Animal & Veterinary
ACCOUNTABILITY BY WAY OF: "THE GOLD STANDARD" -- AAALAC
FDA Veterinarian Newsletter September/October 2000 Volume XV, No. V
By Jerrold Boone, B.A. and Mack Holt, D.V.M
The U.S. Food and Drug Administration (FDA) ensures that safety standards are met for foods, human and veterinary drugs, human biological products, medical devices, cosmetics, and consumer products emitting radiation. The agency verifies that products are honestly, accurately, and informatively represented to the public. Additionally, the agency also guarantees that regulated products are in compliance with FDA regulations and guidelines. If there are any instances of non-compliance, regulated products are identified and corrected, and any unsafe or unlawful products are thus removed from the marketplace.
FDA-regulated decisions are quality science-based decisions in the best interest of human and animal health. To facilitate this process, FDA has research programs that use in vivo and in vitro methodologies in the derivation of supportive data. All the operative units in FDA that have animal care and use programs conduct their research under the oversight of fully constituted and functional Institutional Animal Care and Use Committees (IACUCs). These committees execute all the duties and responsibilities prescribed by the Animal Welfare Act (AWA) and Public Health Service Policy (PHS) on Humane Care and Use of Laboratory Animals. Of the utmost importance to the IACUCs is the salient understanding that "quality animal care is critical to quality science."
FDA strives to be accountable for its laboratory animal programs. Since 1965 the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) has been promoting high standards of animal care through its voluntary accreditation program. Achievement of full-accredited status through AAALAC is considered to be the "Gold Standard" in laboratory animal care. The symbol of AAALAC represents to the laboratory animal community and the public that a program is operating at standards that exceed the Federal rules and regulations. It shows that the program provides and promotes optimal care and use for its laboratory animals. Full accreditation by AAALAC should be the goal of every research, testing, and academic institution because it demonstrates responsibility to the care, use, and welfare of laboratory animals. What better way to show that you are committed to your laboratory animal program and its operation?
Current Accredited Status of FDA Programs
Four out of the seven FDA Centers are currently AAALAC accredited. These four Centers are the National Center for Toxicological Research (NCTR), Center for Veterinary Medicine (CVM), Center for Biologics Evaluation and Research (CBER), and Center for Drug Evaluation and Research (CDER). The Center for Devices and Radiological Health (CDRH) was site visited by AAALAC on July 31, 2000. Upon conclusion of the visit, an indication by the site visitors was made that "Full Accreditation" would be recommended. This will mean that there are five Centers that are now "Fully Accredited." The Center for Food Safety and Applied Nutrition (CFSAN) and Office of Regulatory Affairs (ORA) are now in the process of preparing for AAALAC accreditation. It is a worthy goal for the FDA to have all of its Centers accredited by AAALAC because it says to the research community that FDA is committed to the highest quality of care and use for animals beyond what is stated in the Public Health Service Policy, Animal Welfare Act (AWA), the Guide for the Care and Use of Laboratory Animals, and other applicable regulations and guidelines. Basically, by having all of its Centers AAALAC accredited, FDA will signify the importance of meeting the "Gold Standard" in regulatory decision making.
FDA Accreditation Process
The first step in applying for accreditation is to request an application by either contacting the AAALAC International office or by downloading from the Web. The application packet contains an outline that will guide one through the application process, the "rules of accreditation", a copy of the Guide for the Care and Use of Laboratory Animals, plus any additional resources. The next and arguably most important step is to prepare and submit the Program Description. This includes the animal care and use policies and responsibilities, the animal environment, housing and management, veterinary medical care, and information on the physical plant. The Program Description states how you run your program on a daily basis.
The second step in the FDA process, which is optional, is to have an intramural review of your program and facilities. The Office of Animal Care and Use (OACU) with the approval of the Food and Drug Research Animal Council (FRAC), has developed an intramural review process that has been 100 percent effective for aiding Centers in gaining "Full Accreditation" from AAALAC. This intramural review process parallels that of the formal AAALAC site visit procedures. This process is an integral part because it helps a Center identify areas of deficiency prior to a visit from AAALAC and provides instructive recommendations for corrections. The Office of Animal Care and Use has maintained a 100 percent success rate in helping Centers achieve "Full Accreditation." Dr. Mack Holt, Director of OACU, provides leadership for the intramural review process.
The formal site visit team is made up of two or more AAALAC representatives. One member of the team is always a member of the AAALAC Counsel on Accreditation. It is important that all members of the IACUC be present for the site visit. The actual site visit involves an in-briefing interview where AAALAC representatives sit down and go over the Program Description with the unit seeking accreditation. The interview will be interactive in that the team members will ask questions about the program and possibly request some additional documents. Following the in-briefing interview, there is a tour of the facilities. The site visit team may choose to review selected policies and experimental procedures to assure the IACUC’s performance is consistent with regulatory guidelines. The exit-briefing interview, following deliberation by the team members, is where the site visit team members share commendations, recommendations for program improvement, and accreditation recommendation that will be made to the AAALAC Council.
The first and foremost goal of FDA is to have every Center achieve "Full Accreditation." The formal AAALAC site visit will frequently identify program improvement recommendations, which can usually be fixed in a short period of time. As previously stated, NCTR, CVM, CBER, and CDER have all been granted "Full Accreditation" by AAALAC and a recommended "Full Accreditation" for CDRH. CFSAN and ORA are in various final stages of preparation for making application for accreditation. Because AAALAC’s mission involves helping research institutions maintain excellence in the animal care and use program, they have developed different categories of accreditation. The ultimate goal of every animal care and use program is to achieve "Full Accreditation" on the initial site visit and to be granted "Continued Full Accreditation" with each subsequent triennial site visit. When "Full Accreditation" is granted, an annual program update is required along with site visits by AAALAC every three years. The site visit every three years follows the same process as if the institution was applying for the first time. With the maintenance of good records and strict adherence to the program, continued full accreditation following a three-year review is very rarely a problem.
Why Organizations Value Accreditation, "The Gold Standard"
AAALAC made recent inquiries of more than 600 accredited organizations. The organizations’ responses that are cited below reflect some salient benefits of AAALAC accreditation.
- "It assures the credibility of our program among funding sources."
- "It provides the public with a positive image and validates that our program meets or exceeds high standards for animal care and use."
- "It helps convince our administrators and upper management of the need to commit resources to maintain a high quality program."
- "It coveys a high level of professionalism about our program to the scientific community."
- "The application of AAALAC standards assures high-quality research and animal care, resulting in better science."
- "Completing the Program Description [part of the accreditation process] helps us identify weaknesses and deficiencies and self-correct them."
- "Pressure to stay accredited makes us more diligent in rechecking the basics on a regular basis."
- "The rigorous peer-review evaluation ensures that we’re doing things right."
The enormous benefit for having an animal care and use program AAALAC accredited goes without saying. The benefit of having all the Centers within the FDA AAALAC accredited is more than just having a sticker in the window; it holds FDA accountable to the public, its workers, and the entire research community. FDA will be making a statement in the research community that is everlasting.
Jerrold Boone is a fourth-year veterinary student attending Tuskegee University, Tuskegee, AL. This is his second year as a summer intern in the Office of Animal Care and Use (OACU). Dr. Mack A. Holt is the Director of CVM’s OACU.