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This April edition of the Newsletter comes at a time when the APVMA is working hard to implement a number of important recent changes to its governing legislation. Registrants will no doubt by now be becoming increasingly familiar with the new requirements associated with the data protection legislation which took effect from 1 January this year. A key focus for us now is to ensure everything is in readiness for the implementation of the changes to the APVMA cost recovery framework from 1 July, following the passage of the legislation in March. There is much to be done and, as we go forward with this, we will continue to consult extensively with those that are impacted by the changes. Our finance area is communicating directly with companies to ensure everyone is clear on what needs to be done. In addition we are completing a major revision of all of our guidelines and requirements manuals to reflect the new categories/modules structure and to provide applicants with up-to-date, clear and comprehensive information on what they need to do when submitting an application to the APVMA. We have been consulting with stakeholders in preparing the draft documents (which are now on the website for public comment), and propose to hold a series of seminars on them by mid-year. Keep an eye out for them. Much has been said in the debate that has occurred around the new fees legislation. From the APVMA's part, we look forward to working to address issues that have been raised, to keeping a strong focus on delivering effective regulation of pesticides and veterinary medicines in the interests of all stakeholders, and doing that as efficiently as possible. Dr Joe Smith |
THE LATEST
NEW COST RECOVERY ARRANGEMENTS
The legislation covering the APVMA's new fee structure for the APVMA received Royal Assent passing into law on 1 April 2005. The APVMA is currently assisting with finalising the accompanying Regulations. Full details on the new arrangements are contained in the final Cost Recovery Impact Statement that is available on the APVMA website. The APVMA's Finance Section will be communicating further with stakeholders to ensure everyone is aware of the new framework and its implementation. More information is available.
The new application fee categories are scheduled to commence for applications made to the APVMA from Friday 1 July 2005.
Under the new structure, there is no longer a 'Registration Renewal Fee'. However, the new Annual Fee is due for payment by 30 June 2005. Payment of the $390 Annual Fee will maintain a product's registration for FY 2005-06.
Work is currently underway to expand the existing on-line electronic payment system to allow all product registrants to pay the Annual Fee electronically. Separate advice will be provided to all Registrants in late May on how to login and use the new Annual Fee online system. The new on-line module will be operational in early June 2005.
MANUAL OF REQUIREMENTS AND GUIDELINES
The APVMA is in the process of updating its Ag and Vet Requirements Series. The principal driver of this is the expected commencement of the new cost recovery arrangements on 1 July 2005. Associated with the new cost recovery arrangements will be a revised structure for application categories. Currently there are 50 application categories, however in the revised structure this will be reduced to 24. The updated Requirements Series will be called the Manual of Requirements and Guidelines (MORAG). MORAG will be published in 2 separate editions, Ag MORAG and Vet MORAG.
Drafts of MORAG are available on the website for comment
KEY OUTCOMES OF APVMA BOARD OF DIRECTORS MEETINGS PUBLISHED ON WEBSITE
As part of our continued efforts to improve communications and increase awareness of APVMA activities, a new page has been created on the APVMA website to convey summaries of key outcomes from APVMA Board meetings. The summaries can be found on the APVMA website.
REGULATORY MAP OF POOL AND SPA SANITISERS
The APVMA is seeking nominations from the Industry Technical Committee for an APVMA/stakeholder working group that will undertake a project of developing a regulatory map for products marketed for pool and spa sanitation. The project will look into clarifying those pool and spa products that fall within the scope of the Agvet Code and to develop the most appropriate regulatory framework for such products. The outcome will seek to clarify which products require individual registration, which products may be suitable for a standard for listed registration, which products may be suitable for reservation subject to conditions and which products might be considered for declaration not to be agricultural chemical products under Schedule 3 of the Agvet Code Regulations.
The APVMA plans to arrange the first meeting of the working group, most likely by teleconference, in mid to late May. If you require further information on the project or would like to see the work plan for the project please contact Dr Eva Bennet-Jenkins, Program Manager Pesticides on 02 6272 3195.
EXPORT SLAUGHTER INTERVALS (ESIs) FOR SHEEP AND CATTLE NOW ON APVMA WEBSITE
The APVMA website now includes the Export Slaughter Interval (ESI) information that was previously hosted on the Meat and Livestock Australia (MLA) website. The ESI webpage provides the latest available information on ESIs and will be of particular interest to producers filling out National Vendor Declaration (NVD) forms. ESIs have been agreed upon by veterinary chemical producers, and the sheep and cattle industries. They are used to help manage potential issues related to the differences between Maximum Residue Limits allowed for chemicals in Australia and those of its trading partners.
QUALITY SCHEME FOR AGRICULTURAL ACTIVE CONSTITUENTS AND AGRICULTURAL PRODUCTS
The APVMA will begin formal auditing of records under this scheme in July 2005.
Over recent months, the APVMA has continued visits to companies to discuss records needed to help ensure compliance in future audits conducted by the APVMA. We will also be conducting data call-ins over the next two months. The Questions and Answers previously posted on the website will be updated over the next two months to clarify issues raised during the visits and data call-ins.
To complement auditing activities, the APVMA is currently testing agricultural chemical products containing selected active constituents.
The reconsiderations for the majority of products required as part of the scheme were completed in December 2004, and new conditions were applied to active approvals and product registrations. Extensions were granted for a small number of registrants and the review for these remaining products should be completed in mid 2005.
JECFA APPROACH TO SETTING MRLs
Following review of its approach to setting MRLs for veterinary medicines, the APVMA is considering adopting the approach used internationally by the Joint Expert Advisory Committee on Food Additivies (JECFA). As part of our discussion with stakeholders on this matter, a concept paper has been prepared and is posted on the APVMA website
Registrants of veterinary products are advised that a meeting to discuss the Concept Paper on the JECFA approach to Setting MRLs for Veterinary Drugs will be held in the Boardrooms at the APVMA on Wednesday 11 May at 10am. Those interested in attending should contact Joan Downing on 02 6272 3795.
REGULATORY PROGRAM AT AVA CONFERENCE
The APVMA is contributing to a regulatory program sponsored by the Australian Veterinarians in Industry and the Pharmacology Chapter at the AVA Conference on Monday 16 May. Topics include:
· The JECFA Approach to Setting MRLs for Veterinary Drugs- Dr Phil Reeves
· Consideration of Antibiotic Resistance and Dietary Exposure When Setting MRLs for Veterinary Antibiotics - Dr Bob Munro
· Generic Equivalence and Bioequivalence - Dr Roger Meischke
· APVMA Efficacy Trial Data Requirements and Case Examples- Dr Karina Tyson
MINOR USE HAPPENINGS
The Minor Use Taskforce (MUT) met on 30 March to discuss the progress of the 3 Working Groups and a Strategic Framework for Minor Use proposed by the APVMA. The MUT agreed to prepare a paper outlining the Key Strategies for Minor Use for consideration by the Product Safety and Integrity Committee (PSIC) at its meeting on 26 May 2005.
Stakeholders will be invited to a Forum on 25 May to discuss the Key Strategies, in particular options for the establishment of a Minor Use & Specialty Crops Development Unit based on the US IR4 model.
Minutes of the MUT will be posted on the APVMA website soon.
NEW MEMBERS APPOINTED TO THE COMMUNITY CONSULTATIVE COMMITTEE
The APVMA Board has recently appointed a number of new members to the Community Consultative Committee. The Community Consultative Committee is an important consultative forum for the APVMA and provides for two-way communication between the regulator and members of the general community. Members are appointed for a three year term.
The APVMA would like to thank the three members of the committee whose term of appointment has just expired and who did not seek reappointment, Andrew Duncan, Jane Fuller and Alison Brinson. These members made an outstanding contribution to the committee and we thank them for their valuable input. The APVMA would like to welcome Mr Don Sutherland and Mr Peter Cone as new members of the committee and congratulate Mr Sam Beechey on his reappointment. Further information about the APVMA Community Consultative Committee including the latest community e-bulletin can be found on the APVMA website.
CHEMICAL REVIEW NEWS
Public comments on the second draft final report for atrazine have been received
Following a detailed investigation, the second final draft report of atrazine review concluded that the chemical is not likely to be carcinogenic nor is it likely to be an endocrine disruptor in humans, according to the weight of evidence. Public submissions on the draft report are now being considered by the APVMA. Further information can be found on the APVMA website.
1080 review
It is anticipated that the report for the Preliminary Review Findings for 1080 will be released for public comment in early May.
Methiocarb
It is anticipated that the report for the Preliminary Review Findings for methiocarb will be released early May for public comment.
Endosulfan
The APVMA is near completion of its consideration of submissions from public consultation on the draft Review Findings for endosulfan. It is anticipated that the Final Review report will be released in June/July.
Arsenic timber treatments
The final report for the Review Findings and Regulatory Outcomes for arsenic timber treatments (CCA and arsenic trioxide) was released in March 2005. There will be a 12-month phase-in period to enable industry to implement process and other changes required to meet the outcomes of the review. A copy of the report and Frequently Asked Questions can be found on the website.
Carbon Disulfide
As mentioned in the previous newsletter, the APVMA, at the request of the registrant, cancelled the registration of the grain fumigant in December 2004. The Review Findings report for the remaining product, a pig poison, will be released in May.
Chemical Review Website
The APVMA is updating the chemical review section on the APVMA website. This will include information such as a table of all the chemicals under review and what stage each review is currently up to.
Pesticide Reviews Status (14 April 2005)
| Chemical | Stage of review Completed # Current * |
Reason for review | |||
|---|---|---|---|---|---|
| a | b | c | d | ||
| 2,4-D | # | * | T,O,E, (R-tba) | ||
| CCA, As2O3 | # | # | # | # | T,O,E |
| Atrazine | # | # | # | * | T,E |
| Azinphos-methyl | # | * | T,O,R, E | ||
| Carbaryl | # | # | # | * | T,R |
| Carbon disulfide | # | # | # | * | T,O,R |
| Chlorpyrifos | # | * | T,R, E | ||
| Diazinon (Pest) | # | * | T,O,R, E | ||
Dichlorvos |
# | * | T,R,O | ||
| Dimethoate | # | * | T,O,R, Tr | ||
| Diquat | # | * | T,O,R, E | ||
| Diuron | # | * | T, E | ||
| Endosulfan | # | # | # | * | T,O,R, E, Tr |
| Fenamiphos | # | * | T,O,R, E | ||
| Fenitrothion | # | # | # | * | O, E |
| Fenthion (non-Food) | # | * | T,O, E | ||
| Fenthion (food) | # | * | R | ||
| Maldison | # | * | T,O,C | ||
| Methamidophos | # | * | T, (R-tba) | ||
| Methidathion | # | * | T, (R-tba) | ||
| Methiocarb | # | # | T,O,R, E | ||
| Molinate | # | * | T, O, E | ||
| Omethoate | # | * | T,O,R, Tr | ||
| Paraquat | # | * | T,O,R, E | ||
| Parathion methyl | # | * | T,O,R, E | ||
| Procymidone | * | T,O,R, Tr | |||
| Sodium F (1080) | # | # | E | ||
Veterinary Reviews Status (14 April 2005)
| Chemical | Stage of review Completed # Current * |
Reason for review | |||
|---|---|---|---|---|---|
| a | b | c | d | ||
Chlorfenvinfos |
# | # | # | * | T,O,R,E |
| Diazinon (Vet) | # | * | O | ||
Dimetridazole |
# | # | # | * | T,O,R |
| Fipronil | # | * | T,O, An | ||
| Macrolides | # | * | PH, Eff | ||
| Sheep ectos | # | * | O,E | ||
| Temephos | # | * | O,E | ||
| Virginiamycin | # | # | # | # | PH, Eff |
| Review stages | Codes for reasons | |
|---|---|---|
| a | Initiation of review, scope document released for public comment | T - toxicology O - OH&S R - residues C - chemistry E – environment Tr - trade Eff - efficacy PH - public health An - animal safety |
b |
Data assessment |
|
c |
Release of report of preliminary review findings for public consultation | |
| d | Finalisation of regulatory outcomes | |
New on the website
Summary of outcomes of APVMA Board of Director's meetings
Export slaughter intervals and withholding periods for sheep and cattle
Draft Manual of Requirements and Guidelines
Report on the quantity of antimicrobials sold in Australia
Final version of Cost Recovery Impact Statement - Revision of Fees and Levy for Regulation of Agricultural and Veterinary Chemicals - see Latest News on the website homepage
Announcements relating to the finalisation of the review of arsenic based timber treatments
Outcome of the virginiamycin review
April version of Approved Actives
Two new VICH draft veterinary guidelines released for comment with background information - see vetguidelines
Guidelines for Registration of Biological Agricultural Products - revised edition
Issue 5 of the Community eBulletin
Minor amendment to the label approval process