The EU Continues Its Unscientific, Anti-Innovation Regulation of Genetic Engineering

By Henry I. Miller, MS, MD — Apr 16, 2024
Over millennia, there has been a seamless continuum of technologies for genetic modification of plants, animals, and microorganisms, with progressive improvements in precision and predictability -- a fact that seems to have escaped the notice of EU politicians and regulators.

Humans have practiced genetic modification, or genetic engineering (GE), of plants and animals through selection and breeding for more than 10,000 years. It’s called agriculture.

During the last half-century, newer, molecular GE techniques have been used to modify plants, animals, bacteria, and other organisms. Scientists can move desired genes virtually at will from one organism into another or alter genes with great precision, with or without introducing genetic material from other organisms. 

These newer techniques for genetic modification have created significant breakthroughs in medicine, such as the production of blockbuster drugs and techniques for human gene therapy to treat cancer and genetic diseases. In agriculture, the benefits include more nutritious food, disease-, pest—and drought-resistant plants, less use of chemical pesticides, and higher yields that conserve water and reduce the land needed for farming.

During the last decade, “gene editing” technology via techniques like CRISPR (“clustered regularly interspaced short palindromic repeats") has further refined genetic engineering’s precision, compared to recombinant DNA technology, which has been around for a half-century. Adapted for use in the laboratory from naturally occurring genome editing systems found in bacteria, gene editing is quickly becoming the preferred method of breeding.

In 2018, the U.S., Canada, and 11 other nations, including Argentina, Australia, and Brazil, issued a joint statement supporting agricultural applications of precision biotechnology—that is, gene editing—asserting that governments should avoid arbitrary and unjustified distinctions between end products derived from precision biotechnology and similar end products obtained through other production methods.

That recommendation is derived from our basic understanding that the nature of an organism’s risk is a function of qualities such as toxicity, pathogenicity, and invasiveness, not the process, if any, of genetic modification.  (Moreover, if there are differences, they derive from the fact that because the molecular techniques for genetic engineering are more precise and  predictable, assessments of risk are easier and more – not less – reliable.)

Despite these verities, the European Parliament is planning yet again to arbitrarily and illogically impose more stringent regulation on most products of gene editing. They have just proposed a new law – i.e., regulations -- for organisms commonly dubbed “new genetic technologies,” or NGTs:

The proposal covers plants that contain genetic material from the same plant (targeted mutagenesis) or from crossable plants (cisgenesis, including intragenesis); transgenic plants (which contain genetic material from non-crossable species) will remain subject to the GMO legislation as it stands today.

("GMO" is essentially synonymous with an organism modified with recombinant DNA technology.)

Bureaucrats like to invent new, meaningless pseudo-categories to justify discriminatory treatment—in this case, excessive regulation.

They claim that the objective is to make the food system more sustainable and resilient by developing improved plant varieties that are climate-resilient, pest-resistant, higher-yielding, or require fewer fertilizers and pesticides. However, excessive regulation will not achieve that, and European politics and regulatory foot-dragging will ensure that these objectives are not met.

The new proposal creates even more new, meaningless pseudo-categories that would be subject to disparate regulation, but we would emphasize that the various methods of modification are distinctions without meaningful differences and are irrelevant to risk or risk assessment.

These categories all use “site-directed nucleases” (SDNs) to make genetic modifications. The EU proposal creates two different categories and two sets of rules for NGT plants. NGT-1 plants, which are considered equivalent to conventional (that is, more “natural”) ones, would be exempted from the onerous requirements of the GMO legislation, whereas NGT-2 plants would still be subject to the stricter requirements. (As noted above, “GMO,” or genetically modified organism, is yet another meaningless pseudo-category of genetic engineering, which uses recombinant DNA technology. Despite its greater precision and predictability than conventional breeding technologies, it has been far more stringently regulated and, in some countries, even banned.)

If this all seems confusing, it is – and it all stems from the failure of some legislators and regulators to recognize that there is a seamless continuum of genetic modification or engineering, and that the use of one technology or another is not a determinant of risk (except that the molecular techniques are more precise and predictable).

Because SDN-1 and SDN-2 modifications do not involve the introduction of any foreign DNA and are considered equivalent to conventional breeding, eighteen countries would regulate them like “conventional” or “natural” crops.

Back to the fallacies and shortcomings of the EU’s new pseudo-categories…

The proposal’s first sleight of hand is to separate SDN-1 from SDN-2 (neither of which involves the introduction of foreign DNA). By placing SDN-2 in the NGT-2 category, it ensures that full GMO restrictions will be applied to most gene-edited products. 

Next, they claim that new risk assessments of NGT-2 plants will be accelerated, but only while respecting the Precautionary Principle (PP). This bogus “principle” dictates that every new technology must be proven safe before it can be used. An ounce of prevention is certainly desirable, but because nothing can be proved totally safe — at least, not to the standard demanded by anti-technology activists and legislators — the                Precautionary Principle creates prodigious obstacles to the development of new products. In over 25 years, the EU has deemed exactly one transgenic crop acceptable for cultivation while they have proliferated elsewhere with great commercial success (and no safety problems). Citing the Precautionary Principle, Europe has blocked all the hundreds of other transgenic crop varieties. 

In short, the PP is not fit for the purpose of policy development.

The EU proposal will retain mandatory labeling of products from both NGT-1 and NGT-2 plants, although in most products, gene editing is undetectable, and the only way to ensure accurate labeling would be expensive (and superfluous) tracking of every gene-edited product through the entire food system. (That would be rather like requiring labeling to indicate on which day of the week a plant was cultivated.) Non-EU countries adopting gene editing with minimal or no specific regulations will not comply with this requirement.

The proposal also states that NGT plants should remain prohibited in organic production, as their compatibility supposedly requires further consideration.  Aside from the obvious problem of detection, there has never been a documented case of harm from consuming food derived from transgenic crops (plants that contain genetic material from different, unrelated sources), yet these crops have been banned from organic agriculture for over 25 years. There is no reason to believe the organic lobby will change their position on the newest, most precise breeding methods.

Next, the European politicians want to amend the limits on the size and number of modifications allowable for an NGT plant to be considered equivalent to conventional plants. This brings up an important point – the continuum of genetic modification techniques.  Research sponsored by the EU’s own European Food Safety Authority (EFSA) has been very clear:

The (random) unintended mutational load of CRISPR-Cas9 genome edited plants is much smaller in comparison to conventional mutation breeding methods,..For SDN-2 and SDN-3, the consequence of an off-target mutation will probably be the same as for SDN-1…EFSA Opinion on SDN-3, the GMO Panel concluded that the off-target mutations induced by the application of SDN-3 approaches are fewer than those occurring when applying conventional mutagenesis techniques that  have been used previously and have a long history of safe use.

Even arbitrarily splitting SDN-1(NGT 1) from SDN-2 and SDN-3 (NGT 2) does not change the conclusions of the EFSA about safety related to off-target mutations.  But now, at the request of the French Health Safety Agency, the EU parliament has once again directed the EFSA to evaluate the safety of gene editing.  The EFSA has already done at least three reports on the safety of gene editing (NGTs).  There is no scientific reason for another. 

For decades, European politicians have implemented some of the most unscientific, arbitrary, and restrictive policies toward recombinant DNA technology, even though, as long ago as 2011, the European Commission released a report that concluded:

The main conclusion to be drawn from the efforts of more than 130 research projects, covering a period of more than 25 years of research, and involving more than 500 independent research groups, is that biotechnology, and in particular GMOs, are not per se more risky than conventional plant breeding technologies.

In other words, they endorsed the concept of the seamless continuum of techniques for genetic modification but have consistently ignored it in policymaking.

The most recent, highly restrictive NGT proposal barely passed with just over 50% of the votes. If the science had been followed and applied in a way similar to that of an ever-growing number of countries outside of Europe, any new NGT agriculture policy would have zero chance of gaining the two-thirds majority needed to become law.

The question for boosting needed future food production is, should Europe forego the best technologies in favor of biodynamic, regenerative, organic, or other buzzword, feel-good approaches that incur increased costs, lower yields, and greater risks to human health and the environment?  The European Parliament’s complete disregard of science and track record concerning NGTs show that EU politicians apparently think so.

Rob Wager is a retired scientist from Vancouver Island University, but he continues his work as a researcher on genetically engineered crops. Find him on X @RobertWager1

Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. He was the founding director of the FDA’s Office of Biotechnology. Find him on X @HenryIMiller

Henry I. Miller, MS, MD

Henry I. Miller, MS, MD, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. His research focuses on public policy toward science, technology, and medicine, encompassing a number of areas, including pharmaceutical development, genetic engineering, models for regulatory reform, precision medicine, and the emergence of new viral diseases. Dr. Miller served for fifteen years at the US Food and Drug Administration (FDA) in a number of posts, including as the founding director of the Office of Biotechnology.

Recent articles by this author:
ACSH relies on donors like you. If you enjoy our work, please contribute.

Make your tax-deductible gift today!



Popular articles