How should gene-edited crops be regulated? National Academies meeting seeks answers

On Monday, April 18 the National Academies of Sciences, Engineering, and Medicine are holding their first meeting to consider the regulation of future biotechnology products, including gene-edited crops.  The meeting comes only days after the USDA announced it will not regulate a mushroom gene-edited using CRISPR/Cas9. The White House announced last year that the 1992 Coordinated Framework for the Regulation of Biotechnology is in need of updating, and the NAS committee’s report is likely to play an important role in what future regulation will look like.

GENeS previously collected comments about the CRISPR-edited mushroom, before the USDA announced its decision not to regulate.

 

Dr. Wayne Parrott, Professor, Department of Crop & Soil Sciences, University of Georgia (webpage):

Expertise: Plant breeding and genomics, gene transfer systems for value-added traits in soybean, alfalfa and peanut

On the Coordinated Framework for Biotechnology Regulation and outlook for future regulation:

“The Coordinated Framework is way past its prime.  The FDA component of it is the only truly functional part left.  Any regulation based on process rather than product makes about as much sense as saying that food cooked on a gas stove needs to be regulated but that food cooked on an electric stove does not.  On top of that, ‘Genetic Modification’ is a very artificial concept with little biological relevance as used in regulations around the world.  The result has been a global quagmire of regulations that have stifled small enterprise, forced the formation of large multinationals, kept innovation away from consumers, and created the perception that some plants are somehow riskier than others.

“It is also not appropriate to talk about about gene-editing as if it is one process.  When gene editing is used to mimic what happens in nature or to replicate procedures with a long history of safe use, it is counterproductive to try and regulate them for the reasons mentioned above.  In other words, risk comes with a product, not how the product is obtained.  Therefore, switching to a product-based regulatory system is the only way cover everything from new techniques to synthetic biology, without having to write any new regulations.  Otherwise, technology and products will always run ahead of regulations, as we are seeing now.”

In response to the approval of the gene-edited mushroom:

“They could have done the same thing using X-rays or other radiation, and nobody would have cared, because there is no safety issue.  It is high time to focus on the product, not how it was achieved. So, hooray for APHIS for taking the only scientifically defensible action.”

 

Dr. Joyce Van Eck, Assistant Professor, Boyce Thompson Institute (webpage):

Expertise: Biotechnological approaches to the study of gene function and crop improvement. Dr. Van Eck has used CRISPR in her research on tomatoes.

On the Coordinated Framework for Biotechnology Regulation and outlook for future regulation:

“The technology for genome editing has evolved faster than the regulatory framework for evaluation of material generated through targeted approaches for crop improvement or what is sometimes referred to as precision breeding.  This is especially true for the CRISPR-Cas9 technology, which saw a meteoric rise in adoption for making targeted mutations after the first reports were published.  Overall, I would like to see the regulatory process for all crop improvement approaches be based on evaluation of the end products and not be overly scrutinized based on the process used for development.

“I hope the new regulatory structure will be similar to the five steps outlined in the Nature Genetics article by Huang et al. (2016) with a focus on evaluation of the products and not the methods used to develop them.”

In response to the approval of the gene-edited mushroom:

“This is very exciting news indeed that APHIS regulation was waved for the gene-edited button mushroom!  It will help pave the way for release of other CRISPR-Cas9 genome edited food crops.  Plus, it gives other researchers in this area hope that their efforts on crop improvement with this approach actually have a chance to come to fruition.”

 

Dr. Megan J. Palmer, Senior Research Scholar and William J. Perry Fellow in International Security, Center for International Security and Cooperation (CISAC), Stanford University (webpage):

Expertise: Societal aspects of biotechnology; biotechnology policy and practices; biological safety, security, and governance

“The National Academies Study on “The Future of Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System” is an important step in ensuring the development of biotechnology in the public interest.

“Biotechnology is increasingly important to our national and international prosperity and security (see for example the US Bioeconomy Blueprint). As the scale, complexity and importance of biotechnology matures, so too must our corresponding oversight processes and institutions. Since the development of the coordinated framework over 30 years ago, we have learnt a great deal about the safety and efficacy of biotechnology products. Meanwhile, products not anticipated when the framework was first developed are now revealing considerable regulatory uncertainties.  There are instances where the jurisdiction for new products is not clear – such as for transgenic mosquitoes or probiotics. Products that employ new technologies for gene editing such as CRISPR don’t necessarily fall outside of the current regulatory framework. And in some cases these tools can enhance our assessment of efficacy and safety. These new tools also increase the number and complexity of products, which can risk overwhelming an already resource-limited regulatory system.

“The committee has a big job in attempting to forecast future biotechnology products. Technology forecasting has many limitations, so it will be important for the committee to advise on processes that can account for surprises and allow for adaptation over time. One tool for adaptation is transparency: improving access to the process and evidence base used to assess the efficacy and safety of new biotechnology products. Improving transparency is not a trivial task, but doing so can improve accountability, engender trust, and equip others to identify and resolve emerging issues over time.

“I have witnessed the frustration of practitioners and regulators alike trying to navigate the current regulatory system. To meet this challenge we must incentivize and empower innovators to be more engaged in assessing the efficacy and safety of their products in the early stages of research and development. I hope the committee members will explore how to build stronger partnerships between researchers, industry and policy makers.”

 

Declared interests (see GENeS register of interests policy):

Dr. Wayne Parrott: Does public-sector-funded research with genetically modified crops, and has done public outreach with the cost of travel covered by the ILSI International Food Biotechnology Committee and CropLife International.

Dr. Megan Palmer: Is a volunteer advisor to organizations who may be impacted by changes in the biotechnology regulatory framework. She previously served as the Deputy Director of Policy and Practices for the multi-university NSF Synthetic Biology Engineering Research Center where she interacted with representatives from the regulatory agencies involved in this effort, as well as members of the National Academies meeting committee.

No further interests declared.

Reference:

NAS meeting info: http://www.nas-sites.org/biotech/

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