CENTER FOR VETERINARY MEDICINE (CVM)
One of the first debates involving FDA and modern biotechnology relates to recombinant bovine somatotropin (rBST), an animal hormone drug manufactured by recombinant DNA (R-DNA) methods that was approved in 1993 to increase milk production in diary cattle. The approval triggered significant debates about the economics of milk production as well as a labeling controversy and a related court case. See Office of Technology, U.S. Congress, U.S. Dairy at a Crossroad: Biotechnology and Positive Choices (1991); HHS, FDA, Interim Guidance on the Voluntary Labeling of Milk and Milk Products From Cows That Have Not Been Treated With Recombinant Bovine Somatotropin, Notice, 59 Fed. Reg. 6279 (1994), and International Dairy Foods Association v. Amestoy, 92 F.3d 67 (2d Cir. 1996). The debates continue yet today. See, e.g., FDA and FTC decline to take actions against rBST-free claims, Food Chemical News (Aug. 31, 2007).
With the advent of transgenic animals, CVM has taken the position that the genes used to create such animals, a type of "gene therapy," are new animal drugs either because they are used to treat disease or are intended to affect the structure or function of the body. A real life example is the use of genes coding for growth hormone in salmon to enhance their growth. On the other hand, CVM has decided not to regulate a genetically engineered ornamental fish know as Glofish because of the lack of food or environmental threats, a decision that was upheld in court. See Pew Institute on Food and Biotechnology, Issues in the Regulation of Genetically Engineered Plants and Animals (April 2004); FDA Statement Regarding Glofish at http://www.fda.gov/bbs/topic/NEWS/2003/NEW0094.html; and International Center for Technology Assessment v. Thompson, 421 F. Supp. 2d 1(D.D.C. (2006)).
In 2002 CVM proposed a moratorium on the marketing of food from cloned livestock involving SCNT as well as from their offspring, and has since developed a management plan to identify the relevant issues that must be considered in managing the risks associated with animal cloning in the production of food, essentially saying that most cloned food is safe. See A Risk-Based Approach to Evaluate Animal Clones and Their Progeny - DRAFT (Dec. 1996) at www.fda.gov/cvm/CloneRiskAssessment.htm. This initiative has been challenged in the form of a citizen petition asking that SCNT be regulated as a new animal drug. Center for Food Safety, et al., Citizen Petition Seeking Regulation of Cloned Animals, 2006P-0415 (Oct. 12, 2006), available at www.fda.gov/OHRMS/DOCKETS/06p0415/06p415.htm.
The Senate recently voted to approve the Farm Bill, where its version contains a number of provisions on cloned animals, including the requirement that studies be required before FDA could finalize commercialization of food from cloned animals and their offspring.
A number of enzymes derived through the use of R-DNA methods have been the subject of CVM "no objection" letters for animal feed uses, including alpha amylase, xylanase, protease, and phytase.
