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Regulation in Zimbabwe
• The Research Council of Zimbabwe was empowered by the
Research Act to set up a Biosafety Board that ensures safety,
research and development in Biotechnology
• The Biosafety Board advises the RCZ and the GoZ on
development, production, importation, utilization and release
of GMOs
• The Board drafted biosafety regulations which were published
in the government gazette as Statutory Instrument 20 of 2000
Functions of the Biosafety Board
• Reviewing project proposals concerning high risk category
organisms and controlled experimental trials involving them
and approve, prohibit or restrict such trials
• Reviewing reports of all ongoing approved projects and
controlled experimental trials involving high-risk category
organisms
• Monitoring and approval of the discharge of GMOs or cells or
waste from laboratories and hospitals into the environment
• Ensuring that biosafety guidelines and standards are adhered
to generally and in the execution of project or controlled
experimental trials involving high risk category organisms
Functions of the Biosafety Board cont’d
• Identifying, prioritizing and proposing areas for
standardization of products or recombinant DNA technology to
various bodies such as the Standards Association of Zimbabwe,
the Medicines Control Authority of Zimbabwe and the
Hazardous Substances Control Board
• Approval of safety aspects of the import, export,
manufacture, processing and selling of any GMOs or cells,
including substances, foodstuffs and additives containing
products of genetic engineering
• Advising customs authorities on the import and export of
biologically active material and GMOs, substances or products
Some biosafety guidelines in Zimbabwe
• No person shall own or control any facility utilized for any
potentially harmful research, or generally for the development,
production, use or application of genetically modified organisms,
including any facility utilized in connection with the contained use
or trial release of such organisms, unless such facility is registered
• No person shall carry on potentially harmful research, or
undertake the contained use or trial release of genetically modified
organisms, without a permit
• Any person who contravenes the above shall be guilty of an offence
and liable to a fine not exceeding one hundred thousand dollars or
imprisonment for a period not exceeding one year or both
Some biosafety guidelines in Zimbabwe
cont’d
• Every user of GMOs shall ensure that appropriate measures are taken to
prevent or minimize any foreseeable danger to persons, animals or
plants or to the environment generally that may arise from the use of
such organisms
• A user of GMOs shall notify the Board both orally and in writing in
advance of any general or trial release of GMOs, and shall not release
such organisms until the Board has approved the same in writing
• A user of GMOs shall immediately notify the Board both orally and in
writing of any accident involving GMOs, and shall supply the Board with
information on the circumstances of the accident, the identity and
quantity of GMOs released, and any information necessary to assess the
impact of the accident on the environment, including the emergency
measures taken or needed to be taken to avoid or mitigate any adverse
impact of such accident on the environment
Some biosafety guidelines in Zimbabwe
cont’d
• At every genetic research institute there shall be established a
committee, to be called an “institutional biosafety committee”
which shall consist of a person familiar with the biosafety
requirements of work involving recombinant DNA, to be called a
“biosafety officer”
• The biosafety officer shall be the chairman of the biosafety
committee
• The general function of the committee shall be to ensure that
biosafety regulations, any biosafety guidelines or standards, and
the terms or conditions of any registration or permit are being
complied by all persons engaged in the work of the genetic
research institute
The National Biotechnology Authority of
Zimbabwe (NBA)
• An autonomous research and development institution with a
mandate to develop Zimbabwe through the application of
conventional and cutting-edge biotechnologies
• Established through the National Biotechnology Authority of
Zimbabwe (NBA) Act of 2006
• The NBA is mandated to transform the country from a raw
material-based into a knowledge–based economy through the
application of biotechnology in agriculture, medicine, energy
and the environment
Role of the NBA
• Ports control and inspectorate
https://nba.ac.zw/index.php/regulatory-services/
• Processing applications for import permits for products of
biotechnology
• Supervising the importation/exportation of food, feed, food and
feed additives and seed
• Registration and audit of biotechnology facilities
• Biosafety policy development
• Supervising the contained use, trial release and general release and
commercial release of biotechnology products
• GMO surveillance and testing
Role of the NBA cont’d
• Business enterprise department
https://nba.ac.zw/index.php/bed/
• Collaborating with biotechnology entrepreneurs in translating
research results into products and services
• Commercialization of internally developed or adopted
biotechnologies
• Establish and run strategic business units for the purposes of
fostering further research and generating revenue

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Biotechnology_2.pptx

  • 1. Regulation in Zimbabwe • The Research Council of Zimbabwe was empowered by the Research Act to set up a Biosafety Board that ensures safety, research and development in Biotechnology • The Biosafety Board advises the RCZ and the GoZ on development, production, importation, utilization and release of GMOs • The Board drafted biosafety regulations which were published in the government gazette as Statutory Instrument 20 of 2000
  • 2. Functions of the Biosafety Board • Reviewing project proposals concerning high risk category organisms and controlled experimental trials involving them and approve, prohibit or restrict such trials • Reviewing reports of all ongoing approved projects and controlled experimental trials involving high-risk category organisms • Monitoring and approval of the discharge of GMOs or cells or waste from laboratories and hospitals into the environment • Ensuring that biosafety guidelines and standards are adhered to generally and in the execution of project or controlled experimental trials involving high risk category organisms
  • 3. Functions of the Biosafety Board cont’d • Identifying, prioritizing and proposing areas for standardization of products or recombinant DNA technology to various bodies such as the Standards Association of Zimbabwe, the Medicines Control Authority of Zimbabwe and the Hazardous Substances Control Board • Approval of safety aspects of the import, export, manufacture, processing and selling of any GMOs or cells, including substances, foodstuffs and additives containing products of genetic engineering • Advising customs authorities on the import and export of biologically active material and GMOs, substances or products
  • 4. Some biosafety guidelines in Zimbabwe • No person shall own or control any facility utilized for any potentially harmful research, or generally for the development, production, use or application of genetically modified organisms, including any facility utilized in connection with the contained use or trial release of such organisms, unless such facility is registered • No person shall carry on potentially harmful research, or undertake the contained use or trial release of genetically modified organisms, without a permit • Any person who contravenes the above shall be guilty of an offence and liable to a fine not exceeding one hundred thousand dollars or imprisonment for a period not exceeding one year or both
  • 5. Some biosafety guidelines in Zimbabwe cont’d • Every user of GMOs shall ensure that appropriate measures are taken to prevent or minimize any foreseeable danger to persons, animals or plants or to the environment generally that may arise from the use of such organisms • A user of GMOs shall notify the Board both orally and in writing in advance of any general or trial release of GMOs, and shall not release such organisms until the Board has approved the same in writing • A user of GMOs shall immediately notify the Board both orally and in writing of any accident involving GMOs, and shall supply the Board with information on the circumstances of the accident, the identity and quantity of GMOs released, and any information necessary to assess the impact of the accident on the environment, including the emergency measures taken or needed to be taken to avoid or mitigate any adverse impact of such accident on the environment
  • 6. Some biosafety guidelines in Zimbabwe cont’d • At every genetic research institute there shall be established a committee, to be called an “institutional biosafety committee” which shall consist of a person familiar with the biosafety requirements of work involving recombinant DNA, to be called a “biosafety officer” • The biosafety officer shall be the chairman of the biosafety committee • The general function of the committee shall be to ensure that biosafety regulations, any biosafety guidelines or standards, and the terms or conditions of any registration or permit are being complied by all persons engaged in the work of the genetic research institute
  • 7. The National Biotechnology Authority of Zimbabwe (NBA) • An autonomous research and development institution with a mandate to develop Zimbabwe through the application of conventional and cutting-edge biotechnologies • Established through the National Biotechnology Authority of Zimbabwe (NBA) Act of 2006 • The NBA is mandated to transform the country from a raw material-based into a knowledge–based economy through the application of biotechnology in agriculture, medicine, energy and the environment
  • 8. Role of the NBA • Ports control and inspectorate https://nba.ac.zw/index.php/regulatory-services/ • Processing applications for import permits for products of biotechnology • Supervising the importation/exportation of food, feed, food and feed additives and seed • Registration and audit of biotechnology facilities • Biosafety policy development • Supervising the contained use, trial release and general release and commercial release of biotechnology products • GMO surveillance and testing
  • 9. Role of the NBA cont’d • Business enterprise department https://nba.ac.zw/index.php/bed/ • Collaborating with biotechnology entrepreneurs in translating research results into products and services • Commercialization of internally developed or adopted biotechnologies • Establish and run strategic business units for the purposes of fostering further research and generating revenue