Frequently Asked Questions
Background: The Assessment and Accreditation of Laboratory Animal Care—International (AAALAC-International) reported to CDC serious concerns about its animal care and use program, following a site visit to Atlanta in late 2005. In February 2006, AAALAC decided to allow CDC to maintain its accreditation on a probationary basis.
Late last month, a five-member panel from AAALAC conducted a follow-up site visit to CDC’s Atlanta campus. While the official outcome will not be announced until next year, during an exit briefing members of the review panel said they now found CDC’s animal care and use program “commendable” in every area examined.
While many of AAALAC’s findings involved administrative issues, some were serious and involved infection control and animal care safety issues. For example, they identified instances of multiple ultrasound-directed percutaneous biopsy attempts on a single animal; problems with sipper tubes on some cages that limited access to water, which resulted in the unintentional death of two animals from dehydration; and inadequate cage-washing procedures that could have offered a theoretical risk to animal caretakers and nearby communities.
There were also errors in the 2005 AAALAC report, resulting from miscommunications during the 2005 visit. As a result, the report erroneously indicated things such as CDC withheld post-operative medication for a squirrel monkey, limited the amount of food chimps received, and did not have records for the use of veterinary drugs. CDC was gravely concerned that the accreditation visitors left CDC with these impressions in 2005 and provided evidence to the group that countered these assumptions.
CDC conducted a comprehensive review and determined that there was no single cause for the deficiencies, but a series of issues that led to these failings, including fragmented oversight, lack of centralized accountability, inadequate training, programs that outgrew resources, and outdated information management systems and equipment.
CDC is now committed to being an exemplar of excellence in animal care and use, but remains severely chastened by its past failings. We are deeply committed to maintaining the world class animal care and use program that we have now established.
Frequently Asked Questions
How could this have happened?
No one wants to believe that the things that went wrong did—it was a series of problems which occurred over time that we attempted to fix with patches. We know now that this needed a total reworking. We take full responsibility for the deficiencies we had. While no explanation may seen adequate, CDC did conduct a comprehensive review and determined that there was no single cause for these events. In fact, there was a series of issues that led to these failings, including fragmented oversight, inadequate training, programs that outgrew resources, and outdated information management systems. The agency has taken every possible measure to correct its deficiencies and is deeply committed to maintaining the world class animal care and use program that it has now established.
Why weren’t we informed about this sooner?
In January 2006, CDC told its workforce, while it began its comprehensive review, that AAALAC-International had reported serious concerns about CDC’s animal care and use program, following a site visit to Atlanta in late 2005. And in February 2006, AAALAC-International allowed CDC to maintain its accreditation on a probationary basis. During 2006, CDC was concerned with determining what needed to be done to ensure it addressed all of the concerns noted in the December 2005 AAALAC correspondence and was focused on restructuring its animal care and use program to ensure these system-wide corrections were permanent fixes.
What has been accomplished in the last year?
Late last month, a five-member panel from AAALAC-International conducted a follow-up site visit to CDC’s Atlanta campus. While the official outcome is pending, members of the panel, during a debriefing, said they found CDC’s animal care and use program “commendable” in every area examined. While CDC is awaiting the final formal report, which will not be available until sometime in early 2007, it was encouraged by the debriefing assessment. CDC set out in 2006 to not only address the concerns AAALAC raised but to build a world-class animal and use program and it believes that the final report will reflect that.
What were concerns AAALAC reported in 2005?
AAALAC reported to CDC in late 2005 that it was concerned about some practices that did not meet their standards. While many of AAALAC’s findings involved administrative issues, some were serious and involved infection control and animal care issues. For example, they identified instances of multiple ultrasound-directed percutaneous biopsy attempts on a single animal; problems with sipper tubes on some cages that limited access to water, which resulted in the death of two animals from dehydration; and inadequate cage-washing procedures that offered a theoretical risk to animal caretakers and nearby communities.
There were also errors in the 2005 AAALAC report, resulting from miscommunications during the 2005 visit. As a result, the report erroneously indicated things such as CDC withheld post-operative medication for a squirrel monkey, limited the amount of food chimps received, and did not have records for the use of veterinary drugs. CDC corrected these misperceptions with AAALAC.
What specific steps did CDC take to address AAALAC’s concerns?
CDC conducted a comprehensive review and took immediate and decisive actions to review its procedures to ensure the safety and well-being of its workforce and the animals entrusted to its care for important public health research. Steps taken included:
- CDC recruited additional professional staff and outside consultants with expertise in managing laboratory animal facilities. Working together with CDC’s regular staff, these experts were charged with the mission to quickly modernize the animal care procedures and practices. This charge included ensuring both the continued safety of workers and the highest standards of ethical and humane care of animals in CDC's research program.
- CDC invested an additional $3 million in 2006 to complete important upgrades to laboratory research facilities and to purchase an electronic records management system for its animal care program.
- Workers completed additional safety training and job-risk analyses. Appropriate employees are now entered into a medical surveillance program.
- CDC enlisted the help of experts to develop an environmental enrichment program (i.e., a stimulating environment that improves psychological well-being) tailored to non-human primates and also to other animals housed at CDC. CDC animal caretakers have been trained in animal enrichment and all animals have enrichment items. (CDC has many animal species and they differ over time. They include old world primates such as rhesus monkeys and new world primates such as owl monkeys. At any time CDC may also have ferrets, mice, rats, rabbits, raccoons and hamsters.)
- CDC adjusted lines of authority and responsibility to ensure impartial and highly credible oversight, including the assignment of three veterinarians and two animal caretakers with independent access to CDC's BSL-4 laboratory.
These actions and others have involved leadership oversight, worker-safety, animal care, and upgrades to laboratory facilities.
What was the outcome of the October 2006 AAALAC site visit?
At the October 24, 2006, AAALAC site-visit debriefing, their experts stated that CDC's animal care and use program was commendable, including CDC's institutional support, the energy of current staff to address concerns, and the hiring of 18 new employees in the program. Other areas mentioned as commendable included controlled-drug inventory; and clinical recordkeeping, especially for primates. CDC expects to hear a formal report from AAALAC-International about its accreditation status in the first quarter of 2007.
Would CDC lose its ability to conduct animal research without AAALAC accreditation?
AAALAC-International's voluntary accreditation program evaluates organizations that use animals in research. Those that meet or exceed AAALAC standards are awarded accreditation. CDC has had AAALAC accreditation since 1967. Accreditation, while voluntary, is important in attracting world-class scientists to CDC and ensuring the public’s confidence in the agency’s public health research that involves animals. AAALAC accreditation is not necessary to continue to conduct animal research.
Did you violate the U.S. Government principles for animals used in research by withholding prescribed postoperative pain medication for a squirrel monkey in your lab?
No. The post-operative pain medication for this squirrel monkey was administered as prescribed. The records were in transition and not found by the accreditation visitor. The treatment sheet reflects the drugs were administered as prescribed.
Are you starving animals so you can keep doing research on them?
Emphatically no. We were dismayed by this point in the preliminary report and questioned how anyone reviewing our procedures would conclude this. We believe that it was a miscommunication. The animals have access to food and water and can feed as they desire. After investigating the records and interviewing our staff, we found no evidence of these conclusions.
Then why did AAALAC report that CDC is "feed limiting" its animals.
We did not and do not "feed limit" animals. The weight plateau for some female chimps appears to be an artifact of their hepatitis infection and not limits on food. In the last two years, of about 16 chimps, CDC has retired 5 chimps that exceeded a 50 kg. weight. The animals had access to water and food as they desired. After investigating the records and interviewing our staff, we found no evidence of these conclusions.
Have you denied independent access to animals in the BL4 labs by independent oversight officials, such as veterinarians and the AAALAC investigator?
Unfortunately, in some instance we had to do so because of human safety concerns. To overcome those concerns, CDC is arranged for video monitoring of the animal area within the BL-4 suite which now can be monitored from multiple sites. Also, CDC does have one veterinarian and member of the Institutional Animal Care and Use Committee who had and still has independent access to the animals housed in the BL4 suite. During the October 2006 AAALAC site visit, a member of the AAALAC panel was able to enter the BL4 lab during the site visit.
Did you put the community at risk by transporting dirty and infectious animal cages between one Atlanta area lab ands another Atlanta area lab to use their cage washing machine?
We disinfected soiled cages at an Atlanta area lab before trucking the cages (in a secured truck) to a second Atlanta-area lab for cleaning. We believe them to be of no disease risk following disinfection. Nonetheless, we expedited the installation of cage-washing facilities at the first Atlanta area lab so that this practice is no longer necessary.
Did you put your laboratory workers and support staff at risk for infection by using improper cleaning materials in the labs?
We did use wooden-handled brooms in laboratories. We are replaced them with materials that better resist contamination and can be more easily disinfected. Our Office of Health and Safety has no reports of illness among these workers related to their work.
Did you kill non-human primates by overdosing them during operations?
Sadly, during operations, we did have three animals die from the anesthesia and analgesic combinations. These were administered based on published dosages. We adjusted the dosages based on our own calculations to a safer dose. At the time these deaths occurred, CDC suspended the research to determine the cause of these deaths.
Did CDC scientists do multiple invasive procedures on a single animal?
We did attempt 10 percutaneous biopsies using an 18 gauge needle on an anesthetized animal. With the support of CDC's Institutional Animal Care and Use Committee, an oversight group, this is now limited to no more than three.
Were veterinarian drugs mishandled by CDC?
We did have inadequate pharmaceutical accounting procedures although we have and can account for every milliliter of prescription drugs. However, we were allowing people who had access to the drugs to also do the auditing, which can be considered a potential conflict of interest. This has been corrected through separate, independent chains of authority for inventory control and auditing.
Are your chimps being deprived of badly needed environmental stimulation?
We did need to improve our chimp environmental enrichment program. We worked with the American Society of Primatologists and a highly regarded animal behaviorist to do that. We have also instituted environmental enrichment programs for all of our animals which AAALAC noted in their October visit as commendable.
Are animals not getting the care they need because there's no one to look out for them on weekends or at night?
The animals are cared for seven days a week. We also have environmental controls to alert us if something changes in their environments. We reviewed the ratio of animal caretakers to animals in our care to ensure we achieve the excellence in animal care and use they we are striving to accomplish. We have hired additional caretakers to increase the ratio of caretakers to animals.
Your records sound like they're a mess. How can you know what's going on with the care and management of these animals with sloppy recordkeeping?
We did have serious information management and administrative gaps. We invested in an electronic information system to improve animal medical record keeping and animal care recordkeeping.
Where's the leadership on this? How could this happen?
This is troubling for all of us and has been fixed. CDC takes full responsibility for the mistakes it has made in its laboratory animal care program. We did need more and better organized oversight. We retained external Institutional Animal Care and Use Committee (IACUC) specialists to serve as consultants. In addition, the IACUC program office is now part of the CDC Office of Chief Science Officer, Office of the Director. These steps will improve the independent oversight of the animal care program. In addition, in FY 2006, CDC invested an additional $3 million to upgrade facilities, improve recordkeeping, and train staff and hired 18 additional full-time employees. Each item in the increased budget was linked to a milestone that CDC pledged to AAALAC that would be completed by September 2006.
On what CDC campuses is animal research done?
In Atlanta, three campuses have animal research facilities. These were the focus of the 2005 AAALAC accreditation visit that led to the overhaul of the CDC Atlanta animal care and use program.
How long has CDC done animal research in its laboratories?
CDC has done animal research under AAALAC accreditation since 1967.
What species of animals are involved in CDC institutional research?
We have many species and they differ over time. They include old world primates such as rhesus monkeys and new world primates such as owl monkeys. At any time we may also have ferrets, mice, rats, rabbits, raccoons, and hamsters.
On average, how many non-human primates are in CDC laboratories?
Approximately 500.
Who supplies non-human primates and other animals to CDC for laboratory research?
We are supplied by commercial vendors and, sometimes, from other research labs.
How many animal-control workers does CDC have?
CDC employs clinical veterinarians, animal health technicians and animal care takers. The numbers vary by facility.
Are animals supposed to be monitored 24/7?
Animals are monitored by people 7 days a week. They are monitored at night through technology. A veterinarian is on-call at all times if an animal needs immediate care during the night.
What are CDC's current procedures to report problems related to animal care?
CDC takes this seriously and has a number of ways for people to report their concerns. In fact, posters are displayed around the facilities to tell workers how to report an animal care concern, including how to do it anonymously.
Is this the first incident of violations related to animal care for CDC?
CDC was notified of concerns by AAALAC in the recent past, although the preliminary report from the 2005 site visit was the most serious and spurred the immediate response to overhaul the program.
How long has CDC been aware of AAALAC's findings and decision?
CDC was given an oral report at the end of the actual site visit in 2005 which addressed some, but not all of the issues raised in the Dec. 1, 2005, preliminary written report. CDC received AAALAC's letter with their preliminary findings and pending decision the first week of December. After receiving this letter, CDC contacted AAALAC and asked, per their procedures, for an oral hearing which was held in January of 2006. Also, the CDC director called AAALAC to state firmly the agency's commitment to working with AAALAC and take the steps necessary to maintain its accreditation. AAALAC accepted our preliminary steps and maintained our accreditation on a probationary status during this year as we worked to investigate and correct all deficiencies.
What does this mean regarding ongoing and future animal research at CDC?
Frankly, AAALAC accreditation is the gold standard for animal research laboratories. CDC could continue animal research without AAALAC accreditation and would be designated a Category II laboratory by the Public Health Service. However, CDC highly values AAALAC's accreditation and took immediate steps to allow AAALAC to continue to give CDC their accreditation. AAALAC's work is exceptional and represents the spirit in which CDC wants to manage its animal care program. Our goal is to fix problems swiftly and then work out failsafe systems to ensure that they are prevented in the future.
Who will be held accountable at CDC for these violations?
Some problems, especially in regard to oversight and records management, appeared systemic and these were corrected immediately. The program was beginning to evolve in 2005 with the arrival of a new head of the group than manages animal resources and important steps had been instituted. With the help of AAALAC and other independent external consultants, the team is now in place to build a world class animal care and use program at CDC. We hope that these and other steps that CDC took convey the seriousness of its response to the report and our desire to provide ethical and humane care for our animals.
What would happen if CDC did not do animal research? What are the public health consequences?
There would be consequences. All of CDC's animal research is done to advance knowledge to improve the health and well-being of humans. For example, CDC has ongoing research involving its chimpanzees to look for a vaccine to prevent deadly hepatitis C. Hepatitis C causes chronic liver disease which can be fatal, and is the leading cause for liver transplants. In addition, CDC's scientists work with ferrets to help determine which strains of the influenza virus should be included in the annual vaccine. Research with ferrets is also looking at the Avian Influenza H5N1 which is causing grave concern about potential pandemic influenza. This research as well as other research such as that related to HIV is vital and must continue.
How much money does CDC spend on animal care?
Between FY 2003 and FY 2006, the Animal Resource Branch spent about $5.2 million a year. Following the AAALAC preliminary report, CDC increased that budget by 55%. Excluding one time equipment purchases in FY 2006, the FY 2007 budget included a 3.5% increase over the FY 2006 budget.
Is CDC aware of any persons who may have become ill from these practices? Has CDC investigated this?
CDC’s Office of Health and Safety has no record of illnesses related to any of these practices among humans.
Have you investigated whether the community was or is at risk from these practices?
While the thought of soiled animal cages on the road may sound unpleasant, the risk, at worst, is theoretical. However, we understand the concern and expedited the creation of back up cage washing facilities at the Atlanta animal care site, thus eliminating need for the transport.
Do CDC staff lack training to protect them in these laboratory environments?
CDC's Office of Health and Safety has had no reports of infectious disease illnesses among the animal care personnel or persons in support function roles. CDC carefully reviewed who in the animal care and support function roles should be included in its occupational health and safety program and to what extent. The CDC Office of Health and Safety's working recommendation as of today is that all who enter animal areas (for any reason) would be enrolled in the program.
What is the process to allow someone into these areas?
The following are current components of the medical clearance and the Office of Health and Safety Program for the group that does animal care. These are extensive and broad interventions to assure the health and well-being of those working in the animal areas.
Initial ARB Fitness for Duty exam includes:
Height, weight, B/P, Pulse
Vision/ color perception
Baseline serum
Hepatitis C titer
Td booster if >10yrs. since last immunized
MMR immunization or titer
Positive varicella history or titer
Hepatitis A, B, Rabies immunizations or Hepatitis B and/or Rabies titers as
indicated
2 step TB skin test
Respiratory clearance and fit testing and training
Audiogram
**Physical exam performed by NP or PA for Fitness for Duty (we have specific
clinical forms for this)
Position description accompanies exam.
All animal caretakers must be able to lift 40lbs above the head.
Annual renewal exam includes:
Baseline serum
Hepatitis C titer
Rabies titer
TB skin testing - ** this is done every 6 months
Respiratory clearance and fit testing and training
Audiogram