Regulations for Animal Biotechnology

REGULATIONS FOR ANIMAL BIOTECHNOLOGY
  • The regulation of animal biotechnology currently is performed under existing government agencies. To date, no new regulations or laws have been enacted to deal with animal biotechnology and related issues. The main governing body in USA for animal biotechnology and their products is the FDA. Specifically, these products fall under the new animal drug provisions of the Food, Drug, and Cosmetic Act (FDCA). In this use, the introduced genetic construct is considered the “drug.” This lack of concrete regulatory guidance has produced many questions, especially because the process for bringing genetically engineered animals to market remains unknown.
  • Currently, the only genetically engineered animal on the market is the GloFish, a transgenic aquarium fish engineered to glow in the dark. It has not been subject to regulation by the FDA, however, because it is not believed to be a threat to the environment.
  • The European Medicines Agency is responsible for the approval of phar­maceuticals derived through animal biotechnology, and the EFSA is respon­sible for approval of food derived from animal biotechnology. Regarding regulation of food bio­technology, the EFSA is responsible for scientific risk assessment. Directive 2001/18/EC regulates the distribution of GMOs and GMO use in food products, but there are no specific European regulations for food products derived from biotechnol­ogy, such as cloning that does not in­volve genetic modification. No distinc­tion is made between animal or plant products .
  • China currently is the sixth largest producer of GM crops, and its govern­ment has made a strong commitment to both plant and animal biotechnol­ogy. Animal biotechnology in China is governed primarily by three agencies: the Ministry of Health, the Ministry of Science and Technology, and the Ministry of Agriculture.
  • There are two main internation­al protocols that affect animal bio­technology. The Codex Alimentarius Commission (Codex) and the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.
  • The Codex, jointly administered by two United Nations agencies—the World Health Organization and the Food and Agriculture Organization—sets inter­national safety standards for foods. Before a food produced by biotechnol­ogy can be marketed, it is subjected to a pre-market assessment that evalu­ates both the direct and unintended effects on food safety and nutritional aspects that might arise because of the use of technology. Although it is a thorough risk assess­ment of the food safety issues, the Codex does not address the environ­mental, ethical, moral, or socioeconom­ic impacts of the technology.
  • The Cartagena Protocol on Biosafety to the Convention on Biological Diversity primarily is an environmental treaty. Its main purpose is to protect biologi­cal diversity from risks posed by “liv­ing modified organisms” (LMOs), taking into account potential risks to human health. Although the Cartagena Protocol thus far primarily has focused on plant biotechnology, its definition of LMOs equally encompasses ani­mals. The protocol adopts a precau­tionary approach; if a potential but not yet scientifically proven risk might ex­ist, that potential risk may be used as a reason to limit the importation or use of an LMO. There are 157 parties to the Cartagena Protocol, including India , most European countries and China . The United States and Australia are not parties.

Biotechnology authorities which controls biotechnology activities in India

  1. Genetic Engineering Approval Committee (GEAC) - functions under Ministry of Environment and Forests (MOEF).
  2. Review Committee on Genetic Manipulation (RCGM - function under Department of Biotechnology (DBT).
  3. Review Committee on Genetic Manipulation (RCGM) - function under Department of Biotechnology (DBT).
  4. Monitoring Cum Evaluation Committee (MEC)
  5. Institutional Biosafety Committee (IBC) - functions at research institution/ Organization level
  6. State Biotechnology Coordination Committee (SBCC) - functions under the state government where biotech research occurs.
  7. District-Level Committee (DLC) - functions under the district administration where biotech research occurs
Last modified: Tuesday, 15 May 2012, 8:01 AM