This content is current only at the time of printing. This document was printed on 20 February 2017. A current copy is located at http://apvma.gov.au/node/1079
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Monitoring and audit activities
The APVMA Compliance team conducts a range of activities to identify emerging issues and assess compliance of products in the marketplace.
Online and retail supply
APVMA compliance staff routinely monitor the retail market for agvet chemicals. This includes online monitoring and checks of advertising material.
Monitoring of marketed product labels
The holder of a label approval is responsible for ensuring that the label attached to the container as offered for sale (the marketed product label or MPL) contains all the particulars approved by the APVMA and meets the requirements of the relevant labelling code.
The APVMA conducts routine monitoring of MPLs to check for compliance with this requirement.
This monitoring is in two parts—a desktop review of copies of the labels that holders are required keep in their records and checks of labels at the point of retail supply.
The monitoring is targeted. A key group of products included are those where changes to labels have been required by the APVMA as a result of chemical review.
Other products are included on a risk-management basis.
Action taken in response to this monitoring is in accordance with the APVMA’s compliance and enforcement policy.
Low risk issues are addressed cooperatively with holders using tools appropriate to the risks posed. Higher risk matters, where labels have significant errors that could lead to harm will be prioritised for action. In such cases label approvals (and hence product registration) may be suspended and/or recall of stock may be required. Other enforcement options may also be used.
Monitoring of labels for products containing carbendazim, dichlorvos or diuron has been completed. The APVMA required stock of two diuron products to be recalled and relabelled because the labels had not been changed as required by the review of the chemical. There were minor and administrative errors noted on labels for a significant number of products. These errors did not pose risks to users or the environment, but the labels were not in line with the APVMA’s Ag Labelling Code. Companies were contacted to have these errors corrected.
The APVMA will conduct another round of monitoring in the coming months. This will cover labels for the products containing carbaryl, haloxyfop or dimethoate. Approval holders will be contacted and requested to supply samples of labels currently in use for these products.
Testing and sampling of chemical substances
From time to time, samples are obtained from the market for analytical testing to provide information to the APVMA about compliance with product quality requirements. This sampling may be part of a broader sampling program or focussed on a specific issue of interest to the APVMA.
Using a risk based compliance approach, we may target sampling towards a certain type of chemical, industry sector or region. For instance, while undertaking a targeted compliance program on pool chemicals, the APVMA may obtain a range of these chemicals nationwide to check their quality and active constituents.
APVMA Compliance staff may also randomly sample agvet chemical products from the market to provide information on product quality and active constituents. This sampling program is used to gain broad information that can be used to guide future targeted compliance activities.
As a general rule, where sampling is undertaken to monitor product quality, Compliance officers will purchase chemicals from the retail market at market price.
The APVMA’s compliance audit programs aim to:
- determine the level of compliance with conditions attached to an active constituent approval, product registration, permit approval or manufacturing licence
- evaluate those conditions for enforceability, comprehension, and ease of assessment for business-improvement purposes
- demonstrate to the community that there are systems in place for measuring and improving compliance, thereby increasing community confidence in the APVMA’s regulatory system
- evaluate whether compliance with the conditions attached to the authorisation is assisting to protect human and animal health, agriculture, the environment and trade.
Audits are planned events and may include a combination desk-based auditing and field-based auditing activities. Companies being audited will receive sufficient notice of the audit.
Preliminary audit findings will be communicated to the auditee and there will be opportunity for comment and discussion. All audits will conclude with a final written audit report. A copy of the audit report will be provided to the auditee for their records.
If the audit identifies matters of non-compliance the APVMA will consider what action is necessary to facilitate and ensure compliance. All matters of non-compliance will be risk-assessed and may be referred to the APVMA Enforcement Committee for consideration.
A compliance campaign approach may be taken where the APVMA identifies that non-compliance appears widespread in a particular industry or product type. The need for campaign activity is based on consideration of risk, frequency of allegations received and monitoring in the marketplace. A campaign may include a range of activities including mail-outs, preparation of relevant guidance material and information on our website, presentations and seminars. The complexity of a campaign will be based on our assessment of the most effective ways to assist entities back to compliance. The aim of a campaign is primarily to educate and raise awareness about the requirements of national agvet laws. Current compliance campaigns can be viewed here.