This consultation closed on 11 October 2024
Background
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is reviewing and updating the guidelines for determining a minor use, to ensure they remain fit-for-purpose in a modern regulatory environment.
The APVMA is seeking stakeholder feedback on the proposed draft guidelines.
We invite written comment on the draft guidelines from 16 August 2024 to 11 October 2024.
Your feedback will help us to identify ways to improve the guidance for determining a minor use. The APVMA may follow up with you for further information about your submission.
Please note: submissions will be published on the APVMA’s website, unless you have asked for the submission to remain confidential, or if the APVMA chooses at its discretion not to publish any submissions received (refer to the public consultation coversheet).
Submissions received
The APVMA sought comments from interested stakeholders on the proposed draft guidelines for determining minor use, in a consultation that closed on 11 October 2024.
The APVMA received 24 submissions from industry groups. A copy of these submissions, where consent to publish was provided, is available on our website.
Consultation feedback
Submissions concerned with access to AgVet Chemicals
A common theme in submissions was that the broader objective should be to reduce the reliance on minor use permits by having more minor uses registered. Submissions indicated a need for a pathway to move minor use permits to full product registrations.
APVMA Response
The APVMA acknowledges that Australia’s relatively small market size can be a disincentive for registrants to invest in label registration. The APVMA acknowledges the preference for registrations over minor use permits. However, new initiatives to move minor uses to label are outside the scope of the current project.
Previously, the permit-to-label project was initiated to improve access to agricultural and veterinary (agvet) chemical products by migrating uses from permits to a registered product label. Although the project has formally closed, permit-to-label outcomes are published on our website and applicants can still apply for ‘permit-to-label uses’ if the invitation remains relevant.
The Australian Government provides funding support through the Access to Industry Priority Uses of Agvet Chemicals program for industries to gain improved access to safe and effective agvet chemicals. To date, the grants have contributed to 45 new permit uses and the inclusion of 21 additional uses on an existing product labels.
Submissions concerned with data requirements for crops moving from ‘minor’ status to ‘major’
Respondents expressed concern that classification as a ‘major’ crop would greatly increase data requirements for applications. For example, the current APVMA guidance on residue trial numbers indicates 8–12 trials for major crops, 4–6 for minor-major crops and 2 trials for minor crops.
APVMA response
Under the proposed Guide for Determining a Minor Use, commodities are classified as ‘major’ solely for the purpose of determining minor use criteria under subsection 112(2)(e) of the Agvet Code and regulation 57(2)(a) of the Agvet Code Regulations.
This classification should not be conflated with registration data guidelines (for example, residues data guidelines) or risk assessment requirements. Crops that are considered ‘major’ under the minor use guidelines due to their economic value are not necessarily considered ‘major’ for the purposes of risk assessment due to other factors, such as export volume, dietary consumption, and degree of risk involved in extrapolating data from trials to commercial practice.
The Residues data guidelines provide specific information on the recommended number of trials per crop, and the major-minor designation is provided as general guidance only. Regardless, data requirements for all proposed uses will be considered on a case-by-case basis.
Submissions concerned with a transition period for affected industries
A 5 year transition plan was proposed by industry groups for commodities moving from ‘minor’ status to ‘major’ status.
APVMA response
Implementation of the new guidelines will be accompanied by a 12 month phase-in period, as outlined in the transition map.
Submissions suggesting alternative guidelines for minor use
Several submissions posited that minor use determination should rely on whether there is a genuine, unmet need, rather than economic analysis. Other suggestions were to replace the guidelines with the Permits 6A Guidelines. These submissions suggested that the proposed guideline is not necessary and would increase regulatory burden for applicants.
APVMA response
The Agricultural and Veterinary Code Regulations 1995 state that a minor use:
- in relation to a chemical product or an active constituent, is a use of the product or constituent that would not produce sufficient economic return to an applicant for registration of the product to meet the cost of registration of the product, or the cost of registration of the product for that use, as the case requires (including, in particular, the cost of providing the data required for that purpose).
Changes to this definition were not within the scope of this project. Therefore, the guidelines must reflect the definition of minor use under the legislation, that is, pertaining to economic return. Other areas of the legislation (section 112(2)(f) of the Agvet Code) address a lack of suitable registered alternatives. The Permits 6A Guidelines work in conjunction with the Guide for determining a minor use to provide guidance to applicants and staff on interpreting legislative requirements as they relate to permits.
The list of major crops, animals and situations under Section 1 of the Guide serve to reduce regulatory burden by streamlining the determination of minor use status for minor crops, animals and situations. This decreases the amount of information that must be provided by applicants and reduces assessment time for the regulator. Without this list, all applications would need to demonstrate that the use would not produce a sufficient economic return by other means. As sufficient economic return can be a subjective concept, these guidelines provide a framework by which to justify minor use as it relates to the definition under the AgVet Code.
The suggestion that if unmet needs/uses were major uses, then the commercial sector would be registering, or have already registered, products to service these needs creates a circular argument. The minor use pathway imposes less regulatory burden in terms of cost and data requirements, so if misused it may disincentivise registration. The purpose of the guidance is not to restrict access to AgVet chemicals but to ensure appropriate pathways are available, when needed, without undermining the integrity of the registration system.
Submissions concerned with guideline development and appropriate proxies for ‘economic return’
Several submissions requested a clearer explanation for how guidelines were developed, including how criteria for determining minor use were chosen and applied. Other submissions noted that while the area under cultivation and production volumes are useful metrics, they should not be the sole determinants for classifying crops as major or minor.
APVMA response
The metrics used to develop the proposed list of major crops, animals, and situations are current statistics regarding volume of production, area under cultivation or numbers of trees or animals and the value of crop or animal. These statistics were sourced from the Australian Bureau of Statistics (ABS), Australian Bureau of Agricultural and Resource Economics (ABARES), and industry reporting, where available. The values used to develop the matrix in Table 2 are derived from current industry statistics for major and minor commodities. The values chosen differ between broadacre and horticultural crop use to reflect the different nature of the cropping systems and the market for agricultural chemicals.
Dietary consumption and export quantities were not considered in developing the guideline. These are important metrics for risk assessment but do not provide meaningful insights into the potential for economic return on registration.
The APVMA acknowledges that production volumes should not be the sole determinants for classifying uses as major or minor. This is why further guidance is provided in sections 2 and 3 of the guidelines on limited use and economic return.
Submissions concerned with veterinary-specific guidance material
Several respondents noted that veterinary medicines are used in different ways and for different reasons to agricultural products, such that the criteria to determine minor uses in one sector are not necessarily applicable to the other sector. Minor uses to address animal health and welfare needs may be more effectively supported through veterinary-specific guidance material.
APVMA response
The current guidance addressed both agricultural and veterinary uses. The definition of minor use in the Regulations is the same for both agricultural and veterinary chemical products. Creation of separate guidance material would result in duplication. However, the APVMA recognises the need for further guidance around uses in companion animals, as the ‘value’ of this ‘commodity’ can be difficult to quantify. This is noted as an area for future work.
Submissions concerned with requirement to submit a Pre-Application Assistance (PAA) application
The draft guidance mandated the use of a Tier 2 PAA to demonstrate insufficient economic returns under Section 3. Concerns were raised around the cost of the PAA application, which is greater than the cost of a minor use permit. There are no rebates on application fees for PAAs related to minor use permits. This was seen as a potential deterrent to seeking minor use permits.
APVMA response
The intention of the mandatory PAA was to ensure applicants understood the level of assessment required for registration so they could accurately predict costs of data generation and registration fees. The PAA requirement has been changed to a recommendation and is strongly advised for new applicants or those unfamiliar with the registration process. The APVMA will accept a substantial argument (including full costs and projected incomes associated with a particular use covering a period of no less than 3 years) under Section 3 without a PAA but may request further information or refuse the application if estimated costs of registration do not accurately reflect the level of assessment required.
Notes on certain commodities
Olives
Olives were proposed for inclusion as a major crop based on ABS statistics which put the industry as comparable in scale and value to other major tree crops.
In response to the consultation, the Australian Olive Association presented data from the Centre for International Economics illustrating that the value of Australian olives is much less than estimated for other major tree crops. Due to the nature of the industry and the requirement for commercial growers to have infrastructure to process olives into olive oil, smaller producers may not run commercially to full potential. This means the number of trees is not a good indicator of industry size.
The response also highlighted challenges unique to olives. Olives are grouped in Group 005 Assorted Tropical and Sub-Tropical Fruit – Edible Peel. However, they are grown in Mediterranean climates which means extrapolation to olives is not always appropriate, increasing data requirements for registration.
In addition, chemical use by the Australian olive industry is low and would not be attractive to chemical companies for investment in chemical registration. This is reflected by the lower number of registered products available for olives (~500) compared to other tree crops (~1000 +).
APVMA Response
Olives will not be listed as a major crop in the updated guidelines.
Organics
Australian Organic Limited (AOL) raised concerns that reclassification of crops as major could limit the availability of Minor Use Permits.
APVMA response
The draft guidelines do not explicitly distinguish organic farming from non-organic farming. However, this does not mean that the requirements of organic producers are not considered "minor use.”
As the organic industry is considered a limited sector, use of organic products in ‘major’ crops can be considered a limited use under Section 2 of the guidance.
Salmon
Several respondents raised concerns over the proposed re-classification of Salmon as a major animal species.
Concerns were raised that restricting the available options to the salmon industry by making registration necessary, or the process of acquiring MUPs more onerous, could be detrimental to the industry and affect the health and welfare of fish.
APVMA response
Based on feedback from consultation, the proposed listing has been amended from ‘Salmonids’ to ‘Atlantic Salmon’, recognising that trout and other salmonids are minor contributors to the industry and may have different registration data requirements.
Registration is the preferred pathway for veterinary medicines to ensure the safety and efficacy of products and welfare of animals. Registration also provides certainty to industry as it provides more stable access to veterinary medicines. The minor use pathway should only be used where appropriate.
The APVMA acknowledges that veterinary medicine use in salmon is different to that of terrestrial animals. However, there are a number of veterinary chemicals (for example, antibiotics) that are used in significant volumes in aquaculture and could feasibly be registered for this use. Where products are used sporadically, in small volumes or a small number of fish, an application can be made under Section 2 of the guidance.
Respondents suggested that vaccines would be outdated before the registration process was complete. The APVMA notes that the same safety, efficacy and trade criteria apply to minor use permits as to registration, and lead times for data collection and assessment should not differ significantly.
In addition, any updates to vaccines such as changes to strains or adjuvants must still be reflected in permit updates, including appropriate supporting data and assessments. It has not been the experience of the APVMA that changes are made frequently or urgently.
Raspberries
Raspberries were proposed for inclusion as a major crop on the basis of the growth of the industry and high value of the crop. Based on feedback from consultation, it is recognised that globally, the Australian market for agricultural chemical products is minor. Available statistics indicate raspberries should be reconsidered as minor.
APVMA Response
Raspberries will not be listed as a major crop in the updated guidelines.
Blueberries
Concerns were raised by the blueberry industry that classification as a major crop will add additional barriers to accessing relevant agvet chemicals, and loss of access to chemicals under permits which are due to expire.
APVMA Response
Classification as a major crop does not preclude issue of a minor use permit. Under Section 2, minor use permits can be issued to provide for appropriate uses for specific chemicals, or unmet crop protection needs. The APVMA has developed a transition plan for the implementation of the new guidelines to ensure access to critical agvet chemicals is not lost.
Lemons
Lemons were proposed for inclusion as a major crop based on the growth of the industry and its status as a representative crop for the citrus group. In response to consultation, Citrus Australia noted that of the approximately 1,800 ha of lemons planted nationally, only approximately one-third (600 ha) are of baring age. In addition, Lemons are grown in every Australian mainland state and territory with each region having unique pest and disease challenges and therefore agrichemical use patterns. Based on the provided statistics and cropping situations, the status of lemons has been reconsidered.
APVMA Response
Lemons will not be listed as a major crop in the updated guidelines.
Cucumber, Zucchini and Celery
Concerns were raised that reclassification as a major crop would result in increased data requirements for registration, and loss of access to chemicals under permits which are due to expire.
APVMA Response
As outlined above, classification is for the purposes of minor use permits only and does not directly correlate with registration data guidelines. In addition, classification as a major crop does not preclude issue of a minor use permit, and the APVMA has developed a transition plan for the implementation of the new guidelines to ensure access to critical agvet chemicals is not lost.
Cucumber, zucchini and celery were proposed for re-classification partly because they are produced on a similar scale to other major crops including capsicum and asparagus. A search of PubCRIS indicates that a similar number of products are registered for use in celery (~420), zucchini (~570) and cucumber (~620) as for capsicum (~530) and other major crops including pumpkins (~580) and carrot (~440). While this is not a nuanced approach to the availability of crop protection solutions for specific pest or disease problems, it does indicate that these crops do not lack incentive for product registration in general. Therefore, the proposed reclassification is appropriate.
Bees
Bees were not originally included in the consultation on the draft Guidelines as there has historically been little need for bee protection products in Australia. However, since the incursion and establishment of Varroa mite (Varroa destructor) in Australia, there has been increased interest in permits and registrations for bee protection products.
Based on 2023 industry statistics, there are 630,000 commercially managed hives in Australia with a total of about 1,870 commercial beekeepers. The farmgate value totals $640 million with $365 million attributed to commercial operations (1).
However, the industry has experienced contraction in areas affected by Varroa mite and this trend is expected to continue as the pest spreads.
Based on current industry trends, bees are not considered a major species at this time. This decision was based on the following factors:
- The primary market for agvet chemicals in bees in Australia is for Varroa control
- Globally there are a limited number of products/modes of action available
- There are already significant efforts to register these products in Australia
- Only a limited portion of the industry is currently affected by Varroa and spread is expected to be slow and controlled
Therefore, until Varroa is geographically widespread, the actual market for bee protection products in Australia can be considered minor. However, this may be revised in future.
Revisions to proposed guidelines
Following consultation, the following revisions have been made to the proposed guidelines:
- Remove raspberries, lemon, and olives from the proposed list of major crops
- Clarify ‘green peas’ to exclude snow peas and sugar snap peas
- Revise ‘Salmonids’ to ‘Atlantic Salmon’ in the list of major animal species
- Clarify that the matrix in Section 2 does not apply to companion animals
- Revise medium and high parameters for number of poultry and mammals in Table 2 to better reflect size of the national flocks/herds
- Clarify that the production quantity of ‘other’ animals in Table 2 includes fish
- Revise the requirement for a PAA under Section 3 to a recommendation
Next steps
The new guidelines will come into effect on 5 August 2025. Prior to this, the APVMA will engage with permit holders to manage the transition to the new guidance.
References
1. Clarke, Michael and Le Feuvre, Danny. Size and scope of the Australian honey bee and pollination industry. s.l. : Agrifutures Australia, 2024.