Keeping ACVM users, importers, and manufacturers up to date ✉️👍 No images? Click here Welcome to our November edition of the ACVM News & Views newsletter. In this month’s edition we will cover:
ACVM Christmas cut-off dates for 2024 As we near the end of 2024, please be aware of the below cut-off dates for applications submitted to the Agricultural Compounds and Veterinary Medicines (ACVM) teams. These dates will also be in the email signatures of the Operations Team and the automatic reply from the Approvals inbox. New Zealand Food Safety (NZFS) will endeavour to process ACVM applications prior to Christmas. Applications must be submitted by 12 noon, Monday 2 December 2024 to be considered for the last pre-screen of 2024. For any applications submitted after this date, you may not be notified of the pre-screen outcome until after 16 January 2025. Should the need arise for us to request further information, your application is unlikely to be approved prior to 16 January 2025. For all other applications received after 12 noon Monday 2 December, these may not be processed until the new year. Welcoming Josie Weston to the Veterinary Medicines Assessment team Josie Weston, who many of you will know from her role in the Approvals Operations team, is starting a new role as an Adviser in the Veterinary Medicines Team. Josie started her new role on Monday 4 November and will initially be focussing on Class Determination applications. Below are a few word from Josie to introduce herself. I hold a Bachelor of Science in Zoology and Animal Science from Massey University and a New Zealand Certificate in Animal Management - Captive Wild Animals. Since finishing my studies, I spent time as a manager and nutritional advisor for a raw pet food company, and most recently have been a Senior Advisor in the Operations team. I’m excited to be making the move from an advisor handling ACVM applications to be getting stuck in on the assessments side. In my spare time you can find me with my horse Riley where we compete in the local circuits and if I’m not at the horses I enjoy time travelling and hanging out with friends and family. Updated Chemistry & Manufacturing Information for Agricultural Chemicals Guideline comes into effect from 11 November 2024 Earlier in May, the new ACVM Guidance for Chemistry and Manufacturing Information for Agricultural Chemicals was published. The updated requirements will come into effect from 11 November 2024. The following related templates and documents will be updated to align with the new guidance and will be available on our website from that date:
From 11 November 2024, all agricultural chemical chemistry and manufacturing volumes will be assessed against this new document. However, we know that some testing is underway or has been recently concluded using the requirements of the previous standard, so a transition period of 1 year (until 11 November 2025) will be adopted. During this time, chemistry and manufacturing data can be submitted with testing components conducted prior to 11 November 2024 which will be considered against the old requirements. This will be required to be noted in the application. Information submitted after 11 November 2025 generated using the old requirements will be considered on a case-by-case basis where justification has been provided. As there will be a new PDS template for use, we request that you please convert your PDS for all your registered products to the new template at your next variation or registration renewal application. New guidance will be available on how to fill out the new PDS template. There were 32 reports of potential or confirmed non-compliant ACVM products or activities received in September to mid-October 2024: Inhibitor update Maggie Wuerz, Senior Adviser Inhibitors has finished her role with ACVM in October. Recruitment is currently underway to fill this position. In the interim, if you have any inhibitor related queries, please send these to Amanda McKay (amanda.mckay@mpi.govt.nz) for Agricultural Chemicals or Stacey Northover (stacey.northover@mpi.govt.nz) for Veterinary Medicines. AMR team update World Antimicrobial Resistance Awareness Week (WAAW) 18-24 November This year, the World Health Organization’s global theme for World AMR Awareness Week is Educate. Advocate. Act Now. We are using this opportunity to promote the importance of vaccinating pets and livestock to prevent infections that may require antibiotic treatment, and for the horticulture sector, the importance of having an integrated pest management strategy in place. We encourage you to take part in this year’s campaign by promoting WAAW in your stakeholder newsletters and on your social media channels. Check out the AMR Education and Resources section on our website where we’ll be adding more resources, including social media tiles and a poster highlighting the importance of vaccinating animals to protect all family members. If you’d like help developing material specific to your stakeholders contact the AMR team amrteam@mpi.govt.nz. AMR in the world news recently World leaders commit to decisive action on antimicrobial resistance – New York, 26 September – Global leaders have approved a political declaration at the 79th United Nations General Assembly (UNGA) High-Level Meeting on Antimicrobial Resistance. The declaration commits to a clear set of targets and actions for human health, agriculture and animal health and the environment. On agriculture and animal health, the declaration has commitments to, by 2030, meaningfully reduce the quantity of antimicrobials used globally in the agri-food systems by prioritizing and funding the implementation of measures to prevent and control infection and ensuring prudent, responsible and evidence-based use of antimicrobials in animal health. New Zealand is already well placed in achieving the goal of reducing antimicrobial use in agriculture and animal health, as demonstrated in the 2023 Antibiotic Agriculture Compound Sales Analysis. This shows a reduction in antibiotic sales for use in animals and plants for the 6th consecutive year, and a 46% reduction in critically important antibiotic sales since 2022. Global Research on Antimicrobial Resistance (GRAM) published phase 2 of their project in the Lancet, 28 September, which marks a significant advance in global research on antimicrobial resistance. It makes for sobering reading - new estimates reveal that 39 million deaths directly attributable to bacterial antimicrobial resistance will occur between 2025-2050, which equates to three deaths every minute. Global burden of bacterial antimicrobial resistance 1990–2021: a systematic analysis with forecasts to 2050 - The Lancet The Institute for Health Metrics and Evaluation (IHME)/University of Oxford MICROBE visualisation has updated an interactive tool with GRAM 2 estimates available here: VizHub - MICROBE (healthdata.org) Also released prior to the UNGA High-Level meeting was the EcoAMR series (Health and Economic Impacts of AMR in Human and Food-Producing Animals), led by the World Organisation for Animal Health (WOAH), which used the latest data from 204 countries and 621 subnational locations to forecast the impact of AMR on mortality, health care costs, food security and the global economy. The EcoAMR series estimates that about 39 million people could die due to AMR by 2050, especially older people and those in low- and middle-income countries. This study is consistent with the results from the GRAM project. Together, these findings provide a complete picture of the critical global threat posed by AMR. Drug-resistant pathogens could jeopardise the food supply of over two billion people and increase health care costs by US$ 159 billion annually by 2050. The analysis is the first to comprehensively forecast the economic and health burdens of AMR on both humans and food-producing animals. It also found a return of US$ 28 for every US$ 1 invested if urgent action were to be taken now. ACVM applications approved in September 2024 Agricultural chemicals application update As of 25 October, there were:
In the queue, there are:
The team continues to manage the balance between the screening of incoming new applications, continued work on in-progress appraisals, and picking up new applications. More than half of the applications in the queue (64%) are for new products (12 A-type, 13 B-type). An additional nine applications (23%) in the queue are new use/use-change (C4-C8) applications. Collectively, these applications (which make up 87%) take much longer to assess and therefore constitute a significant amount of work for the team. Veterinary medicine application update As of 25 October, there were:
In the queue, there are:
The Veterinary Medicines queue remains largely compact, with the oldest application in the queue due to complete technical appraisal on 26 August 2024. The queue remains largely made up of chemistry and manufacturing variation applications, making up 70% of the queue. A significant portion of these applications, once picked up for assessment, have at least 1 RFI due to missing information/data. The requirements are outlined in the ACVM-79 form, and further detail is in our guidance documents. All of the relevant forms and guidance documents can be found on our website here. Submission of complete applications allows for a more efficient assessment, less RFIs and a shorter overall assessment time. Thank you to applicants who are already doing this. Update on the Food Residue Survey Programme The Food Residue Survey is a long-standing annual programme run by NZFS. The programme objective is to monitor agricultural chemical residues in plant-based foods grown and imported for sale in New Zealand. The programme helps check that:
NZFS uses the Codex Alimentarius classification of commodities as a basis for the types of foods to be sampled in the programme. Each year between five to seven of these commodity classes are selected for sampling and testing. The 2022/23 FRSP final report has been published on the New Zealand Food Safety (NZFS) website at: Food Residues Survey Programme Report 2022-2023 (mpi.govt.nz) The 2022/23 programme focused on ‘bulb vegetables’, ‘brassicas’, ‘stalk and stem vegetables’, ‘fruiting vegetables’, ‘leafy vegetables’ and ‘herbs and spices’ from domestic and imported sources. Altogether, NZFS collected 300 samples and tested each sample for more than 500 agricultural chemical residues between July 2022 to June 2023. There were 22 domestic samples that did not comply with the applicable Maximum Resides Levels for agricultural chemical residues. These results do not represent a food safety risk to consumers. The root causes of the non-compliances found in domestic samples were traced back to:
NZFS follows up on every non-compliant result and works with the New Zealand food businesses on a case by case basis. When choosing a suitable agricultural chemical product for the control of pests or diseases, some growers have confirmed that they asked their sales representatives for recommendations. It was noted that that growers did not always understand that when they are using a permitted agrichemical product in an off-label manner, they are responsible to ensure that the residues on their crops will comply with the New Zealand default Maximum Residue Level of 0.1 mg/kg. NZFS would like the Product sale representatives to remind their customers and users that it is important that:
The FRSP reports are available on the MPI website: (Documents for Food Residues Survey Programme | NZ Government (mpi.govt.nz) The 2024/25 Food Residues Survey Programme sampling plan Sampling and testing of domestic and imported plant-based foods for the 2024/25 Food Residues Survey Programme (FRSP) has begun on the 1 July 2024 and will end by 30 June 2025. The survey will collect altogether 300 samples from selected Codex commodity classifications and test for agricultural chemical residues. This survey will sample crops that include fresh, frozen and minimally processed fruits and vegetables from various points of sale. More details can be found here: Food Residues Survey Programme 2024/2025 Sampling plan (mpi.govt.nz). Contact Us ACVM Team, Assurance, New Zealand Food Safety / Haumaru Kai 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) |