Caretakers of lab animals are still struggling to meet complex federal guidelines, said members of the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) at the group's conference in Washington, D.C. this week. Membership in the voluntary accreditation organization continues to grow, but each year more than a quarter of members fail to meet the federal standards on first inspection, largely due to budget constraints or merely confusion.

"Even I still get confounded when I pick up the manual of regulations," said J.G. Collins, professor of anesthesiology at Yale University and chairman of Yale's Institutional Animal Care and Use Committee (IACUC).

According to AAALAC, 27% of member labs are found to have protocol violations during the organization's regular accreditation inspections. The most frequent violations involve insufficient evaluation of pain and distress in laboratory animals, inadequate justification for withholding analgesia, and flaws in physical plant or monitoring of facilities and procedures.

Occupational health and safety (OHS) regulations for lab personnel, covering facilities, procedures and monitoring, are also a growing source of problems. OHS violations detected in AAALAC inspections increased from just one in 1996 to 28 in 2002.

The United States Department of Agriculture (USDA) and Public Health Services (PHS) guidelines dictate laboratory protocol, including humane endpoints of pain and distress for animals, when to administer analgesics and anesthesia, as well as the criteria and procedures for timely interventions such as removal of animals from a study, or if euthanasia should be used.

US institutions using laboratory animals for research or instructional purposes must establish an IACUC to oversee and evaluate all aspects of the institution's animal care and use program. But semiannual reviews and reports submitted by IACUC officials to the Public Health Service are frequently found to be deficient by AAALAC reviewers—partly due to ambiguity in the federal guidelines.

"Laboratories have a lot of latitude for how to review particular activities such as animal care, so that's where some deficiencies may come in," said Joy Mench director of the Center for Animal Welfare at the University of California, Davis.

Deficiencies in physical plant cited by AAALAC reviewers mainly involve matters of airflow, such as heating, cooling, or ventilation, essential to the well being of the lab animals.

While AAALAC scrutiny is voluntary, many foundations make AAALAC accreditation a condition of eligibility for research grants. The private nonprofit organization founded in 1965 promotes humane treatment of animals in science through its accreditation program that includes site visits to laboratories every three years. Currently, 650 institutions in 18 countries are fully accredited by AAALAC.

To make certain that regulatory requirements are addressed, Collins urged labs to hire and train individuals whose main concern is to oversee the design of the protocol review process, instead of asking staff members to pitch in where they can. Because compliance with animal care guidelines may come at additional costs, Collins suggested that cash-strapped labs look into making the salaries of such dedicated staff a direct cost to the grant, despite dwindling federal support for such overhead expenses.