Setting Standards: How Best to Meet the Needs of Nonhuman Primates in Research

As the USDA considers a Petition for Rulemaking to establish criteria to promote the psychological well-being of primates, a discussion concerning regulations based on “performance standards” as opposed to “engineering standards” is timely. The use of performance standards for animals in research was the topic of a roundtable this spring by the Institute for Laboratory Animal Research, at the National Academy of Sciences. AWI laboratory animal advisor, Dr. Kenneth Litwak, gave a presentation on AWI’s concerns and objections to their use.

The term “performance standard” as used with animals in research describes a desired outcome, but is intentionally vague about how the outcome will be met. It differs from an “engineering standard,” which details the specific requirements concerning what must be provided for the animals. AWI views performance standards with much cynicism given how, historically, they have been used by those seeking to maintain the status quo and to hinder the move toward improvements in laboratory animal care. The following is an abbreviated history regarding the adoption of performance standards:

A vocal segment of the research industry spent years throwing up roadblocks to prevent passage of the Improved Standards for Laboratory Animals (ISLA) amendments to the Animal Welfare Act. In 1985, the bill finally passed, despite an attempt to secure a last-minute amendment to scuttle it. Then, having failed to prevent the law’s adoption, the effort shifted to the regulatory process, and opponents of the law managed to hold up promulgation of regulations for years. Initially, engineering standards were drafted to establish the parameters of a physical environment that would promote the psychological well-being of primates. However, opponents raised a great hue and cry about the cost to comply with these requirements. (We respectfully disagreed, as these estimates had been greatly inflated.)

In the end, opponents of ISLA prevailed in securing weak regulations for enforcement. Performance standards were finalized, which left it up to each facility to determine how to achieve the required outcome. Further, each facility’s unique plan would be hidden from public scrutiny. The plans were to be held at the premises and could be perused by USDA inspectors when conducting their inspections. But ensuring that the plans would not be submitted to the USDA, however, also ensured that the Freedom of Information Act could not be invoked by those who might wish to examine the plans in order to assess their adequacy.

The result? The USDA’s own veterinary inspectors had no idea how to enforce the law and those within the labs who wanted to meet the spirit of the law did not know how to proceed. Those who were doing nothing for primates and who wanted to continue on that course were able to do so with impunity. When, in 1999, a USDA team produced a first-rate, scientifically based draft policy as an aid to compliance with and enforcement of the law, opponents made sure it was shelved.

Now, the same groups that tried to scuttle ISLA will proclaim the success of performance standards. We would hope the situation has improved for primates in research, as 30 years have transpired since the law was passed. However, much remains to be done. There are still too many primates housed alone in inadequate, stress-inducing environments; more space is needed and the quality of that space must be improved; finally, positive reinforcement training (whereby animals are trained to willingly comply with routine handling procedures so as to reduce stress and forced restraint) needs to be standard practice. After all, improved housing, care and handling will also result in better science; let’s make clear what the primates need.