacturers make GRAS determinations regardless of whether they voluntarily submit a notice to FDA for review. They rely on their own employees, the employee of a hired consulting firm or a panel of experts, known as GRAS panel, to review the safety information. Because this process determines whether a chemical is safe for use in food, conflicts of interest and biases need to be avoided or minimized to credibly ensure food is safe. Recently, FDA has published guidance for industry on best practices to convene GRAS panels to manage conflicts of interest and reduce biases that have plagued the process. Here, we perform a qualitative assessment of the compliance of GRAS panels with basic elements of FDA’s guidance. We assessed 403 GRAS notices filed by FDA between 2015 and 2020 and identified whether a GRAS panel was convened and by whom, its members, affiliations, and relationships between panelists and panel conveners. Then, we compared FDA’s recommendations against the information included in the notices voluntarily submitted by manufacturers. We found no evidence that GRAS panels have adhered to FDA’s guidance. Panels are populated from a very small pool of professionals; we found that seven panel members alone occupied almost half of all available panel positions and that they often serve together. Against guidance recommendations, ad-hoc panels have been substituted by panels with recurring members in hired consulting firms’ payroll. The widespread persistence of conflicts of interest, appearance of conflict and bias in GRAS determinations continue to put the health of Americans at risk and undermine confidence in the safety of food ingredients in the US market. FDA should require notice for all GRAS determinations including how the financial conflicts of interest of those who make these determinations are minimized