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2 The Evolving Regulatory Environment
Pages 7-20

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From page 7...
... The nature of this balance can vary among countries due to differences in culture, economy, religion, and social factors. To explore similarities and differences across countries and regions, four invited speakers from Europe, North America, Asia, and South America described current regulations in their regions and emerging issues surrounding animal research.
From page 8...
... , approved Directive 86/609, which very specifically governed the use of laboratory animals (European Communities and Office for Official Publications, 1986)
From page 9...
... 9 THE EVOLVING REGULATORY ENVIRONMENT BOX 2-1 Key Features of European Union Directive 2010/63 Chapter I (General Provisions) • idened scope: Specific invertebrates and fetuses in last trimester of develop W ment; animals in basic research, education, and training (Art.
From page 10...
... , referred participants to the Guide for the Care and Use of Laboratory Animals which summarizes the U.S. animal regulatory environment.
From page 11...
... to develop definitions, regulations, and standards for the care and use of animals, including laboratory animals. The USDA licenses animal dealers, registers research institutions (~1,100 in the United States)
From page 12...
... The IACUC has the authority to suspend research activity and must report any such suspensions to regulatory and funding agencies. Attending Veterinarian and Adequate Veterinary Care Program Institutions conducting research involving animals are required to employ an attending veterinarian with the authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of the animal care and use program.
From page 13...
... The increasing use of Freedom of Information requests is leading to a growing administrative burden to fulfill requests and increasing visibility of individual investigators as identities are disclosed.4 Finally, as financial resources decline, the cost of assuring regulatory compliance is being passed on to the investigators in the form of increased per diems and service charges, reducing the resources available for research itself, Bennett asserted. ASIA: CHINA Jianfei Wang, director of laboratory animal science at GlaxoSmithKline Research and Development Center, China, provided a high-level summary of laboratory animal regulation in Asia (Box 2-3)
From page 14...
... Laboratory Animal Science and Regulations in China Thirty years ago, Wang said, there was essentially no concept of laboratory animal science in China. However, this has changed in recent years.
From page 15...
... Wang mentioned three legal milestones governing laboratory animal science in China: the 1988 Statute of Laboratory Animal Administration, the 2001 Regulation on the Management of Laboratory Animal License System, and the 2006 Guideline on Humane Treatment of Laboratory Animals. Guideline on Humane Treatment of Laboratory Animals The Guideline on Humane Treatment of Laboratory Animals is the country's first broad animal welfare regulation and is aligned with practices in countries/regions such as the United States and the European Union.
From page 16...
... Emerging Trends Although enormous progress has been made, laboratory animal science across Asia, including China, is uneven and rudimentary. Factors influencing the quality of animal care and use include globalization, international exchange, economic development, and increased AAALAC-accredited institutions.
From page 17...
... , prohibits grants to be awarded to projects that have not passed an ethical review. This, Rivera said, was a critical step toward better science and animal care in Brazil as it caused a significant change in the approach scientists have toward laboratory animals.
From page 18...
... Currently, Brazil, Mexico, and Uruguay have specific laws on the use of animals in research. Argentina, Chile, Colombia, and Costa Rica have animal welfare laws with at least one provision relevant to laboratory animal science.
From page 19...
... Animal Welfare and Scientific Quality • uggestions for improving both animal welfare and scientific quality: S o inimize non-experimental (e.g., environmental) confounding variables.


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