The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) has operated its accreditation program for more than 45 y by using the Guide for the Care and Use of Laboratory Animals (the Guide) as a basic guide in the generation of accreditation
standards. AAALAC supplements its reliance on the Guide with a number of documents, referred to as reference resources, that undergo a formal review and adoption process by AAALAC. Two reference resources have grown in importance to the accreditation process over the past decade as
institutions from outside of the United States have increasingly sought accreditation and as greater numbers of agricultural animals are used in research programs. These 2 reference resources were the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other
Scientific Purposes, Council of Europe (ETS 123), and the Guide for the Care and Use of Agricultural Animals in Research and Teaching (Ag Guide). During the past 2 y, the Guide, Ag Guide, and ETS 123 were revised, prompting AAALAC to reevaluate these resources to
determine the role each should play in the development of standards used for accreditation by AAALAC. As a result of AAALAC's review and analysis, the organization has adopted these 3 documents as primary standards. This article summarizes AAALAC's processes for the review, adoption, and implementation
of these standards offering insights into the application of these standards in the accreditation process.
The third edition (January 2010) of the Guide for the Care and Use of Agricultural Animals in Research and Teaching (the Ag Guide) was the collaborative effort of a group of 64 authors and provides a science-based reference and performance-based guidelines for institutions
that use agricultural species in research and teaching. The adoption of the Ag Guide by the AAALAC Board of Trustees as a primary standard signifies its importance in the AAALAC accreditation process.
Originally enacted in 1966, the Laboratory Animal Welfare Act has been amended several times and renamed the Animal Welfare Act. Responsibility for administering the Animal Welfare Act was delegated within the United States Department of Agriculture to the Administrator of the Animal
and Plant Health Inspection Service, and regulations and standards have been developed to implement the intent of Congress conveyed in the language of the Act. In our opinion, the key to compliance with the Animal Welfare Act and its regulations and standards is to have in place a proactive,
progressive Animal Care and Use Program that uses the semiannual inspection and programmatic review process to improve the day-to-day manage- ment of the program. Successfully managing the inspection process has taken on new meaning in what has recently become known as the 'Age of Enforcement.'
As part of this approach, the Animal and Plant Health Inspection Service made changes to the inspection process and issued an Enhanced Animal Welfare Enforcement Plan, which included the development of an Inspection Requirements Handbook. The Inspection Requirements Handbook provides inspectors
with information on conducting inspections and includes as an attachment a flow chart for Enforcement Action Guidance. The chart describes 4 types of actions that may occur as part of the enforcement process and the steps that will be followed if noncompliant items are documented during an
inspection.
The Freedom of Information Act (FOIA) and state 'open-records' laws govern access to records in the possession of federal agencies and state entities, such as public universities. Although these laws are intended to promote 'open government' and to assure the existence of an informed
citizenry capable of holding government officials accountable for their decisions, an inherent tension exists between the public's access to information and biomedical research institutions' need to ensure the confidentiality of proprietary records and to protect the personal safety of employees.
Recognizing these and other conflicts, the federal FOIA and state public-disclosure laws contain express exemptions to protect sensitive information from disclosure. Although some state open-records laws are modeled after the federal FOIA, important differences exist based on the language
used by the state law, court interpretations, and exemptions. Two specific types of exemptions are particularly relevant to research facilities: exemptions for research information and exemptions for personal information. Responding to FOIA and state open-records requests requires knowledge
of relevant laws and the involvement of all interested parties to facilitate a coordinated and orderly response.
The Federation of European Laboratory Animal Science Associations (FELASA) has been releasing guidelines and recommendations on several laboratory animal science disciplines for more than 15 y. The Working Groups producing these documents comprise specialists in each of the addressed
topics, are nominated by the FELASA constituent associations, and are elected by the FELASA Board of Management. The FELASA guidelines and recommendations are not regulatory but rather are proposals based on scientific knowledge and the state of the art of laboratory animal science activities.
Because they are supported by laboratory animal science associations that represent the vast majority of European professionals, these guidelines and recommendations have influenced the development of various regulatory requirements in Europe, including those related to education and training,
routine laboratory animal activities, and animal health monitoring. Some reports fill existing gaps in the European legal framework or complement it. The Working Groups occasionally collaborate with other European organizations, thus enhancing the professional input and effect of the documents
produced. The recently established AALAS–FELASA Liaison Body may result in future international cooperation that benefits laboratory animal science and welfare in a global context.
The eighth edition Guide for the Care and Use of Laboratory Animals sets standards for diverse laboratory animal care and use practices. It frames its standards as performance, engineering, and practice standards, with a strong emphasis on performance standards, allowing for
multiple routes to clearly defined outcomes. Standards intended to be upheld rigorously are indicated through the use of must in the description, and those accommodating more flexibility are indicated through may and should statements. With respect to pain management standards,
a fourth type of standard—the jurisdictional standard—has been prevalent through all 8 editions of the Guide. Under jurisdictional standards, specific methods and outcomes for measuring, preventing, or alleviating pain are not detailed, but the various jurisdictions of veterinarian,
investigator, and IACUC are elaborated. Although data on pain management in laboratory animals has expanded greatly since the 1996 Guide, the eighth (2011) edition does not contain major new standards or guidance regarding animal pain management. Requirements for veterinary and IACUC
involvement remain as in prior editions, and the duty of veterinarians and scientists to stay abreast of new developments is expected to drive refinement of animal pain management institution by institution. The current article details selected specific pain management standards in the 2011
Guide, lists topics in pain management for which the Guide does not set clear standards, and suggests possible standards for those topics.
The eighth edition of the Guide for the Care and Use of Laboratory Animals recognizes the widespread use of aquatic and semiaquatic research animals by including, among other references, an entire section on aquatic animals in its chapter on environment, housing, and management.
Recognizing the large number of aquatic and semiaquatic species used in research and the inherent diversity in animal needs, the Guide refers the reader to texts and journal reviews for specific recommendations and suggests consultations with persons experienced in caring for aquatic
species. Here we present considerations that may add to the basic information presented in the Guide and offer some recommendations that may be useful for aquatic animal model caregivers and researchers.
In the interval between the publication of the seventh and eighth editions of the Guide for the Care and Use of Laboratory Animals (Guide), much has changed with regard to the regulation and funding of highly pathogenic biologic agents and toxins (Select Agents). Funding
of research involving highly pathogenic agents has increased dramatically during this time, thus increasing the demand for facilities capable of supporting this work. The eighth edition of the Guide briefly mentions Select Agents and provides a limited set of references. Here we provide
some background information regarding the relevant laws and regulations, as well as an overview of the programmatic requirements pertaining to the use of Select Agents, with a focus on use in animals.
Here we sought to determine whether a nonsocial cage enrichment program, identical to one we previously used with male rats, was effective in reducing heart rate or systolic blood pressure (SBP) in female Sprague–Dawley rats and spontaneously hypertensive rats (SHR). Young adult
rats, each instrumented with a radiotelemetry pressure transmitter, were housed individually under enriched or nonenriched conditions. Heart rate and SBP were monitored at 5- and 1-min intervals, respectively, when the rats were undisturbed or after several different types of experimental
manipulations some of which are considered stressful. Cage enrichment did not significantly alter heart rate or SBP of undisturbed rats in either strain at any time during the day or night. However, activity of female SHR was increased in the afternoon and at night under enriched conditions
compared with nonenriched conditions. The enrichment program did not significantly reduce heart rate or SBP responses to most acute manipulations in either strain. However, cage enrichment increased the responses to some procedures (Sprague–Dawley: handling, 1-h restraint; SHR: subcutaneous
injection, tail-vein injection, handling). We conclude that a nonsocial cage enrichment program did not reduce physiologic indicators of stress in female Sprague–Dawley rats or SHR.
A method for blood collection from the jugular vein of mice without anesthesia was compared with a tail-incision technique. Jugular vein blood collection allowed withdrawal of almost 15% of the circulating blood volume at a time in less than 1 min. Hemolysis, hematocrit, and plasma
thrombin–antithrombin complexes (a marker of blood coagulation) were higher in samples collected from the tail vein than the jugular vein. Mice produced similar plasma corticosterone levels after serial blood collection by either method. Tail incision led to a slight but significant
increase in C-reactive protein levels. Using the jugular venipuncture technique, we then performed a pharmacokinetic study and an oral glucose tolerance test. Plasma concentrations of levofloxacin, an antimicrobial agent, were dose-dependently elevated after oral administration, and linear
increases in Cmax and AUC were observed. We also confirmed that overall glucose excursion is significantly decreased in mice treated with exendin 4, a glucagon-like peptide 1 agonist. These results indicate that the jugular venipuncture is a useful technique from the point of view
of no requirement for anesthetics, serial blood collection at short intervals, large volume of blood collection, quality of sample and animal welfare. This technique is of particular interest for studies that examine time-dependent changes in blood variables.
Research investigators often choose to euthanize mice by cervical dislocation (CD) when other methods would interfere with the aims of a research project. Others choose CD to assure death in mice treated with injected or inhaled euthanasia agents. CD was first approved for mouse euthanasia
in 1972 by the AVMA Panel on Euthanasia, although scientific assessment of its humaneness has been sparse. Here we compared 4 methods of spinal dislocation–3 targeting the cervical area (CD) and one the thoracic region–in regard to time to respiratory arrest in anesthetized mice.
Of the 81 mice that underwent CD by 1 of the 3 methods tested, 17 (21%) continued to breathe, and euthanasia was scored as unsuccessful. Postmortem radiography revealed cervical spinal lesions in 5 of the 17 cases of unsuccessful CD euthanasia. In addition, 63 of the 64 successfully euthanized
mice had radiographically visible lesions in the high cervical or atlantooccipital region. In addition, 50 of 64 (78%) mice euthanized successfully had radiographically visible thoracic or lumbar lesions or both. Intentionally creating a midthoracic dislocation in anesthetized mice failed
to induce respiratory arrest and death in any of the 18 mice subjected to that procedure. We conclude that CD of mice holds the potential for unsuccessful euthanasia, that anesthesia could be valuable for CD skills training and assessment, and that postmortem radiography has minimal promise
in quality-control assessments.
Sepsis research relies heavily on animal models. One of the most frequently used models, cecal ligation and puncture (CLP), involves surgery, and animal use committees may require the use of analgesics after CLP. However, some analgesics are im- munomodulatory and may affect research
outcomes. In addition, both septic inflammation and responses to opioids may vary with the sex of the subject. Therefore, we investigated the effects of buprenorphine in inbred mice of both sexes undergoing CLP. We hypothesized that buprenorphine would not significantly change the outcome
or patterns of inflammation in C57BL/6 mice after CLP. Male and female C57BL/6 mice underwent CLP surgery and were randomized into 2 groups to receive either buprenorphine or saline. Three-week survival studies were performed (n = 20 per group). Survival did not differ between groups
of female mice, but male mice that received buprenorphine had decreased survival compared with that of controls. Reducing the dose of buprenorphine in male mice ameliorated the difference in survival. To examine inflammation, mice (n = 10 per group) were euthanized at 12, 24, or 48
h after CLP. Cell counts and cytokines were measured in the blood and peritoneal lavage fluid. In female and male C57BL/6 mice, buprenorphine treatment resulted in few differences in inflammatory parameters, although peripheral neutrophil counts were decreased transiently in male mice. The
findings suggest that the effects of buprenorphine on sepsis models in C57BL/6 mice may be sex-specific. Consequently the use of analgesics must be assessed on a study-by-study basis, and investigators should define analgesic regimens when publishing sepsis studies.