The manufacture of the drug must satisfy the "current Good Manufacturing Practices" regulations of the FDA. They are typically manufactured in a clean room environment with set standards for the amount of airborne particles. One approach to this technology is the creation of a transgenic mammal that can produce the biopharmaceutical in its milk (or blood or urine). Once an animal is produced, typically using the pronuclear microinjection method, it becomes efficacious to use cloning technology to create additional offspring that carry the favorable modified genome.[1] The first such drug manufactured from the milk of a mammal, such as a cow, sheep, or goat, is a common application, as milk production is plentiful and purification from milk is relatively easy. Hamsters and Rabbits have also been used in preliminary studies because of their faster breeding. Within the United States, Transgenic plants including but not limited to those which produce pharmaceuticals, are regulated by three government agencies which comprise the Coordinated Framework for Regulation of Biotechnology established in 1986. 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 field. Although the chance of gene flow between species is claimed to be low and there was in this case no threat to consumers, the USDA has a zero.