By United States. Food and Drug Administration

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J. Alderman scientifically based reasons for any refusal. Alternately, parallel applications may be made simultaneously to several MS, once the first MS approves the others have 90 days to accept or produce cogent scientific reasons why they will not. New applications are required for changes in active ingredient, addition or change of indication or target species, change of MRL or change of withdrawal period 11. CONCLUSIONS In 1998 we are at an intermediate stage in the development of a common legislatory framework for the control of all aspects of veterinary medicines within the ED.

Department of Health and Human Services, 1997, Guidance for Industry #6, FDA Approval of Animal Drugs for Minor Uses and for Minor Species. Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD. S. Office of the Federal Register, 1998, Good Laboratory Practice for Nonc1inical Laboratory Studies. S. C. S. Office of the Federal Register, 1998, Tolerances for Residues of New Animal Drugs in Food. S. C. 3 REQUIREMENTS FOR THE APPROVAL OF VETERINARY THERAPEUTICS OR GROWTH ENHANCERS USED IN FISH PRODUCTION European Union David 1.

Barron and K. B. 2. Fish Metabolism Study The objective of the fish metabolism study is to determine the metabolic fate of an aquatic-use pesticide in fish. This study is categorized as a "nature/magnitude of residue study" under FIFRA. A fish metabolism study quantifies the parent chemical and metabolites in fish at exposure concentrations greater than the maximum-proposed use rate (EPA, 1996b). Study data are intended to be used in dietary risk assessments and to establish acceptable residue levels (tolerances) for enforcement purposes.

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