Newsletter Issue 01 June 2013 - absanz

Newsletter
Issue 01
June 2013
this issue
• facility leakage
• new aquatic
Standard
• from our regulators
• SSBAs
Welcome
H
ello and welcome to the first
issue of the ABSANZ
newsletter. The editorial
committee hopes that you
will find it a valuable industry
resource and a valuable
communication tool. This first issue
is experimental and we welcome
feedback from our members as to
what you would like to see in the
publication, what you think of the
format and if you find the content
appropriate.
In this issue we focus on changes that have occurred within the standards as well as
the activities of two of our key regulators DAFF and OGTR.
There is also a feature article on pressure testing of high level containment facilities
from Dr Gordon McGurk and a basic guide to SSBA compliance and requirements.
Next issue we will be presenting a feature article on gaseous facility decontamination
to attempt to demystify the process, give an unbiased overview of each technology and
describe the limitations and the benefits of each technology and technique. I hope you
enjoy the publication and remember your feedback is important to us - please let us
know what you would like to see.
Stephen Coulter
(Editorial Committee Chair)
• the pressure myth
next issue
• gaseous
decontamination
and fumigation
explained
“Strengthening biosafety linkages and collaborations between Australia & New Zealand”

Air-tightness testing of high level containment facilities: regulatory necessity
or simply nice to know?
Gordon McGurk Ph.D.
gordonmcgurk@aapt.net.au
This article is a summary of a presentation from the 2012 ABSANZ conference
T
he majority of guidelines and standards that are
applicable to the construction or design of biocontainment
facilities in Australia contain either
guidance on, or relate to, a requirement around
the air-tightness of the facility. However, given the way
in which high-level containment facilities operate, by
maintaining the facility at negative pressure, the rationale
for this requirement is uncertain. Does it relate to
containment of micro-organisms, or is it more about the
ability to decontaminate the facility following the use of
the microorganisms without jeopardising the health and
safety of personnel outside the facility?
From a regulatory perspective, there was a lack of airtightness
information available with respect to facilities
currently in operation. Therefore, in order to address the
information gap regarding the air-tightness of PC3 biocontainment
facilities, and perhaps provide evidence to
support any relevant regulatory change, a project to
quantify the structural and seal integrity of laboratory and
small animal PC3 containment facilities by means of an
air-tightness test was conducted. Air-tightness was
measured by calculating the amount of air leaking from
the facility when pressurised to a positive pressure of
200Pa over a 20 minute period.
Of the 20 facilities tested 10 had an air-leakage rate
which was within or better than the range (120 L/min.-
1200 L/min.) advised for PC3 level containment facilities
in Part 3 of the Australian and New Zealand Standard for
Safety in Laboratories (AS/NZS 2243.3 [2010]).
A further 8 facilities had an air-leakage rate of
approximately 1400 L/min. or more. The remaining two
facilities were unable to be measured due to structural
issues.
The results of this testing indicated that the air-tightness
of facilities varies due to the combination of a number of
factors including age of the facility, construction method,
and number of penetrations through the containment
barrier.
In general, air-tightness decreased with the increasing
age of the facility, with the most recently constructed
facilities having air-leakage rates of

Considering Becoming a Member?
Membership details
Individual - annual fee of $110 incl. GST per Member
Corporate - $495 incl. GST for the first 5 Members and $420 incl. GST per additional 5 Members. For Corporate
Membership, individual names and contact details must be supplied. The Member names can each be changed once
during the membership year.
Renewal: Membership is for one year, beginning 1 February.
Who are our members?
Currently we have over 200 members:
• Architects
• Engineers
• Microbiologists
• Scientists
• Facility owners
• Facility operators
• Maintenance Managers
and staff
• Regulators
• Consultants
• Suppliers
• Inspectors
What are the benefits of becoming a member?
• Receive regular industry updates
• Access to ‘Members Only’ section of website, which includes educational materials, discussion papers and
useful website links
• Discounts on conferences, training and workshops run by the Association
• Exclusive opportunities to provide conference and workshop materials at ABSANZ run events
• Access to LinkedIn Group, providing a secure chat space to access and share expertise, network with other
biosafety professionals and keep abreast of developments in biosafety
• Receive news of significant changes and events affecting biosafety
• Voting rights to elect ABSANZ key members, President, Vice President, Secretary and Treasurer
• Input into the development of ABSANZ Strategic Plan
• Join Standing Committees; and
• Ability to influence the direction and future of biosafety in Australia and New Zealand
What are “Security Sensitive Biological Agents”, and who is DoHA?
Stephen Coulter
stephen.coulter@amec.com
SSBAs are biological agents and toxins that have been
determined to be a potential bioterrorist risk.
This list and the legislation is covered in the National
Health Security Act 2007 that is administered by the
Department of Health and Ageing (DoHA). SSBA
agents are divided into two groups, which are determined
as Tier 1 and Tier 2 by the Minister of Health.
Tier 1 agents are considered the highest Biosecurity risk.
Tier 2 agents are agents that pose a moderate biosecurity
risk and are subject to proportionally moderate regulatory
requirements.
Those facilities holding either Tier 1 or Tier 2 agents are
required to register with DoHA. Those laboratories are
required to comply with the SSBA Regulations and with
the ‘SSBA Standards’, which are a management tool. As
a result it requires SSBAs to be managed safely and
securely, with regular reports to DoHA. Because the
SSBA Standards is a management standard that depends
on risk assessments and management policies to attain
the outcomes of the Act, there is some concern expressed
by designers, facility owners and inspectors that the
requirements for buildings are not spelt out in detail but
“Strengthening biosafety linkages and collaborations between Australia & New Zealand”

offers the possibility of various options to achieve these
outcomes.
In essence the premise of SSBA agent protection is
twofold:
One: Keep the SSBAs secure (including all
documentation relating to the products), know
who has accessed them (samples and
documentation) and when
Two: Provide levels of active and passive protection
built into the facilities to ensure unauthorized
access is either eliminated or delayed sufficiently
for law enforcement agencies to attend.
The second item represents the biggest challenge,
because designers and facility owners must consider
many factors, including:
• prevention of coerced tailgating (preventing
registered staff being forced under duress to
access areas),
• prevention of multiple entry under one access
control (intentional or unintentional internal
tailgating)
• access protection – including securing ceiling
spaces, securing mechanical ducts that are large
enough to crawl through, securing windows and
walls that would ordinarily not represent a
challenge to unauthorized malicious access.
What if I am a diagnostic laboratory? Unless you know
that you will be routinely encountering known SSBAs
there is generally no expectation that the facility needs to
comply with the requirements of the National Health
Security Act. However you must have procedures in
place such that if a sample is found to be SSBA positive
you know how you are going to handle it from that point
forward. The laboratory must notify DoHA and either
destroy, ship to an appropriate registered laboratory or
become a registered laboratory.
The first item can be addressed relatively simply using
conventional tracking devices such as registers, logs,
electronic access control (ingress and egress), and
security cameras.
It is important that all laboratory plans are discussed with
the authorities in the planning phases to ensure any
requirements can be met should the need arise.
Current standards, templates, guidelines and check sheets
are available at the DoHA SSBA website.
(www.health.gov.au/SSBA)
The ABSANZ Professional Development Standing Committee (PDSC) has
been busy in 2013
Joanna Gray
Joanna.gray@rcpaqap.com.au
The committee is working to establish the training biosafety requirements of current and future Australian and New
Zealand members whilst keeping a keen interest in the activities of international organisations such as the
International Federation of Biosafety Associations (IFBA).
To date the Committee has:
• reviewed 2012 Conference Feedback
• produced a Charter to establish the direction of the committee
• developed a Training Model
• conducted an assessment of training synergies and opportunities, in particular the IFBA group who are
working on training competencies and examination schedules, reviewed the content with plans to adopt a
Principles and Practices document that outlines potential module offerings
• agreed to assess who will receive the Neil Walls Consulting Scholarship in 2013
• commenced preparations for the ABSANZ Conference in Auckland, 2013
We will continue to provide ABSANZ members with PDSC updates in ongoing Newsletters.
“Strengthening biosafety linkages and collaborations between Australia & New Zealand”

Conference 2013
Dates: 29 October 2013 – 1 November 2013
Cost: Early bird registration (prior to 13 September 2013) $860 AUD (members) / $970 (non members), $1060 /
$1170
Location: The Heritage Auckland New Zealand
Preliminary Program Link: A preliminary Program is available on the ABSANZ website www.absanz.org.au
The Neil Walls Consulting Pty Ltd ABSANZ Scholarship for attendance at
the 2013 ABSANZ conference in Auckland, New Zealand
B
oard member and foundation supporter of ABSANZ Mr Neil Walls has generously offered to provide a
scholarship for an individual to attend the 2013 ABSANZ conference in Auckland New Zealand.
Submissions are to be made in accordance with the criteria listed below and the final recipient decision will
be made by the Professional Development Standing Committee (PDSC). Good luck to all prospective
applicants and thanks to Neil for his generosity in supporting both the industry and the growth of our association.
Purpose: To support an employee of a Not for Profit
Research Organisation who would otherwise be unable to
attend the conference for cost reasons.
Terms: The successful applicant will receive up to
AUD$2,200 towards travel, accommodation and
conference registration. Receipts totalling up to
AUD$2,200 are to be provided to ABSANZ within four
weeks of the conference concluding. These expenses
will then be refunded. The successful applicant will be
asked to prepare either a poster or a short 10 minute
presentation at the conference.
Applying: Applications should be in writing, no longer
than one A4 page in length, stating the organisation,
position and work/duties of the applicant and the reason
for applying for the scholarship to attend the conference
and emailed to admin@absanz.org.au by 1 July 2013.
The successful applicant will be advised in writing by
Thursday 1st August 2013.
No discussion will be permitted between applicants and
ABSANZ Professional Development Standing
Committee concerning the scholarship.
Subject to mutual agreement, the successful applicant
will also be announced on the ABSANZ web site.
Cancellation: If, for some reason, the successful
applicant is unable to accept the scholarship or is unable
to attend the conference, ABSANZ should be notified
immediately. The ABSANZ Professional Development
Standing Committee will attempt to offer the scholarship
to an alternative applicant if time permits.
Notification: The successful applicant will be
determined by the ABSANZ Professional Development
Standing Committee.
The decision will take into account the nature of the work
being carried out by the applicant and the reason for the
application as stated by the applicant.
“Strengthening biosafety linkages and collaborations between Australia & New Zealand”

A new aquatic containment standard for Australia and New Zealand?
Neil Walls
neil@nwalls.com
The current 6 th edition of AS/NZS 2243 part 3: 2010
“Safety in laboratories, part 3: Microbiological safety and
containment” was published on 17 September 2010.
The committee responsible for this is known as Joint
Technical Committee CH-026.
It should be noted that this information is still very much
a draft and that it does not constitute a formal Standards
Australia Limited draft release.
There will be further opportunity for comment from
stakeholders should a formal Standards Australia release
become a reality.
Support for progressing the document to a formal draft
stage requires us to make a formal “Project Proposal”
submission to Standards Australia.
In this edition, the requirements for animal, plant and
invertebrate containment facilities were revised to make
them independent of the requirements for laboratories.
During its development, the committee noted the absence
of aquatic facilities in these revisions. This is referred to
by a note in the preface.
It was considered too late to develop these prior to the
release of edition 6 as this could have resulted in an
unacceptable delay.
Neil Walls, as a representative of this committee, agreed
to develop a “first step” draft aquatic standard for
circulation and review.
This early draft was completed on 03 May 2012 and
circulated for comment amongst a small number of
specialist aquatic facility professionals.
Comments from this initial circulation were incorporated
and the draft has now been updated to a point where
wider circulation and invitation for comment is
appropriate.
It is currently posted on the ABSANZ web site,
www.absanz.org.au and is also available from Neil’s web
site, www.nwalls.com.
This is an open invitation for any of our readership to
download the document and provide critical comment.
In order for this to gain traction, our ABSANZ readership
is encouraged to provide comments and/or supporting
statements to acknowledge the importance of such an
inclusion into AS/NZS 2243.3.
Any comments are welcome, and should be titled “A
new aquatic containment standard for Australia and
New Zealand”
They may be sent to ABSANZ admin@absanz.org.au or
to Neil Walls directly neil@nwalls.com.
Please assist ABSANZ to make this a success.
“Strengthening biosafety linkages and collaborations between Australia & New Zealand”

From Our Regulators
OGTR Issue of Revised PC2 Facility Guidelines
O
n 1 March 2013, the Gene Technology Regulator issued revised Guidelines for the Certification of PC2
Laboratories, and Animal, Aquatic, Plant and Invertebrate Facilities. Copies of these guidelines are
available on the OGTR website at:
/www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/certifications-1#pc2
DAFF Review of Biosecurity Containment Criteria
Jeff Cates
Jeff.cates@daff.gov.au
More than 1200 Quarantine Approved Premises
(QAPs) across Australia are required to conform to
an array of construction, quality and risk
management criteria in order to be approved by the
Department of Agriculture Fisheries and Forestry
(DAFF) to contain and handle specific biosecurity
risk materials. These materials include biological
products, soil, animals, plants and animal and plant
products. Most of these facilities are analytical and
research laboratories, but there are also a number of
premises such as insectaries, live animal operations
and plant handling facilities.
QAP containment criteria were last reviewed in
2005. Since that time Standards Australia have
developed new editions of Australian New Zealand
standards (AS/NZS) incorporating expanded
structural and procedural requirements for
laboratories and containment facilities.
DAFF is currently undertaking a review of QAP
containment criteria with a view to aligning criteria
to the AS/NZSs as much as possible.
The review will focus on:
1. Harmonising requirements with the AS/NZS for
physical containment. The relevant Standards
are: AS/NZS 2982:2010 (Laboratory design
and construction) and AS/NZS 2243.3:2010
(Safety in laboratories, Microbiological safety
and containment).
2. Streamlining criteria and where possible
removing requirements which do not directly
affect containment.
3. Potential audit efficiencies through
harmonisation and alignment of DAFF and
related agency audits with business operations.
As part of this review DAFF will be engaging
with relevant QAP operators and industry
stakeholders to ensure the alignment of the
standards impose a minimal burden on industry
while maintaining biosecurity integrity.
The draft containment criteria will be
forwarded to all relevant QAP operators for
comment and will be published on the DAFF
website. ABSANZ members will also be
invited to comment. Information on the draft
criteria and consultation period will be
provided in future ABSANZ newsletters.
“Strengthening biosafety linkages and collaborations between Australia & New Zealand”

The pressure myth
Stephen Coulter
Stephen.coulter@amec.com
QC3 and PC3 facilities require (by code) to be at
least 50Pa below adjacent spaces to maintain
containment. 50Pa in itself is not considered much
pressure – sucking water up 10cm long straw for
example requires almost 1000Pa of strength –
something most of us can do with not too much
trouble.
However, the stress that 50Pa puts on a facility is
not to be underestimated.
Consider a small laboratory say 10m x 7m – a
ceiling area of 70m 2 . The effect of 50 Pa across
70m 2 equates to an equivalent force of 3500
Newtons or 360kg exerted on the ceiling.
Hardwired interlocks are often set at 200Pa which
can balloon the force out to a massive 1500kg. This
is why it is vital that emergency independent
pressure controls are installed to ensure that facility
pressures are not exceeded in the event of a
controller failure or some other cause.
The other added stress on the facility is caused by
people opening and closing doors which leads to the
pressure within the facility fluctuating.
So while 50Pa may not seem like a high pressure the
stress that it puts on our containment facilities is not
to be underestimated.
Want a bigger role?
The Editorial committee is a small group of dedicated industry savvy individuals who would really appreciate
additional support from the ABSANZ members. If you have a desire to contribute articles or have a series of
topics that you would like to see us research and publish information on please let us know - we welcome all
input. We would also welcome members who would be interested in becoming part of the editorial committee to
not only share the duties but to provide a greater diversity in views and opinions on ABSANZ printed material.
Editorial Committee
Stephen Coulter, AMEC
Denise Elson, Deakin University
Neil Walls, Neil Walls Consulting
Contact Details
The contact details for ABSANZ are as follows:
www.absanz.org.au
Telephone: +61 3 5222 7298
Fax: +61 3 5222 7226
Email: admin@absanz.org.au
Postal Address: PO Box 1620 Geelong Victoria 3220 Australia
ABN: 38 147 502 556
Disclaimer.
Articles published in this newsletter reflect the opinions of individual authors and are not necessarily those of
ABSANZ. All items presented in this newsletter have been published in accordance with the ABSANZ Editorial
Committee Charter. Copies of the Charter are available on the ABSANZ website or can be made available by
contacting the ABSANZ office.
“Strengthening biosafety linkages and collaborations between Australia & New Zealand”