Laws and Regulations

Animal Welfare Act

The Animal Welfare Act (AWA) (7 U.S.C. § 2131) is the only U.S. federal law that covers animals in research. (The federal Public Health Service Policy on the Humane Care and Use of Laboratory Animals covers animals in NIH-funded research through recommended policy only, not requirements. While it has the power to inspect, it relies on self-reporting.) Enacted in 1966, it regulates the care and use of animals in research, testing, teaching, exhibition, transport, and by dealers. However, the AWA provides only minimal protection for certain species while excluding others such as rats, mice, and birds bred for research—who together constitute an estimated 90-95% of animals in laboratories. It excludes cold-blooded animals (fish, reptiles, and amphibians), as well as farmed animals raised for food and fiber or used in agricultural research—e.g., cows and pigs. For the less than 10% of animals in labs covered by the AWA (dogs, cats, nonhuman primates—such as chimpanzees and monkeys—guinea pigs, hamsters, rabbits, and other warm-blooded animals), the law sets minimal standards for housing, feeding, handling, veterinary care, and for some species like chimpanzees, their psychological well-being. While it is impossible to determine the precise number of animals in U.S. laboratories, since government statistics do not currently include the species named above, conservative estimates indicate that U.S. labs use over 25 million animals annually. Considering the number of genetically engineered mice and rats used, an estimate of over 100 million animals may be a more likely figure.

USDA

The U.S. Department of Agriculture (USDA) is charged with enforcing the AWA. The USDA’s Animal and Plant Health Inspection Service (APHIS) Animal Care program administers AWA regulations and standards. Under the AWA, businesses and individuals using regulated animals must be licensed or registered with the USDA and facilities with regulated animals must be inspected yearly by APHIS. There is no legal requirement for the inspection of federally-owned and operated research facilities. The USDA has no jurisdiction over facilities using animals not covered under the AWA.

With just 115 USDA inspectors to oversee more than 7,750 licensed facilities involved in research, exhibition, breeding, or dealing of animals, adequate inspection and regulation is impossible.  Often, the USDA has acted to force compliance with the AWA only after activists have exposed violations to the media and Congress. In several instances, testimony and film have indicated major violations of the AWA, even in labs that the USDA had recently inspected and approved. The AWA “does not allow [the USDA] to prevent the use of animals in research or experimentation” nor does it exclusively prohibit any experiments regardless of the amount of pain or distress they might cause. The USDA’s 2009 Annual Report indicated that researchers used more than 76,000 (AWA-covered) animals in research that caused unrelieved pain and distress to the animals.

When the USDA finds facilities in non-compliance with AWA regulations, they may issue penalties—typically so small as to be inconsequential. For example, in 2004 a 10-year-old chimpanzee named Dover died from overheating due to improper ventilation in a “stainless steel box with solid flooring, roof, rear and sides” during transit at the Yerkes National Primate Research Center. The USDA fined Yerkes a trivial $1,375 for negligence leading to Dover’s death. In 2008, maximum fines under the AWA were increased from $2,500 per violation to $10,000, but for facilities bringing in millions of dollars from animal research, these fines are simply the cost of doing business.

The USDA is in the process of developing a proposed rule for the creation of regulations to cover rats, mice, and birds other than those bred for research that will govern humane handling, care, treatment, and transportation, as mandated by the 2002 Farm Bill. Though the vast majority of mice and rats are exempt from the definition of "animal" under the law, the USDA estimates at least 5 million captive birds will become covered by this new regulation because they were not specifically bred for research. The comment period for the USDA-APHIS notice of proposed rulemaking (NPRM) ended August 2012.  It may take 1-2 years to develop and publish a final rule.

IACUC

Under the AWA, research institutions are required to establish an Institutional Animal Care and Use Committee (IACUC) “to oversee and evaluate all aspects of the institution’s animal care and use program.”

Acting as “an agent of the research facility,” the IACUC’s responsibilities include:

  • reviewing the facility’s animal care and use program
  • inspecting the animal labs at least twice a year
  • reviewing and approving, disapproving, or requiring modifications to research protocols
  • responding to and, if necessary, investigating and acting on any public complaints or facility personnel reports of noncompliance involving animal care and use
  • reporting deficiencies in animal care and use
  • submitting evaluation reports to the institution

The IACUC is required to have at least three members and must include an attending veterinarian from the facility and one person not affiliated with the facility who will “provide representation for general community interests in the proper care and treatment of animals.” However, since the animal facility’s CEO selects all the IACUC members, research facilities are self-regulating. Any dissenting vote is outvoted since most committees allow a majority and not a unanimous vote for approval, and the majority of experiments are approved, regardless of the amount of suffering they inflict. In preparing and reviewing research protocols involving animals, researchers and IACUCs are supposed to consider “availability or appropriateness of the use of less-invasive procedures, other species, isolated organ preparation, cell or tissue culture, or computer simulation.” However, once an institution’s IACUC approves a research protocol, what can be done to an animal in an experiment or in testing cannot be changed or prohibited by any regulatory agency, including USDA inspectors. In 2005, the USDA’s Office of Inspector General found that many of the IACUCs in U.S. research facilities were failing in their mandate to search for alternatives to animals, review painful procedures, monitor for unnecessary duplication of research, or provide adequate veterinary care.

Shortcomings

While the USDA and the AWA and IACUC systems purport to ensure “humane” treatment of animals in labs, the system is plagued with loopholes that leave animals with little to no protection. Recent incidents at several major research institutions point to profound inadequacies within the federal enforcement program, and to AWA regulations that are so limited that physical and psychological cruelty and suffering continue. For example, while the AWA stipulates that researchers “… avoid or minimize discomfort, distress, and pain to the animals,” procedures that cause pain and distress merely require that the “principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources…used to determine that alternatives were not available.” While the AWA “requires researchers to provide anesthesia or pain-relieving medication [to regulated animals] to minimize the pain or distress caused by the experiment…,” they can withhold anesthetics, painkillers, and tranquilizers if deemed "scientifically necessary." This same vacuous “protection” applies to conducting multiple survival surgeries on an animal, where the animal will recover from one major experimental surgery and then be subjected later to more surgery. The AWA prohibits this, yet it is allowed if called for by an IACUC-approved experiment. Ultimately, the possibility exists for any procedure or protocol to be allowed as long as a researcher can state a “scientific need” for using animals in that manner to advance human health.

Regarding alternatives to animals, the AWA requires only that scientists and other personnel be trained and instructed on “the concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress” and the use of services (such as the National Agricultural Library or National Library of Medicine) that provide information on “alternatives to the use of live animals in research.”  It is sufficient for investigators merely to consider the "three R’s"—replacement of animals, refinement of animal methods, and reduction of the animals used. Regarding proper training, AWA requires only “that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties,” and leaves this responsibility to the lab itself. Overall, the law which provides for minimizing pain and suffering and replacing animal use with alternatives is weak and inefficient, allowing egregious practices to continue. For the tens of millions of animals not covered under the AWA, there are no legal requirements for researchers to consider alternatives to their use, nor to provide them with relief from pain and distress, or even the most basic standards of care.

In short, the AWA regulates husbandry practices. It has no bite to change or stop what is done to an animal in research or testing (despite what the American public is led to believe, which is that animals are “protected” by law). Of note, however, is that many USDA inspectors are themselves frustrated over their inability to help protect animals in labs. More and better welfare laws, enabling people like them to make a difference, are essential, even while organizations like NEAVS work to get all animals out of labs.

Public Health Service

Along with the AWA, facilities using live vertebrate animals in research funded by the U.S. Public Health Service (PHS) must also adhere to the Public Health Service Policy on Humane Care and Use of Laboratory Animals (the PHS Policy) and follow the Guide for the Care and Use of Laboratory Animals produced by the Institute for Laboratory Animal Research (ILAR). This applies to all institutions receiving federal funding from any PHS agency, which includes the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, and the Food and Drug Administration (FDA). On behalf of the PHS, NIH’s Office of Laboratory Animal Welfare (OLAW) has responsibility for the administration and coordination of the PHS Policy and provides oversight of all PHS supported animal research activities.

As with the AWA, facilities are expected to set up IACUCs; under the PHS policy, IACUCs should have at least five members, yet unlike the AWA, the unaffiliated member does not need to represent the general community interests in how the animals are cared for and treated. Again, the facility’s CEO chooses IACUC members, a practice that puts the committee’s so-called independent oversight role into question. This conflict of interest is intensified in that “NIH will not fund research that uses animals if the IACUC has not given its approval to the proposed study.” This places increased pressure on the IACUC to agree to research that is in the best financial interest of the researchers and the facility, with the needs of the animals—or even the research—coming last.

To receive PHS funding, each facility is required to provide OLAW with a written Animal Welfare Assurance of Compliance with the PHS Policy, in which “…OLAW expects that institutions will adhere to the promises made and procedures described in their Assurances.” Facilities are subject to review by PHS staff and advisors, “which may include a site visit” to check “accuracy of the institution’s compliance or expressed compliance.” However, if OLAW finds a facility to be out of compliance, OLAW takes no action but instead allows the facility to take remedial action itself. The facility need only communicate to OLAW that compliance has been reached; no follow-up on-site inspection is required. Overall, the institution’s IACUC (who approved the research in the first place) is in charge of monitoring the care and treatment of its animals. If any violations of the PHS Policy are found, the institution is supposed to report them to OLAW.

While the PHS Policy covers more species than the AWA, it is based on a “trust relationship” and is essentially self-policing. It is not federal law, but facilities must state their compliance to qualify for PHS funding. The most serious penalty for uncorrected infractions is the suspension or loss of the federal grant or contract, which rarely happens.

Association for Assessment & Accreditation of Laboratory Animal Care International 

To increase chances for government funding, facilities can request accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). AAALAC is a privately funded, membership-based organization whose financial support comes from the very same research institutions it credits and inspects. AAALAC “believes that the use of laboratory animals in scientific and medical research is essential to the improvement and protection of the quality of all life.” AAALAC follows the guidelines recommended in the Guide for the Care and Use of Laboratory Animals and can revoke a facility’s accreditation for non-compliance. “Members of AAALAC have been intimately involved in the formulation of the initial and each succeeding edition of the Guide for the Care and Use of Laboratory Animals...” AAALAC is another example of “self-policing” under the guise of an external and objective regulatory body.  A research facility does not forfeit its federal funding if it loses AAALAC accreditation through failure to meet its guidelines.

U.S. Food and Drug Administration

The FDA is “an agency within the U.S. Department of Health and Human Services (HHS)…responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation.” In order for drugs, medical devices, and other products to be approved, the FDA does not require that animals be used in product testing and drug development. Instead, it requires that certain safety and efficacy tests be met and as such has the authority to vastly reduce the number of animal tests by making the use of existing, validated alternatives mandatory. Currently they allow alternatives and merely suggest that they be considered.

The Mandatory Alternatives Petition (MAP) coalition, of which NEAVS is a founding member, submitted a scientific petition to the FDA requesting that pharmaceutical companies, device manufacturers, and other entities regulated by the FDA must use validated non-animal methods whenever they exist. If accepted, such a mandate would change the way industry meets requirements to show drug and product safety for humans, sparing tens of millions of animals horrific testing and deaths. For cosmetics, personal care products, and household products, many companies already are using existing data or non-animal tests such as in vitro methods to demonstrate product safety. Alternatives such as human cell and tissue culture tests are cheaper, more accurate, and more reliable than crude and archaic animal testing. The FDA is now developing (with MAP input) better policy guidelines that will make it clear that animal tests are not required to meet FDA criteria for safety and efficacy—a partial but significant accomplishment of the MAP.

For decades, animals have been used in medical research and testing. Animal use is entrenched in the status quo. As long as companies are not required to use existing alternatives, the animal model is familiar and they have little incentive to change the way they operate. Companies may also be afraid to implement changes because of fear of litigation, and continue to rely on traditional animal testing methods because they view them as the safest and most secure route to FDA approval...not because they are the best or even good science.

Conclusion

The AWA and the PHS Policy on Humane Care and Use of Laboratory Animals are the two main regulations governing the use of animals in U.S. labs. However, even with the supposed "protections" afforded by the AWA and PHS Policy, millions of animals suffer and die in unnecessary, inadequately monitored, and counterproductive research. In the end, the minimal protections offered by the AWA and PHS Policy provide no real safety or relief to the millions of animals in labs and offer only a false sense of security to the caring public. Rather, so-called "scientific necessity" remains in place for the continued unbridled use of animals in unimaginable manners in research and testing.

 

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