United States Law and Policy
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There are 3 main services that manage genetically engineered (GE) crops: the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the Animal and Plant Health inspection Service (APHIS). The FDA ensures that the foods are safe for humans and animals to eat. The EPA makes sure that the pesticides introduced for the development of the GE plants are safe for humans to consume. The APHIS (Animal and Plant Health Inspection Service) oversees the growing process of the plants. Because no law has actually been passed, they are regulated in interpretations of the laws, which are grouped into the areas above.
FDA
The FDA’s basis is to guarantee to the consumers that the GE foods are substantially equivalent to conventionally grown food. In May of 1992, the FDA stated in the “Statement of Policy: Food Derived from New Plant Varieties” that the GE crops do not have to be labeled because transgenic genes are not considered food additives. In 1996, the FDA publishes the guidelines for the “consultation” in order to evaluate the GE products to know if they are safe for humans and animals to consume. Lastly, in 1998 the FDA releases guidelines that state that they should evaluate the use of antibiotic resistance markers.
EPA
The EPA’s main focus is to oversee both chemical and biological pesticides used in plants are safe for humans to eat. The EPA has a division of Biopesticides and Pollution Prevention that manages the distribution, use, and testing of the pesticides. The pesticides may not be utilized in the US if not registered by the EPA. The EPA approves pesticides based on if they will cause unreasonable environmental effects. This is evaluated by means of a “risk assessment” which focuses on the positives and the negatives of the pesticides and sees how they balance out. The EPA is developing practices to manage potential harm from Bt products.
APHIS
APHIS is responsible for protecting the plants from diseases and pests. Depending on the organism, APHIS has some requirements in order to allow a field test to occur for a company/university. They either need a letter notifying them of the filed test or a permit. This requirement is important to ensure that no risk may escape into the wild. After the field test, they need approval from APHIS. The approval process includes a simple impact of the environment check. After finding no significant impact, they can officially be “commercialized” even though the EPA and FDA can still raise questions. Therefore, the APHIS reviews developed food to ensure the products are safe, and allow them to be sold.
The science of embryonic research has been controversial. Stem cell research involves the retracting of cells from one embryo to be used to treat diseases or injuries. But the retracting of cell will cause the embryo to be destroyed, which many believe to be taking a life. Therefore, Bush released his stem cell research policy in 2001: the limiting of stem cell research to more than 60 lines already in existence. It turns out that only 23 of those lines are available under Bush’s policy. The result has been a decrease in the research treatment of Alzheimer, Parkinson’s, diabetes, spinal injuries, heart disease, and muscle dystrophy.