Institutional Animal Care and Use Committees: Creativity and InnovationBy Mack A. Holt, D.V.M. The U.S. Food and Drug Administration (FDA) has as its principal mission that of ensuring safety standards are met for food, human and veterinary drugs, human biological products, medical devices, cosmetics and consumer products emitting radiation. The Federal Food, Drug, and Cosmetic Act (The Act) requires manufacturers of certain consumer products to determine prior to marketing which products meet safety and effectiveness requirements of the law and are properly labelled. The FDA fulfills its regulatory mission through the activities of six organizational Centers and the Office of Regulatory Affairs (ORA). All Centers and ORA have independent Institutional Animal Care and Use Committees (IACUCs) which carry out their responsibilities in a manner consistent with those described in the Animal Welfare Act and the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each IACUC has oversight for the animal care and use program in its operational area. These areas involve research, product testing, and method development. The IACUCs of the Centers carry out their responsibilities in a rather conventional manner. These Centers have the major portions of their animal care and use programs located in the same geographical location as the IACUC members. However, to accommodate the animal care and use program for the Office of Regulatory Affairs, the facilities are situated in three geographical areas--North West, North East, and South West. The ORA fulfills its mission in FDA through the conduct of inspections and investigations of food, drug, medical devices and biological establishments (both domestic and foreign), performs regulatory sample analyses, conducts research, and recommends enforcement actions. The animal care and use program encompasses regulatory sample analyses and research portions of the mission fulfillment. Much of the work that ORA does in sample analyses and research involves in vitro activities. However, some regulatory procedures require the use of in vivo techniques. The in vivo techniques utilized require only rodents. To accommodate these procedures, ORA's IACUC has used innovative and creative mechanisms to carry out its responsibilities. The innovative and creative activities of the IACUC are illustrated in its membership, training, protocol review, veterinary care, and program reviews/facilities inspections. The membership is comprised of two representatives from each of the three facilities, a non-affiliated member, an FDA veterinarian, and a headquarters representative. In addition to the nine members, there are alternates representing each of the above areas. The members serve three year terms. Upon the initial appointment, a training/orientation program was developed and all members participated at a central location. Ongoing training needs are identified and addressed through utilization of appropriate resources. Since the members are situated in multiple geographic locations, the meetings are held monthly via teleconference at pre-determined times and dates. The teleconferences are initiated at the location of the chairperson. Prior to the meeting, the agenda and other items or documents to be reviewed are sent to all members and alternatives via E-mail, regular mail, or fax. At the conclusion of each meeting, the chairperson does a summary of derived decision and action items which provide the agenda framework for the next meeting. All protocol reviews are coordinated through the chairperson. There is a designated protocol review panel comprised of at least two scientists, the non-affiliate member, and the veterinarian. The panel reviews are conducted via teleconference prior to the scheduled meetings. All members receive copies of the protocols to be reviewed in order that they are apprised of the reports/recommendations from the protocol review panel during a given teleconference. However, a full review may be requested by any member. The requirements of semiannual program reviews and facilities inspection are coordinated for timeliness and economy. Efforts are made to conduct them when possible during the time of or in conjunction with the attendance of meetings or conferences to the three geographical areas. The chairperson strives to have the appropriate make-up of members present for the conduct of the reviews or inspections at a designated location. There is an innovative program plan for veterinary care. The IACUC veterinarian has delegated authority for veterinary care with a prescribed means of communicating animal observations by persons responsible for husbandry at each locale. Should the need arise, agreements are established with trained local veterinarians familiar with the facilities and programs to address emergency needs. The successful oversight of animal care and use programs as described above can only be a reflection of organizational support, committee leadership, a spirit of committee cooperation, and a strong sense of purpose. IACUCs have important responsibilities and can frequently fulfill them in unconventional ways through creative and innovative means. | 
