Now, maybe you are not worried about China. It's true, they are rather terrible in science. They learn by rote, which is why their kids beat ours on standardized tests, but when it comes to creativity America is number one. But how will we continue to be number one if it takes 19 years to approve moving a gene from one salmon to another salmon? Even flowers have to be destroyed if there is no market big enough to justify going through a decade of government bureaucracy and hearings about Frankenpetunias.
Just before the inauguration, the Obama administration produced some new USDA guidelines for how to streamline approval for food products and the public comment period just closed. Writing in the Chicago Tribune, I considered the updates needed. After all, we have been using agrobacterium, "nature's genetic engineer", for 110 years ago to prevent disease in plants naturally. Why is government still acting like agrobacterium mediated transfer is still a big deal?
The Coordinated Framework for the Regulation of Biotechnology was passed in 1986 and then slightly modified in 1992. It mandates approval for anything that can be deemed a new food technology to three government bureaucracies: EPA, USDA and FDA. EPA regulates anything to do with pesticides, while USDA governs plant health and FDA has control over food safety. USDA proposed changes that would mandate approval based on risk to the environment and human health - not just because they have been genetically modified.
Yes, please.
Not so fast when it comes to FDA, says Dr. Henry Miller, now of the Hoover Institution but formerly founding director of the FDA's Office of Biotechnology. He and John J. Cohrssen, Counsel to the White House working groups that established the policy, say the new "midnight regulations" pushed out by the Obama administration at the end of his term are seriously flawed on both scientific and organizational grounds.
The reason is because they don't honor the intent of the 1986 framework. Well, that is true. But leaving in awful rules because the new ones are not perfect isn't an approach. Maybe he knows something I don't, but I've had no indications that President Trump is going to throw them all out entirely. In a comment on the FDA site he wrote (bold mine)
That framework, deliberately indifferent towards the technology or process used to create the product, makes clear that the "Exercise of oversight in the scope of discretion afforded by statute should be based on the risk posed by the introduction and should not turn on the fact that an organism has been modified by a particular process or technique ... (O)versight will be exercised only where the risk posed by the introduction is unreasonable, that is, when the value of the reduction in risk obtained by additional oversight is greater than the cost thereby imposed" (Office of Science and Technology Policy (OSTP), 1992). This suggests that U.S. government agencies will only exercise regulatory authority over organisms — plants, animals and others — based on the risks they pose, irrespective of the breeding technique or technology used to produce them, and that that regulatory authority will be applied only when the risk posed is unreasonable. "Unreasonable risk" is clarified to mean the cost of regulatory oversight is not greater than the reduction in risk gained by that oversight.
Which would be fine, except the 1986 and 1992 versions don't do that at all. What we are left with is 19-year approvals that cost nearly $40 million. That is a lot of money for a small company that wants to do innovation.
Dr. Miller argues that other groups will be better suited to approval, and that may be a fine point.
Hank Campbell is the President of the American Council on Science and Health.
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