RESUMO
The production of pharmaceutical proteins in plants, particularly in maize (corn), offers solutions to the limited production capacity and flexibility of current cell culture technologies. Implementation of this technology presents unique challenges to industrial hygiene, safety, and occupational medicine, including the handling of pharmaceuticals in the context of agricultural production and the processing of grain for extraction. Protein-related challenges include: (1) widely varying potential for hazard depending upon the activity of the protein and nature and location of the target molecule; (2) limited data related to industrial routes of exposure; and (3) the inability to obtain relevant animal data because of high species-specificity. These challenges necessitate the development of novel approaches to industrial hygiene and safety. Realizing that much remains to be learned, our approach uses conservative assumptions to assure protection of employee health.