Gaps, Inexperience, Inconsistencies, and Overlaps: Crisis in the Regulation of Genetically Modified Plants and Animals

92 Pages Posted: 8 Aug 2003 Last revised: 19 Nov 2012

See all articles by Gregory N. Mandel

Gregory N. Mandel

Temple University - James E. Beasley School of Law

Date Written: May 6, 2011


The regulation of genetically modified products pursuant to statutes enacted decades prior to the advent of biotechnology has led to a system that is passive rather than proactive about risks, that has difficulty adapting to biotechnology advances, and that is highly fractured and inefficient - genetically modified 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 the downside risks of biotechnology and introduce numerous inefficiencies into the regulatory system. These risks and inefficiencies include gaps in regulation, duplicative and inconsistent regulation, unnecessary regulatory expenses, regulatory agencies acting outside of their areas of expertise, and unnecessary increases in the cost of and delay in the development and commercialization of new biotechnology products. These deficiencies also result in a further risk: the failure to properly regulate biotechnology has led to unnecessary scares, which in turn cause a public over-reaction against biotechnology products, preventing society from fully optimizing its potential benefits.

With science and society poised to soar from first-generation biotechnology focused on crops genetically modified for agricultural benefits to next-generation developments including nutrient-enriched foods, transgenic animals, and pharmaceutical-producing plants, it is necessary to establish a comprehensive, efficient, scientifically rigorous regulatory system at this juncture in order to maximize social welfare. This article details the steps necessary to achieve this result through fixing the deficiencies in and risks created by the current regulatory structure. Ignoring many details for the moment, the solutions can be summarized in two categories. First, statutory and regulatory gaps that are identified must be filled with new legislation and regulation. Second, regulation of genetically modified products should be shifted from a haphazard model based on statutes not intended to cover biotechnology to a regulatory system based upon each agency's expertise in handling particular types of risks.

Keywords: genetically modified, genetic modification, genetically engineered, genetic engineering, transgenic, biotechnology, pharmaceutical-producing, pharming, regulation, regulatory, regulatory agencies, human health, environment, starlink, monarch butterfly, prodigene, coordinated framework, FDA, EPA

JEL Classification: I18, K2, K20, K23, K32, O13, Q18, Q2, Q20

Suggested Citation

Mandel, Gregory, Gaps, Inexperience, Inconsistencies, and Overlaps: Crisis in the Regulation of Genetically Modified Plants and Animals (May 6, 2011). William & Mary Law Review, Vol. 45, p. 2167, 2004, Available at SSRN: or

Gregory Mandel (Contact Author)

Temple University - James E. Beasley School of Law ( email )

1719 N. Broad Street
Philadelphia, PA 19122
United States
(215) 204-2381 (Phone)

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