Applying the Good Laboratory Practice regulations to studies involving genetically modified plants.
How can the Environmental Protection Agency's Good Laboratory Practice (GLP) regulations, originally written primarily for mammalian toxicology studies, be applied to regulatory studies conducted for genetically modified plants? Do they fit? Can they be applied and still make sense? How is a Quality Assurance Unit (QAU) to interpret the requirements in this new area of biotechnology? The answers to these questions are discussed in this brief presentation of how one team within the Monsanto QAU, along with the researchers, developed am effective and comprehensive compliance program by applying the "traditional approach" to the GLP regulations to a new and important scientific field in regulatory compliance. Topics discussed will address the differences in the approach between traditional toxicity testing and the newer technology and how the differences were resolved, new and innovative definitions of particular phases and other aspects of regulatory studies, and how the draft regulations for pesticidal plants will help this area of technology in the future.
Holden
D E
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Monsanto Company, St. Louis, MO 63198, USA.
D000818:Animals; D005161:Facility Regulation and Control; D007221:Industry; D007753:Laboratories / Q000592:standards*; D010573:Pesticide Residues / Q000592:standards; D010575:Pesticides / Q000592:standards* / Q000633:toxicity; D030821:Plants, Genetically Modified; D011786:Quality Control; D014116:Toxicology / Q000592:standards; D014481:United States; D014484:United States Environmental Protection Agency
D010573:Pesticide Residues; D010575:Pesticides