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Regulatory slowdown on GM crop decisions

Nature Biotechnology volume 24, pages 748–749 (2006)Cite this article

To the editor:

The speed of regulatory decision-making is an important constraint on the ability of industry to innovate and bring new products to market. To determine whether the US federal government's regulation of biotech crops has become more or less efficient and effective over time, I have analyzed eleven years of information from the US Food and Drug Administration (FDA) and the Animal and Plant Health Inspection Service (APHIS) of the US Department of Agriculture about genetically modified (GM) crops that have passed the mandatory or voluntary regulatory hurdles required before a crop can be commercialized in the United States. The analysis shows that the time it took each agency to reach a regulatory decision more than doubled in the past five years for no explainable reason (see Table 1). That trend should worry those who believe that genetic engineering can be used safely and can benefit farmers, consumers and the environment in the United States, other developed countries and developing countries. Public discourse is needed to understand what factors account for the trends and whether and how they can be reversed.

Table 1 Average number of months for US government review and decision on GM crops
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References

  1. Office of Science and Technology Policy (OSTP) Coordinated framework for regulation of biotechnology products. Fed Register 51, 23302 (1986).

  2. http://www.isb.vt.edu/cfdocs/biopetitions1.cfm

  3. http://www.cfsan.fda.gov/~Ird/biocon.html

  4. United States Department of Agriculture (USDA). Statement: USDA Creates New Biotechnology Unit (http://www.aphis.usda.gov/lpa/news/2002/08/bioreorg.html) August 2, 2002.

  5. United States Department of Agriculture (USDA). Animal and Plant Health Inspection Service (APHIS). Fed Register 69, 3271–3272 (2004).

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Authors and Affiliations

  1. Biotechnology Project, Center for Science in the Public Interest, 1875 Connecticut Ave., NW #300, Washington, 20009, DC, USA

    Gregory Jaffe

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  1. Gregory Jaffe
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Supplementary information

Supplementary Table 1

FDA Completed Voluntary Consultations for Biotech Crops (1995-2005).

Supplementary Table 2

Genetically Engineered Crop Petitions Approved by USDA for Non Regulated Status (1994-2005).

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Jaffe, G. Regulatory slowdown on GM crop decisions. Nat Biotechnol 24, 748–749 (2006). https://doi.org/10.1038/nbt0706-748

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