Think This is Biotech Regulatory Relief? Not Yet.

By Dr. Nina Fedoroff, as published in Agri-Pulse

USDA and FDA proposals to regulate genetically engineered (GE) plants and animals following the recent update of the regulatory framework are on their websites awaiting public comment by June 19, 2017.  The documents on which comments are requested are long, dense and, at times, internally inconsistent.  Here’s a detailed analysis of these proposals.

My purpose here is to boil the key issues down to two pages. First, is this regulatory relief?

In place since 1986, the Coordinated Framework for the Regulation of Biotechnology specified that organisms modified by modern biotechnology methods should be regulated based on their characteristics, not on the method by which they were modified. (This is pretty obvious, if you think about it.  It’s like saying a pure chemical is what it is regardless of how it was produced.)

But in practice, ONLY organisms modified by biotechnology methods have been regulated under the Framework.  We have now had 30 years of field experience with GE organisms, primarily in agriculture.

There is no evidence that using biotech methods to modify organisms is hazardous.  Based on a thorough review of the scientific evidence, the US National Academy of Sciences 2016 report concludes that the GE crops on the market today are just as safe as their non-GE counterparts.

Moreover, the USDA’s Animal and Plant Health Inspection Service (APHIS), which regulates GE organisms, has issued 18,000 authorizations for environmental release of GE organisms, roughly 12,000 each authorizations for importation and interstate movement, and 124 determinations of non-regulated status. Based on this experience, APHIS has concluded that using GE techniques does not produce organisms that present a plant pest risk, even when the added DNA is from a plant pest.

But instead of easing the regulatory burden by simply complying with the original framework’s dictate to regulate GE organisms based on their characteristics, not on the method by which they were modified, the USDA stands the framework on its head by creating a new category of regulated organism modified by “genetic engineering.” By this, APHIS means “techniques that use recombinant or synthetic nucleic acids with the intent to create or alter a genome.” This proposal institutionalizes regulation based on process, not product.  Or guilty until proven innocent.

Ah, you were perhaps misled by APHIS’ proposal to exclude GE organisms if they could be produced using what they view as “traditional breeding techniques” or “chemical or radiation-based mutagenesis.”  Also excluded are organisms to which a “naturally occurring nucleic acid sequences from a sexually compatible relative” has been added.  But, that doesn’t mean you get to make that decision. 

APHIS will decide, based on a “Request for Evaluation or Reevaluation,” the requirements for which are to be found here.  Watch out for GE plants that have “a plant/trait combination that the Agency has not yet evaluated for plant pest and/or noxious weed risk” or if they contain DNA from an organism that has pathogenic or weedy relatives.  These will be regulated.  That is, APHIS is proposing to extend its regulatory mandate to “weediness,” even though noxious weeds are already regulated.  And they propose to continue regulating plant pest-derived DNA, despite the above-cited conclusion.

What should the Trump Administration do to unsnarl this mess?  It should instruct APHIS to set aside its current proposal and, with input from the scientific community, compose a list of traits that are problematic.  Remember, it’s the trait that matters, not the method used to introduce it.  Then, they should be instructed to identify regulations, such as the Plant Protection Act, under which the traits are already regulated or, if a new trait is deemed to pose an identifiable risk that isn’t already covered, to develop management methods proportional to the risk.

Then there’s the FDA, which proposes to regulate “animals whose genomes have been intentionally altered using modern molecular technologies” as “new animal drugs.”  Worse yet, each genomic alteration would be regulated separately as a new a new animal drug.  Worst of all, “both the founder animal in which the initial alteration event occurred and the entire subsequent lineage of animals” derived from the founder would be subject to regulation.

How irrational is this?  Here’s an example.  There are hornless beef cattle, but no hornless dairy cattle, so they’re mechanically de-horned.  The gene inactivated in the hornless beef cattle has been identified and disrupted in dairy cattle using modern gene-editing methods.  Why should these dairy cattle be regulated? Genetic dehorning is painless, mechanical dehorning is painful.

And how long would it take to get this “new animal drug” approved? Well, it took 20 years for the FDA to approve a genetically modified salmon that is identical to wild salmon, but grows to market weight in half the time, making it economically feasible to farm in environmentally sustainable closed facilities.  It took 7 years for the FDA to approve even a small test of a genetically modified mosquito capable of rapidly reducing wild mosquito populations to levels that can’t sustain transmission of diseases like Zika and dengue.

What should the Trump administration do to focus the FDA on real hazards? They should direct the FDA, in consultation with the scientific community, to identify traits that pose real hazards in the food supply. And they should require the FDA to confine regulation to such traits.  This might, in turn, lead to delegation of primary responsibility for regulation to other agencies, as the FDA has recently done by handing off the GE mosquito to the EPA in view of its pesticidal properties. 

The bottom line is that it’s the new or modified trait that’s important, not the process by which it was introduced. It’s time to stop regulating biotechnology as if it’s hazardous.  It isn’t. And the newest biotechnology methods, such as gene editing, hold unprecedented promise for adapting agriculture to a warming climate, protecting it from diseases and pests, and making it environmentally sustainable.

What you can do is to let the USDA and FDA know how important it is to relieve the regulatory stranglehold on biotechnology. The ability of agriculture to feed a global population fast approaching 10 billion depends on the ability of agricultural scientists to use the best science available. 

The deadline for comments is Monday, June 19thHere is where you should enter you comments on the USDA proposal.  Here is where you submit comments on the FDA proposal.

About the Author: Dr. Nina Fedoroff is a molecular geneticist.  She serves as Senior Science Advisor to OFW Law, on science and policy issues associated with the use of modern molecular methods, including recombinant DNA (rDNA) techniques, for the improvement of agricultural plants, animals and microorganisms. She is an Evan Pugh Professor Emerita at Penn State University.

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