New Biotech Products: Federal Agencies May Not be Ready – DTN

    Dr. Chor Tee Tan, a Texas A&M AgriLife Research associate research scientist in Amarillo, prepares KASP assays. Photo: Kay Ledbetter, Texas A&M AgriLife.

    New biotechnology products may attempt to enter the market in the next decade at a breakneck pace, but federal regulatory agencies may not be ready to keep up, according to a National Academies of Sciences (NAS) report released on Thursday.  

    The NAS committee that authored the report spent the past year or so reviewing new biotech techniques, such as gene editing and gene drives (a technique to make a desired genetic trait become dominant within a population).

    Gene editing techniques in particular are expected to be significant players in the next generation of biotech agricultural products. Already, DuPont Pioneer is in the process of commercializing a waxy corn hybrid produced by a popular new gene-editing technique called CRISPR-Cas9.

    “The scale, scope, complexity, and tempo of biotechnology products are likely to increase in the next five to 10 years,” the NAS report concluded. “Many products will be similar to existing biotechnology products, but they may be created through new processes, and some products may be wholly unlike products that exist today.”

    The report, “Preparing for Future Products of Biotechnology,” was produced by a team of 12 scientists and was peer reviewed by 17 independent scientists before its release.


    The NAS report offered a number of recommendations to address the expected growth of the biotechnology industry.

    Chief among those was a suggestion to create “a single point of entry” into the regulatory system in order to best handle the coming wave of biotech products.

    One of the study’s authors, Richard Murray, a professor of control and dynamical systems and bioengineering at the California Institute of Technology, said the single-point concept will be critical, along with expanded investments by federal agencies on the biotech front.

    “A single point of entry might enable federal agencies to decide early in the product development cycle which [regulatory] authorities are relevant,” he said during a webinar announcing the study results.

    Currently, the existing regulatory system for biotechnology is “complex and fragmented, resulting in a system that can be difficult for individuals, nontraditional organizations, and small- and medium-size enterprises to navigate,” the report stated.

    As a result, it might cause “uncertainty and a lack of predictability” for developers of future biotechnology products, and could lead to “potential for loss of public confidence” in regulation of future biotechnology products.

    The authors also fretted about staffing levels, expertise and resources available in federal agencies relevant to future biotechnology, and said they “may not be sufficient to handle the expected scope and scale of future” biotech products.


    The committee offered 3 main recommendations regarding biotechnology regulation.

    First, it recommended that federal regulatory agencies ramp up scientific capabilities, tools and expertise in key areas of expected biotechnology growth, including natural, regulatory and social sciences.

    Second, the committee called for increased investments in internal and external research by federal agencies, as well as their use of pilot projects that would improve their own ecological risk assessments and benefits analyses of future biotech products.

    “The National Science Foundation, the Department of Defense, the Department of Energy, the National Institute of Standards and Technology and other agencies that fund biotechnology research that has the potential to lead to new biotechnology products should increase their investments in regulatory science and link research and education activities to regulatory science activities,” the authors concluded.

    So far, very few of the biotechnology techniques mentioned in the report have hit the market. However, last year, USDA set a precedent on one such technique — gene editing — by announcing that it would not regulate a Pioneer corn hybrid produced by CRISPR-Cas9.

    The agency’s decision hinged on the fact that no new genetic material from a separate organism was inserted into the plant genome, such as happens in older biotech products, such as Bt corn hybrids.

    This announcement raised broader questions about how federal agencies including the U.S. Environmental Protection Agency and the Food and Drug Administration should foster what is expected to be a biotechnology explosion in the next decade — questions this NAS report has aimed to answer.

    Read the full report here:…

    Todd Neeley can be reached at

    Follow him on Twitter @toddneeleyDTN

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