LEI 11794 DE 2008 PDF

Lei n° de 8 de Outubro, (Arouca Law): ccivil_03/_ato// lei/lhtm. Brazil. El Senado y la Cámara de . A sample postapproval monitoring program in academia. ILARJ 19(4): law). em experimentos cien cos, considerando o delineamento da Lei Arouca, por meio da leitura de ar gos .. / (Common law /) 14, which.

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A review of existing legislation covering laboratory animals in Latin America is presented. The region presents a spectrum of economic development, political stability, and cultural diversity. With the exception of a few nations, there is a lack ee regulations as well as minimal enforcement of existing laws pertaining to laboratory animals.

Brazil, Mexico, and Uruguay stand out as the only nations in this region with specific legislation regulating laboratory animal care and use; the history and current status of regulations in these three nations is reviewed. Laboratory animal science has a brief history in Latin America. However, those nations in which this science is advancing are moving towards adopting and implementing ideals 11974 directives of the international laboratory animal science community.

Latin America is not a uniform collection of nations; it is a multicultural part of the world, home to 4 official languages and additional recognized local languages. The region consists of 21 sovereign countries as well as several dependencies and territories. Geographically, Latin America describes the territory from northern Mexico to the southern end of South America, including the Caribbean.

Political and economic stability is variable throughout the region as well. As such, there is great diversity across Latin America in the development of science and the approach to science regulation.

Animais em laboratórios e a lei Arouca

Many countries in the region have not considered implementing any specific laws concerning experimental animals, while other nations have adopted general animal protection laws, with 1 or 2 articles that apply specifically to experimental animals. There have been, however, promising steps in adopting international standards for consideration of laboratory animal care and use; in several Latin American countries, there has been implementation of ethical review committees in academic and other research institutions, in some nations even where there is no legal mandate for such oversight.

In several other nations, there are ongoing efforts to enact specific laws regulating the use of animals in research, testing, and teaching ILAR ; Rivera et al. Three countries stand out from the rest in this regard: These laws were enacted relatively recently, which has necessitated a period of adaptation for the governments and for affected laboratories and academic institutions to put in place necessary components.

For the new regulations to move forward, there is a need for appointment and education of responsible individuals, appropriate committees, and infrastructure changes that support the regulations. With the assistance of laboratory animal science associations, there are increasing numbers of courses, national and international congresses, and other scientific meetings that are promoting education in the field of laboratory animal science, often with emphasis on adopting a culture of care.

One positive aspect of the new laws and their guidelines is that they are in general based on the 3Rs and the same core principles, with small differences due to regional legislative peculiarities Aguilar ; Rivera et al. Though adoption of laws regulating laboratory animal science may be a challenge, the influence of international harmonization can be see as an advantage in the development of new programs of legislation in this region Figure 1.

Map of Latin America. Twenty-one nations and additional territories and dependencies are included in the region. Regulatory safeguard for animals in Brazil began in the s, with a federal decree to ensure protection and welfare of animals and to guard them from mistreatment and abuse Brasil A second similar piece of legislation related to general animal welfare, the law of penal contraventions, was passed Brasil The first attempted legislation related specifically to scientific use of animals was a federal law to establish procedures on vivisection in higher education institutions, as long as these institutions were properly registered and supervised by qualified personnel Brasil However, this law was not enacted.

Ina law passed to deal with environmental crimes included an article on cruelty to animals in experiments Brasil However, because this law was written in very general terms, and its provisions have not been enforced. The main law of the nation is the Brazilian Constitution, issued in This constitution establishes government responsibility for protection of fauna and flora Brasil This proposal was discussed for over 13 years in the National Congress until its approval in Brasil Thus, the current law that regulates use of animals in experiments Law Key points of this law are that it covers all live nonhuman vertebrates; allows the use of animals only in institutions of higher education and in technical schools of biomedical science; creates the National Council on the Control of Animal Experiments CONCEA ; obliges institutions to have an Animal Ethical Committee CEUA ; and requires registration and licensing of institutions that breed, maintain, or use experimental animals in a CONCEA database.


The Federal Decree enactment established guidelines for the organization and functioning of CONCEA and also penalties to be applied to institutions that do not comply with these standards. Since becoming active in December ofCONCEA has issued a number of regulatory resolutions, guidelines, and technical guidance documents on the use of animals in teaching, 2008, or testing.

Figure 2 gives an overview of the current Brazilian legislation applied to experimental animals. Overview of current Brazilian legislation applied to the use of animals for scientific and educational purposes. CONCEA is a regulatory, advisory, deliberative body composed of a multidisciplinary panel of experts.

CONCEA’s main functions are to develop regulations and guidelines on the ethical and humane use of animals in research, teaching, and testing; monitor compliance with those guidelines and regulations; register and authorize institutions that breed or use animals for experimental purposes; monitor and evaluate the introduction of alternatives; periodically review the standards for the care and use of animals for teaching and research, according to international conventions in which Brazil is signatory; periodically review standards for the accreditation of institutions that use animals for teaching and research; keep an updated record of completed projects for the registered institutions, as well as a CV for the researchers and other participants in the projects; have the final decision on problems eli by institutional CEUAs sent to CONCEA; and inform the government, when asked, about the activities covered by this law.

Decisions voted on at CONCEA meetings require a quorum of 8 representatives, fe approval is by an absolute majority of votes from the members present.

They state in detail what is established in Federal Law and Federal Decree For example, NRs are in place to specify composition and function of CEUAs; examples of forms to be filed by institutions for approval of research protocols; guidance on how to prepare the final report and list of projects approved by 117994 CEUA; administrative infractions; recognition of alternative methods to animal use in research and teaching activities; and registration of institutions CONCEA a.

As of earlythe following chapters of the Brazilian Guide were approved: Technical guidelines are documents providing information to researchers, 20088, and institutions on how to proceed in order to comply lej the law and the federal decree or any other regulations such as NRs.

Brazilian legislation obliges institutions to undergo a certification process, after which they receive an institutional license for the use of experimental animals. Thus, in Brazil, researchers and scientists do not need to have a separate license to work with laboratory animals, but their institution must be previously licensed. Achieving an institutional license requires that the institution demonstrate the following are in place: An institution may request temporary suspension or cancellation of its license.

The required CEUA is composed of veterinarians, biologists, professors, or researchers as well as a representative of a legally established society 1174 the protection of animals.

The CEUA must have at least 5 full members and alternates and be composed of Brazilian citizens of recognized expertise and knowledge and established professional activity in areas related to the scope of Law Inspection of all activities regulated under Law is done by the Ministry of Agriculture and Supply, Ministry of Education, Ministry of Health, Ministry of the Environment, and Ministry of Science and Technology according to their dee of expertise.

CONCEA is a consultative and deliberative body and therefore has no surveillance functions, thus depending on these ministries to complete the inspections. CONCEA can carry out assessment visits to institutions at the time of the institutional licensing process or at any time if demanded. Uruguay is remarkable for having developed and enacted laboratory animal-specific regulations despite the small number of scientists working with research animals in this nation of just under 3.

The first animal-related regulation in Uruguay was enacted leprimarily intended to ban bullfights and similar activities Sienra Since then, additional regulations passed in and enacted as recently as have been based in great part on the Brazilian regulatory model. The regulatory bodies established in Uruguay by the recent laws are actively creating and implementing the designated facets to oversee animal-based research. As in Brazil, the Uruguayan regulations are specific to vertebrate animals.

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The UdelaR regulation contains 5 chapters dealing with facilities, organizational and operational aspects, an honorary council on animal experimentation, staffing for animal facilities and research laboratories, and users of animal facilities.


Also inNational Law This act created an Honorary National Commission for Animal Welfare and stated that the use of animals for scientific research was to be governed by special rules. The Honorary National Commission for Animal Welfare served untilwhen new legislation was passed. InNational Law Once enacted by the Uruguayan Parliament, this law established a national legal framework for work with experimental animals Uruguay b.

Some specifics of the law include: A decree enacting Law CNEA guidelines have the goal of promoting standards for handling of vertebrate animals during breeding and use in research and teaching in accordance with international regulations. The National Registry of Institutions is the Uruguayan body that registers animal research and breeding centers, regulates the use and transport of animals for scientific purposes, and directs the Personnel Accreditation National System, which ensures training and gives licenses to those who use animals in teaching and scientific research.

The National Registry of Institutions is required to keep a record of experimental procedures approved by the CEUA of each institution and to monitor each CEUA’s performance; its main task is to assure compliance and apply penalties for noncompliance with Law The CNEA is a relatively new entity. The CNEA includes representatives from key Uruguayan institutions and associations that are affected by or participate in animal research.

In the period from throughthe CNEA’s operational rules were drawn up, and subcommissions were formed to work on different areas.


A webpage with general information, guidelines, a database, and online forms for applications was created CNEA The Regulatory Decree for Law InCNEA began work on implementation of the National Control System, with the goal of setting minimum standard guidelines for institutions about appropriate conditions for and operation of research animal facilities, staff, and experimental procedures CNEA Inthe first term of the CNEA members concluded, and representatives were replaced.

Work priorities are set for the coming years with the following themes: The NOM was based on three internationally accepted documents: NOM includes 15 chapters, as well as several appendices that describe minimum requirements for the use of laboratory animals and provide information and references.

The regulations apply to entities that produce, maintain, or use animals for scientific and educational purposes. This includes academic institutions, government laboratories, and private companies.

Both the Mexican Animal Welfare Act and NOM do not allow the use of animals in elementary primary or junior high secondary school science classes.

At each institution, the senior director holds ultimate responsibility for assuring compliance with the regulatory requirements. The regulations include mandates for veterinary care, emergency services, reporting of health or welfare eli, and record-keeping. In addition, there must be one administrator, paid by the institution. Each committee reports to and derives authority from the senior administrator of the institution. The committee has a number of responsibilities, which are, among others, to review animal protocols and define and review standard operating procedures, as well as postapproval monitoring and facilities inspection.

Once a protocol has been approved, the investigator is allowed to initiate work. Researchers should report back to the CICUAL on an annual basis with a progress report and request any amendments to the 11749. CICUALs are also required to implement an effective postapproval monitoring program designed to meet the specific needs of the institution. NOM gives specific guidelines for animal facilities, including descriptions for outdoor and indoor facilities. Enclosure dimensions recommended by the NOM are used as only a bare minimum.

The dimensions cited are based on llei NRC Guide. Protocols that involve single housing must describe proposed measures for meeting the social requirements of isolated animals. The NOM provides guidelines in relation to the daily care of animals, including detailed requirements for nutritional needs, minimum space requirements, and environmental conditions, including some behavioral considerations. There are specific provisions governing health concerns for nonhuman primates.

A 117994 is devoted to transportation and includes regulations for health certificates. NOM additionally obliges institutions, when building facilities, to consider the 22008 and safety of the animals 1794 personnel and to establish a stable research environment.

The law includes guidelines on spaces and areas, construction materials, sanitary requirements, localization and distribution areas, caging, bedding, and nesting materials.