Guidelines

Importing or Working with Quarantine Material - Guidelines

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1. Purpose and Objectives

This guideline is for all activities involving the import, use, storage and transport of quarantine-regulated material at The University of Queensland.

2. Definitions, Terms, Acronyms

AS 2243.3 – Australian Standard 2243 Part 3: Microbiological safety and containment

DAgWRB – Commonwealth Department of Agriculture and Water Resources Biosecurity (previously DAgB (Dept of Agriculture Biosecurity)/DAFF (Dept of Agriculture, Fisheries and Forestry)/AQIS (Australian Quarantine Inspection Service))

HOS/HOI - UQ Head of School/Head of Institute

BICON - DAgWRB Import Conditions database for searching commodities and applying for import permits

SNM – Senior Nominated Manager (HOS or HOI) - registered with DAgWRB as the person responsible for the QAP

QAP – Quarantine Approved Premise

QC2/PC2 – Quarantine Containment/Physical Containment level 2

QEN – Quarantine Entry Number/Order Number or Direction Number

3. Guideline Scope/Coverage

This document is for all staff and students involved in the importation and use of biologicals, animal and plant material subject to quarantine regulation.

4. Guideline Statement

This guideline will assist researchers in ensuring that they are compliant with the requirements for working with imported quarantine material, as described in the Quarantine Act 1908 and Quarantine Regulations 2000.

5. Department of Agriculture - Biosecurity

The Department of Agriculture and Water Resources - Biosecurity (DAgWRB), previously DAgB/DAFF/AQIS, is a regulating authority that oversees Australia’s strict quarantine restrictions and prosecutes offenders in accordance with the Quarantine Act 1908. DAgWRB provides quarantine inspection services for the arrival of international passengers, cargo, mail, animals and plants or their products into Australia, and inspection and certification for a range of animal and plant products exported from Australia. DAgWRB also monitors products being imported that may pose a risk to Australia’s plant, animal and human health – including the subsequent derivatives.

DAgWRB issues permits for import and monitors compliance through auditing Quarantine Approved Premises (QAPs), including extensive record keeping required for all Quarantine Material (see your Yellow Folder for templates). DAgWRB sections Australia into Regions.  Most UQ sites are located in DAgWRB's North East Region, which covers an area stretching from Coffs Harbour in New South Wales to Townsville in Queensland, and out to the western border of Queensland.

The DAgWRB website has multilingual guidelines explaining what can and cannot be admitted into Australia. OHS Biosafety recommends that you send these links to your overseas collaborators, visitors and students prior to them sending you biological, animal and plant material and/or coming to Australia (http://www.agriculture.gov.au/biosecurity).

DAgWRB is a full cost recovery organisation, which means the user pays for all services including DAgWRB inspections, audits, QAP registration, training, import permit applications (even if unsuccessful), phytosanitary certificates for exports and variations to permits and transfers.

6. Importing Material

6.1 Import permits

To determine if you require an import permit, check the BICON database on the DAgWRB website see https://bicon.agriculture.gov.au/BiconWeb4.0 .

BICON will enable you to apply for import permits and links to information on the associated costs. To apply for an import permit first contact your local BICON administrator and ask them to register you on the Account as a user.  BICON Administrators are  usually your Safety Manager/Co-oridnator/Compliance Officer (see link to 'BICON Administrators' http://www.uq.edu.au/ohs/bicon-account-admistrators-uq).

Import permits are legal documents, so all users of the permits must abide strictly by the exact permit conditions relevant to the quarantine material they are importing. If the permit conditions on your permit do not match what you intend to do then you must have the permit amended. Note that the person who is “named” on the permit is held ultimately responsible for everything imported under that permit (even if you allow others to use it), so you must be completely confident that ALL users of material imported under your permit abide by the permit conditions. It is inappropriate for students to be permit holders, supervisors or Organisational Units should take on this responsibility. For in vivo work on animals/humans/plants not specified on your import permit conditions you may need to apply for an In Vivo Approval see http://www.agriculture.gov.au/import/biological/in-vivo/application.

Import permits for some high risk materials or not previously imported materials may take months to process through DAgWRB and Biosecurity Australia so it is best to give as much information as possible with the original application. This may include attaching published data and/or references to peer-reviewed papers to support your application.

Many imports will only require an initial inspection at the point of entry to the country (eg airport, seaport) before being permanently released from Quarantine (ie. are no longer considered a quarantine risk and do not remain “Under Quarantine”). However, sometimes post-entry requirements of the permit conditions will stipulate that you must keep the material under Quarantine until it has been treated or destroyed. Treatment options usually include gamma irradiation (usually either 25 or 50kGray) and, if possible, this is recommended as it means your material can then be released from Quarantine. SteriTech provides this service in Brisbane and can be contacted by telephone (07) 3293 1566 for quotes etc. For cases that can not be treated on arrival you will need a Quarantine Approved Premise (QAP).

6.2 Quarantine Approved Premises

To determine if your lab or facility is a QAP, check your entrance door signage for a bright yellow A3 size sign stating “Quarantine Area”, and check with your Safety Manager/Coordinator/Compliance Officer or with the UQ Biosafety Quarantine Advisor. The containment level you require for the QAP will be stated on your permit eg. The level of containment must be QC2 (this means Class 5.2 for labs, 7.2 for insectary). Note that QC2 risk level is roughly equivalent to PC2.

There are specific criteria for QAPs depending on their type/class (see http://www.agriculture.gov.au/biosecurity/import/general-info/qap/qapcriteria). UQ has classes 5 - 7. If you need to set up a QAP contact UQ Biosafety for information on the required inspections and general costings involved. If you have permission to use a collaborator's QAP, the Senior Nominated Manager (SNM) for that school/institute (usually HOS or HOI) must agree to take on your risk within their jurisdiction, so apply to them first.

QAPs have a unique number allocated to them (eg. Q1234, N1234 – note the prefix letter pertains to the State) and DAgWRB use this number to identify your facility in permit applications and audits. Do not let others outside your School or Institute use your QAP number unless your SNM (HOS or HOI) has agreed. You need to list down all the QAPs you want to use on your permit application. Remember to include any service facilities eg. glasshouses, animal houses or interstate collaborators with your application.

If your material is required to remain "Under Quarantine" then it is very important to include in the permit application a request for release of derivatives of your material from Quarantine (if applicable). The recommended wording should be similar to: “Once DNA is extracted we request that the material be released from quarantine as it is no longer replicable or is disarmed.” Note that for certain pathogens the DNA or RNA will not be allowed to be released.

All quarantine material is traced by DAgWRB based on its Quarantine Entry Number (QEN), which can also be called an ‘order number’, 'direction number' or a ‘reference number’. The QEN is issued by DAgWRB at time of import on the DAgWRB Orders/Directions (paperwork arriving with your import and after initial DAgWRB inspection) and is unique for each shipment. DAgWRB consider the QEN to be the most important piece of information for tracing your import material from arrival at the border to full destruction and/or approved treatment. If your material arrives without a QEN it is your responsibility to source it immediately. Check with your courier company or broker or, if that fails, use the airway bill number or flight number as an identifer and contact nationalquarantine.processing@agriculture.gov.au.

All quarantine material must be kept physically separated from non-quarantine material at all times. Physical barriers, labelling, locked and signed storage areas and designated workspace areas are required. All work practices must follow the Australian Standard ASNZS 2243.3 http://www.saiglobal.com/online/autologin.asp.

UQ uses a “Yellow Folder” system for record keeping of quarantine material. For detailed information on this system, attend the UQ Biosafety course “Working with Quarantine Material” and see Section 6.2.1 Training (below). DAgWRB auditors will ask questions about any of your local procedures pertaining to the relevant QAP class criteria and your import permits (especially strict adherence to your conditions) during their audits.

6.2.1 Training

If you are handling quarantine material, DAgWRB Biosecurity mandates that you MUST complete on-line training entitled “Quarantine Approved Premises for Accredited Persons (Classes 1 - 8)” accessible from http://www.iwgq.com.au. The only exception to this is if you are directly, physically supervised by a Quarantine Accredited Person while handling quarantine material, which means the Quarantine Accredited Person must accompany you at all times. UQ Biosafety recommends you attend the comprehensive, research focussed, internal training entitled “Working with Quarantine Material”, which can be booked through Staff Development see link: https://staffdevelopment.hr.uq.edu.au/course/OBS005. You must ensure you train new staff or students in your specific permit conditions, QAP criteria and local requirements in preparation for audits.

6.2.2 Transfers and transport of quarantine material

You may transfer quarantine material between any nominated QAPs listed on your permit. If the particular QAP you wish to transfer to is not listed on your permit you may apply to have your permit varied through the BICON system OR you can apply for a transfer, or in rare cases a ‘permission’. The transfer application is sent to the relevant DAgWRB issuer of the permit type (ie Animal/Biologicals/Food/Plant etc). The transfer application form is located at http://www.agriculture.gov.au/forms/biosecurityforms. You cannot enact a transfer until you have received documented approval from DAgWRB. Contact UQ Biosafety for more information on transfers.

If you are transferring material to another group or organisation you must supply them with a copy of the import permit and ask them to sign an agreement stating that they will abide by the conditions on the permit and all other DAgWRB requirements (including training etc).

Transport of quarantine material must follow the usual transport requirement for biologicals (eg. double containment - sealed primary containment with the secondary containment being sealed and unbreakable; full labelling with "Quarantine Material" and contact details of lab and a copy of permit). See http://www.uq.edu.au/ohs and click on biosafety for details of transporting biologicals, and also follow any extra requirements specific for DAgWRB as listed on the Driver Checklist in Yellow DAgWRB Folder. Photocopy and send this checklist with the courier.

6.2.3 Waste treatment

Quarantine waste must be kept separately to other waste. It must be double bagged, held in rigid, lidded, pest-proof bins labelled “Quarantine” and must remain within the QAP until removed to an autoclave room for disposal or treatment.

The allowable disposal methods are stipulated in the permit conditions (eg. autoclaving, high temp incineration, chemical sterilisation). Because the waste bin cannot be left on the kerb or in a loading dock (even if locked), most waste is autoclaved.  After autoclaving (for a minimum of 30mins sterilisation), the material is no longer classified as being "Under Quarantine" and can be disposed of as clinical waste. Waste disposal must be fully documented in the Yellow Folder usage documents AND the Autoclave Log. Note that autoclaves must be calibrated annually, with the proof/printout/graph of the full 30 minute sterilisation time available for auditing, along with the monthly spore tests.

6.2.4 Closing down a QAP (permanently or for refurbishment)

Contact UQ Biosafety as soon as you know the QAP is to close or be refurbished, as DAgWRB must do a final “close-out” inspection. This must be done at least 15 working days prior to intended closure or refurbishment.

Prior to closure of the QAP the quarantine material must either be transferred, stored or destroyed as per permit conditions and the facility must be fully decontaminated with a DAgWRB approved disinfectant (see AS2243.3 Appendix F - Yellow Folder).

All records must be kept for a minimum of 18 months after destruction or transfer of material. UQ Biosafety will hold these records for you if you are leaving the University. The records will be shredded after 18 months.

7. Exporting Material

If you wish to export material you need to check with the country of import and your collaborators for their country’s specific importing requirements. If your export is rejected the material will need to be imported back into Australia and you will probably have to apply for an import permit to allow this. You may also need to get permission from DAgWRB to export. Contact DAgWRB EXPORTS for advice on this.

Some countries require a phytosanitary inspection certificate to accompany the export (particularly for plant material). DAgWRB can issue these, usually through the local DAgWRB Regional Office.

Remember to check the requirements of Department of Defence Defence Strategic Good List (DSGL) see https://dsgl.defence.gov.au/Pages/Search.aspx - not just for biologicals this also includes certain types of equipment.

8. Contact for Additional Information

Biosafety Quarantine Advisor: Sue Marshall

Email: sue.marshall@uq.edu.au

Phone: 07 3346 9173 (ext 69173)

Webpage: www.uq.edu.au/ohs and click ‘biosafety’

Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael
Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael