Biosafety Regulation : A Review of International Approaches
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Washington, DC
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The focus of this report is crop
biotechnology, as developing countries are faced with
evaluating genetically engineered plants for human,
livestock, and environmental safety. These genetically
engineered plants can potentially contribute to agricultural
productivity in developing regions when appropriately
deployed, but there is uncertainty about the potential for
adverse consequences to environmental and human health. The
result has been regulatory regimes that are applied
specifically to assess the safety of these products. The
experiences of countries with long-established biosafety
systems, while not providing a single best practice model
for ensuring biosafety, point to a common set of issues
facing governments and policymakers. These issues are in
the areas of: the design and objectives of a regulatory
system; implementation mechanisms and regulatory
structures; a series of crosscutting considerations
including transparency, public involvement, integrating
biosafety regulation in other national policy objectives;
and regional or international harmonization. Drawing from
selected country experiences, the report explores each of
these issues in detail and provides policy direction on
points of consensus. Additional country-specific detail on
the regulatory approaches tested in countries where
genetically engineered plants have been approved for
commercialization is presented.
Palabras clave
BIOSAFETY; PLANT GENETICS; PLANT ENGINEERING; AGRICULTURAL ENGINEERING; REGULATORY FRAMEWORK; TRANSPARENCY; COMMUNITY PARTICIPATION; AGENDA 21, AGRICULTURAL BIOTECHNOLOGY, AGRICULTURAL COMMODITIES, AGRICULTURAL LAND, AGRICULTURAL PRACTICES, AGRICULTURAL PRODUCTIVITY, AGRICULTURAL PRODUCTS, AGRICULTURE, ANIMALS, APPLICATIONS, ASSURANCE, BIODIVERSITY, BIOLOGY, BIOSAFETY, BOVINE SPONGIFORM ENCEPHALOPATHY, BREEDING, CAPACITY BUILDING, COMMERCIALIZATION, COMMODITIES, COMPETITIVENESS, CONSUMERS, CONVENTION ON BIOLOGICAL DIVERSITY, CORN, COTTON, CROP, CROPS, CULTIVATION, DECISIONMAKING, DIET, DISEASES, ECOLOGY, ECOSYSTEMS, ENVIRONMENTAL IMPACT, ENVIRONMENTAL PROTECTION, ENVIRONMENTAL RISK, ETHICS, EUROPEAN COMMISSION, FAO, FARM, FARMERS, FEED, FINANCIAL RESOURCES, FISH, FOOD PRODUCTION, FOOD SAFETY, FOOD SECURITY, FORESTS, GENETIC ENGINEERING, HEAVY METALS, HERBICIDES, HYBRIDS, IMPORTS, INTERNATIONAL SERVICE FOR NATIONAL AGRICULTURAL RESEARCH, ISNAR, LAND RECLAMATION, LEGISLATION, LIVESTOCK, NEW TECHNOLOGIES, NUTRITION, PESTICIDE, PLANT BREEDERS, PLANT BREEDING, PLANT HEALTH, PLANT PESTS, PLANT PROTECTION, PRIVATE SECTOR, PRODUCE, PROGRAMS, PUBLIC PARTICIPATION, QUARANTINE, RAPE, RAPESEED, RATES, REGULATORY APPROACHES, RICE, RISK ASSESSMENT, RISK ASSESSMENTS, RISK MANAGEMENT, RURAL DEVELOPMENT, SALINIZATION, SCIENTIFIC ADVICE, SEED, SEEDS, SOIL CONSERVATION, SOILS, SUSTAINABLE USE, TOMATOES, TRANSFER OF TECHNOLOGY, TROPICAL RAIN FORESTS, UNCED, UNEP, UNION FOR THE PROTECTION OF NEW VARIETIES OF PLANTS, UNITED NATIONS, UNITED NATIONS ENVIRONMENT PROGRAMME, UPOV, YIELD LOSS