Lessons for a SECURE Future: Evaluating Diversity in Crop Biotechnology Across Regulatory Regimes

Area of Science:

• Agricultural Biotechnology
• Genetics and Genomics
• Regulatory Science

Background:

• The U.S. implemented the SECURE rule to regulate next-generation crops, aiming to diversify agricultural biotechnology innovation.
• Proponents theorize SECURE will expand regulatory exemptions, increasing variety in traits, genes, organisms, and developers.
• Limited data-driven studies exist on how past regulatory pathways affected crop biotechnology diversity.

Purpose of the Study:

• Analyze 30 years of regulatory submission data to understand historical diversification trends in crop biotechnology.
• Forecast the potential impact of the new SECURE regulations on future diversification trends.
• Provide an empirical basis for data-driven analysis of regulatory outcomes in biotechnology.

Main Methods:

• Utilized 30 years of historical regulatory submission data for crop biotechnology.
• Analyzed diversification trends across different regulatory pathways.
• Applied empirical methods to forecast the impact of the SECURE rule.

Main Results:

• Crop biotechnology diversity does not follow a single trajectory dictated by regulatory shifts.
• The SECURE rule's outcomes may be more varied and potentially restrictive than anticipated, despite expanded exemption categories.
• The role of confidential business information in past and future biotechnology regulation was reviewed.

Conclusions:

• Regulatory shifts in agricultural biotechnology do not guarantee increased diversity.
• Future outcomes of the SECURE rule warrant careful monitoring for potential restrictive impacts.
• An empirical approach is crucial for understanding the complex interplay between regulation and innovation in crop biotechnology.