Gazette APVMA 9, 6 September 2005 page 22

NOTICE

FORCHLORFENURON

[in the product: Sitofex 10 EC Plant Growth Regulator]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Degussa Ag for registration of a new product containing the active constituent forchlorfenuron. The product is SITOFEX 10 EC PLANT GROWTH REGULATOR. The product is for use as a plant growth regulator to increase berry size in table grapes.

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

Particulars of Application

Product Name: SITOFEX 10 EC PLANT GROWTH REGULATOR
Applicant Company: Degussa Ag
Active Constituent: Forchlorfenuron
Poisons Scheduling: Exempt
Statement of Claims: For the increase of berry size in table grapes
Pack Sizes: 250mL and 1L
Withholding Period:

Harvest (grapes): Not required when used as directed
Grazing: Do not graze treated vineyards or cut treated areas for stockfeed until after completion of grape harvest

Summary of the APVMA’s evaluation of Sitofex 10 EC Plant Growth Regulator in accordance with Section 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 APVMA has evaluated the application and in its assessment in relation to human and environmental safety under section 14(3)(e) of the Agvet Code, it proposes to determine that:

(i) The APVMA is satisfied that the proposed use of SITOFEX 10 EC PLANT GROWTH REGULATOR 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 SITOFEX 10 EC PLANT GROWTH REGULATOR and concluded that it can be used safely. The APVMA accepts the findings and recommendations of the NOHSC evaluation.

The product will be formulated in 250mL and 1L pack sizes; repackaging will not be required in Australia. The main acute hazards associated with SITOFEX 10 EC PLANT GROWTH REGULATOR are skin and eye irritation and also skin sensitisation. During application, the most concentrated spray will contain up to 0.01% product. At this concentration, the risk of skin and eye irritation and of skin sensitisation is low.

(ii) The APVMA is satisfied that the proposed use of SITOFEX 10 EC PLANT GROWTH REGULATOR will not be an undue hazard to the safety of people using anything containing its residues. Residue data was assessed by the APVMA and Maximum Residue Limits (MRLs) and Withholding Periods (WHPs) were set for forchlorfenuron when used on grapes.

(iii) The APVMA is satisfied that the proposed use of the forchlorfenuron / SITOFEX 10 EC PLANT GROWTH REGULATOR is not likely to be harmful to human beings if used according to the product label directions.

The active constituents have been evaluated and approved and the product is exempt from the requirement for poisons scheduling. First Aid and Safety Directions for forchlorfenuron have been recommended by the Commonwealth Department of Health and Ageing and NOHSC and have been included on the label.

The APVMA accepts the findings and recommendations of its advisers on this criterion.

(iv) The APVMA is satisfied that the proposed use of the product SITOFEX 10 EC PLANT GROWTH REGULATOR containing the new active, forchlorfenuron, for the increase of berry size in table grapes is not likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

The Department of the Environment and Heritage (DEH) has assessed the data in support of this product. Environmental fate studies indicate that forchlorfenuron is not readily degraded and persistence in soils is expected. Similarly, forchlorfenuron is expected to persist in aquatic systems. However, the low application rate associated with the proposed use pattern means that levels of the active in the environment will be low.

The proposed use of forchlorfenuron is not likely to present unacceptable risk to birds, mammals, aquatic species, beneficials, soil respiration processes or non-target plants. This is as a result of the low to moderate toxicity of the compound to these species and the low environmental concentrations expected from its use on table grapes.

The APVMA has considered the findings of DEH and accepts its recommendations on this criterion.

(v) The APVMA is satisfied that the proposed use of forchlorfenuron / SITOFEX 10 EC PLANT GROWTH REGULATOR would not adversely affect trade between Australia and places outside Australia.

It is concluded that use of the new product in accordance with the label instructions would not constitute an undue risk to Australia’s export trade in table grapes, since the levels of residues in grapes from treated vines are expected to be non-detectable (<0.01 mg/kg) when harvested at maturity.

No animal transfer studies were provided in support of the application to register the use of forchlorfenuron on table grapes. Therefore, in the absence of any animal commodity MRLs, the following grazing restraint is considered necessary and appropriate: DO NOT graze treated vineyards or cut treated areas for stockfeed until after completion of grape harvest.

In relation to its assessment of efficacy under section 14(3)(f), the APVMA proposes to determine that:

(i) The APVMA is satisfied the data from trials supporting the efficacy of SITOFEX 10 EC PLANT GROWTH REGULATOR adequately demonstrates that under local conditions this product is effective for the proposed uses.

Public Release Summary

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

Trevor Humphery
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6271 6347
Fax: (02) 6272 3218