Abstract
Abstract
Background
In the US, the Food and Drug Administration (US FDA) is charged with protecting the safety of food from both pathogens and chemicals used in food production and food packaging. To protect the public in a transparent manner, the FDA needs to have an operational definition of what it considers to be an “adverse effect” so that it can take action against harmful agents. The FDA has recently published two statements where, for the first time, it defines the characteristics of an adverse effect that it uses to interpret toxicity studies.
Objective
In this brief review, we examine two recent actions by the FDA, a proposed rule regarding a color additive used in vegetarian burgers and a decision not to recall fish with high levels of scombrotoxin. We evaluated the FDA’s description of the criteria used to determine which outcomes should be considered adverse.
Overview
We describe three reasons why the FDA’s criteria for “adverse effects” is not public health protective. These include an unscientific requirement for a monotonic dose response, which conflates hazard assessment and dose response assessment while also ignoring evidence for non-linear and non-monotonic effects for many environmental agents; a requirement that the effect be observed in both sexes, which fails to acknowledge the many sex- and gender-specific effects on physiology, disease incidence and severity, and anatomy; and a requirement that the effects are irreversible, which does not acknowledge the role of exposure timing or appreciate transgenerational effects that have been demonstrated for environmental chemicals.
Conclusions
The FDA’s criteria for identifying adverse effects are inadequate because they are not science-based. Addressing this is important, because the acknowledgement of adverse effects is central to regulatory decisions and the protection of public health.
Publisher
Springer Science and Business Media LLC
Subject
Health, Toxicology and Mutagenesis,Public Health, Environmental and Occupational Health
Reference42 articles.
1. Drexler M. Foodborne Illness: Who monitors our food?, vol. 21 Jan 2020. Waltham: Schuster Institute for Investigative Journalism at Brandeis University; 2011.
2. CDC. Estimates of Foodborne illness in the United States. 2018. https://www.cdc.gov/foodborneburden/index.html. Accessed 21 Jan 2020.
3. Groh KJ, Backhaus T, Carney-Almroth B, Geueke B, Inostroza PA, Lennquist A, Leslie HA, Maffini M, Slunge D, Trasande L, et al. Overview of known plastic packaging-associated chemicals and their hazards. Sci Total Environ. 2019;651(Pt 2):3253–68.
4. Muncke J, Andersson AM, Backhaus T, Boucher JM, Carney Almroth B, Castillo Castillo A, Chevrier J, Demeneix BA, Emmanuel JA, Fini JB, et al. Impacts of food contact chemicals on human health: a consensus statement. Environ Health. 2020;19(1):25.
5. Geueke B, Groh KJ, Maffini MV, Martin OV, Boucher JM, Chiang YT, Gwosdz F, Jieh P, Kassotis CD, Łańska P et al. Systematic evidence on migrating and extractable food contact chemicals: Most chemicals detected in food contact materials are not listed for use. Crit Rev Food Sci Nutr 2022:1–11.
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