The costly illusion of regulating unknowable risks

Area of Science:

• Toxicology
• Risk Assessment
• Regulatory Science

Background:

• Man-made toxic episodes necessitate regulation for substance safety, particularly for cancer-causing agents.
• Novel substances lack human use data, creating uncertainty in safety evaluations.
• Current regulatory practices rely on animal testing to predict human cancer risks.

Purpose of the Study:

• To critically evaluate the scientific validity of using animal tests for human cancer risk assessment.
• To highlight the limitations and challenges of extrapolating animal data to human populations.
• To propose a more rational and resource-efficient regulatory framework.

Main Methods:

• Analysis of the assumptions and biological/statistical differences inherent in animal-to-human extrapolation.
• Review of authoritative opinions, such as those from the National Academy of Sciences, on regulatory approaches.
• Examination of the economic burden imposed by current regulatory processes.

Main Results:

• Animal testing, filtered through numerous assumptions, fails to overcome insurmountable human/animal biological, exposure, and statistical differences.
• Authoritative scientific bodies have repeatedly found the regulatory approach lacking factual or scientific justification, deeming it arbitrary.
• The current regulatory process imposes a significant economic burden, exceeding total U.S. industrial after-tax profits.

Conclusions:

• The reliance on animal testing for human cancer risk assessment is scientifically unjustified and legally vulnerable.
• A more rational regulatory approach is needed, considering socio-economic utility and scientifically relevant human safety evidence.
• Reallocating resources towards evidence-based, human-relevant safety assessments would improve national resource utilization.