Pulse

By GCN Staff

Blog archive
lab testing (Shutterstock image)

Biotech advances may stress regulatory agencies

Federal agencies involved in regulation of biotechnology products should increase their scientific capabilities, tools and expertise to get ready for the expected wave of new products, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Regulating new biotechnology products that have not been evaluated by the current regulatory system -- such as genetically modified plants, engineered microbes and even insects -- will impact agencies that currently conduct evaluation and testing, the report said.

“The rate at which biotechnology products are introduced -- and the types of products -- are expected to significantly increase in the next five to 10 years, and federal agencies need to prepare for this growth,” said committee chair Richard Murray of the California Institute of Technology.

To prepare, the report suggests, agencies should:

  • Evaluate current risk-analysis approaches to determine those most appropriate for new products entering the regulatory system.
  • Create pilot projects that evaluate future product types as they move from laboratory scale, to field- or prototype-scale, to full-scale operation.
  • Review existing statutes to ensure adequate oversight will cover a wider range of biotechnology products.
  • Determine whether ethical, cultural and social implications should be factored into risk assessments.
  • Ensure staffing levels, expertise and resources are sufficient to address the expected scope and scale of future biotechnology products.
  • Establish appropriate federal funding levels for sustained, multiyear research to develop the necessary advances in regulatory science.

Overall, the federal government should develop a strategy that scans the horizon for new biotechnology products, identifying and prioritizing those products that are less familiar or that present a need for more complex risk analysis, the report said.

The study was sponsored by the Environmental Protection Agency, the Food and Drug Administration, and the Department of Agriculture.

Posted by GCN Staff on Mar 16, 2017 at 3:23 PM


Featured

  • Workforce
    By Mark Van Scyoc Royalty-free stock photo ID: 285175268

    OPM nominee plans focus on telework, IT, retirement

    Kiran Ahuja, a veteran of the Office of Personnel Management, told lawmakers that she thinks that the lack of consistent leadership in the top position at OPM has taken a toll on the ability of the agency to complete longer term IT modernization projects.

  • Defense
    Soldiers from the Old Guard test the second iteration of the Integrated Visual Augmentation System (IVAS) capability set during an exercise at Fort Belvoir, VA in Fall 2019. Photo by Courtney Bacon

    IVAS and the future of defense acquisition

    The Army’s Integrated Visual Augmentation System has been in the works for years, but the potentially multibillion deal could mark a paradigm shift in how the Defense Department buys and leverages technology.

Stay Connected