What is biotechnology?
According to the Organisation for Economic Co-operation and Development (OECD), “biotechnology is the application of science and technology to living organisms as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services”.
One consequence of the universal nature of the genetic code is that we are able to transfer genes from one living organism to another. Transgenesis has thus been used for industrial, medical and agricultural research and innovation since the end of the last century, to introduce one or more genes coding for desired properties into the genome of another living organism. Organisms whose genetic material has been altered in this way, especially plants, are called GMOs, meaning “genetically modified organisms”. The specific regulatory framework for GMOs in force today, including European Directive 2001/18/EC, amended by Directive (EU) 2015/412 on the deliberate release of GMOs into the environment, has been built around transgenesis.
Since the mid-2000s, the range of genetic modifications that are possible has expanded significantly, most notably through genome editing techniques. Following a ruling by the Court of Justice of the European Union and a decision by the French Council of State to have organisms derived from recent mutagenesis techniques fall under the same requirements as GMOs, discussions are under way at European level to determine whether the framework for the assessment and authorisation of organisms derived from more recent technologies requires changes to regulations dating from the early 2000s.
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For the use of GMOs in contained (closed) environments, preventing organisms from coming into contact with people and the environment is a priority, with laboratories complying with strict biosafety requirements. Regulatory approval of this type of use therefore focuses on the effectiveness of containment measures. Such uses are generally associated with the research and development stages of new GMOs.
In contrast, deliberate release into the environment is the term used in legislation to refer to the use of GMOs without containment measures, but under strictly controlled conditions. A release for any other purpose than for placing on the market may be requested prior to the commercial stage, in the case of field trials for example. A new authorisation will need to be granted for a release for the purpose of placing on the market, that is for the production and marketing of GMOs or products derived from GMOs. For both types of GMO use in an open environment, an authorisation application must be submitted to the competent authority for the intended use.
The main uses of biotechnology
Biotechnology techniques are common in scientific research. Such techniques are increasingly used in the agricultural, industrial and medical fields.
They are used worldwide mainly to produce:
crops, to improve their resistance to harmful organisms (pests and parasites) or their tolerance to herbicides;
micro-organisms capable of producing enzymes or other compounds of interest to medicine and the food industry.
In medicine, gene therapy aims to introduce genetic material into cells to cure a disease. Genetically modified micro-organisms are also used for the production of vaccines and medicinal products for human and veterinary use. Therapeutic proteins, such as insulin or growth hormones, are produced from genetically modified micro-organisms, plants or animals.
Other applications are being developed. For example, the United States has authorised the use of genetically modified mosquitoes to combat vector-borne diseases transmitted by these insects, such as malaria, dengue fever, chikungunya fever and Zika virus infection.
Zooming in on biotechnology and food in Europe
For biotechnology uses in the food and agriculture sectors, the assessment of health and environmental risks is centralised at European level. Member States send comments on the authorisation applications submitted by industry and examined by the European Food Safety Authority (EFSA). Once an application has been assessed, a decision is made on the product by the European Commission after a vote by the 27 Member States. The following aspects are assessed:
- impacts on human health (e.g. toxicity and allergy risks) and animal health;
- environmental impacts such as the risk of transferring genes introduced into GMOs to other living organisms.
Concerning crops, as of 2021, only one genetically modified plant variety (maize) has been authorised inside the European Union. Each Member State may authorise or prohibit crops from being grown on their land. In France, growing genetically modified plants for commercial purposes has been prohibited since 2008.
Concerning import and use in food and feed, about 100 GMOs have been approved in the European Union and in France. The authorisations are for maize, soybean, rapeseed, cotton and sugar beet. But the approvals do not allow the corresponding genetically modified crops to be grown. The regulations include labelling requirements for products containing GMOs.
ANSES’s role in the assessment of biotechnology
The Agency’s historical role in biotechnology
Since its creation, the Agency has contributed to the assessment of health risks associated with the use of genetically modified plants in food or feed. The French competent authorities rely on the Agency’s expert appraisals for the content of their comments to EFSA and to inform their decisions when required to vote with other Member States on marketing authorisation applications for GMOs intended for use in food or feed. The Agency also participates in the consultations organised by EFSA to develop the guidance documents used by industry to prepare their marketing authorisation applications for genetically modified plants.
As the French Agency for Veterinary Medicinal Products, ANSES is also responsible for evaluating, approving and verifying any veterinary medicinal products derived from biotechnology.
New roles assigned to ANSES in 2022
Since 1 January 2022, following the Order of 14 October 2021, ANSES has been tasked with assessing the environmental risks associated with organisms that comply with the regulatory definition of a GMO and for which applications for deliberate release into the environment have been submitted. This could be for field cropping including field trials, clinical trials for veterinary medicinal products, and in the context of marketing authorisations at European level for veterinary and human medicinal products.
For medicinal products for human use, the French Health Products Safety Agency (ANSM) may ask ANSES to carry out environmental risk assessments before the products are used in an open environment (marketing), and in some cases before authorisations for early access or compassionate use are issued, to treat rare diseases for example.
Furthermore, ANSES may be required to carry out specific expert socio-economic reviews on the uses of biotechnology applications in the open environment.
How does ANSES conduct its expert appraisals on biotechnology applications?
The assessments conducted by ANSES on biotechnology applications comply with the same rules as for all assessments it carries out. These rules ensure that the assessments are of high quality, transparent and independent through declarations of interest, multi-disciplinary groups of experts, and adversarial debate on evidence and uncertainties. The processes coordinated by ANSES comply with the specifications of reference standard NF X 50-110 and the legislative and regulatory requirements for health assessments.
In order to implement its new role in biotechnology since the beginning of 2022, the Agency has strengthened the groups of independent experts who produce the scientific assessments on which its opinions are based. In January 2022, ten new experts joined its Working Group on “Biotechnology” to expand its scope to environmental aspects and gene therapy. ANSES has also set up an Expert Committee on socio-economic analysis, whose role will cover all its areas of work, including biotechnology.
As part of its engagement approach with wider society, ANSES will also set up a Bbiotechnology, environment and health” dialogue committee in 2022. The role of this committee will be to share ANSES’s scientific methodologies and research with stakeholders, as the Agency has done for nanotechnologies, radiofrequencies and plant protection products for several years.
The forum for dialogue will not deal with issues connected with the societal and ethical implications of biotechnology. In accordance with the Order of 14 October 2021, discussions and public debate are facilitated by the Economic, Social and Environmental Council and the National Consultative Ethics Committee, within the scope of their respective roles.
The ANSES Plant Health Laboratory, the national reference laboratory for the detection of plant GMOs
The ANSES Plant Health Laboratory develops or validates methods for detecting genetic modifications in plants, whether or not they have been authorised in France.
As the national reference laboratory in this field, it develops and validates official analytical methods. In this capacity, it carries out the following tasks:
- carrying out official tests as part of the control plans implemented by the Ministry of Agriculture and Food;
- identifying genetic modifications that are being developed worldwide for different plant species;
- evaluating or developing suitable analytical tools for the detection of authorised or unauthorised GMOs, from DNA extraction to the identification of transformation events where possible.