This content is current only at the time of printing. This document was printed on 26 August 2019. A current copy is located at https://apvma.gov.au/node/4136
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Hormonal growth promotants
The European Union (EU) requires continued assurance from Australia that beef and beef products that its member states import have not been treated with hormonal growth promotant (HGP) products. The National HGP Monitoring Control System provides this assurance by enabling Australian authorities to account for the importation, supply and use of HGPs. The APVMA plays a significant role in the operation and management of the system by authorising importers and resellers and requiring that accurate records of supply be kept.
On this page:
- Secure storage of HGPs
- Accurate and complete record keeping
- Supplying HGPs under the post office arrangement (Regulation 47C(2))
- Documentation for exporting HGPs
- Disposing of date expired and unwanted HGPs
- Identity of purchaser
- Consequence of failing to renew your notification number
- More information
The supply of HGPs is controlled by the requirements that all suppliers be registered and that all importers, manufacturers and suppliers keep records. The supply of HGPs may be subject to audit by the APVMA.
The National HGP Control and Monitoring System may also be audited by European Union auditors at any time. Should the auditors find systemic deficiencies in the procedures, Australian trade with the European Union could be jeopardised. Adhering to the requirements of the National HGP Control and Monitoring System, including maintaining good records and accounting for every dose of HGPs, will ensure that Australia’s good trading reputation with the European Union is maintained.
At some premises HGP products are displayed on open shelving, which increases the potential for theft or loss of doses. The APVMA requests that all suppliers keep these products in a secure area with limited access, such as a locked cabinet or a coolroom, so as to minimise possibility of theft and to maintain the integrity of the National HGP Monitoring Control System.
While the accuracy and completeness of HGP records relating to acquisition and supply are generally of a high standard, APVMA inspectors have noted that errors do occur, and can involve doses remaining unaccounted for. When doses go missing it is not acceptable to merely note in the records that doses have been lost. Instead, every effort must be made to locate the missing doses, and where this is not achieved an explanation of the loss must be provided in the records.
APVMA inspectors also note that often records are left to the end of the month to be completed rather than at the time of supply. The regulations state that the supply record must be completed at the time of supply and the monthly returns submitted to the state coordinator within 14 days after the end of the month.
APVMA inspectors have also reported that the problem most frequently encountered during audits is failure by suppliers to obtain a purchaser declaration at the time of supply. We wish to remind all suppliers that under no circumstances can an HGP be delivered without receiving a fully completed purchaser declaration. It is the supplier’s responsibility to obtain a declaration, not the purchaser’s to provide it.
The post office arrangement was introduced in 1996 following concerns that HGPs could only be supplied in person to the purchaser and that these arrangements disadvantaged property owners who lived in remote locations. The government amended the Agricultural and Veterinary Chemicals Code Regulations 1995 to allow remote property owners to have the packaged and unopened HGPs delivered to the local post office or to a local retailer who did not trade in HGPs and therefore did not possess a notification number. Until recently, only a few suppliers have used this provision.
It is a requirement for companies using the post office arrangement to obtain a copy (or fax) of the purchaser declaration before proceeding with a supply. Upon receipt of the HGPs, the purchaser must send the original purchaser declaration to the supplier. It will be the supplier’s responsibility to ensure that the copy and the original purchaser declaration are available during audits conducted by the APVMA.
Under no circumstances can products supplied under the post office arrangement be returned by a user to premises which have not been assigned a notification number.
A number of companies have been involved in the export of HGPs, either directly or implanted in live animals. The supply in both situations must be recorded.
Where an exporter obtains an HGP for export and will not use it for implantation, that exporter must have been assigned a notification number by the APVMA, must keep records of supply and must retain documentation that is evidence of export. Such documentation may include a letter from the agent acting on behalf of the exporter or an invoice from an international carrier. This documentation must clearly identify the date of export, the product name, the batch number and the quantity exported.
Where an exporter obtains an HGP for implantation into animals in Australia that will be exported, the exporter must provide a completed purchaser declaration at the time of purchase. Records of implantation and evidence of export of the animals must be retained for audit by state or territory inspectors.
Suppliers should note that HGPs can only be supplied to persons in Australia who have been assigned a notification number by the APVMA or who provide a completed purchaser declaration (including the tail tag or property number). Supply under any other circumstances is a contravention of the Agvet Code Regulations.
Date expired or surplus stock of HGPs may be returned to the manufacturer, supplied to another premises that has been assigned a notification number by the APVMA, or destroyed; however date-expired stock can only be destroyed or returned to the manufacturer. A record must be kept of the disposal and this must be supported by documentation which is evidence of disposal. This may include a letter from the manufacture, complementary HGP supply and acquisition records at both premises, or a letter from an agent regarding disposal.
Concerns have been raised about the credentials of purchasers of HGPs and whether all purchasers are in fact cattle owners and intend to use the HGPs on cattle. The APVMA requests that suppliers ensure that purchasers of HGPs are known to them and, in any instances where a supplier has concerns about the legitimacy of the use by the purchaser, that the supplier contacts either the APVMA or the local state or territory department responsible for agriculture.
Strict adherence to these requirements and the general requirements for the supply of HGP products is crucial in protecting Australia’s good trading reputation and our export meat trade with the European Union.
The Agvet Code Regulations state that once a notification number is issued it remains in force for a year. The APVMA helps notification number holders to ensure they renew their notification numbers by the timely issuance of renewal applications. The regulations state that unless the notification number is renewed it ceases to have effect. The impact of this provision is that when a number ceases to have effect it cannot be renewed and a new notification number must be issued. Once the number ceases to have effect the retailer can no longer retain HGPs for supply or supply HGPs. They must therefore immediately send the HGPs in their possession either back to the original supplier or importer or to another supplier with a valid notification number. Failure to do so constitutes an offence against the Agvet Code Regulations.
Notification number holders are solely responsible for ensuring their number remains current and must ensure their renewal form with the appropriate payment reaches the APVMA by the required date. Where retailers’ payments for renewal of notification numbers are centralised to a regional or head office or similar, those retailers may have to put in place additional steps to ensure the payment process does not result in a late payment whereby the number may have already ceased to have effect.
Please address any queries to:
Hormonal growth promotants (HGPs)
Phone: +61 2 6770 2302