2022-04-13 14:03:30
Biotechnology: what are we talking about?
According to the Organization for Economic Co-operation and Development (OECD), “biotechnology refers to the application of science and technology to living organisms, as well as their components, products and designs, to modify living materials or non-living for the purposes of producing knowledge, goods and services.
The universality of the genetic code makes it possible in particular to introduce genes from a living organism into another organism. The transgender has been used for industrial, medical or agri-food research and innovation purposes since the end of the last century, to incorporate one or more genes coding for sought-after properties into the genome of another living organism. Organisms whose genetic material has been modified in this way, particularly plants, are designated by the acronym GMO for “genetically modified organism”. It is around transgenesis that the specific regulatory framework for GMOs in force today is structured, with in particular European Directive 2001/18/EC, modified by Directive (EU) 2015/412, relating to the dissemination voluntary release of GMOs into the environment.
Since the mid-2000s, the possibilities for modifying genetic heritage have diversified considerably, particularly with genome editing techniques. Following a ruling by the Court of Justice of the European Union and a decision by the French Council of State ordering organisms resulting from recent mutagenesis techniques to be subject to the obligations imposed on GMOs, discussions are underway at European level to determine whether the evaluation and authorization framework for organizations that come from the most recent technologies requires an evolution of the regulations dating from the early 2000s.
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Pour the use of GMOs in a confined (closed) environment, the priority is to avoid any contact of the organism with the population and the environment, for example in laboratories meeting the required biosafety conditions. Regulatory authorization of this type of use therefore focuses on the effectiveness of containment measures. These uses are generally associated with the research and development phases of new GMOs.
Par opposition, deliberate release into the environment is a regulatory term to designate the use of GMOs without containment measures, but under very regulated conditions. Dissemination without placing it on the market may be requested before the commercial phase, for example to carry out field trials. A new authorization will be necessary for release with placing on the market, that is to say the production and marketing of GMOs or products derived from GMOs. For these two types use of GMOs in an open environmentan authorization application file must be submitted to the competent authority for the intended use.
The main uses of biotechnologies
Biotechnologies are part of the current methods of Scientific Research. They are increasingly used in the agricultural, industrial and medical fields.
Globally, these technologies are mainly used to produce:
plants for agricultural usein order to improve their resistance to harmful organisms (pests or parasites) or to make them tolerant to herbicides;microorganisms capable of producing enzymes or other molecules of agri-food or medical interest.
In medicine, the genetical therapy aims to introduce genetic material into cells to treat a disease. Genetically modified microorganisms are also used for the production of vaccines and medicines for human or veterinary use. Proteins of therapeutic interest are produced from genetically modified microorganisms, plants or animals, such as insulin or growth hormones.
Other applications are developing. Thus, the United States authorized the use of genetically modified mosquitoes for the purposes of combating vector-borne diseases that they transmit such as malaria, dengue fever, chikungunya or zika.
Focus: biotechnologies and food in Europe
For the uses of biotechnologies in the agricultural and agri-food fields, the assessment of risks to health and the environment is centralized at the European level. Member States send their comments on the authorization application files submitted by manufacturers and examined by the European Food Safety Agency (EFSA). At the end of the evaluation of the file, the product is the subject of a decision by the European Commission taken after a vote of the 27 member states.
Are evaluated:
impacts on human health (toxicity, risks of allergies) and on animal health; impacts on the environment such as the risk of transfer of the gene introduced into the genetically modified organism to other living organisms.
For cultivation, in 2021, only one variety of genetically modified plant (maize) is authorized on the territory of the European Union. Each Member State can authorize or prohibit cultivation on its own territory. In France, the cultivation of genetically modified plants for commercial purposes has been prohibited since 2008.
Concerning importation and use in human and animal food, around a hundred GMOs are authorized in the European Union and in France. The authorizations concern corn, soya, rapeseed, cotton and sugar beet. They do not allow the cultivation of the corresponding GMOs. The regulations provide for labeling obligations for products containing GMOs.
ANSES assessment missions on biotechnologies
Historical missions of the Agency on biotechnologies
Since its creation, the Agency has contributed to assessing the health risks linked to the use of genetically modified plants in human or animal food. The competent French authorities rely on the Agency’s expertise to formulate their comments to the EFSA and to determine their position during the vote of the Member States on the application files for authorization to place a product on the European market. GMOs for use in human and animal food. The Agency also participates in consultations organized by EFSA to develop the guide documents on which manufacturers rely to prepare their applications for marketing authorization for genetically modified plants.
As the National Veterinary Medicines Agency, ANSES also has the mission of evaluating, authorizing and controlling all veterinary medicines resulting from biotechnologies.
New missions entrusted to ANSES in 2022
Since January 1, 2022, following the order of October 14, 2021, ANSES has also assessed environmental risks for organisms meeting the regulatory definition of GMO and subject to requests for use in an open environment: cultivation of plants in the open field including at the experimental stage, clinical trials of veterinary medicinal products, and at the European level in within the framework of the marketing authorization of veterinary and human medicinal products, etc.
For medicinal products for human use, ANSES may be contacted by the ANSM (National Agency for the Safety of Medicines and Medicinal Products) to carry out environmental risk assessments upstream of the phases of use in an open environment (placement on the market), and in certain cases upstream of the issuance of early access or compassionate access authorizations to treat rare diseases, for example.
Furthermore, ANSES will be able to carry out specific socio-economic analysis assessments relating to the uses of biotechnology applications in open environments.
How are ANSES’s assessments on biotechnologies carried out?
The assessments carried out by ANSES on biotechnologies comply with the rules common to all assessments carried out at ANSES. They guarantee their quality, transparency and independence: declaration of links of interest, multidisciplinarity of groups of experts, contradictory debate around elements of evidence and uncertainties. The processes coordinated by ANSES meet the specifications of the reference standard NFX50-110 and the legislative and regulatory requirements of health expertise.
To implement the new missions relating to biotechnologies entrusted to it at the beginning of 2022, the Agency has strengthened the groups of independent experts producing the scientific evaluations on which its opinions are based. From January 2022, ten new experts will join its “Biotechnology” working group and extend its skills to environmental aspects and gene therapy. Furthermore, ANSES has set up a committee of specialized experts dedicated to socio-economic analysis whose missions cover the different fields of intervention of ANSES, including biotechnologies.
As part of its measures to open up to society, ANSES has also set up a “Biotechnologies, environment & health” dialogue committee. Its role will be to discuss with stakeholders the methods and scientific work of ANSES, as the Agency has been doing for nanotechnologies, radio frequencies and plant protection products for several years.
This dialogue body will not be intended to address questions relating to the societal and ethical implications of biotechnologies. In accordance with the order published on October 14, 2021, reflection and public debate are carried out by the Economic, Social and Environmental Council and the National Ethics Consultative Committee, within the scope of their respective missions.
The ANSES Plant Health Laboratory, national reference laboratory for the detection of plant GMOs
The ANSES Plant Health Laboratory develops or validates methods to detect genetic modifications made to plants, whether or not they are authorized on our territory.
As a national reference laboratory (NRL) on this subject, it develops and validates official analysis methods. As such, it fulfills the following missions:
carrying out official analyzes of control plans piloted by the Ministry of Agriculture and Food; identification of genetic modifications that are developed around the world for different plant species; evaluation or development of analytical tools adapted for the detection of GMOs authorized or not, from DNA extraction to the identification of transformation events when possible.
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