programme for Biosafety Systems (PBS)

The NCST has been implementing the Programme for Biosafety Systems (PBS). This is a programme that is promoting the adoption and use of biotechnology in Malawi.

To enhance Malawi’s future development and economic growth, the National Commission for Science and Technology is promoting biotechnology as one of the tools to address poverty, hunger and disease. To guide development and use of modern biotechnology in the country, NCST has facilitated development of the necessary legal and policy instruments such as:

  • Biotechnology and Biosafety Policy,
  • Genetically Modified Seed Import Procedure Manual,
  • Trials Managers Manual,
  • Inspectors Manual
  • and Malawi Guidelines on Biotechnology.

In line with the policy, Government approved the first application for Bt-cotton Confined Field Trial at Bunda College of Agriculture in October 2011, making Malawi among the very few countries in Africa and the world to conduct Confined Field Trials.

The government of Malawi signed the Cartagena Protocol on Biosafety in May 2000 and ratified it in 2009. In line with the requirements of the Protocol, the Malawian Parliament enacted the Biosafety Act in October 2002, which is administered by the Minister responsible for Environmental Affairs. The Act provides for an institutional framework for its operationalization consisting of the following:

  • National Biosafety Regulatory Committee
  • Reviewers
  • Inspectors
  • Biosafety Registrar

A national biotechnology and biosafety policy was approved by the Malawi Cabinet on 26th June 2008.

Among provisions in the Malawi biotechnology and biosafety policy is the delineation of roles and responsibilities at government level as well as at the R&D and other service delivery institutional levels. In the policy, the mandate for promoting and developing biotechnology in Malawi is vested in the National Commission for Science and Technology (NCST).

The NCST hosts the National Biotechnology Committee, which is responsible for promoting biotechnology, public awareness and coordination of biotechnology research and development.

On the other hand, the Department of Environmental Affairs (EAD) is responsible for regulation of biotechnology, which entails receiving and reviewing applications for activities with genetically modified organisms and issuing licenses or permits. The EAD hosts the National Biosafety Regulatory Committee (NBRC). In addition, there is a third set of public institutions that are
responsible for providing biosafety regulatory and enforcement services in the country. The mandate of these institutions is provided through regulatory provisions included in the various Acts that established them.

These include:

  • the Ministry of Agriculture and Food Security;
  • Ministry of Industry and Trade;
  • Ministry of Health;
  • Malawi Bureau of Standards;
  • Pharmacy and Medicines Board;
  • Pesticides Control Board;
  • Seed Services Unit;
  • Plant Protection Unit;
  • Ministry of Labour;
  • Fisheries Department;
  • Forestry Department;
  • National Herbarium and Botanic Gardens of Malawi;
  • Department of National Parks and Wildlife; Ministry of
  • Local Government;
  • Ministry of Women and Child Welfare;
  • and Malawi Investment Promotion Agency.

The Ministry of Agriculture and Food Security has also established its institutional biosafety committee (IBC) known as the Agricultural Biotechnology and Biosafety Committee (ABBC) which is technically and financially supported by the Ministry of Agriculture and Food Security.

Commencement of Insect-Resistant Cotton CFT in Malawi
In 2009, Bunda College of Agriculture of the University of Malawi through Professor Moses Kwapata submitted applications for confined field trials of insect resistant and herbicide tolerant cotton. The two applications for confined field trials (CFTs) for cotton (Gossypium hirsutum) with the events MON88913 (herbicide tolerant) and MON15985 (insect resistant) were submitted according to the provisions of the Malawi Biosafety Act #13 of 2002 and Biosafety Regulations, 2007, and the Malawi Biotechnology Guidelines, 2009; to the National Biosafety Regulatory Committee (NBRC) through the Biosafety Registrar.
In January 4, 2013, Malawi commenced CFT for cotton at Bunda College.

The first biotechnology crop was therefore planted in Lilongwe at the Lilongwe University for Agriculture and Natural Resources in January 2013.  After a successful trial, the trials have gone to a number of sites which are traditional cotton growing areas in Malawi namely, Salima, Chikwawa and Balaka and at Makoka Research Station in Zomba.

Identified Biosafety Needs and Gaps:
Areas that require ABNE intervention are:
Support to the NBRC in biosafety communication using the ABNE Biosafety Communication Manual.

Training of members of the Agricultural Biotechnology and Biosafety Committee (ABBC) as an agricultural technical group of experts to serve as a team of scientific safety reviewers and strengthen their capacity in risk assessments

Training of the Biosafety Registrar, institutional biosafety committee members and members of the NBRC for their roles and responsibilities as biosafety regulators

Training of inspectors for monitoring and compliance
Facilitating attendance of the Biosafety Registrar and members of the NBRC in a functional biosafety committee meeting of another country.

Why are Confined Field Trials needed?
The CFTs are needed to:

  • Restrict GM plant material to a specific area of research activities, the Trial Site.
  • Provide technology developers with the opportunity to evaluate the performance of genetically modified plants
  • Permit the production of sufficient quantities of plant material for use in livestock feeding trials and compositional analyses which are necessary for human food safety assessments
  • Provide an opportunity to collect the agronomic and ecological data required to complete the environmental safety assessment of the transgenic plant.
  • Provide an opportunity to evaluate the potential risks and benefits of cultivating the new crop.
  • Some key characteristics of Confined Field Trial
  • The key characteristics of CFTs include the following:
  • Restricted, but similar to field experiments done for conventional breeding;
  • Field experiments designed to evaluate the performance of GM plants;
  • It is done in the open field, thus exposing the plants to the general environment;
  • It is done on a small scale normally less than 1 hectare;
  • Performed under stringent terms and conditions that isolate the experimental material; and
  • Regenerated plants (volunteers) arising from the trials are destroyed after the test.