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).

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.

A Challenging Diagnosis of Systemic Lupus Erythematosus with Status Epilepticus.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder of unknown pathogenesis. In SLE, the body's immune system mistakenly attacks healthy tissues and organs thereby involving multiple body systems including joints, skin, blood, brain, heart, and lungs. SLE has a wide variation in the symptoms, hence making the diagnosis more challenging at the time of initial presentation. Sometimes, the patient presents with Status epilepticus (SE) without prior history of epilepsy, as SE is common at the beginning in the course of SLE. In this report, there is a case showing correlation of seizures with SLE, without prior history of epilepsy. A 43-year-old female presented in the emergency department of the hospital with SE. Her previous medical and family history for epilepsy was unremarkable. The patient had high titers for positive anti-nuclear antibody (ANA), while other autoimmune workup was negative. A complete evaluation of the symptoms and investigations revealed that she met the criteria of American College of Rheumatology (ACR) for the diagnosis of SLE. Hence, physicians should be diligent with regards to the variations in the initial presentation and complications of SLE. With the advancement in treatment modalities of SLE, it can be managed successfully, if diagnosed early.

Localized seminal plasma protein hypersensitivity.

Human seminal plasma protein hypersensitivity is a rare disorder. Since the first case report in 1958, allergic reactions to semen have gone relatively unnoticed or improperly diagnosed. Dozens of medical case reports and research prove that allergy to seminal fluid is a legitimate health concern.