Negligible risk has been established by the risk assessor conducting risk assessment of transgenic goats provided that transgenic goats will be kept in a potential receiving environment - on the territory of the Biotechnological Experimental Production of Animals` Transgenesis. Expert concluded that transgenic goats, producers of recombinant human lactoferrin, may be allowed for passing procedure of new breed State Registration, as well as for the purpose of carrying out relevant tests and subsequent use of the target protein. The risk assessor also concluded that Biotechnological Research and Experimental Production of Animals` Transgenesis meets the safety requirements for objects intended for the economic use of non-pathogenic genetically engineered organisms (goat-producers of human lactoferrin), and their registration.
The Expert Council on the Safety of Genetically Engineered Organisms of the Ministry of Natural Resources and Environmental Protection of the Republic of Belarus, having heard the expert’s opinion, decided to adopt recommendations on the acceptability of using a transgenic goat line with an integrated gene construct responsible for the production of recombinant human lactoferrin in the mammary gland for commercial purposes subject to the recommendations of the Expert Council.
The Expert Council`s recommendations are as follows:
A herd of transgenic goats should be kept in a controlled environment that prevents the exchange of genetic material with non-transgenic individuals;
appropriate environmental monitoring by botanists and zoologists should be provided;
the final product (lactoferrin) can only be used for economic purposes;
it is necessary to screen the final product for presence of the inserted new genetic sequence.