Complying with the 8 th edition of The Guide for the Care and Use of Laboratory Animals Joan T. Richerson, DVM Assistan

1. Complying with the 8th editionofThe Guide for the Care and Use of Laboratory AnimalsJoan T. Richerson, DVMAssistant Chief Veterinary Medical Officer

2. Comparison of Guide editions

3. New Topics in the Guide 8th ed. Chapter 1 – Key Concepts The Three R’s (replacement, refinement, and reduction) • Case by case consideration. • Animal reuse should not be encouraged as a reduction strategy. Chapter 2 – Animal Care and Use Program Institutional Collaborations • If collaboration involves more than animal transport, the collaborating institutions should have a formal written understanding of their respective responsibilities.

4. New Topics in the Guide 8th ed. Chapter 2 – Animal Care and Use Program Post Approval Monitoring (PAM) • Includes all types of protocol monitoring subsequent to initial protocol approval. • May range from protocol review to laboratory inspections, to veterinary/IACUC observations of selected procedures to animal care staff observations of animals as well as other methods. • The formality and intensity of PAM will vary with institutional size and complexity.

5. New Topics in the Guide 8th ed. Chapter 2 – Animal Care and Use Program Disaster Planning and Emergency Preparedness • Facilities must have a disaster plan. • Plan should specify actions that will be taken to prevent animal pain, distress and deaths due to loss of services . • If animals cannot be relocated, they must be humanely euthanized.

6. New Topics in the Guide 8th ed. Chapter 3 – Environment, Housing, and Management Vibration • Excessive vibration may cause biochemical and reproductive changes. • Sources of vibration – within the animal facility (vibration from housing systems with moving parts) or outside of the animal facility (groundborne vibration). • Should attempt to minimize the generation of vibration and take steps to avoid excessive vibration.

7. New Topics in the Guide 8th ed. Chapter 3 – Environment, Housing, and Management Environmental Enrichment • On a regular basis review these programs to ensure they are beneficial and consistent with animal use goals. • One study in mice found housing conditions can be enriched without compromising experimental results. • Additional research is needed to confirm this conclusion in other species. Procedural Habituation and Training of Animals • Encouraged to help reduce experimental related stress.

8. New Topics in the Guide 8th ed. Chapter 3 – Environment, Housing, and Management Aquatic Animals • Animal well-being hinges on water quality. • Chlorine and related agents in domestic water are toxic to aquatic animals and must be removed or neutralized before use. • Frequency of enclosure cleaning and disinfection is determined by water quality, which should permit adequate viewing and animal health monitoring.

9. New Topics in the 8th ed. Chapter 4 – Veterinary Care Animal Biosecurity • All measures to control known or unknown infections in laboratory animals. • Should apply to all species. Clinical Care and Management • Recurrent or significant health issues in experimental animals should be reported to the IACUC, and all treatments and outcomes should be documented. • Emergency veterinary care must be provided during and outside of regularly scheduled hours.

10. New Topics in the 8th ed. Chapter 4 – Veterinary Care Clinical Care and Management • If the PI cannot be reached or disagrees with the veterinarian about an urgent animal health concern, the veterinarian must have the authority delegated by the IO and the IACUC to render appropriate medical care, including euthanasia if necessary. Intraoperative Monitoring • Anesthetic depth and physiologic parameters should be assessed and appropriately documented.

11. New Topics in the 8th ed. Chapter 5 – Physical Plant Centralization versus Decentralization • Centralized animal facilities tend to have operational advantages over decentralized animal facilities. • Decentralization may be preferred for some specialized research services (i.e. imaging, biocontainment, etc.). Vibration Control • Groundborne vibration transmission is a factor in selecting the building structure type. • All vibration sources should be identified and suppressed where possible.

12. New Topics in the 8th ed. Chapter 5 – Physical Plant Environmental Monitoring • Environmental monitoring of conditions in animal holding areas and other sensitive areas is encouraged. • The function and accuracy of these systems should be verified on a regular basis. Security and Access Control • The size of the facility and the type of activities conducted will determine of the scope of the security system required.

13. Expanded Topics in the 8th ed. Chapter 1 - Key Concepts Chapter 1 – Key Concepts Engineering and Performance Standards • Rabbit cage height as an example – 2011 Guide (16”); USDA AWR (14”). • AAALAC recommends a performance based approach. • If rabbits housed in 14” cages are able to assume natural postures and make postural adjustments including holding their ears erect without touching the walls or ceiling, then the 14” cage height is acceptable. • “The performance approach fosters animal welfare and quality science.”

14. Expanded Topics in the 8th ed. Chapter 2 – Animal Care and Use Program Non-Pharmaceutical Grade Chemicals and Other Substances • Pharmaceutical grade chemicals avoid toxic side effects and when available should be used for all animal-related procedures. • The use of non-pharmaceutical grade chemicals should be justified in the animal use protocol and approved by the IACUC.

15. Expanded Topics in the 8th ed. Chapter 3 – Environment, Housing and Management Space Recommendations • Pair or group housing is the rule rather the exception. • Rabbit cage height changed from 14” to 16”. • NHP – changed from 7 to 8 groups with separate recommendations for chimpanzees and other large brachiating species. • Rats and mice – new recommended space for dam and litter.

16. Expanded Topics in the 8th ed. Selected Expanded Topics Rats and Mice continued • The Guide now states that 51 in2 (330 cm2) are recommended for a dam with a litter. • US mouse cages measure 75-82 in2 (484-529 cm2). • ETS 123 states 51 in2 (330 cm2) is acceptable for a monogamous pair (outbred/inbred) or a trio (inbred). • AAALAC has indicated this cage size is appropriate for trio breeding ; however, multiple factors influence adequacy of cage space (i.e. litter size, multiple litters, age of pups in different litters, pup growth rate, etc. ).

17. Expanded Topics in the 8th ed. Chapter 4 – Veterinary Care Surgical Training • Personnel performing surgical procedures must have appropriate training. • The IACUC and veterinarian share responsibility for determining if personnel are appropriately qualified and trained to perform surgery. Surgical Procedures – major versus minor • To categorize a particular surgical procedure consider the potential for pain and other complications, nature of the procedure, incision size, length of the procedures, as well as species, health status and age of the animal.

18. Expanded Topics in the 8th ed. Chapter 5 – Physical Plant HVAC • Constant –volume systems (CVS) are most commonly used. • Variable –volume systems (VAV) allow ventilation rates to be set according to the heat load and other variables. • Compared to CVS, VAV systems are more flexible and conserve energy.

19. Expanded Topics in the 8th ed. Chapter 5 – Physical Plant Specialized Facilities • may be needed for barrier housing, imaging, whole body irradiation, behavioral studies, and aquatic species housing. • Each type of facility will present unique challenges in regard to location, physical plant, equipment, vibration and noise issues, as well as cross contamination issues.

20. NIH-OLAW Expectations Excerpt for Federal Register Notice (February 24, 2011) “...if NIH decides to adopt the eighth edition of the Guide, NIH's proposed implementation plan, which would require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012.”

21. Sources • http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf • http://www.gpo.gov/fdsys/pkg/FR-2011-02-24/html/2011-4172.htm • http://dels.nas.edu/resources/static-assets/ilar/miscellaneous/Guide-Presentation.pdf • http://www.aaalac.org/accreditation/faq_landing.cfm#E6