SUMMARY OF SUBMISSIONS RECEIVED ON PROPOSED AMENDMENT NO. 2 TO THE NEW ZEALAND (MAXIMUM RESIDUE LIMITS OF AGRICULTURAL COMPOUNDS) FOOD STANDARDS 2007

ISBN 978-0-478-31182-2 (Print)

ISBN 978-0-478-31183-9 (Online)

ISSN 1176-1652 (Print)

ISSN 1178-5985 (Online)

Proposal

Submitters

Comments

NZFSA Response

Proposals to set an MRL of 0.1mg/kg for abamectin when used as an insecticide for tomatoes.

Two public submitters and one Community group.

Each submitter expressed concern regarding the proposal to increase the MRL for abamectin on the basis of potential toxicity.

NZFSA proceeded with the recommendation to the Minster on the following grounds:

- The proposed MRL has been assessed in accordance with international methodologies such as those utilised by the expert committees advising the Codex Alimentarius Commission;

- NZFSA has concluded that the use of abamectin, within the limits of the proposed MRL, does not pose a risk to public health; and

- The increase in the MRL for abamectin in tomatoes is required to allow for the use of this compound in glasshouse production. Abamectin is used internationally for insect and mite control in crops and for parasite treatment of animals. It is naturally derived from the soil bacteria streptomyces avermitilis. Up until 2005, there was no New Zealand MRL specified for abamectin in tomatoes. This meant that residues of up to 0.1mg/kg were permitted (refer MRL Standards Section 6). In 2005, NZFSA reassessed abamectin and determined that its use in field-grown tomatoes, in accordance with good agricultural practice (GAP), would result in no residues at harvest. As part of the policy of setting MRLs at the limit of analytical quantification in order to monitor GAP, the limit for abamectin in field-grown tomatoes was reduced to 0.02mg/kg (this is the current Codex MRL for abamectin in tomatoes). Following this, new data was provided to indicate that when abamectin was used in tomatoes grown in glasshouses in accordance with GAP, slightly higher residues were likely. It was therefore proposed that the MRL be set at 0.1mg/kg for glasshouse use of abamectin in tomatoes. This permitted level of abamectin residues in tomatoes has been assessed relative to the consumption of tomatoes in New Zealand and was found to pose no toxicological health risk.

Proposals to set an MRL of 1mg/kg for spinosad when used as an insecticide for stonefruit.

Two public submitters and one Community group.

Each submitter expressed concern regarding the proposal to increase the MRL for spinosad on the basis of potential toxicity.

NZFSA proceeded with the recommendation to the Minster on the following grounds:

- The proposed MRL has been assessed in accordance with international methodologies such as those utilised by the expert committees advising the Codex Alimentarius Commission;

- NZFSA has concluded that the use of spinosad, within the limits of the proposed MRL, does not pose a risk to public health; and

- Spinosad is used internationally and is considered as a ‘risk reducing’ compound relative to older chemistries. Spinosad has been specifically attributed ‘risk reducing’ status in Canada and the United States. As spinosad is naturally derived from bacteria, it has been permitted for use in organic production by the United States Department of Agriculture. The MRL proposed for spinosad in stonefruit will allow the compound to be used closer to harvest in accordance with GAP. Insect and pest control is necessary in this stage of fruit development. As spinosad is considered to be of very low toxicity, there is no risk to public health associated with consumption of stonefruit containing spinosad residues within the MRL.

Proposals to set an MRL of 0.05mg/kg for pyrimethanil when used as a pre-harvest fungicide for apples.

One international agency.

The submitter expressed interest in harmonising new MRLs, where possible, and noted the following:

- the equivalent US MRL is 3.0mg/kg;

- in the US pyrimethanil is registered for both pre-harvest and post-harvest uses; and

- the proposal may cause a barrier to trade.

- NZFSA notes that in 2007 the Joint Meeting on Pesticide Residues (JMPR) proposed a range of pyrimethanil MRLs for consideration by the Codex Committee on Pesticide Residues (CCPR) in April 2008. These proposals include an MRL for apples (pome fruit) of 7.0 mg/kg. It is anticipated that these MRL proposals will be adopted by the CCPR by the end of 2008;

- NZFSA did not proceed with the recommendation to the Minster at that time and will reconsider setting an MRL subsequent to the CCPR decision; and

- In the meantime, the status quo remains i.e. all imported and domestically produced food (e.g. apples containing pyrimethanil residues) must comply with the default MRL of 0.1mg/kg if there is no relevant MRL set under the MRL Food Standards or set and published by Codex (refer MRL Standards Section 6).

Proposals to exempt microbial pesticide organisms (MPOs) from the MRL Standards provided the MPO:

- is registered under the ACVM Act;

- is intended for use as a plant compound;

- leaves no quantifiable residue of toxins or metabolites exceeding that of expected background levels; and

- has been determined to be non-pathogenic or non-toxic to humans.

One industry association.

This submitter expressed concerns regarding the proposed exemption for MPOs, particularly those that are genetically modified.

NZFSA proceeded with the recommendation to the Minster on the following grounds:

- NZFSA considers that the Environmental Risk Management Authority of New Zealand (ERMA) process, coupled with NZFSA processes under the Agricultural Compounds and Veterinary Medicines Act 1997 (ACVM Act), offer suitable protection for consumers from the consumption of pathogenic and/or toxic residues resulting from primary production. For example:

- NZFSA notes that ERMA is required, under the Hazardous Substances and New Organisms Act 1996, to undertake assessments of hazardous substances and new organisms. This includes MPOs (including those that are genetically modified) as appropriate; and

- If a product (including an MPO) is defined as a hazardous substances or new organism, assessments of pathogenicity and/or toxicity and an approval by ERMA are a prerequisite for NZFSA to issue registration of that product under the ACVM Act. ERMA assessments are also required before such products are eligible for exemption under the MRL Standards.

- The exemption for MPOs is intended to ensure the MRL Standards are as science-based as feasible. Because MPOs are not single chemical substances they cannot be measured against a set chemical concentration limit, as in for example a science-based mg/kg measure. Because of this, in the past NZFSA has considered it suitable to individually exempt MPOs (e.g. bacillus subtilis) from the MRL Standards. However, it has now been determined that a generic MPO exemption is appropriate, provided strict conditions are met (Importantly, NZFSA still has the ability to set MRLs for individual MPOs, if necessary. This is particularly so if a specific chemical residue can be attributed to the MPO). As part of the product registration process that is required under the ACVM Act, it must be demonstrated that the product will be used in accordance with GAP. As MPOs are not single chemical substances, this generic MPO exemption (subject to meeting the criteria) will remove the inconsistencies in the MPO product registration process by providing a set of strict criteria by which the MPO’s residue status can be determined.