How do you establish a witholding period for a drug for use in aquaculture?

This is a simple and well-laid out experiment to produce the data needed by licensing authorities to test for the safety of using antibiotics in fish. Here they were able to establish a 500 degree day witholding period for florfenicol in rainbow trout.

 

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Journal of Fish Diseases
  Volume 36, Number 8 (August 2013)
     Florfenicol depletion in edible tissue of rainbow trout, Oncorhynchus mykiss(Walbaum), and sea bream, Sparus aurataL.
   Authors: A Di Salvo, G della Rocca, E Terzetti, J Malvisi
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   Source: Journal of Fish Diseases, Volume 36, Number 8 (August 2013)
   Page Numbers: 685 – 693
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   Abstract: An increase in fish production has consequently brought an increase in infectious diseases in fish farms. The use of chemotherapic drugs is the most effective instrument against common bacterial agents. The number of registered drugs for use in aquaculture is limited and often veterinary practitioners resort to the off-label use of chemotherapic agents authorized for different food-producing animal species. Florfenicol is well known for its outstanding effect against various pathogenic bacteria affecting fish, and therefore, it may be a useful drug for off-label use in aquaculture. The aim of this study was to evaluate the depletion of florfenicol and its major metabolite, florfenicol amine, from the edible tissue of two fish species, rainbow trout and sea bream, following treatment with medicated feed at a dosage of 10 mg kg-1of bw day-1, for 10 consecutive days. At prefixed time points after the end of administration (0.25, 1, 2, 3, 4, 6, 7, 10, 14 and 21 days after treatment), edible tissues (muscle plus adherent skin) from 15 individuals in each group were collected and analysed by HPLC, to determine concentration of the drug in the tissue. On the basis of the obtained concentrations, withdrawal times of florfenicol in the two species were calculated. The results indicate that a drug withdrawal time of 500 °C-day, as established by Directive 2004/28/EC, for off-label drug use is more than satisfactory to guarantee the healthiness of fish products against the risk of drug residues.
   Citation: A Di Salvo, G della Rocca, E Terzetti, J Malvisi . Florfenicol depletion in edible tissue of rainbow trout, Oncorhynchus mykiss(Walbaum), and sea bream, Sparus aurataL.. Journal of Fish Diseases, Volume 36, Number 8 (August 2013), pp. 685-693, <http://ejournals.ebsco.com/direct.asp?ArticleID=486D87E380E1F12864A6&gt;
   URL: http://ejournals.ebsco.com/direct.asp?ArticleID=486D87E380E1F12864A6

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