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By GCN Staff

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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


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