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Good Laboratory Practice Considerations in the Use of Fish Models

Experimental Pathology Laboratories, Inc, Sterling, Virginia 20166? jwolfepl{at}aol.com

Marilyn J. Wolfe

Experimental Pathology Laboratories, Inc, Sterling, Virginia 20166

In the late 1970's, Good Laboratory Practice Regulations (GLP) were instituted by agencies such as the USFDA, the USEPA, and the OECD to provide a system for the monitoring of animal studies submitted in support of the safety of regulated products. Although GLP regulations are regularly employed in laboratory mammal projects, they have been comparatively under-utilized in aquatic animal research. This situation is changing due to the continuing emergence of fish as toxicological and pharmaceutical test subjects, human and animal disease models, genetically-engineered food sources, and environmental sentinels. The application of GLP principles to aquatic animal studies poses a variety of challenges, especially in the areas of Study Protocol design and the creation of Standard Operating Procedures (SOP's). This presentation will highlight differences between mammalian and fish studies in the application of GLP principles, and identify specific concerns associated with the formulation of SOP's for fish projects.

Key Words: Good laboratory practices • quality assurance • aquatic toxicology • fishes • medaka • zebrafish • rainbow trout • EPA • FDA • OECD.

References

• Astm (1996). Standard Guide for Conducting Acute Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and Amphibians. ASTM Designation E 729-96, West Conshohocken, Pennsylvania.
• Busey WM, Runge P. (1992). Good laboratory practice regulations: The need for compliance. In: Food Safety Assessment, Finley JW, Robinson SF, Armstrong DJ (eds). American Chemical Society, ACS Symposium Series No 484, pp 115—119.
• DiGiulio N., Malloy AV (1995). Good laboratory practices. In: Fundamentals of Aquatic Toxicology: Effects, Environmental Fate, and Risk Assessment, 2nd ed, Rand GM (ed). Taylor and Francis, Philadelphia, Pennsylvania, pp 345—370.
• EPA (1998). Federal insecticide, fungicide and rodenticide act (FIFRA) Good laboratory practice standards. 40 CFR Part 160 (OPP-300165A:FRL-3518-2), RIN 2070-AB68, Revised as of July 1, 1998.
• Hein MM (1996). Why GLP's. Standard Operating Press 2(2): 1—6.
• Matthews M., Trevarrow B., Matthews J. (2002). A virtual tour of the Guide for zebrafish users. Lab Animal 31(3): 34—40.[Medline] [Order article via Infotrieve]
• McCann JA (1988). Quality assurance for ecotoxicology studies. In: Good Laboratory Practices, an Agrochemical Perspective, Garner WY, Barge MS (eds). ACS Symposium Series 369, American Chemical Society, Washington DC, pp 131—138.
• Ostrander G. (2000). The Laboratory Fish. Academic Press, San Diego.

Toxicologic Pathology, Vol. 31, No. 1 suppl, 53-57 (2003)
DOI: 10.1080/01926230390178739


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This Article Abstract Free Full Text (Free PDF) Free Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Wolf, J. C. Articles by Wolfe, M. J. Search for Related Content PubMed PubMed Citation Articles by Wolf, J. C. Articles by Wolfe, M. J. Social Bookmarking                         What's this?