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Regulatory Affairs and Biosafety

Regulatory affairs and biosafety are two distinct concepts. Regulatory affairs refers to compliance of the project to local, national and international legal requirements while biosafety focuses on the prevention of large-scale loss of living organisms in the natural environment and their function relative to the potential or original state of an ecosystem before human alterations were imposed. Both concepts are interrelated as the purposes of most government regulations on biotechnological research are the maintenance of operational safety and preservation of human health and biological integrity of the environment.

The Regulatory and Biosafety team ensures that the work of the Technology and Product Development teams with the rigorous set of biotechnology regulations and the principles and practices of biosafety set by national laws and policies as well as international conventions.  They also provide advice to other teams on how regulatory frameworks impact their work and support on cross-functional aspects such as regulatory training to the media.

They team is involved in developing and monitoring operational protocols such as detection and analytical methods and lab recording procedures. Risk management to human and animal health, the environment and agriculture are also competencies developed by the team. Issues such as allergenicity and toxicity of novel proteins, assessment of biodiversity and investigations into gene flow are within their scope. They work with the regulatory personnel within consortium institutions to generate permit application dossiers and support them through the application process.

As many African countries are building capacity in biotech regulations and biosafety, the team has partnered with other institutions to train government-appointed biosafety regulators on the principles and intricacies of evaluating biosafety applications and procedures.

Regulation and Biosafety in Africa
Biosafety relates to efforts aimed at reducing the risk of alien genes in GM plants. The Food and Agricultural Organisation/World Health Organisation (FAO/WHO) have provided decision trees for a rigorous assessment and testing for GM foods.  Government regulations affect biotechnology research choices, laboratory construction and practices, testing procedures, manufacturing practices, and marketing of new products in Africa, in order to ensure that new biotechnology products are safe for the environment and human and animal health. 

The African Union Biosafety Project is a project on capacity building for an Africa-wide biosafety system. The Project aims to integrate the topic of biosafety into the political and institutional frameworks of the AU and into its support services for the Member States.

ABS Regulatory and Biosafety Initiatives
The ABS project put together a full-fledged Regulatory and Biosafety initiative to ensure that the regulated project activities conform to the national and international regulations, protocols or laws governing genetically modified (GM) crops and their products.  This initiative is responsible for development of safety guidelines and core-related activities that include: gene flow studies, toxicity tests, allergenicity tests, non-target studies (ecotoxicology), bio-availability analysis, digestibility assays and compositional analysis for promising transgenic events generated by the technology development group.

The Regulatory and Biosafety initiative also provides leadership for permit application dossiers for those elite events for import, contained greenhouse, confined field and large-scale field experimentations as well as other uses by the product development group.  The Regulatory and Biosafety team is responsible for gathering regulatory data requirements, training project personnel in regulatory and biosafety issues and providing oversight to the other ABS programs, thereby contributing directly to the Public Acceptance and Communication strategy.

The ABS project is committed to complying with biosafety regulations and legislation of the African countries where it operates.  The project is committed to working with national and regional biosafety institutions and structures, to align with agricultural and biotechnology policies. 

In the early phase of the project, the Regulatory and Biosafety team focused on internal capacity building, with an emphasis on the development of a comprehensive work plan for the biosafety activities of the entire ABS project.  The second phase of training at Pioneer Hi-Bred focused on the development of ABS regulatory data packages.  A regulatory training manual and dossiers on the regulatory and bio-safety requirements in the countries of product deployment were compiled.

  8. Schmidt M, Bothma G (2006). Risk Assessment for Transgenic Sorghum in Africa: Crop-to-Crop Gene Flow in Sorghum Bicolor (L.) Moench. Crop Ecology, Management and Quality. Crop Science Vol. 46. pp 790-798 (2006)
  10. The Africa Biofortified Sorghum Project Mid-Term Report, December 2007
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