Dimetridazole Review
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Final Review Report and Regulatory Decision Australian Pesticides & Veterinary Medicines Authority The reconsideration of registrations of products containing dimetridazole and their associated approved labels 28 June 2007 © Australian Pesticides and Veterinary Medicines Authority 2007 This work is copyright. Apart from any use permitted under the Copyright Act 1968, no part may be reproduced without permission from the Australian Pesticides and Veterinary Medicines Authority. ISSN 1448-1553 This review findings report for dimetridazole is published by the Australian Pesticides and Veterinary Medicines Authority. For further information about this review or the Veterinary Medicines Review Program, contact: Manager, Veterinary Medicines Review Australian Pesticides and Veterinary Medicines Authority PO Box E240 Kingston ACT 2604 Australia Telephone: 61 2 6210 4765 Fax: 61 2 6210 4776 Email: [email protected] APMVA web site: http://www.apvma.gov.au Review of Dimetridazole Final Review Report and Regulatory Decision FOREWORD The Australian Pesticides and Veterinary Medicines Authority (APVMA) is an independent statutory authority with responsibility for the regulation of agricultural and veterinary chemicals in Australia. Its statutory powers are provided in the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code). The APVMA can reconsider the approval of active constituents, the registration of chemical products or the approval of labels for containers of chemical products at any time. This is outlined in Part 2, Division 4 of the Agvet Code. The basis for the reconsideration is whether the APVMA is satisfied that continued use of products containing dimetridazole in accordance with the instructions for their use: • would not be an undue hazard to the safety of people exposed to them during their handling • would not be likely to have an effect that is harmful to human beings. The APVMA also considered whether the use of products containing dimetridazole in accordance with the instructions for use that the APVMA has approved would be effective according to the criteria demanded by the APVMA for the products. The requirement for continued approval of a label for containers for a chemical product is that the label contains adequate instructions. Such instructions include: • the circumstances in which the product should be used • how the product should be used • times when the product should be used • frequency of the use of the product • the withholding period after the use of the product • disposal of the product and its container • safe handling of the product. A reconsideration may be initiated when new research or evidence has raised concerns about the use or safety of a particular chemical, a product or its label. The process for reconsideration includes a call for information from a variety of sources, a review of that information, and following public consultation, a decision about the future use of the chemical or product. In undertaking reviews, the APVMA works in close cooperation with advisory agencies including the Office of Chemical Safety (OCS), the Department of Environment and Water Resources, and state departments of agriculture as well as other expert advisors as appropriate. The APVMA has a policy of encouraging openness and transparency in its activities and community involvement in decision-making. The publication of review reports is part of that process. Page i of xiv Review of Dimetridazole Final Review Report and Regulatory Decision The APVMA also makes these reports available to the regulatory agencies of other countries as part of bilateral agreements or as part of the Organisation for Economic Cooperation and Development (OECD) ad hoc exchange program. Under this program it is proposed that countries receiving these reports will not utilise them for registration purposes unless they are also provided with the original data from the relevant applicant. This document, The reconsideration of registrations of products containing dimetridazole and approvals of their associated labels: Final Review Report and Regulatory Decision, relates to all products containing dimetridazole that were nominated for review by the APVMA. The review’s findings and regulatory decision are based on information collected from a variety of sources, including data packages and information submitted by the registrants, information submitted by members of the public including users/industry groups and government organisations, and literature searches. The information and technical data required by the APVMA to review the safety of both new and existing chemical products must be derived according to accepted scientific principles, as must the methods of assessment undertaken. The Final Review Report and Regulatory Decision is available from the APVMA website: http://www.apvma.gov.au/chemrev/chemrev.html. Page ii of xiv Review of Dimetridazole Final Review Report and Regulatory Decision GLOSSARY Time Weight d day bw body weight h hour g gram min minute kg kilogram mo month µg microgram wk week mg milligram s second ng nanogram yr year wt weight Length Dosing cm centimetre id intradermal m metre im intramuscular μm micrometre inh inhalation mm millimetre ip intraperitoneal nm nanometre iv intravenous po oral sc subcutaneous mg/kg bw/d mg/kg bodyweight/day w/w weight/weight Volume Concentration L litre M Molar mL millilitre ppb parts per billion μL microlitre ppm parts per million Chemistry HPLC High Pressure Liquid Chromatography Terminology ADI Acceptable Daily Intake Agvet Code Agricultural and Veterinary Chemicals Code Act 1994 ARfD Acute Reference Dose LOD Limit of Detection LOQ Limit of Quantitation LOEL Lowest Observed Effect Level MRL Maximum Residue Limit NOEL No Observed Effect Level OHS Occupational Health and Safety SD Sprague Dawley WHP Withholding period Page iii of xiv Review of Dimetridazole Final Review Report and Regulatory Decision Organisations & publications APVMA Australian Pesticides and Veterinary Medicines Authority (previously NRA) EMEA European Agency for the Evaluation of Medicinal Products EU European Union FAO Food and Agriculture Organization (of the United Nations) FAISD Handbook Handbook of First Aid Instructions and Safety Directions JECFA FAO/WHO Joint Expert Committee on Food Additives NHMRC National Health and Medical Research Council NOHSC National Occupational Health and Safety Commission NRA National Registration Authority for Agricultural and Veterinary Chemicals (now APVMA) OCS Office of Chemical Safety OECD Organisation for Economic Cooperation and Development PACC Australian Pesticides and Agricultural Chemicals Committee PACSC Pesticides and Agricultural Chemicals Standing Committee of the NHMRC SUSDP Standard for the Uniform Scheduling of Drugs and Poisons US EPA United States Environmental Protection Agency USFDA United States Food and Drug Administration WHO World Health Organization Poultry industry terminology Breeder chicken hen Alternate term for female broiler breeder Breeder hen Refers either to a breeder chicken hen or breeder turkey hen Breeder turkey hen Alternate term for female turkey breeder Breeder poultry Refers in this document only to broiler breeder, layer breeders and turkey breeders Broiler chicken Young chicken fattened to produce meat for human consumption Broiler breeder Chicken hen that lays fertilised eggs from which chickens for fattening are hatched. Males fertilise the eggs. Broiler/Grower Young turkey fattened to produce meat for human consumption (meat) turkey Chicken layer hen Chicken that produces table eggs for human consumption Layer breeder Chicken hen that lays fertilised eggs from which chickens reared for table egg production are hatched. Males fertilise the eggs. Poultry Collective term representing birds that produce meat and eggs for human consumption Replacement pullet Immature male or female chicken. Females are reared to produce table eggs for human consumption or fertilised eggs for hatching Replacement poult Immature male or female turkey. Females are reared to produce table eggs for human consumption or fertilised eggs for hatching Squab Young pigeon reared for meat production for human consumption Turkey breeder Turkey hen that lays fertilised eggs from which turkeys for fattening are hatched. Males (toms) fertilise the eggs. Turkey layer hen Turkey that produces table eggs for human consumption Page iv of xiv Review of Dimetridazole Final Review Report and Regulatory Decision CONTENTS FOREWORD ................................................................................................................... I GLOSSARY................................................................................................................... III EXECUTIVE SUMMARY...............................................................................................IX Introduction............................................................................................................ix Public submissions................................................................................................ix Registrants’ submissions.......................................................................................ix Toxicology assessment ..........................................................................................x Occupational health and safety assessment.........................................................xi Residues assessment ...........................................................................................xi