By EMMA HOPKINS-O’BRIEN

Indiana Correspondent

GREENWOOD VILLAGE, Colo. — CoBank, part of the Farm Credit System, emphasized that gene-editing tools for agriculture will intensify in 2019, following a report from its Knowledge Exchange Division verifying the technology has the potential to be a game-changer.

“The low cost of gene-editing technologies position them as viable solutions to critical food system challenges,” said Crystal Carpenter, senior economist of specialty crops at CoBank.

Gene editing has a bright future in the ag industry. The latest in such technology, CRISPR (clustered regularly interspaced short palindromic repeats), is so far the cheapest method – and is also simpler, easier to use, and has fewer intellectual property restrictions than other gene-editing technologies.

The catch is that gene editing first must be accepted by consumers in a way genetically modified organisms (GMOs) were not. The difference between the technologies is that GMOs have had an outside gene introduced into them from another species, while gene-edited organisms have not. The resulting genetics of a gene-edited crop are some that could also be achieved in nature or through traditional breeding techniques.

Eric Williams, a partner in the Indianapolis office of Barnes & Thornburg LLP, recently presented his thoughts and knowledge on gene-editing at an Indiana Pork event. His practice is focused on counseling clients in the protection of intellectual property; in the case of gene editing, Williams said the U.S. regulation system should fare better than that of the European Union.

“Last year, the Court of Justice of the European Union ruled that plants created with gene-editing tech, such as CRISPR, must go through the same lengthy approval process as traditional transgenic plants, even those that don’t involve transferring genes between organisms,” he explained. “The ruling effectively killed CRISPR crop sales in Europe.”

Here, the USDA and U.S. Food and Drug Administration (FDA) have agreed to jointly review regulations for gene-editing technology, deciding USDA editing products do not require the same oversight as GMOs, but FDA-edited products do. The USDA will be responsible for regulating crop and food applications, while the FDA will regulate human and animal applications.

Carpenter said agricultural labor and water shortages, disease and chemical resistance, climate change, food waste, and food security are problems gene editing has the potential to alleviate, should the tech become widely accepted.

“These technologies do face potential challenges, particularly with consumer acceptance,” she said. “However, barring widespread rejection by consumers, gene editing will be a significant boon to producers, food and agriculture supply chains, and allied industries in the years ahead.”

As a potential billion-dollar industry, inventorship issues have arisen regarding CRISPR, according to Williams.

“Two different parties claim to be the inventor of CRISPR: Jennifer Doudna at the University of California-Berkley and Feng Zhang at the Broad Institute/MIT,” Williams said. “Zhang won inventorship in eukaryotic cells – the most lucrative application – and Doudna won inventorship of prokaryotic cells.”

There were also roadblocks to CRISPR patents. In 2017, Broad Institute and DuPont Pioneer agreed to create a joint licensing framework for the use of CRISPR in ag, and jointly provide non-exclusive licenses for use in commercial ag research and product developments.

For livestock specifically, Williams said gene editing has the potential to improve animal health, welfare, and production efficiency. In 2017, the FDA released draft guidance titled Regulation of Intentionally Altered Genomic DNA in Animals and requested public comment on the matter. Williams described the current status of animal gene editing regulation as “uncertain.”

“In general, the agency considers genomic alteration to meet the definition of a ‘new animal drug,’” he added. “Increased innovation will eventually reach a tipping point and will provide consumers with improved gene-edited products.”

In livestock, some improvements he mentioned are reductions in the frequency and severity of diseases such as porcine reproductive and respiratory syndrome and African swine fever in the pork industry, tuberculosis in the cattle industry, and improvement of animal welfare with hornless cattle, castration-free swine, and heat-tolerant livestock.

The possibilities seem endless, but Williams said it all depends on consumer acceptance. “There are real differences between GMOs and gene-edited products. We must embrace science and provide a clear message. That message starts with members of the industry like you,” he told Indiana Pork members.