Emamectin benzoate[in the product PROCLAIM INSECTICIDE] - APVMA

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Emamectin benzoate[in the product PROCLAIM INSECTICIDE] - APVMA Powered By Docstoc
					Commonwealth of Australia Gazette
No. NRA 1, 4 January 2000                       Agricultural and Veterinary Chemicals Code Act 1994   13



                                             NOTICE

                                         Emamectin benzoate

                                [in the product: PROCLAIM INSECTICIDE]

The National Registration Authority for Agricultural and Veterinary Chemicals (NRA) has before
it an application from Novartis Crop Protection Australasia Pty Ltd for registration of a new
product containing the active constituent emamectin benzoate. The product is PROCLAIM
INSECTICIDE for use on broccoli, Brussels sprout, cabbages and cauliflowers.

In accordance with sections 12 and 13 of the Agvet Code, the NRA invites any person to submit a
relevant written submission as to whether the application for registration of this product should be
granted. Submissions should state the grounds on which they are based. Such grounds should
relate only to matters outlined below that the NRA is required to take into account in deciding
whether to grant the application. Comments must be received by the NRA within 28 days of the
date of this notice.

Particulars of Application

Proposed product name:                                  PROCLAIM INSECTICIDE
Applicant company:                                      Novartis Crop Protection Australasia Pty Ltd
Name of active constituent:                             emamectin benzoate
Signal heading:                                         Schedule 6
Statement of claims:                                    For the control of diamondback moth on
                                                        broccoli,     Brussels   sprout,     cabbages,
                                                        cauliflowers.
Pack sizes:                                             500g, 550g, 1.0kg, 1.1kg, 2.0kg, 5.0kg
Withholding period:                                     Do not harvest for 3 days after application.
                                                        Do not use treated produce for stockfood.

Summary of the NRA’s evaluation in accordance with Sections 14(3)(e) and (f) of the
Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the
Agricultural and Veterinary Chemicals Code Act 1994

The NRA’s evaluation of this applications has included recommendations made to the NRA by its
advisers. In the NRA’s assessment in relation to human and environmental safety and efficacy
under sections 14(3)(e) and (f) of the Agvet Code, the NRA proposes to grant the application and
register PROCLAIM INSECTICIDE on the basis that it intends to determine as follows:

(i)     The NRA is satisfied that the proposed use of PROCLAIM INSECTICIDE would not be an
        undue hazard to the safety of people exposed to it during its handling and use.

        The National Occupational Health and Safety Commission (NOHSC) has conducted a risk
        assessment on PROCLAIM INSECTICIDE and concluded that it can be used safely.

        The product will be formulated overseas; repackaging will not be required in Australia.
        PROCLAIM INSECTICIDE is determined to be hazardous according to NOHSC
Commonwealth of Australia Gazette
No. NRA 1, 4 January 2000                      Agricultural and Veterinary Chemicals Code Act 1994   14


        Approved Criteria for Classifying Hazardous Substances based on acute oral toxicity and
        eye irritation effect.

        The NRA has considered the findings of the NOHSC evaluation and accepts its
        recommendations on this criterion.

(ii)    The NRA is satisfied that the proposed use of PROCLAIM INSECTICIDE will not be an
        undue hazard to the safety of people using anything containing its residues. Residue data
        was assessed by the NRA and maximum residue limits (MRLs) and Withholding Periods
        (WHPs) were set for emamectin benzoate when used on broccoli, Brussels sprout,
        cabbages, cauliflowers.

(iii) The NRA is satisfied that the proposed use of the PROCLAIM INSECTICIDE is not likely
      to be harmful to human beings if used according to the product label directions.

        The active constituent has been evaluated and approved (Technical Grade Active
        Constituent (TGAC) approval number 50921). The product is scheduled as 6. The
        appropriate Signal Heading is on the label. First Aid and Safety Directions for emamectin
        benzoate have been recommended by the Commonwealth Department of Health and Aged
        Care and NOHSC and have been included on the label.

        The NRA has considered these findings of its advisers and the NRA accepts their
        recommendations on this criterion.

(iv) The NRA is satisfied that the proposed use of PROCLAIM INSECTICIDE on broccoli,
     Brussels sprout, cabbages, cauliflowers is not likely to have an unintended effect that is
     harmful to animals, plants or the environment.

        Environment Australia has assessed data in support of PROCLAIM INSECTICIDE and
        believes that the application contains adequate environmental fate and toxicity data to
        demonstrate that the use of PROCLAIM INSECTICIDE according to the label is unlikely
        to result in primary poisonings of wildlife, fish etc. Environmental fate studies indicate
        residues will not persist or accumulate, as degradation occurs through a mixture of
        photolysis and microbial means. Emamectin has high to very high toxicity to fish and
        aquatic invertebrates, hence aquatic contamination should be avoided. Environment
        Australia has recommended suitable label advice to minimise the hazard from spray drift,
        which appears to be the greatest hazard with the proposed use regime. Rapid initial
        degradation and strong adsorption to soil minimise the potential hazard from run-off.

        The NRA has considered the findings of the EA evaluation and accepts its
        recommendations on this criterion.

(v)     The NRA is satisfied that the proposed use of PROCLAIM INSECTICIDE would not
        adversely affect trade between Australia and places outside Australia.

(vi) The NRA is satisfied the data from trials supporting the efficacy of PROCLAIM
     INSECTICIDE adequately demonstrates that under local conditions this product is effective
     for the proposed uses.

Public Release Summary
Commonwealth of Australia Gazette
No. NRA 1, 4 January 2000                    Agricultural and Veterinary Chemicals Code Act 1994   15




A Public Release Summary of the evaluation will be available on 4 January 2000 by contacting
David Hutchison on telephone (02) 6271 6384. Written submissions on the NRA’s proposal to
grant the application for registration should be addressed in writing to:

Paul Thomas
Agricultural &Veterinary Chemicals Evaluation
National Registration Authority for Agricultural and Veterinary Chemicals
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6272 3598
Fax: (02) 6272 3218
e-mail: pthomas@nra.gov.au

				
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