Within the United States, the Food and Drug Administration (FDA) exerts strict control over the commercial distribution of a pharmaceutical product, including biopharmaceuticals. Approval can require several years of clinical trials, including trials with human volunteers. Even after the drug is released, it will still be monitored for performance and safety risks. Biopharmaceuticals are medical drugs (see pharmacology) produced using biotechnology. They are proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source. [1] Bioreactors for producing proteins, NRC Biotechnology Research Institute, Montreal, Canada Arabidopsis is often used as a model organism to study expression in plants, while actual production may be carried out in maize, rice, potatoes, tobacco, flax or safflower. The advantage of rice and flax is that they are self-pollinating, and thus gene flow issues (see below) are avoided. However, human error could still result in pharm crops entering the food supply. Using a minor crop such as safflower or Tobacco, avoids the greater political pressures and risk to the food supply and the environment can occur to make this form of production socially desirable, or even economically feasible. Pharming in plants In 2002, ProdiGene was fined $250,000 and ordered by the USDA to pay over $3 million in cleanup costs after allowing a fraction of a bushel of volunteer pharm corn to comingle with the soybean crop later planted in that.