Gazette APVMA 8, 1 August 2006 page 24

NOTICE

PROHEXADIONE-CALCIUM

[in the product: REGALIS PLANT GROWTH REGULATOR]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from BASF Australia Ltd for the registration of a new product containing the active constituent Prohexadione-calcium. The product is REGALIS PLANT GROWTH REGULATOR and is for the suppression of shoot growth in apples.

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

Proposed Product Name: Regalis Plant Growth Regulator
Applicant Company: BASF Australia Ltd
Active Constituents: Prohexadione-calcium
Poisons Sheduling: Schedule 5
Statement of Claims: For the suppression of shoot growth in apples
Pack sizes: 1 kg, 2 kg 3 kg,
Withholding Period:Apples

Harvest: Do not harvest for 8 weeks after application.
Grazing: Do not graze or cut for stockfood for 8 weeks after application.

Summary of the APVMA’s evaluation of TORPEDOHERBICIDE 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 REGALIS PLANT GROWTH REGULATOR would not be an undue hazard to the safety of people exposed to it during its handling and use.

The Office of Chemical Safety (OCS) has conducted a risk assessment on REGALIS PLANT GROWTH REGULATOR and concluded that it can be used safely. Prohexadione-calcium has an ADI of 0.2 mg/kg bw/d which was established by applying a 100-fold safety factor to a NOEL of 20 mg/kg bw/d in a 52 week study in dogs. An ARfd of 1.5 mg/kg bw/d for Prohexadione-calcium was established by applying a 100-fold safety factor to a NOEL of 150 mg/kg bw/d in a developmental study in rabbits.

REGALIS PLANT GROWTH REGULATOR has displayed low acute oral, dermal and inhalational toxicity. It is a slight skin and eye irritant, but not a skin sensitiser.

The APVMA having considered the findings and recommendations of the OCS evaluation accepts these findings and recommendations.

The APVMA is satisfied that the proposed use of Regalis Plant Growth Regulator will not be an undue hazard to the safety of people using anything containing its residues. Residue data were assessed by the APVMA and Maximum Residue Limits (MRLs) and associated Withholding Periods (WHPs) are recommended for REGALIS PLANT GROWTH REGULATOR when used on apples. The MRLs are as follows: Compound Food MRL (mg/kg) ADD:
prohexadione-calcium FP 0226 Apple *0.02
MM 0095 Meat (mammallian) *0.05
MO 0105 Edible offal (mammallian) *0.05
ML 0106 Milks *0.01

Compound Animal feed commodity MRL (mg/kg) ADD:
prohexadione-calcium Apple pomace (dry) 0.1

The recommended WHPs and Restraints are as follows

Restraints:
Do Not apply by aerial application
Do Not apply within 3 days of sprays containing calcium, ethylene or gibberellic acid
Do Not apply more than 3 sprays per season

Withholding periods:
Harvest: Do Not harvest for 8 weeks after application.

The residue definition for Prohexadione-calcium is the sum of the free and conjugated forms of prohexadione expressed as prohexadione.

The APVMA is satisfied that the proposed use of REGALIS PLANT GROWTH REGULATOR is not likely to be harmful to human beings exposed to it during its handling and use.

The active constituents have been evaluated and approved and the product is placed in Schedule 5 of the SUSDP. The appropriate Signal Heading appears on the label. First Aid and Safety Directions for Prohexadione-calcium have been recommended by OCS and have been included on the label.

The product will be formulated overseas and imported ready to use in HDPE containers. REGALIS PLANT GROWTH REGULATOR is determined to be a hazardous substance, based on NOHSC hazard classification of active and non-active constituents and product toxicology information provided.

The APVMA accepts the findings and recommendations of its advisers on these criteria.

(iv) The APVMA is satisfied that the proposed use of the active constituent Prohexadione-calcium in the product REGALIS PLANT GROWTH REGULATOR for the suppression of shoots in apples is not likely to have an unintended effect that is harmful to animals, plants or things, or to the environment when it is applied in accordance with its label instructions.

The Department of the Environment and Heritage has assessed data in support of the proposed use and has concluded that the risks to the environment from the proposed use are acceptable.

Prohexadione-calcium is practically non-toxic to birds by acute oral and dietary routes; and is also classified as non-toxic to fish and aquatic invertebrates with acute exposure. Chronic exposure also showed no effects on Daphnia reproduction. Although Prohexadione-calcium is non-toxic to alga there were effects on aquatic plants.

With good agricultural practice, the use of REGALIS PLANT GROWTH REGULATOR in apple orchards is unlikely to pose an environmental hazard when applied with typical orchard application equipment according to the proposed label.

The APVMA has considered the findings of DEH and accepts these findings.

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

Detectable residues of the active constituent, Prohexadione-calcium, are not expected to occur in treated apples following application of the product as per the proposed label use pattern.

A grazing withholding period of 8 weeks after treatment will apply to REGALIS PLANT GROWTH REGULATOR. The feeding of treated produce of forage, straw and grain to animals is unlikely to result in detectable residues in meat and dairy commodities following this period.

The APVMA has considered the need for export slaughter intervals (ESIs) for livestock that have been exposed to REGALIS PLANT GROWTH REGULATOR through treated cereals and has determined that none are required when the product is used as directed.

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 REGALIS 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) 6272 6384. Written submissions on the APVMA’s proposal to grant the application for registration should be addressed in writing to:

Dr G.F.Smart
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6272 3354
Fax: (02) 6272 3218