No. APVMA 8, Tuesday, 27 April 2010 Published by The Australian Pesticides & Veterinary Medicines Authority AGRICULTURAL AND VETERINARY CHEMICALS The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be published in the Gazette containing details of the registration of agricultural and veterinary chemical products and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code and related legislation also requires certain other notices to be published in the Gazette. 26466 Cat. No. 0189623 ISSN 1837 - 7629
Transcript
No. APVMA 8, Tuesday, 27 April 2010 Published by The Australian Pesticides & Veterinary Medicines Authority
AGRICULTURAL AND
VETERINARY CHEMICALS
The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be published in the Gazette containing details of the registration of agricultural and veterinary chemical products and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code and related legislation also requires certain other notices to be published in the Gazette.
26466 Cat. No. 0189623
ISSN 1837 - 7629
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 2
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Other Notices 4 Systematic Spray Drift Reviews - Reconsideration of Approvals and Registrations Related to Products Containing MCPA and their Labels......................................................................................................................................................................4 Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade ...............................................................................................................................................................14 Suspension of Vetkleen Veterinary Disinfectant...................................................................................................................16 Comment Invited on a Proposal to Improve the Efficiency of Label Approval and Regulation .............................................18 Review of List of Registration Consultants on the APVMA Website.....................................................................................19 Application Summaries.........................................................................................................................................................20
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 4
OTHER NOTICES
Systematic Spray Drift Reviews - Reconsideration of Approvals and Registrations Related to Products Containing MCPA and their Labels
The APVMA, in accordance with Part 2, Division 4, of the Agvet Codes, is reconsidering all registrations of all products containing MCPA and the approvals of all labels associated with those products.
2-methyl-4-chlorophenoxyacetic acid, commonly known as MCPA, is a phenoxy compound used as a post-emergence herbicide in agriculture and the home garden. It is used for the selective control of annual and perennial broadleaf weeds in an extensive range of crops and non-cropping situations. A large number of products containing MCPA, either as the only active constituent or together with other active constituents, is currently registered for use in Australia for weed control.
The basis of the reconsideration of the products containing the active constituent MCPA is whether or not the continued use of, or any dealing with, products in accordance with the recommendations for its use or for such a dealing that the APVMA has approved would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and that the labels for products containing MCPA may not contain adequate instructions and warning statements.
The scope of this reconsideration will consider the environmental aspects of product registrations and label approvals for MCPA, limiting it to the APVMA’s concern about the potential risk of non-target damage that spray drift of such products can cause.
The APVMA has conducted spray drift modelling and risk analysis for products containing MCPA. The assessment showed that spray drift of MCPA may pose risks to aquatic organisms, non-target terrestrial vegetation and neighbouring crops.
It also appears that the labels for products containing MCPA may not comply with the prescribed requirements under paragraph 14(3)(d) and contain the adequate instructions relating to the matters referred to in paragraph 14(3)(g) of the Agvet Codes.
Thus it is necessary to place all products containing MCPA and their labels under reconsideration to enable further assessment of the products for spray drift risks and to make label amendments if necessary to mitigate spray drift risks.
The APVMA will consider whether product labels carry adequate instructions and warning statements. The requirements for product labels are that the label contains adequate instructions. Such instructions include:
• the circumstances in which the product should be used;
• how the product should be used;
• the times when the product should be used;
• the frequency of the use of the product;
• any other matter prescribed by the regulations.
All product registrations and label approvals that are to be reconsidered are listed in Table 1.
The APVMA’s detailed reasons for these reconsiderations can be found in the APVMA’s MCPA Spray Drift Review Scope document, available on the APVMA website (http://www.apvma.gov.au).
Other Notices - Systematic Spray Drift Reviews - Reconsideration of Approvals and Registrations Related to Products Containing MCPA and their Labels
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 5
Submissions specifically addressing the areas of concern noted in the scope document must be in writing and reach the APVMA by 28 May 2010, by email to [email protected] or by mail to:
Subbu Putcha Senior Chemical Reviewer Chemical Review Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604
Please note that subject to the Freedom of Information Act 1982, the Privacy Act 1988 and the Agvet Codes, all submissions received may be made publicly available. They may be listed or referred to in any papers or reports prepared on this subject matter.
The APVMA reserves the right to reveal the identity of a respondent unless a request for anonymity accompanies the submission. If no request for anonymity is made, the respondent will be taken to have consented to the disclosure of their identity for the purposes of Information Privacy Principle 11 of the Privacy Act 1988.
The contents of any submission will not be treated as confidential or confidential commercial information unless they are marked as such and the respondent has provided justification such that the material is capable of being classified as confidential or confidential commercial information in accordance with the Freedom of Information Act 1982 or the Agvet Codes as the case may be.
64188 COUNTRY BROMOXYNIL / MCPA SELECTIVE HERBICIDE
ACCENSI PTY LTD
64337 TITAN MCPA 750 SELECTIVE HERBICIDE
TITAN AG PTY LTD
64364 FARMALINX MCPA 500 HERBICIDE
FARMALINX PTY LTD
64452 AW LETFLY 500 HERBICIDE AGRI WEST PTY LIMITED
64667 AGRISMART PICLORAM/ MCPA HERBICIDE
GOOBANG PTY LTD
47090 BANVEL M SELECTIVE HERBICIDE
CROP CARE AUSTRALASIA PTY LTD
Other Notices - Systematic Spray Drift Reviews - Reconsideration of Approvals and Registrations Related to Products Containing MCPA and their Labels
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 13
Product No. Product Name Registrant
58684 SUMMIT MCPA 500 HERBICIDE SIPCAM PACIFIC AUSTRALIA PTY LTD
59222 ALLFIRE MCPA 500 SELECTIVE HERBICIDE
OSPRAY PTY LTD
60236 TRADELANDS MCPA 500 SELECTIVE HERBICIDE
OSPRAY PTY LTD
63101 ALLFIRE MCPA 500 LVE HERBICIDE
OSPRAY PTY LTD
Other Notices - Systematic Spray Drift Reviews - Reconsideration of Approvals and Registrations Related to Products Containing MCPA and their Labels
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 14
Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade
Pursuant to paragraph 2 of section 69C of the Agricultural and Veterinary Chemicals (Administration) Act 1992, notice is hereby given that following the fourth conference of parties to the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, amendments are being prepared to the export controls imposed on certain chemicals. These alterations are proposed to come into force on 1 June 2010.
Amendments are being developed for the Agricultural and Veterinary Chemicals (Administration) Regulations 1995 to prohibit any export of the chemicals specified below without written authorisation from the Department of Agriculture, Fisheries and Forestry. This is proposed to take effect from 1 June 2010.
Under the Rotterdam Convention, export of these chemicals to countries that are Parties to the Convention for use as a pesticide may be prohibited absolutely, or only authorised if certain specified conditions given by the importing Party are met. Exporting Parties must ensure that exports do not occur when the importing country has indicated that it does not consent to imports of that chemical.
In order to meet export notification requirements under the Rotterdam Convention, chemical companies seeking to export a controlled chemical must apply to the Australian Government Department of Agriculture, Fisheries and Forestry for permission to export (contact details at end of notice). Exporters exporting these chemicals to countries that are Parties to the Convention must:
(i) include the Harmonised System Customs Code for the chemical (where assigned) on shipping documentation; and
(ii) ensure adequate labelling of the chemical: include information regarding risks and/or hazards to human health or the environment; comply with relevant international standards applicable to labels; and
(iii) provide to the importer (if the chemical is to be used for occupational purposes) a safety data sheet that follows an internationally recognised format, with the most up to date information available, in one of the official languages of the importing Party if practicable; and
(iv) comply with any specified conditions stipulated by the importing country and promulgated by the Secretariat to the Rotterdam Convention as advised by the authorised officer.
A person must not export an active constituent for a proposed or existing chemical product, or a chemical product, in contravention of a condition or restriction prescribed by a regulation. Penalty: 300 penalty units.
The amendments to the Regulations will apply to the following active constituents or chemical products:
Chemical Name CAS number
Tributyltin 688-73-3
Tributyltin oxide 56-35-9
Tributyltin fluoride 1983-10-4
Tributyltin methacrylate 2155-70-6
Tributyltin benzoate 4342-36-3
Tributyltin chloride 1461-22-9
Other Notices - Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 15
Chemical Name CAS number
Tributyltin linoleate 24124-25-2
Tributyltin naphthenate 85409-17-2
As further information is available, it will be made available on the Department of Agriculture, Fisheries and Forestry website: www.daff.gov.au; emailed to subscribers of APVMA news information; and notified in a future Gazette.
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 16
Suspension of Vetkleen Veterinary Disinfectant
The APVMA has suspended the following product registration and label approval:
Table 1: Suspended registered products and label approval
Product No. Product Name Registrant
59615 Vetkleen Veterinary Disinfectant Twenty First Decwood Pty Ltd
The suspensions are in effect from 9 April 2010 to 17 March 2011.
REASONS
The reasons for the suspension
• Lack of efficacy against label pathogens
The APVMA has issued the following instructions for using or dealing with suspended product.
INSTRUCTIONS FOR POSSESSING, HAVING CUSTODY OF, USING OR DEALING WITH SUSPENDED PRODUCT, OR PRODUCT CONTAINING THE SUSPENDED LABEL
Possession and custody
Possession and custody of existing stocks of the product is permitted.
Supply
The effect of the suspension of the product is to revoke its registration status. Supply of unregistered chemical products constitutes an offence under the Agricultural and Veterinary Chemicals Code 1994 and may also constitute an offence under other State/Territory and Commonwealth legislation.
Use
The use of unregistered chemical product may be prohibited under State or Territory legislation.
Any person who possesses, has custody of, uses or deals with the product listed above in accordance with the instructions in this notice is taken to have been issued with a permit to possess, have custody of, or deal with the product for the period of the suspension.
Warning
These products are unregistered and labels are not approved during the period of suspension. A person must not possess with the intent to supply, or deal with any of these products during this period except in accordance with the instructions contained in this notice. A failure to comply with them will result in an offence against the Agvet Codes and the APVMA will take appropriate compliance action.
Other Notices - Suspension of Vetkleen Veterinary Disinfectant
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 17
APVMA CONTACT
For any enquiries or further information about this matter, please contact:
Other Notices - Suspension of Vetkleen Veterinary Disinfectant
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 18
Comment Invited on a Proposal to Improve the Efficiency of Label Approval and Regulation
The APVMA has developed a proposal to improve the efficiency of label approval and regulation by clearly distinguishing a labelling hierarchy for the information required by APVMA legislation, other legislation and the registrant.
The APVMA invites comment on the Reform Proposal to Improve the Efficiency of Label Approval and Regulation. The consultation paper is available on the APVMA website at www.apvma.gov.au/consultation/public/label_reform.php.
The APVMA is specifically seeking to:
• ensure the reform offers genuine benefit in terms of improving the efficiency of labelling regulation; and
• ensure the proposal provides a regulatory framework that is unambiguous and readily understood from the perspective of achieving compliance.
Comments, submissions or enquiries may be directed via email or post to the contact details listed below. Submissions close 5pm, Wednesday 19 May 2010.
APVMA CONTACT
For further information please contact:
Reform Manager Regulatory Strategy and Compliance Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Email: [email protected]
Other Notices - Comment Invited on a Proposal to Improve the Efficiency of Label Approval and Regulation
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 19
Review of List of Registration Consultants on the APVMA Website
Early in 2009 the APVMA published a list of registration consultants on its website. This initiative sought to address difficulties some intending registrants experienced in locating consultants who could provide assistance in developing applications to the APVMA.
With the list in place now for a year the APVMA is interested in your views as to its effectiveness and value, particularly if you have used the list to access a consultant.
Is the list useful? Does it satisfy a need? Are you aware of any issues relating to its publication and maintenance by the APVMA? Any additional comments?
Please email your comments to Simon Cubit by 14 May 2010.
APVMA CONTACT
For further information please contact:
Dr Simon Cubit Manager Public Affairs Regulatory Strategy and Compliance Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4869 Fax: (02) 6210 4874 Email: [email protected]
Other Notices - Review of List of Registration Consultants on the APVMA Website
Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 27 April 2010 Agricultural and Veterinary Chemicals Code Act 1994 20
Application Summaries
The APVMA publishes complete application summaries on the APVMA website, www.apvma.gov.au. They are published in weekly instalments using the date the application was accepted for assessment. If an application summary has been amended, the APVMA will publish the amended version on the website and list it separately in the APVMA Gazette Notice for Application Summaries.
As a requirement of Regulations 8C and E of the Agvet Code, some product names will appear as 'NOT AVAILABLE'.
A summary will be removed from the website 28 days after the application has been finalised. Therefore, some summaries published in this notice may have already been removed prior to the Gazette being published.
APPLICATION SUMMARIES PUBLISHED SINCE THOSE PUBLISHED IN APVMA GAZETTE NO. 7, APRIL 13, 2010.
