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Proposals to Amend the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards 2008

5 Proposal to set an MRL for Fludioxonil

It is proposed that an MRL is set for Fludioxonil when used as a fungicide for bulb onions.

It is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended to include the following:

Compound	CAS#	Residue definition	Food	Maximum Residue Limit (mg/kg)
Fludioxonil	131341-86-1	Fludioxonil	Bulb onions	0.01*

NOTE: (*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.

The final entry for fludioxonil in Schedule One of the NZ (MRL) Food Standards 2008 will therefore read:

Compound	CAS#	Residue definition	Food	Maximum Residue Limit (mg/kg)
Fludioxonil	131341-86-1	Fludioxonil	Bulb onions Grapes Strawberries	0.01* 0.05 1

NOTE: (*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.

Amendment Rationale

The proposed MRL represents a new use patterns in New Zealand for the active ingredient fludioxonil. The proposed MRL will manage the new use of fludioxonil as a fungicide on bulb onions to the application rates and withholding periods that are approved good agricultural practice in New Zealand

Chemical Information

Common name of compound	Fludioxonil
Use of compound	Fungicide
Chemical Abstract Services (CAS) Registry number	131341-86-1
Type of compound	Phenylpyrrole
Administration method	Spray

Good Agricultural Practice

Fludioxonil is proposed for use as a fungicide for bulb onions. Application may be up to 2 times per season, at 200gai/ha with a withholding period of 7 days.

Residues Information

Residue data for bulb onions supports a limit of quantification MRL of 0.01mg/kg at 7 days after the last treatment. An MRL of 0.01mg/kg is therefore proposed to support GAP.

Dietary Risk Assessment

Acceptable Daily Intake (ADI)

0.033mg/kg bw/day

The potential daily exposure via food (PDE_(food)) is used for dietary intake calculation where a value has been set. An appropriate acceptable daily intake (ADI) is used in the absence of a PDE_(food).

The chronic dietary exposure to fludioxonil is estimated by the National Estimated Dietary Intake (NEDI) calculation encompassing all registered uses of the chemical and food consumption data based upon the 1997 National Nutritional Survey for adults and the 1995 National Nutrition Survey of Australia, for children. The NEDI calculation is made in accordance with Guidelines for predicting dietary intake of pesticide residues (revised) [World Health Organisation, 1997].

The current NEDI for fludioxonil is equivalent to 0.7% of the ADI. It is therefore concluded that the chronic dietary exposure is small and the risk is acceptable.

Toxicological / Public Health Assessment

It has been determined that the use of fludioxonil as a fungicide for use on bulb onions, according to the good agricultural practice specified above, is very unlikely to pose any health risks from consumption of the harvested commodity.

Other International MRLs

To meet New Zealand’s obligations under the Agreement on the Application of Sanitary and Phytosanitary Measures the proposed MRL will be notified to the World Trade Organization. Any country may choose to comment if they believe the proposed MRL represents a barrier to their trade.