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Gazette APVMA 7, 4 July 2006 page 23
NOTICEPreliminary Review Findings of the Review of Approvals and Registrations
Related to Diazinon (Part 2)
Diazinon is a broad-spectrum organophosphorus insecticide and acaricide. Products containing diazinon have been registered for use in Australia for over 30 years and are widely used in the control of sucking and chewing insects and mites on animals and plants.
In accordance with Part 2 Division 4 of the Agvet Code, the APVMA has reviewed the following aspects of active constituent approvals, product registrations and label approvals for diazinon:
Toxicology
Environment
Occupational health and safety
Residues in food
Efficacy
The adequacy of instructions and warnings on product labels.
This Preliminary Review Findings (PRF) report of Part 2 of the review of diazinon, supplements previous draft reports published in August 2000 and September 2002. The PRF report sets out the findings developed in response to information and data that have became available since 2002, including data generated by registrants and user groups in response to this review. Where the supplementary assessments do not further address particular findings in the September 2002 draft report, the previously published draft findings have not changed.
In April 2003 the APVMA released the Review Findings of Part 1 of the APVMA review of diazinon which dealt only with the proposed cancellation of certain products which were hydrocarbon-based formulations containing insufficient stabiliser to prevent the breakdown of diazinon into more toxic substances. The Review Findings of Part 1 also proposed the cancellation of a small number of dog flea treatment products containing diazinon, on the basis of environmental concerns related to disposal of these products in urban environments. The APVMA took regulatory action to cancel the registrations of relevant products following the publication of this report.
The proposed key finding of Part 2 of the diazinon review is that use of products containing diazinon in some situations may pose undue risks to workers, human health, trade and the environment. These risks can be eliminated by deletion of a number of uses and changes to instructions on labels for a number of products.
The label instructions for five agricultural and two veterinary products cannot be varied to contain adequate instructions and therefore the APVMA proposes to cancel the registration of these products.
The APVMA’s detailed proposed findings can be found in the APVMA Preliminary Review Findings Part 2 report , available on the APVMA website - http://www.apvma.gov.au.
In view of these findings, the APVMA proposes the following regulatory actions:
a. The APVMA proposes that the active constituent approvals for diazinon listed in Attachment 1, Table A1 (page 77) of the PRF be affirmed.
b. The APVMA proposes to find that it is not satisfied that the labels of the products in Table 8 (page 44) of the PRF contain adequate instructions in relation to the criteria set out in 14(3)(g) of the Agvet Codes as well as those referred to in Regulations 11 and 12 of the Agvet Code Regulations.
However, the APVMA proposes to find it is satisfied that labels for the products in Table 8 of the PRF can be varied in such a way consistent with the summary in Table 9 (page 49) of the PRF such that they do contain adequate instructions in accordance with section 14(3)(g) of the Agvet Codes.
c. The APVMA proposes to find that in the absence of adequate packaging for products that are emulsifiable concentrates, it is not satisfied that these products would not be likely to have an effect that is harmful to human health.
d. The APVMA proposes to find that it is not satisfied that the product label approvals listed in Table 12 (page 61) of the PRF can be varied in such a way that the requirements prescribed by the regulations for continued approval will be complied with in accordance with section 34(5)(a) of the Agvet Codes. Therefore the APVMA proposes that all label approvals listed in Table 12 of the PRF be cancelled.
e. The APVMA proposes to find that because it proposes to cancel all the label approvals for products listed in Table 12 of the PRF, the Agvet Code requires that all product registrations listed in Table 12 of the PRF must also be cancelled.
f. The APVMA proposes to find that it can be satisfied that provided product labels and where necessary registration particulars are varied, the products listed in Table 13 (page 63) of the PRF meet the prescribed requirements for continued registration. Therefore the APVMA proposes that the product registrations listed in Table 13 of the PRF be affirmed.
g. Products containing diazinon that were registered after the commencement of the review in December 1996 are subject to the outcomes of the review. The APVMA proposes that all products identified by the symbol Ω in the PRF (products subject to the outcomes of the review) will have the review outcomes applied to them.
The APVMA invites persons and organisations to submit their comments and suggestions on this PRF directly to the APVMA. These comments will assist the APVMA in preparing the Final Review Report and Regulatory Decision.
Submissions specifically addressing the areas of concern noted in the PRF report must reach the APVMA by 29 September 2006, by email to chemrev@apvma.gov.au, or by mail to:
Evaluator Diazinon Review
Australian Pesticides & Veterinary Medicines Authority
PO Box E 240
KINGSTON ACT 2604
For further information please contact (02) 6272 3213 or Fax (02) 6272 3218.