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February 2005 1/05
Welcome to the first edition of the APVMA newsletter for 2005. The newsletter provides an important means for us to stay in touch with stakeholders. It is vital for us to maintain valuable communication links with you, to know of your issues and concerns and, in turn, to keep you abreast of developments at our end. Improving stakeholder interaction will continue to be a priority for the APVMA in 2005. Of particular importance in the year ahead will be continuing our efforts to strengthen the efficiency and effectiveness of what we do. We will also be focussing on finalising the implementation of recent legislative reforms such as data protection and major reforms in areas such as minor use. We will keep you up-to-date with progress in these various areas over the coming months.
Dr Joe Smith |
The LATEST
APVMA and Spray Drift Management
As many of you know, the APVMA has published a discussion paper (
PDF - 659KB) containing proposals for refining its approach to spray drift risk management.
Since then the APVMA has meet with a number of key agricultural organisations to discuss these proposals. It has also been gathering comment and new information to further refine the proposals.
Some 30 written submissions commenting on the proposals have been made by a range of industry and community groups. In October 2004, the APVMA took part in an international spray drift conference where useful new information and approaches to spray drift risk management were discussed.
On 16 and 17 February the APVMA hosted two major meetings on spray drift management. The first, a day of discussion of fundamental issues with State regulators followed the next day with a day-long spray drift forum with both industry, farmer and State representatives. The industry forum provided an opportunity for the APVMA to listen to and respond to industry concerns on its spray drift proposals. Over the next two months, the APVMA will refine its proposal paper drawing on the new industry comments as well as additional input from community and technical groups. The APVMA will make the new draft available for a final round of public consultation and comment before any final decisions are made.
Labelling review
As many of you know, the APVMA has been working on a review of product labelling principles. The aim is to develop product labels that are both clearer to users and more useful to States and Territories from a control of use perspective. Some basic principles have been established and the APVMA now has several example labels available in the proposed new format for consideration and comment from users, chemical suppliers and other interested groups.
Comments on the label concepts are sought by 15 April. The concepts can be found on the APVMA website at www.apvma.gov.au/registration/labels_review.shtml
Data Protection - application summaries
As part of the new data protection provisions the APVMA is required to publish a summary of an application shortly after the applicant has been notified that the application is to be assessed. The first batch of application summaries has now been published on the APVMA website.
Updates have also been made to documentation about data protection requirements and can be found at http://www.apvma.gov.au/registration/data_protection.shtml
Accessing information through the service centre
The APVMA has been trialing a new method for clients to access information and ask questions of the Registration Client Services (RCS) team.
This new online Service Centre will allow clients to
- browse and search APVMA information
- ask questions of the APVMA and attach documents to questions
- keep track of changes or updates to information that is accessed frequently
- keep a record of previous questions to the APVMA for future reference
- track the progress of the questions sent to the APVMA
- send automatic updates or cancel questions in progress
- provide feedback and suggest improvements to the information available through the Service Centre
Feedback on the Service Centre trial (complaints, compliments, suggestions for new content etc) is most welcome. If you have comments to make you can do so by contacting:
Dr Wendy Cooper
Acting Manager RCS
Phone (02) 6272 3081
Fax (02) 6272 5788
New Veterinary Residues Manager
Dr Bob Munro, BVSc (Hons) PhD has been recently appointed as the new Veterinary Residues Manager replacing Kerryn McDougall who is retiring later in 2005. Bob comes to the APVMA with a strong background in veterinary research, animal welfare and animal ethics and until recently as Principal Research Scientist at the Bureau of Rural Sciences at the Department of Agriculture, Fisheries and Forestry. Bob is a previous winner of the Sir Ian Clunies Ross Award for Veterinary Research from the Australian College of Veterinary Scientists and the AVA Akzo-Nobell International Veterinarian Award for Research in Veterinary Science
2004 Levy Audit results
Each year the APVMA conducts audits of registrants' product sales declarations. During the audit, sales declarations were checked against each company's financial records to ensure that they are accurate. In 2004 the audits focused on the declarations made to the APVMA by registrants for product sales that occurred during the 2002 calendar year.
The results of the 2004 audit program indicated that problems existed in 11 of the 20 companies audited. 30% of declarations audited were found to be fully accurate. 30% of companies audited materially understated their sales. Two companies were unable to provide documentation to support their declarations. The APVMA is in contact with these companies in relation to further action flowing from the audit result.
As has occurred in previous years the APVMA publishes the results of the levy audit. View a summary of the outcomes for individual companies.
For further information, contact Tony de la Fosse, Program Manager Corporate Services on 02 6272 5874.
NEW GUIDELINES AND ADVISORY DOCUMENTS
Revision of the Ag and Vet Requirements Series
This series of documents, developed to provide applicants with detailed advice on the information required for the registration process, was first published in 1997. The APVMA has made updates along the way and published these on the website. A comprehensive review of the entire series has never been undertaken previously. One of the outcomes of the fees review will be a redefinition of the existing 50 application categories. For this reason the APVMA is currently undertaking a complete review of the Ag and Vet Requiremens series. It is expected that the revision will be finalised in time for the proposed introduction of revised fees on 1 July 2005.
GMP Compliance of overseas veterinary chemical product manufacturers
New procedures commenced on 17 February to help assure the enduring GMP compliance of overseas veterinary chemical manufacturers. Details of the scheme (including links to the APVMA Gazette) can be found at http://www.apvma.gov.au/qa/gmp_overseas.shtml. Conditions of product registration will require registrants to keep records to demonstrate GMP compliance. Conditions will be added to new veterinary chemical product registrations and through a review of existing veterinary chemical product registrations. The APVMA will audit such records over the life of the product.
Revised 'Code of Good Manufacturing Practice for Veterinary Chemical Products' and 'APVMA Manufacturing Principles'
A joint APVMA-industry working group met during 2004 to develop revisions to the Code and the Manufacturing Principles. The APVMA expects to release drafts of revised documents to licensed manufacturers in March for a consultation period prior to development of a consultation Regulation Impact Statement.
Quality Scheme for Agricultural Active Constituents and Agricultural Products
Most re-considerations of existing product registrations and active approvals as part of this scheme were finalised in December 2004. The APVMA has visited some companies to discuss the types of records that need to be kept to ensure compliance in any future audits conducted by the APVMA. Further similar visits and data call-ins are planned in the next few months
Comments sought on draft VICH guidelines
Two new VICH draft guidelines have been released for comment. The draft guidelines are available via our veterinary guidelines page on the APVMA website. Comments should be sent to the APVMA by 1 May 2005. VICH is an international body responsible for developing data guidelines for international use. The Australian Government and industry have made significant contributions to the development of a number of guidelines, all of which are available on the APVMA website.
MINOR USE HAPPENING
Minor use communications strategy
Growcom, a peak agricultural industry body, has developed a minor use communications strategy designed to improve future communication, to ensure coordinated and consistent information about minor use matters and, in turn, to engender widespread understanding and application throughout industry. The Department of Agriculture, Fisheries and Forestry and the Minor Use Taskforce requested Growcom to prepare the strategy based on a review of existing communication methods and the consideration of options on how these could be improved. Input to the strategy was received from the Communications Working Group and stakeholders.
(At the minor use workshop held in November 2003, a Minor Use Taskforce was established to provide input into the minor use reform agenda. The Communication Working Group is a sub-committee of the taskforce formed to identify areas requiring improvement and suggest effective and practical solutions to enhance communication between stakeholders on minor use issues.)
View a copy of the Minor Use Communications Strategy. ( PDF - 2.31MB)
Use of pesticides for minor uses in grains project
APVMA staff met with the project team on 15 December 2004, to discuss objectives of a Grains Research and Development Corporation funded initiative to build on identifying and managing access to a broad range of pest management solutions for the Australian grains industry.
The project team will be canvassing the views of manufacturers, advisors, peak bodies, regulators, growers and other co-operators to identify critical pest problems, minor use chemical needs and determine regulator requirements prior to establishing priorities for future projects.
As part of this process the project team currently wants feedback from grain industry value chain participants and have established an interactive web site to gather input data and provide feedback on all aspects of the project.
Further details on the project and other minor use developments are also available in the December 2004 edition of Minor Use News, that can be found at: http://www.apvma.gov.au/minor_use/minor_use_news.shtml
CHEMICAL REVIEW NEWS
Benomyl review terminated
The registration of the only benomyl product and approval of the benomyl active constituent were cancelled at the request of the registrant in December 2004. As a consequence, the review of benomyl has been discontinued.
Review of carbon disulfide
The APVMA, at the request of the registrant, cancelled the registration of the grain fumigant in December 2004. The review for the remaining product, a pig poison, is still ongoing. A final report is expected to be released in mid 2005.
Improvement to chemical review communication with stakeholders
Work is underway to update the chemical review section of the APVMA website. A table showing the status of current reviews, similar to the one below, will be available on the APVMA website in the near future.
PESTICIDE REVIEWS STATUS (10 Feb 2005)
| Chemical | Stage of review completed current . | Reason for review | |||
| a | b | c | d | ||
| 2,4-D | T,O,Env, (R-tba) | ||||
| CCA, As2O3 | T,O,Env | ||||
| Atrazine | T,E | ||||
| Azinphos-methyl | T,O,R, Env | ||||
| Carbaryl | T,R | ||||
| Carbon disulfide | T,O,R | ||||
| Chlorpyrifos | T,R, Env | ||||
| Diazinon (Pest) | T,O,R, Env | ||||
| Dichlorvos | T,R,O | ||||
| Dimethoate | T,O,R, Tr | ||||
| Diquat | T,O,R, Env | ||||
| Diuron | T, Env | ||||
| Endosulfan | T,O,R, Env, Tr | ||||
| Fenamiphos | T,O,R, Env | ||||
| Fenitrothion | O, Env | ||||
| Fenthion (non-Food) | T,O, Env | ||||
| Fenthion (food) | R | ||||
| Maldison | T,O,C | ||||
| Methamidophos | T, (R-tba) | ||||
| Methidathion | T, (R-tba) | ||||
| Methiocarb | T,O,R, Env | ||||
| Molinate | T, Env | ||||
| Omethoate | T,O,R, Tr | ||||
| Paraquat | T,O,R, Env | ||||
| Parathion methyl | T,O,R, Env | ||||
| Procymidone | T,O,R, Tr | ||||
| Sodium F (1080) | Env | ||||
Review stages |
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Codes for reasons |
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a |
Initiation of review, scope document released for public comment |
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T - toxicology O - OH&S R - residues C - chemistry Env - environment Tr - trade |
b |
Data assessment |
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c |
Release of report of preliminary review findings for public consultation |
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d |
Finalisation of regulatory outcomes |
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VETERINARY REVIEWS STATUS (10 Feb 2005)
| Chemical | Stage of review completed current . | Reason for review | |||
| a | b | c | d | ||
| Chlorfenvinfos | T,O,R,Env | ||||
| Diazinon (Vet) | O | ||||
| Dimetridazole | T,O,R | ||||
| Fipronil | T,O, An | ||||
| Macrolides | PH, Eff | ||||
| Propetamphos | tba | ||||
| Sheep ectos | O,Env | ||||
| Temephos | O,Env | ||||
| Virginiamycin | PH, Eff | ||||
Review stages |
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Codes for reasons |
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a |
Initiation of review, scope document released for public comment |
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T - toxicology O - OH&S R - residues Env - environment Eff - efficacy PH - public health An - animal safety |
b |
Data assessment |
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c |
Release of report of preliminary review findings for public consultation |
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d |
Finalisation of regulatory outcomes |
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New on the APVMA website
Application summaries: http://www.apvma.gov.au/data_protection/appl_summaries.shtml
New concept for labels http://www.apvma.gov.au/registration/labels_review.shtml
Feb version of Approved Actives:http://www.apvma.gov.au/actives/aubpage_actives.shtml
Minor updates to data protection information (especially datalists information) http://www.apvma.gov.au/registration/DP_appreqs.shtml
Vet Guidelines previously only available to request (eg no 7,9,10,24, 25) progressively being added to list on website: http//www.apvma.gov.au/guidelines/vetguidelines.shtml
Overseas GMP scheme http://www.apvma.gov.au/qa/gmp_overseas.shtml
Two new VICH draft veterinary guidelines released for comment with background information - see http://www.apvma.gov.au/guidelines/vetguidelines.shtml
Mid January list of recent permits http://www.apvma.gov.au/minor_use/minor_use_news_05Jan_mid.shtml
February MRL standard http://www.apvma.gov.au/residues/mrl_standard.shtml
Updates to forms, templates and instructions for product applications and the data protection implications : see http://www.apvma.gov.au/forms/subpage_forms.shtml
Those with an interest in Data Protection should watch http://www.apvma.gov.au/registration/data_protection.shtml
January edition of Minor Use News http://www.apvma.gov.au/minor_use/minor_use_news_05Jan.shtml
MRL Standard, January 2005 http://www.apvma.gov.au/residues/mrl_standard.shtml
Update legislation http://www.apvma.gov.au/about_us/legislat.shtml
Guidelines for Registration of Biological Agricultural Products - revised edition http://www.apvma.gov.au/guidelines/bioagprod.pdf
Issue 4 of the Community eBulletin