License and control of genetically modified organisms (DK)
Challenge
The main guiding directive is an EU regulation which stipulates that risks associated with the contained use of GMOs must be assessed on a case-by-case basis based on a set of requirements for risk assessment. The rules further regulate, that a person must notify authorities before using GMOs in a particular installation for the first time, so that the authority can make sure that it does not present a hazard to human health and the environment.
The use of GMOs receives a classification to ensure a high level of protection, the containment and other protective measures applied to a contained reflecting the level of classification. Authorities also need to establish appropriate procedures for the case-by-case notification of specific operations involving the contained use of GMOs and the degree of risk involved.
Furthermore, the authorities must handle any incident involving emissions from contained use of GMO.
KEYWORDS
Thematic
GMO
Legal
DIRECTIVE 2009/41/EC on the contained use of genetically modified micro-organisms
Tech
Approvals, Inspections, automated risk assessment
The GMO unit of the Danish Environmental Protection Agency (EPA) is responsible for granting approvals for the use of GMO in different contexts and is in charge of conducting the necessary environmental inspections leading to approvals for usage and application of GMOs.
Solution
The Danish EPA has previously been handling their GMO-related workflow as a manual and paper-based process, where information was saved in physical binders for many years.
cBrain streamlined the EPA’s GMO-related processes and workflows related to the inspection and approval of different applications and the usage of Genetically Modified Organisms (GMO) in products’ production, classification, and research. The digital solution covers the categories of plants, animals and microorganisms in one single digital case management system.
The F2 solution developed provided a fully digital approval process of classifications and case-by-case assessment of specific operations. cBrain’s GMO solution supports both the administration of the current permission of use of GMOs, as well as the process of granting new permissions for the use of GMOs in different contexts like in research, classification and production.
The solution consists of eight case guides in total to handle both the business process of GMO inspection cases and the process of granting new permissions.
The case guides for inspection guide the caseworker through the necessary tasks to execute during an inspection, based on regulations. Moreover, the solution provides a systematic way to handle and plan upcoming inspections. Additionally, a risk-based scoring system helps single out cases for inspections and automatically creates inspection cases linked to the approvals given.
Physical inspections are based on online forms pre-filled with data from the system, and automatically updating cases with data from on-site inspections, and automatically providing inspection reports to the GMO user. Four of the case guides handle the granting of permits related to the usage of GMOs in both production, research, and classified areas. The information about the usage of GMOs feed information into the parts of the solution dealing with inspections. This way, information across all the different case guides in the solution is continuously up to date.
For example, the inspection case guides allow for complying with the regulatory requirements of the simplified inspection process, making it more effective. The GMO solution provides a systematic way to handle and plan upcoming inspections, too. It facilitates the management and overview of all processed cases, increasing transparency around decisions, as all data and documents are accessible to all employees in a single system. The solution ensures that the inspection processes of GMO’s usage are based on a systematic risk-based model, increasing the level of quality assurance.
The case guides simplify and guide with consistent steps on how to execute tasks and define a more formalized process for the caseworker to handle cases. Besides, all official documents (licenses and permits) are generated automatically using document templates, ensuring consistency and accuracy, reducing errors. All data of the GMO cases is structured, organized and documented digitally. The search templates allow for searching across all the data saved inside the solution, and extracts and groups data for reporting purposes.
The solution also integrates technical assistance from outside experts and handles the payment of fees by applicants.
Results
Within an implementation timeline of 9 months, the new digital GMO solution by cBrain has not only secured a higher quality of inspections, but also allowed for a much more efficient and less user-dependent platform for complying with EU regulations in the area.
By supporting the digitalization of the main GMO processes at the Danish EPA, it has become possible to manage all cases for inspection and grants, as well as knowledge sharing in one system.
F2 Climate Software Solutions
