TY - JOUR
T1 - 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)
AU - Vom Saal, Frederick S.
AU - Antoniou, Michael
AU - Belcher, Scott M.
AU - Bergman, Ake
AU - Bhandari, Ramji K.
AU - Birnbaum, Linda S.
AU - Cohen, Aly
AU - Collins, Terrence J.
AU - Demeneix, Barbara
AU - Fine, Anne Marie
AU - Flaws, Jodi A.
AU - Gayrard, Veronique
AU - Goodson, William H.
AU - Gore, Andrea C.
AU - Heindel, Jerrold J.
AU - Hunt, Patricia A.
AU - Iguchi, Taisen
AU - Kassotis, Christopher D.
AU - Kortenkamp, Andreas
AU - Mesnage, Robin
AU - Muncke, Jane
AU - Myers, John Peterson
AU - Nadal, Angel
AU - Newbold, Retha R.
AU - Padmanabhan, Vasantha
AU - Palanza, Paola
AU - Palma, Zandra
AU - Parmigiani, Stefano
AU - Patrick, Lyn
AU - Prins, Gail S.
AU - Rosenfeld, Cheryl S.
AU - Skakkebaek, Niels E.
AU - Sonnenschein, Carlos
AU - Soto, Ana M.
AU - Swan, Shanna H.
AU - Taylor, Julia A.
AU - Toutain, Pierre Louis
AU - von Hippel, Frank A.
AU - Welshons, Wade V.
AU - Zalko, Daniel
AU - Zoeller, R. Thomas
N1 - Publisher Copyright:
© 2024, Public Health Services, US Dept of Health and Human Services. All rights reserved.
PY - 2024/4
Y1 - 2024/4
N2 - BACKGROUND: The European Food Safety Authority (EFSA) recommended lowering their estimated tolerable daily intake (TDI) for bisphenol A (BPA) 20,000-fold to 0:2ng/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) non-guideline 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.
AB - BACKGROUND: The European Food Safety Authority (EFSA) recommended lowering their estimated tolerable daily intake (TDI) for bisphenol A (BPA) 20,000-fold to 0:2ng/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) non-guideline 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.
UR - http://www.scopus.com/inward/record.url?scp=85190322676&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85190322676&partnerID=8YFLogxK
U2 - 10.1289/EHP13812
DO - 10.1289/EHP13812
M3 - Comment/debate
C2 - 38592230
AN - SCOPUS:85190322676
SN - 0091-6765
VL - 132
JO - Environmental health perspectives
JF - Environmental health perspectives
IS - 4
ER -