title: Gaps, inexperience, inconsistencies, and overlaps: crisis in the regulation of genetically modified plants and animals.
abstract: The regulation of genetically modified products pursuant to statutes enacted decades prior to the advent of biotechnology has created a regulatory system that is passive rather than proactive about risks, has difficulty adapting to biotechnology advances, and is highly fractured and inefficient--transgenic plants and animals are governed by at least twelve different statutes and five different agencies or services. The deficiencies resulting from this piecemeal approach to regulation unnecessarily expose society and the environment to adverse risks of biotechnology and introduce numerous inefficiencies into the regulatory system. These risks and inefficiencies include gaps in regulation, duplicative and inconsistent regulation, unnecessary increases in the cost of and delay in the development and commercialization of new biotechnology products. These deficiencies also increase the risk of further unnecessary biotechnology scares, which may cause public overreaction against biotechnology products, preventing the maximization of social welfare. With science and society poised to soar from first-generation biotechnology (focused on crops modified for agricultural benefit), to next-generation developments (including transgenic fish, insects, and livestock, and pharmaceutical-producing and industrial compound-producing plants and animals), it is necessary to establish a comprehensive, efficient, and scientifically rigorous regulatory system. This Article details how to achieve such a result through fixing the deficiencies in, and risks created by, the current regulatory structure. Ignoring many details, the solutions can be summarized in two categories. First, statutory and regulatory gaps that are identified must be closed with new legislation and regulation. Second, regulation of genetically modified products must be shifted from a haphazard model based on statutes not intended to cover biotechnology to a system based upon agency expertise in handling particular types of risks.
authors.affiliation: Albany Law School, USA.
authors.forename: Gregory N
authors.initials: GN
authors.lastname: Mandal
mesh_terms: D000818:Animals; D030801:Animals, Genetically Modified; D001709:Biotechnology / Q000331:legislation & jurisprudence* / Q000592:standards*; D035082:Federal Government; D033161:Government Regulation; D030821:Plants, Genetically Modified; D018570:Risk Assessment; D014481:United States; D016885:United States Department of Agriculture; D014484:United States Environmental Protection Agency; D014486:United States Food and Drug Administration