Frequently Asked Questions -About Animal Program Management
Here are answers to common questions related to animal program management, animal facilities, and the way in which AAALAC approaches certain topics during assessments...
- Q.1: At some recent meetings I have heard the terms “program-wide exception” and “global exception” used when talking about an Institutional Animal Care and Use Committee or Ethics Committee (IACUC/EC) approving exceptions to the Guide. Can you clarify these terms for me? (click here to jump to the answer)
- Q.2: Can we have exposed pipes and ductwork in our animal facility? (click here to jump to the answer)
- Q.3: If an investigator contracts with a company (that is not AAALAC accredited) to produce antibodies or transgenic animals for a specific protocol, and the PI purchases the animals for the contract company to use for these purposes, are these activities considered part of our AAALAC accredited program? (click here to jump to the answer)
- Q.4: We just purchased some new ventilated isolator caging systems for our mice and rats which utilize solid bottom cages. Can we decrease our cage changing frequency below the Guide recommended minimum frequency of once per week? (click here to jump to the answer)
- Q.5: We have a technician come to our facility to calibrate our anesthetic vaporizers on a regular basis. Does this meet AAALAC’s expectations for calibration and maintenance of our anesthetic machines? (click here to jump to the answer)
- Q.6: Can we house mice and rats in the same room in our animal facility? They are both from approved vendors and have a similar pathogen status. We also use strict barrier techniques and equipment (e.g., HEPA filtered ventilated racks and cage changing stations) when housing animals and performing husbandry or experimental procedures. (click here to jump to the answer)
- Q.7: Does AAALAC International have a checklist, or other resources, that can be used when designing a new animal facility, or conducting a major renovation, to help ensure that the facility meets accreditation standards? (click here to jump to the answer)
- Q.8: What are the requirements for having an emergency power supply for our animal facility? (click here to jump to the answer)
- Q.9: We use a variety of invertebrates in our research program and I heard somewhere that they have to be included as part of our accredited program. Can you clarify this for me? (click here to jump to the answer)
- Q.10: What level of monitoring and record-keeping are expected for rodent surgery? (click here to jump to the answer)
- Q.11: We are considering using a former employee as our unaffiliated member. They are no longer affiliated with our program and they are familiar with the type of research we perform. Are there any concerns with this approach? (click here to jump to the answer)
- Q.12: We use wood pallets to store animal feed and bedding off the floor of the storage room. Is this acceptable? (click here to jump to the answer)
Q.1: At some recent meetings I have heard the terms “program-wide exception” and “global exception” used when talking about an Institutional Animal Care and Use Committee or Ethics Committee (IACUC/EC) approving exceptions to the Guide. Can you clarify these terms for me?
A:
The Guide for the Care and Use of Laboratory Animals (Guide), NRC 1996 supports the use of performance standards in the event that acceptable alternative methods to engineering standards are available or unusual circumstances arise. With the advent of new scientific information and new technology, there are situations where new methods or procedures not described in the Guide may be available and result in equal or greater welfare for the animals involved. In most cases, these exceptions involve a specific project or are limited in scope within an animal care and use program. Occasionally, exceptions are wider in scope and may involve the entire animal care and use program or even apply globally in the case of organizations with facilities in multiple countries; these are often referred to as program wide and global exceptions, respectively. In all cases where practices deviate from Guide standards, AAALAC expects each IACUC/EC to establish an ongoing, documentable, site specific, data driven approach that allows for approval and monitoring of exceptions to the Guide. These criteria are essential to ensure that performance standards are properly developed and implemented in accordance with the intent of the Guide.
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Q.2: Can we have exposed pipes and ductwork in our animal facility?
A:
The Guide for the Care and Use of Laboratory Animals (Guide), NRC 1996 states on page 75 that exposed plumbing, ductwork, and light fixtures are undesirable unless the surfaces can be readily cleaned. Construction materials that can not be readily cleaned, such as insulation, or materials such as exposed electrical wiring in an environment that will be constantly wet or with a high humidity level would not be acceptable. While not optimal, exposed ductwork or plumbing can be acceptable in animal rooms or support areas if they can be readily cleaned and there is a good program in place for routine sanitizing of these components. Having many horizontal surfaces in an animal facility makes sanitizing more difficult, but it can be accomplished through good practices, as long as all of the surfaces are sealed or fabricated of impervious materials that are capable of being sanitized. For animal containment facilities, the report, Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH 2007), states that “Internal facility appurtenances, such as light fixtures, air ducts, and utility pipes, are arranged to minimize horizontal surface areas, to facilitate cleaning and minimize the accumulation of debris or fomites.” When designing new animal facilities, you should also consider the cost of future personnel time in keeping all the ductwork and pipes clean versus the cost of placing them in the interstitial space or using a suspended ceiling. While suspended ceilings may be an alternative, they are not the most desirable type of ceiling in animal or animal support areas. But, they can be used if they are fabricated of impervious materials and free of imperfect junctions (page 75 of the Guide).
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Q.3: If an investigator contracts with a company (that is not AAALAC accredited) to produce antibodies or transgenic animals for a specific protocol, and the PI purchases the animals for the contract company to use for these purposes, are these activities considered part of our AAALAC accredited program?
A: AAALAC follows ownership in terms of defining who is responsible for animals at an offsite facility. When the accredited institution owns the animals then AAALAC considers those facilities to be an integral part of the institution's animal care program, and they must be evaluated. In the case described, your institution would own the animals; therefore, a description of the services and facilities provided by the contract facility must be included in your AAALAC Program Description and your annual report to AAALAC. These facilities would also be visited as a part of the triennial site visit. Contractual agreements must provide for the inspection of the contracted facility by AAALAC site visitors. If the contract facility is separately accredited by AAALAC, it will not be necessary to visit that facility during the site visit to your institution. However, if an accredited institution does not own the animals, but just owns the data (or intellectual property) that result from studies or procedures conducted using those animals, AAALAC will not visit the non-accredited site. For example, if a contractor provides most or all specified facilities, services, personnel, animals, etc., and the animals are owned by the contractor, then AAALAC will not visit the contractor as part of the site visit to the accredited institution. The Spring 2003 issue of the Connection Newsletter contains an in-depth article on this particular issue on page 6 and is available to download for free on the AAALAC International website (http://www.aaalac.org/publications/newsletter.cfm). For programs within the U.S., the article also provides perspectives from the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture (USDA), both which have a slightly different approach from AAALAC on this issue. Also, certain agencies such as the Veterans Administration have their own internal policies regarding the acquisition of antibodies that differ from AAALAC and may impact the level of oversight required from an Institutional Animal Care and Use Committee or Ethics Committee. AAALAC encourages every institution/agency to establish their own policies on this issue so that the lines of responsibility and level of internal oversight are clearly defined.
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Q.4: We just purchased some new ventilated isolator caging systems for our mice and rats which utilize solid bottom cages. Can we decrease our cage changing frequency below the Guide recommended minimum frequency of once per week?
A: While the Guide for the Care and Use of Laboratory Animals (Guide), NRC 1996 recommends solid bottom cages be sanitized at least once a week, it goes on to say that some types of cages might require less-frequent sanitation, which include individually ventilated cage (IVC) units. The Guide stresses the use of performance standards when making these determinations. As an example, scientific studies have looked at environmental conditions (1) and cage changing frequency (2) for IVC systems and determined that under normal circumstances, changing cages in these types of units once every two weeks provided for an acceptable environment for the mice. However, there are other factors to take into consideration. While this frequency of cage changing may be acceptable for many mice, it may not be acceptable for others (e.g., diabetic mice that exhibit increased urine output). The Institutional Animal Care and Use Committee/Ethics Committee (IACUC/EC) should review current cage changing practices for IVC units based on current literature and other factors (phenotype of the mice, type of bedding, housing density, etc.) and if they decide to increase the cage changing interval, then they should approve an exception to the Guide recommended standards. Also, as with any performance standard, there should be a system in place to monitor the outcome and report back to the IACUC/EC should it not be effective in maintaining an appropriate environment for the mice. The IACUC/EC should establish an ongoing, documentable, site specific, data driven approach that allows for monitoring approved program-wide exceptions to the Guide.
Helpful references may include:
- Memarzadeh F, Harrison PC, et al. 2004. Comparison of environment and mice in static and mechanically ventilated isolator cages with different air velocities and ventilation designs. Cont Topics, 43(1):14-20.
- Reeb CK, Jones RB, et al. 1998. Microenvironment in ventilated animal cages with differing ventilation rates, mice populations, and frequency of bedding changes. J Am Assoc Lab Anim Sci, 37(2):13-19.
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Q.5: We have a technician come to our facility to calibrate our anesthetic vaporizers on a regular basis. Does this meet AAALAC’s expectations for calibration and maintenance of our anesthetic machines?
A: There is a difference between an on-site calibration and having the vaporizer sent to the manufacturer for preventive maintenance. The services performed in each of these instances can be significantly different. During most on-site calibrations, the vaporizer is checked to ensure it is delivering the amount of anesthetic as reflected by the setting. When vaporizers are sent in for preventive maintenance, the vaporizer is broken down and a detailed maintenance is performed that includes cleaning and replacement of worn gaskets and other parts. The frequency of these types of services depends on the type of vaporizer and anesthetic being used. For example, a precision vaporizer using halothane requires more frequent calibration and maintenance due to the buildup of thymol (a preservative used in halothane) residues within the vaporizer. Other volatile anesthetics, such as isoflurane and enflurane, do not contain thymol and do not require as an intensive calibration and maintenance schedule. Note that NIOSH (Health Care Workers Guidelines/Chap5) states that all anesthetic equipment must be regularly monitored for leakage, improper design, or defects. This includes the anesthesia machine as well as the vaporizer since anesthetic machines can develop improperly functioning components such as flutter valves, gaskets, and scavenging equipment. AAALAC International expects that anesthetic machines and vaporizers are evaluated for safe and effective operation on an established schedule, consistent with the the manufacturers recommendations. The manufacturer of your vaporizer should have recommended intervals for both on-site calibration and for maintenance that requires sending the vaporizer in to them, as well as recommended maintenance intervals for the rest of the anesthetic machine.
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Q.6: Can we house mice and rats in the same room in our animal facility? They are both from approved vendors and have a similar pathogen status. We also use strict barrier techniques and equipment (e.g., HEPA filtered ventilated racks and cage changing stations) when housing animals and performing husbandry or experimental procedures.
A: The Guide for the Care and Use of Laboratory Animals (Guide), NRC 1996 does recommend physical separation of animals by species to prevent interspecies disease transmission and anxiety due to interspecies conflict, which is usually done by housing in separate rooms, but the Guide does also say that the use of specialized equipment (ventilated caging systems, etc.) to accomplish this may also be a suitable alternative. It is important to remember that the Guide does discuss the fact that some of the things that may impact this decision are whether or not the animals are from multiple sites or sources, either commercial or institutional, and their pathogen status. The Guide states that if two species have a similar pathogen status and are behaviorally compatible, housing them in the same room may be acceptable. Although the housing methods and husbandry practices you described would probably be very effective in preventing disease transmission between groups of animals with a similar pathogen status, they may not necessarily prevent interspecies conflict unless the ventilated rack system was connected to the room exhaust and not exhausted back into the room. Since rats are a natural predator of mice, there would be a concern of inducing stress/anxiety in mice housed in the same room if the mice could detect the presence of rats. We would expect the IACUC to review and either approve or withhold approval, based on data they have reviewed for this particular circumstance. For example, a few of the considerations the IACUC might review could be the ability of the mice to detect the presence of the rats through either the visual or olfactory senses, the type of research being performed and any potential effects resulting from the housing arrangement. Some references below discuss the rat/mouse predator relationship and the resulting effects on mice, which include not just anxiety and fear, but also immunological and behavioral consequences as well.
Helpful references may include:
- Calvo-Torrent A, Brain PF, Martinez M. 1999. Effect of predatory stress on sucrose intake and behavior on the plus-maze in male mice. Physiol Behav. Aug;67(2):189-96. PMID: 10477049 [PubMed - indexed for MEDLINE]
- Apfelbach R, Blanchard CD, Blanchard RJ, Hayes RA, McGregor IS. 2005. The effects of predator odors in mammalian prey species: a review of field and laboratory studies. Neurosci Biobehav Rev. 29(8):1123-44. Epub 2005 Aug 8. PMID: 16085312 [PubMed - indexed for MEDLINE]
- Merali Z, Levac C, Anisman H. 2003. Validation of a simple, ethologically relevant paradigm for assessing anxiety in mice. Biol Psychiatry. Sep 1;54(5):552-65. PMID: 12946884 [PubMed - indexed for MEDLINE]
- Hebb AL, Zacharko RM, Dominguez H, Laforest S, Gauthier M, Levac C, Drolet G. 2003. Changes in brain cholecystokinin and anxiety-like behavior following exposure of mice to predator odor. Neuroscience.;116(2):539-51. PMID: 12559109 [PubMed - indexed for MEDLINE]
- Lu ZW, Song C, Ravindran AV, Merali Z, Anisman H. 1998 Influence of a psychogenic and a neurogenic stressor on several indices of immune functioning in different strains of mice. Brain Behav Immun. 12(1):7-22. PMID: 9570858 [PubMed - indexed for MEDLINE]
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Q.7: Does AAALAC International have a checklist, or other resources, that can be used when designing a new animal facility, or conducting a major renovation, to help ensure that the facility meets accreditation standards?
A: AAALAC International has several resources available to assist in the design and construction of animal facilities. Animal facilities must first and foremost meet the recommendations set forth in the Guide for the Care and Use of Laboratory Animals (Guide), NRC 1996 where there is significant guidance provided on animal environment, housing, and physical plant requirements. Other resources include "The Handbook of Facilities Planning: Volume 2, Laboratory Animal Facilities" which was published in 1991, but contains detailed information which is still relevant. The order form for this book can be downloaded on the AAALAC International website (www.aaalac.org/resources/available.cfm) and a searchable CD ROM purchased for $25.00, or a hardcopy spiral bound book for $35.00. At the same website address you can also download, for free, a copy of a PowerPoint presentation entitled "Facilities and Operations" which discusses many aspects of AAALAC International's expectations for animal facilities from a construction and operational viewpoint. The American College of Laboratory Animal Medicine (ACLAM) has published a very thorough textbook entitled “Planning and Designing Research Animal Facilities” (Hessler 2009) and can be ordered from the Elsevier publishing company website (www.elsevier.com). You can also download a free copy of the National Institutes of Health (NIH) publication "NIH Design Policy and Guidelines" (2003 edition) at http://orf.od.nih.gov/PoliciesAndGuidelines/DesignPolicy/ which contains a section on animal research facilities on pages 138-213. While this document is intended to provide guidance on design and construction requirements for animal facilities built for NIH, it contains a wealth of useful information. The “Biosafety in Microbiological and Biomedical Laboratories” handbook (CDC/NIH 2007, 5th Edition) provides details on physical plant requirements for biocontainment facilities designed to house animals for research utilizing hazardous infectious agents and biological toxins. An online version of this publication is available for free on the CDC website at http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm.
While many of these resources speak to technical details of animal facility design and construction, AAALAC International uses a performance standard, or outcome, approach for evaluating animal facilities during the site visit process. The Guide provides a multitude of performance standards for animal facility design and construction. For example, rather than AAALAC International stating that 1/4 inch thick poured epoxy floors are required for animal facilities, it gives a detailed description of what is expected of an animal facility floor, such as being moisture-resistant, nonabsorbent, impact-resistant, and relatively smooth, although textured surfaces might be required in some high-moisture areas and for some species (such as farm animals). Further details are provided in the paragraph that describes additional attributes expected of an animal facility floor. The Guide was intentionally written using a performance standard approach since the design and size of animal facilities varies tremendously depending on the scope of institutional research activities, the species of animals to be housed, the physical relationship to the rest of the institution, and the geographic location. While performance standards allow facilities to be constructed in a variety of manners to meet the needs of each institution, the performance standard approach does not lend itself well to the development of checklists for animal facility design and construction. The best checklist would be to use the Guide to ensure that all applicable areas have been considered during the design and construction phases of a new animal facility or renovation of an existing facility.
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Q.8: What are the requirements for having an emergency power supply for our animal facility?
A: The Guide for the Care and Use of Laboratory Animals (Guide), NRC 1996 states that: “In the event of power failure, an alternative or emergency power supply should be available to maintain critical services (for example, the HVAC system) or support functions (for example, freezers, ventilated racks, isolators) in animal rooms, operating suites, and other essential areas.” AAALAC does not have any independent requirements above the recommendations of the Guide. However, the Program Description submitted as part of your application packet, does include questions about emergency power. They are:
- Describe the physical aspects (location, type) of electrical power arrangements and components. Note if the electrical receptacles and switches are moisture proof.
- Note if emergency power is provided for the animal facility and if so, what electrical services it maintains in the event the primary power source fails.
- Give history of power failures to the animal facility. Note frequency and duration. If emergency power was not available during a power failure, describe steps taken to assure the comfort and well being of the animals and the temperature extremes reached in the animal rooms during the failure.
- Describe animal losses or health problems resulting from power failures (if any).
To best meet the recommendations of the Guide and AAALAC expectations, your Institutional Animal Care and Use/Ethics Committee (IACUC/EC), in consultation with your facilities management and scientific staff, would need to identify those components of the program that should continue to have electrical power in the event of an HVAC failure so as to prevent adverse effects to people or animals. As you might imagine, such needs will vary among institutions, depending upon the type of program (e.g., intensive surgical load, aquatics, biocontainment), facility equipment (e.g., rodents housed in ventilated units, freezers storing research samples), history of power failures, and facility design issues that could impact personnel safety during a power failure.
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Q.9: We use a variety of invertebrates in our research program and I heard somewhere that they have to be included as part of our accredited program. Can you clarify this for me?
A: The following statement in blue is from the Rules of Accreditation as found on the AAALAC website:
"All animals used or to be used in research, teaching or testing at accreditable units are to be included and evaluated in accordance with the standards set forth in Section 2 of these Rules. This includes traditional laboratory animals, farm animals, wildlife, and aquatic animals. Nontraditional animals, inclusive of invertebrate species, are also included where they are relevant to the unit's mission."
Of particular concern to Council, vis-à-vis invertebrate colonies, is the inclusion of their review when such inclusion would benefit the program as a whole, or their exclusion would potentially jeopardize the overall program mission. Also, Council acknowledges the need to evaluate management of invertebrate colonies when those colonies are within a core animal facility and therefore subject to creating, or being subject to, potential adverse influences from activities in adjacent spaces. Possible areas of evaluation could include:
- Training of personnel caring for and handling the animals.
- Husbandry practices, including sanitation, diet, and adequate space (especially if contiguous with vertebrate holding areas).
- Health monitoring and record keeping.
- Species interactions for those held in the same room or area.
- Physical plant provisions (e.g., emergency power availability for species whose environment would be negatively impacted by a power outage).
- Occupational health and safety risks (e.g., GFI circuitry, zoonotic diseases, containment of mosquitoes used in malaria research, etc.).
While AAALAC does require that invertebrates used as a part of the research mission of the institution be included as part of the animal care and use program, there are many ways in which that can be accomplished. Many institutions do not have a formal protocol for invertebrate work, but notify the Institutional Animal Care and Use or Ethics Committee (IACUC/EC) via letter about the work they will be doing with these species. Or the oversight may be a Standard Operating Procedure (SOP), policy statement, guideline, etc., that is reviewed by the IACUC and delineates the committee's responsibility over the use of invertebrates and provides guidance to investigators using invertebrates. Some of the issues the document may want to include are listed above. The intensity of oversight by the IACUC/EC may depend on such things as the species of invertebrate being used and the type of procedures being performed. Site visit teams will generally not review research activities involving lower level invertebrates such as zooplankton, sea slugs, nematodes, or mosquitoes, but will most likely review research with higher level invertebrates such as lobsters, squid or octopi. For example, if invasive procedures are being conducted on a higher level invertebrate, an IACUC/EC approved protocol may be an appropriate requirement. The guidance from AAALAC is, of necessity, flexible because it is likely that a site visit team would be very interested in the IACUC's oversight of invasive octopus research, as compared to oversight of work with zooplankton or nematodes.
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Q.10: What level of monitoring and record-keeping are expected for rodent surgery?
A: There is clear general consensus in relevant resources (e.g., the Guide for the Care and Use of Laboratory Animals (Guide), NRC 1996; Medical Records for Animals Used in Research, Teaching, and Testing: Public Statement from the American College of Laboratory Animal Medicine, ILAR 2007; Rodents: Laboratory Animal Management, NRC 1996; Research Animal Anesthesia, Analgesia and Surgery, SCAW 2007) that monitoring of rodents during surgery is critical so that animals are maintained under a surgical plane of anesthesia and that therapeutic intervention can be provided should unexpected physiological responses occur. Perioperative assessment of the physiological status (especially body temperature, but depending on other factors, also respiratory rate, heart rate, blood pressure, blood gases, ECG, etc.) and anesthetic depth are valuable metrics for this purpose. Monitoring is also key to ensuring that sound research data will ultimately be collected from the animals. The level of detail contained in the records should accurately reflect the monitoring being performed.
Therefore, while AAALAC does not have a policy that stipulates the level of documentation for surgical procedures, the Guide does recommend that pre-surgical planning include consideration of record-keeping, and AAALAC would expect that this would occur and that the level of monitoring and record-keeping would be adjusted to the type of procedure, health of the animal, etc. Good record-keeping is also important so the Institutional Animal Care and Use or Ethics Committee (IACUC/EC) can track whether or not a specific animal had undergone more than one survival surgical procedure, as multiple survival surgical procedures need to be handled in a specific manner by the IACUC/EC. To summarize, then, there is no “cookie-cutter” approach to monitoring and documentation associated with surgical procedures, but AAALAC site visitors would expect all the factors described to be evaluated by the IACUC/EC for all surgical procedures when making these determinations.
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Q.11: We are considering using a former employee as our unaffiliated member. They are no longer affiliated with our program and they are familiar with the type of research we perform. Are there any concerns with this approach?
A: The Guide for the Care and Use of Laboratory Animals (Guide), NRC 1996, does offer some guidance on the issue of what should be some of the traits of the unaffiliated (public) member. The Guide states this person should represent the general community interests in the proper care and use of animals, should not be laboratory-animal users, and not be affiliated with the institution or be members of the immediate family of a person who is affiliated with the institution. The OLAW/ARENA Institutional Animal Care and Use Committee Guidebook (which is an AAALAC International reference resource) expands on this by stating that the unaffiliated member can bring significant value to the committee by bringing a non-institutional perspective to the research endeavor. For programs with an NIH Assurance, OLAW provides some additional guidance in their frequently asked questions section of their website (http://grants.nih.gov/grants/olaw/faqs.htm#IACUC_1) by stating that "the unaffiliated member should have no discernable ties or ongoing affiliation with the institution, and may not be a member of the immediate family of a person who is affiliated with the institution. Immediate family includes parent, spouse, child and sibling. Appointment of an individual who is unambiguously unaffiliated is the best way to fulfill the letter and spirit of this provision." Using a former employee as the unaffiliated member is certainly a gray area that might come into question during a site visit based on the above guidance, especially in context of the comments about the value of that member bringing a non-institutional perspective to the research endeavor and not having any discernable ties or ongoing affiliation with the institution. While not specifically prohibited, the IO should give special consideration to the use of a former employee as an unaffiliated member to ensure that both the intent and the spirit of the Guide are being met.
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Q.12: We use wood pallets to store animal feed and bedding off the floor of the storage room. Is this acceptable?
A: Means of feed and bedding storage should protect these supplies from spoilage, contamination, deterioration and vermin infestation. To achieve these goals, it is advisable to store feed and bedding on pallets, carts or racks. This storage method also facilitates adequate cleaning of the area. In general, pallets made of non-porous material, such as plastic, are preferred because they can be sanitized and tend to have a longer use. However, wood pallets may be acceptable. When wood pallets are used, it should be assured that they are not an immediate or continuing source of contamination or vermin into the facility. Also, the presence of wood on the floor should not impede room sanitation methods. Regardless of the pallet material used, the structural integrity of the pallets should be ensured to promote a safe work environment for personnel and to protect the supplies.
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