Comments to the European Commission Regarding Regulation of Plants Produced With “New Genomic Techniques”

The Information Technology Innovation Foundation (ITIF) submitted comments to the European Commission in response to a public consultation for its regulatory initiative covering products of “new genomic techniques” (NGTs).

Issue Background

Gene editing via CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) burst onto the world stage barely a decade ago, but it has massively disrupted and rearranged the innovation landscape. Rendering genetic improvements more quickly, easily, and far reaching than ever before thought feasible, the technology has been rapidly applied in almost every imaginable field of human endeavor, but no place more beneficially than in agriculture. Keen to harness the potential without unleashing undue harms, people and governments around the world have devoted considerable energy to the challenges of hazard identification and risk assessment.

Just as with recombinant DNA technologies (aka “GMOs”) regulators have failed to identify any novel hazards. Instead, all those flagged to date are similar to issues with which we are familiar from thousands of years of history domesticating and improving agricultural crops, livestock, and microbes, This has heightened the desire of many to avoid repeating the mistakes some governments made by imposing new regulatory regimes for such innovations; regulations that added nothing to human safety or environmental sustainability, delivering little more than unnecessary delays, heightened costs, and perpetuating imprudent reliance on obsolete technologies.

Many in the European Union have been particularly intent on avoiding repetition of their disastrous approach to regulating GMOs, the results of which have been uniformly and profoundly negative both in its impacts on Europe and wherever it has been emulated around the world. The European Commission has solicited public comment on how this might be accomplished, but the Commission’s survey instrument indicates European policymakers have missed key lessons from their experience regulating GMOs and are headed in the wrong direction.

Summary of ITIF’s Comments to the Commission

The European Union’s regulatory reform envisioned in this solicitation of public input is narrow and procrustean where it should be expansive, timid where it should be confident, and contemptuous of accumulated experience and science when it should build on them to correct a regulatory regime widely derided, especially by European scientists, as unjustified, and not fit for purpose. (See commentary by the European Academies’ Science Council on regulation of genome-edited plants and the UK Advisory Committee on Releases into the Environment’s (ACRE) reports, “Why a modern understanding of genomes demonstrates the need for a new regulatory system for GMOs” and “Towards a more effective approach to environmental risk assessment of GM crops under current EU legislation.”) It thus squanders the best opportunity in a generation to re-shape its regulatory regime into one that would advance human and environmental safety and encourage and enable innovations fit for the future and the challenges facing Europe and the world.

The suggested EU GMO legislation for plants produced by targeted mutagenesis and cisgenesis is unscientific, lacks a supporting basis in data or experience, and provides no utility in considering how to ensure safety of innovations produced with new (developed since 1992) genetic techniques. The current regulations have not improved food safety or the environmental sustainability of agricultural production. They have prolonged the use of obsolete and inefficient technologies w/ negative impacts on environmental sustainability and food safety vs. results with crops and foods improved through biotechnology. The existing legislation should be entirely set aside and completely abandoned as any basis for moving forward with NGTs.

Condemnations of the existing EU regulatory regime for GMOs have been widespread. Scientific and policy bodies in the EU and around the world have condemned it for decades and the opportunity costs and environmental damage have been considerable. Its best use is as an example to be shunned.

The current EU regulations on “GMOs” in agriculture have not improved food safety or the environmental sustainability of agricultural production. They have, however, prolonged the use of obsolete and inefficient technologies with negative impacts on environmental sustainability and food safety vs. the results seen with the use of crops and foods improved through biotechnology. The existing legislation should be entirely set aside and completely abandoned as any basis for moving forward with NGTs.

Any putative positive consequences from the proposed new regulations for NGTs (new genomic technologies) are purely illusory, serving only to delude the uninformed they are thus protected from hazards no different than those seen with other genetic improvement methods or entirely imaginary. Decades of experience confirm "GMOs" are as safe as or safer than innovations developed with other methods, and there is no justification or benefit from singling them out for unusually onerous regulatory oversight.

The negative consequences of such unwarranted regulation are abundant. The EU GMO regulations disincentivize innovation and have prolonged reliance on obsolete technologies that are less sustainable, less productive, more profligate in the generation of greenhouse gases, and less economical, thus depressing the entire European agricultural industry and negatively impacting the global environment. The burdens have caused modern biotechnology as applied to agriculture largely to flee the European continent with dramatic negative consequences for economic growth, brain drain, European competitiveness, and environmental sustainability.

Since no novel or unique hazards have been identified for NGT products vs those familiar from centuries of experience w/ older forms of genetic modification, there is no justification for a regulatory regime which singles out NGTs for extra scrutiny. The first two options listed in the EU survey instrument under B4 lack any justification in science or experience.

The fourth bullet provides the least bad option. In no case has EFSA identified novel or unique hazards associated with GMOs or products of NGTS that would justify regulatory regimes singling them out for regulation beyond what is applied to the products of conventional breeding. It is long past time for the EU to incorporate the approach it is required to adopt under the World Trade Organization Sanitary and Phytosanitary agreement (WTO/SPS) and International Plant Protection Convention (IPPC) to implement measures for safety assurance of these products that align with the internationally agreed standards laid out therein. The EUs present GMO regulations and proposed approach to devising a system for NGTs demonstrates a contempt for the rule of law as well as science and common sense.

Experience with GMOS has confirmed large benefits to food safety, environmental sustainability, and economic growth, most of which has accrued to the benefit of smallholders in developing countries. (See: Wilhelm Klümper and Matin Qaim, “A Meta-Analysis of the Impacts of Genetically Modified Crops,” PLoS One. 2014 Nov 3;9(11):e111629; Graham Brookes and Peter Barfoot, “GM crop technology use 1996-2018: farm income and production impacts,” GM Crops and Food, 11:4, 242-261; Brookes and Barfoot, “Environmental impacts of genetically modified (GM) crop use 1996–2018: impacts on pesticide use and carbon emissions,” GM Crops and Food, 11:4, 215-241; International Service for the Acquisition of Agri-biotech Applications, “Global Status of Commercialized Biotech/GM Crops: 2019,” ISAAA Brief No. 55.)

The survey asks what provisions should be incorporated into new NGT regulations to incentive innovations beneficial to sustainability. The primary purpose of regulation is to ensure safety. Regulations tainted by encrusting provisions designed to serve other objectives do not enhance safety and undermine public confidence in the regulations, as the EU experience with GMO legislation has shown. Non safety related objectives should be pursued by policies outside the realm of regulation for safety assurance. How many times must this experiment produce the same unhappy result for it finally to be heeded by the Commission?

The demonstrated potential contributions to sustainability of GMO and NGT product traits reveal no need for new legislation on plants produced by targeted mutagenesis or cisgenesis. Given the absence of novel or unique hazards, risks that arise will be familiar from experience with conventional plant breeding. History has shown the methods of safety assurance there applied are sufficient to deliver very high levels of safety.

The “best incentives to encourage the development of plant products of targeted mutagenesis or cisgenesis with traits contributing to sustainability” would be none of the proposals listed in the survey instrument. They would follow from a regulatory system focused on identifying actual hazards and building on experience/science to apply rational methods of risk assessment as a basis for scientifically defensible measures for risk management/mitigation. This process would start with a regulatory trigger focused on identified, actual hazards rather than an evidence-free presupposition of hazard triggered without foundation by the arbitrary stigmatizing of specific techniques against all evidence and experience, as in the present proposals and the existing EU regulatory scheme.

As far as sharing information with consumers and the public, transparency should be the rule. But general information should not be mandated to appear on labels. Information mandated for labels should be limited to that directly relevant to nutrition, or food safety, e.g., the presence of allergens.

Measures such as those suggested in B10 would impose complicated and costly logistical burdens without delivering any improvement to safety or sustainability, nor any information useful to consumers. They cannot be justified under any rational standard.

In the absence of any purpose or effect related to safety assurance or improved sustainability, there is no justification for any labeling, traceability, or other required measures that would stigmatize NGTs simply because they are less archaic than exempted methods of genetic improvement/production. There are no such requirements for products of radiation or chemical mutagenesis, or random/natural cosmic rays and errors in DNA replication and repair. Why then would they be helpful in enhancing safety for GMO/NGT products? Such measures serve only superstition and neophobia, and would violate science, common sense, and EU treaty obligations under WTO/SPS and the IPPC.

The legislative problem here is less a lack of legal clarity than a complete lack of scientific coherence. The present EU regulatory regime stigmatizes innovative products with no justification in science or experience. To impose regulatory burdens on new products based on nothing but their inception date is a system driven by neophobic superstition. Such systems are especially ill-considered and counterproductive given the challenges presently facing society and should be jettisoned ASAP.

None of the measures outlined in section B should be employed to enhance co-existence between the use of NGTs and any other methods of genetic improvement, modern or archaic. The practice of agriculture is not a public good deeded exclusively to organic growers. If organic growers wish to reap a premium price for products brought to market according to a particular dogma they should bear the costs and burdens of adhering to such dogma. They have no moral right to impose their costs of production onto others growing safe and sustainable products, and society should not subsidize or favor them, particularly in light of their inferiority in terms of safety and sustainability compared to other production methods. Pastoral nostalgia is not a defensible basis for agricultural policy.

New legislation should be adopted to facilitate access to targeted mutagenesis or cisgenesis/plant genetic resources that would prohibit discrimination against their use until and unless novel and unique hazards can be shown to be present in their products. If and when that occurs, regulations applied must be fit-for-purpose, i.e., they should be proportional, and no more burdensome than necessary to manage or mitigate unacceptable levels of risk. This would, of course, properly require setting aside the existing EU legislation and Directives.

Any legislation in this sphere should be required to ensure there are no regulatory burdens placed on innovators without the prior confirmation of a hazard likely to lead to unacceptable levels of risk unless managed. Risk management/mitigation measures should be proportional, and no more burdensome than required to reduce unacceptable risks to acceptable levels.