Ethical tensions in regulation of agricultural biotechnology and their impact on policy outcomes: evidence from the USA and India.

Abstract

Abstract This chapter uses the USA and India as case examples to analyse how ethical tensions arise related to agricultural biotechnology policy and how institutional framework and domestic politics address these ethical tensions and contribute to divergence in regulatory policy outcomes. It is shown, for example, that because the US regulatory system is relatively centralized (operating through three main federal regulatory agencies), and because it provides a mechanism for public comment, the system is less susceptible to external political influence than the system in India, which consists of a complicated hierarchical structure with statutory bodies at state and federal levels and provides little opportunity for public comments. Hence, regulatory decision making in the USA is effective and predictable, at least compared with the system in India, which is complex and uncertain. However, the centralized regulatory approach in the USA creates a unique ethical tension that is less evident in India. While social and economic concerns can be raised in regulatory decision making in the USA, they rarely make their way into final rules, which largely reflect risk-based concerns about potential harm to human health and the environment. In contrast, social justice concerns can become dominant in the policy discourse and influence the regulatory outcomes in India.