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FDA proposing to update food gene-edit guidelines
 
By KEVIN WALKER
Michigan Correspondent
 
 WASHINGTON, D.C. — The American Soybean Assoc. (ASA) and other groups are evaluating two proposals from the U.S. Food and Drug Administration (FDA) that relate to genetically modified (GMO) animals as well as plants.
 
Some 30 years ago the federal government developed a Coordinated Framework on how to address the rise of biotechnology.

 According to an announcement from the White House just before the changeover in administration this year, a planned update to the 1980s-era Coordinated Framework for the Regulation of Biotechnology represents the first time in 30 years that the government has produced a comprehensive summary of the roles and responsibilities of the three principal regulatory agencies, with respect to regulating biotechnology products.
 
Those are the FDA, USDA and EPA. The two proposals are a part of this goal to update the regulations. They originate from the FDA and pertain to the regulation of GMO animals and plants, with each being a separate proposal.
 
After requests from the ASA and others in the agriculture industry, the FDA agreed to extend comment periods for the two proposed regulations, which were proposed Jan. 19. The old deadline for comments was April 19, but has been extended to June 19.
 
The first is a request for information on genome editing in new plant varieties used for foods; it seeks input on safety risks associated with foods derived from gene-edited crops.
 
The second is draft guidance on regulation of intentionally altered genomic DNA in animals, which extends the scope of FDA authority to include gene-edited animals. Both proposals have been extended to coincide with a comment deadline for another, related proposal having to do with GMO mosquitoes for use in for mosquito control. According to the ASA, it and other stakeholders need additional time to thoroughly review all the documents and take a more coordinated approach to public comments.
 
The proposals are somewhat connected because they’re both about plants and animals that people consume as food. Renee Munasifi, regulatory affairs manager at the ASA, noted there’s an additional layer of complexity to the situation due to the change in presidential administration.
 
She also made a distinction between products that are genetically modified or GMO, in which a gene from another species is inserted into a plant or animal; and a situation in which DNA from the plant or animal is somehow altered without any foreign DNA inserted into the host. The latter technique is referred to as gene editing. 
 
As an example, Munasifi pointed to a new technology called CRISPR-Cas9. According to a webpage managed by the Wellcome Genome Campus in Cambridge, United Kingdom, CRISPR-Cas9 is a unique technology enabling geneticists and medical researchers to edit parts of the genome by removing, adding or altering sections of the DNA sequence.

 The site calls CRISPR-Cas9 the simplest, most versatile and precise method  of genetic manipulation to date. CRISPR- Cas9 is also stated to be far less expensive than more traditional methods of genetic manipulation.
 
In one public comment, The American Assoc. of Bovine Practitioners (AABP) wrote that technologies such as CRISPR- Cas9 have “significant useful applications to livestock welfare, disease resistance and productivity of animal agriculture.” 
 
However, it also stated it does not support any regulation requiring each specific intentional genome alteration to be considered a new animal drug subject to new animal drug approval requirements. Such a regulation would be “flawed,” AABP said. In another letter, the Florida Department of Agriculture stated the proposal on genome-altered animals does not contain any guidance regarding genetically engineered animals imported into the United States. Any regulation should stipulate that someone wanting to bring such an animal into the country should have to apply for a new animal drug or investigational new animal drug.

 More information about the two proposals, including public comments, can be found at the top of search results by searching with the terms “proposal FDA-2008-D-0394” and “proposal FDA-2016-N-4389” on Google. 
5/11/2017