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.

中文翻译：

---

欧洲食品安全局 (EFSA) 将双酚 A (BPA) 每日容许摄入量 (TDI) 降低 20,000 倍，监管机构之间发生冲突。


背景欧洲食品安全局 (EFSA) 建议将双酚 A (BPA) 的估计每日耐受摄入量 (TDI) 降低 20,000 倍至 0.2 纳克/公斤体重 (BW)/天。 BPA 是一种经过广泛研究的高产量内分泌干扰化学物质 (EDC)，与多种疾病相关。 EFSA 以及美国食品和药物管理局 (FDA) 之前对 BPA 的风险评估依赖于行业资助的研究，这些研究是根据良好实验室实践协议 (GLP) 进行的，需要指导终点和详细记录保存，同时还声称要检查（但拒绝）学术科学家发表的数千项发现。许多监管机构仍在使用最初于二十世纪中叶正式制定的指导方案。 EFSA 采用 21 世纪的方法重新评估 BPA，并进行了透明但有时限的系统审查，其中包括指南和学术研究。德国联邦风险评估研究所 (BfR) 反对 EFSA 对 BPA 的 TDI 进行修订。目标 我们发现了德国 BfR 和 FDA 用来证明将 BPA 的 TDI 维持在高于大量学术研究表明会造成伤害的水平的合理性的假设中存在缺陷。我们认为，监管机构需要在政府-学术合作项目模型中使用 CLARITY-BPA（将双酚 A 毒性的学术和监管见解联系起来的联盟）非指南性学术研究，将 21 世纪的科学纳入化学危害识别中。讨论 我们强烈支持 EFSA 修订后的 BPA TDI，并支持欧盟委员会 (EC) 明显接受这一更新的 BPA 风险评估。 我们讨论了当前关于 EDC 的化学品风险评估假设面临的挑战，我们认为监管机构需要解决这些挑战，才能真正保护公众健康。解决这些挑战有望导致双酚 A 以及最终具有已知不利影响的其他结构相似的双酚（称为令人遗憾的替代品）从欧盟和其他地方的所有食品相关用途和许多其他用途中被消除。 https://doi.org/10.1289/EHP13812。