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ADS 211: Biosafety Procedures for Genetic Engineering Research

ADS 211: Biosafety Procedures for Genetic Engineering Research. Draft USAID Guidance. Activities Covered. Transferring genetically engineered products to a developing country for release outside a contained facility Field testing livestock vaccines in a LDC

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ADS 211: Biosafety Procedures for Genetic Engineering Research

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  1. ADS 211: Biosafety Procedures for Genetic Engineering Research Draft USAID Guidance

  2. Activities Covered • Transferring genetically engineered products to a developing country for release outside a contained facility • Field testing livestock vaccines in a LDC • Field testing crop varieties in a LDC • Testing or releasing GE bioremediation products in LDCs

  3. Activities not covered • Genetically engineered human pharmaceuticals, incl. vaccines, which undergo FDA approval, thus already reviewed for potential environmental impact • Use of GE products in contained facilities such as labs, which are subject to existing NIH guidelines…

  4. Responsibilities • EGAT appoints Agency Biosafety Officer, responsible for: • Assisting CTOs or SO Teams in implementing ADS 211 • Supporting MEO, REO, BOE in incorporating external biosafety reviews into Agency env. Procedures • CTOs & SOTs ensure full compliance with ADS 211

  5. Policy & Procedures • Grantees are prohibited from transferring or releasing GE products prior to obtaining required written procedures as detailed • Proposal review – info required is in Reference Document to ADS 211 • External Review required • Host Country approval required of designated national authority

  6. USAID Determination • Upon receipt of above, Agency Biosafety Officer submits to CTO/SOT a recommendation • SOT/Mission submits recommendation, with IEE, to BEO of geographic Bureau • BEO, in consultation with Biosafety Officer, MEO, REO, makes threshold determination, provides to SOT, CTO, etc. • CTO/SOT conveys to grantee or contractor in writing the determination and any conditions

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