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FENTHION PRELIMINARY REVIEW FINDINGS for PART 2: Food Producing Uses and Revised OHS Recommendations for PART 1: Non-Food Producing Uses

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FENTHION PRELIMINARY REVIEW FINDINGS for PART 2: Food Producing Uses and Revised OHS Recommendations for PART 1: Non-Food Producing Uses FENTHION PRELIMINARY REVIEW FINDINGS for PART 2: Food producing uses and revised OHS recommendations for PART 1: non-food producing uses MAY 2014 © Australian Pesticides and Veterinary Medicines Authority 2014 ISBN: 978-1-922188-65-6 (electronic) Ownership of intellectual property rights in this publication Unless otherwise noted, copyright (and any other intellectual property rights, if any) in this publication is owned by the Australian Pesticides and Veterinary Medicines Authority (APVMA). Creative Commons licence With the exception of the Coat of Arms and other elements specifically identified, this publication is licensed under a Creative Commons Attribution 3.0 Australia Licence. This is a standard form agreement that allows you to copy, distribute, transmit and adapt this publication provided that you attribute the work. A summary of the licence terms is available from www.creativecommons.org/licenses/by/3.0/au/deed.en. The full licence terms are available from www.creativecommons.org/licenses/by/3.0/au/legalcode. The APVMA’s preference is that you attribute this publication (and any approved material sourced from it) using the following wording: Source: Licensed from the Australian Pesticides and Veterinary Medicines Authority (APVMA) under a Creative Commons Attribution 3.0 Australia Licence. In referencing this document the Australian Pesticides and Veterinary Medicines Authority should be cited as author, publisher and copyright owner. Use of the Coat of Arms The terms under which the Coat of Arms can be used are set out on the Department of the Prime Minister and Cabinet website (see www.dpmc.gov.au/guidelines). Disclaimer The material in or linking from this report may contain the views or recommendations of third parties. Third party material does not necessarily reflect the views of the APVMA, or indicate a commitment to a particular course of action. There may be links in this document that will transfer you to external websites. The APVMA does not have responsibility for these websites, nor does linking to or from this document constitute any form of endorsement. The APVMA is not responsible for any errors, omissions or matters of interpretation in any third-party information contained within this document. This publication is available from the APVMA website: www.apvma.gov.au. Comments and enquiries: Manager, Public Affairs Australian Pesticides & Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Australia Telephone: +61 2 6210 4701 Email: [email protected] ii FENTHION – PRELIMINARY REVIEW FINDINGS 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 Agvet Codes scheduled to the Agricultural and Veterinary Chemicals Code Act 1994. The APVMA has legislated powers to reconsider the approval of an active constituent, registration of a chemical product or approval of a label at any time after it has been registered. The reconsideration process is outlined in sections 29 to 34 of Part 2, Division 4 of the Agvet Codes. A reconsideration may be initiated when new research or evidence has raised concerns about the use or safety of a particular chemical, a product containing that chemical, or its label. The reconsideration process (illustrated in Figure 1) 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. The information and technical data required by the APVMA to review the safety of both new and existing chemical products must be generated according to scientific principles. The APVMA conducts science and evidence-based risk analysis with respect to the matters of concern, analysing all the relevant information and data available. In undertaking reconsiderations, the APVMA works in close cooperation with advisory agencies including the Office of Chemical Safety within the Department of Health, Food Standards Australia New Zealand (FSANZ), the Department of the Environment and the state departments of agriculture, as well as other expert advisers as appropriate. The APVMA makes these reports available to the regulatory agencies of other countries as part of bilateral agreements. The APVMA recommends that countries receiving these reports will not utilise them for registration purposes unless they have access to the raw data from the relevant applicant. FOREWORD iii Figure 1: Chemical reconsideration process 1. Nomination. Any person or group (including the APVMA and its 1. Nomination partner agencies) may nominate an active constituent, product or label for reconsideration, including the reasons and any supporting information. 2. Prioritisation 2. Prioritisation. The APVMA (with input from its advisory agencies) determines whether a reconsideration is warranted and determines the priority for the reconsideration. 3. Scoping 3. Scoping and Work Plan. A scope document is prepared that outlines the areas of concern which may include toxicology, occupational health and safety, residues and dietary risk, risks to international trade, environmental risks and efficacy. From 01 July 2014 4. Notice of the APVMA is also required to publish a work plan for new Reconsideration reconsiderations to provide predictability about the timeframe for the reconsideration. 5. Assessment 4. Notice of Reconsideration. To begin a reconsideration, the APVMA gives each holder a written Notice of Reconsideration that invites the holder to make a written submission to the APVMA and may also publish the Notice and the Scope for public comment. 6. 5. Toxicology Assessment 5. Environment risk assessment Office of Chemical Safety The Department of the conducts the toxicology Environment conducts the assessment and sets public health environmental risk assessment, 7. standards for exposure to the including consideration of the chemical, determines whether the potential hazards and the likely active constituent can be exposures resulting from their use supported and recommends first of the chemical or products. The aid directions, scheduling and any resulting risk characterisation 8. necessary warnings for product determines whether or not the risk labels. is acceptable and whether or not any risks may be mitigated by appropriate label advice or other action. 9. iv FENTHION – PRELIMINARY REVIEW FINDINGS 1. Human exposure Residues and dietary exposure risk assessment: Toxicology assessment (includes trade): assessment findings are used Toxicology assessment findings and 2. in the Occupational Health available residues data are used in the and Safety (Human exposure residues and dietary exposure risk assessment) conducted by the assessment (APVMA). This assessment OCS. This assessment recommends withholding periods, MRLs recommends safety directions, and restraints for all use patterns 3. re-entry periods and restraints supported by this assessment. It also for all the uses supported by considers the potential trade risks arising the assessment. from all the supported uses of products. Efficacy: If included in the scope of the review efficacy assessments are 4. conducted by the APVMA. Further data. During the assessments the APVMA may be advised that additional data or information is required for the assessments and may 5. Assessment (continued) issue a notice requiring the holders to provide this data within the due date. Interim Regulatory Action At any time during a reconsideration, the APVMA may take regulatory action to mitigate any risks identified in 6. Draft Regulatory relation to the use of a chemical. The aim of any such action is to protect Measure human health or the environment (or both) while a final decision is being reached through the reconsideration process. 6. Draft Regulatory measure (Preliminary Review Findings PRF) The 7. Consultation APVMA considers all the assessments and develops draft recommendations for the reconsideration which summarise the results of the assessment, identified risks, risk mitigation measures, proposed review findings and draft regulatory decisions. The PRF and the assessment 8. Regulatory reports provided by the advisory agencies are released for public Decision consultation. 7. Consultation. Further data or information may be submitted to the APVMA from a range of stakeholders including holders, users of the 9. Implementation chemicals, peak industry bodies, interest groups, non-government organisations, state and territory governments and the public. FOREWORD v 1. 8. Regulatory decision. After the public consultation period has closed, the APVMA assesses all the comments received and amends the assessment, review findings and the proposed regulatory measures as necessary. We then make the final regulatory decision. 2. There are three possible regulatory outcomes from a reconsideration: affirm the approvals or registrations vary the relevant particulars or conditions and affirm the approval or 3. registration, or suspend or cancel the approval or registration. The APVMA will affirm the approval or registration only if satisfied that it meets all safety, efficacy, trade and labelling criteria and also complies with 4. all requirements in the regulations If the active constituent, product or label does not meets the criteria as described above, the APVMA will examine whether the relevant particulars or conditions of the approval or registration can
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