

Before you read further, please bear in mind that this is an edited version of an article that was originally published on 11/26/2014. The original article was biased and factually inaccurate. We have a full disclosure about what went wrong here.


Medical research on lab animals is considered by many to be a necessary evil, and virtually everyone agrees that it should be done in the most considerate and humane way possible. To that end, experimenters are told to follow the three R's of research: reduce the number of animals used in experiments, replace animals with non-animals (or replace "higher-order" animals with "lower-order" animals), and refine experimental procedures causing pain or distress.


The problem in the United States, however, is that a confusing thicket of laws and regulations govern the use of lab animals. The system is confusing, and guidelines for animal welfare are interpreted in a wide variety of ways, depending on where the experiments take place. Though many researchers are guided in their work by ethicists, and adhere to a high standard of care, animal rights advocates worry that U.S. regulations don't prevent loopholes that allow for abuses.

As time passes, the need for medical research on lab animals is diminishing in some areas.

The best estimates suggest that there are anywhere between 14 to 25 million lab animals in use in the United States, followed by Japan's 11 million and the U.K.'s four million (total global figures are hard to come by owing to incomplete reporting, but as many as 100-115 million lab animals may be in use). The number of animals being used in experiments is declining in Europe and the U.K, but as Tom Holder from Speaking of Research told me, this could be due to a fall in funding due to the recession (interestingly, he also told me that, given a change in the way animals are counted by the EU (breeding of GM mice is now a procedure) we should expect an 80% + rise in the numbers for 2014).


As for the situation in the United States, it's impossible to know if animal use is decreasing as some contend because stats are not collected for mice, rats, birds, and animals used in agricultural research (for reasons we'll get to in just a bit).

Patchwork Acts and Regulations

As it stands, the Animal Welfare Act (AWA) is the only U.S. federal law that governs the treatment of animals in research, exhibition, and transport. Other laws, policies, and guidelines exist (such as Animal Welfare Regulations and the Public Health Service Policy), but all refer to the AWA as the minimal acceptable standard.

The act was passed back in 1966 as an effort to control pet breeding and sales practices. Initially, it wasn't meant to protect laboratory animals; it came about as a result of a public outcry about the mistreatment of dogs sold to labs. Over the years, however, the AWA has been twisted and contorted to fit a variety of animal-related needs, including such things as pet shops, circuses, zoos, and research laboratories.


For some reason, the U.S. Department of Agriculture (USDA) continues to maintain sole responsibility for enforcing the AWA. This government body works to ensure that labs adhere to the act's stipulations on the standards of care, such as making sure that cages are big enough and that the temperature and humidity in labs are within a certain range. For the most part, however, the AWA only considers the living arrangements of lab animals, while making very few provisions for the kinds of experiments that can be performed. Other regulations, like the AWR and PHRS, make up the slack.

These patchwork laws are part of what fuels the rage of controversial animal rights organizations like PETA. PETA's Senior Laboratory Oversight Specialist Alka Chandna thinks the AWA is a wholly inadequate piece of legislation. "Virtually anything goes in American laboratories," she told io9. "There's no prohibition on any kind of experimentation no matter how cruel, painful, redundant, frivolous, or pointless."

But research scientists in the United States say that in practice, animal researchers strive to be as ethical as possible. They work to reduce animal stress and pain, even during safe procedures like drawing blood. University of Miami shark conservation researcher David Shiffman points to his lab's practices when tagging and testing wild sharks, which are posted for the public to view on their website. They include measures to keep the shark calm, breathing properly, and to make sampling as rapid as possible.


"The idea that scientists can do whatever they want for no reason and with no oversight is blatantly wrong and inflammatory," says Shiffman.

Still, the AWA contains a loophole. The standard of care can't interfere with "the design, outlines, or guidelines of actual research or experimentation." In other words, any variable deemed to be a confounder by the researchers could potentially override the AWA's minimal provisions for care.


Europe, on the other hand, has some of the strictest animal protection laws in the world, including the U.K.'s Animals (Scientific Procedures) Act 1986 and the EU's Directive 86/609/EEC on the protection of Animals used for Experimental and other scientific purposes which was recently updated to "strengthen legislation, and improve the welfare of those animals still needed to be used, as well as to firmly anchor the principle of the Three Rs, to Replace, Reduce and Refine the use of animals, in EU legislation." Now, it needs to be said that the U.K. is no saint when it comes to animal testing, but one of its ministers has called for an outright ban on animal tests.

Oversight Committees

Enforcement of the AWA is delegated to the USDA's Animal and Plant Health Inspection Service, whose inspectors make unannounced site visits to research facilities. Violations of the AWA can result in fines and, in extreme cases, criminal prosecution.


Up until 1985, there was a provision in the AWA that explicitly prohibited the USDA from having any say about how the experiments were to be conducted, or how the animals were to be treated. This changed with the introduction of an amendment that called for an oversight process. Today, oversight comes from the Institutional Animal Care and Use Committees (IACUC), which are responsible for reviewing any proposed protocol or experiments on animals.




In order for a lab experiment with animals to be approved, the members of an IACUC sift through a checklist to ensure that the principle investigator or lead experimenter has considered a host of factors, including those that fall within the three R's. Experimenters must write out a protocol describing everything they're going to do with the animal, give justifications for the type of species being used, the number of animals that will be used, whether or not alternatives were considered, and the justification for the use of painful or stressful methods. They also have to provide a historical rundown of the research to show why they're using animals for that particular avenue of investigation.

Cardiologist John J. Pippin, director of academic affairs for the anti-animal experimentation group Physicians Committee for Responsible Medicine, told io9 that there are still problems with the way the IACUC makes decisions because ethics aren't taken into account:

Nobody in the decision chain at research institutions makes ethical judgments or evaluates the usefulness of animal research protocols. Nor do the AWA itself or the USDA inspectors weigh in on whether specific research is useful or self-serving or frivolous. IACUC members either toe the line or are replaced. Institutional decisions regarding animal experiments are driven by the associated financial benefits (NIH grants and other funding sources totaling $12-14 billion dollars annually) and institutional or investigator prestige, and not by the ability of that research to advance human health. Even the NIH evaluates the quality of animal experiments by the number of publications and the impact factors of journals publishing the research, not by the impact on human health — despite the fact that the NIH trademark states "NIH...Turning Discovery Into Health."

Membership in an IACUC is dictated by the AWA and its regulations. In general, it calls for a veterinarian to be on board, an unaffiliated member (meaning a person not affiliated with the institution), and a chairperson. But University of California at San Diego neuroscientist Lawrence Hansen, who has worked with PETA, argues that these oversight committees are heavily weighed in favor of people who engage in animal experimentation themselves. So he and his colleagues believe that IACUCs tend to be quite biased.


But shark conservation researcher Shiffman says IACUCs are responsible and accountable. Here's what he told io9:

I am a researcher who has dealt with IACUCs and I can tell you from my experience that we are very careful to make sure when we're preparing our projects that we follow the Three R's. We do as little harm as possible to get the information that we need in order to confirm our question, whether that means modifying our method, or reducing the sample size or the number of animals we work with. We're happy to do that. We also do thorough literature reviews, some of which can take a month or more, to come up with a project plan just for the animal welfare component.

After we submit a proposal to the IACUC, they read it as a committee, they ask themselves questions as a committee, they ask us further questions or for clarification, and they oftentimes ask us to modify the proposal. If they're unfamiliar with certain things they'll bring in independent experts to confirm that what we're saying is true and to ensure it's the best way to do it.

So it's a system that works pretty well. There certainly has been abuses in the past, but the notion that scientists can do whatever they want and with no oversight is completely wrong and PETA knows it's wrong — it's been explained to them. But their people are interested in headlines and not actually fixing any problems."

There's no way that a scientist could get something by them just for fun and there's no reason why any scientist would.

Animal rights groups also say there is a problem because IACUCs show such a range of responses to similar experiments, which means there's a lot of variation in what gets approved.



"There are several problems with the IACUC process," says Western Carolina University psychologist Harold Herzog. "In our study published in Science, Scott Plous and I found that the decision-making process was shockingly unreliable. That is, different committees often made different decisions when they evaluated the same proposals."

San Jose State ethicist Janet Stemwedel has served on IACUCs, and says that the variability in IACUCs is actually a strength, because it means their decision-making processes reflect local values. She says that local IACUCs often make decisions that are far more compassionate than a federal regulation might require. She told io9:

Some of the variability is by design — IACUCs are local communities seeing to the implementation of the relevant animal welfare regulations, each with a "community member" representative ... This means that the committees looking at research protocols have to take into account the mood of the public in the community they are part of with respect to treatment of animals, value of scientific knowledge of the sort being built, etc. If there were a single national IACUC in the U.S., I don't assume the mood of the public it reflected would be that of the [San Francisco Bay Area] public — it might end up considerably less concerned with animal welfare. There are surely pros and cons of this sort of local oversight (as there are with local control of public schools and their curricula), but it doesn't mean that IACUCs aren't working to provide good animal welfare oversight.

Stemwedel added that local IACUCs are also valuable because they get to know the researchers in their communities:

IACUCs have history with researchers as far as how well they train and supervise personnel on their protocols, how their prior animal work has gone, how forthcoming or not they have been in previous interactions with the IACUC or animal care program personnel. This means an IACUC that knows a researcher to be extraordinarily skilled, conscientious, and attentive to animal welfare may approve a protocol for her that they would *not* approve for a less skilled, less conscientious, more combative researcher. This familiarity with researchers ... doesn't default to "we know you so you can do whatever you want with the animals."

The oversight situation is quite different in Canada. While there's no federal law in Canada to govern the treatment of animals in labs, it does have the Canadian Council on Animal Care (CCAC) — a not-for-profit organization that oversees the ethical use of animals in science. This organization actively promotes the ethical use and welfare of animals in science by

providing standards informed by scientific evidence, verifying their effective implementation, and by increasing the level of knowledge, awareness, and sensitivity to relevant ethical principles.

Any institute in Canada that receives money from a medical research council or big government funding body must be CCAC accredited. To receive money, these institutions must abide by CCAC standards — standards that are considerably better than what's seen in the United States. That said, it doesn't have legally binding regulations to empower it, and, due to its limited resources, it can only visit labs every few years or so.

Some Animals Aren't Actually Animals

Owing to its roots, the AWA's reach is confined to warm-blooded animals, including dogs, cats, rabbits, and monkeys. But its regulations don't account for the bulk of warm-blooded animals used in research, namely rats, mice, and birds bred for experimentation. In fact, the AWA does not recognize these creatures as even being animals.

According to the AWA, this is not an animal. (Photo: lculig/shutterstock)

The reason for this goes back to the late 1970s when animal rights groups made the case that animals used in experiments should be provisioned for in the AWA. Indeed, when Congress first passed it, the intention was that all vertebrates would be included — but the USDA failed to come up with standards for certain animals like rats and birds. Concerned that important medical research would be thwarted by such a reading of the legislation, and pushed by lobbyists from the National Association for Biomedical Research and the Foundation for Biomedical Research, a congressional amendment spearheaded by Jesse Helms in 2002 legally and permanently formalized the agency's longtime practice of excluding rats, mice, and birds from the definition of "animal."



"It is gratifying that Congress acted to protect laboratory animal endeavors, which, along with concern for the animals' well-being, enjoy strong public support," noted American Psychological Association Fellow Nancy Dess back in 2002 when the legislation was passed. "Humane treatment of laboratory animals is essential to good science and education, and is the right thing to do. The research community works hard at ensuring it and must continue to do so."

The 2002 amendment also excluded animals used in agricultural research. So for example, while the AWA covers pigs used in skin-burning lab experiments, it does not protect pigs involved in agricultural experiments involving such things as gestational crates.

Clearly, there's nothing scientific about the definition of animals in the AWA, and the vast majority of animals used in research are excluded from it. Former Emory University neuroscientist and animal rights activist Lori Marino told io9, "It's a way to gerrymander ethics."


But ethicist Stemwedel noted that there are many ways that rats, mice and other animals' treatment gets regulated. The NIH has its own protocols for humane treatment of animals, and "any institution that gets or wants to get NIH funding affords mice, rats, and birds protection that is indistinguishable from that given the species covered by the AWA," she said. And Shiffman said that IACUCs always regulate the treatment rats, mice and birds as heavily as other species.

Psychologist Herzog disagrees. He told io9 that NIH protection isn't enough, and we need to expand the AWA to include the species that are currently unregulated:

The AWA exclusion of rats, mice and birds is a travesty and an embarrassment. As a result, we have no idea how many animals are even used in research. Estimates range from 17 million to 100 million. In a survey we did of researchers, we found that most of them felt that rats and mice should be covered under the AWA.

Breakdown of the percentages of different species of animals used in research across the EU in 2011. The rates are probably similar in the US. Via SoR.

Herzog supports animal research, but believes that the situation needs to change.

Frivolous Experiments

Another area where the United States lags behind the rest of the world is its allowance for so-called frivolous experiments, or experiments that have no real therapeutic or medical benefit to humans. Many American companies continue to test their products and ingredients on animals despite the fact that alternatives to animal testing exist.



Because the AWA doesn't require that all lab animal use in the U.S. be reported (remember, not all animals are animals), it's not known how many animals suffer or die because of a new product — but estimates are in the millions.

Many countries around the world, including those of the European Union, Vietnam, China, and Brazil, have banned the marketing of cosmetics tested on animals (such as eyeliners, lipstick, or shampoo). Prohibitions in Israel and India are among the world's strictest when it comes to this issue, including outright import bans of such products. Similar injunctions are also being put into place to prevent household products from being tested on animals.

But there's nothing quite like this in the United States. Efforts in the U.S. to stop such practices do exist, but the various industries involved are so strong that they're successfully preventing such measures from taking hold.

The Problem with Primates

The U.S. is one of the only countries in the world that permits the use of great apes in invasive experiments, including ones that involve diseases such as HIV/AIDS, Hepatitis, and the Norovirus.

Remarkable video showing retired lab chimps as they see the sky for the very first time.

In the U.S., the NIH is phasing out the use of great apes on the recommendation from the Institute of Medicine that chimpanzees are no longer necessary in experimentation. But it has been a frustratingly slow process.

"The NIH recently mandated that chimpanzees in invasive research — with the exception of those in hepatitis research — should not be used in this way anymore and should go to sanctuary," activist Marino told io9. "Of course, the fact that some are left behind to endure invasive biomedical research shows that, as much as this is an improvement, we still have not recognized the inherent rights of chimpanzees to live their lives unobstructed by humans."



Ultimately, the problem isn't animal research, which is still a necessary part of medicine and science. The issue — for activists, at least — is that U.S. regulations and laws are allowing some animals to slip through the cracks, placing them outside the reach of the law and leaving them vulnerable to possible abuse.

This article was revised on November 28 to include further comments from members of the research community. It is still undergoing revision, as we continue to receive comments from scientists who work in U.S. laboratories.

Related: Bioengineered monkeys with human genetic diseases have almost arrived

Sources: The Hastings Center | NEAVS | National Institutes of Health | Science, Medicine, Animals

Image: Ramon Grosso Dolarea/Shutterstock | Everett Collection/Shutterstock

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