Ethical, Legal, and Social Issues

Skepticism

Every development in science is accompanied by skepticism. This skepticism comes from misconstrued ideas and false impressions. Although there are also risks taken in order to pursue a greater goal, especially in biotechnology, the risks must be weighed along with the benefits. Crop Pharmaceuticals provide numerous benefits in comparison to the potential risks. Below are common anxieties of consumers from plant made pharmaceuticals.

PMP Crop and Food Crop Interactions

Many consumers are worried by possible mixups between PMP and food crops. This could occur by improper labeling or a mixing of seeds during planting, harvesting or transporting. Also, many are worried of the pollen flow between PMP and food crops. If pollen from genetically modified plants used to produce pharmaceuticals pollinate nearby food crops, this could cause negative effects for human or animal consumers.

As a solution to possible mixup of seeds, the USDA-APHIS require equipment for harvesting crop pharmeceuticals to be labeled and require tractors used on crops producing pharmeceuticals to be thoroughly cleaned before use on any other crop. Also, as the risk of pollen flow is greater in cross pollinating plants, plants that do not produce viable pollen are used to provide the pollen source.

Citation 1.7

Citation 6.1

Effects on Environment and Farmers

The potential effects plant made pharmaceuticals will have on the environment is a prominent stressor for consumers. Specificially, the rise in PMP levels in wildlife feeding off the crops, and microorganisms in the soil worry many. Farmers would be effected from the biopharmaceutical crops due to absorption through the skin, or inhaling pollen.

The effects of plant-made pharmaceuticals on the environment and on farmers is unknown at this early stage in development- it could be negative or have no effect. Biopharming is such a new field to know the possible side effects on the environment and farmers, the only way to be certain is to experiment with caution.

Citation 1.7

Citation 6.2

Regulations

The Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and U.S. Department of Agriculture - Animal and Plant Health Inspection Service (USDA APHIS) all have major roles in regulating genetically modified crops. Crops producing pharmaceuticals require additional regulatory oversight compared to genetically modified food crops. Clinical trials and marketing of PMPs must be approved by the FDA.

Citation 1.7

Citation 6.3

Citation 6.4

Citation 6.5