CENTER FOR VETERINARY MEDICINE (CVM)
FDA and the Centers for Disease Control (CDC) have executed a Memorandum of Understanding (MOU) pertaining to the regulation of select agents and toxins (see Part II and Table I) used in investigational clinical studies. See DHHS, FDA, Memorandum of Understanding Between the Divisions of Select Agents and Toxins Center for Disease Control and Prevention and the Food and Drug Administration, 73 Fed. Reg. 9122, 9123 (2008). The MOU allows the exchange of limited information without violation of FDA's information disclosure prohibitions, upon receipt of consent by the sponsor product. It covers investigational uses of medical devices or human or other animal drugs that are, have, or contain a select agent or toxin. This exchange will enable the Division of Select Agents and Toxins within CDC to decide whether to grant an exemption from the registration requirements of the select agent regulations.
FDA and USDA recently confirmed their views of the safety of SCNT cloned animals and their offspring for food uses. See FDA Issues Documents on the Safety of Food from Animal Clones, Agency Concludes that Meat and Milk from Clones of Cattle, Swine, and Goats, and the Offspring of All Clones are as Safe to Eat as Food from Conventionally Bred Animals, FDA News (January 15, 2008) at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01776.html; and Statement of Bruce Knight, Under Secretary for Marketing and Regulatory Programs on FDA Risk Assessment on Animal Clones, Release No. 0012.08 (January 15, 2008) at http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?
contentidonly=true&contentid=2008/01/0012.xml. Clones that are also "bioengineered" through the use of recombinant DNA methods are not part of the decisions.
FDA released three documents that follow up on its 2002 cloning initiative (see Part III, CVM). These documents pertain to its risk assessment and its management plan, and a guidance for industry. See http://www.fda.gov/cvm/cloning.htm. The voluntary moratorium on food from clones continues until USDA addresses how to provide an orderly market transition, although it believes that clones themselves will be used primarily for breeding purposes, not food. Food from the offspring of clones can now be marketed. Because insufficient information is available on clones other than cattle, swine and goats, such as on sheep, the agencies continue to recommend that food from clones of species such sheep not enter the food supply. The guidance repeats this limitation. Special labeling is not required as with other "biotech foods." Importantly, the guidance also states that FDA does not intend to regulate SCNT under the new animal drug provisions of the FFDCA as a matter of its enforcement discretion, without addressing or deciding the substantive issue of whether some aspect of such cloning falls within such provisions. This discretion applies to both food and non-food cloned species.
Federal legislation to mandate labeling of food from cloned animals or their progeny as part of a Consumer Product Safety Commission (CPSC) reform initiative has recently failed, as did another legislative effort as part of the Farm Bill to delay FDA's release of its risk assessment on cloning (see Part III, CVM). FDA released the risk assessment before the legislation was acted upon. Nevertheless, various bills in states such as California, Kentucky, Michigan, and New York continue to endorse such labeling.
The issuance of FDA's latest position on cloning has prompted USDA also to clarify the status of animal cloning in terms of organic livestock production. The Agricultural Marketing Service, which administers the National Organic Program, notes that cloning is incompatible with organic food production and that food from clones cannot be certified as organic. It is planning a rulemaking to address the similar status of food from the offspring of cloned animals. See http://www.ams.usda.gov/nop/Newsroom/Cloning/1-15-08NOPCloningQA.pdf.
The CVM's position about the new animal drug status of "genetically engineered" materials used to create transgenic and other animals (see Part III, CVM) was recently explained in detail in a Federal Register notice announcing the availability of a draft guidance document. HHS, FDA, Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs; Availability (Sept. 19, 2008). See also Draft Guidance, Guidance for Industry, Regulation of Genetically Engineered Animals containing rDNA Constructs (Sept. 18, 2008). APHIS also issued a notice seeking comment on the subject of its options for the regulation of genetically engineered animals (see Part IV, BRS).
The CVM draft guidance addresses primarily "genetically engineered" animals that have been modified by recombinant DNA techniques, although the focus is on GE animals with heritable rDNA constructs. A majority of the provisions of the new guidance addresses investigational new drug (INAD) and new animal drug application (NADA) data and other requirements pertaining to such constructs and animals that contain them. Constructs involving different transformation events would be subject to separate NADA requirements, but a single INAD could still be used during investigational phases.
CVM emphasizes that it will use its enforcement discretion to apply INAD and NADA requirements to certain GE animals of non-food species. Similar to the position that FDA has taken with respect to other GE foods (see Part III, CFSAN), no special labeling is required, although the agency notes that FSIS has authority over most meat, poultry, and egg products. The lack of a special labeling requirement for GE foods has prompted some retailers to encourage developers to join tracking programs for cloned and GE food.
