Trump Administration has opportunity to base biotech regulations on science, not fears

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At least when it comes to biotechnology, President Trump’s Executive Order of 20 January freezing recent regulations provides a chance to get industry regulations right.

As currently practiced, the regulatory system is functionally locked into the grossly overestimated potential for hazardous impacts perceived when the regulatory framework, titled “The CoordinatedFramework (CF) for the Regulation of Biotechnology,” was first implemented 30 years ago.

Dr. Nina Fedoroff (Doug Mills, New York Times

The CF was developed by the White House Office of Science and Technology Policy (OSTP). OSTP brought together representatives of the three federal agencies seeking to regulate commercial applications of biotechnology to develop this guidance document.

These were the Animal and Plant Health Inspection Service (APHIS) at the U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA).

The CF was written before we knew much about how organisms modified by the modern molecular methods (aka biotechnology) would be different from those modified by traditional methods when they came into use outside of laboratories. People worried a lot about unforeseen hazards, so the main objective of the CF was to find ways the new products could be captured for regulatory evaluation under existing statutes.

We now have had many decades of experience with biotechnology and the resulting genetically modified organisms (GMOs). We can say with confidence that no hazards have emerged that can be attributed to using biotechnology methods. Crops modified by such molecular methods have been in commercial production for two decades with no evidence of harm to either human health or the environment, according to a last year’s report from the National Academies of Sciences, Engineering and Medicine. Older overviews, including a 2010 report on a decade of EU-funded GMO research, have likewise failed to identify hazards unique to the use of the modern molecular modification techniques. By contrast, the economic and environmental benefits have been substantial.

So a restructuring of the regulations to reflect growing scientific evidence and experience was overdue. What makes this challenge especially urgent is recent rapid development of new genome editing techniques based on the CRISPR/Cas9 system and various composite enzymes, such as TALENS, that cleave double-stranded DNA at specific sequences. These can be used to create the same kinds of genetic changes (mutations) that underlie all of plant and animal domestication, blurring the distinction between natural mutations (not regulated), mutations induced by chemicals and radiation (not regulated) and mutations created by the new enzyme systems.

In 2015, President Obama requested a reexamination of the CF. The OSTP issued a memorandum to the heads of the Food and Drug Administration, the Environmental Protection Agency and the United States Department of Agriculture titled “Modernizing the Regulatory System for Biotechnology Products.” This initiated an interagency effort that was to include the objectives of “….reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.”

But that didn’t happen – and therein lies the opportunity. In late 2016, the interagency working group produced an update of the CF that – in many, many words – says which agency is responsible for which type of biotechnology product. It didn’t say anything about easing the regulatory burden in the light of evidence and experience.

And neither did the second document they produced, titled “National Strategy for Modernizing the Regulatory System for Biotechnology Products.” This one outlines ways the responsible agencies can learn about new technologies and how they can better inform the public – and potential product developers – what they need to do to comply with the regulations.

The devil, of course, is in the details – the rules – published in draft form in the Federal Register on January 19, 2017. In the new proposed rules, APHIS (the USDA’s Animal and Plant Health Inspection Service) acknowledged that experience had taught the agency that biotechnology methods do not produce plant pests, the fear of which was their original regulatory rationale. So they have come up with a new rationale, proposing to focus on the possibility that molecular genetic modification (GM) might produce noxious weeds.

That seems reasonable for plants that start out as noxious weeds, but makes no sense at all for plants that have long been domesticated and have lost their weediness. The proposed rules apply to all plants that have been modified by any of the modern molecular methods.

So what the USDA seems to be saying is that even though biotechnology hasn’t turned a crop plant into a plant pest, we now have to worry that any kind of genetic change might turn a non-weed into a weed. No evidence. Just concerns. What they give with one hand, they propose to take away with the other.

Then there is the FDA’s draft guidance for genetically modified animals. The FDA proposes to regulate all animals with “intentionally altered genomic DNA” as new animal drugs! That is, except certain GM mosquitoes, which they’re turning over to the EPA to regulate as pesticides.

So even if the genetic change produced by a modern method is exactly like one that occurs in
nature, the animal must be regulated. Take hornless cattle. There are hornless beef cattle, but not hornless dairy cattle. Since horns are dangerous, dairy cattle are physically dehorned, a painful process. Scientists have produced hornless dairy cows by using genome-editing technology to disrupting the same gene in dairy cattle that a spontaneous mutation disrupted in beef cattle. FDA’s proposed rules would make the gene-edited dairy cattle a new animal drug. How much sense does this make? What’s the likelihood of an animal-calssified-as-a-drug making its way through the approval process?

These rules were just published or are just being published as draft guidance, so they’re subject to President Trump’s Executive order titled “Regulatory Freeze Pending Review.  Might it be possible to go a step further and revamp the entire existing regulatory framework for agricultural and environmental biotechnology using the CRA (Congressional Review Act) and the new executive order mandating the revocation of two regulations for every new one adopted?

The scientific evidence of safety is in. Genetic modification by modern methods is as safe or safer than the still unregulated older methods, such as chemical and radiation mutagenesis, used for most of the last century. Existing regulations have protected us from nothing but our fears. Those fears may have been justifiable thirty years ago, but we now know them to be unjustified. Yet the original CF remains in place and is still applied only to organisms modified by biotechnology methods. This continues to cost millions of dollars, jobs, and opportunities to innovate.

The multi-million dollar cost of regulatory compliance is out-of-reach for public sector researchers and a crushing burden to private sector companies. And the time required to gain regulatory approval is outrageous. The FDA, for example, took more than a decade to approve the AquaBounty’s GM salmon and more than 7 years to approve the first trials of Oxitec’s GM mosquito (both companies are now subsidiaries of Intrexon).

Regulation must focus on the product, not the process by which it was created. And it’s time to regulate only real hazards, of which there is a small number. The vast majority of agricultural applications represent minor tweeks of well-known organisms, from grains, fruits and vegetables, to chickens, pigs and cows. These can easily be classified as GRAS (generally regarded at safe) and don’t need regulation.

Real regulatory reduction can substantially decrease the cost and time it takes to improve an agricultural organism through biotechnology. If done properly, it will unleash innovation and create jobs.  GM crops, animals and microorganisms can make – and already have made – critical contributions to expanding the world’s food supply. Best of all, they can do this biologically, decreasing agriculture’s environmental footprint and making it more sustainable.

This opinion piece was first published in shortened form on AgriPulse on February 6, 2017.

Dr. Nina Fedoroff,  Senior Science Advisor, OFW Law, Washington, DC and Evan Pugh Professor Emerita, Penn State University

  • Stuart M.

    Trump is a global warming denier and believes vaccines cause autism. I don’t think he will base any biotech regulations on science. Maybe on corporate solidarity, though…

    • Good4U

      Your snipe vs. ‘corporate’ entities is telling; it signals ingratitude, and repudiates the ‘corporate’ efforts which have kept you alive to date. If you don’t like ‘corporate’ things, take a short trip to places where they don’t exist, then come back (if you can) after a decade or so and tell us again how bad things here are.

      • Stuart M.

        Now, now, don’t go ballistic. My “snipe” was aimed squarely at Trump and other science deniers. It is unlikely he would base any loosening of restrictions on the biotech industry on scientific reasons. I was trying to say tongue in cheek that we can still hope his pro-corporate proclivities might make him friendlier to the biotech industry, an industry you know I have the utmost respect for and frequently defend against the Food Nazis. I try to judge corporations like I judge people, on their behavior. Some corporations do deserve criticism, others praise. Have a nice day.

        • Good4U

          I’m not a Trump supporter, neither a Hilliary one. But of the ‘corporate’ entities I hate the most are the Hollywood creators of fiction peddled as truth. You know, the ones who sell you theater tickets to movies that trick you into believing that corporations are entities to be despised, when in fact the “organic” corporations are the ones profiting from the erstwhile slant against biotech. I don’t really care where you stand on climate change (formerly called global warming), what’s your stance on the Food Nazis who impugn ‘corporations’ at the expense of human health and environmental integrity?

          • Stuart M.

            I will come right out and say that I think Monsanto is a wonderful company that is on the cutting edge of biotechnology. I am absolutely amazed at the clever things they have done to make farmers’ lives easier. Most of the hostility to Monsanto is still antipathy that most of the Left feels for Monsanto’s role during the Vietnam War. A lot of water has gone under the bridge since then, and Monsanto might just be the company that saves the world from famine and starvation as the population grows to 12 billion in the year 2100. Heck, all my retirement money is invested in corporations that are paying me dividends and capital gains, so I would be the last to harbor any ill will towards them. However, I think corporations like Volkswagen which intentionally circumvented pollution controls set by the US government are criminal and should be banned from the American market for 10 years.

          • Good4U

            No argument there! Have a good day.

  • Peter Peter

    I agree with Mr. Trump on his attitude to Autism; and I also think that we should be concerned about bio engineering of our foods, if that is the topic.
    A lot of times a gene from bacteria is used in that engineering; and as most immunologist know; the body generally/usually reacts to that as a bacterial invader. We also have more alliegeries today than ever. I do not know for sure however if there is a connection.
    On subject #1 re Autism (not suggesting a connection however i.e. new subject or topic)
    We also have more Autism since 1960 than ever before. Prior to that all we ever heard of was mental illnesses in adults; and of course that derogatory term no longer used, mental retardation; which is now incl in ASD, I would say.
    I worked at these things incl. with those previous children; and I was an approved CSLT; and a one time head certified General Medical lab technologist working in the various laboratories in a children hospital back in the 196sixties and seventies; and i have currently being researching these things for at least 7 years, longer than i ever intended. I think that Mr. Trump has a point when he wants an investigation into the cause of Autism; and I hope he will review and conglomerate all of the facts on Autism research as to me one of the big problem is that our strong attitude on genes as a cause is blinding us to other potential causes that were once considered but never researched; and as you know; no cause has ever being official;;y identified and or ever been research other than gene which are found abnormal after the fact i.e. after the illnesses. Everyday children are getting these disorders in spite of at least 50 years of genetic research only.

    • Good4U

      You really don’t know much (anything?) about transgenesis. The gene doesn’t come from a bacterium (your term ‘bacteria’ is the plural form of the term you are searching for). The bacterium is used simply as a vector for the gene coming from a different plant. The bacterium’s genes aren’t in the recipient organism. The bacterium itself is not in the recipient organism. The bacterium is killed after it does its gene transfer. Thus in humans or animals that consume the recipient plant there are no body reactions, or allergies, or autism, or anything such as your imaginary post implies. There’s simply nothing in the transformed plant to react to. You really should study up on the process of transgenesis before posting half baked visions that exist only in your head.

      • Peter Peter

        Thank you for your reply. I wasn’t really talking about transgenesis as i did not even know that they were doing that and thus was not familiar with the term. It is a good one; and now that i know that scientists are doing such a thing; I wonder why. What I was talking about is where they take one gene from a bacterium and engineer it to a plant; and thus that makes the plant more productive in what ever that gene does. So animal genes usually say produce more protein, fats and or carbohydrates more so than plants genes particularly when it comes to oil; and that was my understanding of genetic engineering; but you are absolutely right; it can be done in bacteria also by transferring genes from one to another; and that will, be passed on to the offspring. Bacteria i think do that naturally any way i think because single cell organism and or virus mutate easily; but I can see why they would do it with food; however i did not realize that they had done it with so many foods until I read/scanned that article; and so my comment was meant to say with so many foods like that, maybe that is why we have different things and maybe it even somehow cause autism or anything else but I never meant to suggest it as i do not think it do except maybe it does with a scattered case because they have found associations with several things including toxics pollutions etc ; but none of the associations are near sufficient to be the cause. Many people think it is vaccines but once again it doesn’t seems to be enough associations to come close; but i do not even know how they evaluate and decide. I would like to and then I could even discus it;, It is interesting. i enjoy discussing and learning and it is never to late.

        Thanks again for your discussion; Love to hear more; and even any other comments that tell me that I am wrong on what i said above. Thanks again; have a good one; and regardless of what anyone says; I hope that they ‘do not delete it; because sometime they do delete mine, sometime too long, etc.and i enjoy all discussions particularly on SIDS, Autism, ASD, mental illnesses, dementias, psychology, mind development etc.. particularly in infants, babies, the toddlers and young child; and i do think that all of these conditions are preventable; however I still love other discussions also.

        • Good4U

          Likewise, and I also appreciate your careful reading and response. Keep up your good work and attentiveness to the subject of ADHD (autism) and other afflictions, not only of humans but of animals and the environment. You will be a good, objective, and valuable contributor to good decision making for the benefit of human health and integrity of the environment. Good day.