FDA extends public comment period on genetically engineered foods and animals… post your comments here

Monday, May 29, 2017 by

The U.S. Food and Drug Administration (FDA) has extended its Request for Comment period on genome edited foods and animals. The move aims to continue gaining public input on the draft revised guidance about the agency’s stance on human and animal foods derived from plants that have undergone genome editing. The federal agency has also extended the comment period for the draft guidance regarding the regulation of intentionally-engineered genomic DNA in animals. The FDA’s recent action was in response to requests for additional time to submit comments. The comment periods for the two draft guidance will close on June 19, 2017.

The two draft guidance were originally released in January, which discuss the steps that the federal agency takes to clarify how it regulates specific biotechnology products. The recent announcements were in line with the federal agency’s commitments highlighted in the “National Strategy for Modernizing the Regulatory System for Biotechnology Products” issued in September last year. The document aims to ensure that the FDA is efficiently equipped to evaluate any risks associated with future biotechnology products.

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FDA outlines pros, cons of genome-editing technology

In its blog the FDA Voice, the federal agency outlined that recent scientific innovations have led to the development of more efficient and precise methods in modifying plant, animal, and microorganism genomes to produce ideal traits. According to the FDA, these genome editing technologies were relatively easy to use, and may have extensive applications to a wide range of sectors including the medical, food and environmental industries. The federal agency also noted that genome-editing technologies may have potential use in the introduction, removal, or replacement of one or more specific nucleotides at a specific region in the organism’s genome. According to the agency, a number of research are currently at work to determine how genome-editing technologies can be applied to the following:

  • Treatment of  HIV, cancer, or rare medical conditions
  • Control or modify organisms that carry infectious diseases such as Zika-bearing mosquitoes and lyme disease-causing mice
  • Enhance the health and welfare of animals that produce food
  • Modify specific characteristics of food plants or fungi

However, the federal agency also stressed on the potential risks associated with genome editing technologies. According to the FDA, the risks include the technology’s effects on individual genomes, and its potential impact on the environment and ecosystem.

“Accompanying the enthusiasm about these promising technologies are questions about whether FDA is prepared to ensure the safety of regulated products that use this technology. Providing appropriate and balanced regulatory oversight for applications involving an emerging technology is not a new or unique challenge for FDA, but the potential breadth of applications and the fundamental nature of altering the genome call for the participation of multiple constituencies in considering the most effective regulatory policies to address any potential risks…Genome editing applications are relevant to three main FDA-regulated product classes. The specific regulatory approaches for each of these classes vary, reflecting differences in underlying statutory authorities. FDA is maintaining a product-focused, science-based regulatory policy, in accordance with specific legal standards applicable to each type of product and consistent with overarching U.S. Government policy principles,” the FDA blog read.
In 2015, the FDA has collaborated with a number of other federal agencies —  including the White House Office of Science and Technology Policy, the U.S. Environmental Protection Agency and the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service — in an initiative meant to ensure public confidence towards the regulatory system that oversees biotechnology products. The collaborative effort also aimed to enhance the said system’s transparency, coordination and efficiency.
Sources include:

IFT.org

Blogs.FDA.gov

FederalRegister.gov



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