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

10 Proposal to set MRLs for Spinosad

It is proposed that MRLs are set for Spinosad when used as an ectoparaciticide for sheep. It is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended by deleting the following entries:

As a replacement for the deleted entry it is proposed that Schedule One of the NZ (MRL) Food Standards 2008 be amended to include the following:

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

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

Amendment Rationale

The proposed MRL represents the setting of a New Zealand MRL for spinosad in sheep offal and fat that will be harmonised with MRLs set internationally by Australia, the European Union and by the Codex Alimentarius Commission.

Chemical Information

Good Agricultural Practice

Spinosad is currently approved for use as a topical ectoparaciticde for sheep for treatment of lice and flystrike. No change to the current good agricultural practice is proposed however the incorporation of the proposed MRLs may allow a reduction in the withholding period allowing greater flexibility in the use of the product.

Residues Information

The proposed MRL has been determined by Codex to represent a suitable international standard for residues

Dietary Risk Assessment

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 PDE_(food) is a value set by the Environmental Risk Management Authority (ERMA), which represents the proportion of the acceptable daily exposure (ADE) to a substance via the food route as relevant to the New Zealand population. The methodology for calculation of these values is set out in the Hazardous Substances (classes 6, 8, and 9 controls) regulations 2001 and can be found at www.legislation.govt.nz.

The chronic dietary exposure to spinosad 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 spinosad is equivalent to 3.8% 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 spinosad as an ectoparaciticide for use on sheep 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.