Guide for the Care and Use of Agricultural Animals in Research and ...

kept of individual work assignments and should includethe date and time of injuries or unusual illnesses. Supervisorsshould be instructed to fully inform personnelof potential health hazards, and personnel should be instructedto notify their supervisor if a zoonosis occurs.SPECIAL CONSIDERATIONSHazardous MaterialsThe use of certain hazardous biological, chemical,or physical materials necessitates compliance with applicablelaws and regulations as well as compliancewith guidelines issued by granting agencies and organizations.Institutions should have written policiesgoverning experimentation with hazardous materialsand should ensure that staff members conducting andsupporting research projects involving hazardous materialsare qualified to assess the dangers to animalsand humans and are capable of selecting appropriatesafeguards. Special facilities and equipment may be requiredfor certain hazardous materials, and additionalrequirements exist for those biological materials ortoxins deemed as select agents by federal law. Furtherinformation about recommended practices and procedurescan be found in publications by CDC and NIH(2000, 2007), CFR (2005), and NRC (1997).Genetically Engineered and Cloned AnimalsINSTITUTIONAL POLICIESAs advancements in research drive the discoveryand development of new technologies, specific considerationsmay need to be made for the care and use ofagricultural animals in research and teaching. Institutions,researchers, and IACUCs should assure that assessmentof animal care and use protocols reflects differencesin various animal technologies. Guidelines forresearch involving genetically engineered (GE) animalsor livestock clones do not differ materially from thosethat apply to conventional animals used in research exceptunder special conditions. The published scientificliterature has not established the need for unique guidelines.The general standards of care associated with GEor cloned agricultural animals should be the same asthose applied to all agricultural animals in research unlessthe specific genetic modification requires an alterationin management within the research environment tospecifically facilitate animal welfare.In the future, institutions may wish to establishguidelines used in keeping with federal, state, and localgovernment regulatory requirements. The animalbiotechnology industry recently released guidelines forresearch and development with GE animals as a stewardshipprogram for GE animals (Biotechnology IndustryOrganization, 2009). The BIO Guidance providesinformation for the development and implementation ofstewardship programs for all institutions and researchersthat plan to engage in research and development,and possible commercialization, of GE animals.Research Involving Genetic Engineering ofAgricultural AnimalsGenetic engineering of agricultural animals is thedirect manipulation of an organism’s genes, includingheritable and nonheritable recombinant DNAconstructs. Genetic engineering is different from traditionalbreeding, in which the organism’s genes aremanipulated indirectly. The genetic engineering of agriculturalanimals has been extensively reviewed (NationalResearch Council, 2002; Council on AgriculturalScience and Technology, 2003, 2007, 2009; Wheeler,2007). All GE animals in the United States are in researchand development, with currently only one approvedproduct from a GE agricultural animal in theUnited States. Animal welfare for GE animals used inresearch is regulated by law, regulations, and guidelinesof the US Department of Agriculture (USDA) and theNational Institutes of Health (NIH). For animals usedin biomedical research, their needs for thermal comfort,humidity control, floor space, and husbandry practicesshould be based on the performance standards outlinedin this Ag Guide. Animals in certain biomedical settingsand with certain genetic backgrounds may havespecial requirements that should be understood so thatanimals are comfortable. The same performance standardsthat indicate adequate animal welfare in an agriculturalsetting will apply for animals in a biomedicalsetting. Welfare of animals used in biomedical researchis currently regulated by law, regulations, and guidelinesof the USDA and the NIH. Specific informationcan be obtained by reviewing the NIH guidelines forresearch involving recombinant DNA molecules (NIH,2002) and the Animal Welfare Act regulations overseenby USDA. Furthermore, the US Food and Drug Administration(FDA) recently released guidance for industrythat may be helpful in the conduct of research with GEanimals (FDA, 2009).Research Involving Cloning of AgriculturalAnimalsAnimal cloning is an assisted reproductive technology(FDA, 2008) similar to artificial insemination, embryotransfer, and in vitro fertilization. The current techniqueused for animal cloning is somatic cell nucleartransfer (SCNT). In research, GE animals may be producedusing SCNT. There are no published US guidelinesfor unique requirements regarding the care anduse of animal clones in research. The care and use ofanimal clones in research does not differ from care providedfor conventional animals to assure good animalwelfare and animal well-being. In addition, because theprogeny of animal clones are not clones, clearly progenydo not require special consideration.5