ACVM workshop in Wellington

This year’s workshop will be held at Te Papa, Wellington, on Wednesday 31 July, the day before the planned Animal Plant Health New Zealand (APHANZ) Annual Conference.

The workshop is scheduled to run from 9am to 4pm, with tea and coffee available from 8.30am. Please see the draft agenda for the workshop below.

A link to register for the workshop will follow.

Monitoring for AMR in food animals

In accordance with the World Organisation for Animal Health (WOAH) recommendations, New Zealand Food Safety (NZFS) has started an ongoing surveillance programme for antimicrobial resistance (AMR) in bacteria that pose a human or animal health risk, isolated from animals.

Surveillance and monitoring of antimicrobial resistance is necessary to:

• Assess and determine the trends and sources of antimicrobial resistance in bacteria; detect the emergence of new antimicrobial resistance mechanisms.
• Provide the data necessary for conducting risk analyses as relevant to animal and human health.
• Provide a basis for policy recommendations for animal and human health.
• Provide information for evaluating antimicrobial prescribing practices and for prudent use recommendations.
• Assess and determine effects of actions to combat antimicrobial resistance.

The NZFS AMR surveillance and monitoring programme tracks levels of antibiotic-resistant bacteria in New Zealand animals. Bacteria collected from poultry, pigs, calves, and dairy cattle sent to meat-processing plants are being tested for antibiotic resistance. One-off surveys from lower-risk species, such as sheep, are also being undertaken. The surveillance programme will target one species each year on a rotating basis.

NZFS is also tracking antibiotic-resistant bacteria from live animal samples sent to veterinary diagnostic laboratories. This surveillance covers both production and companion animals. NZFS will start publishing results from the programme on the AMR webpage, starting in 2024.

The surveillance programme builds on results from previous NZFS AMR surveys.

The most recent survey carried out between 2018-2022 has been published in the Journal of Food Protection. It was carried out by The Institute of Environmental Science and Research (ESR) and was codesigned and funded by NZFS. The survey found that AMR in food animals in New Zealand poses a limited public health risk due to low levels of resistance to critically important antibiotics used in humans.

The full study is available here: Antimicrobial Resistance in Selected Bacteria from Food Animals in New Zealand 2018–2022 – Science Direct 

For more information and resources about AMR, visit the MPI AMR webpage.

Inhibitor update

ACVM continues to process four inhibitor applications. These products are all urease inhibitors that prevent the release of ammonia into the atmosphere. ACVM has not received any applications for methane inhibitor products. Additionally, 41 research trials have been approved by ACVM for urease, nitrification, and methane inhibitors.

Warren Hughes, Principal Advisor ACVM and Maggie Wuertz,Senior Advisor Inhibitors gave a joint presentation at the Mooving on Methane event held by Venture Taranaki on 28 May 2024.

The methane inhibitor guidance document, which was published in November 2022, was amended on 31 May 2024 to include clarification that ACVM will consider qualitative label claims. This is in contrast to previous guidance, which indicated that methane inhibitors needed to come with a quantitative claim. Qualitative claims must still be backed by data.

Reassessment of antibiotic-based trade name products

New Zealand Food Safety (NZFS) is undertaking a reassessment programme to re-evaluate the regulatory controls applied to antibiotic-based trade name products registered under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997.

The reassessment programme has been divided into four tranches:

• Tranche 1: later generation cephalosporins, macrolides, and penicillins.
• Tranche 2: veterinary and horticultural aminoglycosides, first and second generation cephalosporins, fluoroquinolones, and lincosamides.
• Tranche 3: fusidic acid, polypeptides (polymyxin and zinc bacitracin), sulphonamides/diaminopyrimidines and tetracyclines.
• Tranche 4: amphenicols, nitrofurans, nitroimidazoles, pleuromutilins, and streptogramins.

The reassessment of antibiotic-based trade name products captured by tranche 1 has been completed. The outcomes of these reassessments, including importance classifications, are published on the Ministry for Primary Industries’ Antimicrobial Resistance (AMR) webpage.

The reassessment of antibiotic-based trade name products captured by tranche 2 will be proposed in the next two months. Affected registrants will be advised of the proposal and the scope of the tranche at that time, and reassessment applications will be requested once the consultation period has been completed.

Without prejudging the outcomes of the reassessment, it is expected that antibiotic-based trade name products will require changes to their product labels to reflect importance classifications and revision of certain aspects of their product claims and label information as per the outcomes of tranche 1. These changes are likely to include:

• A clear label statement identifying the importance classification.
• Revised product claims to ensure a target organism and/or clinical disease relative to the target species is included in the indications of use, as needed.
• Revised dosing information to include appropriate treatment intervals and durations, as needed.
• Inclusion of the standardised prudent use statement applicable to the product’s classification ranking.

Information on how these changes apply to each affected trade name product, and any other product-specific changes required as an outcome of the reassessment, will be provided to ACVM product registrants once individual product appraisals have begun.

Because the re-appraisal of approved uses and risk profiles for each antibiotic compound will have a direct impact on what is considered good agricultural practice (GAP) for that compound post-reassessment, a review of the applicable maximum residue levels (MRLs) and withholding periods will also be incorporated in the reassessment.

Agricultural chemical product labels 

Before making an application, please check that your label is up to date with the labelling guidance ‘Labelling Agricultural Chemicals’ and any relevant position statements (which can be found in ‘Documents for Agricultural Chemicals’ under ‘Non-registration documents – Manufacturing, sale, and use’). This particularly applies to:

• Correct wording for registration statements
• Application rates (whether /100L water or /ha)
• Leaf-plucking statements for products used in vineyards, other than herbicides. (Note: This does apply to MRL exempt products)
• Products with ‘0 day’ WHPs
• Products with claims for use in pasture
• Including a Resistance Management Statement.

Herbicides and plant-safety data

A quick reminder that the provision of dedicated plant-safety trials (in the absence of weeds and separate from the efficacy studies) is a default expectation in support of new herbicides registrations and applicable herbicide variation applications (e.g. addition of a new crop/use situation or some changes in timing). Plant-safety trials should also include a suitable industry standard, examine the effect of both 1X and 2X rates, and include a suitable assessment of yield/crop quality.

If you believe a deviation from these expectations is appropriate, robust technical arguments (and any information supporting your position) should be included in your submission. If no dedicated studies or appropriate technical arguments are included, it is likely that your application will be rejected at pre-screen. Note, acceptance at pre-screen does not necessarily mean that an argument will be sufficient.

Dedicated plant-safety trials are not a default expectation for insecticides or fungicides and, in most cases for those product types, crop-safety assessments can be included in the efficacy trials. However, if damage is observed in efficacy studies (in association with the proposed use pattern), specific plant-safety trials should be undertaken to more closely examine the extent and nature of damage that could be experienced. There may also be specific situations where additional information is required (e.g. information examining the effects of seed treatments on germination).

Further information is available in the Pesticides efficacy and crop safety general guideline (Part 8) and the European and Mediterranean Plant Protection Organisation (EPPO) guidance on  Phytotoxicity assessment.

Compliance update

The number and status of incidents received in April 2024 (Total 23):

Reassessment update

Brodifacoum

Work continues to review, summarise and respond to all of the submissions from the public consultation (which closed on 26 January 2024) on the proposed changes to the regulatory controls covering the manufacture, sale, storage and use of brodifacoum. This document will be shared with all submitters once finalised. This is expected to be by end of July 2024.

There is still a significant amount of work to be undertaken by NZFS before a decision is reached on whether to progress with the proposed reassessment of brodifacoum; and there will be further engagement with industry and stakeholders beforehand. This includes plans to hold one (or more if required) workshops for submitters and industry etc to talk through areas of concern and NZFS response to these. The workshop(s) would be held once the ‘Summary of Submissions’ document is finalised.

Once NZFS is able to fully review all of the submissions, there will be a further opportunity for NZFS to modify the current proposed changes (to the regulatory controls covering the manufacture, sale, storage and use of brodifacoum), in response to the feedback received in the submissions if deemed appropriate, before making a decision on whether to progress with the reassessment. NZFS would engage with submitters, industry and stakeholders on any further changes.

A dedicated page on the website to share all the relevant information and ongoing updates in relation to this area of work is being developed. This expected to go live this month. The link to this will also be shared in the next issue of News & Views.

ACVM & APVMA joint position statement on harmonised vet med labels

Together, ACVM and the Australian Pesticides and Veterinary Medicines Authority (APVMA) have written a joint position statement on the harmonisation of veterinary medicine labels. This position statement aims to clarify the requirements for harmonised labels between Australia and New Zealand to be approved, and also includes examples of specific situations.

This position statement is in the final stages before being published on both the ACVM and APVMA websites. Publication of the joint position statement can be expected in the coming weeks.

Contact Us

ACVM Team, Assurance, New Zealand Food Safety / Haumaru Aotearoa

Pastoral House, 25 The Terrace

PO Box 2526

Wellington 6140

New Zealand

Email approvals@mpi.govt.nz  

Website Agricultural compounds and veterinary medicines (ACVM) | Agriculture | NZ Government (mpi.govt.nz)