Institutional Infrastructure of Eg-BCH Operations:
1. The NEA and the project setup:   

The Egyptian Environmental Affairs Agency (EEAA) has shown the greatest interest in biosafety of biotechnology products, being constitutionally responsible for environmental concerns in Egypt and the national focal point for international environmental agreements including the Convention of Biological Diversity (CBD) and its Cartagena Protocol on Biosafety (CPB).
  EEAA represented Egypt during the negotiation of both the CBD and the CPB and spearheaded consultations within the Government and the civil society on positions expressed during meetings related to the two agreements. As the executive arm of the Ministry of State for Environmental Affairs (MSEA) EEAA was responsible for presentation of the CPB to the Legislators for ratification and was commissioned to implement a Ministerial Decree, which established the inter-ministerial committee, which drafted the national law on intentional release of biotechnology products into the environment.
  EEAA is responsible for implementation of Law 4 of 1994 (the Law of the Environment) and Law 2 of (the Law of Protected Areas). Like other laws in Egypt the official text is in Arabic and there are un-official translations to the English language. Each law also has an Executive Directive Regulation outlining the implementation procedures. All 4 instruments are accessible on EEAA site (www.eeaa.gov.eg). EEAA maintains an internet site (www.eeaa.gov.eg), which describes its activities. In addition, one of the component structures of the EEAA (the Nature Conservation Sector, NCS) maintains three subdomain sites: www.eeaa.gov.eg/nbd/nbu for the Nature Conservation Unit, www.eeaa.gov.eg/protectorates for the Unit of Protectorates and National Parks, and www.eeaa.gov.eg/NBD/CHMegypt for the Clearing House Mechanism of the Convention of Biological Diversity.
  EEAA maintains two subdomain sites: one for the basic environmental law (www.eeaa.gov.eg/english/main/law4) and www.gov.eg/english/main/orgchart6.asp for the organizational chart of the Ministry. The site for the environmental law states that the English translation of the law is only an aid to information dissemination, while the Executive Regulations of the law is in Arabic only. It includes links to scores of Egyptian and foreign sites, but not including the CBD secretariat itself. Through the site it is possible to download Environmental Impact Assessment Forms (A and B) in English as well as guidelines for filling them. Finally, the NCS of EEAA operates Egypt's site on the CBD Clearing House Mechanism (www.eeaa.gov.eg/NBD/CHMegypt).

2. Governmental Network of Institutions Relating to the BCH :

i. Ministry of Public Health and Population (MPH)
The relevant mission of MPH comprises safety to human health of products placed on the market. This includes medicines, vaccines and other immunologicals, foods and special food formulas. The Ministry maintains a user-friendly internet site (www.moph.gov.eg). 6 supervisory structures are specifically focused on this mission:
   1. National Institute of Nutrition (NIN): It was designated as a ‘Collaborating Institute for Research and Training’ by WHO. In addition to nutritional functions, it is concerned with food safety, and is responsible for analytical procedures for quality control of general & specialized foods.
   2. Biosafety Unit: This unit is being prepared to be the testing facility for genetically modified products in foods, in compliance with the Ministerial Decree No 242 of 1997 (based on Law No. 10 for 1966 on regulation and control of the handling of food), which prohibits the import "food products" whose "production involved genetic engineering until proven safe" requires that "all shipments of foods being grains or legumes" must be accompanied by a certificate from the country of origin "confirming that genetic engineering was not involved in its growing or production". With MALR more favorable to the release of GMOs, it requested a joint meeting for the Supreme Committee on Food Safety and with the National Biosafety Committee, General Organization for Standards and Quality, the Ministry of Provisions and the Ministry of Trade to place specific regulations for implementation of the MD. The meeting was held in August 1997 and produced an explanatory note, which was approved by the Minister of Health:

•  Re-confirming the need for transparency, protection of the local market, the right of the consumer to information and to choice and the right of the state to implement regulations which protect the health of its citizens;

•  No need for a certificate if the product is free from GMOs;

•  Shipments, which partly or wholly consist of foods produced using genetic engineering must carry a label stating "produced by genetic engineering" or "may contain foodstuff produced by genetic engineering".

• In all cases, documents should be presented to the Supreme Committee on Food Safety for examination of certificates and consideration of release and the committee may require laboratory analysis.
  The current laboratory capability of the unit includes: DNA extraction, electrophoretic analysis of DNA and proteins, PCR, ELISA reader and tissue culture propagating facilities. Three qualified scientists are fairly well trained. They have limited capacity for assessment of health risks in laboratory animals but they carry out ambitious training for technicians.

   3. Food Registration Unit: This unit is responsible for registration of "special foods" which includes: infant formulas, infant foods, bottled water, athletic foods, vitamin and/or minerals fortified foods, low calorie foods, high calorie foods, foods for special clinical cases, energy drinks, special volatile oils, non-drug herbs, honey, royal jelly, food fibers, etc.

   4. Egyptian Holding Company for Immunological Products: The company is home to several production companies for immunological products and their raw material. Several such products are of GMO origin, but no such products are manufactured as raw material: it is only formulated from imported products.
   5. Central Directorate for Laboratories: Since there are currently no obligatory regulations relating to the disclosure of the GMO origin of products, the laboratories do not carry out testing, monitoring and certification.
   6. Central Directorate for Environmental Concerns, with 2 relevant subsidiaries: General Directorate for Food Control and Supreme Committee of Food Safety.

ii. Ministry of Agriculture and Land Reclamation (MALR)  

 MALR maintains an internet site: www.agri.gov.eg. Among the relevant sectors of the Ministry is the Agricultural Services Sector, which includes the Central Directorate for Seed Production and the Central Directorate for Seed Testing and Certification. Among the more important structures are: The Agricultural Research Center, the Fisheries Development, the Veterinary Services and the Desert Research Institute.
   

  The Agricultural Research Center (ARC): This large research institution with 2,500 Ph.D in 16 research institutes, 5 central laboratories and 46 experimental stations maintains the web site: www.agri.gov.eg/MainMenuIe.aspx?Phd=1350. Among the more relevant are:

• Agricultural Genetic Engineering Research Institute, (www.agri.gov.eg/MainMenu-Ie.aspx?Id=gene.htm&Ph=870) with 10 laboratories (including Molecular Manipulation and gene Transfer, Micropropagation, Gene expression and Protein and Nucleic Acid Sequencing and Synthesis). The institute leads activities of the ARC in genetic engineering as a tool to improved productivity of agriculture and quality of its products. Current research includes genetic engineering of cotton, tomatoes, potatoes, wheat, barley, maize, marrow, bananas, etc. In addition the institute produces a non-genetically engineered bio-insecticide. It could also works on genetic mapping of agricultural crops and on genetic fingerprinting of plant varieties for purposes of intellectual property rights.

• The Central Laboratory for Aquaculture Research

• The Central Laboratory for Food and Feed

• The Veterinary Serum and Vaccine Research Institute (VSVRI) has 13 Departments and produces 15 poultry, 5 cattle, 5 sheep, and 3 domestic animal vaccines. None of these is genetically engineered and they represent 1.8% of total national consumption of veterinary vaccines.

  The National Biosafety Committee (NBC): Historically, a biosafety committee was first established at the ARC in 1992 in order to fulfill requirements for joint research projects with US funding. As part of the system it was deemed necessary to establish a "network" of such committees (departmental and institutional) channeling all its actions into a "National Committee". MD No. 85 of 25/1/1995 thus established the NBC of 13 members including an expert from the EEAA, an expert from the Ministry of Foreign Affairs and one environmental and two medical experts from universities. NBC was, however established under the authority of the Seed Registration Law.

iii. Ministry of Industry and Trade
The ministry is concerned with dealing with industrial products and facilitating trade with foreign partners. Among the key players are: the General Egyptian Organization for Standards and Quality, National Accreditation Council, Industrial Control Authority, General Organization of the Center for Egyptian Exports Development, General Authority for Regulation of Exports, The Chemistry Department, and the Sector on Trade Agreements.

iv. Ministry of Foreign Affairs (MFA)
The ministry maintains a well charted web site: www.mfa.gov.eg . Relevant offices are the Assistant to the Minister for International Organizations, the Assistant to the Minister for Sustainable Development and Environmental Affairs and the Assistant to the Minister for Economic Affairs and International Cooperation (www.mfa.gov.eg/MFA_portal/ar.eg/)

v. Ministry of Higher Education and State for Scientific Research (MHE)
The Ministry maintains an extensive web site: www.egy-mhe.gov.eg. It also maintains a web site for the Supreme Council of Universities (SCU): www.scu.eun.eg which is in charge of the Sectoral Committee on Biotechnology and Genetic Engineering Education which plans higher education in biotechnology. It also maintains a web site for the Universities Network: www.eun.eg which coordinates activities relating to, i.a., biotechnology and genetic engineering in 25 public and private universities in Egypt. The ministry also is home to the Academy of Scientific Research and Technology (ASRT): www.asrt.sci.eg which is the executing agency for the Ministry's National Strategy and Program for Biotechnology and Genetic Engineering.