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Risk Assessment
Record information and status
Record ID
114572
Status
Published
Date of creation
2019-03-25 11:15 UTC (g.mozgova@yandex.ru)
Date of last update
2019-03-25 12:02 UTC (g.mozgova@yandex.ru)
Date of publication
2019-03-25 12:02 UTC (g.mozgova@yandex.ru)

General Information
Country
  • Belarus
Title of risk assessment
Expert conclusion on genetically engineered organism - Domestic goat modified to produce human lactoferrin for economic purposes
Date of the risk assessment
2019-02-28
Competent National Authority(ies) responsible for the risk assessment
Ministry of Natural Resources and Environmental Protection of the Republic of Belarus
10 Kollektornaya street
Minsk
Belarus, 220048
Phone:+375 17 200-6691
Fax:+375 17 200-5583
Email:minproos@mail.belpak.by
Url:Ministry of Natural Resources and Environmental Protection
Contact details of the main responsible risk assessor
Assoc. Prof. Minina
Grodno State Agrarian University
Grodno
Belarus
Phone:+375 152 77 09 09
Email:zifgen@ggau.by
Risk assessment details
Living modified organism
Domestic goat modified to produce human lactoferrin
Dr Alexander Ivanovich Budevich Production of medical or pharmaceutical compounds (human or animal)
Scope of the risk assessment
Risk assessment report / Summary
Methodology and points to consider
Estimation of the overall risk
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.

Receiving environment(s) considered
Biotechnological Experimental Production of Animals` Transgenesis of the Republican Unitary Enterprise "Scientific and Practical Center of the National Academy of Sciences of Belarus" is a protected fenced area with service personnel that meets all the requirements of high-tech animal content.
LMO detection and identification methods proposed
PCR
Additional Information
Other relevant website address or attached documents