Assessing Environmental Impacts of Veterinary Products: Lessons from VICH
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Assessing Environmental Impacts of Veterinary Products: Lessons From VICH
Joseph A. Robinson, PhD Research Fellow and Group Leader, Metabolism, Pharmacokinetics, and Environmental Safety— Development, Pfizer Animal Health, Kalamazoo, Michigan
Key Words Veterinary drugs; Veterinary medicinal pharmaceuticals (VMPs); Harmonization; VICH; Environmental impact assessment (EIA); Phase I; Phase II; Ecotoxicity testing; Predicted environmental concentrations (PECs) Correspondence Address Joseph A. Robinson, Pfizer Animal Health, Veterinary Medicines Research and Development, Laboratory Sciences—Metabolism and Safety, B300-3-302.3, Kalamazoo, MI 49001 (e-mail [email protected]).
In 1996, the Steering Committee of the VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products)1 selected ecotoxicity as one of the five initial topics2 for harmonization under this joint government-industry program. This topic was selected for harmonization by the principal parties to VICH (viz., European Union, United States, and Japan) because of the gulf in drug registration requirements that existed among these regions at the time. A working group (VICH Ecotox Working Group or VICH EWG) was formed in 1997 to develop harmonized guidelines, taking into account any existing guidance documents and legislative/ regulatory requirements. The VICH EWG included representatives from industry and regulatory authorities from the European Union, United States, Japan, Australia, New Zealand, and Canada. The VICH EWG held nine faceto-face meetings over a 7-year period that ended in 2004. The task of developing the guidelines was split into two phases: phase I and phase II. For drugs that qualify for a VICH phase I assessment only, environmental fate and effects data are not required for evaluation of the potential risk of drug residues on nontarget species in the environment. For products that require a full assessment (VICH phase II), environmental fate and effects study data are required to assess the potential impact of veterinary drug residues (parent and metabolites, in certain situations) on nontarget species in aquatic and terrestrial ecosystems. A phase II assessment of a given veterinary drug residue includes studies of (1) physicochemical properties (eg, water solubility, octanol/water partitioning), (2) binding to soils, (3) biodegradation in soil or aquatic test systems, and (4) effects of the drug residue on select aquatic (algae, daphnia, fish) and terrestrial species (soil microflora, plants, earthworms, and possibly dung beetles and flies). The studies recommended for a phase II assessment are to be done in accordance with
Organization for Economic Cooperation and Development (OECD) protocols (found at www.oecdwash.org/PUBS/PERIOD/per-chem ical.htm). Alternatively, International Organisation for Standardization (ISO) protocols (found at www.iso.ch/iso/en/CatalogueListPage .CatalogueList) are used if final OECD protocols do not exist. Whether these studies are to be done
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