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Gazette APVMA 4, 3 April 2007 - Page 31
Back to Gazette APVMA 4, 3 April 2007
NOTICE
Reconsideration of Approvals and Registrations
Related to Carbendazim and Thiophanate-Methyl
The APVMA, in accordance with Part 2, Division 4, of the Agvet Codes, intends to reconsider all approvals of the active constituents carbendazim and thiophanate-methyl, registrations of all products containing carbendazim or thiophanate-methyl, and the approvals of all associated product labels.
Carbendazim and thiophanate-methyl are members of the benzimidazole group of fungicides. They are broad-spectrum systemic fungicides effective against a wide range of fungal diseases.
Carbendazim products are used for the control of mould, spot, mildew, scorch, rot and blight in a variety of crops including cereals, fruit (pome, stone, citrus, currants, strawberries, bananas, pineapples, mangoes, avocados), vines, hops, vegetables, ornamentals, cotton, pasture and turf. It is also used as a timber preservative. Thiophanate-methyl is not registered in Australia for use on food producing species, only for the control of soil-borne diseases of ornamentals plants.
The basis of the reconsideration of the approvals of the active constituents carbendazim and thiophanate-methyl is whether or not the continued use of, or any dealing with, the active constituent in accordance with the recommendations for its use or for such a dealing that the AMPVA has approved:
- would not be an undue hazard to the safety of people exposed to it during its handling; and
- would not be likely to have an effect that is harmful to human beings.
The basis of the reconsideration of the approvals of products containing the active constituent carbendazim or thiophanate-methyl is whether or not the continued use of, or any dealing with, the product in accordance with the recommendations for its use or for such a dealing that the AMPVA has approved:
- would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
- would not be likely to have an effect that is harmful to human beings.
It also appears that labels for products containing carbendazim and thiophanate-methyl may not contain adequate instructions and warning statements.
Therefore the APVMA will review the following aspects of active constituent approvals, product registrations and label approvals for carbendazim and thiophanate-methyl:
- Toxicology, including:
- The potential risks following exposure of humans via the oral, dermal and inhalational routes; and
- The potential for impairment of reproduction and development;
- Occupational health and safety, including:
- Risks arising from exposure during handling and applications;
- Re-entry exposure risks; and
- Determination of appropriate personal protective clothing requirements.
- Residues, including:
- Residues in treated produce arising from application of carbendazim in accordance with label instructions; and
- Determination of dietary exposure resulting from the consumption of produce treated with carbendazim (both chronic and short-term)
The APVMA will also 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;
- the re-entry period after the use of the product;
- the withholding period after the use of the product;
- the disposal of the product and its container;
- the safe handling of the product and first aid in the event of an accident caused by handling the product;
- any other matter prescribed by the regulations.
The active constituent approvals to be reconsidered are listed in Table 1. Table 2 lists all product registrations and label approvals that are to be reconsidered.
The APVMA’s detailed reasons for these reconsiderations can be found in the APVMA Carbendazim and Thiophanate-methyl Review Scope document, available on the APVMA website (http://www.apvma.gov.au).
Interested parties are invited to make comments or submissions on the Review Scope Document. These should reach the APVMA by 30 June 2007, by email to chemrev@apvma.gov.au or by mail to:
Pesticides Review Manager
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
For further information please contact (02) 6210 4773
or email: chemrev@apvma.gov.au.