Module IV: Biotechnology and Biosafety

Faculty presented a case study of biosafety in Egypt. The Egyptian biosafety system was instituted in 1995, following an intensive workshop on biosafety held in Cairo in 1994 involving the Agricultural Genetic Engineering Research Institute (AGERI), the Agricultural Biotechnology for Sustainable Productivity (AGSP), and the Egyptian National Agricultural Research Project, along with other international agricultural organizations and seed companies. The guidelines were drafted very quickly, from the January 1994 workshop to the issuance of the guidelines in January 1995, and were based on US and European guidelines.

The Egyptian biosafety guidelines are not legally binding, with only advisory status; they lack details regarding review, decisionmaking, and reporting processes; and they have not been well publicized within the country. The initial biosafety committee comprised ten scientists, but was later expanded to include 30 people. However, the committee included only technical members, despite a specification in the guidelines recommending the inclusion of non-technical members. Nevertheless, the guidelines have functioned since 1995, with 23 permits for field trials issued and three GM crops moving toward commercial release. Findings on the Egyptian experience to date include:

• Relevant safety issues were not always raised in the review procedures; for example, geneflow and pest resistance concerns were not considered.
• Significant delays were experienced during the application and review procedures.
• There is a need to streamline the seed registration process.
• There has been no mechanism for public feedback and no strategy in general for public relations.
• There have been no reporting requirements at the end of field tests.
• The system includes no funding for information acquisition or attendance at meetings and workshops for education and training.

After discussing the case study, participants broke into working groups for the purpose of making biosafety system recommendations in four key areas: guidelines, people, review process, and feedback mechanisms. Their recommendations are summarized below.

• Guidelines: The first priority recommended was to define the legislative framework, i.e., clarify what relevant laws and regulations are already in place, what new ones may need to be written, and what enforcement and punitive mechanisms will be associated with the biosafety process. Participants recommended the establishment of an inter-ministerial body, with the secretariat within the Ministry of Environment, to coordinate government policy and serve on a national committee on biosafety.
  
  
• People: Participants recommended that a national committee on biosafety should include farmers’ associations, industry representatives, universities, research institutes, NGOs, churches, and other "opinion leaders," as well as a range of government ministries (agriculture, environment, trade, finance, commerce, justice, science and technology, health, education) and mass media contacts. Priorities included developing clear terms of reference for the committee and ensuring public participation in decisionmaking.
  
  
• Review process: Again participants called for a clarification of the existing legal regime and the establishment of a national biosafety review committee with broad representation to monitor and control genetically modified organisms. Other recommendations included the creation of a publicly accessible database of genetic research developments and product approval applications, and an investment in training and information access to build local institutional capacity for performing biosafety assessments.
  
  
• Feedback mechanisms: Recommended mechanisms included consultations with experts (actively seeking multiple points of view), publications to help keep the public informed and better able to respond, and open channels of communication with stakeholders, including researchers, private firms, farmers, NGOs, et cetera.

Participant recommendations were closely aligned with the recommendations generated by the review committee that analyzed the Egyptian biosafety system. Other recommendations in the Egyptian case included:

• Revise guidelines to include a clear statement of purpose with specific objectives and a detailed "road map" with instructions and examples; upgrade status of biosafety committee to have legal authority to ensure compliance with recommendations.
  
  
• Institute a secretariat for administration of the national biosafety committee, responsible for information collection and dissemination; broaden the funding base to include multiple ministries; rotate committee membership; consider ad hoc technical committees rather than a standing subcommittee; consider delegating laboratory and greenhouse approval requests to an international biosafety committee.
  
  
• Improve procedures by creating realistic timelines for review and decisionmaking; include financial support for information acquisition and meeting attendance; commission risk assessment studies tailored to Egypt’s particular circumstances; assign national laboratories to certify food and feed safety.
  
  
• Define a feedback process; create a strategy for public awareness, e.g., train spokespersons in risk communication and use mass media.

In conclusion, a consensus among participants emerged that biotechnology is to some extent inevitable, and has great potential to benefit Africa; the continent must better prepare itself through capacity-building measures in research, industry, and biosafety regulations.