Regulations and Standards

Final Version of the New Guide for the Care and Use of Laboratory Animals Now Available
The final version of the 8th edition of the Guide for the Care and Use of Laboratory Animals is now available online from the National Academies Press at www.nap.edu.

A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references.

It is organized around major components of animal use:

• Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals.
• Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee.
• Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more.
• Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management.The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia.
• Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs.

The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.

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FDA To Update 1978 Good Laboratory Practice Regulation On 21 December 2010, in an effort to update its 1978 Good Laboratory Practice (GLP) regulations, the Food and Drug Administration (FDA) asked the public whether to amend these regulations in order to achieve a GLP quality system for all facilities and laboratories, update, and more completely address the conduct of nonclinical studies under the GLP regulation.¹

We describe this topic in some detail here, because of its intrinsic significance to FDA studies involving animals and those who conduct them, and their potential influence on future regulations by other government and state agencies on the care and use of laboratory animals.

As in other articles in this column, texts below is copied liberally, summarized, or interpreted as faithfully to the original texts they reference as possible. In its announcement, the FDA described its plan to update its GLP regulation as follows:

1.GLP Quality System
Include in the regulations a core set of essential elements for a GLP quality system such as internationally recognized standard,Quality management systems–Requirements ISO 9001, (http://www.iso.org/iso/home.html), that will include management responsibility for all activities at the facility and specifying a requirement for standard operating procedures for all essential functions.

2.Multisite Studies
Expand the GLP regulations applicable to the conduct of all aspects/phases of a study in a single facility to describe personnel and study aspects in studies conducted in multiple site, e.g., by requiring that an individual be designated as the responsible person for each site of a multi site study. Such an individual would be responsible for any phase(s) of the study conducted at the site and would report to the study director.

3. Electronic/Computerized Systems
Update the regulation to reflect the use of new electronic and computerized systems, because—while not excluding them from current regulations, they are currently more consistent with paper-based systems (e.g., an individual as archivist Sec. 58.190(c));maintenance of copies of study protocols and the Master Schedule by the quality assurance unit (Sec. 58.35(b)(1) and (b)(2))).

4. Sponsor Responsibilities
Include additional specific responsibilities of sponsors of nonclinical laboratory studies, such as development and/or approval of study protocols, even when conducted at contracted facilities.

5. Documentation of Compliance with Animal Welfare
Determine whether and how to receive documentation of compliance with provisions of the US Animal Welfare Act (7U.S.C 2131-2159) or comparable international standards governing the ethical and humane use of laboratory animals in nonclinical laboratory studies.

6. Information on Quality Assurance Inspectional Findings
Require quality assurance units to prepare and maintain yearly summaries of general inspection findings that would reveal problems detected and recommendations made to management to resolve them. Aval such reports to FDA upon request during bioresearch monitoring inspections.

7. Process-Based Systems Inspections
Permit a combination of systems inspections and study-specific inspections, instead of study-specific inspections only.The results of the appropriate systems inspection(s)would be referenced in the study-specific inspection reports relevant to those aspects of the procedures for the study under inspection.

8.Test and Control Article Information
Add under the Sec. 58.105 on test and control characterization, and under Sec. 58.113 on mixtures of articles with carriers, information not currently required about time frames for providing basic information on test articles, such as their strength, purity, stability, and for mixtures thereof, their concentration and uniformity.

9. Sample Storage Container Retention
Eliminate the requirement at Sec. 58.105(c) for maintaining test article storage containers for the duration of the study (21CFR58.105(c)), because information required by the existing requirements for handling of tests and control articles—which include documentation of receipt, distribution, and use of each batch (Sec. 58.107(d))—are adequate.