The reconsideration process comprises legislative, administrative and scientific elements that lead to a final regulatory decision as to the ongoing registration of an agricultural and veterinary chemical product. Reconsiderations are often complex processes relying on component inputs from diverse groups both internal and external to the Australian Pesticides and Veterinary Medicines Authority (APVMA).
Figure 1 illustrates the steps involved in a typical chemical review process. This process includes mandatory legislative phases (preparation of a work plan, Notice of Reconsideration; Consultation); phases necessary to assess a chemical against our statutory safety, efficacy, trade and labelling criteria; and phases necessary for best-practice project management (prioritisation).
Figure 1: The reconsideration process
Phases vary in complexity, duration, and overall contribution to the reconsideration decision(s). The scientific assessment phase is usually more technically complex and time-consuming than other phases, as significant amounts of data are evaluated to determine the underlying hazards and whether risk mitigation can be used to protect human health and/or environmental risks.
Three critical steps prior to the commencement of a reconsideration are the nomination of a chemical, prioritisation phase, and the planning phase.
Nomination
There is an extensive body of evidence supporting the safe and effective use of most approved chemicals. A compelling scientific case is required to question this evidence. A product used in contravention of the instructions contained on its approved label (off-label) is not a valid basis for a chemical reconsideration. These matters are referred to the state and territory authorities responsible for the enforcement of agvet chemical control-of-use.
A nomination must include adequate reasoning to support a proposal for reconsideration, including evidence of risk when the chemical is used in accordance with the label instructions. If a nomination is made in response to an invitation notice issued by the APVMA, the nomination must also conform to any criteria described in the notice.
Examples of the types of information that the APVMA considers when evaluating a nomination include:
- Regulatory decisions from international counterpart authorities (such as de-registration, restrictions on use, or changes to use patterns). Products and use patterns must be relevant to Australian conditions for the APVMA to consider overseas regulatory actions.
- Adverse experience reports where label directions have been followed. This may include reports relating to a lack of efficacy.
- Confirmed reports of pesticide residue violations including trade issues such as the rejection of exported agricultural produce.
- New credible scientific evidence (for example high-quality, peer-reviewed scientific literature, or international scientific assessment reports by the WHO or FAO) indicating a new or higher risk than that determined when the product was initially registered.
- Information submitted to the APVMA in compliance with existing statutory obligations (Agvet code, s 161).
- Information obtained by state and territory authorities during the administration of their control-of-use functions.
The APVMA will assess information that forms the basis of nominations and determine if a reconsideration of the approval or registration of a chemical is warranted or whether other regulatory pathways can be used to mitigate any risks identified.
Prioritisation
The APVMA prioritises nominated chemicals for review based on criteria of concern which include toxicology, public health, occupational health and safety, environment, residues, trade, target crop and animal safety, and efficacy.
Scoping and work plan
The APVMA is required to prepare work plans for all new or existing chemical reviews from 1 July 2015 according to the Agricultural and Veterinary Chemicals Code Regulations 1995, reg 20. Work plans and a (Agvet Code) section 32 notice are provided to holders and registrants, triggering the commencement of a review, and requesting available data be submitted to the APVMA for evaluation. The work plan provides predictability as to the timeframe and scope of any reconsideration.
A work plan for a proposed reconsideration must include:
- the date of any notice inviting nominations for reconsideration
- the date on which the reconsideration will begin
- detail on how a proposed timeframe for the reconsideration has been calculated
- the matters proposed to be dealt with during the reconsideration
- the date on which we expect to give the Notice of Reconsideration to the holder
- the date on which we expect to inform and invite other parties to make submissions relating to the reconsideration, and details of who those parties are
- the date on which we expect to give a notice (if any) to the holder/registrant to provide information, reports, results or samples, and a summary of the type of information, report, result or sample required by the APVMA
- the date on which we expect to issue a notice (if any) proposing to vary conditions or particulars, or to suspend or cancel the approval or registration, and the anticipated recipients of the notice
- the date on which we expect to make a decision in relation to the reconsideration.
Work plans are required to be updated at least yearly, and if any of the following events occur:
- The issue of a Notice of Reconsideration to holders or any others.
- A notice requesting that the holder provide information, reports, results or samples.
- A decision in relation to the reconsideration.
- A variation to the label instructions.
- The issuance of a permit in relation to the reconsideration.
- Any suspension, cancellation or recall action in relation to the reconsideration.
Notice of Reconsideration—the clock starts
To begin a reconsideration, the APVMA provides each approval holder and/or product registrant with a written Notice of Reconsideration according to the Agvet Code, section 32, that outlines:
- the matters we propose to deal with in the reconsideration
- the reasons for the reconsideration
- the work plan
- relevant information, including data, that the holder is required to submit to APVMA for reconsideration and the timeframe for this information to be submitted (a minimum of 28 days).
The section 32 notice invites the holder to make a written submission to the APVMA on the matters relating to the reconsideration, within the notice period.
On the day after the notice period, the reconsideration begins, although the APVMA may also extend this period if reasonable grounds exist (e.g. the holder requires additional time to produce the required information or data).
A notice will be published on our website and in our gazette announcing the commencement and details of each reconsideration, its scope, and the associated work plan.
Assessment
The scientific assessment phase is resource intensive and technically complex. Our scientific assessment teams utilise an internationally accepted framework of risk analysis comprising risk assessment, risk management, and risk communication.
Data submitted to the APVMA in fulfilment of the Notice of Reconsideration is assessed by specialists regulatory scientists within the APVMA. In some cases, the APVMA may contract national or international subject matter experts to provide advice on certain aspects of the risk assessment.
Data submitted to the APVMA for assessment may include laboratory studies, field trials, target animal or crop studies, or human studies. These studies must meet international standards of scientific quality in terms of study design and a level of reporting detail necessary to allow the independent evaluation of the data.
Component assessments aim to identify risks from the approved (label) use of an agricultural or veterinary chemical which may include dietary exposure, bystander exposure, worker exposure, the environment, residues in food, and International trade (via the exceedance of maximum residue limits). The conclusions of these component risk assessments are foundations for risk management decisions.
Chemistry assessments: The Pesticides and Veterinary Chemistry teams evaluate the chemistry and manufacturing data of active constituents and their formulated products. This evaluation considers the manufacturing method, quality control, composition, stability and chemical characteristics of a particular active constituent or formulated product.
An important aspect of this assessment is the identification of significant impurities and those of toxicological concern, and the setting of minimum standards for purity and composition. These standards can be found in the Agricultural and Veterinary Chemical Code (Agricultural Active Constituents) Standards 2022.
Toxicological assessment: Evaluation of the mammalian toxicity of an active constituent utilises studies conducted in laboratory animals, and observations of humans (including clinical experiments, worker exposure studies, poisoning case reports and epidemiological studies). The assessment comprises of hazard identification, which identifies the health effects the chemical can cause at excessive levels of exposure, and hazard characterisation, which determines the exposure thresholds below which no adverse health effects are expected to occur.
Exposure thresholds are the starting point for public health standards covering dietary exposure to pesticide and veterinary medicine residues, and occupational exposure thresholds. These dietary exposure standards and occupational exposure thresholds are subsequently used in residues and dietary risk assessments, and in occupational health and safety assessments.
A worker risk assessment estimates or measures the occupational exposure a worker may experience as a result of the approved label use of an agricultural or veterinary chemical.
Occupational exposure thresholds are determined in the toxicological assessment, and exposures below the threshold are usually considered acceptable.
This assessment also recommends safety directions, including the use of personal protective equipment, re-entry periods, and restraints for the uses supported by the assessment to be listed on the label.
Residues and dietary risk assessment: Data produced by laboratory studies and field trials is examined to establish withholding periods, maximum residue limits, residue definitions, and restraints for the use patterns supported in the assessment.
Dietary exposure to pesticide and veterinary medicine residues is compared to the public health standards set during the toxicological assessment. Dietary exposures below these health standards are considered to be acceptable dietary exposure to residues.
Environmental assessment: Toxicity to aquatic and terrestrial organisms (including the determination of environmental exposure limits), the fate of the chemical in the environment, and the estimated or measured environmental exposures resulting from the approved label uses are all considered in an environment assessment. The resulting risk characterisation determines if the risk is acceptable, and whether any risks may be mitigated by label directions or other actions.
Efficacy assessment: Data for efficacy assessments is generated from clinical trials or field trials on the target crop or animal pests. The data must demonstrate that, to a reasonable degree, the product will be effective as claimed on the product label.
Trade assessment: An assessment of potential trade risks arising from the supported uses of products on major trading commodities involves a comparison of the maximum residue limits set by Australia and those of our trading partners.
The APVMA makes use of all available data during a reconsideration. When additional information is necessary for the APVMA to be satisfied, the APVMA may issue a notice under section 33 of the Agvet Code requiring approval holders and product registrants to:
- provide specific information
- carry out a literature search and submit a report of the search
- conduct trials or laboratory experiments and submit the results
- provide a sample of an active constituent, a product or the product’s constituents for analysis.
At any time during a reconsideration, regulatory action may be taken to mitigate identified risks in relation to the use of a chemical, with an aim to protect human health and the environment while a final decision is being reached.
The type of regulatory action taken will depend on the identified risk and the extent of possible harm that may occur from the continued use of the chemical. Possible actions range from variations to registered labels, to the suspension of active constituent approvals, product registrations or label approvals.
If regulatory action is taken before or during a chemical reconsideration, stakeholders are consulted to assist in the development of an appropriate risk-management plan.
Proposed regulatory decision
The APVMA will consider the component scientific assessments, and develop draft recommendations for the reconsideration which summarise the results of the assessment, the identified risks, risk mitigation measures, proposed review findings and the proposed regulatory decision.
Summaries of the assessment reports and the proposed regulatory decision are released for public consultation prior to the implementation of any regulatory actions.
Consultation
The review process includes public consultation which involves stakeholders; approval holders, product registrants, peak industry bodies, interest groups, non-government organisations, the Australian Government, state and territory governments, the public, and other users of the chemicals. All stakeholders have an opportunity to provide the APVMA with information or comment on the risk assessments and proposed regulatory decision.
All submissions related to the scientific information used and methods of the assessments conducted by the APVMA will be considered prior to the final regulatory decision.
Submissions related to commercial or financial impacts will be noted; however, these cannot be considered by the APVMA to determine whether a chemical meets the statutory criteria (safety, efficacy, trade and labelling) in the Agvet Code.
Final regulatory decision
After the public consultation period expires, the APVMA assess the comments, information and supplementary data received, which may result in the refinement of component risk assessments and risk management recommendations.
A final regulatory decision will be published, which will affirm, vary or cancel the active constituent approvals, product registrations and label approvals subject to the reconsideration.
Affirm the active constituent approval, product registrations and product labels
The APVMA will affirm the approval or registration if we are satisfied that:
- an active constituent meets the safety criteria
- a product meets the safety, efficacy, and trade criteria
- a label meets the labelling criteria
- a constituent, product or label complies with any requirement prescribed by the regulations.
If the APVMA affirms an approval or registration, a written Notice of Affirmation is given to the holder within 14 days of the decision being made. The notice includes any relevant particulars and conditions of the affirmed approval or registration. The Notice of Affirmation, including a brief statement of the reasons for the affirmation, will be published in the Gazette.
Vary the label or conditions of approval or registration
If the APVMA is not satisfied that an active constituent, product or label meets the safety, trade, efficacy and labelling criteria, an approval or registration will not be affirmed. The APVMA will examine if we may be satisfied if relevant particulars or conditions of approval or registration were varied.
In deciding to vary relevant particulars or conditions, the APVMA will:
- Consult with each state coordinator if the variation would affect any instructions for use and take into account any recommendations made by the coordinators.
- Give the approval holder, registrant or any other relevant stakeholder a Notice of Proposed Decision. This notice will include a draft statement of reasons for any proposed actions, information based on the stated proposed variations, and an invitation to provide written submissions on the reconsideration to the APVMA within three months. The APVMA will consider these submissions when deciding to implement the variation and the specifications of any variation.
If a product label is varied prior to affirming an approval or registration, we will decide whether to cancel any old product labels, and whether to allow a phase-out period during which a product can be used in accordance with a cancelled label.
Suspend the approval or registration
A written notice of suspension will be provided that outlines the reasons for the suspension, specify the duration of any suspension and explain what actions are required to be carried out by the holder for the suspension to be revoked. A notice containing these details will be published in the APVMA Gazette and on our website.
Cancel the approval or registration
A written notice of cancellation will be provided that outlines the reasons for the cancellation and explain what actions are required to be carried out by the holder for product in the supply chain including details of any phase out period.
The APVMA will take a risk-based decision on the phase-out period for cancelled labels, products and active. Where a product or active constituent is cancelled the phase out period is up to 12-months, if the product remains registered but the label is cancelled the phase out period for the previously approved label is up to 2 years, however a shorter period may be applied depending on the risk posed by continued use of the product under the old instructions.
A notice containing these details will be published in the APVMA Gazette.
Implementation
Within 14 days of the final decision, the APVMA will update the register to reflect the outcomes of the reconsideration and vary or cancel labels as required then issue a notice with the updated details to holders.