 Good morning, good afternoon, and good evening to everyone, and welcome to the workshop Discussing and Understanding Animal Welfare Challenges in Research and Education on Wildlife, Non-Model Species, and Biodiversity. My name is Karine Lutz, and I am a Senior Program Officer with the Institute for Laboratory Animal Research. On behalf of the National Academies of Sciences, it is my privilege and great pleasure to warmly welcome all of you to this public workshop, and thank you for your participation. We have a very exciting program, and we are extremely grateful to our invited speakers for their important contributions to this workshop. I also want to extend my special thanks to the planning committee members for their service, and to the members of the National Academy of Sciences Roundtable on Science and Welfare of Laboratory Animal Use for their support. The Academy's Division on Earth and Life Studies is committed to actively conducting a range of activities where policy meets the life sciences, including the environment, geography, natural resources, and the care and use of animals in research. Ilar is in the process of expanding its mission to improve the science and welfare of not only laboratory animals, but all animals in research, testing, and education. Our main task with this workshop is to discuss the current understanding of animal welfare challenges in research and education on wildlife and biologically diverse animal species. By heightening awareness, increasing sensitivity, and promoting discussions on these non-traditional research animals, the workshop will help inform humane care and use of a wide variety of species, both in captive and natural conditions. We are honored to have so many experts with us today, all esteemed specialists striving to promote animal welfare, both in captivity and in the wild. Once again, thank you very much for joining our workshop today, and I would now like to invite opening remarks from Anne Maglia, the workshop planning committee co-chair. Thank you. Thank you, Karine. On behalf of the organizing committee, I am pleased to welcome you to this workshop. Over the course of the next two days, we will hear from an outstanding array of experts in animal welfare, veterinary medicine, wildlife research, and animal welfare policy. We are delighted that you have joined us. I'd like to acknowledge and thank the planning committee members for their commitment to this workshop, especially my co-chair, Dr. Bob Sykes. It has been a true pleasure to work with such an outstanding group of experts. I'd also like to thank the National Academy, the Ilar Council, and the Round Table of Science and Welfare and Laboratory Animal Use for their support. And of course, none of this would be possible if it wasn't for the dedicated National Academy's team, who have kept us all on track and shepherded us through this entire process. Thank you all for your dedication to this project, and to animal welfare in general. It's unfortunate that we can't all be together in person for this workshop, but we hope to make it as interactive an experience as possible. Although these presentations have been pre-recorded, the speakers will be logged in during the broadcast of their talks, and you can post questions to them in real time through the presentation interface. Your questions will go to the moderator, who will in turn forward them to speakers. And at the end of each day, we'll have live summary sessions in which our moderators will highlight their sessions, including some of the most interesting and important questions that came up. We hope you'll join us for those summary sessions. I do want to mention that the presentations and discussions in this workshop will be captured in a proceedings. We are fortunate to have two members of the Standing Committee for the Care and Use of Animals in Research joining us for our summary sessions. And the talks and discussions today and tomorrow will help inform that committee as they consider updates and additions to the guide for the care and use of laboratory animals. And finally, I'd like to thank our speakers, our moderators, and you, our audience members. I'm confident that these two days will be transformative for the welfare of wild animals in research and educational settings. I'm happy to welcome you to our first session of the workshop. This introductory session offers an overview of and some context for this workshop, as well as perspectives from several cognizant organizations. Bob Sykes will start us off with the overview of the workshop as well as some larger context of the importance for the workshop. I'll then talk about the NSF perspective. Carol Clark will talk about the USDA perspective and the Animal Welfare Act. Nicolette Peter-Verry will talk from the Olaw perspective. And Jeff Wyatt will close us out talking from the perspective of ALAC. Thank you to all our speakers for your insights and audience members for attending. And don't forget to post your questions to the speakers in the presentation interface. And now I'm pleased to turn it over to my co-chair and opening speaker, Dr. Robert Sykes of the University of Arkansas Little Rock. Bob, it's all yours. Hello, I'm Robert Sykes. As have the previous speakers, I welcome you to this workshop. I'm a professor of biology at the University of Arkansas Little Rock. More specifically, for the purposes of this event, I'm a field biologist and have worked exclusively with wild animals throughout my career. My background in the arena of animal oversight includes currently serving as co-chair of the Animal Curing Use Committee of the American Society of Memelogists, where I've been senior author on the last two editions of the ASM guidelines for the use of wild mammals in research. So the oversight of animals and specifically of wildlife is an area that I have worked in and am passionate about. The purpose of this introductory talk is to give you an overview of the workshop and the intent of the organizing committee regarding how we develop the format. There's broad recognition that activities involving wild animals are a difficult fit within the framework of animal oversight and use for research. This awkward fit really should not be surprising because that very framework was developed around the use of domesticated species, primarily in laboratory environments. The challenge of fitting wildlife into this framework is especially important now with the recent establishment of a standing committee for the care and use of animals within the National Academy of Sciences. Thus, the results of this workshop will provide insights for the work of that committee. But there is also clear recognition that the challenges associated with wildlife fall under the purview of many other entities. So this workshop additionally will provide information for this broader assembly of stakeholders as they address these challenges moving forward. With these points in mind, the committee felt that the best approach would be to focus on identifying challenges associated with oversight of wildlife rather than to provide any sort of a how to approach. With these general goals in mind, my aim with this introduction is to provide a 30,000 foot overview of the organization and main challenges as identified by the planning committee. I will explain how the committee went about its work and how key topics were identified and subject matter experts selected. We've designed the workshop with seven topical sessions split across two days and with an additional session at the end of each day to summarize the main points of that day's content. In this first session, you will hear from a series of speakers regarding the main challenges as perceived by the National Science Foundation as a funding agency by N.H. O'Law as the agency responsible for welfare assurances across many U.S. funding agencies and responsible for implementing PHS policy. The USDA as the main body responsible for enforcing regulation of animal welfare statutes in the United States and you'll hear from ALAC International as an accrediting organization whose accredited units include many of those conducting wildlife research. Secondly, I wish to provide some historical context regarding how we've arrived at this point with regard to the current structure of regulations and guidance affecting wild animals. Finally, I would like to provide a broad overview of the nature of the challenges themselves. These really break down into two primary areas that of the animals and activities. When we consider the animals, there are key differences between wild animals and the animal models typically used in biomedical research. These include the fact that the subject animals in wildlife research are not domesticated and they are at least initially free ranging. There's a diversity of species, environments and behaviors in these animals that are not related to what we see in laboratory research. The animals themselves are the focus of the research and they are not merely used as models for humans. Finally, because these animals are free ranging, they are in fact state owned. They cannot be owned, they cannot be the property of the individual doing the research or the institution in which the research is being conducted. They belong to the public in almost all countries. This brings in permitting regulations and requirements that have no parallels in the biomedical environment. The activities are much more diverse in wildlife research. These research objectives can be ecological, physiological, they may concern conservation, they may concern behavior. And all of these approaches are all of these types of studies involve different approaches. These different components fall under different jurisdictions. That means for wildlife research to be conducted legally, the oversight bodies and the investigators have to be cognizant of the entities that have jurisdiction in these various areas and make sure that they're complying with the required regulations. In addition to these two main categories, terminology can present additional obstacles. And this applies to terms that are commonly used by field researchers or oversight bodies but have very specific definitions within the regulatory framework or guidance documents that are used. One example of these terms is field study. This is a term that has a specific regulatory definition by the U.S. Department of Agriculture and that definition is often in conflict with the way it's commonly used by field biologists. Dr. Clark will address this in a more detailed manner a little bit later in this introductory session and she will do so from the USDA perspective. Another term where usage often causes difficulties is that of euthanasia. This is one that I will come back to a little bit later in this introductory segment and that also will be treated in the session on euthanasia and humane killing. It's important to remember that the ultimate goal is to identify not only the challenges but the various entities and actions that are needed to address these challenges as we move forward. The planning committee first reviewed the taxon guidelines for capture and handling of wild species. Our thinking was that the topics addressed in these documents were the issues that the taxon experts themselves deemed critical as they were working to mesh concerns relevant to their species environments and activities into the overarching framework for the oversight of animal activities that are animal activities in research and education. In addition to the topics identified therein, we added additional topics based on more recent developments in various fields and changes in guidance or regulations that have occurred since the taxon guidelines were published. To address these topics, we sought individuals with backgrounds and training that would provide different perspectives and who would see these challenges from very different viewpoints. A common theme that came through in all of these taxon guidelines was that the subject animals were not domesticated, which means that fitting them into a framework designed for domesticated strains poses a challenge from the very start. This slide depicts domesticated and non domesticated strains of a single species that is Canis lupus. For the puppies on the left, humans are viewed as the provider of food, shelter, and play items. Human presence is soothing for these animals and rewarding. For the wild strain on the right, humans are to be avoided. For many wild animals, humans are typically viewed as potential predators and hence we are stressors. In other words, the mere presence of humans by itself is a stressor for these animals. These fundamental differences entirely alter how we interact with these animals. Wild subject animals are at least initially free ranging. So regardless of the type of data we need to collect from these animals, the process first involves finding them and then either capturing or collecting data remotely if that's possible. Activities that involve remote data collection typically do not require approval from an oversight body such as an eye cut and hence they're not the type of activities that are the subject of this workshop. If, on the other hand, we need to capture or collect the animals, the first step is to identify a suitable means of capture. Depending on the target species and methods employed, we often have little control over the age, sex, reproductive status, number, or perhaps even species of animals that might be taken in a given capture attempt. Most of the capture techniques such as a trap for small mammals is they're not species specific. You don't know what type of individual you might capture in that trap and this is certainly true with nets when it comes to such animals as fish or drift fences for herp tiles. The capture of non target species and variable numbers of animals that may be captured are issues that have no parallel in the laboratory environment, but they're constant challenges with wildlife. A non target animal in a laboratory environment means that the investigator has walked into the wrong laboratory, whereas non target animals in wildlife research are part and parcel of being in the field. I've made the point already that one of the main differences between wildlife research and typical laboratory animal research is that the animals are not domesticated. Biomedical research typically involves a very limited number of species and even the strains selected are often highly inbred specifically to reduce genetic variability or statistical noise around the phenomenon of interest. There are only about 37 species of domesticated vertebrates depending on which source you consult and if you tally the total number of animals used in biomedical research, well over 95% of the individuals used can be accounted for by only a handful of species, probably over 99%. Those are going to be mus musculus, the lab mouse, ratus norvegicus, the lab rat, Daniel Ririo, the zebra fish, and then you're going to have a handful of of dogs of agricultural animals of rabbits and other small rodents. In contrast, there are in excess of 73,000 species of wild vertebrates, each of which is a potential study subject. These diverse species occupy equally diverse habitats and they differ profoundly in virtually every parameter that one might care to measure. This very diversity presents an enormous challenge for anybody concerned with the ethical oversight or regulation of these animals because what is appropriate and reasonable for one species might well be inappropriate and unethical for the next species. This especially pertains to behaviors and activities that are appropriate for lab animals, for domesticated animals, when we translate those to wild animals. Not only are the species different, but the types of questions posed and the very reasons for those questions differ profoundly from those of biomedical research. In biomedical research, the animal models are typically used as surrogates for humans, they're substitutes. To be sure, biomedical research often benefits animals as well, but the primary focus is to improve human health and well-being. In other words, for biomedical research, humans are the ultimate beneficiaries. For wildlife research, the objectives are most often to understand the biology, the ecology, the evolution, or the behavior of the wild animals themselves. These factors are the basis for management and for coexisting with these species on planet Earth. Rather than being surrogates, the wild species themselves are the focus and most often the ultimate beneficiaries of wildlife research. These different foci for wildlife research should now be in sharp focus for the entire world. This slide shows just a few recent headlines or titles of recent publications regarding declining biodiversity. The data are becoming increasingly clear that we are now in a sixth mass extinction event, and this is the first one that is linked specifically to human activities. These anthropogenic influences include habitat alteration on a local scale that affects local populations of animals. It includes harvesting of animal populations for human use and the multiple impacts of climate change. There have been many ecological studies demonstrating that ecological stability is positively correlated with community diversity. So, it is in our best interest to preserve this biodiversity on a very broad scale. But if we are to preserve biodiversity, that first requires knowledge of the species and of their natural systems, and this is exactly the type of research that is the focus of this workshop. Populations of wild animals originally were, and for many species still are, viewed as economic resources. Examples include the harvest of beaver for their pelts, which led to much of the early exploration of North America. The harvest of American bison for pelts and for meat. The harvest of whales for meat, for oil, and the harvest of many species today for food, either for humans or for other animals that we maintain. Because harvest pressures adversely impacted populations, we saw the development of laws and regulations that were established, often with international cooperation, to manage the exploitation of these animal populations. Examples include limits on the numbers and size of individuals that can be harvested, and in some cases, the outright bans on harvesting of many species when the populations are threatened. These regulations were aimed primarily at management, and they still apply today. And navigating these applicable laws and regulations that are focused on preserving and protecting populations is an ongoing challenge that continues for investigators and for oversight bodies alike. In the very next session of the workshop, we're going to see the speakers highlight some of the levels of regulations, and the differences that exist in the laws, the regulations, and the permits that are associated with work involving wildlife. This is really the left-hand side of this slide, where many of these regulations are really focused on management, on preserving the populations. For the right-hand side, this is a development of regulations that we'll see more recently. Specifically, these are associated with the ethical handling of wildlife species when they are the subjects of research and educational activities. Because this component is the focus of the workshop, I'm going to next give a brief overview of how these regulations and guidance documents came about, and how they were expanded to include wildlife. I want to emphasize that this history is focused on animal use and ethical handling of animals used in research, not in management. So some key dates. In 1953, we see the establishment of the Institute for Animal Resources, which is now the Institute for Laboratory Animal Research, or ILR, and that is the entity, the unit that is producing this workshop. ILR was originally intended to develop a procurement mechanism for animals that were destined for use in biomedical research. Ten years later, we see publication of the first edition of what will be the guide for curing use of laboratory animals. This also was intended as the standard for animal care in biomedical research. The next key date, 1966, we see passage of the Animal Welfare Act, which is prompted in large part by public outrage over the use of dogs destined for use in biomedical research. This act was very quickly signed into law, and it authorized the U.S. Department of Agriculture's Animal and Plant Health Inspection Service to regulate the use of vertebrate animals in research. The initial act and its subsequent amendments have remained focused primarily on laboratory research. In 1986, this focus is going to change. In 1986, we see passage of the Health Research Extension Act and promulgation of U.S. Public Health Service or PHS policy on the animal care, on the human care and use of laboratory animals extended to cover most vertebrates. And, importantly, this policy and the act linked eligibility for PHS funding to compliance with PHS policy. Now a key part of this policy is that it requires that research be conducted in a matter consistent with the ILR guide, the guide for care and use of laboratory animals. This, in effect, makes the guide quasi-regulatory. Also in 1986, the National Science Foundation and other federal agencies, federal granting agencies voluntarily adopted this PHS policy. But the NSF recognized that the guide for care and use of laboratory animals was a difficult fit for wildlife, particularly for field research. And as they funded quite a bit of this field research, they asked for the tax on societies to develop guidelines specifically to address the absences for use of these types of animals that occurred in the guide for care and use of laboratory animals. As a consequence, in 1987 and 1988, we see the tax on specific guidelines produced by all these tax on societies and they covered the use of fish, herptiles, mammals and birds. It's important to note that these tax on guidelines came about at the request and with funding from the National Science Foundation and they were developed specifically in an attempt to fit these wild animals and the different types of questions and activities into a framework that was largely established for biomedical research. So what are some of the major challenges? First off, wild animals are initially free ranging and exist as part of a wild population. That means that there's a potential that our research activities can impact these native populations and communities. Some species pose serious risk to humans because they are inherently dangerous or because they are venomous. Similarly, because these are free ranging animals, there are potential hosts to a range of natural pathogens and parasites that can be transferred to humans. What is not fully appreciated by oversight bodies, for which wildlife is not a major portion of their portfolio, is that there are additional and very significant risks of research personnel inadvertently spreading pathogens in wild populations of animals. The current coronavirus pandemic underscores the fact that many of these agents can be spread broadly and rapidly among populations, among diverse populations. So biosafety concerns must be viewed from both perspectives, meaning safeguarding the well-being of human investigators, but also ensuring the continued health of natural populations. These different types of biosafety risks will be the topic of session three. Capturing handling methods must be tailored to the species and to the environment. In many cases, and depending on species, animals often can be handled by experienced researchers quietly and swiftly to minimize the stress associated with human presence or prolonged handling time. As is the example shown here, where these investigators are inserting passive integrated transponder or pit tags into pocket gophers. But in other cases, handling and specific procedures might require sedation. In these cases, sedation is often used not to relieve pain or distress, but for the safety of both the animal and the researchers. Regardless of whether sedation is required or not, challenges associated with handling include tailing procedures to the species and to the conditions. Sedation often presents an additional challenge in the use or transport of controlled substances, which is often conducted by non-veteran areas. And it has to be done in a manner consistent with the regulations in whatever country the activities are taking place. As with the potential inadvertent introduction of pathogens into natural populations, the use of chemical compounds can have broader unintended effects as well. Examples of these types of challenges and those associated with broader handling and capture techniques of diverse species will be addressed in much more detail in session four. Wildlife veterinary medicine is a specialty all its own, and there are many procedures and activities for which veterinary input and involvement is critical, whether the veterinarian is actually part of the field crew or not. Because the wildlife focus is a niche specialty and because of the diversity of species and activities, locating the needed expertise can be a challenge. This is where broad collaborations and engaging outside consultants, whether by the veterinarians, the investigators or oversight bodies, can pay huge dividends. These interactions underscore that the unique challenges associated with wildlife activities benefit from and often demand attention from different perspectives. Session five of this workshop will address the role of veterinarians in wildlife work, both from the perspective of veterinarians and as collaborators with non-veteranians in the form of field personnel. Humanely dispatching animals is a necessity for many reasons. Injuries resulting from research activities are the responsibility of the researcher, but often the most realistic course of action for serious injuries is euthanasia rather than treatment. Remember that these are wild animals, so bringing a wild animal into captivity for treatment often is not feasible. Also remember that the term euthanasia is one of those where usage varies and where definitions matter. Very often in field circumstances, the conditions and constraints make it difficult or impossible to meet the conditions for euthanasia as detailed in the AVMA guidelines for euthanasia. As a consequence, the methods of death are more often termed lethal take, humane termination or the like. Regardless of the definition and the term used, the ethical expectation always remains that the end of the animal's life come in the most humane manner possible. It is common for research objectives to require samples or perhaps the entire carcass from dead animals so lethal take or capture and then humane termination are often required. Challenges in these situations include selecting methods for humane termination that are consistent with the species, with the research objectives, with the environmental limitations, and all without subjecting the animal to additional undue stress or distress. Selecting methods that are applicable within the existing regulations that are available and usable by field personnel. Methods typically must be applicable in field settings and useful within whatever logistical constraints exist. Capture of animals often occurs in remote settings and all equipment must be carried by the researcher. This is going to put a logistic limit on some of the techniques that may be considered. The methods selected must not put other animals at risk either through their use or perhaps by leaving carcasses or tissues in the field if chemical compounds are used. These topics are among those to be discussed in session 6 of the workshop. Session 7, the last topical session, will address the challenges faced when wild animals are brought into a captive environment. Most of these challenges are related in one way or another to the fact that these individuals are not domesticated and they simply cannot be handled as if they were. Special consideration must be given to minimizing stress during acclimation to captivity, to identifying and providing species-appropriate environments and enrichment, to identifying and providing appropriate food. For example, there are no domesticated animals that consume live prey yet this is quite common with animals taken from the wild as exemplified by the water snakes on the right hand side of this slide. When brought into captivity, these animals are expecting their native prey, their natural prey. Getting them to eat dead animals is difficult and in some cases not possible. We need to provide conditions that permit collection of naturalistic behaviors and responses if those are important because we're studying these wild animals. And the final concern is the disposition of the captive animals. In most cases these animals cannot be returned to the wild for a number of reasons. They have no familiarity with the environment if they're being out of the native environment or the natural environment for very long. And putting them back can pose risk for the natural populations. In most cases there are regulations that prohibit release of animals that have been in captivity back to the native environment except in the case of endangered species or species of special concern. It's important that we comply with all the regulations regarding potential release of these animals. With that, I want to bring this overview to a close and begin to delve into the specifics of the challenges from various perspectives. But I want to close by emphasizing that although these challenges have arisen naturally enough over the course of many decades, and because of the growth and development of regulations, guidance and jurisdictions of many different entities, addressing the challenges in a meaningful way will require a cooperative approach. If we are to have a reasonable chance of preserving much of the Earth's diversity, that is a challenge that we all must meet head on. Thank you. Hi, thanks for attending this portion of the workshop. My name is Anne Maglia and I'm the Associate Vice Chancellor for Research, Administration and Integrity at the University of Massachusetts Lowell. Prior to my current position, I served as the animal welfare officer at the US National Science Foundation and managed a portfolio of awards that included Ilar and other National Academy funding. Today I'll be speaking about the NSF's portfolio of funded wildlife research. Although I'm focusing on NSF, this talk is really an overview of the breadth of wildlife research in general and some of the animal welfare challenges faced by wildlife researchers. I do want to note that I'm not speaking for the NSF, but from my own experiences and from conversations I've had with current NSF employees who are familiar with this topic. The US National Science Foundation is an independent government agency with a budget of about $8.5 billion. Unlike other federal science agencies, the NSF does not conduct research and almost 95% of their budget goes to fund basic research in the US. A significant portion of the NSF's supported research involving vertebrate animals includes wildlife. The wildlife research funded by NSF is broad and diverse and ranges from physiological and developmental mechanisms to landscape ecology and everything in between. Some general themes uniting the research are that the research is being conducted to understand and benefit the organisms under study. In other words, these animals are not models being used to understand what's happening in humans. Another theme and a challenge is that because these aren't lab-bred and raised animals and for some of these species there may be conservation concerns, the availability of the animals will have a major impact on the study design and the numbers that can be studied. And finally, because of this limited availability of study organisms, researchers tend to design their studies to maximize the data collected so that it can be reused for other studies. The design of wildlife studies also varies a great deal. Some studies are purely observational, others might be manipulative, and others might result in museum vouchers documenting to biodiversity. These studies may also include just a field component, just a lab component, a field in the lab component, or any combination of some or all of these shown on the slide. And here's just a sample of the wildlife research funded by the NSF. In the Division of Integrated Organismal Biology, they fund research such as this recent study on the evolution of cooperative behavior in vampire bats. This study they recently funded is developing new methods for measuring body water input and metabolism in wildlife. And they also funded a study to understand the development and functional impact of genetic variation in cichlidfish cranial evolution. And in the Division of Environmental Biology, they fund studies such as this recent project on identifying and recognizing hidden biodiversity in eastern U.S. woodland salamanders. They also funded a study on the evolutionary mechanisms leading to and resulting from co-migrating bird species. And they funded a study of environmental response that looks at genetic and phenotypic diversity in city mice versus country mice. Given the diversity in NSF's funded wildlife portfolio, the guidance for researchers regarding animal welfare points to both the guide and the guidelines developed by the taxonomic societies shown here. But as we know, some of those taxonomic guidelines have not been updated in quite a while. I'm going to switch gears now and talk about some of the animal welfare related challenges faced by investigators conducting wildlife research. These, what I'll cover, are real examples that came directly from either my experience as a wildlife researcher funded by NSF as the NSF Animal Welfare Officer or from current NSF program directors. My goal in identifying these is simply to provide some tangible examples for why it is so critical that we are having this workshop right now. Certainly one of the most pressing challenges is that many of our standard protocols, for example methods of anesthesia, were developed on captive bred models and these don't always have the same effect on wild animals. Similarly, using housing and feeding protocols developed for captive raised animals for wildlife in the lab can stress or even kill sensitive animals. For example, frequent water changes can be detrimental to aquatic frogs and frequent bedding changes can interfere with animal communications that may be important to, let's say, a behavioral study. Another challenge that some wildlife researchers face is that some institutions require mandatory PPE protocols such as eye protection. This can potentially lead to harm of animals or investigators. For example, goggles fog up in the field, especially at night. And similarly, sometimes gloves can make it difficult to capture and handle sensitive wildlife with minimal impact. Sometimes field sites are so remote and may have no internet or cell service that it can be a challenge to implement standard IOC protocols like inspections. These can be hard to do even virtually or it may even be difficult to find a third party to rely on for inspections. Another challenge facing wildlife researchers often the field component of the research is done in a different country than their home country or than the country that they are funded through. And while this is not impossible to navigate it certainly does add complexity to studies and points to the importance for good communications and an understanding of local rules and regulations. Another challenge is that particularly at small institutions, IOCs or attending veterinarians may not have the taxonomic or wildlife expertise needed to evaluate wildlife studies. And despite being able to tap into external expertise, IOCs may not be aware of who to contact for guidance on wildlife research. And often they must rely on the investigator to provide guidance of names of experts. While this isn't all bad, it certainly could present the appearance of a conflict or a lack of independence in review. Another challenge is that some field sites, especially in remote locations and or smaller institutions, don't have the infrastructure or resources to support standard housing protocols. This can be especially challenging if the studies also require conducting and recovery from minor surgeries like, for example, embedding trackers. And although this one is a bit esoteric, it is important and it can present a big hurdle for researchers. Organizations that receive NSF funds for field research, but no other federal funds for animal research, such as museums and independent field stations, may have challenges obtaining a PHS approved assurance, which is required to have NSF funding. While this is mainly a policy or agency issue, researchers can find themselves stuck between the agencies because it affects their ability to get funding and to conduct their research in a timely manner. So I hope that I've provided a good overview of the breadth of wildlife research, both that funded by the NSF as well as just wildlife research in general. I also hope I've demonstrated the importance of wildlife research and identified some of the real animal welfare challenges facing wildlife researchers. It is my hope that this workshop will lead to efforts to provide more guidance and resources to researchers to ensure the welfare of wildlife in research and education. Thank you for your attention and thank you to the planning committee, the National Academy staff, and the NSF staff who helped inform this presentation. Good morning. My name is Dr. Carol Clark. I am the senior staff officer with USDA Animal Care. Today I will discuss research conducted on wild animals and the Animal Welfare Act. Some information about my background, I began my laboratory animal medicine career as a post-doctoral fellow at Smithclime Beach and Pharmaceuticals. Later, I moved to the National Institutes of Health where I supported AIDS and malaria research. In 2011, I accepted my current position with the USDA where I enforced the Animal Welfare Act for animals using research, teaching, and testing. For our discussion today, I will cover the regulatory requirements under the Animal Welfare Act, challenges in determining Animal Welfare Act covered activity, challenges regarding husbandry and standards of care for wild animals taken to the facility, the annual report, and available guidance. The Animal Welfare Act provides humane care to covered species and requires pain and distress to be minimized during regulated activities. The focus for this talk is on research, teaching, and testing. Regarding species regulated under the Animal Welfare Act, in summary, the Act covers warm-blooded animals with some exclusions, namely rats of the genus ratus, mice of the genus moose, and birds bred for research, horses not used for research, and livestock and poultry used for food and fiber, essentially livestock and poultry used for agricultural purposes. Regarding birds, in 2002 it was determined that rats, mice, and birds bred for research were excluded from coverage under the Animal Welfare Act. As a result, birds not bred for research are covered under the Act. The USDA is in the process of developing regulations and standards. Inspections of birds will begin when the regulations and standards are in place. The regulatory definition of a wild animal is any animal that is now or historically has been found in the wild or in the wild state within the boundaries of the U.S. its territories or its possessions. Regarding the definition of wild state, it means any animal that is living in its original natural condition and is not domesticated. So what are some of the challenges that Iacooks face? One of the challenges is having sufficient expertise to evaluate wildlife protocols. Another is understanding the Animal Welfare Act definition of a field study. Another is determining the activities that are covered under the Animal Welfare Act. And lastly, the Iacook knowing what its responsibilities are. And I will discuss each one separately. Regarding sufficient expertise, the regulations provide guidance by stating consultants and outside experts can be used. Regarding the definition of a field study, the regulation states that a field study is a study conducted on free living wild animals in their natural habitat. However, it excludes any study that involves an evasive procedure, harms, or materially alters the behavior of an animal under study. Animal care has provided some guidance to assist Iacooks in determining what is Animal Welfare Act regulated activity. This guidance is found as a tech note entitled research with free living wild animals in their natural habitat and the Animal Welfare Act. The next slides are summaries of this guidance. Regarding activities that are not covered under the Animal Welfare Act, strictly observational studies where no animals are captured or handled or where human presence does not impact animal behavior is not covered because these studies meet the definition of a field study. What is also not covered are activities using species that are not regulated under the Animal Welfare Act. So any study that uses invertebrate, fish, reptiles, amphibians, as well as the species I've mentioned earlier, rats, mice, and birds bred for research, horses not used for research, and livestock and poultry used in agricultural research are not covered under the Animal Welfare Act. And lastly, activities that are animal pest and population management programs for the purposes of limiting wildlife damage and human interaction are also not covered under the Animal Welfare Act because the purpose is not for teaching, testing, or research. So what is covered under the Animal Welfare Act? Well, studies with procedures such as major operations or surgical implantations of devices and intracardiac blood collections are covered because those procedures are considered invasive. Studies where the animal experiences death, trauma, overheating, excessive cooling, behavioral stress, physical harm, or unnecessary discomfort from handling are also covered because these are considered harmful. Studies that use hormones and pheromones to change mating or migration behaviors are covered because the animal's behavior is being materially altered. And lastly, studies that cause repeated nest and disturbances during breeding and rearing of young or relocation of migratory animals beyond natural migration routes are also covered because the animal's behavior is being materially altered. Regarding IACUC responsibilities, the regulations state that field studies as defined are exempt from IACUC review of activities. Going further, the IACUC is responsible for conducting the semi-annual review, namely inspections every six months of all animal facilities, including animal study areas. Note, animal areas with free living wild animals in their natural habitat need not be included in the inspections. Animal study area is defined as any enclosure or containment outside of a core facility or centrally designated area where animals are housed greater than 12 hours. Now I will discuss the challenges facilities face when caring for wildlife in-house and when completing the annual report. The regulations provide guidance for wild animals taken in-house. This guidance can be found in subpart F, which essentially covers the warm-blooded species that do not have a specific section and part three standards of the regulations. As a result, subpart F is written very generally. However, this is the section that wildlife would be covered under. So I'll discuss some of the regulatory requirements as far as husbandry that you can find in subpart F. One of the things to be concerned about is space and feeding. Regarding space, having sufficient space is challenging. The animal must be allowed to make normal, postural, and social adjustments. Evidence of malnourishment, poor body condition, debility, stress, and abnormal behaviors may be indicators of insufficient space. Feeding is another challenge. The food must be of sufficient quantity and nutritional value to maintain the animal's health. The diet is to take age, species, condition, size, and type of animal in consideration. Animals must be fed once daily except as dictated by hibernation, veterinary treatment, normal fast, and professionally accepted practices. Regarding food and water receptacles, they must be kept clean and sanitized. Cell feeders must have measures to ensure that mold and caking of food and contamination or deterioration does not occur. Regarding enclosures, there must be a pest control program in place. If greeter is to be removed as often as necessary to minimize disease and reduce odors. Enclosures that have gravel, sand, or dirt are sanitized when needed under the direction of the attending veterinarian. Other enclosures are sanitized using one of three ways. The use of a mechanical washer where the water is 180 degrees Fahrenheit and there is some type of soap or detergent used. Or can be sanitized using a detergent and a disinfectant or can be sanitized using pressurized steam. Another challenge that facilities face is annual reporting. All facilities that conduct teaching, testing, and research must submit an annual report. Only Animal Welfare Act covered species in regulated activities are reported. Animals used in field studies are not reported. I have provided the APHIS Form 7023. This is where the annual reports can be placed. I've circled the section that says other species. This is the area to use to indicate wildlife. If more space is needed, APHIS Form 7023A can be used. In conclusion, IACUCs can use consultants with expertise in wildlife research to assist in evaluating protocols. Determining whether a study is Animal Welfare Act covered or exempt dispends on the species and the activity. Guidance is available to help IACUCs determine Animal Welfare Act regulated activity. The regulations under Part 3 subpart F applies to wildlife taken to facilities. And animals on a field study as defined in the regulations are not indicated on the annual report. Please visit our website. It contains a wealth of information. The link is at the bottom of the slide. You can find the act and the regulations. There are also webinars and trainings. And the tech note that I mentioned on the work with wildlife is also there. You can also sign up for our stakeholder registry. And that allows you to find out what is coming down the pike as far as new regulations and new guidance. If you have any questions, please reach out to us at AnimalCare at USDA.gov. Thank you. Hello and welcome. OLA is honored to be a part of this very important workshop. I'm Nicolette Peterberry, part of the Division of Policy and Education within the National Institutes of Health Office of Laboratory Animal Welfare. Before we dive in, I'd like to go back to my opening slide image. I know this is what many people think of when I talk about OLA. Laboratory mice in biomedical research settings. However, today I'd like to shift gears a little and talk to you about research using free living wild animals. The PHS policy is very well suited to provide guidance for biomedical research. But as you'll see, there are many challenges in applying the PHS policy to field research and even to research using some non-domesticated species in a laboratory setting. It's my hope to outline some of the main difficulties both regulators and I could space in research involving these animals and to reframe them as opportunities for collaborative and productive problem solving. But first, a little background about our regulatory requirements. The Health Research Extension Act of 1985 provides the statutory mandate for the PHS policy. Even the title of the law, Health Research Extension Act, indicates the focus on biomedical research. The PHS policy implements this mandate and also requires adherence to several additional guidance documents. These include the guide for the care and use of laboratory animals, the AVMA euthanasia guidelines, unless a deviation is justified for scientific reasons in writing by the investigator and is approved by the IACUC, and where applicable, the USDA Animal Welfare Act and Animal Welfare Act regulations. If you look at the PHS policy of the guide, you'll see little guidance on research involving free living wild animals. As with the Health Research Extension Act, the focus is primarily on research involving traditional animal models in the laboratory. The PHS policy actually makes no specific mention of research involving free living wild animals. The guide does make mention of field research, but the information is very brief and very general. There are only four paragraphs on field research in the guide on page 32. It mentions several important considerations for researchers, IACUCs, and institutions, including permits, determination of the potential impact on the population or species, occupational health and safety issues, consultation with relevant professional societies and professional guidelines, consultation with veterinarians, return of animals to their habitat or final disposition, and issues for IACUCs that review field studies, including encouragement to consult with a qualified wildlife biologist. But the guide goes on to say that it does not purport to be a compendium of all information regarding field biology and methods used in wildlife investigations, but rather outlines the basic principles of humane care and use as they apply to animals living under natural conditions. These generalized, flexible approaches can certainly help institutions, but they also present challenges for both regulators and the regulated community. OLA has clarified some guidance in its FAQs, and FAQ A6 talks about whether the PHS policy applies to animal research that is conducted in the field. It states that no protocols are required if the IACUC determines that the proposed activity will not alter or influence the activity of the study animals. However, there is certain information that must be provided to the IACUC, including location procedures, how procedures are likely to affect biology and ecology of the study animals, and assurance that all permit requirements are met, and then and only then if the IACUC determines that the study is purely observational with no impact to the animals, no protocol is required. But impact is really challenging to evaluate. If animals see or smell the researchers, does that impact behavior, even if no trapping or invasive procedures are performed? And if so, how long and how significantly? What about effects on mating, offspring, and prey species? And how can IACUCs work with researchers to effectively answer such questions? OLA guidance in FAQ E4 further states that IACUCs need not conduct semi-annual inspections of field sites, but that there are health and safety, as well as animal welfare issues to consider. IACUCs should be apprised of study circumstances for the purposes of assessing personnel risks and impacts on study subjects, and this can be accomplished by means such as photographs and videos. OLA has also provided educational webinars on permits and on the oversight of wildlife research. So, we see that OLA supplies some guidance to clarify guide requirements, but there are many more issues unique to wild animal research that require consideration. Next, I'll discuss some guide requirements that are especially challenging to apply in wildlife research. The musts and should in the guide can be very challenging to apply in field research settings. For example, one must is veterinary consultation must occur when pain or distress is beyond the level anticipated in the protocol description, or when interventional control is not possible. But in many cases, veterinarians for institutions are not in the field, and even telecommunication can be challenging in remote locations. It's also challenging to bring veterinary equipment and substances into field settings. This is particularly true of controlled substances or hazardous materials where there are important legal, health and safety and welfare considerations. Another must is veterinary care must be provided if lesions or illnesses associated with restraint are observed. However, restraint looks very different in the field than in the laboratory. You can see this just by comparing the pictures of the gently restrained cat and the macaque receiving positive reinforcement on the left and the misnet and the trap containing the rabbit on the right. The differences are true in terms of the type of restraint, duration and effects on the animal. And in the field, effects can be particularly significant on non-domesticated prey animals. Remember, there's no acclimation, no positive reinforcement and certainly potential unreleaved distress. And with regard to the must in the previous slide, the must to provide veterinary care in the case of restraint related injuries or illnesses. Once again, options are limited. Further, how do you balance the benefits of veterinary care with the detrimental effects of continued handling on non-domestic species? Even if animals are anesthetized in the field, that also has effects. Will the anesthesia affect the animal's fitness upon release and will social groups be disrupted? The issues are much more complicated than they may appear on first glance. The guide has a section on veterinary care on pages 105 to 131 and subsections on surgery, minimization of pain and distress and euthanasia. As mentioned previously, veterinary care can be challenging in the field. What does that look like, especially when veterinarians may not be on site and communication issues may exist in remote areas? What does that look like in terms of equipment that you can take to remote locations? And drugs. This is especially important when conducting invasive procedures. How can appropriate preoperative, interoperative and postoperative conditions in care be maintained? The issues surrounding anesthesia or sedation are magnified when invasive procedures are performed. And again, what are the recovery issues and impacts on short and long-term survival, reintegration into social groups and mating? The same challenges exist for euthanasia where field conditions may preclude many recommended options. The guide talks about animal identification. And while the cage card on the left would work very well for a cage of mice or rats in a laboratory animal setting, this certainly wouldn't work for animals in the field. What does identification in wild animals look like in terms of placement, monitoring and effects on the animal? If surgical, what are the preoperative, intraoperative and postoperative conditions? How are pain and distress managed? And what are the impacts on survival, reproduction and the ecosystem? And what about occupational health and safety, disaster planning and training? What does occupational health and safety look like in the field? And what would disaster planning look like, especially in terms of personnel safety and animal welfare? And how can institutions best develop, implement and ensure appropriate training for field researchers and students? Other challenges include being aware of and coordinating other regulatory requirements and developing appropriate care standards for non-domestic, non-traditional species. For example, is daily observation feasible and appropriate for animals in torpor or hibernation? How often do they need to be provided food and water? While it may not be feasible to have specific standards for every species, some guide information may benefit from clarifications regarding some requirements when non-traditional species are used. While the challenges I've described are significant, I do not believe that they're insurmountable. Workshops like these that bring together laboratory animal professionals, field biologists and regulators are a great way to identify problems and brainstorm solutions. I'm very glad to be part of this event, and I'm hopeful that it will pave the way for more open, collaborative discussions on the topic. This slide shows OLAW's contact information. While I fully expect that sessions like this one will result in some initiatives and some guidance for IACUCs dealing with field research or research using wild animals in other contexts, until then, OLAW is here to help you on a case-by-case basis. There's no reason for any institution to have to struggle with this without help, and we're happy to answer your questions by email or by phone. Just give us a call or write to us, and we're happy to provide guidance. This concludes my presentation, but I hope that it generates discussions and solutions to some of the regulatory challenges that I highlighted today. Thank you, and I'm happy to take any questions during the question-and-answer portion of the workshop. Good morning, afternoon or evening, to our audience across time zones around the world. Over the next 15 minutes, I will present the ALAC perspective on the IACUC challenges posed by free-ranging wildlife field studies. We will learn about ALAC's guidance using reference resources beyond the three primary standards. The emerging drivers of more and more scientific studies enrolling free-ranging wildlife, the wildlife expertise of ALAC site visitors, and the four ALAC-adopted taxonomic-specific wildlife reference resources. We will end by summarizing the IACUC challenges to be covered by subject matter experts over the next two days of the workshop, and finally our next steps moving forward. But first, a little bit about me. I am Jeff Wyatt, a traditionally trained lab animal veterinarian at the University of Rochester, fortunate enough to have participated in free-ranging wildlife studies over the past 40 years. After volunteering 12 years on ALAC Council, and now three years as an emeritus council member, I have appreciated how ALAC has increasingly provided guidance to both site visitors assessing programs and IACUCs reviewing and approving wildlife studies. I have also learned that our success requires strong interdisciplinary collaboration with partner organizations. My field research has prioritized a one-health, one-medicine approach to evaluate and promote ecosystem health. At the intersection of human, animal, and environmental health. My research has taken me as far away as Madagascar, assessing indigenous community and lemur health through a climate change lens. To my own backyard in upstate New York, validating repatriated lake sturgeon as biomonitors of legacy pollutants in the Rochester Embayment EPA area of concern. We know ALAC is the only international accrediting body enhancing the quality of research, testing, and education by promoting humane and responsible animal care and use through voluntary participation in a peer review process. ALAC asks that we no longer decipher the acronym, eliminating the limitation that the letter L conveys narrowing our scope to laboratory animals. We have moved far beyond the traditional animals found in laboratories to include agricultural species on farms, free-ranging wildlife, and even mice and fish in outer space. ALAC's three primary standards used as basis for program assessments are the guide for the care and use of laboratory animals, the guide for the care and use of agricultural animals in research and teaching, and the Council of Europe ETS123 protection of vertebrate animals used for experimental and scientific purposes. While these three primary standards provide valuable ethical considerations and sound principles of humane treatment of animals in science, they all refer readers to consult with subject matter experts to address the unique challenges posed by and unusual experimental conditions encountered in field studies or wildlife research. What is driving the increased scientific interest studying free-ranging wildlife? This bibliometric analysis of publications in the Web of Science, the world's largest database of academic multidisciplinary publications, reflects a 100-fold increase in publications mentioning the One Health concept. The One Health concept is defined by the World Health Organization, OIE, the World Organization for Animal Health, and the UN's FAO, Food and Agricultural Organization, as an approach to address a health threat at the human-animal-environment interface based on collaboration, communication, and coordination across all relevant sectors and disciplines. With the ultimate goal of achieving optimal health outcomes for both people and animals. Wildlife, now more than ever, serves bioindicators in and biomonitors of a healthy planet in the face of ecosystem shifting and a degrading planet life support system caused by climate change. We are experiencing an anthropogenic, a human-caused, sixth mass extinction of free-ranging animals. Thousands of populations of critically endangered animal species have been lost in a century. As biodiversity collapses and as human pressures on the environment increase, we see unprecedented human health impacts as currently evidenced by our COVID zoonotic pandemic. IACUCs will see more baseline, metagenomic, and wildlife biodiversity surveys to monitor trends and identify risks to prevent the next zoonotic pandemic at its source. Governments and NGOs are funding bold new research ideas advancing the One Health concept to holistically address emerging zoonotic and vector-borne diseases as evidenced by USAID's $125 million project, Predict, to detect unknown viruses with pandemic potential. And the leveraging of $2.5 billion from the Biden administration to fund research on zoonotic pandemic prevention. All of these studies will involve scientific assessment of wildlife and IACUC review and approval of proposals. IACUC deploys greater than 400 ad hoc site visitors and over 100 council members to assess more than 1,000 accredited institutions worldwide. With the diversity of accredited units and new applicants, including academic institutions, pharmaceutical corporations, contract research organizations, government research entities, and research animal production businesses, ALAC strategically recruits site visitors with equally diverse expertise. ALAC office appoints at least one council member, including Emeriti, like me, to lead a site visit. The lead site visitor selects the most qualified site visit team members to perform institutional assessments. Fortunately, the ALAC council and ad hoc database identify species-specific expertise, including wildlife, of potential site visit team members. ALAC and institutions being assessed recognize the value of including peer subject matter experts for review of research and teaching programs and rolling free-ranging wildlife and field studies. Subcommittees of ALAC council review guidelines proposed for adoption as a reference resource, much like an IACUC would review a proposal with attention to animal welfare and consistency with other ALAC standards and reference resources. ALAC identifies caveats, clarifications, and exceptions when adopting a reference resource. Four ALAC clarifications for the FISH guidelines include non-approval of immersion of conscious fish in 10% formalin or liquid nitrogen as a method of euthanasia, scientific justification of mortality as an experimental endpoint, consideration of regulatory impact of field studies outside of the United States, and registration of researchers with U.S. Fish Wildlife Service when using investigational new animal drugs. Two ALAC caveats for the amphibian and reptile guidelines include requirement for aseptic technique for survival surgery and non-approval of immersion of conscious animals in formalin as a method of euthanasia. Two ALAC clarifications and three exceptions for the BIRD guidelines include IACUC review and approval of thoracic compression of small birds under field conditions where alternatives are not feasible, IACUC review and approval for survival intracardiac blood collection under anesthesia, non-approval of digit amputation for blood collection, chilling of a surgical site as an analgesic, and performing major invasive surgeries such as celiatomy laparotomy without general anesthesia. Five ALAC clarifications and one exception to mammal guidelines include IACUC approval of field studies exempted by USDA Animal Welfare Act regulations, enrollment of dogs used to locate or track wildlife in the IACUC protocol, justification of blood collection at a volume greater than 1 ml per kilogram body weight, scientific justification and IACUC approval for toe clipping without anesthesia or analgesia, IACUC review and approval of thoracic compression of small mammals under field conditions when alternatives are not feasible, and non-approval of drowning as a means of euthanasia. Despite these relatively few clarifications, caveats and exceptions, these four resources provide unique information most valuable to an IACUC on regulatory agent permit requirements, population and habitat impact considerations, netting, trapping and capture techniques including safeguards, interval, manual, mechanical and chemical restraint techniques, capture myopathy, bycatch considerations, recommended marking methods, species-specific biomethodology techniques such as blood collection, surgical and post-surgical management, euthanasia and carcass disposition. Familiarity with these four ALAC reference resources well position IACUCs to understand best practices for consideration when reviewing and approving protocols and rolling free-ranging wildlife species. Often the most valuable resource available to the IACUC is the principal investigator who is most familiar with the peculiarities and attributes of the wild animal being studied, differentiating them from the more traditional captive bred laboratory animals that our IACUCs are most experienced with. The challenges posed to IACUCs by free-ranging wildlife proposals may appear daunting, but are relatively easily addressed with an openness to collaboration and listening, as well as awareness of the taxonomic species-specific guidelines adopted by ALAC. The challenges including a pertinent harm-benefit analysis, occupational health and emergency preparedness and evacuation protocols, the specialized capture and chemical restraint techniques unique to the study of wildlife, field anesthesia and analgesia considerations, aseptic surgical technique, intraoperative monitoring, recovery and euthanasia will be covered in more detail by subject matter experts over the two days of this workshop. Next steps include IACUCs being intentional expanding committee expertise in wildlife studies with the use of consultants and familiarity with current and future best practice guidelines adopted by ALAC. Very importantly, we all will have expanded our expertise after participation in this IALAR workshop. Enjoy all of the workshop's presentations as we together take a walk on the wild side.