E4L11P1 - Molecular Biotechnology and Society

Recombinant gene safety concerns

Intorducing foreign genes to microorganisms raised concerns about bio-weapons, specifically for toxin genes of pathogenic bacteria. Concerns about unintentional release of modified organisms into the environment

NIH guidelines 1976

containment protocols, work with organisms least likely to proliferate in the wild, Negative pressure rooms(prevent escape of airborne pathogens), Prohibit release of recombinant microorganisms into environment.

Regulations of GMO deliberate release

assessed on case-by-case basis for pathogenicity. EPA regulates under Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). TSCA regs microorganisms with intergenic genetic material. FIRFA regs microbes engineered to be bio pesticide or herbicide

Chymosin

Enzyme used in cheese production. Historically obtained from 4th chamber of calf stomach. Gene cloned, expressed in E. coli K-12, and proved to be as safe as natural enzyme. Gene sequence assessed to be identical, same molecular weight, and same biological activity. Then demonstrate that the enzyme is free of toxic components of E. coli. FDA recognizes enzyme as Generally Recognized as Safe (GRAS)

Bovine Somatotropin

growth hormone in cows that increases milk production. FDA analysis assessed for ‘hormone laced milk’ and increase rate of bacterial infection of milk glands. Neither concerns were significant enough to hault the growth hormone.

Genetically modified crops

US processes 40% of global supply of GMO crop plants. Resistance to herbicides and insect predation. Climate change brought about interest in drought resistant GMOs. Trivial flower color engineering.