 |
|
Now two months into the new financial year, we remain clearly focused on delivering on the objectives of our new Operational Plan. Within this there are consistent threads of strengthening the quality, efficiency and transparency of what we do. To this end we have restructured our Registration and Client Service and Registration Finalisation and Information Teams to create a combined Application Management and Enquiry (AME) team to better integrate and coordinate our administrative related to applications processing and enquiries. In relation to transparency, we have completed a draft report of a review of our consultation arrangements and are currently seeking stakeholder feedback before completion. Our program of innovation to the regulatory framework is also moving well in several areas, and we appreciate the active engagement of our different stakeholders in doing this. In the last month, we have released a new draft of our 'Operating Principles and Proposed Registration Requirements in Relation to Spray Drift Risk' for public comment, which we see as important advance in the mitigation of spray drift risk. So, too, have we released consultation Regulatory Impact Statements covering our revised Manufacturing Principles and Code of GMP for veterinary medicines manufacturers and Adoption of the JECFA Approach for the Setting of MRLs for Veterinary Medicines. All of these initiatives will help to ensure that Australia's regulation of pesticides and veterinary medicines serves Australia's interests well and remains at the forefront of international practice. Looking to the future, we are about to embark on the preparation of our new Corporate Plan, which provides the broad strategic direction for the APVMA for the period 2006 to 2009. In doing this we will be seeking input from stakeholders and I encourage you to give us your views. Dr Joe Smith |
THE LATEST
Second Edition of MORAG
The Manual of Requirements and Guidelines (MORAG) was published on the website on 1 July 2005. MORAG gives information to applicants on the new application categories which came into effect on 1 July 2005. MORAG also gives information on data requirements, and it replaces the Ag and Vet Requirements Series.
MORAG will be updated in October and April, and the October 2005 second edition will go up on the website as scheduled, on 1 October.
The second edition will correct some typographical errors in the first edition and will also clarify some potential points of confusion which have emerged after three months use of MORAG. The second edition will be also be published on CD and a CD will be sent with the October APVMA Gazette to each Gazette subscriber. Additional CDs can be requested from the APVMA.
The APVMA will also launch revised application forms on 1 October. The forms have been revised to remove unnecessary information. They will also incorporate text fields which can be easily filled in from a computer.
Manufacturing Principles and Code of GMP
A draft (consultation) Regulation Impact Statement and revised Manufacturing Principles and Code of Good Manufacturing Practice for Veterinary Chemical Products are on the APVMA website for public comment until September 9.
Quality scheme for agricultural active constituents and products
In July 2005, the APVMA began formal monitoring of records, visiting three companies. Data call-ins of records will begin soon. We are continuing testing of chlorothalonil and trifluralin products, and will test four actives and associated impurities described in APVMA Standards in other products over the next 12 months.
To cover issues raised during previous monitoring visits, revised Questions and Answers are now available on the APVMA website.
Adverse experience reporting
Registrants are reminded that in accordance with the Guidelines for the Adverse Experience Reporting Program for veterinary medicines (AERP Vet) and agricultural chemicals (AERP Ag), they are requested to provide the APVMA with an annual summary of all suspected adverse experiences by the close of business 30 September. Provision of these annual summaries is a mechanism by which registrants can fulfil some of their obligations under section 161 of the Agricultural and Veterinary Chemicals Code Act 1994.
The Annual Reports for the AERP Ag and the AERP Vet will soon be published on the website. These include the reports for the 2004 calendar year where a link to the use of chemicals is classified as either 'probable' or 'possible'.
In the AERP Ag during the 2004-2005 financial year, 24 reports were classified 'probable' and 34 were 'possible' out of a total of 158 reports.
Responsibilities for recalls and submission of new information
At a recent APVMA Industry Technical Committee (ITC), industry sought clarification on the role of manufacturers and distributors in recalls and reporting adverse experiences. A summary follows.
Manufacturing Licensing Scheme for Veterinary Chemical Products
Under the Manufacturing Licensing Scheme for veterinary chemical products, licensed manufacturers have complaints handling and recall responsibilities described in the Codes of Good Manufacturing Practice. Distributors of veterinary chemical products do not have such responsibilities under the Manufacturing Licensing Scheme.
Distributors as suppliers of agricultural and veterinary chemical products do have various responsibilities under the Agvet Code, including recalls as summarised below.
Recalls
Any person who has, or has had, possession or custody of a chemical product, including distributors, may be responsible for recalls of chemical products in Australia. The first contact for a recall will be the sponsor (the person, business or company having the primary responsibility for the possession or supply of a non-compliant product or advertising/promotional material subject to a recall). A Sponsor will generally be the registrant of the product and may be a manufacturer, importer, wholesaler, distributor, reseller or retailer of the agricultural or veterinary chemical product. For further information, refer to the APVMA Recall Guidelines.
Submission of new information including adverse experiences
Under section 161 of the Agricultural and Veterinary Chemicals Code Act 1994, the interested person (being the applicant, the contact person on APVMA product records or the permit holder) must submit 'new information' to the APVMA. The APVMA is working with industry to develop guidelines on the submission of new information to the APVMA to assist industry comply with legislative requirements under section 161. Both AERP Ag and AERP Vet programs also allow any person (including distributors) to provide adverse experience reports to the APVMA.
Non-compliance reports
The APVMA encourages the submission of reports about non-compliant products from any person, including distributors. Non-compliance reports can be submitted by using the form available on the APVMA website.
JECFA Approach to Setting Veterinary MRLs
Following a review of residue evaluation processes, the APVMA is proposing to adopt the approach used by the FAO/WHO Joint Expert Committee on Food Additives (JECFA) for setting MRLs for veterinary chemicals. Implementation of the proposal will align the Australian approach better with other countries. Interested parties are invited to submit comments on the consultation Regulation Impact Statement covering this proposal.
Spray Drift Discussion Paper
Following extensive stakeholder consultation, the APVMA has revised its draft spray drift discussion paper "Operating Principles and Proposed Registration Requirements in Relation to Spray Drift Risk." Comments are invited by 21 October 2005.
Pesticides Program Field Trip
Staff from the APVMA Pesticides Program recently embarked on a field trip to the South West slopes of NSW on 22- 24 June 2005 to discuss a range of pesticide issues in a variety of agricultural industries.
The visits began with a look at "Broadacre farming/Conservation Farming". The group travelled to Harden, through Greenthorpe, finishing in Cowra, with farm visits focusing on spray application and new spray technology. They discussed current issues faced by farmers related to application of pesticides and the importance of nozzle selection to suit various environmental conditions.
A visit to Cowra Turf provided a good example of chemical usage in a complex mixed farming situation. Grapes and turf are grown next to each other, making any potential spray drift a significant issue. This was followed by visits to discuss integrated pest management and chemical management for a local vineyard, to the NSW DPI Agricultural Research and Advisory Station (Cowra) and to a chemical reseller for an update on the issues currently faced with the storage and selling of agricultural chemicals.
The group also visited NSW Forests, Bathurst, where a presentation on the forestry industry in NSW was provided. The last stop was at a market garden outside Bathurst to discuss chemical usage and the issues faced by minor chemical users.
The field trip was of great benefit to APVMA staff as it provided real life experiences from people using or working closely with users of agricultural chemicals. It also provided a great opportunity to meet more people in the industry, see the issues firsthand, and the steps being taken to overcome these.
Changes to Pesticides Management Team
Following the retirement of Mal Arney, Jay Kottege (previously Manager Insecticides) has taken over the role of Manager Herbicides. Gavin Hall has been newly appointed to the Pesticides Management team as Manager Insecticides.
Ron Hogg has moved from his role as Manager Pesticides Review to take over the management of some key organisational reform projects. Recruitment is underway for a replacement for Ron.
OH&S Commitment Made
The APVMA has signed an Employer Statement of Commitment to continue its excellent record in ensuring the occupational health and safety of its employees.
The commitment with Comcare requires that the APVMA will:
Ensure that its senior executive management team review OHS and rehabilitation performance at least six monthly
Ensure that all levels of management and employees are briefed and, where relevant, appropriately trained to enable them to play their part in reducing the incidence of workplace injury and disease
Integrate OHS into normal risk management activities and undertake an OHS risk assessment (if not already completed in the previous 12 months) to identify current and emerging risks and to develop and promote a strategy to eliminate or minimise those risks; and,
Initiate an evaluation of OHS and rehabilitation policy, practice and procedures (where not already undertaken in the previous 12 months) to ensure relevance and currency, and to actively promote good policy and effective procedures.
Accommodation Options for the APVMA Being Considered
The APVMA's leases on its current office expire in April 2006. Work is currently underway to determine the most appropriate option for accommodation beyond that. Key considerations are that the outcome is cost effective and that staff can all be accommodated in the one building.
Chemical review news
Announcement of Polihexanide Review
A review of polihexanide was announced in August 2005. A scope document is available on the APVMA website. The closing date for comment is 2 September 2005.
Pesticide and veterinary Review Status summaries to 1 September 2005
NEW ON THE WEBSITE
Polihexanide review - scope and FAQ
Outcomes of Board of Directors Meeting
GMP Code - drafts and call for comment
JECFA approach to MRL setting - Regulation Impact Statement
Rabbit Haemorrhagic Disease Virus Suspension registration
Data protection - - Advice Summaries - first entry
Trade Advice Notes on website - first entry
Actives List for August
Public Release Summary for Quinclorac