New Zealand: Update on the new Import Health Standard: Biological Products (IHS BIOLOGIC.ALL)

The Import Health Standard for Biological Products (BIOPRODIC.ALL) is about to be replaced by the Import Health Standard: Biological Products (IHS BIOLOGIC.ALL).

It is anticipated the IHS BIOLOGIC.ALL will be provisionally issued this month (November 2021). If there are no calls for an independent review, the IHS will become final two weeks after being provisionally issued. If you would like to receive notification of the provisional issue, please ensure you subscribe to Biosecurity under the Consultations section (you may need to check your junk or spam email folder as sometimes notifications can end up in there).

I’d like to thank you for your patience, feedback and contribution to the review process. The IHS BIOLOGIC.ALL is likely to be reviewed in 2022, or once the additional Risk advice is received, in order to incorporate that additional advice and to ensure the IHS is fit for purpose.

Please feel free to provide any feedback to Katherine Garnett, Senior Adviser, Animal Imports, Ministry for Primary Industries on the benefits and issues you come across when implementing the IHS – it’s really important feedback is provided as otherwise MPI won’t know how you, the user, find the IHS and accompanying guidance document.

The following IHSs will be revoked as a result of the creation of IHS BIOLOGIC.ALL:

• Import Health Standard for Biological Products BIOPRODIC.ALL; dated 05 November 2015
• Import Health Standard for Nonviable Animal Specimens INESPEIC.ALL; dated 11 May 2004
• Import Health Standard for Tested, Filtered and Irradiated Foetal Bovine Serum, Calf Serum and Bovine Serum from Australia BOVFBSIC.AUS; dated 12 March 2001
• Import Health Standard for Foetal Bovine Serum, Calf Serum and Bovine Serum for Further Processing from Australia BOVSFPIC.AUS; dated 08 May 2001
• Import Health Standard for the Importation into New Zealand of Surgical Catgut from All Countries SURCATIC.ALL; dated 5 July 2004

 

What happens now?

Any new import permits issued after the IHS becomes final will need to comply with the IHS BIOLOGIC.ALL. This is also the case for products imported that currently do not require an import permit for biosecurity clearance purposes (such as commodities that currently meet the requirements of INESPEIC.ALL or fall on the negligible risk register under BIOPRODIC.ALL).

 

Once you receive notification of the provisional issue, please begin reviewing any import permits you have issued under BIOPRODIC.ALL, as well as any products that met the requirements for biosecurity clearance without the need for an import permit, and familiarise yourselves with the new requirements within the IHS BIOLOGIC.ALL. Any import permits currently issued under BIOPRODIC.ALL will remain valid until you either amend the import permit, or apply to renew the import permit, whichever comes earlier. This is stated in section 1.8 of the IHS BIOLOGIC.ALL.

What are the main changes?

The new IHS BIOLOGIC.ALL has a few changes when compared to both the ‘old’ BIOPRODIC.ALL and the IHSs that have been incorporated into the new IHS BIOLOGIC.ALL – these include:

• Minimum concentrations of preservation liquids used for specimens that used to come in under INESPEIC.ALL
• No more negligible risk register – instead, importation requirements have been aligned with the IRA 2005.
• Certain items no longer require an import permit but do require an official manufacturer’s declaration. This includes test kits (not containing viable microorganisms) and media.
• Redefining what biological products is in the context of the IHS BIOLOGIC.ALL – the main difference being that the IHS BIOLOGIC.ALL does not apply to biological products derived from plants. Plant Imports have confirmed they will not need to use IHS BIOLOGIC.ALL due to the import health standard work that has been undertaken in that space.
• Incorporation of the requirements for veterinary medicines that are authorised under the ACVM Act, veterinary biological implants, and agricultural compounds described as exempt from the ACVM regulations.

What are the additional pieces of advice that are yet to be incorporated?

Additional Risk advice has been sought on the following subjects:

• Removal of the requirement for naked DNA, RNA, and/or nucleic acid to be not contained within a vector and inclusion of purified DNA plasmids.
• Requirements for fixed tissue microscope slides without coverslips
• Commercially produced antisera and antibodies sourced from goats and donkeys
• Treating highly purified antibodies separately to antisera and plasma
• Specimen preservation concentrations and additional preservation solutions (DMSO, Lugol’s iodine, 4% formaldehyde).

Risk advice on bovine serum from Australia and the United States of America (USA) was received on 25 June 2021. This advice assesses the biosecurity risks associated with the importation of bovine serum from Australia and the USA to New Zealand. It also assesses the effectiveness of the current risk mitigation measures for tested, filtered, and irradiated fetal bovine serum, calf serum, and bovine serum of Australian origin (currently set out in the IHS BOVFBSIC.AUS).

The IHS BIOLOGIC.ALL does not contain new requirements for bovine serum because this review has yet to be prioritised. Reviewing IHS BIOLOGIC.ALL in 2022 will allow this advice, as well as the additional requested advice, to be incorporated and will allow sufficient time to consider any feedback received from you, the user.