The need for strategic development of safety sciences

Area of Science:

• Chemical safety assessment
• Regulatory science
• Risk management

Background:

• Current substance regulation in the US and Europe follows divergent paths: risk-based (US) vs. precautionary (Europe).
• Existing international regulatory tools have evolved incrementally, creating a fragmented approach.
• Strategic scientific development for regulatory application, termed Safety Science, is lagging in Europe compared to the US.

Purpose of the Study:

• To provide a rationale for establishing a European Safety Sciences Institute (ESSI).
• To align with EU missions and political priorities for better legislative implementation.
• To address the need for enhanced scientific approaches in chemical risk assessment and regulation.

Main Methods:

• Analysis of current regulatory practices in the US and Europe.
• Review of strategic reports and initiatives from US agencies (National Academies, NIH, EPA, FDA).
• Examination of emerging European initiatives (EFSA, ECHA, EU-ToxRisk).

Main Results:

• A significant gap exists in Europe regarding strategic development in Safety Science compared to the US.
• The proposed ESSI would create a coordinated European effort analogous to the US 'triple alliance' (EPA, NIH, FDA).
• Establishing ESSI aligns with the European Commission's agenda for effective implementation of existing legislation.

Conclusions:

• A European Safety Sciences Institute (ESSI) is crucial for advancing regulatory science and harmonizing chemical safety assessment.
• ESSI can foster a more proactive and scientifically robust approach to regulation in Europe.
• The institute's structure and functions can be modeled after successful US regulatory science initiatives.