By PAUL HETZLER
A North Country biotechnology startup has been granted provisional approval for a patent to genetically modify Escherichia coli bacteria for the manufacture of medical-grade compounds. Cell Signals, LLC, based in Depeyster, NY, plans to break ground on an addition to its facility in the spring of 2018. The new research and manufacturing space, which will more than triple its production capacity, will be equipped with a state-of-the-art research lab as well as a two-story heated warehouse space with batch-process reactor vats. It is anticipated that as many as six full-time jobs will be added.
The first modification of E. coli was made by Dr. Herbert Boyer at a University of California facility in 1978 to produce synthetic human insulin, a process that was approved by the US Food and Drug Administration in 1982. Since then, it has become common to modify E. coli and other organisms to make life-saving drugs like interferon, a treatment for multiple sclerosis, leukemia, and many types of cancer. Human growth hormone, Hepatitis C vaccine, and other medicines are also made in this way.
For the past five years, Cell Signals has been using modified E. coli bacteria to make ascorbic acid (vitamin C) and acetic acid (vinegar) for food-service and industrial applications. When its new equipment comes online, however, it will be able to make a broad spectrum of chemicals for the pharmaceutical industry on a highly flexible, as-needed basis. While this is seen as a positive development by many, it has generated some criticism. Perhaps the most controversial product on its patent is synthetic Milk of Human Kindness.
Currently the dairy industry is lobbying for strict labeling regulations on use of the term “milk.” Beverages made from soy, almond, cashew and rice have been marketed as milk, a fact which has gotten under the skin of dairy proponents. Should they succeed in regulating what can and cannot be called milk, it is not known how that could affect the sale of Milk of Human Kindness.
Not surprisingly, critics of genetically modified (GM) crops and foods are also opposed to the new Cell Signals initiative. To be fair, there is no consensus in the scientific world on the overall safety of GM products, unlike the case with climate change, where 98 percent of scientists acknowledge both its existence and its genesis. In the lead article in its March 2015 issue, National Geographic concludes with the statement that the “long-term health and ecological consequences [of GM products] are unknown.”
What is surprising, though, are harsh words from places which normally champion GM products. Responding to a sidebar in The Wall Street Journal that mentioned Cell Signals’ intentions, a background source at The Cato Institute, a right-wing think tank, said “We can’t have cheap Milk of Human Kindness flooding the market. Compassion is a rare commodity, and we should keep it that way. What if someone added it to the food supply? We might get people starting to feel happy against their wishes. It could be a dangerous situation; I don’t think the FDA thought this through.”
For its part, the FDA has stated that “There is no statistically significant difference between genetically modified and unmodified ascorbic acid, acetic acid, or Milk of Human Kindness in any of the parameters normally used to characterize those products.”
Wishing you a happy April Fools’ Day, and an abundance of Milk of Human Kindness.
Paul Hetzler is a forester and Cornell Cooperative Extension of St. Lawrence County horticulture and natural resources educator.
