Approved Arrangement for Biosecurity Containment Level 2 (BC2) Facilities Requirements

Approved arrangement for biosecurity containment level 1 (BC1) facilities requirements

Requirements for approved arrangements class5: biosecurity containment level1 (BC1) facilities

Version 1.1

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Cataloguing data

Department of Agriculture and Water Resources 2017, Approved arrangement for biosecurity containment level 2 (BC2) facilities requirements, Canberra. CC BY 4.0.

This publication is available at requirements for operating approved arrangements.

Department of Agriculture and Water Resources

Postal address GPO Box 858 Canberra ACT 2601

Switchboard +61 2 6272 2010

Web agriculture.gov.au

Disclaimer

The Australian Government acting through the Department of Agriculture and Water Resources has exercised due care and skill in preparing and compiling the information and data in this publication. Notwithstanding, the Department of Agriculture and Water Resources, its employees and advisers disclaim all liability, including for negligence and for any loss, damage, injury, expense or cost incurred by any person as a result of accessing, using or relying on information or data in this publication to the maximum extent permitted by law.

Version control

Date / Version / Amendments / Approved by
7/4/17
18/12/2017 / 1.0
1.1 / First version of document
Second version of document / Compliance Policy Branch
Compliance Policy Branch

Contents

Guide to using this document

Definitions

Guide to using this document

This document sets out the requirements that must be met before the Director of Biosecurity will consider approval of a premise to operate as a place for the performance of biosecurity control under the Biosecurity Act 2015, otherwise known as an approved arrangement (AA) site.

This document specifies the requirements to be met for the approval, operation and audit of this (BC1) class of approved arrangement site. Compliance with the approved arrangement site requirements will be assessed by audit. In the event of any inconsistency between the approved arrangement site requirements and any Import Permit condition, the Import Permit condition applies. If the Applicant chooses to use automatic language translation services in connection with this document, it is done so at the Applicant’s risk.

Further information on AAs, regional contact details and copies of relevant AA documentation is available on the approved arrangements page on the department’s website.

Definitions

See the Approved arrangements glossary. For terms not included in the glossary, see Macquarie online or the Biosecurity Act 2015.

Part 1: Generic requirements(applicable for all containment types)

Purpose

To ensure the secure handling, storage, treatment, disposal (including destruction) and transport of goods subject to biosecurity control.

Scope

General requirements

The Biosecurity Containment Level 1 (BC1) requirements apply to approved arrangement sites housing biosecurity goods that pose a low biosecurity risk. A low economic impact would result to people, the community, or environment, should the goods (including organisms) escape and spread outside the approved arrangement site.

Assessments and the decision to direct an imported good to a containment facility is made in accordance with policy and on a case-by-case basis. Multiple classification approval may be required. For example, in vivo work with animals may require both microbiological and animal containment approvals.

Biosecurity industry participants must comply with thegeneric requirements, as they are applicable for all containment types, for approval of a biosecurity containment level1 (BC1) approved arrangement site.

Microbiological

The types of goods and work classified as microbiological include:

food products for in vitro analysis
soil and water samples for destructive analysis
sealed culture vessels
biological material used in vaccine research or manufacture.

Animal

The types of goods and work classified as animal include:

approved in vivo studies with Australian animals (non-imported animals).

Aquatic organisms

The types of goods and work classified as aquatic organisms include:

aquatic organism display (for example, for crustaceans)
research and analysis of some low risk molluscs.

Plant

The types of goods and work classified as plant include:

imported plants (for example, yuccas, dracaena, cacti, rose scion wood for budding onto domestic root stocks) held for a specific containment period for disease screening for the purposes of release.

Invertebrate

The types of goods and work classified as invertebrate include:

research and analysis of some low risk chelicerata and crustacea (horseshoe crab, Christmas Island crab)
low risk invertebrate display.

1Compliance

Purpose

To have administrative conditions, site access and work health and safety measures in place to ensure relevant conditions are carried out for goods subject to biosecurity control.

Table 1 Compliance requirements

Requirement / Non-conformity
1.1 / In addition to approved arrangement site requirements, biosecurity industry participantsmust also comply with:
i)the Biosecurity Act 2015 and subordinate legislation
ii)import permit conditions
iii)directions given by the department
iv)the import conditions database (BICON). / i)major/critical
ii)major/critical
iii)major/critical
iv)major/critical
1.2 / Biosecurity industry participantsmust notify the department in writing as soon as practicable within 15 days of any change in:
i)persons in positions responsible for controlling, directing, enforcing or monitoring people performing activities associated with the approved arrangement
ii)biosecurity industry participant details, including
a)entity name
b)ABN or ACN
c)postal address
d)email address
e)facsimile number
f)telephone number. / i)major/critical
ii)major
a)major
b)major
c)minor
d)major
e)minor
f)major
1.3 / The biosecurity industry participant must notify the department in writing as soon as practicable within 15 working days of becoming aware of any change of status, not previously been notified to the department, of the biosecurity industry participants or their associates relevant to the operation of the approved arrangement in relation to any of the following matters:
i)conviction of an offence or order to pay a pecuniary penalty under the Biosecurity Act 2015, Quarantine Act 1908, Customs Act 1901, the Criminal Code or the Crimes Act 1914
ii)debt to the Commonwealth that is more than 28 days overdue under the Biosecurity Act 2015, Quarantine Act 1908, Customs Act 1901, the Criminal Code or the Crimes Act 1914
iii)refusal, involuntary suspension, involuntary revocation/cancelation or involuntary variation of an Import Permit, quarantine approved premises, compliance agreement or approved arrangement under the Quarantine Act 1908 or the Biosecurity Act 2015. / i)critical
ii)critical
iii)critical
1.4 / Department approved auditors must be provided with facilities and assistance as requested and any required documents, records or things relevant to the audit.
Note: Temporary office space may be required by auditors. / major/critical
1.5 / The department must be notified of any Reportable Biosecurity Incident as soon as practicable, in accordance with the determination made by the Director of Biosecurity. / major/critical
1.6 / Department approved auditors must be permitted to collect evidence of compliance and non - compliance with approved arrangement requirements through actions including the copying of documents and taking of photographs. / major/critical
1.7 / The biosecurity industry participant must:
i)ensure compliance with all relevant conditions and procedures carried out in relation to goods subject to biosecurity, at the approved site
ii)ensure that its officers, employees, agents and contractors act consistently with, and ensure the proper performance of, the relevant conditions and the procedures in relation to the goods subject to biosecurity, at the approved site
iii)assistthe department with any investigation relating to compliance with the Actand subordinate legislation. / i)major
ii)major
iii)major
1.8 / When solicited, unsolicited and or substituted goods arrive at the approved arrangement site without a biosecurity direction, the biosecurity industry participantmust, within 2 business days:
i)refer to the import conditions database to confirm the status of the goods, and
ii)contact the departmentif the goods are subject to biosecurity control, or if the biosecurity status of the goods is uncertain. / i)major

2Approved arrangements site changes

Table 2 Approved arrangements site changes requirement

Requirement / Non-conformity
2.1 / The department must be notified, in writing, and approval granted, prior to:
i)making alterations to the physical structure of the approved arrangement site which affects the containment boundary (excluding minor works as follows)
ii)assigning, transferring or relocating the biosecurity operations
iii)ceasing or materially reducing or expanding the scale of biosecurity operations
iv)entering into, or changing a sub-lease arrangement. / i)major
ii)major
iii)major
iv)major

3Permissible minor works without notification

Table 3Permissible minor works without notification requirement

Requirement / Non-conformity
3.1 / Biosecurity goods must be contained and protected when undertaking minor works.
Works on the containment boundary, that are permissible without notification, include:
i)replacing like for like items after damage or deterioration
ii)repainting, resealing and other maintenance type activities. / major

4Work health and safety

Table 4 Work health and safety requirement

Requirement / Non-conformity
4.1 / Health and safety must be maintained at the approved arrangement site so that biosecurity officers can safely perform their duties.
Note: The biosecurity industry participant should advise the biosecurity officer of any safety issues that preclude or restrict access (for example fumigation in progress, inadequate vaccination for agent in use). / minor

5Approved arrangements site access

Table 5 Approved arrangements site access requirements

Requirement / Non-conformity
5.1 / Biosecurity officers must be granted access to the approved arrangement site at any time. / minor
5.2 / The department must be provided with details of the approved arrangement site’s nominatedoperatinghours. / minor
5.3 / Access to the approved arrangement site must be through property owned, rented or leased by the biosecurity industry participant. / minor
5.4 / Access to the approved arrangement site must be via an all-weather road. / minor
5.5 / Parking must be available for biosecurity officers.
Note: Parking areas may be allocated immediately prior to audit or inspection at the approved arrangement site. / minor

6Construction

Purpose

To have in place the physical measures to minimise the risk of unauthorised removal, loss or release of goods or waste subject to biosecurity.

Table 6 Construction requirements

Requirement / Non-conformity
6.1 / On application and to maintain approved arrangement site approval, a site plan must be submitted to the department and show:
i)the overall dimensions of the site, buildings and structures, whether utilised for biosecurity operations or not
ii)the location of biosecurity areas
iii)the movement pathways of goods subject to biosecurity control
iv)whether the biosecurity control area/s are open or enclosed
v)road access into and within the approved arrangement site
vi)parking for departmental officers
Note: Designated parking areas may be allocated immediately prior to audit or inspection at the approved arrangement site. / minor
6.2 / A sign showing the level of containment (for example BC1 or QC1) must be prominently displayed at each:
i)entry to the approved arrangement site when goods subject to biosecurity control are held, stored, handled or grown
ii)entry to a biosecurity containment storage area located outside the facility, or
iii)on a biosecurity containment unit located outside the facility.
Note: Refer to signage in the Informative Text. / minor
6.3 / Biosecurity control areas must not be used as a thoroughfare or access point to non-control areas or other non-related biosecurity areas.
Note: This excludes support functions (for example imaging) which may be in common space areas to enable these activities to be used by a number of facilities. / minor
6.4 / Biosecurity containment storage and/or treatment areas located outside the BC1 facility must be fully enclosed within walls (for example includes screened openings such as those used with nitrogen dewar storage), doors, windows, floors and ceilings. The floor surface must be impermeable. Doors and windows must be lockable. / major
6.5 / Treatment areas for goods subject to biosecurity control, located outside the BC1 facility, must be equipped with hand disinfection facilities and have available department approved disinfectants for the clean-up of spills. / major
6.6 / Holding areas for biosecurity waste awaiting sterilisation, incineration or movement off site for treatment require:
i)the container or room/cold room to be cleanable, impervious to the waste being contained, free of defects, vermin (for example rodent) proof and able to be closed
ii)protection from unauthorised access
iii)segregation from other goods
iv)protection from loss, spread, spillage or escape into the environment of pests and/or disease
v)labelling the container or room/cold room as ‘Biosecurity Waste’.
Note: Lockable steel mesh cages with biosecurity waste held in secure, vermin proof bins/containers is acceptable where this provides an equivalent standard of biosecurity to items (i) – (v) above. / i)major
ii)minor
iii)minor
iv)major
v)minor

7Risk and incident management

Purpose

To ensure that known biosecurity risks in relation to goods subject to biosecurity control are identified and managed.

Table 7 Risk and incident requirements

Requirement / Non-conformity
7.1 / The biosecurity industry participant must undertake incident control actions and contact the department when there is:
i)a major spillage of goods/waste subject to biosecurity control outside the containment facility (Any major spillage or loss of goods/waste subject to biosecuritycontrol must be immediately reported to the department. All spilled/unrecoverable goods/waste subject to biosecuritycontrol must be treated by a department approved method)
ii)suspected or established presence of pest or disease (this will require the biosecurity industry participant to immediately contact the department)
iii)unauthorised removal, loss or release of goods, waste or equipment subject to biosecurity control. / i)critical
ii)critical
iii)critical
1.97.2 / The biosecurity industry participant is required to contact the department;
i)within 48 hours of the unauthorised removal, loss or release of equipment subject to biosecurity control
ii)immediately for other incidents, including unauthorised loss or release of goods or waste subject to biosecurity control.
Note: Unrecoverable goods/waste subject to biosecurity control is that whichcan no longer be used for its intended purpose / i)major
ii)critical
7.3 / If contact occurs between goods or waste subject to biosecurity control and non-controlled goods/waste, all goods/waste must be treated as being subject to biosecurity control. / major

8Management system

Purpose

To establish a systematic approach to the management of goods subject to biosecurity control that takes into account traceability, reconciliation and information management in accordance with the Biosecurity Act, subordinate legislation and any other directions given by the department (for example, Import Permits and in vivo/transfer approvals).

Table 8 Management system requirement

Requirement / Non-conformity
8.1 / A system must be in place to, identify and date the arrival of all goods subject to biosecurity control. The system must include tracking the creation of direct and indirect derivatives and tracking and control of the distribution of goods/derivatives.
The system must:
i)enable clear reconciling of the goods subject to biosecurity control to Import Permits, biosecurity directions, in-vivo approvals and other documentation, for exampleshipper’s declarations, treatment processing
ii)be maintained and kept up-to-date. / i)major
ii)major

9Work practices

Purpose

To ensure that all goods or equipment subject to biosecurity control are handled securely

Table 9 Work practices requirement

Requirement / Non-conformity
9.1 / All goods subject to biosecurity control must be handled only within the containment boundary unless being inactivated, destroyed and transported (by a department approved method) or being dealt with in specialised containment equipment. / major

10Approved arrangement site personnel

Purpose

To have personnel management systems in place that manages the movement of persons and the security of goods subject to biosecurity control.

Table 10.1Training and competency requirement

Requirement / Non-conformity
10.1.1 / All personnel who have responsibilities for, or perform tasks that may impact on goods subject to biosecurity control, must be able to demonstrate an understanding of department requirements related to their duties (for example Import Permit conditions, directions, Import Conditions database requirements - BICON). / major

Table 10.2Security arrangements requirement

Requirement / Non-conformity
10.2.1 / The biosecurity industry participantmust ensure that enclosed facilities (for example laboratories, animal or green houses) have physical security measures in place to prevent unauthorised access to goods subject to biosecurity control. / major

Table 10.3Personal protective equipment contamination control requirement

Requirement / Non-conformity
10.3.1 / After personal protective equipment is used:
i)disposable personal protective equipment (for example gloves) must be disposed of as biosecurity waste
i)reusable personal protective equipment (for exampleeye and face protection) must be cleaned when contamination occurs, with department approved disinfectants
ii)clothingmust be laundered (for example gownslaundered commercially or non-commercially). / i)major
ii)minor
iii)minor

11Transport of goods subject to biosecurity control

Approved Arrangement for Biosecurity Containment Level 2 (BC2) Facilities Requirements

Requirements for approved arrangements class5: biosecurity containment level1 (BC1) facilities

Guide to using this document

Definitions

Other documents

Part 1: Generic requirements(applicable for all containment types)

Purpose

Scope

General requirements

Microbiological

Animal

Aquatic organisms

Plant

Invertebrate

1Compliance

2Approved arrangements site changes

3Permissible minor works without notification

4Work health and safety

5Approved arrangements site access

6Construction

7Risk and incident management

Table 7 Risk and incident requirements

8Management system

Table 8 Management system requirement

9Work practices

Table 9 Work practices requirement

Table 10.1Training and competency requirement

Table 10.2Security arrangements requirement

Table 10.3Personal protective equipment contamination control requirement