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

6 Proposal to set an MRL for Formetanate Hydrochloride

It is proposed that an MRL is set for formetanate hydrochloride when used as an insecticide for onions. It is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended to include the following; this will be the resulting entry for formetanate hydrochloride in Schedule One of the NZ (MRL) Food Standards 2008:

Compound

CAS#

Residue definition

Food

Maximum Residue Limit (mg/kg)

Formetanate hydrochloride

23422-53-9

Formetanate free base

Onions

0.2

Amendment Rationale

The proposed MRL for formetanate hydrochloride represents the registration in New Zealand of a new active ingredient. The proposed MRL will manage the new use of formetanate hydrochloride as an insecticide on onions to the application rates and withholding periods that are approved good agricultural practice (GAP) in New Zealand (see below).

Chemical Information

Common name of compound

Formetanate hydrochloride

Use of compound

Insecticide

Chemical Abstract Services (CAS) Registry number

23422-53-9

Type of compound

N-methyl carbamate

Administration method

Spray

Good Agricultural Practice

Formetanate hydrochloride is proposed for use as an insecticide for onions. Application may be on mature crops, at 0.75kgai/ha with a withholding period of 14 days.

Residues Information

Residue data for onions support an MRL of 0.2mg/kg at 14 days after the last treatment. An MRL of 0.2mg/kg is therefore proposed to support GAP.

Animal Transfer

Onions are not a primary animal feed crop. It is conceivable that failed crops may be fed to animals; however it is unlikely that detectable residues will arise in animal derived food products. Animal derived food product limits are therefore not proposed.

Dietary Risk Assessment

Acceptable Daily Intake (ADI)

0.004mg/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 formetanate hydrochloride 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 NEDI for formetanate hydrochloride is equivalent to 2% of the ADI/PDE(food). 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 formetanate hydrochloride as an insecticide for use on onions, according to the GAP specified above, is very unlikely to pose any health risks from consumption of the harvested commodity.

Other International MRLs

Compound

Food

Maximum Residue Limit (mg/kg)

The Netherlands

   

Formetanate

All foods

0.05*

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

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.

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