New advances in biotechnology

Introduction

Genetic engineering, a process that alters the genetic structure of an organism by modifying, removing or introducing DNA, is a rapidly developing scientific field.

For example, new genome editing techniques may allow for much faster and more precise results than conventional breeding techniques. And advances in molecular biology have delivered molecular and computational tools that allow scientists to design traits of interest, an approach termed synthetic biology. One outcome of synthetic biology is the engineering of so-called gene drives, which spread genes of interest at a frequency greater than would otherwise be achieved by natural inheritance.

Before genetically modified organisms engineered in this way are released on the market, their risks need to be assessed. Scientific bodies like EFSA assesses their potential adverse effects on humans, animals and the environment.

Current work

EFSA is working on four scientific opinions – on synthetic biology, genome editing and gene drive – that will all be made available for public consultation before being finalised. (See Engage section for the timeline).

Synthetic biology

Synthetic biology is a field devoted to the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic material in living organisms.

The European Commission has asked EFSA to provide scientific opinions on the appropriateness of existing guidance documents for risk assessment in light of the developments in synthetic biology.

The existing guidance documents that EFSA is considering are those on the molecular characterisation and environmental risk assessment of genetically modified (GM) plants and on GM microorganisms.

Genome editing

Genome editing allows DNA to be inserted, modified or deleted in the genome of a living organism with very high precision compared to conventional breeding techniques or classical GM techniques.

The European Commission has asked EFSA to advise whether the conclusions of its 2012 scientific opinion on the safety assessment of plants developed using Zinc Finger 3 and other site-directed nucleases with a similar function (a genome editing technique that allows the introduction of new DNA) may be applicable to plants developed with type 1 and type 2 site-directed nucleases and with oligonucleotide-directed mutagenesis (a genome editing technique that modifies the existing plant DNA without introduction of new DNA).

Gene drive

Gene drives consist of genetic elements that can pass traits among sexually reproducing individuals with higher efficiency than expected under natural (or Mendelian) inheritance.

This emerging technology has sparked both enthusiasm and concerns. While gene drives could be used to control agricultural pests and invasive species, rescue endangered species or suppress disease vectors, there is concern that they may lead to undesired side effects and alter ecosystems irreversibly.

The European Commission has asked EFSA to identify novel risks to human and animal health and the environment from gene drive modified insects. Experts are also assessing whether previously published EFSA guidelines are adequate for the molecular characterisation and environmental risk assessment of gene drive modified insects.

Milestones

2012 EFSA issues two opinions on cisgenesis/intragenesis and zinc finger nuclease 3 and other site-directed nucleases, assessing the potential risks of these techniques and the applicability of the existing EFSA guidance documents on GM plants for their risk assessment.

Experts conclude that the existing guidance documents are applicable for the evaluation of food and feed products derived from plants modified with these techniques and for performing an environmental risk assessment and do not need to be developed further.

EFSA's role

EFSA assesses the safety of GMOs in relation to human and animal health, and the environment in Europe. Its scientific advice is used by risk managers such as the European Commission and EU Member States to decide on their possible authorisation.

Policy makers and risk managers in the EU want to be ready for the possible marketing of products that could enter the market because of the new advances in biotechnology. To be better prepared for the future and possible emerging risks, EFSA is assessing if its guidelines are fit for purpose for the safety assessment of such products.

EU framework

The European Union has established a legal framework to ensure that the development of modern biotechnology, and more specifically of GMOs, takes place in safe conditions. The framework applies to new organisms developed through synthetic biology.

In July 2018, the Court of Justice of the European Union (CJEU) clarified that organisms from new mutagenesis techniques fall within the scope of the EU GMO legislation.