This excellent new volume edited by Chris Wozniak and Alan McHughen maps in considerable detail the legal and institutional terrain governing agricultural biotechnology regulation in both the United States and Canada. Most of the chapter authors are either regulators themselves or academic specialists comfortable with the legal and technical thinking of regulators. If you want to learn how GMO crops – and animals – are seen by regulators in the United States and Canada, and also by some of the applicants for regulatory approval, this is the book to read.
B.F. Johnson Professor of Political Science, Robert Paarlberg
Wellesley College, Adjunct Professor of Public Policy
Harvard Kennedy School
Regulation of Agricultural Biotechnology: The United States and Canada
Chris A. Wozniak • Alan McHughen
Editors
Preface
" A book on Agricultural Biotechnology regulations? That seems oxymoronic." At first thought, perhaps it is. After all, a published book is as permanent as regulations are fleeting. Once a book is printed, any errors or omissions, even simple typos, are there for readers to spot and chuckle over for years to come.
In contrast, regulations can and do change quickly. It would take a virtual blog to keep up with the barrage of regulatory changes, considering the multitude of statutes, agencies and departments involved, not to mention the policy calls which influence the direction of oversight as well as enforcement and compliance matters.
So, knowing that regulations are subject to such rapid modification, why would anyone endeavor to compile a book on regulations – Why would anyone buy one – when the permanent book is destined to be out of date before the ink is dry?
While it is true that the minutia of regulations do evolve rapidly, the underpinning supports for the regulations do not. Regulations governing agricultural biotechnology in the USA, Canada, and, for that matter, even those of the European Union are founded on unmoving monoliths, essentially unchanged over the quarter century since the first products of the technology were developed. Scientific and regulatory analyses of the safety issues surrounding rDNA as applied to food and agriculture date back to the early and mid-1980s, including those from the Organisation for Economic Cooperation and Development (OECD 1982), US National Academies of Science (NAS 1983, 1987), US Office of Science and Technology Policy (OSTP 1986), and the Canadian Agricultural Research Council (CARC) in 1988. These scientific analyses were hypothetical and predictive, as they were conducted, for the most part, prior to actual field trial experience with genetically engineered plants, which only started in 1987–1988. In this respect, those studies have been remarkably prophetic, as the findings and recommendations have largely borne out with time and experience.
In this volume we strive to present and describe the underlying concepts supporting the US and Canadian regulatory structures, less so on the ephemeral, minute details. To that end we contacted authorities from US and Canadian government agencies, industry and academia to share their expertise so readers can benefit from their collective diverse perspectives in describing our regulatory structures. With the regulatory conceptual framework thus provided, specific details may then be acquired from the various agency websites.
It is important to keep in mind that authors of the chapters contained in this volume are writing from their own perspective, which may be that of a government regulator, academic researcher, industry scientist, attorney or program administrator. It is this mix of viewpoints, some contrasting and some in harmony, which makes this compilation intriguing and historical. While the regulatory system for biotechnology in agriculture has often been perceived as static in nature and in flexible (i.e. written in stone!), this is far from the truth. In addition to the dry matter of regulations and statutes, you will find helpful information to aid in navigating the system, an indication of some of the potential pitfalls of those traversing the gauntlet of biotechnology regulation and suggestions on what can be done to improve this dynamic system.
Wozniak and McHughen
@ Regulation of Agricultural Biotechnology: The United States and Canada:
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