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Gazette APVMA 11, 4 November 2003 page 36
NOTICE
Suspension of Approvals of the Active Constituent Benomyl,
Registrations of Products Containing Benomyl and Associated Label Approvals
The APVMA has suspended approvals of the active constituent benomyl,
registrations of products containing benomyl and associated label approvals
for the following:
| APPROVAL NUMBER | ACTIVE CONSITUENT |
|
52856 |
Benomyl |
| APPROVAL NUMBER. | PRODUCT NAME | LABEL APPROVAL NUMBER |
|
54552 |
Farmoz Marvel Fungicide | 54552/1201 |
The approvals and registrations for benomyl have been suspended effective
from 20 October 2003 until 20 April 2004.
The reasons for the suspension
The APVMA has received advice from OCS that benomyl causes impairment
of reproduction and development in laboratory animals, and that women
of childbearing age should avoid contact with benomyl.
In view of the concerns raised by the OCS, the APVMA no longer maintains
satisfaction that the continued approvals of the active constituent
benomyl and products containing benomyl:
- 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.
Having regard to advice received from OCS, the APVMA has initiated the reconsideration of benomyl to assess the concerns relating to human health and to seek information to address the remaining data gaps for benomyl. The APVMA has issued the following instructions for dealing with benomyl and products containing benomyl for the purposes of sections 45A(2) and 55(2) of the Agvet Codes:
INSTRUCTIONS FOR DEALING WITH BENOMYL AND PRODUCTS CONTAINING BENOMYL
(for the purposes of sections 45A(2) and 55(2) of the Agvet Codes)
The following instructions set out how a person can deal with the suspended
active constituent and product until 20 April 2004.
Supply
A person already in possession of existing stocks of the suspended product may supply that product only if:
- a copy of the MSDS for the product accompanies the product; and
- the following FAISD warning statement, written in prominent font and colour capable of attracting the attention of users, is securely affixed to the container:
"Contains benomyl which cause birth defects in laboratory animals Women of child bearing age should avoid contact with benomyl".
Use
A person may use the suspended product in accordance with its existing
label instructions.
Possession and custody
Any person already in possession of existing stocks of the suspended
active constituent can continue to possess the active constituent without
the intention of supply. They must not supply the active constituent
to any person.
Any person already in possession of existing stocks of the suspended
product may continue to possess them only if they comply with these
instructions.
Any person dealing with the suspended active constituent and/or or product
in accordance with the instructions in this notice is deemed to have
been issued with a permit to do so in accordance with these instructions.
The APVMA declares that s.45A(5) and 55(3) of the Agvet Codes cease
to apply in respect of the suspended active constituent and product.
WARNINGS
A person must not deal with the suspended product except in accordance
with these instructions. A failure to comply with them will result in
an offence and the APVMA will take appropriate compliance action.
It is an offence for a person to import into Australia the suspended
active constituent and products during the period of suspension.
A person may not manufacture the active constituent benomyl and/or products
containing benomyl.
For any queries or further information about this matter, please contact:
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604For further information please contact:Ph: (02) 6272 3213
Email: chemrev@apvma.gov.au.