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PERSPECTIVES FROM INTERNATIONAL ORGANIZATIONS International Council for Laboratory Animal Science (ICLAS) Cecilia Carbone ICLAS is an international nongovernmental and nonprofit scientific or- ganization that exists mainly to provide good principles to achieve good science and to promote high standards in the care of animals used in research, testing, diagnosis, and education. According to its mission, ICLAS strives to serve as a premier source of laboratory animal science guidelines and standards and as a laboratory animal welfare information center. ICLAS has a strategic plan according to which it promotes worldwide har- monization in the care and use of laboratory animals. ICLAS recognized five or six years ago that the harmonization of existing guidelines for the use of animals in research, testing, teaching, and education is an emerging issue in the context of the regularization of research. Since ICLAS can act as an international um- brella organization, it has worked in these matters since 2004, when it began organizing meetings on harmonization of guidelines. We are going to have the next meeting in conjunction with the American Association for Laboratory Animal Science (AALAS) meeting in November. The main goal that ICLAS hopes to achieve with this program is the im- plementation of a dialogue on harmonization of a number of published guide- lines on emerging issues, with consensus and recognition of these documents at the international level. ICLAS hopes that the largest impact of this project will occur in developing countries or regions that do not currently have laws or self- regulation and surveillance for the use of animals in research. It is hoped that this project will (1) ensure the implementation of good ani- mal practices in all parts of the world and stimulate collaboration in animal- based research—for instance, in data sharing and information exchange among investigators; (2) facilitate collaboration among scientists in implementing the 3Rs (reduction, replacement, and refinement in the use of animals); and (3) help 25

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26 Animal Research in a Global Environment: Meeting the Challenges facilitate the movement of scientists around the world—for instance, to partici- pate in meetings or collaborate in multidisciplinary and international working groups. I want to clarify that for ICLAS, harmonization of guidelines does not mean standardization. This is an important point of this program. ICLAS sup- ports harmonization of animal care and use policies, guidelines, and other forms of regulations on a worldwide basis as a reflection of the globalization of re- search. It does not mean standardization. ICLAS considers that each country should be able to maintain an animal welfare oversight system that reflects its own culture, tradition, religion, laws, and regulations. One of the big challenges that will face this program is whether the various countries and regions will in- corporate this kind of document into their regulations while maintaining respect for their own laws, culture, and religion. Let me conclude this presentation by saying that the objective in which the ICLAS harmonization program would like to succeed is the international har- monization of existing guidelines for the use of animals in research, teaching, and testing. This will be essential in the globalization of research all over the world. In addition, communication and partnership among national, regional, and international organizations will ensure the global harmonization of the use of animals. It must be understood that national guidelines will always supersede inter- national guidelines. However, it is also important that each country recognize and implement international core principles for the care and use of laboratory animals.

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World Organization for Animal Health (OIE) David Bayvel My objective in the short time available is to raise the profile of the OIE, for those people not too familiar with the organization, and to give some indica- tion of the role that the OIE might play in this public policy area in the years ahead. OIE, Office International des Epizooties, has rebranded itself as the World Organization for Animal Health, the animal or veterinary equivalent of the World Health Organization. It is headed in Paris by Director General Dr. Ber- nard Vallat. A number of you might be aware that he was the recipient of the inaugural Penn Vet Award in 2007 as the veterinarian who had made the most significant contribution globally to veterinary science. Here is some background to the OIE: It was established in 1924 to deal with international issues relating to epidemic disease—rinderpest, bovine pleu- ropneumonia, and others. In the 80-plus years since, it has established itself as an intergovernmental organization playing a vital international harmonization role and with a commitment to science-based standards. In 1995, with the establishment of the World Trade Organization (WTO), the profile of the OIE increased dramatically. It is the body that the WTO looks to for any disputes relating to SPS (sanitary or phytosanitary) agreements. In addition to a central bureau in Paris, with approximately 40 members of staff, which is truly international in its makeup, the organization has a regional infrastructure, with something like 20 offices distributed throughout the OIE’s five regions around the world. Moving a little bit closer to the relationship in the laboratory animal sci- ence area, for the last two or three years the OIE has been working closely with the International Council for Laboratory Animal Science (ICLAS) and the Inter- national Association of Colleges of Laboratory Animal Medicine (IACLAM) in terms of a potential role that it could play globally in relation to laboratory ani- mal science and welfare. There has been quite a bit of discussion: Where could the OIE add value? What unique role could the OIE play, rather than just duplicating the myriad of current activity? 27

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28 Animal Research in a Global Environment: Meeting the Challenges There is an organization called VICH—whose full title is International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products—that was established 10 years ago with a spe- cific mission to harmonize the regulatory requirements for veterinary biologicals and veterinary pharmaceuticals around the world. VICH was formed under the auspices of the OIE with a mandate to harmonize standards. That obviously re- lates to the current regulatory requirements in most countries for animal tests, many of which go back 60 or 70 years and, in some cases, have questionable scientific relevance. But conservative regulators are somewhat reluctant to move from tests that they know to, perhaps, scientifically validated tests that haven’t yet become mainstream. So it seemed that the OIE could play a significant role in this area, as it is 172 members strong and represents governments, thus OIE delegates have a clear mandate to implement any OIE agreements. For those of you who are familiar with this area, there is a comparable or- ganization, the International Council on Harmonization (ICH), which takes care of biologicals and pharmaceuticals in the human area—obviously, a lot of ani- mal testing is equally involved in that area. I would like to highlight three further points to give you some flavor of OIE interests, emphasis, and potential future involvement. The OIE works by having a permanent Animal Welfare Working Group, which I have chaired since 2002. It establishes ad hoc groups to address specific issues. The ad hoc Group on Laboratory Animal Welfare met for the first time in Paris last December; a number of people in this room are members of that group. Again, it is truly international in its membership. It has commenced draft- ing some material that eventually will be approved and issued and promulgated as OIE guidelines. Since the OIE is a veterinary body, there will be a strong veterinary em- phasis in terms of veterinary training, reflecting some of the input received from groups like ICLAS and IACLAM. Laboratory animal transport is an area where again the OIE could probably add value. As I have mentioned already, facilitat- ing a more rapid acceptance of scientifically validated nonanimal tests, where that is possible, will probably be an area of future unique emphasis of the OIE.

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Adequate Veterinary Care and the International Association of Colleges of Laboratory Animal Medicine (IACLAM) Judy MacArthur Clark I am going to present the challenge of providing adequate veterinary care to laboratory animals from the perspective of the International Association of Colleges of Laboratory Animal Medicine (IACLAM). IACLAM was established in 2005 and comprises the four key global col- leges of laboratory animal medicine: the American college (ACLAM), which is the oldest; the Japanese (JCLAM) and the European (ECLAM) colleges, both of which were established within the last 12 years; and the Korean College of Laboratory Animal Medicine (KCLAM), which is our newest member college. Full membership in IACLAM is restricted to established colleges with by- laws and a constitution, an elected council, approved training programs, creden- tialing processes for candidates, and a number of other elements that make up a competent and fully fledged college. We also are considering a class of mem- bership, probably called associate membership, for emerging colleges. This lat- ter point touches on some of our concerns for the future in terms of training and provision of competent veterinarians in this field. It is worth remembering that laboratory animal medicine has been an in- ternational field for many years. IACLAM has essentially formalized relation- ships that have existed for a long time in one way or another. IACLAM’s charter is to provide a common platform at a global level for communication by, for, and with representation of diplomates. Thus it is primar- ily a communication and representative role. That is manifested in the way in which we promote the welfare and responsible use of laboratory animals through the certification of veterinary specialists in the colleges—that’s diplo- macy of colleges—education of veterinarians, dissemination of information relevant to the field, and serving as research partners. Those are the four ele- ments of IACLAM’s purpose, its charter and mission. 29

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30 Animal Research in a Global Environment: Meeting the Challenges Having given you an introduction to IACLAM, I would like to focus on the major challenge for veterinarians in our field. In the time available, it is im- portant we really get an understanding of that challenge. The first point is that we believe veterinarians are key to effective control of laboratory animal well-being. That is not to say that it is entirely managed by veterinarians, but the competence of veterinarians in this whole scenario of en- suring laboratory animal well-being is essential. Elements of that control include disease control, refinement of procedures, training of staff, creating a culture of care—all important responsibilities of laboratory animal veterinarians, who have a very significant role to play. But the effectiveness of that role depends on both the competence and the status of the veterinarians who are operating in the field. Competence derives not only from specialist training but also from the quality of basic veterinary training. Status derives from demonstrating such competence as well as the re- spect in which the profession is held. I refer here to the respect for veterinary professionalism, and therefore the respect that would be accorded to the views of a competent veterinarian in a research organization. Underlying all of this, and one of the key issues for veterinarians and sci- entists, is understanding that promoting good welfare is an important part of delivering good science. Therefore good welfare leads to good science. We have all been through the debates about the interrelationship between science and welfare. Should we apply good standards of welfare for their own sake? Of course, there is an ethical impetus for that. But the argument that most effec- tively carries weight with our research colleagues is that good welfare improves the quality of their science. But let’s return to the subject of veterinary competence and the status of veterinarians, both of which vary significantly across the world. This is a major challenge for veterinarians, we believe. It has a direct impact on the effective- ness of any regulatory system that involves veterinary input. It is something that urgently needs to be addressed. We support the development of global standards for adequate veterinary care, harmonization of welfare standards, and so on. But without veterinary training—at both a basic and a specialist level—to meet those standards, bene- fits will not be realized. Therein lie both a threat and an opportunity. We know that in some countries the veterinary qualification follows a two-year technical training, as opposed to a much longer-term, more complete professional educa- tion in other countries. Until we can start to raise the standards of that basic vet- erinary education and then grasp those well-educated veterinarians and add the specific specialist training that can develop their competency as laboratory ani- mal veterinarians, there will continue to be challenges. The threat, therefore, is continuation of the status quo. The opportunity is to have an impact on that, which requires a twofold approach. First, we have to improve basic veterinary training globally. It has to be- come a professional education rather than a technical training, right across the world in order for this impact to be effective.

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Adequate Veterinary Care and the IACLAM 31 Second, we need to develop new colleges for specialist veterinary training in laboratory animal medicine. This is not to say that all veterinarians working in laboratory animal medicine will need to be diplomates of colleges. But colleges will raise standards globally and they will encourage the improvement in com- petence of all veterinarians in this field—for example, in Asia, where there are already discussions for further colleges of laboratory animal medicine, or in South America, where, again, discussions for colleges are under way. We also need to see ECLAM, the European college, having a greater impact in Eastern Europe. Thus we will embrace essentially all of the countries where we cur- rently see emerging science taking place. So that’s the challenge that IACLAM currently sees and that this con- ference, I hope, will be able to help us to take forward.

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Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International Kathryn Bayne The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International, like every organization, has challenges and op- portunities facing it. One that we are acutely aware of is the necessity to ensure both consistency and flexibility—which one might think are diametrically op- posed concepts—in the AAALAC International assessments and in the applica- tion of our standards globally. It is a delicate balancing act. The AAALAC Council on Accreditation and ad hoc consultants who conduct site visits must ensure that the institutions they assess adhere to a high-quality standard of ani- mal care and use that is applied consistently worldwide. Because we use the NRC Guide for the Care and Use of Laboratory Animals (the Guide) in our as- sessments1 we strive to ensure that it is applied in a meaningful manner by the institution, with the understanding that each institution is unique, and thus pro- fessional judgment is necessary in the application of performance standards per Guide recommendations. Other challenges we face are differences in culture, regulatory framework, and available resources where we travel. I want to take a moment to reflect on two surveys that AAALAC2 has con- ducted of its accredited institutions, what we call “accredited units.” The first customer satisfaction survey was conducted in 1998 and was the first survey of the accredited units that AAALAC had conducted in its history. There were 600 responses, a 71.5% response rate. Two key areas were identified in those re- sponses: the need for flexibility in applying the standards to unique or cutting- edge programs, and the need for consistency in the way the standards are applied 1 In February 2011 AAALAC announced that in the fall of 2011 it would begin using, in addition to the NRC Guide, the following two documents in its evaluations: the Guide for the Care and Use of Agricultural Animals in Research and Teaching (Ag Guide), FASS 2010; and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, Council of Europe (ETS 123); accessed March 8, 2011. 2 AAALAC refers to AAALAC International. 32

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AAALAC International 33 from site to site—in other words, from institution to institution, no matter what country—and for individual programs from site visit to site visit (AAALAC conducts site visits every three years). In that 1998 survey, concern was ex- pressed that there may be relaxation of the standards and the goal to harmonize the many and varied regulatory standards across countries. Written comments expressed this concern, but it was in the context that respondents saw value and benefits in an international accrediting body. Eight years later, in 2006, AAALAC conducted a follow-on survey to see how our many initiatives developed and implemented in response to the 1998 survey were going and how our internationally accredited institutions felt about those initiatives. There was more than a 75% response rate of our accredited institutions. About two-thirds of the respondents agreed or strongly agreed that AAALAC is flexible in applying its standards to meet the specific context of the institution and that it consistently applies relevant standards from site visit to site visit. About half agreed that AAALAC consistently applies relevant standards from institution to institution, the concern expressed being more how AAALAC conducts assessments across borders of countries rather than within a single country. Of note, however, is that approximately a third of the respondents think that AAALAC is not flexible enough, perhaps a third think that AAALAC is not consistent enough, and perhaps 50% of respondents have both of these concerns. This feedback creates an opportunity for AAALAC, specifically in the area of applying performance standards. With at least half of the new applications for accreditation coming from the international community, AAALAC has the op- portunity to do great things to advance both science and animal welfare through the use of performance standards. Performance standards are the path to harmonizing laboratory animal care and use, through the support and visionary directives of our board of trustees, to reflect both science- and medicine-based organizations; our ad hoc consultants, who are over 200 in number and represent about 13 countries; and the 49 mem- bers of our Council on Accreditation from 10 different countries. So, AAALAC has a tremendous amount of input from different perspectives as we strive to harmonize our approach for accreditation on a truly global basis.

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International Air Transport Association (IATA) Carl Kole Much like the first speaker today, I don’t have a lot of connection with this part of your industry, other than getting your animals from point A to B. The International Air Transport Association is the trade group for over 200 airlines. I would like to address some issues confronting the animal research com- munity—for example, high fuel costs, over which we have absolutely no control except through hedging; Transportation Act access; and a few other issues. It’s interesting to note that we are talking about globalization and how things shrink. The aviation business has had a lot to do with that. However, we are seeing less and less animal transport. There are a couple of reasons for that. When one looks at the data for the top 15 airlines from 2007, based on revenue (passenger kilometers), it is clear that cargo plays a very small role in the transportation system. The traveling passenger to some extent subsidizes the cargo business for the airlines. Recognizing that the part of the cargo that re- flects transportation of laboratory animals probably is .0001 percent it is clear that this does not represent high revenue for the airline business, and it is terribly intensive in terms of handling if it is done right. Consequently, the airlines are not in the business of shipping a lot of animals. This is further compounded by the fact that when we mishandle animals, we have a regulatory system that fines us. So therefore it becomes a situation of spending $5 to make $1. The greatest fear is that eventually there will be no opportunity, at least in- ternationally, to transport animals for biomedical research. These are a few of the limitations that shippers are faced with today: shippers’ expectations and carriers’ limitations are not always conveyed or understood by each party; air- craft systems, ground facilities, weather, traffic, equipment, and staffing affect the carrier’s ability to provide an adequate shipping environment; strict adher- ence to a narrow temperature range is not possible without adequate active or passive packaging systems; and, with increasing fuel costs, shipping animals is not a major revenue stream. So what is needed in the future? Given the current situation, the research community should start talking with the carriers about standard operating plans to ensure the proper handling of animal cargo and ultimately to create an ongo- 34

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International Air Transport Association 35 ing dialogue with the aviation industry that currently does not exist. Most of those who have been involved in that part of the business have retired and there is no one to take their places. While this is not good news, it is a realistic view of what is happening in the transportation industry today.

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Institute for Laboratory Animal Research (ILAR) Joanne Zurlo The Institute for Laboratory Animal Research and the National Academies have a role to play in international harmonization. The National Academies are nongovernmental organizations consisting of the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine, and the Na- tional Research Council. The first three organizations are composed of members elected for their scientific and technological expertise and renown, and the Na- tional Research Council is the part of the Academies that produces expert re- ports on topics that the government requests. Dr. Neureiter talked about some Academy studies that have influenced international policy. The purposes of the Academies are to advance science and technology and to advise the government and the nation on policy for science and on applications of science to policy. ILAR, a component of the National Research Council, was established in 1952 to develop and disseminate information and guidelines for the care and use of laboratory animals. Our mission is to:  evaluate and disseminate information on issues related to the scientific, technological, and ethical use of animals; and  promote high-quality science through the humane care and use of ani- mals and the implementation of alternatives. The 3Rs—reduction, refinement, and replacement—are the principles that guide our work. ILAR meets its mission through the development of expert re- ports, through the ILAR Journal, through our Web-based resources, and other means of communication. The key issue in the mission statement is that we pro- vide advice to the international biomedical research community. The Guide for the Care and Use of Laboratory Animals (the Guide) is our seminal publication, used as a standard of compliance with US Public Health Service policy and for AAALAC accreditation. The Guide has been translated into 12 languages as an international resource and thus gives ILAR an interna- tional profile. 36

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Institute for Laboratory Animal Research 37 As was mentioned earlier, ILAR planned the workshop in 2003 to look at the state of the science and to identify data gaps and look at the question of har- monization. ILAR was in a unique position to hold that meeting because of our position in the National Academies. This was the first meeting of its kind and it initiated many of the harmonization efforts that you have heard about. Some of these issues have already been mentioned by other speakers—for example, the fact that we have to consider globalization, the fact that we have to generate more reliable and reproducible data among laboratories around the world, and the importance of aiding developing countries in drafting guidelines. The science that supports guidelines for animal care and use is inadequate. Until there is solid scientific evidence to support guidelines, it will be difficult to harmonize internationally. But in the interim, where there is no reliable scien- tific evidence, animal care and use should be guided by best practice. However, there should be mechanisms to coordinate and share new scientific information. ILAR can offer the credibility, objectivity, and scientific reputation of the National Academies. ILAR has convened and will continue to convene meetings that offer a platform where representatives of international constituencies can gather and express their views. It can coordinate efforts to identify areas of re- search needed to produce the best scientifically based guidelines for laboratory animal care and use.

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The European Union Malachy Hargadon Good morning, ladies and gentlemen. For 20 years the European Union has had legislation in place governing the protection of animals used for experi- mental and other scientific purposes. For those of you who are not familiar with the way the European Union works, all legislation is subject to regular review by the European Commission. I would have liked this morning to be able to present to you the Commission’s official proposal to update the legislation, but all I can say is that it is imminent. I will instead provide some indication of what can be expected.1 As everyone knows, the world has changed since 1986. Advances in tech- niques and knowledge have left the EU legislation outdated because it is some- what removed from best practice. There has been some difficulty in implementa- tion in the EU member states, as some have pursued significantly more stringent standards than others, and this has led to fragmentation of our internal market in the industry, has compromised harmonization across the European Union, and has also undermined compliance and respect for the law. At the same time, European public opinion—and not just from so-called animal rights activists—has moved strongly in support of ever-increasing stan- dards of welfare for animals used for scientific purposes. In a sense, what the EU is now trying to do is to play catch-up with the 3Rs principles, which you will all know far better than I. Emblematic of this was the decision by the heads of state and government of the European Union to adopt a protocol to the EU Treaty—an action that might, I dare say, be comparable to modifying the Con- stitution of the United States, so it is not an insignificant event—requiring that the EU and all its member states pay full regard to the welfare requirements of animals, particularly in relation to EU policy on the internal market and on re- search. In line, therefore, with the 3Rs principles, our starting point is an ultimate goal of replacing the use of animals for scientific purposes. I trust that this goal 1 The EU Action Plan on Animal Welfare 2006–2010 is available on the Internet (http://europa.eu). 38

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The European Union 39 will not come as a shock. It is a reasonable goal for an advanced and civilized society. If we can achieve our scientific objectives by means other than animal research and experiment, then that is a good thing. But we are not there yet. The European Commission fully recognizes this and accepts the conclusions of reports that state that a complete phaseout of animal experimentation is not yet achievable. But that is not a reason to ignore the replacement, reduction, and refinement of animal use. We intend to present a proposal that offers significant improvement in ani- mal welfare, such as more generous and binding minimum standards in housing and care requirements. We are considering extending the coverage of the legisla- tion to some invertebrates as well as embryonic forms of vertebrates and animals killed for tissue and organ use in experiments. We also intend to restrict as far as possible the use of nonhuman primates and animals caught in the wild. At the same time, our intention is to strike a balance with the genuine needs of the research community and industry and to ensure a level playing field for all concerned. It is hoped that the legislation will reduce unnecessary and, of course, unpopular bureaucratic burden and boost innovation and development in alternative methods. Such support for innovation will be a boost for competitiveness, and we expect that one of the consequences will be better-quality science. We hope to reduce the burden, for example, by allowing group authorization of regulatory testing projects to reduce time and administration, and by setting a deadline of 30 days, as a general rule, for competent authorities to provide authorization decisions. The current worst-case scenario in the European Union can lead to delays of up to a year in response to requests. As an example of flexible implementation in the way we move ahead, let me offer the following. While ethical evaluation and authorization would be compulsory, member states would be free to decide the most appropriate compe- tent authority to carry out this task. That accommodates the existing structures in member states—some of which are more centralized (e.g., France), some of which are more decentralized (e.g., Germany)—to do that. [These are] brief indications, given the time allowed, of what you and I can expect to see in the proposal, which I would expect to be adopted by the Commission. After that, the European Parliament and the Council of Ministers will examine the proposal. I would guess formal entry into effect will be in about 2010.2 For my closing comments, let me emphasize that the EU is pursuing har- monization in this area. We have supported efforts in the Council of Europe (which is not to be confused with the European Union) to encourage greater 2 In September 2010 the EU adopted Directive 2010/63/EU to update the 1986 Direc- tive 86/609/EEC on the protection of animals used for scientific purposes. The aim of the new Directive is to strengthen legislation and improve the welfare of animals still needed for research as well as to firmly anchor in EU legislation the principle of the Three Rs— to reduce, refine, and replace the use of animals in research.

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40 Animal Research in a Global Environment: Meeting the Challenges harmonization among a record number of countries. The Commission’s proposal itself is a demonstration of harmonization among 27 member states, but with the crucial element of legal requirement rather than simply an exhortation to be bet- ter. The Commission seeks to advance further harmonization—of course, based on the standards that we support—in the wider international community, and especially through the OIE. Let me conclude by saying that there should be no real surprises in the forthcoming proposal. Similar animal welfare measures are already in place in a number of countries, including the United States and Canada and Australia, whether in legislation or as established operating practices required by funding bodies. Other countries are also increasingly responding to public opinion in pursuit of animal welfare. The Commission’s proposal, therefore, will substan- tially be about, as I said earlier, adopting best practice, but giving it the force of law.