The Conflict between Regulatory Agencies over the 20,000-Fold Lowering of the Tolerable Daily Intake (TDI) for Bisphenol A (BPA) by the European Food Safety Authority (EFSA).

Autor: Vom Saal FS; Division of Biological Sciences, University of Missouri-Columbia, Columbia, Missouri, USA., Antoniou M; Department of Medical and Molecular Genetics, King's College London School of Medicine, London, UK., Belcher SM; Department of Biological Sciences, North Carolina State University, Raleigh, North Carolina, USA., Bergman A; Department of Environmental Science (ACES), Stockholm University, Stockholm, Sweden., Bhandari RK; Division of Biological Sciences, University of Missouri-Columbia, Columbia, Missouri, USA., Birnbaum LS; Scientist Emeritus and Former Director, National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), Research Triangle Park, North Carolina, USA.; Scholar in Residence, Duke University, Durham, North Carolina, USA., Cohen A; Integrative Rheumatology Associates, Princeton, New Jersey, USA., Collins TJ; Department of Chemistry, Carnegie Mellon University, Pittsburgh, Pennsylvania, USA., Demeneix B; Comparative Physiology Laboratory, Natural History Museum, Paris, France., Fine AM; Environmental Medicine Education International, Mancos, Colorado, USA., Flaws JA; Department of Comparative Biosciences, University of Illinois Urbana-Champaign, Urbana-Champaign, Illinois, USA., Gayrard V; ToxAlim (Research Centre in Food Toxicology), University of Toulouse, Toulouse, France., Goodson WH 3rd; California Pacific Medical Center Research Institute, San Francisco, California, USA., Gore AC; Division of Pharmacology and Toxicology, University of Texas at Austin, Austin, Texas, USA., Heindel JJ; Healthy Environment and Endocrine Disruptor Strategies, Raleigh, North Carolina, USA., Hunt PA; School of Molecular Biosciences, Center for Reproductive Biology, Washington State University, Pullman, Washington, USA., Iguchi T; Graduate School of Nanobioscience, Yokohama City University, Yokohama, Japan., Kassotis CD; Institute of Environmental Health Sciences, Wayne State University, Detroit, Michigan, USA.; Department of Pharmacology, Wayne State University, Detroit, Michigan, USA., Kortenkamp A; Centre for Pollution Research and Policy, Brunel University London, Uxbridge, UK., Mesnage R; Department of Medical and Molecular Genetics, King's College London School of Medicine, London, UK., Muncke J; Food Packaging Forum Foundation, Zurich, Switzerland., Myers JP; Environmental Health Sciences, Charlottesville, Virginia, USA., Nadal A; Instituto de Investigación, Desarrollo e Innovación en Biotecnología Sanitaria de Elche (IDiBE) and CIBERDEM, Miguel Hernandez University of Elche, Elche, Alicante, Spain., Newbold RR; Scientist Emeritus, NTP, NIEHS, Research Triangle Park, North Carolina, USA., Padmanabhan V; Department of Pediatrics, Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan, USA.; Department of Molecular and Integrative Physiology, University of Michigan, Ann Arbor, Michigan, USA.; Department of Environmental Health Sciences, University of Michigan, Ann Arbor, Michigan, USA., Palanza P; Unit of Neuroscience, Department of Medicine and Surgery, University of Parma, Parma, Italy., Palma Z; PalmaMD, Miami, Florida, USA., Parmigiani S; Unit of Evolutionary and Functional Biology, Department of Chemistry, Life Sciences and Environmental Sustainability, University of Parma, Parma, Italy., Patrick L; Environmental Medicine Education International, Mancos, Colorado, USA., Prins GS; Department of Urology, University of Illinois at Chicago, Chicago, Illinois, USA., Rosenfeld CS; Biomedical Sciences, Thompson Center for Autism and Neurobehavioral Disorders, University of Missouri-Columbia, Columbia, Missouri, USA.; MU Institute of Data Science and Informatics, University of Missouri-Columbia, Columbia, Missouri, USA., Skakkebaek NE; Department of Growth and Reproduction, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark., Sonnenschein C; Department of Immunology, Tufts University School of Medicine, Boston, Massachusetts, USA., Soto AM; Department of Immunology, Tufts University School of Medicine, Boston, Massachusetts, USA., Swan SH; Department of Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Taylor JA; Division of Biological Sciences, University of Missouri-Columbia, Columbia, Missouri, USA., Toutain PL; Royal Veterinary College, University of London, London, UK.; NTHERES, INRAE, ENVT, Université de Toulouse, Toulouse, France., von Hippel FA; Department of Community, Environment & Policy, University of Arizona, Tucson, Arizona, USA., Welshons WV; Department of Biomedical Sciences, University of Missouri-Columbia, Columbia, Missouri, USA., Zalko D; ToxAlim (Research Centre in Food Toxicology), University of Toulouse, Toulouse, France., Zoeller RT; Department of Biology, University of Massachusetts, Amherst, Massachusetts, USA.
Jazyk: angličtina
Zdroj: Environmental health perspectives [Environ Health Perspect] 2024 Apr; Vol. 132 (4), pp. 45001. Date of Electronic Publication: 2024 Apr 09.
DOI: 10.1289/EHP13812
Abstrakt: Background: The European Food Safety Authority (EFSA) recommended lowering their estimated tolerable daily intake (TDI) for bisphenol A (BPA) 20,000-fold to 0.2  ng / kg  body weight  ( BW ) / day . BPA is an extensively studied high production volume endocrine disrupting chemical (EDC) associated with a vast array of diseases. Prior risk assessments of BPA by EFSA as well as the US Food and Drug Administration (FDA) have relied on industry-funded studies conducted under good laboratory practice protocols (GLP) requiring guideline end points and detailed record keeping, while also claiming to examine (but rejecting) thousands of published findings by academic scientists. Guideline protocols initially formalized in the mid-twentieth century are still used by many regulatory agencies. EFSA used a 21st century approach in its reassessment of BPA and conducted a transparent, but time-limited, systematic review that included both guideline and academic research. The German Federal Institute for Risk Assessment (BfR) opposed EFSA's revision of the TDI for BPA.
Objectives: We identify the flaws in the assumptions that the German BfR, as well as the FDA, have used to justify maintaining the TDI for BPA at levels above what a vast amount of academic research shows to cause harm. We argue that regulatory agencies need to incorporate 21st century science into chemical hazard identifications using the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) nonguideline academic studies in a collaborative government-academic program model.
Discussion: We strongly endorse EFSA's revised TDI for BPA and support the European Commission's (EC) apparent acceptance of this updated BPA risk assessment. We discuss challenges to current chemical risk assessment assumptions about EDCs that need to be addressed by regulatory agencies to, in our opinion, become truly protective of public health. Addressing these challenges will hopefully result in BPA, and eventually other structurally similar bisphenols (called regrettable substitutions) for which there are known adverse effects, being eliminated from all food-related and many other uses in the EU and elsewhere. https://doi.org/10.1289/EHP13812.
Databáze: MEDLINE
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