May 9, 2017

FDA Extends Comment Period on Genome Editing Tech for Plants and Animals

FDA
FDA Building 21 stands behind the sign at the campus's main entrance and houses the Center for Drug Evaluation and Research. https://commons.wikimedia.org/wiki/File:FDA_Sign_%26_Bldg_21_at_Entrance_(5204602349).jpg

The U.S. Food and Drugs Administration announced the extension of the comment period for two documents regarding genome editing techniques that are currently up for public comment. Initially closing on April 19, comments will now be accepted until June 19, 2017. The extension is the FDA’s response to numerous requests for additional time to comment, highlighting that the initial 90-day comment period did not allow sufficient time to develop meaningful responses to the questions in the notice.

The process was initially announced on January 19, when the FDA established a docket to receive comments on the use of genome editing techniques to produce new plant varieties used for human or animal food. The FDA provided a set of specific questions to help inform their thinking about food derived from new plant varieties produced with new genome editing techniques, as well as animals with genetically altered genomes through current high specificity editing techniques.

The agency’s crowdsourced search for scientific evidence and other factual information on their specific questions sheds a light on a new possible evolution of biotech regulation, where all involved parties might submit the evidence of their claims. This opens the door not only for academics but also for industrial level plant and animal developers, such as Oxitec or TAXA.

Oxitec’s Aedes aegypti strain is a particularly interesting case study for regulation compliance. The company’s self-limiting mosquitoes were designed to spread a lethal gene to dramatically cut down their population, and were released in Piracicaba, Brazil, on 2015. By the end of the year, larvae reduction was up to 82%. And yet, when the company proposed a test release in Florida after a nearly 5-year certification process with the FDA, it was met with controversy.

TAXA Biotechnologies develops ornamental plants through synthetic biology; more specifically, fragrant mosses that contain genes from other plants such as patchouli. Anthony Evans, CEO, mentioned to Science that he is concerned regarding the current possibilities for regulation. Small companies like Taxa, he says, could still be required to run multimillion-dollar safety assessments, even for plants with no risk of acting like weeds, since traits that are considered “well-understood” by regulators are only those developed and licensed by large firms up until now.

The FDA’s willingness to open up discussion in these topics highlights both the agency’s awareness of the need for a new evolution of the regulatory system, but also puts the spotlight on the plant and animal developer biotech companies, whom should take an active role in regulation by sharing their information and supporting their claims not only with the objective of receiving approval, but to help crowdsource a better understanding of new genome editing techniques and their impact on society.

If you are interested in contributing to the discussion, here is a quick summary of the questions:

Regarding New Plant Varieties Used for Food:

  1.       In what ways are the food safety risks associated with human and animal foods from genome edited plants the same as or different from those associated with other plant development methods?
  2.       Are there categories of genome edited plant varieties for which there are scientific basis to conclude that foods from such categories are unlikely to present food safety risks different from or greater than those for traditional plant breeding? Are there categories of genome edited plant varieties that can be said not to be different from traditionally-bred plants in terms of regulatory status? How can safety assessments of these possible categories be performed? Even if these categories don’t raise initial questions, should they still undergo a pre-market regulatory consultation?
  3.       Are there categories of genome edited plant varieties for which there are scientific basis to conclude that foods from these categories are more likely than traditionally-bred plants to present food safety risks?
  4.       What steps can the FDA take to help small firms to engage with the FDA about questions related to food safety and the regulatory status of foods from their new plant varieties?

Regarding Intentionally Altered Genomic DNA in Animals:

  1.       How should we refer to the animals in question? Previously, the term “genetically engineered” was the preferred one by the FDA, but the agency encourages comments and suggestions on other phrases that are accurate and inclusive to properly cover the deliberate modification of an organism’s characteristics by manipulating genetic material.
  2.       Is there existing empirical evidence demonstrating that certain types of genome editing may pose minimal risk? In this regard, are there categories of animals whose genomes have been intentionally altered for which specific empirical evidence indicates that there are no target animal, user safety, food safety or environmental risks? Are there categories where genome editing has been demonstrated to be durable on a genotypic and phenotypic level over the lifetime of a particular product? Is there evidence to demonstrate that there are degrees of introduced changes that are likely less riskier than others? Is there empirical evidence that indicates that the degree of taxonomic relationship between the introduced gene and the recipient animal influences the health of that recipient animal or the extent to which the trait is expressed?