Purdue Animal Care and Use Committee Purdue University

Vol. 15, No. 3, December 2000
 
 

(excerpted from the Journal of the American Veterinary Medical Association, Vol. 217, December 1, 2000)

Under the terms of a controversial out-of-court settlement with an animal rights group, the USDA has agreed to initiate rule making to expand federal animal care regulations to include birds and laboratory rats and mice.

Shortly after the settlement was reached September 25, 2000, some in the biomedical research community sharply criticized the department’s decision, saying the regulations would cost millions of dollars to implement and potentially hinder research.

But a last-minute amendment to the Agriculture Appropriations bill will delay the agreement from moving forward for at least a year. Mississippi Sen Thad Cochran introduced a provision that forbids the USDA from spending funds in the coming fiscal year on any rule-making process that changes the definition of "animal" in the Animal Welfare Act.

In March 1999, the Alternatives Research and Development Foundation, the scientific affiliate of the American Anti-Vivisection Society, sued the USDA to remove the exclusion of birds, rats, and mice from the definition of "animal" in the Animal Welfare Act. The foundation supports the development and use of alternatives to laboratory animals.

Birds and laboratory rats and mice are not included in the rules that direct the USDA to enforce regulations and set standards for veterinary care and animal husbandry. These standards include requirements for handling, housing, feeding, sanitation, ventilation, shelter from extreme weather, veterinary care, and separation of species when necessary.

According to the National Association for Biomedical Research, about 1.2 million animals used annually for research are regulated under the law. These include such warm-blooded animals as nonhuman primates, dogs, cats, rabbits, guinea pigs, hamsters, and farm animals, when used for research. But an estimated 23 million rats and mice are also used for research each year.

NABR Executive Vice President Barbara Rich believes the year allows the research community time to consider the ramifications of the settlement. NABR supports public policy that promotes humane care and treatment of laboratory animals in research. The organization opposes the settlement on account of the logistical burden and associated costs it would create for biomedical research institutions. Rich doubts whether the USDA has the resources to inspect the hundreds of additional research facilities that would have to comply with the new regulations.

Many research institutions, such as the National Institutes of Health, already have in place guidelines regulating the use of research animals not covered by the Animal Welfare Act. NABR estimates that about 90 percent of all laboratory mice and rats are covered by one or more of these rules.

In a letter to those in the biomedical research community concerned about the decision, Agriculture Secretary Dan Glickman explained the reason for settling the suit was to avert a potential court order mandating immediate coverage of rats, mice, and birds, without an opportunity for public comment. "Such a judgment might have required the USDA to immediately extend coverage under existing standards to rats, mice, and birds, with no opportunity for input of any kind from the research community and other interested parties," Glickman wrote. USDA spokesperson Susan McAvoy said, "He felt this was the best that we could do for both parties."
 
 

While no research facility wants "extra" regulations, the feeling of many laboratory animal veterinarians is the decision will not have a great impact on university research institutions. Research institutions, such as Purdue University, that receive federal funding are already required to regulate the use of mice, rats and birds. The PACUC currently reviews protocols and already visits and assures that animal facilities housing mice, rats and birds meet the standards found in the Guide for the Care and Use of Laboratory Animals. This is required by Purdue’s assurance agreement with the Public Health Service. The effects of this court decision are speculative. Having the USDA add mice, rats and birds to their list will most likely result in a greater burden for the USDA but it is not likely to impose a great burden on the individual investigator using animals in teaching or research.

Some individuals feel one effect may be that the USDA veterinary inspectors will need to have more of a physical presence at institutions in order to adequately review institutional compliance with the regulations. However, adding mice and rats to the regulations will potentially require the USDA to visit "thousands" of rodent-only facilities (such as biotech companies or smaller community colleges) that have not been previously regulated. As such, it may be that the USDA will have no choice but to cut back their activities at "low risk" (e.g. those accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International – AAALAC) institutions.

The PACUC will keep you posted of further developments in this area.
 
 

Please visit the PACUC Web Site at http://ag.ansc.purdue.edu/nielsen/PACUC/animals.html. There have been a number of additions, especially to the "Other Links" section. In addition, the site provides information regarding the operation of the PACUC and has a copy of Purdue’s Public Health Service Assurance posted.
 
 

Purdue’s animal care and use program was evaluated by the assigned USDA veterinary inspector on October 10-12, 2000. Only three deficiencies were documented on the report prepared subsequent to the visit.

One item was a physical facility issue that involved standing water on the floor of a recently refurbished animal room. Correction will require additional work by Purdue Physical Facilities in providing for an adequate floor slope so water more readily drains.

The other two items listed were more problematic and might have been prevented. In one facility, a fluorescent light was not operating properly (burned out bulbs) and it was felt the animals in the room could not be properly viewed for signs of abnormality. In addition, issue was taken with the light because the problem had not been reported to the facility manager.

In another facility, an abnormal appearing ("ill") animal was noted and its condition had not been reported to the Laboratory Animal Program (LAP) veterinary staff.

These latter items reinforce the importance of being observant when visiting your assigned animal room(s) or working with your animals. Should you notice a "physical" facility problem, please be sure to bring the item to the attention of the animal facility supervisor or animal care provider such that the problem can be remedied. Had the light been reported, the USDA veterinarian would not have documented the defect on his final USDA inspection report.

It is also very important to notify the LAP should an ill or abnormal animal be noted. The Animal Welfare Act requires that adequate veterinary care be provided to all animals. As the LAP staff does not visit each facility on a daily basis, it is important, as mandated by the Animal Welfare Act, that a mechanism of direct and frequent communication exist between the veterinary staff and the individuals providing daily animal care and observations.

Please make sure all individuals associated with your research or teaching protocols are aware of the need for timely reporting.

If you should have questions regarding the above information, please feel free to contact one of the LAP staff members at 494-9163.

For those with an interest in animal use and regulatory compliance, a recent article in the journal Lab Animal entitled "OLAW (Office of Laboratory Animal Welfare, a.k.a: PHS) and APHIS (Animal and Plant Health Inspection Service, a.k.a: USDA): Common Areas of Noncompliance" was published in May 2000 and can be accessed at http://grants.nih.gov/grants/olaw/LabAnimal.pdf
 
 

Please contact Lisa Snider ( ) if you have any questions regarding these dates. Thank you.
 

All of us at the Laboratory Animal Program/Purdue Animal Care and Use Committee wish you a very Happy Holiday Season!!!