1	Meeting the Information Requirements of the Animal Welfare Act Presented by Animal Welfare Information Center (AWIC) National Agricultural Library U.S. Department of Agriculture
2	Objectives List the information requirements of the Animal Welfare Act. Define the 3 Rs of Alternatives. Become familiar with databases and other resources helpful in searching for alternatives. Design and run a search for alternatives.
3	Animal Welfare Act, Regulations and Other Policies
4	Early History of Animal Protection Legislation in the U.S. 1641 Puritan’s Body of Liberties 1828 First state anticruelty law passed in New York 1873 First Federal legislation: “28 Hour Law” 1965 Disappearance of Pepper and publication of Sports Illustrated article 1966 Life article published “Concentration Camp for Dogs”
5	Early History of Animal Protection Legislation in the U.S.
6	"Animal Welfare Act Amendments" Animal Welfare Act Amendments 1970 1990 1976 2002 1985
7	Laboratory Animal Welfare Act of 1966 Public Law 89-544 Authorizes Secretary of Agriculture to regulate transport, sale, and handling of animals pre-research or “for other purposes.” Defines animal as dogs, cats, nonhuman primates, guinea pigs, hamsters, and rabbits. Establishes licensing of dog and cat dealers.
8	Animal Welfare Act of 1970 Public Law 91-579 Ensures humane treatment of animals for research or exhibition by regulating their transport, sale, housing, care, handling, and treatment in commerce, exhibition, and all stages of experimentation. Clarifies definition of animal as all warm-blooded vertebrates excluding horses not used in research and farm animals used for improving animal nutrition, breeding, management, production efficiency, and the quality of food and fiber.
9	Animal Welfare Act of 1970 Public Law 91-579 Defines regulated and non-regulated institutions: Regulated: research facilities, dealers, and exhibitors. Non-regulated: retail pet stores, state and county fairs, rodeos, purebred dog and cat shows, and agricultural exhibitions.
10	Animal Welfare Act of 1976 Public Law 94-279 Refines regulations on transport and commerce. Requires health certification prior to transport and commerce. Discusses licenses, methods of payments, penalties. Outlaws interstate or foreign transport of animals used in fighting ventures.
11	Food Security Act of 1985 Subtitle F, Animal Welfare, Public Law 99-198 Improved Standards for Laboratory Animals Act “…the farm bill contains legislation dealing with the humane treatment of animals. The main thrust of the bill is to minimize pain and distress suffered by animals used for experiments and tests. In so doing, biomedical research will gain in accuracy and humanity. We owe much to laboratory animals and that debt can best be repaid by good treatment and keeping painful experiments to a minimum.”
12	Food Security Act of 1985 Subtitle F, Animal Welfare, Public Law 99-198 Improved Standards for Laboratory Animals Act Clarifies humane care to include specific criteria such as sanitation, ventilation, and housing. Directs the Secretary of Agriculture to establish regulations for exercise for dogs and a physical environment adequate to promote the psychological well-being of primates. Specifies that animal pain and distress must be minimized (veterinary care, anesthesia, analgesia, tranquilizers, and euthanasia).
13	Food Security Act of 1985 Subtitle F, Animal Welfare, Public Law 99-198 Improved Standards for Laboratory Animals Act Specifies that principal investigators must consider alternatives to any procedure likely to cause pain or distress. Establishes the Institutional Animal Care and Use Committee (IACUC). Explains penalties for the release of trade secrets. Establishes an information service at the National Agricultural Library.
14	AWA Defines Service at NAL (7 U.S.C. 2142, Sec. 13, Subsection e) The Secretary shall establish an information service at the National Agricultural Library. Such service shall, in cooperation with the National Library of Medicine, provide information-- (1) pertinent to employee training; (2) which could prevent unintended duplication of animal experimentation as determined by the needs of the research facility; and (3) on improved methods of animal experimentation which could-- (A) reduce or replace animal use; and (B) minimize pain and distress to animals, such as anesthetic and analgesic procedures.
15	Food, Agriculture, Conservation, and Trade Act of 1990 (Pet Theft Act of 1990) Public Law 101-624 Establishes a five-day holding period requirement for dogs and cats at shelters and other holding facilities. Requires dealers provide written certification about each animal’s background to recipients. Describes mechanisms of enforcement, injunctions, and penalties for violations.
16	Farm Security and Rural Investment Act of 2002 (Farm Bill) Public Law 107-101 Modifies the definition of animals to exclude rats, mice and birds bred for use in research (Helms amendment). Makes it illegal to knowingly sponsor or exhibit an animal in a fighting venture, if any animal was moved in interstate or foreign commerce and increases fines.
17	Code of Federal Regulations Title 9, Chapter I, Subchapter A, Animal Welfare Specifies how to comply with the Animal Welfare Act and its amendments. Definitions: “Animal” excludes Rattus, Mus, and birds bred and raised for use in research. Regulations: Specific requirements for facility licensing, veterinary care, records, stolen animals. Standards: Facilities and operations, health and husbandry, transportation. Rules of Practice: Scope, application, administrative procedures.
18	"Painful Procedure" Painful Procedure, Sec. 1.1 …as applied to any animal means any procedure that would reasonably be expected to cause more than slight or momentary pain or distress in a human being to which that procedure was applied, that is pain in excess of that caused by injections or other minor procedures.
19	Information Requirements of the AWA 9 CFR 2.31 (d) [The] IACUC shall determine that… (ii) The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e.g., the Animal Welfare Information Center, used to determine that alternatives were not available; (iii) The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments.
20	Information Requirements of the AWA 9 CFR 2.31 (d) [The] IACUC shall determine that… (iv) Procedures that may cause more than momentary or slight pain or distress to the animals will: (A) Be performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents is justified for scientific reason, in writing, by the principal investigator and will continue for only the necessary period;
21	Information Requirements of the AWA 9 CFR 2.31 (d) [The] IACUC shall determine that… (x) No animal will be used in more than one major operative procedure from which it is allowed to recover unless: (A) Justified for scientific reasons by the principal investigator in writing. (B) Required as routine veterinary procedure. (C) Approved by the Administrator of APHIS.
22	Final Rules and Regulations Federal Register, Vol. 54 (168), August 31, 1989 “The principal investigator must provide a written narrative of the sources, such as biological abstracts, Index Medicus, the Current Research Information Service (CRIS), and the Animal Welfare Information Center that is operated by the National Agricultural Library. We believe that in fulfilling this requirement Committee members will discuss these efforts with the principal investigator in reviewing the proposed activity. We also believe that considerations of alternatives will be discussed during Committee meetings where proposed activities are presented for approval, and made part of the meeting minutes…”
23	Animal Care Policy #12 Written Narrative for Alternatives to Painful/Distressful Procedures: June 21, 2000 “..the performance of a database search remains the most effective and efficient method for demonstrating compliance with the requirement to consider alternatives to painful/distressful procedures.” The database search narrative must, at a minimum, include Names of the databases searched Date the search was performed Period covered by the search Key words and/or the search strategy used.
24	Other Policies and Guidelines Public Health Service Policy on Humane Care and Use of Laboratory Animals Guide for the Care and Use of Laboratory Animals Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching AVMA Panel on Euthanasia
25	Alternatives and the 3 Rs
26	Definition of Alternatives Russell and Burch (1959) - The Principles of Humane Experimental Technique Full text available online at AltWeb: http://altweb.jhsph.edu/publications/humane_exp/het-toc.htm Development of the concept of the 3 Rs: Reduction Refinement Replacement
27	Alternatives The 3 Rs of Russell and Burch Reduction - Minimize the number of animals used. Refinement - Employ techniques that reduce pain and distress. Replacement - Substitute animal with nonanimal methods or lower organisms.
28	Why Consider Alternatives? Regulatory Social Humane Economic Scientific
29	Regulatory Comply with the Animal Welfare Act. Comply with the PHS Policy. Maintain AAALAC International accreditation.
30	"Respond to social pressures to" Respond to social pressures to Change to non-animals as soon as possible and Make research pain free.
31	"Ask ethical questions such as" Ask ethical questions such as Should animals be used in research? When should animals be used? How should they be used?
32	Economic Reduce the expense of animal use in Specialized facility infrastructure costs-such as caging, building design, and equipment Purchase costs Maintenance costs Personnel costs and Occupational health and safety costs.
33	Economic Animals lower on the phylogenetic scale may be cheaper and more plentiful. Non-animal models May be cheaper to use and Could possibly increase the number of compounds that can be tested.
34	Scientific Keep current in area of research. Become aware of research from unfamiliar resources. Reduce duplication in research. Screen more compounds and predict their effects (computer automated structure evaluation system).
35	Scientific Find opportunities for less painful and invasive procedures. Learn insights into totally new approaches. Determine appropriate numbers. Identify possible collaborators. Reduce stress through proper handling, training, enrichment, group housing, etc.
36	Group Exercise: The 3 Rs
37	Alternatives: Reduction The Principles of Humane Experimental Technique (1959) Quality literature search Appropriate statistical design Pilot studies Sharing animals, tissues, or organs New methods in testing (e.g. limit test, local lymph node assay, etc.)
38	Imaging
39	Alternatives: Refinement The Principles of Humane Experimental Technique (1959) Knowledge of species physiology and normal and abnormal behavior Proper use of anesthetics and analgesics Modifications in restraint, handling, blood collection Increased sensitivity of monitoring devices and chemical assays Proper training of personnel
40	Social Housing
41	Cage Design
42	Handling and Training
43	Environmental Enrichment
44	Alternatives: Replacement The Principles of Humane Experimental Technique (1959) Relative replacement - some animal involvement Isolated cell and nerve preparations Use of tissues from slaughter house or grocer Computer simulations based on in vivo data
45	Virtual Alternatives
46	Non-animal Models Used in Teaching
47	Alternatives: Replacement The Principles of Humane Experimental Technique (1959) Absolute replacement – no animal involvement Endoparasites, microorganisms, plants Computer automated structure evaluation systems Human tissue culture
48	Where Can I Find the Information?
49	Animal Welfare Information Center AWA Defines Service at NAL (7 U.S.C. 2142, Sec. 13, Subsection e) AWIC provides information For employee training To prevent unintended duplication and About the 3Rs: Reduce or replace animal use Minimization of pain and distress
50	Animal Welfare Information Center AWIC Serves as a comprehensive resource. Suggests search terms, strategy, and databases. Provides access to resources that you might not have. Refers you to experts at other institutions. Alerts you to additional information resources.
51	"Reference and referral" Reference and referral Workshops Presentations Publication distribution Conference exhibits Committee members
52	Animal Welfare Information Center Publications Bibliographies Information Resource Guides Animal Welfare Information Center Bulletin Fact Sheets Collaborations on proceedings, manuals, articles, and book chapters
53	Databases Biomedical and Biological AGRICOLA http://agricola.nal.usda.gov file 10 CAB Abstracts file 50 MEDLINE http://www.ncbi.nlm.nih.gov/pubmed/ file 155 ToxFile file 156 EMBASE file 73 BIOSIS file 5 Zoological Record file 185 PsycINFO file 11 ASFA file 44 Pascal file 144 SciSearch file 434 Current Contents file 440 Scopus ScienceDirect
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55	Databases Pharmaceutical and Technological Pharmaceutical News Index file 42 Intern’l. Pharmaceut. Abstracts file 74 NTIS file 6 INSPEC file 2 Ei Compendex file 8 Japanese Science and Technology file 94 Gale Group Computer Database file 275
56	Databases Federally-funded Research CRIS http://cris.csrees.usda.gov/ CRISP http://crisp.cit.nih.gov/ NTIS file 6 FEDRIP file 266 Law and Legislation Gale Legal Resource Index file 150 LexisNexis http://www.lexisnexis.com/ Thomas http://thomas.loc.gov/ State Statutes http://www.law.cornell.edu/statutes.html
57	Databases Education ERIC http://www.eric.ed.gov file1 AVAR http://www.avar.org/ EURCA http://www.eurca.org/ Norwegian Reference Centre for Laboratory Animal Science & Alternatives http://oslovet.veths.no/NORINA/ http://oslovet.veths.no/teaching/materials.html http://oslovet.veths.no/textbase/
58	Additional Databases Available on the Web Scientific and Technical Information Network (STINET) Service http://stinet.dtic.mil/ Alternatives to Skin Irritation Testing in Animals http://www.invitroderm.com/ Altweb http://altweb.jhsph.edu/
59	Additional Databases Available on the Web DoD Biomedical Research Database http://www.scitechweb.com/acau/brd/ Scirus - scientific information search engine developed by Elsevier Science http://www.scirus.com/ Animal Welfare Institute Enrichment and Refinement Databases http://www.awionline.org/lab_animals/index.htm PrimateLit http://primatelit.library.wisc.edu/
60	Organizations European Centre for the Validation of Alternative Methods (ECVAM) http://ecvam.jrc.cec.eu.int/index.htm Fund for the Replacement of Animals in Medical Experiments (FRAME) http://www.frame.org.uk Interagency Coordinating Committee for the Evaluation of Alternative Methods (ICCVAM) and its supporting center, NICEATM (the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods) http://iccvam.niehs.nih.gov/ Johns Hopkins Center for Alternatives to Animal Testing (CAAT) http://caat.jhsph.edu/ National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) http://www.nc3rs.org.uk/
61	Databases Vendors DIALOG http://www.dialog.com/ NLM's Databases http://www.nlm.nih.gov/databases/ OVID http://www.ovid.com/ CSA http://www.csa.com/ AWIC Home Page - http://awic.nal.usda.gov Databases - http://awic.nal.usda.gov/databases
62	Subject Coverage of Selected Databases
63	Subject Coverage of Selected Databases
64	Sources of Information for Selected Databases
65	Sources of Information for Selected Databases
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67	AWIC’s Approach to Meeting the Information Requirements Approach the search in two phases. Analyze the protocol to determine where alternatives might be used and for terminology. Decide where to go for the information. Databases Websites Link terminology appropriately for best search results. Evaluate the search results.
68	Searching for Alternatives Consists of three types of terms: Scientific terms related to the research protocol; Alternative (3Rs) terminology; and Search terminology: boolean operators, limits, truncations, years, types of materials…
69	Searching for Alternatives Tips Description of protocol and area of study Species being used Organ systems involved Acronyms (CNS, BSE, MAb) Spelling (behavior, behaviour) Names of hormones, enzymes, CAS#, trade names (xylazine = rompun) Authors in the field including the PI Is the PI aware of any possible alternatives? Previous searches with keywords, years and databases searched
70	Searching for Alternatives Search Strategy Two Phases Phase I: Reduction and refinement- citations pertinent to PI’s field of study. Phase II: Replacement- use of nonanimal or alternative animal models.
71	Searching for Alternatives Alternative Terms: Refine and Reduce analgesic or analgesia or painkiller technique or method or procedure anesthetic or anasthetic or anaesthetic monitor or evaluate or supervise restrain or immobilize or restrict positive reinforcement or animal training housing or facility or caging
72	Searching for Alternatives Alternative Terms: Replacement artificial or vitro or culture tissue or cell or organ insect or arachnid or invertebrate fish or mollusc or cephalopod simulation or digital image or interactive mannequin or manikin or model
73	Searching for Alternatives Terminology Examples sedative animal testing alternative environmental enrichment bacteria software video display welfare well-being assay
74	Searching for Alternatives DIALOG Commands
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76	Searching for Alternatives DIALOG Commands ? Truncation s behav? = behave, behaves, behaviour, behavior, etc. OR Select at least ONE word from set. s swine or pig or pigs or porcine AND Select more than one word from set. s swine and euthan? NOT Eliminates a search term or group of search terms. s (pig or pigs or swine or porcine) not guinea TI,DE,ID - Limit terms to title, descriptors, or identifiers. s (dog or dogs or cani?)/ti,de,id *use “/” before ti,de,id Note: Use of parentheses is very important !
77	"(W) With" (W) With - Keep words adjacent and the order specified. s lethal(w)dose = lethal dose s route(1w)administration = route of administration (N) Near - Keep words adjacent but in either order. s blood(n)sampl? = blood sample or sampling blood s blood(2n)sampl? = blood sample, blood plasma sample, sampling of arterial blood
78	Alternatives Search Examples
79	Searching for Alternatives Sample Search #2 - Trauma Dr. Stan Breager uses pigs and dogs in his advanced trauma life support training course. All procedures are conducted on anesthetized animals. When the training session is complete, all animals are euthanized. His IACUC has requested that he search for any potential alternatives to the use of animals.
80	Searching for Alternatives Trauma Search Strategy
81	Searching for Alternatives Trauma Search Strategy Set Term Searched Items S1 trauma or life(w)support or 440688 emergenc?(1n)medic? or ems or emst or atls or advanced(w)trauma(w)life(w)support S2 train? or teach? or educat? or instruct? or tutor? 2118835 S3 dog or dogs or canine? or pig or pigs or swine or 2419446 piglet? or ferret? or cat or cats or animal or animals S4 alternative? or model? or simulat? or cadav? or 16081397 carcas? or software or video? or interact? or digital? or virtual or mannequin? or manikin? or computer? S5 (s1 (4N) s2) and s3 621 S6 RD (unique items) 574 S7 (s1 and s2 and s4)/ti,de,id 1387 S8 RD (unique items) 1150
82	Searching for Alternatives Trauma Sample Citations Animal Models Use of the ferret as a model for pediatric endotracheal intubation training. (file 10) Swine and dynamic ultrasound models for trauma ultrasound testing of surgical residents. (file 155) Ocular trauma modeling (file 73) Ultrasound training during ATLS: An early start for surgical interns. (file 5) Battlefield Biomedical Technologies (file 2) Removal of corneal foreign bodies: an instructional model (file 144)
83	"Non-Animal Models and Alternative Methods" Non-Animal Models and Alternative Methods Virtual reality, robotics, and other wizardry in 21st century trauma care. (file 155) Practicing procedures on the recently dead. (file 155) Paediatric resuscitation manikins. (file 155) Animal cadaveric models for advanced trauma life support training. (file 155) 'Full scale' simulation in practical emergency medicine conception as represented by the Wurzburg anaesthesia and emergency medicine simulator. (file 73) MEDSIMM: Computer‑simulated training for pediatric advanced life support (a work in progress). (file 5) Medical Simulation for Trauma Management. (file 6) Enhanced training using the Life Support for Trauma and Transport. (file 144) Simulation and modeling of penetrating wounds from small arms. (file 2)
84	Searching for Alternatives Sample Search #3 – Mouse Lungs Purpose To evaluate the safety and efficacy of different formulations in mouse lungs. These studies will help determine how the body will react to single or repeat doses, how the drug affects the disease, and how long the drug lasts.
85	Searching for Alternatives Mouse Lungs Search Information Materials and Methods Animals – mice Test articles - Viral vectors, cationic lipid-DNA complexes, etc. Anesthesia - Isoflurane
86	Searching for Alternatives Mouse Lungs Search Information Technical Methods Pain Alleviation The animals will be anesthetized with isoflurane until they are no longer responsive to a toe pinch reflex. Torbugesic or diazepam may be given post-procedurally.
87	Searching for Alternatives Mouse Lungs Search Information Administration of Test Articles The lower jaw and tongue are immobilized with light pressure applied to minimize swallowing of fluid. Test article is applied to the nares and the animal is released 3-5 seconds after inhalation of fluid.
88	Searching for Alternatives Mouse Lungs Search Information Blood Collection Blood will be collected under anesthesia via the retro-orbital plexus. Blood may also be collected via tail nick. Euthanasia by cervical dislocation, CO2 or barbiturate overdose.
89	Searching for Alternatives Mouse Lungs Search Information Question Are there alternatives to the painful or distressful procedures being employed in the research on the delivery of test articles to mouse lungs?
90	Searching for Alternatives Mouse Lungs Search Strategy What to Look for When Searching Alternative instillation techniques Research on similar test articles performed by others Alternative blood collection techniques Possible confounding effects of proposed anesthetic/analgesics/anxiolytics.
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92	Searching for Alternatives Mouse Lungs Search Strategy Set Terms Searched Items S1 INTRANASAL? 34283 S2 MOUSE OR MICE 2116730 S3 S1 AND S2 7192 S4 METHOD? OR TECHNIQUE? OR ASSAY? OR 10542290 TEST OR TESTS OR PROCED? S5 S3 AND S4 2219 S6 S1/TI AND S4/TI 230 S7 RD (unique items) 142
93	Searching for Alternatives Mouse Lungs Search Strategy Set Terms Searched Items S8 GENE (W) THERAPY OR (GENE OR 83042 GENETIC) (3N) (VECTOR?) S9 (S1 OR PULMONARY OR INTRAPULMONARY 52484 OR LUNG OR LUNGS) (4N) (ADMINIST? OR INSTILL?) S10 S8 AND S9 377 S11 RD 252 S12 (BLOOD) (5N) (SAMPL? OR COLLECT? OR 418129 BLEED?)
94	Searching for Alternatives Mouse Lungs Search Strategy Set Terms Searched Items S13 REPEAT? (4N) S12 3007 S14 S13 AND S2 101 S15 RD 42 S16 S12 AND (RETROORBIT? OR 118 RETRO(W)ORBIT? OR ORBITAL?) AND S2 S17 RD 61 S18 ISOFLURANE 24016 S19 S9 AND S18 326 S20 RD 288
95	Searching for Information on the Web Choose Your Words Wisely Improve your search results by being specific. Consider International Spellings behavior, behaviour tumor, tumour estrogen, oestrogen, anaesthesia, anesthesia, anasthesia Bookmark Search Results Once you've created a Web search that's giving you great results, use your browser's standard functions for bookmarking the URL. Know Where to Look
96	Searching for Information on the Web Quotation marks: Enclosing a multiword phrase in quotation marks tells the search engine to list only sites that contain those words in that exact order. “animal welfare” Plus and minus signs: A plus sign (+) directly in front of a word indicates that the word or phrase must appear in the search results. tail-biting +pigs A minus sign (-) indicates that the word or phrase should not be included in the search results. pigs -gilts
97	Search Evaluation The PI Role Check terminology, strategy, sources, and dates of search. Review the search before completing the protocol. Assess and evaluate the alternative possibilities. Be prepared to support the use or non-use of any alternatives in writing. Keep a copy of strategy, databases searched, and years of search for future use.
98	Search Evaluation The IACUC Role Review the protocol form. Are the questions asked in a clear way to gather the information needed? Review the Databases searched, Terminology used and Years of coverage. Review the search strategy. Ask about the order of search and protocol writing. Have an information provider on the committee as a resource.
99	Search Evaluation RED FLAGS Search completed at the last minute. Only 1 database searched. Terms only for painful aspects. The term “alternative” used alone with no other alternative terms. Keywords listed not relevant to protocol. Keywords and concepts linked in an incorrect manner (e.g. wrong boolean operators). Search doesn’t cover adequate time period (5-10 years).
100	Contacting AWIC Tel: (301) 504-6212 Fax: (301) 504-7125 Email: awic@nal.usda.gov Website: http://awic.nal.usda.gov Animal Welfare Information Center National Agricultural Library 10301 Baltimore Avenue, Room 410 Beltsville, MD 20705