f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 534 [Entry Date] 04/29/2011 at 11:43:51 AM [Affiliation] Organization [Organization Name] Biotechnology Industry Organization [Organization City and State] Washington, DC [Comments] 
Comment 1: April 29, 2011 Dr. Francis Collins Director, National Institutes of Health Bethesda, MD 20892 (submitted electronically) Dear Dr. Collins, The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide input on the NIH's adoption of the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service (PHS) support for activities involving animals. BIO represents 1,100 member organizations that research, develop, and produce innovative health care, agricultural, industrial, and environmental technologies. Our members depend on accurate research as a part of the discovery and development of these technologies. In order to model diseases, find treatments, and perform translational research, many of our companies utilize animals in their research. The proper care and use of research animals is a high priority for our members. Though research with rodent models continues to provide useful information, grasping a more complete fundamental understanding of specific biological questions and translating the knowledge gained to improve both animal and human health and reproduction require the use of models that more closely resemble each other developmentally and physiologically or that exhibit similar susceptibility to common zoonotic pathogens. As treatments become closer to use in humans, even more complex models are necessary to test these hypotheses. The use of domestic agricultural species to address priority research areas of high impact to biomedicine and agriculture allows a more thorough characterization of research findings. The areas of investigation and experimental approaches may involve the generation of animals that model human diseases, elucidation of the etiology involved in disease or transmission of pathogens, a determination of environmental insults underlying developmental or epigenetic changes leading to pathophysiology, metabolic studies focused on obesity, or the identification of diagnostic tools (genetic markers, biomarkers, or antibodies). This research effort is expected to deepen the fundamental knowledge of biological mechanisms essential to both humans and farm animals, highlight the utility of domestic agricultural animals as more appropriate animal models for specific mechanistic studies, and encourage investigators with farm animal expertise to be involved in research benefiting both agriculture and biomedicine. The use of these more complex models requires animal care that expands beyond that which is required for rats and mice. Reviews of the Institute for Laboratory Animal Research (ILAR) "Guide for the Care and Use of Laboratory Animals" (the "ILAR Guide") provided to us demonstrate the ILAR Guide needs to be enhanced in order to properly accommodate the use of these other species. The ILAR Guide currently contains few items related to farm animal care and treatment, and we are concerned the stringent use of the ILAR Guide as drafted could yield the unintended consequence of negatively impacting farm animal welfare. A review of the ILAR Guide recommendations by scientists trained specifically in farm animal welfare has revealed several examples of recommendations for space allotment, temperature control, and animal management that are not in line with scientifically reviewed literature in the area. A more thorough review of the literature would have allowed the ILAR Guide to recommend measures that more appropriately addressed the needs of the animals, which do not vary whether the animal is in a biomedical or an agricultural research study. In January 2010, the Federation of Animal Science Societies (FASS) published an updated Guide for the Care and Use of Agricultural Animals in Teaching and Research (Ag Guide). This document was written by 64 professionals with expertise in farm animal care and contains a wealth of substantive technical information about the care of farm animals in teaching or research (agricultural or biomedical). The Ag Guide was originally developed to ensure a single science-based source for the most appropriate, tested, and pragmatic protocols for the care, treatment, handling, and housing of farm animals used in agricultural and biomedical research. It was written to ensure scientists in biomedical research would have the best available information. The Ag Guide utilizes scientific literature to identify care conditions for each individual farm animal species, while the ILAR Guide is deficient in these individual husbandry requirements. The use of animals in research from PHS grants can be enhanced through incorporation of the Ag Guide's recommendations and use of the Ag Guide as the primary, if not sole, reference, for farm animal care. Other associations have realized the value of utilizing experts in a species-specific field of animal welfare when providing guidelines for animal use and care. The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) has decided to utilize multiple animal care and use guides as its standards. AAALAC states that, "During the Fall (September through November) 2011 trimester, AAALAC International's Council on Accreditation will begin to use three primary standards to evaluate animal care and use programs: the 8th Edition of the Guide for the Care and Use of Laboratory Animals (Guide), NRC 2011; 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). The Council on Accreditation has used all three documents for several years and their adoption by AAALAC's Board of Trustees as primary standards signifies the importance of these performance based guidelines in the accreditation process." We recommend that the PHS not accept the ILAR Guide as the sole basis for evaluation of programs receiving Public Health Service funded support for agricultural animals in research. We support the use of animals in research, and want to ensure their proper care through the use of best techniques from scientifically-reviewed animal welfare expert research. Sincerely, Biotechnology Industry Organization Comment 2: no comment
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals