The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) requires that Assured institutions base their animal care and use programs on the Guide for the Care and Use of Laboratory Animals (Guide). The Office of Laboratory Animal Welfare (OLAW) is the National Institutes of Health (NIH) office responsible for the administration and coordination of the PHS Policy. In December 2010, the National Academies Press released the 8th Edition of the Guide (PDF) , copyrighted 2011, to update the 7th Edition of the Guide that had been published in 1996.

The NIH has determined that it will adopt the 8th Edition of the Guide effective January 1, 2012. In OLAW's judgment, the 8th Edition of the Guide empowers continued advancement in the humane care and use of vertebrate animals in research, research training, and biological testing.

OLAW prepared Position Statements in response to public concerns. The Statements clarify how OLAW expects Assured institutions to implement the 8th Edition of the Guide, emphasize OLAW's continuing support for performance standards, restate policies that remain unchanged, and endorse several changes that will improve animal welfare.

OLAW requires Assured institutions to base their programs of animal care and use on the 8th Edition of the Guide as of January 1, 2012. Assured institutions must complete at least one semiannual program review and facility evaluation using the 8th Edition of the Guide as the basis for evaluation by December 31, 2012. It is not required that all necessary changes be completed by December 31, 2012, but rather that an evaluation must be conducted and a plan and schedule for implementation of the 8th Edition of the Guide must be developed by December 31, 2012.

In addition to requiring that Assured institutions base their animal care and use programs on the Guide, the PHS Policy directs that institutions must identify specifically any departures from the provisions of the Guide and state the reasons for each departure. (See PHS Policy IV.B.3.) OLAW considers a “must” statement in the Guide to be a minimum standard required of Assured institutions. The Institutional Animal Care and Use Committee (IACUC) must review and approve departures from the minimum standards of the Guide. (See PHS Policy IV.B.3.) IACUC approval must be based on scientific, veterinary medical, or animal welfare issues. Cost saving or convenience alone is not sufficient justification to approve a departure from the minimum standards of the Guide.

“Should” statements in the 8th Edition of the Guide often involve performance standards. OLAW supports and has a high regard for performance standards developed by the research community. OLAW does not consider established performance standards to be a departure from the Guide. A well-established performance standard meets the following criteria:

• supports scientific objectives;
• supports the health and welfare of the animal;
• includes a justified performance index; and
• has associated outcome criteria.

Institutions that have well-developed policies and procedures that meet the above criteria may not have to adjust those policies and procedures as part of their implementation of the 8th Edition of the Guide.

An institution may elect to follow a different course of action than a “should” statement in the Guide if that action results in an equivalent outcome and is reviewed and approved by the IACUC. In addition, institutions are not required to comply with “should” statements that do not apply to their program. The OLAW Semiannual Program Review and Facility Inspection Checklist (Checklist) sample document has been updated to meet the standards of the 8th Edition of the Guide and now includes a “Not Applicable” (NA) column. Use of the Checklist is not required; it is provided for the convenience of Assured institutions. For IACUCs that choose to use the Checklist, appropriate selection of NA is sufficient documentation that the IACUC has considered a standard and determined that it is not applicable to their program.

The PHS Policy requires that Assured institutions “comply with the applicable regulations (9CFR, Subchapter A) issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act and Regulations (AWAR). The Guide may differ from USDA regulations in some respects. Compliance with the USDA regulations is an absolute requirement of this [PHS] Policy.” (See PHS Policy footnote 2.) OLAW reminds Assured institutions that they must also comply with applicable national, state, and local laws, regulations, policies, guidelines, and funding conditions. If standards differ, the institution must comply with the more stringent standard.

NIH solicited comments from the public regarding adoption and implementation of the 8th Edition of the Guide from February 24, 2011 to May 24, 2011. A summary of the activities related to the public comment solicitation can be found in the Background section of this document. OLAW appreciates the commitment of the public in providing numerous well-reasoned comments regarding the welfare of vertebrate animals. A total of 806 responses were submitted by Assured institutions, professional organizations, animal advocacy organizations, and individuals. OLAW reviewed and analyzed all comments. View the comments.

A majority of respondents opposed the adoption of the 8th Edition of the Guide. Many of the organizations and individuals that opposed the adoption of the Guide supported many sections. Their objections were confined to specific topics and issues; these are the subjects of OLAW's Position Statements. Many of those opposed to adoption of the entire Guide applauded the new reference section as excellent, valuable and needed, liked the section on aquatics, and commended the effort put forth to compile the new edition.

A minority of respondents fully supported the adoption of the 8th Edition of the Guide. The consensus among these respondents was that the new material in the Guide was overdue and necessary.

NIH received a comment from the authors of the 8th Edition of the Guide. They noted that, “All decisions made by the committee were determined by consensus.” The authors also commented, “The process for selecting members of the committee was intensive and unprecedented for any previous version of the Guide. The qualifications of the thirteen members were intensely scrutinized over several months, followed by a 20-day public comment period before the committee roster was finalized.”

Performance Standards

The 8th Edition of the Guide further develops the concept and advocates the use of outcome-based performance standards (See inset.) that were a basis of the 7th Edition of the Guide.

Performance standards are the most important component of the infrastructure of PHS oversight of animal programs at Assured institutions. IACUCs are able to meet their responsibility to ensure humane animal care and use while advancing quality scientific research through the use of performance standards in their oversight of institutional animal programs. OLAW encourages the cooperative application of diverse expertise to develop outcome-based performance standards that enhance the quality of animal care and use programs. OLAW expects Assured institutions to apply appropriate professional judgment and experience to the challenges inherent in developing policies and procedures to maintain a quality program that provides humane care to vertebrate animals.

Implementation of the Guide is expected to have a minimal impact on institutions that are currently using policies and procedures based on well-developed performance standards. These policies and procedures may not need to be revised as part of the institution's implementation of the 8th Edition of the Guide.

Institutions that do not currently have performance standards that meet the criteria stated in this document (See inset.) are expected to use the benchmarks provided by the 8th Edition of the Guide to develop performance-based policies and procedures.

Practice Standards

The 8th Edition of the Guide includes standards based on best practices. These standards, developed within the research community itself, reflect efforts to improve vertebrate animal welfare through self-monitoring and the application of outcome-based performance standards in striving for better animal care and use that benefits scientific research. Not all practice standards have been published in the literature. In addition to referencing the published literature, the Guide also captures information based on the experience of biomedical researchers, veterinarians, and IACUC members. (See Guide page 7.) As such, many institutions have developed, and therefore already instituted, the policies and procedures described in the 8th Edition of the Guide.

The following Position Statements describe the ways in which OLAW expects institutions to implement the 8th Edition of the Guide. The public is invited to submit comments on their understanding of these Statements for a period of 60 days until February 3, 2012. In response, OLAW may further clarify the Position Statements. A link for submission of electronic comments to OLAW is provided at the end of each Position Statement.

Position Statement 1) Cost

Nearly 70% of respondents stated that they are concerned about the cost of implementing the 8th Edition of the Guide.

Cost cannot be the overriding factor in decisions related to animal welfare in PHS-funded research. (See U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training Principle II.) Assured institutions are responsible for compliance with the Guide. OLAW believes compliance can be best accomplished using teamwork, professional judgment, and experience. The PHS Policy and the Guide define the minimum standards (“musts”) and performance standards (“shoulds”) that OLAW expects of Assured institutions. OLAW recognizes that there are many ways to achieve humane animal care and use. An institution may use an alternative approach if the approach satisfies the requirements of the PHS Policy as determined by OLAW. In many instances, institutions and IACUCs elect to exceed the standards. This is not required and can add expense to the program.

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Position Statement 2) Housing

About 60% of respondents indicated concern with changes to caging and housing specifications in the Guide.

OLAW concurs with the Guide that performance standards are to be applied to housing issues. (See Guide pages 50-63.) Outcome-based performance standards are paramount when evaluating cage or pen space for housing animals used for research, research training, and biological testing. While the Guide's space recommendations are a starting point for addressing space needs, performance standards allow flexibility to improve animal welfare and scientific research. An institution's animal housing practices must be species-specific, appropriate for the animals, and in compliance with all applicable federal and local regulatory requirements.

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Position Statement 2a) Nonhuman Primate Housing

Like all social animals, nonhuman primates should be socially housed. (See U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training Principle VII and 9 CFR Ch. 1, Part 3, Subpart D.) Staff performing the socialization should be trained and competent in the procedure and knowledgeable about the animals. Behaviorally compatible animals must be used in socialization attempts. Group composition is critical and numerous species-specific factors should be taken into consideration when forming a group. Due to conformational differences of animals within groups, more space or height may be required to meet the animals' physical and behavioral needs. Determination of the appropriate cage size is not based on body weight alone. Professional judgment is paramount in making such determinations. (See Guide pages 58-60.)

When necessary, single housing of social animals should be limited to the minimum period necessary. When single housing is necessary, visual, auditory, olfactory, and (depending on the species) protected tactile contact with compatible conspecifics should be provided, if possible. In the absence of other animals, additional enrichment should be offered (as appropriate to the species or individual animal), such as safe and positive interaction with the animal care staff, periodic release into larger enclosures, supplemental enrichment items, and / or the addition of a companion animal in the room or housing area.

Institutions are encouraged to consult the Animal Welfare Act and Regulations on primate housing requirements. Compliance with the USDA regulations is an absolute requirement of this [PHS] Policy. (See PHS Policy footnote 2.) Housing of nonhuman primates in social settings (pairs or groups) is the requirement of the USDA regulations (9 CFR Ch. 1, Part 3, Subpart D) and single housing is the exception. Protected tactile contact is considered single housing by the USDA, with rare exceptions. Exemptions to the social housing requirement must be based on strong scientific justification approved by the IACUC or for a specific veterinary medical or behavioral reason. Lack of appropriate caging does not constitute an acceptable justification for exemption.

OLAW and USDA concur on OLAW FAQ F14, “Is social housing required for nonhuman primates when housed in a research setting?” A revised version of FAQ F14 has been posted on the OLAW website. OLAW and USDA positions are further defined at the Nonhuman Primate Enrichment and Social Housing resource on the OLAW website.

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Position Statement 2b) Environmental Enrichment

OLAW concurs with the Guide's statement, “The primary aim of environmental enrichment is to enhance animal well-being by providing animals with sensory and motor stimulation through structures and resources that facilitate the expression of species-typical behaviors and promote psychological well-being through physical exercise, manipulative activities, and cognitive challenges, according to species-specific characteristics.” (See Guide pages 50-52.) An institution's environmental enrichment practices must be species-specific and appropriate for the animals. Devices that animals climb on or through, perch on, or nest in contribute to, rather than detract from, the animal's living space and need not be subtracted from the floor dimensions. Some species are upset by the introduction of novel items. Animals should not be subjected to the presence of items that they find distressing.

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Position Statement 2c) Rodent Housing

OLAW supports the Guide's approach to applying performance standards to achieve specified outcomes and expects institutions to use the Guide's space recommendations as a starting point. Adjustments to recommendations for primary enclosures may be made at the institutional level by the IACUC. The IACUC should critically evaluate objective measures of outcome-based performance. The Guide identifies examples of performance indices to assess adequacy of housing including:

• health,
• reproduction,
• growth,
• behavior,
• activity, and
• use of space.

Many institutions currently follow procedures and policies in keeping with outcome-based performance indices that meet the standards of the 8th Edition of the Guide. IACUCs may not need to adjust these policies and procedures.

Rodent cages of the size commonly used in the United States may be appropriate for trio breeding. The 8th Edition of the Guide does not add specific, additional engineering standards for breeding configurations. This empowers institutions to determine appropriate housing. The IACUC must consider relevant factors when assessing the adequacy of cage space according to performance standards. Examples of these factors may include:

• average litter size of the strain(s) of rodents;
• whether multiple litters are present in the cage;
• difference in the age of the pups of different litters;
• growth rate;
• need for cross-fostering;
• cage dimensions; and
• overall management and husbandry practices such as cage sanitation or bedding change.

Blanket, program-wide departures from the Guide for reasons of convenience, cost, or other non-animal welfare considerations are not acceptable. Cages that might be acceptable when litters are born may have insufficient space as pups grow. Whatever parameters are used to establish breeding configurations and weaning procedures, the IACUC must ensure that cage population does not negatively impact animal well-being and overcrowding does not occur.

OLAW's guidance on IACUC-approved departures from the Guide for rodent housing was first posted on September 11, 2006 in FAQ F10, “May the IACUC approve deviations from the Guide for rodent (mice and rats) cage density?” A revised version of FAQ F10 has been posted on the OLAW website.

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Position Statement 2d) Rabbit Housing

OLAW concurs with the 8th Edition of the Guide. “Rabbits should be housed under conditions that provide sufficient space... to meet physical, physiologic, and behavioral needs. The height of an enclosure can be important to allow for expression of species-specific behaviors and postural adjustments. Cage height should take into account the animals' typical posture and provide adequate clearance for the animal from cage structures, such as feeders and water devices. Space allocations should be assessed, reviewed, and modified as necessary by the IACUC considering the performance indices and special needs determined by the characteristics of the animal.” (See Guide pages 51-52, 56, 59.)

IACUCs may consider the use of a rabbit cage that is 14 inches in height, if appropriate. The IACUC should establish, through performance indices related to animal well-being, that the cage provides sufficient space to meet the physical, physiologic and behavioral needs of the animal. For example, the rabbit must be able to hold its ears in an upright position (if this is natural for the breed) and ears must not be forced to fold over by contact with the cage ceiling. OLAW recognizes the necessity of cost-efficiency and the valid concerns of the community about program cost. Programs should function efficiently, but not at the cost of animal welfare.

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Position Statement 3) Non-Pharmaceutical-Grade Substances

Approximately 40% of respondents indicated concern with requirements on the research use of non-pharmaceutical-grade chemicals and other substances.

OLAW and USDA agree that pharmaceutical-grade¹ chemicals and other substances, when available, must be used to avoid toxicity or side effects that may threaten the health and welfare of vertebrate animals and / or interfere with the interpretation of research results. However, it is frequently necessary to use investigational compounds, veterinarian- or pharmacy-compounded² drugs, and / or Schedule I³ controlled substances to meet scientific and research goals.

The IACUC is responsible for evaluating the potential adverse consequences of such agents when used for research. In making its evaluation, the IACUC may consider factors including, for example:

• grade,
• purity,
• sterility,
• acid-base balance,
• pyrogenicity,
• osmolality,
• stability,
• site and route of administration,
• compatibility of components,
• side effects and adverse reactions,
• storage, and
• pharmacokinetics.

The IACUC may use a variety of administrative methods to review and approve the use of such agents. For example, the IACUC may establish acceptable scientific criteria within the institution, rather than on a case-by-case basis. Investigators and IACUCs should consider relevant animal welfare and scientific issues including safety, efficacy, availability of pharmaceutical-grade compounds, and the inadvertent introduction of new variables. Cost savings alone are not an adequate justification for the use of non-pharmaceutical-grade or compounded drugs in animals.

Although the potential animal welfare consequences of complications are less evident in non-survival studies, the scientific issues remain the same. The principles and need for professional judgment outlined above apply to non-survival studies.

Procedures that may cause more than momentary or slight pain or distress to the animals must be performed with sedation, analgesia, or anesthesia agents using veterinary or human pharmaceutical-grade compounds, unless the use of an investigational chemical or formulation is scientifically necessary, appropriately justified, and approved by the IACUC. The use of a non-pharmaceutical-grade euthanasia agent must meet the same standards.

OLAW's guidance on the use of non-pharmaceutical-grade substances was first published in 2003 (Lab Animal. 2003; 32(9):33-36) and posted on the OLAW website on September 11, 2006. The USDA's position on non-pharmaceutical-grade substances may be found in the Animal Care Manual Policy ³. OLAW provided additional guidance on use of non-pharmaceutical-grade substances in FAQ F4, “May investigators use non-pharmaceutical grade compounds in animals?” A revised version of FAQ F4 has been posted on the OLAW website.

¹ A pharmaceutical grade compound is a drug, biologic, or reagent that is approved by the Food and Drug Administration (FDA) or for which a chemical purity standard has been established by the United States Pharmacopeia-National Formulary (USP-NF), or British Pharmacopeia (BP) .

² Veterinary compounding is the customized manipulation of an approved drug by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a research study. IACUCs considering the use of veterinary compounding for research purposes are advised to consult: http://www.avma.org/issues/drugs/compounding/veterinary_compounding_brochure.asp for more information about federal regulations.

³ United States Department of Justice Drug Enforcement Agency controlled substances Schedule I and II-IV drugs may be used in biomedical research according to the standards of the Code of Federal Regulations 1301.13.

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Position Statement 4) Food and Fluid Restriction/Use of Preferred Foods

Approximately 30% of respondents indicated concern with requirements regarding food and fluid restriction.

Ingestion of food and fluid are requirements for proper nutrition. When food or fluid is restricted, the amount of the regulated item earned during testing and the amount of the regulated item freely given should be recorded to ensure each animal receives its minimum daily requirements. (NRC 2003, Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research, Washington: National Academies Press) The IACUC must evaluate the level of restriction and potential adverse consequences in regulating food or fluid. The IACUC must also evaluate the methods for assessing the health and well-being of animals in the animal activities that involve regulation of food or fluid. The IACUC has the authority to approve scientific justifications for departures from the recommendations in the Guide. For instance, using scheduled access to food or fluid sources may be justified by describing procedures based on performance standards that assure adequate maintenance of hydration, body weight, and behavioral and clinical health. It may be necessary to monitor both food and fluid intake if regulation of one influences consumption of the other.

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Position Statement 5) Multiple Surgical Procedures

Approximately 30% of respondents indicated concern regarding the number of survival surgeries to which an animal can be subjected.

Surgical procedures should be defined as major or minor on a case-by-case basis and evaluated by the veterinarian and IACUC to determine their impact on the animal's well-being. (See Guide page 30, 117.) Multiple procedures that may induce substantial post-procedural pain or impairment may be conducted on a single animal only if justified by the PI, and reviewed and approved by the IACUC. Multiple major surgical procedures on a single animal are acceptable only if they are:

• included in and essential components of a single research project or proposal;
• scientifically justified by investigator; or
• necessary for clinical reasons.

Cost savings alone is not an adequate reason for performing multiple major survival surgical procedures. (See Guide page 30.)

Note that under USDA regulations (AWR 2.31 (x) A-C), “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 or to protect the health or well-being of the animal as determined by the attending veterinarian; or (C) In other special circumstances as determined by the [Animal Care] Administrator on an individual basis. Written requests and supporting data should be sent to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale MD 20737-1234”.

OLAW's guidance on use of multiple surgical procedures was first published in 1997 (Contemporary Topics. 1997; 36(2):47-50) and posted on the OLAW website on September 11, 2006 as FAQ F9, “Are major multiple survival procedures permitted on a single animal?” A revised version of FAQ F9 has been posted on the OLAW website.

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Position Statement 6) Agricultural Animals

Approximately 1% of respondents indicated concern with the application of the 8th Edition of the Guide to agricultural animals.

PHS Policy mandates that Assured institutions use the Guide for the Care and Use of Laboratory Animals as a basis for developing and implementing a program for activities involving animals. (See PHS Policy IV.A.1.) OLAW concurs with the Guide that, “the Guide applies to agricultural animals used in biomedical research, including those maintained in typical farm settings. For animals maintained in a farm setting, the Guide for the Care and Use of Agricultural Animals in Research and Teaching, (FASS 2010) [Federation of Animal Science Societies] is a useful resource. Information about environmental enrichment, transport, and handling may be helpful in both agricultural and biomedical research settings.” (See Guide page 33.)

The USDA position on regulation of agricultural animals may be found in the Animal Care Policy Manual Policy 17. OLAW's guidance on using standards for agricultural animals was posted on September 11, 2006 as FAQ G7, “May institutions utilize the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching if their programs include traditional farm animals?” A revised version of FAQ G7 has been posted on the OLAW website.

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The 8th Edition of the Guide for the Care and Use of Laboratory Animals was published in January 2011 by the National Research Council of the National Academy of Sciences as the result of a lengthy study by the Institute for Laboratory Animal Research (ILAR) . Since 1985, the PHS Policy has required that all institutions receiving PHS support for animal activities base their programs of animal care and use on the current edition of the Guide. Because the 8th Edition of the Guide contains substantive changes from the previous edition, NIH sought comments to gain insight from institutions that would be affected by the change.

On February 24, 2011, NIH issued a Federal Register Notice (PDF) requesting public comments on (1) NIH's adoption of the 8th Edition of the Guide as a basis for evaluation of institutional programs receiving or proposing to receive PHS support for activities involving animals and (2) NIH's proposed implementation plan (if NIH decides to adopt the 8th Edition of the Guide). The original implementation plan proposed that institutions complete at least one semiannual program and facility evaluation using the 8th Edition of the Guide as the basis for evaluation by March 31, 2012.

Comments were collected via the internet through a Web link available in the Federal Register and on the OLAW website where respondents could also access both the 7th and 8th Editions of the Guide. The original comment period was scheduled from February 24, 2011 to March 24, 2011. (See NOT-OD-11-042.) This comment period was extended twice, on March 18 (See NOT-OD-11-056.) and April 21. (See NOT-OD-11-066.) Ultimately the comment period spanned 90 days, closing on May 24, 2011. In addition to the time extension, the NIH removed the original 6,000 character limit on the comment form fields in the April 21 extension to maximize the opportunity for individuals and organizations to provide comments to NIH.

A Summary Analysis of the Types of Comments

NIH received a total of 806 comments from Assured institutions, professional organizations, animal advocacy organizations, and individuals. Duplications (7) and comments that were not relevant to issues requested in the Federal Register (2) were removed from the database, leaving 797 comments. Some comments were relevant, but did not address the issues of adoption and implementation of the Guide. These included discussion of rulemaking requirements, comments on the Guide committee selection process, conflicts of interest, requests to extend the public comment period, and requests to remove the character limit on submissions. These comments remain in the database.

600 comments were received from those who identified themselves as individuals. 32 comments identified as official correspondence from Assured institutions were received. (On May 24, 2011, there were 1,030 Assured institutions.) 24 comments were submitted by professional organizations and 4 comments were submitted by animal advocacy organizations. A total of 137 institutions and organizations were represented in the database. A total of 276 comments appear to have originated from form letters authored by 4 organizations or individuals.

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