Research & Commentary: NEPA Requirement Reform and the ‘Stanford Model’

Published March 25, 2011

Agricultural gene-splicing has increased crop yields, reduced the need for environmentally harmful pesticides and herbicides, and decreased food costs for consumers. New gene-spliced crops are reviewed by the Animal and Plant Health Inspection Service (APHIS), a division of the U.S. Department of Agriculture, which considers their expected environmental impact. Under the National Environmental Protection Act (NEPA), APHIS must prepare an environmental assessment if the risk is negligible, or an environmental impact study if it is greater.

The latter type of study is costly and time-consuming, and the former is regularly challenged in court by environmental groups as inadequate. In discriminating against gene-splicing techniques, the regulatory process increases manufacturers’ costs, enables long and costly legal battles, and slows innovation. A gene-spliced herbicide/insect-resistant crop costs as much as $15 million in regulatory compliance costs, several times greater than for other crops of similar risk.

There is no demonstrated risk inherent to gene-splicing technology. Only two varieties of these crops have been denied approval, and these were on procedural matters, not scientific evidence of harm or risk. In 1987 the National Academy of Sciences stated genetically modified products should not be subjected “to special, discriminatory government regulation.” The organization’s report concluded that “there is no evidence that unique hazards exist … in the use of R-DNA [gene-splicing] techniques.”

Reforming the approval process would save millions of dollars in legal fees and promote innovation and efficiency in crop production. APHIS should be removed from the process by eliminating the legal requirement of appeasing NEPA. A much less burdensome approach called the Stanford Model has been adopted by the National Institutes of Health and Centers for Disease Control. Hoover Institution fellow Henry I. Miller, founding director of the FDA’s Office of Biotechnology, says the Stanford Model would “assess risks of new agricultural introductions – whether or not the organisms are genetically engineered, and independent of the genetic modification techniques employed.”

The following documents offer additional information on regulation of genetically modified crops.

The Rush to Condemn Genetically Modified Crops
Henry I. Miller, a fellow at the Hoover Institution and founding director of the FDA’s Office of Biotechnology, contends the antagonism toward biotechnology has created unnecessary legal battles and harmed consumers.

NEPA’s Effect on Farmers
This blog post from the Southern Farmers Network considers the current regulatory regime imposed on gene-spliced crop varieties. The author, Gary Baise, concludes, “It is time for Congress to amend NEPA and follow the advice of the scientists, not the regulators.”

The Regulation of Agricultural Biotechnology: Science Shows a Better Way
Henry I. Miller contends increased regulation on a product shown to be safe, especially when that product is advantageous for the national and international food supply and economy, is wrongheaded and damaging: “Instead of regulatory scrutiny that is proportional to risk, the degree of oversight is actually inversely proportional to risk.”

GM Crops: The Global Economic and Environmental Impact – The First Nine Years, 1996–2004
Graham Brookes and Peter Barfoot, economists at PG Economics, studied the first full-scale use of GM crops. Their conclusion: “There have been substantial economic benefits at the farm level, amounting to a cumulative total of $27 billion. GM technology has also resulted in 172 million kg less pesticide use by growers and a 14% reduction in the environmental footprint associated with pesticide use.”

Introduction of Recombinant DNA-Engineered Organisms in the Environment: Key Issues
This white paper by the National Academy of Sciences (1987) offers guidance to regulators on how to proceed as R-DNA crops become more prevalent. The scientists conclude there are no unique risks involved in the R-DNA process, and they advise regulators to create no discriminatory regulations on this technology.

Estimating the Global Economic Effects of GMOs
This study conducted by the U.S. Naval Academy and the International Food Policy Research Institute examines the economic effects of gene-modified foods. Using econometrics, the team creates several scenarios and examines economic impacts likely with each. It finds that the global advantage of adopting GM technologies is as much as $12 billion.

Benefits and Risks of Food Biotechnology
The California Council on Risk and Regulation says science supports a risk-based regulatory system, but politics has created an unnecessary pseudo-controversy over gene-splicing technologies: “The science is clear. The public policy implications of continuing to apply flawed regulatory paradigms are clear. … Risk-based approaches to regulatory oversight are available.”

New Study Finds Genetically Engineered Crops Could Play a Role in Sustainable Agriculture
This Science Daily article highlights a series of studies of the environmental impact of gene-spliced crops. The studies found that gene-splicing has a positive net impact on the environment and can help the sustainable farming movement.

Agricultural Biotechnology: Overregulated and Underappreciated
This article from Issues in Science and Technology by Henry Miller and Gregory Conko makes the case that unfounded fear and excessive regulation of gene-spliced crops are detrimental in several ways. The authors write, “the pursuit of an integrated action plan, including regulatory reform, will help the United States and the world reap enormous benefits that are now thwarted.”

For further information on this subject, visit the Environment & Climate News Web site at or The Heartland Institute‘s Web site at

Nothing in this message is intended to influence the passage of legislation, and it does not necessarily represent the views of The Heartland Institute. If you have any questions about this issue or Heartland’s work on environment issues, contact Legislative Specialist Marc Oestreich at 312/377-4000 or [email protected].