Skip to Main Content

Strategic Business Insights (SBI) logo

Nanobiotechnology September 2018 Viewpoints

Technology Analyst: Ivona Bradley

European Union's Decision to Regulate Gene-Edited Crops

Why is this topic significant?

The CJEU's recent plans to regulate gene-edited plants may be a major setback for the development of gene-editing technologies such as CRISPR in the European agricultural market.

Description

In 2016, the French government requested that the Court of Justice of the European Union (CJEU) take into consideration any plant-breeding technologies that emerged since the 2001/18/EC directive for genetically modified organisms (GMOs) came into force in 2001. In July 2018, the CJEU announced that it plans to regulate organisms—such as plants, which scientists have designed and developed with new mutagenesis technologies—under the 2001 directive for GMOs. The court's decision covers new mutagenesis technologies such as CRISPR (clustered regularly interspaced short palindromic repeats) that scientists developed after the GMOs directive came into force in 2001. CRISPR is a relatively new gene-editing technology that scientists can use to introduce genetic alterations in plants. The CJEU believes that only mutagenesis technologies that scientists used conventionally for many years in various applications and that "have a long safety record" should be exempt from the regulation. Under the 2001 directive for GMOs, the European Commission regulates transgenic organisms (plants that scientists develop by introducing foreign genes) only and the intentional release of GMOs into the environment.

Implications

Increasing concerns about how climate change may place considerable strain on Earth's food sources are driving the demand for high-yield crops that can resist environmental stresses. In recent years, gene-editing technologies such as CRISPR have become a major focus of research in agricultural products because they can enable plant breeders to develop many new varieties of gene-edited crops that resist drought and disease and have increased nutritional value.

Although CRISPR's potential for revolutionary breakthroughs in agriculture had generated much excitement and anticipation, weak links in scientific-knowledge areas that produce CRISPR-based tools are likely to constrain EU regulatory bodies in their path to improve existing regulation about GMOs. Without doubt, ongoing research in CRISPR is important in establishing a valuable pool of accurate knowledge about the health and environmental safety of the technology and may enable EU regulatory bodies to make a clear regulatory distinction between gene-edited plants and genetically modified plants. Improving the current legislation to cover novel gene-editing technologies also is important to increase the overall pace of development for CRISPR tools and subsequent agricultural products.

Impacts/Disruptions

CJEU's decision is not surprising, given that the European Commission has a history of developing stringent regulations, and it has previously adopted a more cautious approach toward new technologies than that of regulators in the United States. Earlier in 2018, the US Department of Agriculture announced that it plans not to regulate gene-edited plants in an effort that is likely to shorten the time frame for making new plant varieties available to farmers (see the May 2018 Viewpoints). In contrast, CJEU's decision to regulate gene-edited plants is likely to hinder investments in the use of CRISPR technologies in European agricultural products. Large companies, small start-ups, and public research centers that have already invested heavily in the use of such technologies to develop new agricultural products may not see these products reach European farmers. High cost at the developmental stage of emerging gene-edited agricultural products may move investment to other regions where regulatory bodies support the development and market of gene-edited crops.

Scale of Impact

  • Low
  • Medium
  • High
The scale of impact for this topic is: High

Time of Impact

  • Now
  • 5 Years
  • 10 Years
  • 15 Years
The time of impact for this topic is: Now to 5 Years

Opportunities in the following industry areas:

Agriculture, food and drink, gene editing, biotechnology

Relevant to the following Explorer Technology Areas:

Synthetic Biology and Biosecurity

Why is this topic significant?

Ginkgo Bioworks plans to work on various government-funded projects to identify and prevent the accidental or intentional production of biothreats.

Description

In June 2018, Ginkgo Bioworks, a Boston, Massachusetts–based company that uses automated genetic engineering to create product-making organisms rapidly, announced it plans to participate in various US government–funded programs to develop a range of biosecurity tools to prevent the misuse of DNA nanotechnology and other synthetic-biology technologies. The company's contracts with various US government bodies—including the US Intelligence Advanced Research Projects Activity (IARPA), the US Department of Defense, and the US Department of Homeland Security—are worth up to $64 million. As part of one biosecurity program—IARPA's Finding Engineered Linked Indicators program—Ginkgo plans to design and develop software tools, such as deep-learning models and algorithms, to detect whether a DNA sample is wild or engineered. Such software tools may also improve a gene-synthesis company's capabilities to screen DNA-synthesis orders to identify and prevent the production of biothreats. In another biosecurity program—IARPA's Functional Genomic and Computational Assessment of Threats program—Ginkgo plans to apply its software to screen DNA sequences and interpret a gene's function and, as a result, identify if a sample contains pathogens harmful to humans and animals. Such identification enables Ginkgo to determine the threat level of a particular pathogen. In another example, Ginkgo secured an Indefinite Delivery Indefinite Quantity contract: the Joint Enterprise Research, Development, Acquisition and Production/Procurement contract. The ten-year contract may enable Ginkgo to develop software tools that find use in real-world biosecurity applications.

Implications

Synthetic biology can bring significant societal and environmental benefits in industries such as pharmaceuticals, health-care, and energy sectors. Companies use synthetic biology to develop biological design libraries to help transform today's time- and labor-intensive genetic-engineering practices, such as the assembly of long and carefully ordered DNA sequences. Ginkgo's success with investors and funders and rapid growth are strong indicators that DNA technologies and synthetic biology are developing rapidly, although the technologies are still concepts that are most common in the research and development stage.

As DNA technologies develop further, ethical and safety concerns continue to arise about the misuses of synthetic biology—for example, for the development of bioweapons. In early 2018, researchers at the University of Alberta—albeit with no harmful intent and in compliance with government and university regulations—used DNA that they ordered in the mail to develop horsepox virus. Ginkgo's large engineered-DNA database, automated setup, and service business model allows the company to offer biodefense and biosecurity partners easy routes to screen novel DNA sequences for the detection and prevention of biothreats.

Impacts/Disruptions

In the future, effective detection of biothreats will depend mostly on biosecurity tools' ability to progress to a point where they do more than just match DNA sequences to known pathogens and to report results in timely fashion to effect appropriate actions. Government-funded programs are likely to enable such progress. Novel biosecurity tools will likely improve the existing US integrated, end-to-end, national biodefense framework that provides early warning of all forms of biothreats.

Scale of Impact

  • Low
  • Medium
  • High
The scale of impact for this topic is: High

Time of Impact

  • Now
  • 5 Years
  • 10 Years
  • 15 Years
The time of impact for this topic is: Now to 10 Years

Opportunities in the following industry areas:

DNA technologies, genetic engineering, synthetic biology, biosecurity, biodetection

Relevant to the following Explorer Technology Areas: