The UK Home Office has published the 2015 annual statistics showing the number of animal procedures carried out in Great Britain under the Animals (Scientific Procedures) Act, 1986; this covers all vertebrate species (and Cephalopods). In 2015 there were 4.14 million procedures carried out, up 7.1% from 2014 (3.87 million). However, the Home Office have warned that comparisons with 2014 are likely to be problematic as issues with a new counting procedure (introduced in 2014) are only now being ironed out.
[T]hroughout this release, 2015 data are compared with 2013 data, as neither year of data are subject to the same data quality issues as the 2014 data. However, comparisons between 2015 and 2013 should still be exercised with a degree of caution due to the methodological change in 2014.
When compared to 2013, the number of animal procedures rose 0.5% from 4.12 million procedures.
While we often describe these statistics as being for the UK, they do not include Northern Ireland (who carried out 19,857 procedures in 2014), and so are technically the figures for Great Britain (England, Scotland and Wales).
Procedures on animals in Great Britain for research in 2015. Click to Enlarge
Overall, 96.8% of animals used in scientific studies were mice, rats, fish or birds. Dogs and primates (which are offered special protections under UK law) together accounted for less than 0.2% of the total (similar to in previous years), this becomes 2.01% if cats are included. The statistics also reveal that half of all experiments were the breeding of GM animals which were not used in further experiments – this is almost identical to 2014. Overall, over 67% (two thirds) of all experiments involved genetically modified animals.
Trend over time in animal experiments in the UK. Click to Enlarge.
Using the trend graph we can see how 2014 data appears to be a blip (as confirmed by the Home Office), with animal experiments remaining relatively constant around 4.1 million. While this is higher than in the 1990s, it remains much lower than the 5.5+ million animals used in the mid 1960s.
Procedures on non-human primates rose slightly from 3,246 procedures in 2014, to 3,612 in 2015. The number of procedures on cats fell by 1 to 209 procedures and on dogs rose to 4,643 (but down slightly from the more accurate 2013 figures).
A ban on cosmetic testing on animals (1998) and of using great apes (gorillas, orang-utans and chimpanzees) in research (1986) meant both had zero procedures in 2015. It should be noted that some research may continue on great apes in zoos, however such research can be observation-based only as “procedures” on great apes are illegal under ASPA.
For the second time the UK statistics include retrospective reporting of suffering. Rather than just submitting licence proposals to the Home Office that include estimated levels of suffering, the researchers now have to report on what was actually seen (using a variety of measures). Unfortunately the statistics put these in two separate tables (Table 3 and 8). So we have combined them to get severity for all procedures in 2015. We can see most experiments are sub threshold (34%; less than the introduction of a hypodermic needle) or mild (45%), with remainder as moderate (14%), severe (4.5%) or non-recovery (3%; the animal never awakes from anaesthesia). Overall the proportion of moderate and severe fell from 19.2% in 2014 to 18.2 in 2015.
Severity of animal research in the UK in 2015
Other things to note in the UK statistics:
49.8% of procedures were for the creation and breeding of genetically altered animals (not used in other experiments), 26.6% were for basic research, 13.4% was for regulatory purposes and 9.7% was translational/applied research [Table 1]
Over the experimental procedures, two-thirds of the “severe” procedures were regulatory procedures on mice. This is often because death is an endpoint in such procedures [Table 3.1]
Over 97% of the animals were born in the UK [Table 2.1]
47.7% of procedures were conducted in universities and medical schools, 25.1% were in commercial organisations (e.g. pharmaceuticals), 12.4% were done at non-profit making organisations (e.g. medical research charities), and 11.8% were done at other public bodies. [Table 11]
Speaking of Research congratulate the UK government on continuing to produce the most comprehensive statistics on animal experiments worldwide. It is also important to note that these statistics are released as a press conference each year where representatives from the scientific community speak about the importance of animals in research.
A number of countries have ended some types of research with chimpanzees over the past decades. For example, the US National Institutes of Health announced in November 2015 that it would no longer support many types of chimpanzee research. In Europe, the fate of former research chimpanzees has depended upon a mix of private wildlife parks and zoos for the animals’ care and management. The outcomes in term of chimpanzee health and survival remain relatively unknown.
Photo credit: Kathy West
In the US, the American public, via public entities, has legislated long-term support and substantial funding for the construction and maintenance of a facility dedicated to the exclusive care of chimpanzees retired from research. However, the outcomes for retired chimpanzees have been the source of public discussion and increasing concern.
This month, Dr. Cindy Buckmaster, writing in Lab Animal (Vol 45, No 7, July 2016) in an article addressed to the National Institutes of Health Director and titled: “Dr. Collins, please save our chimps!” shared a powerful and very sad story about some of the chimpanzees, asking:
“…why Dr. Collins would force these animals to leave everything they have known and everyone they love to go to a strange place, filled with strangers who cannot care for them nearly as well as their family at MDAKC! Does he know that 69% (9 out of 13) of the chimps already moved from MDAKC to his chosen sanctuary have died? Does he know that most of these treasured family members died within a few months of their arrival at the sanctuary? Does he know how they suffered? Does he know their stories? What about Maynard, who had ‘the best play face and laugh ever,’ and loved playing with his human and animal family at MDAKC? Does Dr. Collins know that Maynard had a fatal heart attack in the sanctuary the day after he was introduced to a new group of chimpanzees? Does he care? I’d like to believe that he does, but I don’t know him. If I did, I would ask him to visit the MDAKC chimps so he would know, beyond doubt, that retirement in place is the most loving thing he could do for these animals. And I would beg him to save our chimps.”
Photo credit: Kathy West
Buckmaster’s plea echoes those of others with concern that unrelenting political pressure on the NIH from groups opposed to animal research has resulted in decisions about chimpanzees that may not be in the animals’ best interests. In the aftermath of a series of decisions by the NIH over the past several years and increasing pressure by opponents of animal research, NIH has mandated the transfer of chimpanzees from their homes, established social groups, and dedicated caregivers to the Louisiana facility (See: Where should US chimpanzees live; Chimpanzee retirement: facts, myths and motivations; and What cost savings: a closer look a GAPCSA 2011).
The result of the transfers has included injuries to chimpanzees as they are introduced into new social groups and to deaths of animals. As Buckmaster notes, for one recent group of 13 relocated chimpanzees, the result was a nearly 70% death rate for animals moved from dedicated research facilities with long-time experience in caring for the animals to the Louisiana sanctuary. As a result of a decades-old ban on breeding, all sanctuaries and research facilities housing chimpanzees are largely populated by aging animals. Yet, the number of chimpanzees that have died upon transfer from research facility to sanctuary contrasts with an average death rate for chimpanzees due to advanced age, health, or other causes for a given facility, an expected average of 3-4 individuals per year (http://www.gao.gov/products/GAO-16-392).
Research chimpanzees make up approximately 40% of the 1,650 chimpanzees estimated to live in the US, which includes chimpanzees not only in research facilities, but also sanctuaries, zoos, and other entertainment and breeding venues (see graph below). As recently announced, a large number of research chimpanzees housed at the New Iberia Research Center will retire to a private US sanctuary in northern Georgia. The remaining US research chimpanzees are under 1/3rd of all chimpanzees housed in the US.
The chimpanzee deaths at Chimp Haven have increasingly raised significant questions in the communities that are concerned with ape well-being These concerns are the subject of considerable private discussion in the chimpanzee research community by those who have cared for the animals for decades. Public expressions of concern have been more constrained, but are emerging, as are calls for a re-examination of where the chimpanzees should live. For example, Buckmaster says:
“In fact, many of our chimps would fare better if they were allowed to retire in place. And several of these precious creatures have already suffered and died because the NIH would not allow them to do so. The MD Anderson Keeling Center (MDAKC) in Texas has been home to the healthiest, happiest chimpanzees in America for decades. Their living quarters are comparable to, or better, than any US sanctuary, and none of these sanctuaries can compete with the level of care provided to chimpanzees at MDAKC. The MDAKC staff includes ten full-time veterinarians with a combined total of 92 years of experience caring for chimpanzees; 6 are specially boarded primate veterinarians, 3 are specially boarded veterinary pathologists, and 3 are specially certified to provide laser and acupuncture therapies to supplement traditional treatment regimens. There are also 22 specially trained, full-time technicians devoted to the chimps’ husbandry, health and behavioral needs, including 3 night technicians. MDAKC also has a full-service clinical pathology laboratory on site that allows for the immediate diagnosis and treatment of animals with health concerns. No US sanctuary is staffed or equipped to care for chimpanzees like MDAKC, not one! In fact, the sanctuary that the NIH is forcing us to send our chimpanzees to currently is not even equipped to carry out its own diagnostic lab work. This is concerning, given the advanced age of many research chimpanzees. Honestly, it would make more sense for Dr. Collins to retire the nation’s research chimps to MDAKC!
Buckmaster’s comments should resonate with all of those concerned with ape well-being. The US public has provided considerable support meant to give these chimpanzees retirement care—on the assumption that such care would be in the animals’ best interests and protective of their health and well-being in retirement. The federal commitment to ape retirement is unusual compared to other countries.It also reflects broad support from the research community as well as the public.
Chimp Haven, the first and only federal chimpanzee sanctuary in the US, was founded in 1995 by a NIH-funded behavioral scientist Dr. Linda Brent along with a group of primatologists and business professionals. Through federal legislation in 2000—the Chimpanzees Health Improvement, Maintenance, and Protection Act (CHIMP Act; 42 U.S.C. §§ 287a-3a)—a national chimpanzee sanctuary system was established and NIH was formally mandated to provide life-time funding for the research chimpanzees it retires. As a result, in 2002 the NIH awarded Chimp Haven a 10-year, cost-sharing contract in which the NIH provided roughly $19 million in total costs for retired chimpanzee care, as well as $11.5 million for initial construction of the sanctuary. Six years later, in 2008, federal sanctuary standards were established (see Fed. Register 73 FR 60423, Oct. 10, 2008: Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee System). These standards apply to Chimp Haven, but do not necessarily extend to other sanctuaries.
Thus far, the federal investment in sanctuary retirement exceeds $30M. An analysis by the Congressional Budget Office (CBO) in 2012 estimated an additional $56M cost to retire and maintain federally-funded chimpanzees for a 5 year period (not the animals’ lifespan). A 2016 Government Accounting Office report determined that the range of per day care costs paid by NIH for a chimpanzee housed in the four facilities NIH supports was between a low of $41 and a high of $61, or between $15,000 – $22,000 per chimpanzee per year. Thus, NIH’s total support for care and maintenance of its 561 chimpanzees each year may be between $8,415,000 – $12,342,000. By extension, over a 5 year period, the cost would be between $42,075,000 – $61,710,000. NIH pays 75% of costs and Chimp Haven is required to provide matching funds via private donations and fundraising. Of critical note, the cost for chimpanzee care will also likely vary significantly with increasing medical and care needs as the population ages.
In light of a complex mix of animal welfare, cost, and pragmatic concerns, a substantial number of NIH-owned research chimpanzees have not yet been transferred to Chimp Haven. The speed of transferring NIH-owned chimpanzees to sanctuaries remains a source of contention and was directly addressed by the 2016 GAO report. The report determined that: “Most of the 561 chimpanzees that NIH owned or supported as of January 15, 2016, had not been retired to Chimp Haven, which housed 179 NIH-owned chimpanzees at that time.” The agency concludes that NIH “has not developed or communicated a clear implementation plan to transfer the remaining chimpanzees, in part because of uncertainties about the available space at Chimp Haven. However, NIH has information about Chimp Haven’s current capacity and about anticipated space that will become available as a result of chimpanzee mortality. Absent a clear implementation plan, the four facilities that care for NIH-owned or NIH-supported chimpanzees may not have the information they need to care for the chimpanzees in the most cost-effective way that considers the timing of the transfers and the welfare needs of the chimpanzees. … Moreover, the absence of such a plan is inconsistent with federal internal control standards that call for effective communication of quality information.”
At the same time, active public discussions are continuing about whether NIH-owned chimpanzees should be retired in their current settings (in situ retirement), or if substantial funds for new construction should be made available in order to provide for their transfer to the federal sanctuary. Among the arguments for retiring the chimpanzees in their current homes is that the research facilities can offer the same level of care as the federal sanctuary, particularly given the new requirement for ethologically-relevant standards of care. From the animal welfare perspective, retirement in place would also have the advantage of protecting the chimpanzees—many of whom are aged— from the stress of relocation and disruption of stable social groups. For example, in an earlier interview about movement of chimpanzees, veterinarian and director of the MD Anderson Keeling Center for Comparative Medicine, Dr. Christian Abee:
“praised Chimp Haven’s facilities, but he said the stress of moving can take a fatal toll on older, more frail chimpanzees. Of the 13 chimps his facility had transferred this year to Chimp Haven, four died or were euthanized within the first three months, he said. Chimpanzees, an endangered species native to West and Central Africa, can live to 60 years in captivity. I don’t mean this as a criticism of Chimp Haven, but we uprooted them, took them from their family groups, we moved them cross country, we put them in unfamiliar settings with caregivers who didn’t know them, and four died,” Abee said. “We would not have anticipated those four to die if they had stayed here” (Walters & Knowles, 2015).
From the perspective of the individual animal’s health and well-being, the type of facility in which he or she lives is only relevant insofar as it affects the provision, stability, and type of care, housing, and other aspects of daily life. In other words, whether the facility is a sanctuary, zoo, or research institute may be irrelevant if the standards for care, housing, and living conditions are substantively similar across settings. Ultimately, from the available data and the chimpanzee deaths that have occurred following their relocation to the federal sanctuary, it may appear that NIH and others advocating for transfer of the animals from their current homes and social groups to the sanctuary may be making a mistake. It is a mistake that is counterproductive to the animals’ welfare. It is one that appears to prioritize political considerations and appeasement of opponents of animal research over the interests of the animals themselves. In short, political expediency seems to be trumping animal welfare for chimpanzees and this serves no one well.
Speaking of Research
Portions of this post are excerpted from Bennett, A.J. & Panicker, S. (in press). Broader Impacts: International Implications and Integrative Ethical Consideration of Policy Decisions about US Chimpanzee Research. Am J Primatology.
Jordana Lenon, B.S., B.A., is the outreach specialist for the Wisconsin National Primate Research Center and the Stem Cell & Regenerative Medicine Center, both at the University of Wisconsin-Madison. In this guest post Jordana talks about WNPRC research on Zika virus.
Wisconsin National Primate Research Center scientist David O’Connor is emphasizing using “as few animals as possible” to answer research questions that desperately need answers as the world watches Zika virus cause birth defects and raise fears among pregnant women and their families across the warmer Americas. These answers, O’Connor expects, will move him and his collaborators at the University of Wisconsin-Madison, Duke University, in Brazil and beyond forward as they learn more each day how Zika virus may be operating inside of infected pregnant women and their newborns, and could cause potential lifelong impairments we don’t even know about yet.
Researchers at the Wisconsin National Primate Research Center perform a fetal ultrasound on a pregnant rhesus macaque, in their quest to learn more about the link between the Zika virus and birth defects. (Images by Justin Bomberg, UW-Madison Communications)
Thanks to research using rhesus macaques, whose immune, reproductive and neurological systems are very similar to ours, the answers are starting to come in. Furthermore, O’Connor and his Zika Experimental Science Team, or “ZEST are sharing their raw research data through an online portal with the public – including of course and very importantly other Zika researchers. Their goal is to share data openly, to eliminate as many impediments as possible to spurring collaborative work around the globe to solve the Zika crisis.
David O’Connor, professor in the Department of Pathology and Laboratory Medicine at the University of Wisconsin-Madison, is pictured on April 19, 2016. (Photo by Bryce Richter / UW-Madison)
Just how severe a problem are we looking at? O’Connor gave some perspective during a public lecture on the UW-Madison campus this week. While HIV – another pandemic virus he has studied exhaustively over the past 20 years – costs society about $400,000 per patient over their life spans, Zika virus impairments in newborns could cost between $1-10 million per patient (using US dollar estimates) over their life spans. Recent studies in macaques found that the Zika virus persisted for up to 70 days in the blood of pregnant female monkeys – much longer than the 10 days it remained in either males or non-pregnant females – this increases the chance of severe birth defects being found in babies.
There are already more than 300 pregnant women in the US with laboratory evidence of Zika. This number is growing daily. Infections in the US are largely being attributed to pregnant women picking up the virus while traveling outside the country: Zika is hitting hard right now in Puerto Rico, infecting nearly 50 pregnant women per day, as Aedes aegypti mosquitos, which can transmit viruses such as dengue and Zika, spread and move northward this summer from South to Central America, to the Caribbean and into the United States. Because Zika is also sexually transmitted, its borders of infection are not limited to places where the mosquitos live and bite.
There is hope, however. A new experimental vaccine has shown to protect mice with just a single dose. Scientists from Walter Reed Army Institute of Research, the Beth Israel Deconess Medical Center and Harvard Medical School found two different vaccines effectively protected 100% of mice from the virus. This compares to a control group which were unprotected and all caught Zika after being exposed to the virus.
Posted onJune 9, 2016byEditor|Comments Off on USDA publishes 2015 Animal Research Statistics
Congratulations to the USDA/APHIS for getting ahead of the curve for a second time and making the US the first country to publish its 2015 animal research statistics. Overall, the number of animals (covered by the Animal Welfare Act) used in research fell 8% from 834,453 (2014) to 767,622 (2015).
These statistics do not include all animals as most mice, rats, and fish are not covered by the Animal Welfare Act – though they are still covered by other regulations that protect animal welfare. We also have not included the 136,525 animals which were kept in research facilities in 2015 but were not involved in any research studies.
The statistics show that 53% of research is on guinea pigs, hamsters and rabbits, while 11% is on dogs or cats and 8% on non-human primates. In the UK, where mice, rats, fish and birds are counted in the annual statistics, over 97% of research is on rodents, birds and fish. Across the EU, which measures animal use slightly differently, 93% of research is on species not counted under the Animal Welfare Act (AWA). If similar proportions were applied the US, the total number of vertebrates used in research in the US would be between 11 and 25 million, however there are no statistics to confirm this.
If we look at the changes between the 2014 and 2015 statistics we can see a drop in the number of studies in hamsters, rabbits, cats and the “all other animals” category. Notably, there was a 7.3% rise in the number of non-human primates used although this comes the year after a 9.9% fall in their numbers.
There has been a downward trend in the number of AWA-covered animals used in the last three decades, with a 64% drop in numbers between 1985 and 2015. It is also likely that, similar to the UK, a move towards using more genetically altered mice and fish has reduced the numbers of other AWA-covered species of animals used. In the UK this change in the species of animals studied has contributed to an overall increase in the numbers of animals used in research in the past 15 years.
Rises and falls in the number of animals used reflects many factors including the level of biomedical activity in a country, trending areas of research, changes to legislations at home and abroad, outsourcing research to and from other countries, and new technologies (which may either replace animal studies or create reasons for new animal experiments).
It is important to note that the number of animals cannot be tallied across years to get an accurate measure of total number of animals. This is because animals in longitudinal studies are counted each year. Thus, if the same 10 animals are in a research facility for 10 years, they would appear in the stats of each year – adding these numbers would incorrectly create the illusion of 100 animals being used.
Speaking of Research welcomes the open publication of these animal research statistics as offering the public a clear idea of what animal research goes on in their country.
Comments Off on USDA publishes 2015 Animal Research Statistics
The media regularly report impressive medical advances. However, in most cases, there is a reluctance by scientists, the universities, or research institutions they work for, and the media to mention animals used in that research, let alone non-human primates. Such omission misleads the public and works against long-term sustainability of a very important means of advancing knowledge about health and disease.
Consider the recent report by Ali Rezai and colleagues, in the journal Nature, of a patient with quadriplegia who was able to use his hands by just thinking about the action. The signals in the brain recorded by implanted electrodes were analysed and fed into the muscles of the arm to activate the hand directly.
When journalists report on such bionic devices, rarely is there mention of the decades of research using macaques that eventually made these early brain-machine interfaces a reality for human patients. The public is shielded from this fact, thereby lending false credence to claims by animal rights groups that medical breakthroughs come from human trials with animal experiments playing no part.
Development of such brain-machine interfaces requires detailed understanding of how the primate brain processes information and many experiments on macaques using different interfaces and computing algorithms. Human ethics committees will not let you try this on a patient until such animal research is done.
Image: Understanding Animal Research
These devices are still not perfect and our understanding of brain function at a neuronal level needs more sophistication. In some cases, the macaque neural circuitry one discovers may not quite match the human’s, but usually it is as close as we can get to the human scenario, needing further fine-tuning in direct human trials. However, to eliminate all animal research and try everything out on humans without much inkling of their effects is dangerous and therefore highly unethical.
The technique Dr Rezai’s team used on human patients draws heavily upon work done on monkeys by many groups. This can be seen by looking at the paper and the references it cites.
The number of monkeys used for such long-term neuroscience experiments is relatively small, with just two used in the study above. Many more are used for understanding disease processes and developing treatment methods or vaccines in the case of infectious diseases such as malaria, Ebola, HIV/AIDS, tuberculosis and Zika.
However, if one looks at what is at stake without these experiments on non-human primates, one must acknowledge a stark reality. In many cases, the situation is similar to that which once existed with polio. Nearly 100,000 monkeys were used in the 1950s to develop the polio vaccine. Before that, millions of people worldwide, mostly children, were infected with polio every year. Around 10% died and many were left crippled.
Now, thanks to the vaccine, polio is almost eradicated.
Similarly, about 200 million people contract malaria every year, of whom 600,000 (75% being children) die, despite all efforts to control the mosquitoes that transmit the disease. Development of a vaccine is our best chance, but again primates are necessary for this, as other species are not similarly susceptible to the parasitic infection.
Circumstances are similar with other devastating ailments such as Ebola, HIV and Zika. The ethical choice is often between using a few hundred monkeys or condemning thousands or more humans to suffer or die from each one of these diseases year after year.
In the popular press and in protests against primate research, there is sometimes no distinction made between great apes (chimpanzees, bonobos and gorillas) and monkeys such as macaques, leading to misplaced emotional reactions. To my knowledge, invasive experiments on great apes are not done anywhere, because of the recognition of their cognitive proximity to humans.
With urgent medical issues of today such as HIV, Ebola, malaria, Zika, diabetes and neurological conditions such as stroke and Parkinson’s disease, monkeys are adequate to study the basic physiology and pathology and to develop treatment methods. There is nothing extra to be gained from studying apes.
Alternatives have limitations
Opponents of animal research often cite the impressive developments of computer modelling, in-vitro techniques and non-invasive experiments in humans as alternatives to animal experiments. These have indeed given us great insights and are frequently used also by the very same scientists who use animals.
However, there are still critical areas where animal experimentation will be required for a long time to come.
Modelling can be done only on data already obtained and therefore can only build upon the hypotheses such data supported. The modelling also needs validation by going back to the lab to know whether the model’s predictions are correct.
Real science cannot work in a virtual world. It is the synergy between computation and real experiments that advances computational research.
In-vitro studies on isolated cells from a cell line cultured in the lab or directly taken from an animal are useful alternatives. This approach is widely used in medical research. However, these cells are not the same as the complex system provided by the whole animal. Unless one delves into the physiology and pathology of various body functions and tries to understand how they relate to each other and to the environment, any insights gained from studying single cells in in-vitro systems will be limited.
Though many studies can be done non-invasively on humans and we have indeed gained much knowledge on various questions, invasive experiments on animals are necessary. In many human experiments we can study the input to the system and the output, but we are fairly limited in understanding what goes on in between. For example, interactions between diet, the microbiome, the digestive system and disease are so complex that important relationships that have to be understood to advance therapy can only be worked out in animal models.
Of course, animals are not perfect models for the human body. They can never be. Species evolve and change.
However, many parts of our bodies have remained the same over millions of years of evolution. In fact, much of our basic knowledge about how impulses are transmitted along a nerve fibre has come from studying the squid, but our understanding also gets gradually modified by more recent experiments in mammals.
Higher cognitive functions and the complex operations of the motor system have to be studied in mammals. For a small number of these studies, nothing less than a non-human primate is adequate.
The choice of species for every experiment is usually carefully considered by investigators, funding bodies and ethics committees, from both ethical and scientific viewpoints. That is why the use of non-human primates is usually a small percentage of all animals used for research. In the state of Victoria, this constitutes only 0.02%.
Medical history can vouch for the fact that the benefits from undertaking animal experiments are worth the effort in the long run and that such experimentation is sometimes the only ethical choice. Taken overall, the principle of least harm should and does prevail. There may come a day when non-invasive experiments in humans may be able to tell us almost everything that animal experiments do today, but that is probably still a long way off.
Priorities in animal use
The ethical pressure put on research seems to be in stark contrast to that on the food industry. It is hypocritical for a society to contemplate seriously restricting the use of the relatively small number of animals for research that could save lives when far more animals are allowed to be slaughtered just to satisfy the palate. This is despite meat being a health and environmental concern.
The ratio becomes even more dramatic when you consider the use of non-human primates alone. In Victoria, for every monkey used in research, more than one million animals are used for meat production. However, the monitoring of the welfare of farm animals is not in any way comparable to that which experimental animals receive.
Reduced use of livestock can greatly reduce mankind’s ecological footprint and also improve our health. This is an ethical, health and environmental imperative. Animal experiments, including some on non-human primates, are also an ethical and medical imperative.
There is sometimes confusion about how US law protects rats, mice and non-mammalian vertebrates such as birds and fish. Much of this confusion is rooted in the fact that the US Animal Welfare Act (AWA) explicitly excludes purpose-bred rodents (rats of the genus Rattus rattus, mice of the genus Mus mus), as well as birds that were specifically bred for research. Research with these purpose-bred rats and mice likely comprises the overwhelming majority of vertebrate animals in research in the US, but it is not overseen by the United States Department of Agriculture (USDA).
Sometimes this fact is used mistakenly (or perhaps purposely?) to suggest that all species not covered by the Animal Welfare Act are not protected by any federal laws.
Claims that research with non-AWA-covered species is not subject to care standards, external oversight, and public transparency are demonstrably untrue.
This post aims to address these misconceptions by looking at when and how rats, mice, and birds in research are covered by federal laws.
Overview of animal research regulation in the US. The Animal Welfare Act (AWA) states that covered species are defined as: “with certain exceptions, any live or dead dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit, or such other warm-blooded animal, as the Secretary [of Agriculture] may determine is being used, or is intended for use for research” (7 U.S.C. 2132(g) The 2002 Farm Bill amended this definition to exclude purpose-bred rats, mice, and birds from the provisions of the AWA. Note that certain types of research with animals and most animal testing are also subject to regulation and oversight by the US Food and Drug Administration (FDA).
Animal Welfare Act (AWA) and USDA. The USDA is charged with enforcement of the AWA. The AWA applies to research with a range of species that includes: “with certain exceptions, any live or dead dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit, or such other warm-blooded animal, as the Secretary [of Agriculture] may determine is being used, or is intended for use for research” (7 U.S.C. 2132(g), referred to here as “USDA-covered species.” Institutions that engage in research with covered species must be registered with the USDA. The AWA also applies to zoos, entertainment facilities, breeders, and other facilities that engage covered species in activities that involve public contact. All such facilities must be licensed by the USDA and research may also be conducted in facilities licensed for non-research purposes.
An amendment to the 2002 Farm Bill specifically excluded from AWA oversight rats of the genus Rattus rattus, mice of the genus Mus mus, and birds specifically bred for research. Thus, research with these rats, mice, and birds, which likely comprises the overwhelming majority of vertebrate animals in research in the US, is not overseen by the USDA.
Does that mean rats, mice, and birds are not covered by federal animal welfare laws?
It depends on the funding! In fact, many rats, mice, and birds bred for research are covered by federal law.
Why? Because, for federally-funded research, another federal regulation specifies the conditions for animal care, animal research, external oversight, and associated public transparency via a second federal agency. This includes, for example, university research funded by the National Institutes of Health, the National Science Foundation, or other federal agencies.
PHS and OLAW. The Health Research Extension Act (HREA; 1985) provides the statutory authority for the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy), which applies to all PHS-funded research with live vertebrate animals. In brief, such research must follow the National Research Council’s Guide for the Care and Use of Animals in Research (The Guide) (NRC, 2011). Each institution receiving PHS funding for research with vertebrate animals is required to have an Assurance of Compliance (Assurance) with OLAW. The Assurance describes policies and procedures adopted by the institution in order to comply with PHS Policy.
The NIH website provides extensive information about PHS policy and OLAW.
Food and Drug Administration (FDA). Certain types of research with animals and most animal testing are also subject to oversight and regulation by the US FDA.
Part of the federal regulation governing animal research also requires that each institution engaged in research has a mechanism for ethical consideration, approval, oversight and monitoring of animal care and research. Thus, there are also oversight bodies at each institution that are charged with the approval, monitoring, and reporting of activities with animals.
What about rats, mice, and birds that are not in federally-funded research?
While privately-funded research is not subject to the AWA or PHS Policy, there are other mechanisms that are used to ensure standards of animal care and research review, such as voluntary accreditation of the institutions’ animal care program. Such research may also fall under FDA oversight and, as such, be required to follow PHS Policy.
Private accreditation. An institution may choose to seek and maintain voluntary accreditation by a private agency, AAALAC, International (AAALAC). In the US, AAALAC accreditation depends on demonstrating compliance with the The Guide; thus, institutions that are not overseen by APHIS or OLAW may choose to be accredited and adopt the same standards for the care and treatment of research animals. Private accreditation for the care of captive animals is common across different kinds of facilities that house nonhuman animals, including those in research, but also in zoos and sanctuaries, who have their own accreditation organizations (e.g., American Zoological Association, AZA; Global Federation of Animal Sanctuaries, GFAS). Importantly, however, unlike oversight by a federal entity, voluntary accreditation does not provide a venue for public oversight and enforcement, nor does it allow for public transparency. For example, both USDA’s APHIS and PHS’s OLAW are responsive to public requests for investigation of facilities and records relating to oversight of those facilities. Private accreditation agencies do not provide public transparency of the accreditation process and/or inspection reports.
There are many sources of federal and local protection of animals in laboratories. Any research on AWA-covered species OR research that receives federal funding will be covered by federal laws aimed at ensuring laboratory animal welfare. Those laws provide for external oversight and for public transparency of records including, for example, inspection and investigation reports.
Most research is also covered by the IACUC system, which provides for oversight and, for many public institutions, another route of public transparency via state open records. Finally, many facilities– both public and private– maintain voluntary accreditation, which also should have a positive impact on animal welfare.
Update 5/24/16: “New MOU Among NIH, USDA, and FDA. NIH, USDA, and FDA have participated under a Memorandum of Understanding (MOU) Concerning Laboratory Animal Welfare for over 30 years. Each agency, operating under its own authority, has specific responsibilities for fostering proper animal care and welfare. This agreement sets forth a framework for reciprocal cooperation intended to enhance agency effectiveness while avoiding duplication of efforts in achieving required standards for the care and use of laboratory animals. The new MOU is available at: http://grants.nih.gov/grants/olaw/references/finalmou.htm.”
We will be clear about when, how and why we use animals in research
We will enhance our communications with the media and the public about our research using animals
We will be proactive in providing opportunities for the public to find out about research using animals
We will report on progress annually and share our experiences
One of the clearest demands is a subsection of Commitment 2, which states (in one very long sentence):
Within one year of signing up to the Concordat we will make a policy statement about the use of animals in research avaiable via our website, to provide clear information about the nature of our own involvement with animal research and its role in the wider context of our research aims, and, and link this to a central portal, publicly available on the Understanding Animal Research (UAR) website, or provide this information to UAR for inclusion in the portal.”
Speaking of Research has the most comprehensive list of these policy statements, including institutions from ten different countries. For some countries we have only a few statements, often because language barriers have prevented us finding them – and for other countries we have many – particularly the US and UK. We have also rated these statements according to the amount of information they provide (see grading details). Nearly every UK Concodat signature has got a statement (some pharmaceuticals with research bases in the UK are classed as “International” in our lists).
Below we should a table of the ratings in different countries. In some countries like Australia and Ireland there are only a few institutions which have statements, which are generally low rated. This is likely because there is no expectation among institutions to have such statements. On the other hand the US and UK have nearly 100 institutional statements each. The UK is particularly impressive given that the 96 institutions represent (plus more in the International column) represents most of the biomedical research institutions conducting animal research in the country.
If we compare the grading of websites in the UK compared with everywhere we find the UK provides more information on average.
We can see that the UK has a higher proportion of statements ranked with 2 or more ticks. Two ticks would tend to mean a high level of website information available about an institution’s animal research.
In our eyes the Concordat on Openness on Animal Research in the UK has had two main victories. Firstly, it has encouraged nearly every animal research institution in the UK to openly explain on their websites that they do animal research – this is true of no other country. Secondly, it has helped drive better information to be provided on these websites, with increasing numbers of universities putting up case studies, images, videos and statistics.
We congratulate the Concordat on Openness on Animals Research in the UK for supporting transparent discussion on this issue, and we wish it all the best as it enters its third year.