Winding Path to Market: Regulators Attempt to Clarify Genetic Engineering Products

New industries and new products evolve rapidly, naturally raising questions on how to classify them. This is especially true with genetically engineered organisms. This relatively young industry that has created thousands of new potential products that regulators must classify.

In an attempt to smooth genetically engineered products’ path to market, the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) are in the process of issuing a series of draft notices outlining the regulatory journey such products must undertake. This action has produced mixed sentiments from biotech firms, because it could simplify the process for some products while complicating it for others. It may also mean seemingly similar products will be regulated differently.

For example, the FDA has issued a ruling that all “new animal drugs,” gene editing tools that alter the function of part of an animal’s body, must undergo pre-market review and testing. The biotech company Recombinetics, which plans to prevent the need for cattle to undergo a painful de-horning process by splicing in a gene that prevents horn growth, would fall under this category, meaning that their cow would be regulated differently than one that was bred to be hornless. The milk, consequently, from these cows can no longer be automatically marketed as “generally recognized as safe,” affecting how consumers see it despite not being substantively different than milk from another cow.

Oxitech, meanwhile, expects to benefit from a FDA ruling on its product, a strain of mosquitoes with a gene designed to reduce the population of its species carrying the Zika virus. According to the FDA, the firm’s controversial product will be classified as a pesticide, changing the agency which has regulatory authority over the product. Now it falls under the purview of EPA, and the company plans to move ahead with a test site in the U.S.

Ultimately, products such as these have the potential to improve the lives of consumers if they receive access to the market. Regulations should seek the right balance between market expediency and safety.

For more information, read the article from Science or the White House’s Coordinated Framework for the Regulation of Biotechnology.

Copyright for image: Photographer Credit, Stock Photo, License Summary.

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