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Regulation Update - April 2011

Thu, 03/24/2011 - 5:26pm
Moshe Shalev, MSc, VMD, DACLAM

AAALAC International Reviews Updated Guidelines
On 14 December 2010, AAALAC International reported it will begin to use three primary standards to evaluate animal care and use programs in the Fall of 2011: the ILAR Guide, the FASS Ag Guide, and the ETS 123.This is a change from simply recognizing the ILAR Guide as AAALAC’s sole primary standard. Until then, the 1996 version of the Guide will continue to be the main standard AAALAC will use to evaluate programs of animal care and use.

In its “Recap”, AAALAC reported it:

  • Reviewed 121 changes, in the ILAR’s 8th edition of the Guide for the Care and Use of Laboratory Animals (the Guide,NRC), some of which are significant and may affect the accreditation process.
  • Determined there was extensive harmonization between the Guide for the Care and Use of Agricultural Animals in Research and Teaching (FASS 2010) and the ILAR Guide, in spite of some key differences.
  • Determined there is extensive harmonization between the principles of the ETS 123—the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purpose, and the ILAR Guide,with some differences identified in engineering standards. AAALAC plans to clarify these differences and its expectations for accredited institutions shortly.

Read AAALAC’s presentation at the 2010 National AALAS meeting: “Implementing the 2010 Guide” for more details.

Hello National Advancing Translational Sciences Center— Goodbye NCRR
On 14 January 2011, Kathleen Sebelius, Secretary of Health and Human Services, informed Tom Harkin,Chairman of the Committee on Health, Labor, and Pensions of the United States Senate that, pursuant to section 401(d)(2) of the Public Health Service (PHS) Act, as amended, she has determined that, based on information the NIH Director provided her:

  • It is necessary to establish the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).
  • The new center will enhance the therapeutic development process and encompass multiple programs at NIH.
  • No longer required, the National Center for Research Resources (NCRR) and its relevant functions and programs will be transferred to this new center in FY 2012.
  • NCRR functions not involving translational sciences will be transferred to other existing Institutes and Centers at NIH, as appropriate.
  • NIH will undertake a thorough scientific review of NCRR programs to make these assessments.

On 24 January 2011, in an effort to calm the ensuing media excitement about this announcement and the dreaded elimination of the popular and historically helpful NCRR, NIH Director Francis S. Collins and his NIH colleagues responded that, committed to continued support for basic, translational, and clinical research, the NIH believes:

  • “The proposal for NCATS [is that it]will be assembled primarily from existing programs within the National Center for Research Resources (NCRR), the NIH Common Fund, and the National Human Genome Research Institute (NHGRI).”
  • “NCATS is not intended to be a drug company. It is a facilitator of translational research across the NIH and complementary to translational research already being conducted and supported on a large scale in the individual NIH Institutes and Centers. NCATS will seek ways to leverage science to bring new ideas and materials to the attention of industry by demonstrating their value.”
  • “The final budget for the proposed center is unknown at the present time. For the most part, the budget and staff for each relocated program will remain with that program. Thus, the overall budget for NCATS will be the sum of the imported programs— an amount much smaller than the several billion dollars currently being spent on translational research by existing Institutes and Centers.”
  • “There are no plans to ‘cannibalize’ the budgets or programs of other NIH Institutes and Centers to form NCATS.”
  • “The new Center will bring several existing efforts together in new ways to enhance the ability of all NIH Institutes and Centers to perform research that leads to the development of drugs, diagnostics, devices, vaccines, and strategies for prevention.”

On 16 January 2011,The NCRR Task Force, co-chaired by Dr. Larry Tabak and Alan Guttmacher posted a draft NCRR Straw Model of the proposed new NIH homes for current programs of NCRR.

NCRR’s Mission and Significance to Laboratory Animal Science
The National Center for Research Resources (NCRR), a part of the National Institutes of Health (NIH), provides laboratory scientists and clinical researchers with the tools and training they need to understand, detect, treat, and prevent a wide range of diseases. NCRR supports all aspects of clinical and translational research, connecting researchers, patients, and communities across the nation.This support enables discoveries made at a molecular and cellular level to move to animal-based studies, and then to patient-oriented clinical research, ultimately leading to improved patient care. NCRR convenes innovative research teams and equips them with essential tools and critical resources needed to tackle the nation's complex health problems through programs such as the Clinical and Translational Science Awards. (http://www.ncrr.nih.gov/about_us/mission_statement.asp)

Research and Animal Facilities Improvement programs increase the nation's ability to conduct state-of-the-art research by providing competitive funding to modernize and construct research facilities that support basic and or clinical investigations. Funding has supported the construction of cancer and other biomedical research laboratories, improved research imaging capabilities, and created facilities for research animals. (http://www.ncrr.nih.gov/research_infrastructure)

USDA’s National Agriculture Library Releases Updated Thesaurus
On 21 January 2011,The U.S. Department of Agriculture’s National Agricultural Library (NAL) released the 2011 edition of its online NAL Agricultural Thesaurus and Glossary (NALT),with new3,441 new terms and 321 definitions.

Expanded especially in areas of nanotechnology, food safety risk assessment, and sustainable agriculture, this thesaurus now contains more than 82,000 terms. It has an international following and is regarded as among the most authoritative resources of its kind. It is produced cooperatively in English and Spanish by NAL and the Inter-American Institute for Cooperation on Agriculture.

Thesaurus and Glossary
National Agricultural Library,USDA, and the Inter-American Institute for Cooperation on Agriculture (http://agclass.nal.usda.gov/agt.shtml)

•The Thesaurus and Glossary are online vocabulary tools of agricultural terms in English and Spanish produced cooperatively by the National Agricultural Library, USDA, and the Inter-American Institute for Cooperation on Agriculture through the Orton Memorial Library, the Mexican Network of Agricultural Libraries (REMBA), as well as other Latin American agricultural institutions belonging to the Agriculture Information and Documentation Service of the Americas (SIDALC).

  • Annual update each January since 2002
  • Spanish/English parallel bilingual versions
  • In depth coverage of agriculture, biology and related disciplines
  • Contains over 80,000 terms, including 33,000 cross references
  • Glossary of definitions for technical terms
  • Regional terms of Latin American Countries
  • Download in XML, SKOS, PDF, MARC and DOC formats
  • 24/7 accessibility since 2002,with backup mirror site

Browsable by 17 subject categories, e.g., “Food and Human Nutrition”

European Food Safety Authority Reports on Welfare of Transported Animals
On 12 January 2011, after reviewing of the scientific literature since 2004, the Animal Health and Welfare (AHAW) panel of the European Food Safety Authority (EFSA) proposed indicators for evaluating the welfare of transported farm animals—horses, pigs, sheep, goats, cattle, poultry, and rabbits. In addition, the panel’s experts proposed further research on traveling times, space, and the levels of temperature during transport: limits and regulation of temperatures during the transport of poultry and rabbits; the effect of ventilation on pigs—the minimum space allowed for rabbits, pigs and newly hatched chickens; and the duration of the journey which will not harm unweaned horses, pigs and calves. See also EFSA Scientific Opinion Concerning the Welfare of Animals during Transport, adopted 2 December 2010 and Stakeholder technical meeting on Animal Welfare during Transport of 13 October 2010.

This regulation will likely affect the welfare of animals transported to research facilities in all of Europe, the U.S., and elsewhere.

Risks to Transported Farm Animals
Copied from the European Food Safety Authority http://www.efsa.europa.eu/en/press/news/ahaw110112.htm?wtrl=01

Cattle: Recent studies indicate that treating cattle in a humane way before transportation reduces the stress during transport. Studies also confirm that heat stress can present a major threat to cattle welfare,which can be prevented by providing ventilation systems in vessels when animals are transported by sea. Scientific evidence show that if adult cattle are transported on journeys longer than 29 hours, fatigue and aggressiveness increase. Reviewed studies show that cattle should be offered water during rest periods during journeys of 8 to 29 hours. Experts say that more research is required to investigate the length of resting periods during the transport of cattle.

Poultry: Various studies indicate an ideal upper limit of 24-25 °C, and a lower limit of 5 °C for the temperature in containers used for transporting chickens raised for meat production (broilers). Scientific evidence indicates that the introduction of temperature limits in the transport of newly hatched chickens could have beneficial effects on the welfare of the birds. Experts encourage further research on ventilation. For journeys longer than four hours scientific studies show that vehicles equipped with mechanical ventilation can maintain satisfactory temperature levels,which ought to be monitored and recorded.

Pigs: New research confirms that pigs have difficulties in adapting to stressful situations. When grouped for transport, pigs kept in stable groups and without the presence of unfamiliar animals, have a reduced level of stress. Recent scientific studies indicate a higher risk of mortality when pigs are fed before transport, and highlight the need for water to be always available at the farm, and assembly points. Moreover, experts suggest carrying out research on how pigs respond to stress linked to fatigue, heat, and cold.

Sheep: Since there is insufficient scientific evidence to determine maximum journey times for sheep,more emphasis should be given to the quality of the journey experienced by the animal.To reduce the risk of injury, aspects such as acceleration, braking, stopping, and uneven road surfaces should be monitored, in particular during long journeys.

Goats: Scientific papers suggest that stress is minimized when goats are kept in stable groups, particularly during loading and unloading. Furthermore, repeated regrouping could lead to an increased level of aggression, as could the introduction of new animals,which should be monitored closely. Horned and hornless goats should be kept separate during transport to avoid injuries.

Horses: The reviewed scientific literature demonstrates that because of their different levels of aggression, horses should always be transported in individual stalls or pens,with the exception of foals which should be traveling with their mothers. Partitions have proven to be necessary not only to avoid overheating but also because horses find it relatively difficult to maintain their position during sudden vehicle movements. Experts recommend further scientific research on partition design for their transport.

Rabbits: Numerous scientific studies indicate that stress linked to temperature during transport can be detrimental to rabbits’welfare, and adequate ventilation during transport has to be ensured to maintain the inside temperature within a range of 5-20 °C. Experts also highlight the need for further research on the effects of temperature on rabbits during transport.

  • EFSA assesses welfare risks to animals during transport. Press Release. 12 January 2011. http://www.efsa.europa.eu/en/press/ news/ahaw110112.htm?wtrl=01
  • EFSA Panel on Animal Health and Welfare (AHAW) Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission.Question number: EFSA-Q-2010-00053 Adopted: 02 December 2010 Published: 12 January 2011. Last updated: 19 January 2011.Affiliation: European Food Safety Authority (EFSA), Parma, Italy
  • Stakeholder technical meeting on Animal Welfare during Transport. Parma, 13October 2010. http://www.efsa.europa.eu/en/events/event/ahaw101013.htm.

Veterinarian Moshe Shalev,MSc (Genetics), VMD, is a Diplomate of the American College of Laboratory Animal Medicine. A recognized expert in medicine, management, and facility designs of small, farm, and exotic laboratory animals, he publishes regularly on animal welfare regulations.

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