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Guidelines for Certification of Physical Containment Facilities

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					Guidelines for
Certification
of Facilities /
  Physical
Containment
Requirements
     June 2001
For more information about the certification of facilities, or about any
 other matter related to the regulation of gene technology, please
                               contact:


   The Office of the Gene Technology Regulator
                       MDP 54
Commonwealth Department of Health and Aged Care
                    PO Box 100
                WODEN ACT 2606
                  Ph: 1800 181 030
                Fax: (02) 6271 4202
            Email: ogtr@health.gov.au
              Web: www.ogtr.gov.au

   Copies of the Gene Technology Act 2000, the Gene
 Technology (Consequential Amendments) Act 2000 and
the Gene Technology (Licence Charges) Act 2000 may be
 obtained from the OGTR or may be downloaded from the
                    following websites:
       www.aph.gov.au (Parliament House website)
   www.health.gov.au/tga/genetech.htm (IOGTR website)


                         IMPORTANT NOTE

  These Guidelines will be updated from time to time. Users should
therefore assure themselves that they have access to the most recent
                              version.
                Glossary of terms and
                   acronyms used

Accredited Organisation An accredited organisation can apply for licences to
                        deal with GMOs under the Commonwealth Gene
                        Technology Act 2000. For more information see the
                        Guidelines for the Accreditation of Organisations.

the Act                   the Commonwealth Gene Technology Act 2000

dealings or deal with     has the same meaning as in the GT Act. Section 10
                          of the GT Act provides that “deal with” in relation to a
                          GMO means the following:
                          (a) conduct experiments with the GMO;
                          (b) make, develop, produce or manufacture the GMO;
                          (c) breed the GMO;
                          (d) propagate the GMO
                          (e) use the GMO in the course of manufacture of a
                          thing that is not the GMO;
                          (f) grow, raise or culture the GMO;
                          (g) import the GMO
                          and includes the possession, supply, use, transport or
                          disposal of the GMO for the purposes of, or in the
                          course of, a dealing mentioned in any of the
                          paragraphs (a) to (g)

GILSP                     Good Industrial Large Scale Practice

CSCG                      Commonwealth State Consultative Group on Gene
                          Technology

GMAC                      Genetic Manipulation Advisory Committee

GMO                       genetically modified organism

GM                        genetically modified

GTCCC                     Gene Technology Community Consultative
                          Committee

GTTAC                     Gene Technology Technical Advisory Committee

GTEC                      Gene Technology Ethics Committee


                                                                                 2
IBC                  Institutional Biosafety Committee

IOGTR                Interim Office of the Gene Technology Regulator (until
                     21 June 2001)

NLRD                 Notifiable Low Risk Dealings

OGTR                 Office of the Gene Technology Regulator (after 21
                     June 2001)

Organisation         Any firm, organisation or institution which intends to
                     'deal with' a GMO

PC2                  Physical Containment Level 2, as certified by the
                     Regulator in accordance with these Certification
                     Guidelines.

PC3                  Physical Containment Level 3, as certified by the
                     Regulator in accordance with these Certification
                     Guidelines

PC4                  Physical Containment Level 4, as certified by the
                     Regulator in accordance with these Certification
                     Guidelines

Project supervisor   An appropriately qualified person within the
                     organisation that is intending to 'deal with' a GMO

the Regulations      the Commonwealth Gene Technology
                     Regulations 2001

the Regulator        the Gene Technology Regulator




                                                                              3
                        Table of Contents
             GLOSSARY                           2

     ABOUT THESE GUIDELINES                     5

CHAPTER 1:        CERTIFICATION OF FACILITIES   10

CHAPTER 2:     TRANSITIONAL ARRANGEMENTS FOR    13
                  CERTIFICATION OF FACILITIES

CHAPTER 3:      APPLYING FOR CERTIFICATION OF   18
                 FACILITIES FROM 21 JUNE 2001

CHAPTER 4:       VARIATION OF CONDITIONS OF     24
                       CERTIFICATION

CHAPTER 5:      COMPLIANCE WITH CONDITIONS OF   25
                        CERTIFICATION

CHAPTER 6:        CRITERIA FOR CERTIFICATION    30

CHAPTER 7:       CONDITIONS OF CERTIFICATION    32




                                                    4
ABOUT THESE GUIDELINES

  What is the purpose of these Guidelines?

  On 21 June 2001, a new system for the regulation of gene
  technology and genetically modified organisms (GMOs) took
  effect.

  The legislation regulates a range of activities or “dealings”
  involving GMOs. These Guidelines describe one aspect of
  the national regulatory scheme – the certification of facilities.

  The Regulator is empowered under section 90 of the Gene
  Technology Act 2000 to issue technical and procedural
  guidelines in relation to the requirements for the certification
  of facilities to specified containment levels.

  These Guidelines are issued in accordance with section 90
  of the Gene Technology Act 2000 and will assist
  organisations to understand and comply with the
  requirements of the new regulatory system for GMOs.

  The Guidelines set out:

     explanatory information about the new system for
      certification of facilities where work with GMOs will be
      conducted;

     the transitional arrangements for facilities that met
      GMAC‟s requirements for physical containment before 21
      June 2001;

     the criteria to be addressed by organisations that wish to
      apply for certification of facilities after 21 June 2001; and

     conditions to be complied with for certified facilities.

      Conditions relate to matters such as: laboratory
      procedures for containing GMOs; essential equipment to
      be available in certified facilities; laboratory signs; and
      construction requirements to ensure that the facility
      presents an appropriate level of physical containment.



                                                                      5
               IMPORTANT NOTE

These Guidelines should be read in conjunction
with the Handbook on the Regulation of Gene
Technology In Australia, the Gene Technology
Act 2000 and the legislation. W here necessary,
organisations should obtain their own
independent legal advice about the operation of
the legislative scheme.

How do the Guidelines relate to other parts of
the regulatory scheme such as the Gene
Technology Act 2000 and the Gene Technology
Regulations 2001?

In December 2000, Federal Parliament passed the Gene
Technology Act 2000 (the GT Act) and its associated Acts,
the Gene Technology (Consequential Amendments) Act
2000 and the Gene Technology (Licence Charges) Act 2000.

These three Acts, together with corresponding legislation
enacted in each State and Territory in Australia, as well as
subordinate legislation and other instruments, will comprise
the national scheme for the regulation of gene technology
and GMOs in Australia.

The corresponding legislation in each State and Territories
will essentially mirror the Commonwealth legislation. The
corresponding laws are currently being developed and
passed by each individual State and Territory.

The Gene Technology Regulations 2000 (the GT
Regulations) complement the GT Act also commenced
operation on 21 June 2001. The Regulations provide
additional detail to assist the interpretation and operation of
the provisions in the GT Act. For example, the Regulations
set out the timeframes for the Regulator to consider
applications for certification of facilities and the transitional
arrangements for certification of facilities that met the
Genetic Manipulation Advisory Committee‟s (GMAC)
requirements for containment before the commencement of
the legislation.

The Regulator is empowered under the GT Act to issue
technical and procedural guidelines. These Guidelines



                                                                    6
are the technical and procedural guidelines relating to the
certification of facilities. The Regulator has also issued:

   Guidelines for the Accreditation of Organisations;

   Guidelines for the Certification of Facilities/Requirements
    for Physical Containment; and

   a Risk Analysis Framework for licence applications
    before the Office of the Gene Technology Regulator.

For more information about the various instruments that
comprise the national regulatory scheme for gene
technology, please refer to the Handbook on the Regulation
of Gene Technology in Australia.

How do these Certification Guidelines differ
from the current voluntary GMAC system of
controls on facilities and physical containment
requirements for GMOs?

Under the GMAC voluntary system of controls on GMOs,
organisations dealing with GMOs were expected to observe
the relevant GMAC Guidelines, in relation to containment
requirements for facilities in which work with GMOs was
conducted.

For example, Appendices 8-21 of the GMAC Guidelines for
Small Scale Genetic Manipulation Work set out the three
levels of physical containment for work with GMOs. The
three levels of physical containment are referred to as:

   Physical Containment Level 2 (PC2);

   Physical Containment Level 3 (PC3); and

   Physical Containment Level 4 (PC4).

PC4 is the highest level of containment.

GMAC set different requirements for different types of work
areas, such as laboratories, plant houses, animal facilities,
and insectaries.

The GMAC Guidelines for Large Scale Genetic Manipulation
Work set out additional requirements to apply in the case of


                                                                  7
large scale, or industrial work with GMOs. This work would
occur in large-scale settings: large scale laboratories, plant
houses, aquaria and insectaries.

These Guidelines for certification of facilities/physical
containment requirements were developed by drawing on
material in both the GMAC Guidelines for Small Scale
Genetic Manipulation Work and the GMAC Guidelines for
Large Scale Genetic Manipulation Work.

In essence, the physical containment requirements for PC2,
PC3 and PC4 are the same as those described in the GMAC
Guidelines. The requirements for the various levels and
types of physical containment are set out in Sections A-P in
Part 2 of Chapter 8 of these Guidelines.

As part of the transition to the new system of regulation, it
has been important that the requirements for physical
containment essentially remain the same as they were under
the GMAC Guidelines. This will ensure that existing facilities
continue to comply from 21 June 2001.

However, it should be noted that some of the conditions
have been redrafted slightly in line with the requirements of
the new regulatory system. For example, references to
„GMAC‟ have been replaced by references to „the Regulator‟.
Such changes are minor and will not affect substantive
matters such as the construction requirements for various
types of facilities.

However, organisations should carefully examine these
requirements and ensure that they are fully complied with.
This applies particularly to organisations who hold “deemed”
certifications for facilities. For more information regarding
the transitional arrangements and the “deeming”
arrangements for facilities that met GMAC‟s requirements for
physical containment before 21 June 2001, please refer to
Chapter 2.

Will there be an opportunity for review
of these Guidelines?

Yes. Many of the requirements for physical containment,
particularly for PC3 and PC4, require that the laboratory - or
relevant work area - be constructed in a certain way. As
such, any changes to the requirements can have serious


                                                                 8
impacts for the owners of the facilities and should not be
made without proper consideration.

However, the need for review was stressed by organisations
and IBC members during consultations on the new
regulatory system. There was a common view that the
requirements for physical containment should have the
following objectives:

   as far as possible, to harmonise the Guidelines with the
    relevant Australian Standards; and

   as much as possible, to reduce the subjectivity in the
    language used in the Guidelines.

It is therefore proposed that the Regulator will undertake a
comprehensive review of the requirements for physical
containment of facilities. It is proposed that the Regulator
will review the requirements for PC3, PC4 and PC2 Large
Scale facilities during the first 12 months of the operation of
the scheme. This will coincide with the transitional
arrangements for such facilities which will expire after 1 year
(by 20 June 2002).

The review of the requirements for PC2 facilities (excluding
PC2 Large Scale) will be conducted over a two year period,
to coincide with the transitional arrangements for such
facilities which expire after 2 years (by 20 June 2003).

The process of review of the requirements for physical
containment of facilities will utilise the expertise of the Gene
Technology Technical Advisory Committee, which replaces
GMAC under the new system of regulation, and experts in
biocontainment. The review will also involve extensive
consultation with stakeholders, particularly owners/managers
of facilities, Accredited Organisations and Institutional
Biosafety Committees (IBCs).

Recognising that any changes to the requirements will have
implications for owners, managers and users of facilities, it is
anticipated that any changes arising as a result of the review
will be implemented over a period of time.

The OGTR will make details of the review available on the
OGTRs website and will also directly contact all holders of
“deemed” certifications for facilities, Accredited
Organisations and IBCs.


                                                                  9
             CHAPTER 1

CERTIFICATION OF FACILITIES

  What is the purpose of certification of facilities?

       Depending on the particular GMO, organisations may wish to
       conduct work in a range of different work settings. The type
       of facility that will be appropriate to the particular GMO will
       depend on:

          the type of GMO being used. For example, it may be
           most appropriate to conduct work with GM
           microorganisms in a laboratory, to conduct work with
           plants in a plant house, and to conduct work with insects
           in an insectary;

          the risks posed by the particular GMO, or the particular
           work proposed to be conducted with the GMO.
           Depending on the type of GMO that is being used, and
           the risks posed by that particular GMO, the level of
           physical containment required to prevent the GMO from
           being released into the environment will vary. The
           experimental procedures that must be complied with, in
           order to ensure the safety of workers, will also vary.

       The purpose of certification is to satisfy the Regulator that
       the facility which is proposed to be used to contain the GMO
       meets the Regulator‟s requirements for physical
       containment. This will apply regardless of whether the
       facility is a laboratory, plant house, insectary, animal house
       or another type of facility. The conditions of certification also
       satisfy the Regulator that certain procedures will be observed
       to ensure the safety of workers with GMOs.




                                                                      10
If the facility I work in is certified by the Regulator
       does that automatically mean that I can
       undertake work with GMOs?

     No. Just because a facility has been certified by the
     Regulator as suitable for containing particular types of
     GMOs, this does not mean that work with GMOs may
     automatically proceed in such a facility.

     A person must not undertake “dealings” with GMOs unless
     those dealings are:

        exempt;

        notifiable low risk dealings;

        licensed by the Regulator; or

        on the Register of GMOs.

     The GT Act and the GT Regulations set out the requirements
     for each of the different categories of dealings with GMOs.

     For example, one of the conditions that must be complied
     with by people undertaking notifiable low risk dealings with
     GMOs is that the work must be conducted in a facility
     certified by the Regulator as being at least Physical
     Containment Level 2 (PC2). The Regulations also provide
     that other requirements must be met before such work may
     commence. For example, the proposal to undertake
     notifiable low risk dealings must be evaluated by an
     Institutional Biosafety Committee and the Regulator must be
     notified of the proposed work.

     To summarise, the work may not commence until ALL of the
     requirements prescribed in the Regulations have been met.
     It is certainly not sufficient that one of the conditions, that is
     that the work must be conducted in a facility certified by the
     Regulator, has been met.

     Similarly, there is a detailed process which must be followed
     by people proposing to undertake work with types of GMOs
     that must be licensed by the Regulator. If the Regulator
     approves work with certain GMOs and issues a licence, one
     of the conditions of licence may be that the work must be


                                                                     11
conducted within a facility certified to a certain containment
level by the Regulator.

In order to decide what type of GMO you are dealing with,
and therefore what type of approval you will need from the
Regulator, you will need to examine the legislation. You will
need to do this before you commence any work with the
GMO. The Handbook on the Regulation of Gene
Technology in Australia may also be a useful resource. It
explains in simple terms, and with examples, the types of
GMOs that fall into each category.




                                                                 12
                 CHAPTER 2

TRANSITIONAL ARRANGEMENTS FOR
         CERTIFICATION OF FACILITIES

      What are the transitional arrangements for
           certification of facilities?

           To minimise disruptions flowing from the commencement of
           the new system, the legislation describes transitional
           arrangements for facilities in relation to which GMAC has
           issued a “Notice that a Facility is Certified to a Specified
           Containment Level” before the commencement of the
           legislation.

           If a GMAC “Notice that a Facility is Certified to a Specified
           Containment Level” has been issued in respect of a facility
           then that facility is taken to be certified to the level specified
           in the notice, for the purposes of the legislation. This is
           sometimes referred to as a “deemed” certification.

      How will I know if the facility I work in has been
          “deemed” to be certified?

           In May 2001 the IOGTR, on behalf of GMAC, wrote to all
           organisations who have existing facilities explaining the
           transitional arrangements for certification of facilities.

           The letter to organisations included a “Draft Notice that a
           Facility is Certified to a Specified Containment Level”.

           The draft notice contained information about:

              the facility proposed to be deemed to be certified
               (including the type of facility);

              the specified containment level (ie PC2, PC3 or PC4);

              the period proposed to be covered by the notice; and
              the draft conditions attaching to the notice.



                                                                                13
Organisations were given until 5 June 2001 to check the
information, ensure that the information was recorded
correctly and to notify the IOGTR of any changes needed.
One example of necessary changes would be where the
facility was no longer in use.

In early June 2001, the IOGTR, on behalf of GMAC, issued
final notices based on the draft provided to organisations and
taking into account any necessary changes.

This final “Notice that a Facility is Certified to a Specified
Containment Level” is an important document.

The effect of the Notice from the IOGTR (on behalf of
GMAC) is that the facility is taken to be certified to the
Physical Containment Level recorded in the notice, for the
purposes of the Act.

In other words, any facility for which a notice has been
issued by the IOGTR (on behalf of GMAC), is “deemed” to
be a certified facility under the Act.

If you are proposing to undertake work with GMOs in
accordance with a „GMAC advice to proceed‟ or in
accordance with transitional arrangements for notifiable low
risk dealings, you must make sure that the facility that you
will be working in has been “deemed” to be certified and is
the subject of a notice issued by the IOGTR on behalf of
GMAC.

If you have any concerns regarding this, please contact your
IBC in the first instance. They are likely to be able to help
you because they have been in receipt of the information
provided by the IOGTR about the transitional arrangements
for certification of facilities.

You can also contact the OGTR to confirm whether the
facility has been “deemed” to be certified and to what level of
physical containment (ie PC2, PC3 or PC4).




                                                                 14
                           How long will the “deemed” certification last?

                                The period of time during which the “deemed” certification
                                will operate will depend on the type of facility that has been
                                deemed to be certified.

                                For a PC2 facility, the “deemed” certification will last for up to
                                2 years. This applies to all PC2 facilities except PC2 Large
                                Scale Facilities.

                                For all other facilities, including PC3, PC4, PC2 Large Scale
                                or other facilities, the “deemed” certification will last for a
                                maximum of one year.

                                During this transitional period of between one and two years,
                                organisations will have to apply for re-certification of their
                                facilities in accordance with the Regulator‟s application
                                requirements.

                                The criteria for certification are set out in Chapter 6 of these
                                Guidelines. The application forms for certification of facilities
                                will be available from the Regulator‟s website or by
                                contacting the OGTR. For more information regarding
                                applying for certification, either for a new facility of for a
                                facility that has been the subject of a “deemed” certification
                                during the transitional period, please refer to Chapter 2 of
FEES AND COST                   these Guidelines.
RECOVERY
The Commonwealth                It is anticipated that the Regulator will commence a rolling
Government has agreed           schedule of reassessment of the certification of facilities.
to postpone any cost
recovery of the new             Organisations will be notified and advised about when they
regulatory scheme for           are expected to reapply for certification of facilities. There
two years, until 20 June        will be no disadvantage to those organisations expected to
2003. Consultation on           reapply earliest, as all organisations will be reapplying before
arrangements to take
                                the commencement of any cost recovery regime, and before
effect from 21 June 2003
will commence in 2002.          the imposition of any fees for the certification of facilities.



                           What conditions will operate in relation to “deemed”
                                certifications?

                                The notice of certification from the IOGTR, which was issued
                                on behalf of GMAC before the commencement of the
                                scheme, describes the conditions that must be complied with



                                                                                                 15
by holders of a certification in respect of facilities “deemed”
to be certified.

The notices provide that the facility certified by the notice
must, at all times, comply with the following conditions set
out in Section 86 of the Act;

   any conditions imposed by the Regulator under section
    87 of the Act after the certification

       Section 87 of the Act provides that the Regulator may
       at any time, by notice in writing given to the holder of
       a certification, vary the certification of a facility. For
       more information regarding variation of conditions of
       certification please refer to Chapter 7 of these
       Guidelines.

   any conditions prescribed in the Regulations in relation
    to the certification, as varied from time to time; and

       Regulation 41 of the Gene Technology Regulations
       2001 describes the transitional arrangements for
       certified facilities including the time periods for
       certification as described in Chapter 4 of these
       Guidelines. Regulation 41 also provides that the
       facility must maintain compliance with the Regulator’s
       guidelines about the requirements for certification
       (that is, these Guidelines).

   any technical or procedural guidelines issued by the
    Regulator under section 90 of the Act.

       The relevant “technical or procedural guidelines” are
       these Guidelines.

In essence, what all of this means is that, from 21 June
2001, the conditions that must be complied with in respect of
facilities that are operating under a “deemed” certification are
the conditions prescribed in Chapter 7 of these Guidelines.

Will the conditions for certification contained in
these Guidelines have to be complied with from
Day 1?

Yes. The requirements for physical containment for facilities
essentially mirror the old GMAC requirements that


                                                                  16
organisations were previously expected to comply with. As
such, it is the expectation of the Regulator that the
requirements set out in Chapter 7 of these Guidelines will be
complied with by all organisations from 21 June 2001.

However, the purpose of the transitional period is to
provide organisations with an opportunity to develop
internal processes which meet the expectations of
the Regulator. The OGTR will be actively assisting
organisations in this process by providing ongoing
training for organisations, as well as information
resources such as the Handbook on the Regulation
of Gene Technology in Australia. Each organisation
will also be notified of a contact within the OGTR
who will be available to provide advice on an as-
needs basis.




                                                           17
             CHAPTER 3

APPLYING FOR CERTIFICATION OF
      FACILITIES FROM 21 JUNE 2001

  Who will need to apply?

       It is expected that the applicant for certification will be the
       owner of the facility or the organisation managing the facility.
       In most cases it is expected that this will be the relevant
       Accredited Organisation.

       For example, if a University wishes to undertake work with
       GMOs in a facility located on the University campus, it is
       expected that the University would apply for the certification
       of the facility. If the University also manages facilities that
       are “off campus”, the University may also apply for
       certification of such facilities.

       Alternatively, if a private organisation is using University
       facilities and is effectively responsible for the management of
       those facilities as well as for safe practices within those
       facilities, the private organisation may apply for certification
       of the facility. The private organisation would then be the
       holder of the certification and would be responsible for
       meeting the conditions of certification.

       In summary, the organisation that is proposing to undertake
       dealings with GMOs in the facility will in most cases be the
       organisation that seeks certification of the facility. If granted
       certification, that organisation will be the holder of the
       certification for the purposes of the GT Act.


  How does an organisation apply for certification of a
      facility?

       From 21 June 2001, an organisation may seek certification of
       a facility by applying to the Regulator.




                                                                       18
     In order for a facility to be certified, an applicant must meet
     the Regulator‟s criteria for certification, as set out in Chapter
     6 of these Guidelines. In essence, this means that the
     Regulator will need to be satisfied that the requirements for
     physical containment described in Chapter 7 are met.

     The Regulator also has the capacity to certify a facility that is
     not of a type detailed in Chapter 7. For example, if an
     organisation wishes to undertake work with GM animals and
     has designed a unique enclosure to contain such animals,
     the Regulator can inspect and certify such a facility if the
     Regulator is satisfied that the facility is appropriate for
     containing the particular GMO. The Regulator can also apply
     relevant conditions relating to procedures and practices to be
     adopted in relation to such facilities.

     The Regulator has issued application forms for certification
     of facilities that detail a number of questions to be answered
     by applicants. The questions seek responses from the
     applicant to ensure that the criteria for certification detailed in
     Chapters 6 and 7 of these Guidelines can be met. The
     application forms are available on the Regulator‟s website or
     from the OGTR.

     All queries about the process of applying for certification, and
     the way the Regulator‟s criteria can be met, should be
     directed to the OGTR.

Will an IBC member be required to inspect the facility
      as was required by GMAC?

     As part of the application for certification, the Regulator will
     require that an inspection report be provided from a
     competent person with knowledge and experience in
     biocontainment. The organisation applying for certification
     may choose to utilise the services of an appropriately
     qualified IBC member or may contract an independent
     expert.

     In addition to the inspection report, the Regulator will require
     that supporting information is provided by the relevant IBC.

     Details of the supporting information required, and the
     information required in an inspection report, are included in
     the application forms available from the OGTR.



                                                                        19
      In relation to PC2 facilities – the Regulator will examine
      closely the advice provided by the applicant including the
      inspection report. If the Regulator has any concerns or
      queries the Regulator may request further information from
      the applicant and may also undertake an independent
      inspection of the facility. If the Regulator is satisfied with the
      information provided, this will not be necessary.

      IMPORTANT NOTE

      It is important to note that a major change from the old
      GMAC system to the new system is that IBCs will not issue
      certifications for PC2 facilities. The Regulator will issue all
      certifications including for PC2 facilities.

      In relation to PC3, PC4, PC2 Large Scale and all other
      facilities – the Regulator will examine the advice provided
      by the applicant (including the inspection report) but will also
      undertake an inspection of the facility. The Regulator will not
      issue a certification in respect of a facility, other than a PC2
      facility, until the Regulator has received a report from an
      independent expert who has been commissioned directly by
      the Regulator following receipt of the application from the
      applicant. The person used by the Regulator may be an
      appropriately qualified staff member of the Regulator or a
      sub-contracted and independent expert.


Can I request that certain information contained in my
     application be treated as confidential
     commercial information?

Yes. The Act provides that a person may apply to the Regulator for
      a declaration that specified information is confidential
      commercial information for the purposes of the Act.

      The Act sets out those areas where the Regulator must
      satisfy himself/herself before the Regulator may declare that
      certain information is confidential commercial information.

      The applicant must satisfy the Regulator that the information
      specified in the application is:
      (a) a trade secret;
      (b) any other information that has a commercial or other
          value that would be, or could reasonably be expected to



                                                                        20
    be destroyed or diminished if the information were
    disclosed;
(c) other information that
    (i)    concerns the lawful commercial or financial affairs
           of a person, organisation or undertaking; and
    (ii)    if it were disclosed, could unreasonably affect the
           person, organisation or undertaking.

Before declaring that such information is confidential
commercial information the Regulator must also consider
whether the public interest in disclosure outweighs the
prejudice that the disclosure would cause. If the Regulator
considers that the public interest warrants disclosure of the
information, the Regulator may refuse to declare that the
information is confidential commercial information, even if the
criteria detailed above have been met.

It is expected that any application for treatment of certain
information contained in the application as confidential
information would accompany the application for certification
of the facility. Relevant application forms are available from
the Regulator‟s website and directly from the OGTR.

For more detail regarding applications for treatment of
information as confidential commercial information please
refer to the Handbook on the Regulation of Gene Technology
In Australia.

IMPORTANT NOTE

Details of facilities that have been certified will not be
included on the public record of GMO and GM Product
Dealings. Organisations will only need to seek a declaration
that information contained in an application for certification of
a facility is confidential commercial information, if the
organisation wishes to protect the information from access
under the Freedom of Information Act, if an application is
made by a third party under that Act.

Each piece of information (for which the organisation seeks
protection) must, however, be detailed in an application for a
declaration and the criteria detailed in the GT Act must be
met for each piece of information.




                                                               21
     What is the Regulator’s process for assessing
     an application for certification?
     These Guidelines describe the criteria that the Regulator will
     apply in determining whether a facility meets the criteria for
     certification (refer Chapter 6 of these Guidelines).

     As detailed in the previous Chapter, in addition to seeking
     detailed information about the facility from the applicant, the
     Regulator may also undertake an independent inspection of
     the facility as part of his/her assessment of the application.
     In the case of PC3, PC4 and PC2 Large Scale facilities, the
     Regulator will always undertake such an inspection as part of
     his/her assessment of the application for certification.

     The GT Regulations stipulate that the Regulator must decide
     an application for certification within 90 working days, subject
     to any “clock-stops”.

     A “clock-stop” will come into force if the Regulator needs to
     seek further information from the applicant in order to make a
     decision. That is, the countdown of the 90 day period will be
     suspended until the required information is provided to the
     Regulator.

     The Regulator may stipulate a time period within which
     additional information must be provided. If the requested
     information is not supplied within the stipulated time, the
     Regulator may refuse the application for certification.

If the Regulator is satisfied that the facility meets the
       criteria for certification, what conditions of
       certification will the Regulator impose?

     If the Regulator is satisfied that a facility meets the criteria
     for certification, the Regulator may impose any conditions
     that he/she considers necessary.

     In general, certifications of facilities will be subject to the
     conditions detailed in these Guidelines. That is, the
     requirements for physical containment. However, on a case
     by case basis the Regulator retains the capacity to impose
     additional conditions or vary any of the standard conditions if
     this is necessary.




                                                                        22
                         How will I know if the application for certification has
                             been successful?

                              The legislation requires that the Regulator notify the
                              applicant organisation in writing of the outcome of its
                              application for certification of a facility.

                              If the application is successful, the Regulator will issue the
                              organisation with a notice of certification which will include:

                                 the organisation‟s name;

                                 the relevant IBC‟s name;

                                 the details of the facility;

                                 the conditions of the certification, by reference to these
                                  Guidelines; and

                                 the expiry date of the certification, if any.

                         Do organisations have any rights of review if the
                              Regulator refuses an application?

                              Yes. Decisions by the Regulator to refuse an application for
                              certification are “reviewable decisions” under the Act. This
Relevant provisions of        means that the applicant may seek review of the decision by
the GT Act:                   the Administrative Appeals Tribunal. The Regulator will
                              include details of those review rights with notification of
Division 2 of Part 12:        his/her decision.
Review of decisions
Sections 179-183              Applicants may also seek review of the Regulator‟s decision
                              to specify certain conditions, or to vary, suspend or cancel
                              certification of a facility.

                              For more information regarding rights of review, please refer
                              to Chapter 16 of the Handbook on the Regulation of Gene
                              Technology in Australia.




                                                                                                23
                                    CHAPTER 4

                       VARIATION OF CONDITIONS OF
                                  CERTIFICATION

                         Can the Regulator vary conditions of certification
                              once the certification has been issued?

                              Yes. The GT Act provides that the Regulator may at any
 Relevant provisions
    of the GT Act             time, by notice in writing given to the holder of the
                              certification, vary the certification.
Division 2 of Part 7
Certification                 The variation may mean imposing additional conditions or
Sections 87, 88, 89           removing or varying conditions that were previously imposed
                              by the Regulator.

                              The Regulator would generally vary a certification in one of
                              two circumstances:

                                 if the holder of the certification applies to the Regulator
                                  for a variation of the certification; or

                                 if the Regulator decides that a variation is necessary.

                              Before the Regulator can unilaterally vary a certification, the
                              Regulator must give written notice of the proposed variation
                              to the holder of the certification.

                              The notice may request relevant information from the holder
                              of the certification and must invite a written submission from
                              the holder of the certification, within a designated timeframe.
                              The Regulator must consider any written submissions made.

                              The requirement that the Regulator provide prior notice of
                              the variation to the holder of the certification may be waived
                              where the Regulator considers that the action is necessary
                              to avoid an imminent risk of death, serious illness, serious
                              injury or serious damage to the environment.




                                                                                                24
                 CHAPTER 5

COMPLIANCE WITH CONDITIONS OF
            CERTIFICATION

  Who will be expected to comply with the conditions of
      certification?
       In essence the conditions of certification, described in
       Chapter 7 of these Guidelines, detail four types of
       conditions:

          conditions relating to the way that the facility must be
           constructed;

              For example:
              -     the facility shall not be adjacent to, nor open
                    onto, corridors used by the general public
                    (PC3);
              -     each laboratory shall be equipped with basin
                    mixers for hand-washing (PC2); and
              -     emergency drench showers and eyewash
                    stations shall be provided in accordance with
                    AS/NZS 2243.1 (PC2).

          conditions relating to equipment that must be contained
           in the facility, or within easy access of the facility;

              For example:
              -     the laboratory shall have convenient access to
                    pressure steam steriliser (autoclave) (PC2);
                    and
              -     the laboratory shall have a biological safety
                    cabinet if significant quantities of aerosol are to
                    be produced.

          conditions relating to how the facility, and necessary
           equipment, must be maintained; and

          conditions relating to work practices that must be
           observed by people working within the facility.

              For example:


                                                                      25
       -      mouth pipetting is prohibited;
       -      laboratory gowns shall be worn during work
              and removed before leaving the laboratory;
              and
       -      work benches and surfaces shall be
              decontaminated with a disinfectant solution
              after spills and when work is completed.

Following is a summary of responsibility for compliance with
various conditions of certification:

   conditions relating to the way that the facility must be
    constructed;

       The holder of the certification is responsible for
       ensuring that the construction of the facility is in
       accordance with the Regulator‟s requirements.
       Construction requirements will generally be satisfied
       before a certification is issued. Holders of certification
       will, however, be responsible for ensuring that over
       time there are no changes to the building (for
       example, rennovations), that effect compliance with
       the construction requirements. If such changes are
       proposed, the Regulator must be notified.

   conditions relating to equipment that must be contained
    in the facility, or within easy access of the facility;

       As for the conditions relating to construction of the
       facility, the holder of the certification is responsible for
       ensuring that the facility contains necessary
       equipment. Such requirements will generally be
       satisfied before a certification is issued.

   conditions relating to how the facility, and necessary
    equipment, must be maintained; and

       It will be the responsibility of the holder of the
       certification to take all reasonable steps to ensure that
       all necessary equipment to be housed in the facility or
       accessible to the facility, is maintained over time. For
       example, the holder of the certification must have
       systems in place for reporting of lost or damaged
       equipment and for replacement of such equipment.




                                                                 26
        conditions relating to work practices that must be
         observed be people working within the facility.

            The holder of the certification will be required to take
            all reasonable steps to ensure that all people working
            within the facility are aware of the specific
            requirements, particularly the work practices, to be
            observed in the facility. Once informed of the
            requirements, Individual workers will be responsible
            for ensuring that their work practices are in
            accordance with the conditions of certification.


How will the Regulator monitor compliance with
    conditions of certification?

     As detailed in Chapter 7, which addresses Conditions of
     Certification, the Regulator will require the holder of the
     certification to report annually.

     The Regulator will review each of these reports to ensure
     that there is ongoing compliance with the conditions imposed
     by the Regulator, in relation to certification of the facility.

     The Regulator will also undertake routine and on-the-spot
     inspections of certified containment facilities.

     It is important to note that the Regulator will not only monitor
     compliance with conditions of certification, but will also be
     monitoring compliance with conditions of individual licences
     to deal with GMOs. Many of these licences will contain
     conditions requiring that the facility be certified by the
     Regulator.

     The Regulator will use a variety of tools to monitor such
     compliance, including:

        auditing written reports provided by the licence holder;

        routine monitoring, to be undertaken by the Regulator or
         his/her monitoring staff;

        on-the-spot monitoring, without advance notice from the
         Regulator; and




                                                                    27
                                inspections where there is a possibility that the legislation
                                 has been breached and the Regulator needs to collect
                                 evidential material.

                        What will the Regulator do in the case of non-
                             compliance with conditions of certification?

                             As the conditions of certification are essentially the same as
                             the conditions of certification required by GMAC, it is the
                             Regulator‟s expectation that the conditions of certification will
                             be adhered to, in full, from the first day of operation of the
                             legislation.

                             If the holder of a certification does not comply with the
                             conditions of certification imposed by the Regulator, the
                             Regulator has a range of options open to him or her.

                             These include:

                                variation of the certification;

                                suspension of the certification; and

                                cancellation of the certification.

                             It is also possible that the failure to meet the conditions of
                             certification may also constitute a breach of a licence. This
                             may occur if it is a condition of the particular licence that the
                             work only be conducted in a certified facility which meets the
                             conditions detailed in Chapter 7 of these Guidelines.

                             The course of action selected by the Regulator will depend
                             on the particular circumstances and the severity of the
                             breach of the condition of certification or breach of licence.

                        The suspension or cancellation of certification

 Relevant provisions         The GT Act provides that the Regulator may, by notice in
     of the Gene             writing, suspend or cancel the certification of a facility if the
Technology Act 2000:         Regulator believes on reasonable grounds that a condition of
                             the certification has been breached.
Division 2 of Part 7:
Certification
Sections 88 and 89
                             Before the Regulator can suspend or cancel a certification,
                             he/she must give written notice of the proposed suspension
                             or cancellation to the holder of the certification.



                                                                                              28
The notice may request relevant information from the holder
of the certification and must invite a written submission from
the holder of the certification, within a designated timeframe.
The Regulator must consider any written submissions.

The requirement for the Regulator to provide prior notice of
the suspension or cancellation may be waived where the
Regulator considers that the action is necessary to avoid an
imminent risk of death, serious illness, serious injury or
serious damage to the environment.




                                                              29
         CHAPTER 6

CRITERIA FOR CERTIFICATION
   As detailed in Chapter 5 of these Guidelines, the
   requirements for physical containment to various levels
   detail four types of conditions:

      conditions relating to the way that the facility must be
       constructed;

      equipment that must be contained in the facility, or within
       easy access of the facility;

      conditions relating to how the facility, and necessary
       equipment, must be maintained; and

      requirements relating to work practices that must be
       observed by people working within the facility.

   In order to gain certification of a facility the applicant must
   satisfy the Regulator that the various requirements detailed
   in Chapter 7 can be met.

   To this end, the applicant must satisfy the Regulator that:

      the facility is constructed in a way that meets the
       requirements for physical containment. These
       requirements are detailed in the relevant Section of Part
       2 of Chapter 7 of these Guidelines;

          This must be supported by an inspection report
          prepared by a competent person with knowledge and
          experience in biocontainment (for example, a
          biocontainment engineer) and supporting information
          from the relevant IBC. Details of the matters to be
          addressed in the inspection report and the supporting
          information required from the IBC is detailed in
          application forms available from the Regulator.

      the facility is equipped with the equipment that must be
       contained in the facility, or within easy access of the
       facility;




                                                                     30
       This must be supported by an inspection report
       confirming that the necessary equipment is present.

   the facility and the required equipment will be maintained
    over time; and

       The applicant must describe to the Regulator the
       internal mechanisms to be put in place to ensure that
       the facility, and necessary equipment, is properly
       maintained over time. For example, processes for
       reporting and maintenance of faulty equipment.

   there are internal processes in place to ensure that
    people working with GMOs within the facility are aware of
    the requirements in relation to work practices.

       The applicant organisation must satisfy the Regulator
       that internal processes are in place to ensure that all
       workers are aware of the requirements for work within
       the facility. For example, the organisation could detail
       training programs, how signs and stickers will be
       utilised, and a range of information booklets to be
       provided to workers.




                                                             31
                          CHAPTER 7

          CONDITIONS OF CERTIFICATION
 This Chapter is divided into two Parts:

                       General Conditions (Part 1); and

                           This outlines the conditions that must be complied
                           with by the holder of any certification for a facility,
                           irrespective of what level the facility is certified to and
                           the type of facility.

                       Specific conditions (Part 2).

                           This outlines the specific conditions that must be
                           complied with for facilities certified to varying levels.


Part 1:             General conditions
                    The holder of the certification shall:

                       take all reasonable steps to ensure that the facility, and
                        all necessary equipment to be housed in the facility or
                        accessible to the facility, is maintained over time;

                       take all reasonable steps to ensure that all people
                        working within the facility are aware of the specific
                        requirements, particularly the work practices, to be
                        observed in the facility; and

                       ensure that the facility is inspected by an appropriately
                        trained and experienced person at least once per year. A
                        copy of the inspection report, regarding compliance with
                        the Regulator‟s conditions of certification, shall be
                        provided to the Regulator.




                                                                                       32
Part 2:   Specific conditions
          For ease of reference, this sub-part is divided into the
          following sections:

          Section A – Requirements for Physical Containment Level
          PC2

          Section B – Requirements for Physical Containment Level
          PC3

          Section C – Requirements for Physical Containment Level
          PC4

          Section D - Requirements for Physical Containment for
          Plant House Level PC2

          Section E - Requirements for Physical Containment for Plant
          House Level PC3

          Section F - Requirements for Physical Containment for Plant
          House Level PC4

          Section G - Requirements for Physical Containment for
          Animal Containment Level PC2

          Section H - Requirements for Physical Containment for
          Animal Containment Level PC3

          Section I - Requirements for Physical Containment for
          Insectary Level PC2

          Section J - Requirements for Physical Containment for
          Insectary Level PC3

          Section K - Requirements for Physical Containment for
          Insectary Level PC4

          Section L - Requirements for Physical Containment of Fish
          and other Aquatic Organisms

          Section M - Requirements for Physical Containment Level
          PC2 Large Scale




                                                                      33
Section N - Requirements for Physical Containment Level
PC4 Large Scale

Section O – Requirements for Physical Containment for
Large Scale Animal Houses

Section P - Requirements for Physical Containment for PC2
Large Scale Plant Houses

Section Q - Requirements for Physical Containment for PC3
Large Scale Plant Houses

Section R - Requirements for Physical Containment for
Large Scale Aquaria

Section S - Requirements for Physical Containment for PC2
Large Scale Insect Houses




                                                          34
     SECTION A:                 Requirements for Physical
                                 Containment Level PC2

Note:          The requirements described below for PC2 physical
               containment are similar but not identical to containment level
               PC2 in the Australian Standard AS/NZS 2243.3: 1995 (Safety
               in laboratories: Microbiology). AS/NZS 2243.3 and AS 2982
               (Laboratory design and construction) provide further detail
               on the requirements for facilities and procedures. Where
               differences occur between the requirements listed in this
               section and those in AS/NZS 2243.3, the OGTR’s
               requirements apply for gene technology work falling under
               the scope of the Gene Technology Act 2000.

The requirements listed for PC2 containment emphasise the procedures to be
observed by the laboratory worker to ensure a basic level of laboratory safety.
There are also some architectural requirements relating to laboratory design
and equipment.

Many of the laboratory procedures detailed below are those that would be
considered essential minimum practices in any microbiological laboratory.

Laboratory Procedures

1.      Laboratory doors shall normally be closed when work is in progress to
        ensure that access to the laboratory is limited to laboratory personnel and
        persons specified by the laboratory management.

2.      Mouth pipetting is prohibited.

3.      Eating, drinking, application of cosmetics or smoking is prohibited.

4.      Storage of food or drink in the laboratory or any storage unit containing
        GMOs (e.g. refrigerator) is prohibited.

5.      Laboratory gowns shall be worn during work and removed before leaving
        the laboratory. Suitable hooks shall be provided within the laboratory and
        adjacent to the access door. Closed footwear shall be worn.

6.      Hands shall be thoroughly washed when leaving the laboratory and after
        handling cultures.



                                                                                      35
7.    All microbiological waste shall be steam sterilised before disposal.

8.    Equipment used for handling cultures or contaminated material which is
      not readily steam sterilised shall be chemically disinfected after use.
      Refer to AS/NZS 2243.3 for appropriate decontamination procedures

9.    Work benches and surfaces shall be decontaminated with a disinfectant
      solution after spills and when work is completed.

10.   Material to be taken from the laboratory to an autoclave, or elsewhere in
      the building, shall be carried in a closed, unbreakable outer container.
      Provision shall be made to allow for the penetration of steam into the
      container during autoclaving.

11.   All technical procedures shall be performed in a way that minimises the
      creation of aerosols. In particular, operations such as sonication or
      vortexing which may generate aerosols are to be done in a biological
      safety cabinet. A period of at least five minutes shall be allowed for
      aerosols to settle before opening homogeniser or sonicator containers in
      a biological safety cabinet.

12.   All work done in the PC2 laboratory shall follow PC2 procedures whether
      or not work with GMOs is involved.

13.   Cultures shall be clearly identified, dated and appropriately stored.
      Cultures should not be stored for long periods on the bench, but should
      be transferred to a dedicated storage area.

14.   Labels shall not be moistened with the tongue.

Essential Equipment

15.   The laboratory shall have convenient access to a pressure steam
      steriliser (autoclave).

16.   Each laboratory shall be equipped with basin mixers for hand washing,
      preferably foot-operated, elbow-operated or electronically operated.
      Emergency drench showers and eyewash stations shall be provided in
      accordance with AS/NZS 2243.1.

17.   The laboratory shall have a biological safety cabinet if significant
      quantities of aerosol are to be produced. The biological safety cabinet
      shall comply with the following Australian Standards:

          AS 2252.1: Biological safety cabinets (Class I) for personnel
           protection and environmental protection; or



                                                                                  36
          AS 2252.2: Laminar flow biological safety cabinets (Class II) for
           personnel, environment and product protection.

      The installation of and use of the cabinet shall comply with the
      requirements and recommendations contained in Australian Standard
      AS 2647: Biological safety cabinets - installation and use. In particular,
      provision shall be made for decontamination of the cabinet in accordance
      with the procedures outlined in the Standard or other process of equal
      efficiency including venting of the formaldehyde gas in a safe manner to
      the outside atmosphere.

Laboratory Signs

18.   The laboratory shall be labelled with adhesive signs (supplied by the
      GTR)

         on the door, with a sign designating the level of containment;
         in the laboratory, with a sign giving procedures required for work at
          this level of containment.

      The signs for laboratories are available from the GTR, only after the
      facility has been certified as PC2.

      Freezers, refrigerators or other storage units for genetically manipulated
      material shall be posted with the universal biohazard symbol, available
      from standard laboratory suppliers.

Constant Temperature Rooms

19.   Walk-in warm rooms and cold rooms used for incubation or storage of
      genetically manipulated material may be certified as PC2 facilities even if
      they do not contain sinks or coat hooks. Work in such rooms shall
      otherwise follow all the procedures required for PC2 laboratories.




                                                                                    37
     SECTION B:                  Requirements for Physical
                                  Containment Level PC3

Note:          The PC3 physical containment requirements described below
               are equivalent to containment level PC3 in the Australian
               Standard AS/NZS 2243.3: 1995 (Safety in laboratories:
               Microbiology). The requirements listed in this section are
               compatible with AS/NZS 2243.3, but are not comprehensive.
               Reference must be made to AS/NZS 2243.3 and AS 2982
               (Laboratory design and construction) for detailed
               requirements for facilities and procedures.

Laboratory Procedures

Work in laboratories at PC3 level shall conform with the procedures set out for
PC2 laboratories. In addition, the following requirements apply:

1.      All aerosol-producing equipment such as that for sonication and vortexing
        shall be kept and used in the biosafety cabinet.

2.      The biosafety cabinet and/or the laboratory shall be decontaminated with
        formaldehyde gas after major spills of contaminated material.

3.      No other work is to be done simultaneously with work requiring PC3
        containment.

4.      While work is in progress a sign on the door shall indicate the level of
        containment required for that work.

5.      Laboratory clothing shall be laundered regularly. Protective clothing shall
        not be worn outside the laboratory; it shall be transported to the
        decontamination area in sealed bags or boxes. Boxes shall have
        provision for penetration of steam during autoclaving. Personal clothing
        and effects shall be kept in storage facilities located adjacent to the
        laboratory area and shall not be taken into the laboratory.

6.      No one may enter the laboratory for cleaning, servicing of equipment,
        repairs or other activities unless the principal investigator or the biosafety
        officer has been informed and laboratory surfaces have been disinfected.

7.      All equipment specified for PC3 requirements shall be dedicated to that
        use and area.


                                                                                         38
8.     The laboratory doors shall be locked when the room is unoccupied.

9.     Where a pressure steam steriliser (autoclave) is not available within the
       laboratory, laboratory wastes shall be bagged and placed in an
       unbreakable container with a secured lid for transport to the pressure
       steam steriliser. The surface of the container should be decontaminated
       with a suitable disinfectant. Wastes shall not be stored outside the facility
       before they are sterilised.

Laboratory Planning and Construction

10.    The laboratory shall not be located adjacent to, nor open onto, corridors
       used by the general public.

11.    As detailed below, the laboratory is required to operate at a reduced air
       pressure. To maintain this pressure during access to the laboratory, an
       airlock shall be provided at the entry.

12.    The airlock shall be fitted with two outward opening doors in series, each
       fitted with glass viewing panels and automatic door closers. The outer
       door shall be fitted with a security lock.

13.    The structural design of all surfaces of the laboratory including windows
       shall allow for all air pressure loads imposed by the ventilation fans
       during normal and restricted inlet operation.

14.    The construction and finish of all of the room surfaces shall be selected
       to ensure substantially airtight construction. These surfaces, including
       those of bench tops and cupboards, shall be smooth, impervious and
       selected to resist attack by all decontaminating liquids, gases and agents
       used in the laboratory. Benches, cupboards and engineering services
       shall be either sealed to the room surfaces or mounted on stand-offs thus
       permitting wipe down access for decontamination. Windows in the
       laboratory shall be closed and sealed.

15.    The use of false ceilings and inaccessible spaces shall be avoided.

16.    Accessible voids such as roof spaces around the laboratory shall be
       protected against inadvertent access which could cause structural
       damage or penetration of the barrier.

Laboratory Ventilation

17.    A ventilation system that establishes a negative pressure in the
       laboratory shall be provided so that there is a directional airflow into the



                                                                                       39
      working area. Where laboratories have supply air systems, the supply air
      and exhaust systems shall be interlocked to ensure inward airflow at all
      times. The proper directional air flow into the laboratory shall be verified
      by airflow tests.

18.   The laboratory shall be maintained at an air pressure of at least 50
      pascals below the pressure of adjacent rooms when both doors of the
      airlock are closed. When either door is open, this pressure shall remain
      at least 25 pascals below that of the adjacent rooms.

19.   The pressure differential shall be achieved by means of an independent
      room exhaust fan discharging to the outside atmosphere through a filter.
      A variable speed drive on the exhaust fan is preferred to facilitate manual
      or automatic room pressure control.

20.   Replacement air to the room shall be drawn through a filtered aperture
      which is adjustable to assist in setting up the reduced room pressure.
      The replacement air filter shall be a Type 1 Class A or Class B complying
      with AS 1324 and having a minimum arrestance efficiency of 90 percent
      when tested in accordance with AS 1132.5 with Test Dust No. 2.

21.   The exhaust filter shall be a HEPA type as specified in AS 1324. This
      filter shall be fitted with a prefilter having the same specification as the
      replacement air filter. The HEPA filter shall have metal separators. Fluid
      or grease seals shall not be used. Access shall be provided to facilitate
      determination of the integrity of the HEPA filter installation in accordance
      with AS 1807.6. Magnehelic gauges shall be provided to monitor
      separately the air pressure drop across the prefilter and HEPA exhaust
      filters.

22.   A Magnehelic type differential pressure gauge shall be provided within
      the laboratory to indicate room negative pressure. Other air conditioning
      control switches and the exhaust fan speed setpoint control shall be
      located adjacent to the gauge. An audible alarm to indicate loss of room
      pressure control shall be provided.

Supplementary Cooling

23.   Where the exhaust ventilation rate is inadequate to offset room heat
      loads, supplementary cooling in the form of a fan coil unit may be used,
      using chilled water or refrigerant as the cooling medium. Particular
      attention shall be taken in the positioning of this unit in the room in order
      to avoid airflows likely to disturb the operation of the biosafety cabinet.




                                                                                      40
Biosafety Cabinet

24.     A biosafety cabinet of the type specified for PC2 containment shall be
        provided. Installation of the cabinet shall comply with the requirements
        and recommendations of Australian Standard AS 2647: Biological safety
        cabinets - installation and use. This standard also makes reference to
        airflow disturbances in front of biological safety cabinets.

Decontamination

25.     Provision shall be made to decontaminate the biological safety cabinet(s)
        and the room independently with formaldehyde gas, and for the gas to be
        purged safely to atmosphere upon completion of the procedure.

26.     Decontamination of the safety cabinet(s) shall be performed in
        accordance with the requirements of Australian Standard AS 2647
        Appendix C and will require the provision of a front cover plate and
        exhaust duct adaptor to fit the particular cabinet.

27.     Decontamination of the room will require a close-off damper in the
        discharge from the exhaust filter and means of closing the room
        replacement air aperture. Remotely switched power points facilitate the
        safe generation of the formaldehyde gas.

Pest Control Program

28.     A pest control program against insects, rodents, birds, possums, etc.
        shall be instituted.

Signs

The entrance doors shall be clearly labeled with signs indicating the type of
facility and the containment level. These signs are available from the OGTR
only after the OGTR has approved certification of the facility.




                                                                                    41
     SECTION C:                 Requirements for Physical
                                 Containment Level PC4
Note:          The PC4 physical containment requirements described below
               are equivalent to containment level PC4 in the Australian
               Standard AS/NZS 2243.3: 1995 (Safety in laboratories:
               Microbiology). The requirements listed in this section are
               compatible with AS/NZS 2243.3, but are not comprehensive.
               Reference must be made to AS/NZS 2243.3 and AS 2982
               (Laboratory design and construction) for detailed
               requirements for facilities and procedures.

Laboratory Procedures

Work in laboratories at PC4 level shall conform with the procedures set out for
PC3 laboratories. In addition, the following requirements apply:

1.      Personnel shall enter and leave the facility through the clothing change
        and shower rooms (except in cases of emergency, where alternative
        exits may be used). Except in cases of emergency, shower facilities
        shall be used by personnel leaving the laboratory.

2.      All street clothing, including underwear, shall be removed and retained in
        the outer clothing change room. Complete laboratory clothing, including
        shoes, shall be provided by the organisation and shall be used by all
        personnel entering the facility. When leaving the facility, personnel shall
        remove their laboratory clothing and store or discard it in the inner
        change room before showering

3.      Personnel entering or leaving the laboratory shall indicate, either
        manually or electronically, the time of each exit and entry.

4.      There should always be at least two workers present (or, if only one, a
        second person located at an observation window or in tele-
        communication or video surveillance) to assist in case of an emergency.

5.      Supplies, materials and specimens shall only be brought into the facility
        through the change and shower rooms, the double-doored autoclave, the
        fumigation chamber or the airlock.

6.      The autoclave and fumigation chamber shall be decontaminated after
        each exposure to the laboratory environment.




                                                                                      42
7.    Biological materials to be removed from flexible film isolators or from the
      maximum containment laboratory in a viable or intact state shall be
      transferred to a non-breakable, sealed primary container, the external
      surface of which is decontaminated before enclosure in a non-breakable,
      sealed secondary container. The secondary container shall be removed
      from the facility through the disinfectant dunk tank, fumigation chamber or
      an airlock designed for this purpose. No other materials shall be
      removed from the maximum containment laboratory unless they have
      been autoclaved or decontaminated. Equipment or materials which
      might be damaged by high temperatures or steam shall be
      decontaminated in an airlock or specially designed chamber by means of
      sterilising gas or vapour.

8.    A primary container holding viable or intact biological material shall be
      opened only in a flexible film isolator or a maximum containment
      laboratory. Containers may be opened in other laboratories only if the
      biological material has been rendered non-infectious or non-toxic, and
      the space in the primary and secondary containers has been
      decontaminated.

Laboratory Construction

9.    The laboratory shall be housed in a separate building or shall form an
      isolated part of a building.

10.   An outer and inner change room, separated by a shower, with
      interlocking, self-closing doors, shall be provided for personnel entering
      and leaving the facility. The outer door shall be lockable.

11.   A telephone or other means of outside communication shall be provided
      inside the laboratory unit.

12.   Walls, floors and ceilings of the facility shall be constructed in such a
      manner as to form a sealed internal shell which facilitates easy
      fumigation. The internal surfaces of the shell shall be resistant to liquids
      and chemicals used in the facility and shall facilitate easy cleaning and
      decontamination. All apertures in the structures and surfaces shall be
      sealed to prevent vermin or insects from entering the area. Any windows
      shall be resistant to breakage.

13.   A double-ended pressure steam steriliser (autoclave) shall be provided to
      decontaminate materials from the facility and from the clothing change
      room. The outer autoclave door shall open to the area external to the
      facility, and shall be sealed to the outer wall. The inner door shall
      automatically interlock with the outer door in such a manner that the outer
      door can be opened only after the autoclave sterilisation cycle has been
      successfully completed.


                                                                                     43
14.   A pass-through dunk tank, fumigation chamber or equivalent
      decontamination equipment shall be provided, so that materials and
      equipment that cannot be decontaminated in the autoclave can be
      rendered safe for removal from the facility.

15.   A separate supply and exhaust, non-recirculating air ventilation system
      shall be provided. The system shall maintain such pressure differentials
      and directional airflow as assure airflows toward areas of highest
      potential risk within the facility. There shall be a differential pressure of at
      least 25 Pa between each area. The system shall be provided with an
      alarm to detect malfunction. The supply and exhaust airflow shall be
      interlocked to ensure inward (or zero) airflow at all times. A manometer
      shall be used in such a manner as to sense pressure differentials
      between adjacent areas.

16.   The exhaust air from the facility shall be filtered through a HEPA filter,
      and discharged to the outside atmosphere in such a manner that it is
      dispersed away from occupied buildings and air intakes. Air supplied to
      the facility shall be filtered through a coarse pre-filter and a HEPA filter to
      prevent outward flow of contaminated air should air pressures become
      unbalanced in the facility. Within the facility, the air-filters shall be
      located as near to the laboratories as practicable to reduce the length of
      potentially contaminated air ducts. The filter chambers shall be designed
      to allow in situ decontamination before filters are removed and to
      facilitate certification testing periodically and after they are replaced.

17.   The air from flexible film isolators, incorporating two HEPA filters in
      series, shall be discharged through the facility exhaust system.

18.   Controlled access only shall be allowed for authorised staff. A list of
      contact names and telephone numbers shall be provided outside the
      laboratory entry point.

19.   A shatter-resistant observation window, or suitable alternative monitoring
      facilities, shall be installed so that laboratory occupants can be observed
      from outside the laboratory.

20.   Prior to disposal, all laboratory effluents, including those from the shower
      facility, shall be decontaminated by either heat or chemical treatment.

21.   All services of the completed facility shall be tested, commissioned and
      the results documented, before use. An operating manual shall be
      prepared and adopted.

22.   An automatically-starting emergency power source, emergency lighting
      and communication system shall be provided.


                                                                                         44
Positive Pressure Suit Area

   23.     For certain requirements, a specially designed suit area may be provided
           within the facility. Personnel who enter this area shall wear a one-piece
           positive pressure suit that is ventilated by a life support system that
           includes an alarm and emergency back-up breathing air system.

   24.     Please refer to AS/NZS 2243.3 for additional requirements which apply to
           suit areas.

   Signs

   The entrance doors shall be clearly labeled with signs indicating the type of facility and
   the containment level. These signs are available from the OGTR only after the OGTR
   has approved certification of the facility.




                                                                                                45
     SECTION D:                 Requirements for Plant
                                  House Level PC2

Construction

1.   The plant house shall have a floor of concrete, or some other substance
     approved by the Regulator. Any openings in the walls or roof (e.g.
     windows, vents, and air supply and exhaust inlets and outlets) shall be
     screened with fine screens (thirty-gauge 30/32 mesh wire gauze). The
     drainage exits shall be designed to avoid entry of rodents and insects.
     Transparent sections of the plant house shall be made of impact-resistant
     material selected to maintain the integrity of the structure during all
     foreseeable impact events, including windstorm, and impacts from golf
     balls, stones picked up by grass mowers, hailstones and the like. If
     ordinary glass is used, a protective screen shall be fitted.

2.   Entrances to the plant house shall be posted with a sign identifying the
     type of plant house and listing the procedures applicable, including
     emergency and maintenance procedures.

3.   If the plant house is free-standing, it shall have an anteroom for entry and
     exit. The anteroom shall be fitted with a sticky pest strip or automatic
     insecticide aerosol device designed to kill arthropods which gain entry.
     An anteroom is not necessary if the plant house connects directly with a
     certified small or large scale containment facility.

4.   A wash-basin shall be provided within the plant house adjacent to the
     entry door. Where a laboratory is directly connected to the plant house,
     the basin may be in the laboratory.

Operating Procedures

5.   The plant house shall be inspected regularly to ensure that its
     containment features are intact. Screens, filters and the like shall be
     cleaned regularly (in accord with manufacturer‟s specifications when
     provided).

6.   All doors to the plant house shall be locked for the duration of the work
     except for those periods when personnel are actually working inside it.

7.   Hands shall be washed with soap and water before leaving the plant
     house.


                                                                                    46
8.      Only persons authorised by the IBC are to enter the plant house. All
        such persons shall be trained to follow normal plant house routines as
        well as these operating procedures.

9.      All plants in the plant house shall be treated as containing genetically
        manipulated DNA. Work in the plant house other than that involving
        genetic manipulation shall be discouraged.

10.     Operations which may generate aerosols shall be done in a biological
        safety cabinet as specified for PC2 laboratory containment.

11.     Plants and tissues taken into or out of the plant house shall be carried in
        closed containers. Waste plants, tissues, soil, soil substitutes and the
        containers shall be sterilised.

12.     Living plants or tissues shall not be taken from the plant house except to
        a containment laboratory or, with the approval of the IBC, when they are
        being transferred to another organisation.

13.     If the work permits, plants shall be sprayed regularly with a systemic
        insecticide. The plant house shall be sprayed or fumigated to kill other
        arthropods (especially mites) at regular intervals, and at the end of each
        series of experiments. The organisation shall have an effective insect
        and rodent control program.

14.     The experimental materials shall be inspected regularly for signs of
        arthropod infestation. The inspection regimen shall pay particular
        attention to mites as they would not normally be excluded by the window
        and vent screens.

Signs

The entrance doors shall be clearly labelled with signs indicating the type of
facility and the containment level. These signs are available from the OGTR
only after the OGTR has approved certification of the facility.




                                                                                      47
           SECTION E:                   Requirements for Plant
                                          House Level PC3

Note that references to plants or plant tissues in PC2 should be regarded as referring
     to all organisms when PC3 standards are being considered.

 The PC3 standard plant house and operating procedures shall meet all the
    requirements of the PC2 standard as well as the following:

     Construction

     1.      All structural joints in the plant house, including transparent sections,
             shall be fully sealed using an elastomeric sealant.

     2.      If the plant house is free-standing it shall have an anteroom for entry and
             exit. The innermost door shall have a door-closing device fitted. The
             anteroom shall be fitted with a sticky pest strip or automatic insecticide
             aerosol device designed to kill arthropods which gain entry. An anteroom
             is not necessary if the plant house connects directly with a certified small
             or large scale containment facility.

     Operating Procedures

     3.      Personnel shall decontaminate their hands by washing with soap and
             warm water in the wash-basin provided on entering and leaving the plant
             house. When entering, personnel shall put on overshoes, covering
             clothes (e.g. gown/boiler suit) and a hat in the anteroom. These
             garments shall be removed on leaving the plant house and kept in the
             anteroom (or laboratory) between uses. They shall be laundered
             regularly.

     4.      Materials and equipment taken into or out of the plant house shall be
             treated by a technique demonstrated to be effective in destroying or
             removing all stages of the life-cycle of arthropods. This requirement
             applies to soil substitutes and where feasible to soil. Soil substitutes
             which can be readily decontaminated shall be used whenever possible.
             Use of soil is discouraged.

     Signs




                                                                                            48
5.   The entrance doors shall be clearly labelled with signs indicating the type
     of facility and the containment level. These signs are available from the
     OGTR only after the OGTR has approved certification of the facility.




                                                                                   49
     SECTION F:                  Requirements for Plant
                                   House Level PC4

The PC4 standard plant house and operating procedures shall meet all the
requirements of the PC2 and PC3 standards as well as the following:

Construction

1.    The transparent sections shall be constructed of high impact-resistant
      materials, such as laminated glass or polycarbonate. Ordinary window
      glass is not sufficient irrespective of whether it is proposed to install
      hail-screens.

2.    All drains in the plant house and anteroom shall empty into collecting
      tanks. The floor of the plant house, the lower parts of the walls and the
      sills under doors shall be constructed and sealed to ensure that water
      spillages drain only into the collecting tanks.

3.    Sealing of the plant house and anteroom shall be sufficient to enable
      decontamination by gas.

4.    The anteroom shall contain an autoclave and the hand-basin shall be
      fitted with foot or elbow-operated taps.

5.    The air pressure in the plant house shall be maintained at a level 50 Pa
      below the external air pressure. A Magnehelic differential air pressure
      gauge shall be mounted outside the barrier wall to display visually the
      room air pressure differential and to raise an audible alarm on loss of
      differential pressure. The room pressure sensing line connected to the
      Magnehelic gauge shall be fitted with a 0.2
      mounted in the plant house. Air supply and exhaust ducts shall be fitted
      with HEPA filters.

6.    Mechanical equipment (for example, air supply and exhaust units, water
      pumps) shall be located outside the facility to allow for repair and
      maintenance without entry to the facility. Where this equipment may
      contain or process materials from inside the plant house, it shall be
      designed to prevent the escape of viable organisms or be located in a
      sealed housing which can contain any leaks and be decontaminated if
      required. (In the event of a power failure, no entry to the plant house is
      permitted until services have been restored.)



                                                                                   50
    Operating Procedures

    7.      Except where the experimental organism(s) is a microorganism, all
            materials and equipment brought into the plant house shall be treated to
            kill microorganisms.

    8.      Footbaths (metal trays containing cloth pads soaked in a disinfectant)
            shall be located in the anteroom adjacent to the internal plant house
            door.

    9.      Plant containers shall be located in or over watertight trays which drain
            directly into the drainage system.

    10.     Before waste water is discharged from the collecting tanks, it shall be
            decontaminated in a way which will destroy microorganisms as well as
            plant and arthropod material.

    11.     Work surfaces and the floors shall be decontaminated regularly and
            immediately after spillages. The plant house and anteroom shall be
            fumigated against microorganisms at the end of each series of
            experiments.

    Signs

The entrance doors shall be clearly labelled with signs indicating the type of facility
   and the containment level. These signs are available from the OGTR only after
   the OGTR has approved certification of the facility.




                                                                                          51
             SECTION G:                  Requirements for Animal
                                          Containment Level PC2
        Note:          Reference must be made to the Australian Standards AS/NZS
                       2243.3: 1995 (Safety in laboratories: Microbiology) and AS
                       2982 (Laboratory design and construction) for detailed
                       physical containment requirements.


        General

        Facilities for laboratory animals used for genetic manipulation work of either an
        infectious or a non-infectious nature shall be physically separated from other
        activities such as animal production and animal quarantine areas.

Construction

        1.      Entrance to the animal house shall be posted with a sign identifying the
                type of animal house and listing procedures applicable, including
                emergency and maintenance procedures.

        2.      The animal room shall be constructed with impermeable and easily
                cleaned surfaces. Any openings in the walls or roof (e.g. windows or
                vents) shall be screened with fine screens (60 x 40 swg mesh - 51% free
                area). The doorway and room structure shall be rodent-proof. Drainage
                exits in the floor shall always contain water or disinfectant in the trap.

        3.      Doors to animal rooms shall open inwards and be self-closing, and shall
                be kept closed when experimental animals are present, and for those
                periods when work is being carried out within the room.

                If the animal house connects directly with a containment facility, there
                may be a requirement for an anteroom. If the animal housing is
                separated from the containment laboratories, an anteroom in which
                protective clothing and footwear can be stored is required.

        Operating Procedures

        4.      The animal facility shall be inspected regularly by the IBC to ensure that
                its containment features are intact. Only people authorised by the IBC
                can enter the animal house. All such people shall be trained in normal
                animal house procedures as well as these operating procedures. A
                record book shall be maintained to provide an up-to-date inventory of the
                procedures performed.


                                                                                             52
5.    Standard procedures for containment at PC2 level shall be followed:

         Work surfaces shall be decontaminated after use and after any spill of
          viable material. Eating, drinking, smoking and the storage of food for
          human use are not permitted in animal rooms.
         Personnel shall wash their hands after handling cultures and animals
          and before leaving the animal room.
         Operations which may generate aerosols shall be carried out in a
          biological safety cabinet as specified for PC2 containment.
         Protective clothing, gloves and footwear shall be worn. It is further
          recommended that such clothing not be worn in other areas.
          Protection against inhalation of aerosols, scratches or bites shall be
          considered.
         Bedding material and waste from cages or pens used to house
          animals infected with genetically manipulated agents shall be
          autoclaved before removal from cages and shall be handled in such a
          manner as to minimise the creation of aerosols. Bedding material and
          wastes from cages and pens used to house uninfected transgenic
          animals do not require autoclaving before disposal.
         Pens and cages from uninfected animals shall be decontaminated
          after use and washed regularly.

6.    Special attention shall be paid to constraining animals during experiment.
      The prevention of their escape shall be ensured.

7.    Animals or animal tissues transported into or out of the animal house
      shall be carried in closed containers. Animals involved in genetic
      manipulation experiments are not to be used for other purposes or to
      provide tissues for other purposes.

8.    Live animals or animal tissues taken from the animal house shall only go
      to another containment facility, or be transferred to another organisation
      which has suitable animal containment facilities. (See Guidelines for
      Transport of Genetically Modified Organisms.)

9.    Carcasses of animals infected with genetically manipulated agents shall
      be rendered safe by sterilisation before disposal. Carcasses of
      uninfected transgenic animals do not require sterilisation before disposal.

10.   If genetic manipulation experiments are conducted on aquatic animals, a
      mechanism shall be provided to ensure that neither the organisms nor
      their gametes can escape into the supply or discharge system of the
      rearing container (e.g. tank or aquarium). The top of the rearing container
      shall be covered to avoid escape of the organism and its gametes.



                                                                                    53
    It should be remembered that invertebrates can harbour infectious organisms,
           for example, viruses in mosquitoes, midges and biting flies, Borrelia in
           soft ticks, trypanosomes in triatomid bugs, organisms from sewage in
           mollusca, crustacea or echinodermata. Such invertebrates shall be kept
           at a containment level appropriate to the risk from the human pathogens
           carried by these invertebrates.

    Signs

The entrance doors shall be clearly labelled with signs indicating the type of facility
   and the containment level. These signs are available from the OGTR only after
   the OGTR has approved certification of the facility.




                                                                                          54
     SECTION H:                   Requirements for Animal
                                   Containment Level PC3

Note:          Reference must be made to the Australian Standards AS/NZS
               2243.3: 1995 (Safety in laboratories: Microbiology) and AS
               2982 (Laboratory design and construction) for detailed
               physical containment requirements.

General

The requirements for PC2 animal containment facilities shall be complied with in
addition to the requirements below.

Construction

1.      Entrance to the PC3 animal facility is limited only to people aware of the
        potential hazard. The entrance door shall be fitted with a „fire-escape
        lock‟ (i.e. accessible only from the outside using a special key but freely
        accessible from inside).

        The door shall be posted with signs identifying the facility and listing the
        procedures applicable. The name and telephone number of the animal
        facility supervisor or other responsible person shall be attached.

2.      The PC3 animal facility shall not be accessible to the general public or
        open on to a public thoroughfare.

3.      The PC3 facility shall be isolated from other areas of the animal facility by
        an airlock having two doors in series, each fitted with automatic closers.

        The PC3 area shall be maintained at a minimum negative pressure of 50
        Pa when both doors are closed and 25 Pa when one door is open. The
        negative pressure shall be achieved by means of an independent room
        exhaust discharging to open air through a filter. The replacement air
        shall be drawn into the room through a filtered aperture the size of which
        can be adjusted and set to achieve the room negative pressure.

        All filters shall be of medium grade having a minimum efficiency to arrest
        95% of all particles above 5 micrometers. To prolong the life of the
        exhaust filters against rapid clogging by animal hair and feed dust, or in
        the case of poultry, skin danders and feather down, a roughing filter shall
        be used preceding the main filter. This will enable filter changing


                                                                                        55
      procedures in which one filter is always interposed between the room and
      outside atmosphere.

      Ventilation rates shall ensure an acceptable atmosphere quality for
      animal welfare. If air cooling is required, this shall be through cooling
      coils mounted external to the animal rooms.

4.    The facility shall be constructed so that the finishes on walls, floors,
      ceilings and benches are smooth, impervious and easily cleanable on all
      faces and are able to withstand all relevant decontaminants.

5.    All liquid and solid wastes from the animal facility shall be
      decontaminated by autoclaving prior to disposal. If floor drains are
      present, the drain traps shall always be filled with water or suitable
      disinfectant. When animals are in the room, floor drains shall be sealed
      with an airtight plug.

6.    Pest control systems for insects, rodents etc. shall be instituted.

7.    It shall be possible to decontaminate the PC3 area independently with
      formaldehyde gas and for the gas to be discharged safely to the
      atmosphere upon completion.

8.    The facility shall have access to an autoclave either within the PC3 area
      or in the animal building.

9.    The facility shall have a hand-basin and foot and elbow operated taps
      located near the exit.

10.   Biological safety cabinets shall be used within the PC3 facility for
      containment of aerosols and control of infectious material.




                                                                                  56
Operating Procedures

11.     Standard procedures for operating at PC3 laboratory level shall be
        followed. No other work is to be done simultaneously with work requiring
        PC3 containment.

        The PC3 animal facility shall be inspected at least annually by the IBC to
        ensure that its containment requirements are intact.

        Only people authorised by the IBC are to enter the animal facility and
        only after they have been advised of the potential hazard, and meet any
        specific requirements (e.g. immunisation). A record shall be maintained
        to provide an up-to-date inventory of the animals present and a
        chronological record of procedures performed.

12.     Protective clothing, gloves and footwear shall be worn. Protection
        against aerosols, scratches and bites shall be considered. Protective
        clothing shall be removed before leaving the facility. Dirty clothing shall
        be decontaminated, preferably autoclaved, before being laundered.

13.     Eating, drinking, smoking and storing of food for human use are not
        permitted in animal rooms.

14.     Personnel shall wash their hands after handling cultures and animals and
        before leaving the animal room.

15.     Work surfaces shall be decontaminated after use or spills of viable
        materials.

16.     Bedding material and waste from infected animal cages or pens shall be
        autoclaved before removal from cages and shall be handled in such a
        manner as to minimise the creation of aerosols.

17.     Cages shall be decontaminated by autoclaving before cleaning and
        washing.

18.     Special attention shall be paid to constraining animals during experiment
        and to the prevention of their escape.

19.     Live animals shall not leave the facility. Animal carcasses shall be
        rendered safe by sterilisation before disposal. Animals used in genetic
        manipulation experiments are not to be used for other purposes or to
        provide tissues for other purposes.

Signs



                                                                                      57
The entrance doors shall be clearly labelled with signs indicating the type of facility
     and the containment level. These signs are available from the OGTR only after
     the OGTR has approved certification of the facility.




                                                                                          58
     SECTION I:                Requirements for Insectary
                                      Level PC2
Note:          Reference must be made to the Australian Standards AS/NZS
               2243.3: 1995 (Safety in laboratories: Microbiology) and AS
               2982 (Laboratory design and construction) for detailed
               physical containment requirements.


Construction

1.      The insectary shall be fitted with a self-closing door that provides a seal
        sufficient to contain the insect species under study. The insectary shall
        also be free of other possible escape routes, e.g. false ceilings. Windows
        shall be closed at all times and, preferably, permanently sealed.

2.      Entrances shall be clearly labelled with signs stating that the room
        contains genetically manipulated insects.

3.      Signs explaining handling procedures shall be displayed inside the room.

4.      All air-conditioning inlets and outlets shall be covered with gauze of a
        sufficient gauge to prevent insects passing through.

5.      The insectary shall be fitted with at least one electric insect trap or, for
        Drosophila work only, more than one yeast-based Drosophila trap. Yeast
        traps must be regularly replaced and the IBC must be satisfied that their
        number, composition and operation yield effective recapture rates that
        are equivalent to those of an electric trap.

Operating procedures

6.      General practices shall be as required for PC2 laboratory work.

7.      Manipulated and non-manipulated insects shall be kept in separate
        containers except where genetic crosses have to be made. Such
        crosses shall be clearly labelled and treated as manipulated insects.

8.      All containers shall be clearly labelled and a central log-book of all
        recombinant insect stocks kept in the laboratory.

9.      All containers shall be adequately sealed before disposal and deposited
        in clearly labelled bins prior to decontamination.


                                                                                       59
10.     All containers that contain or have contained manipulated insects shall be
        decontaminated prior to disposal.

11.     Material to be autoclaved shall be transported to an autoclave in an
        adequately sealed bag.

Signs

12.     The entrance doors shall be clearly labelled with signs indicating the type
        of facility and the containment level. These signs are available from the
        OGTR only after the OGTR has approved certification of the facility.




                                                                                      60
     SECTION J:                Requirements for Insectary
                                      Level PC3
Note:         Reference must be made to the Australian Standards AS/NZS
              2243.3: 1995 (Safety in laboratories: Microbiology) and AS
              2982 (Laboratory design and construction) for detailed
              physical containment requirements.

General

The PC3 standard insectary and operating procedures shall meet all of the
requirements in the PC2 standard as well as those listed below.

Construction

1.      The outermost door of the insectary shall be fitted with a fire-escape lock
        accessible from the outside only by using a key but freely accessible from
        the inside.

2.      The insectary shall be provided with an access room and anteroom
        located in series. The access room shall be finished with dark coloured
        walls and have no direct source of natural or artificial lighting. Directional
        entry and exit signs inside the access room should preferably be in
        luminous paint. Both the anteroom and access room should be fitted with
        insect traps of the high voltage electrical type or chemical spray type.
        Access room doors should be sealed to be insect-proof and preferably be
        electrically interlocked so that only one door is open at a time. The
        anteroom shall be provided with a wash-basin and vacuum system to
        enable staff to remove any insects, eggs or larvae from their person
        before leaving the facility.

3.      The joins between any structural components of the insectary shall be
        sealed. Transparent sections, e.g. windows, shall be made of an impact-
        resistant material. Windows shall be permanently sealed.

4.      Air supply and exhaust ducts shall be fitted with fine screens (thirty-
        gauge 30/32 mesh wire gauze) and designed so as to preclude insect
        escape.

5.      The insectary shall be provided with contained cabinets for
        handling/transfer of insects.




                                                                                         61
Operating procedures

6.      The insectary shall only be accessible to those people directly involved in
        laboratory work.

7.      Personnel shall decontaminate their hands by washing with soap and
        warm water in the wash-basin provided on entering and leaving the
        insectary. When entering, personnel shall put on overshoes and
        covering clothes (boiler suit style) and hat in the anteroom. Before
        personnel leave the insectary, stray insects shall be removed from these
        garments with the vacuum device provided, and the garments removed
        and kept in the anteroom between uses. Prior to washing (or disposal),
        garments shall be sealed in bags and autoclaved.

8.      Materials taken into and out of the insectary shall be treated with a
        technique demonstrated to be effective in destroying or removing all
        stages of the life-cycle of insects and their pathogens. This requirement
        applies to soil substitutes and soil. Soil substitutes which can be readily
        decontaminated shall be used in preference to soil.

Signs

The entrance doors shall be clearly labelled with signs indicating the type of
facility and the containment level. These signs are available from the OGTR
only after the OGTR has approved certification of the facility.




                                                                                      62
     SECTION K:                Requirements for Insectary
                                      Level PC4
Note:          Reference must be made to the Australian Standards AS/NZS
               2243.3: 1995 (Safety in laboratories: Microbiology) and AS
               2982 (Laboratory design and construction) for detailed
               physical containment requirements.

General

The PC4 standard insectary and operating procedures shall meet all the
requirements of the PC2 and PC3 standards as well as the following.

Construction

1.      Any transparent sections shall be constructed of impact resistant
        materials. Ordinary window-glass is not sufficient, irrespective of whether
        it is proposed to install hail-screens.

2.      All drains in the insectary and anteroom shall empty into collecting tanks.
        The floor of the insectary, the lower parts of the walls and the sills under
        doors shall be constructed and sealed to ensure that water spillages
        drain only into collecting tanks.

3.      Sealing of the insectary and anteroom shall be sufficient to enable
        decontamination by gas.

4.      The anteroom shall contain an autoclave and the hand-basin shall be
        fitted with foot or elbow-operated taps.

5.      The air pressure in the insectary shall be maintained at a level 50 Pa
        below the external air pressure. There shall be a meter showing the
        pressure differential and an alarm which operates when the differential is
        not maintained. Air supply and exhaust ducts shall be fitted with HEPA
        filters.

6.      Mechanical equipment (for example, air supply and exhaust units, water
        pumps) shall be located outside the facility to allow for repair and
        maintenance without entry to the facility. Where this equipment may
        contain or process materials from inside the insectary, it shall be
        designed to prevent the escape of viable organisms or be located in a
        sealed housing which can contain any leaks and be decontaminated if
        required. (In the event of a power failure, no entry to the insectary is
        permitted until services have been restored.)


                                                                                       63
Operating Procedures

7.      Only one series of experiments, involving one strain or genotype of
        genetically manipulated organism, shall be conducted in the facility at any
        one time.

8.      Except where the experimental organism(s) is a microorganism, all
        materials and equipment brought into the insectary shall be treated to kill
        microorganisms.

9.      Footbaths (metal trays containing cloth pads soaked in disinfectant) shall
        be located in the anteroom adjacent to the internal insectary door.

10.     Any plants used during experiments shall be located over watertight trays
        which drain directly into the drainage system. All plants and soil/soil
        substitutes used in such experiments shall be autoclaved before removal
        from the insectary.

11.     Before waste-water is discharged from collecting tanks, it shall be
        decontaminated in a way that will destroy microorganisms, arthropod and
        plant material.

12.     Work surfaces and floors shall be decontaminated regularly and
        immediately after spillages. The insectary and anteroom shall be
        fumigated to destroy all microorganisms and insects after each series of
        experiments.

Signs

The entrance doors shall be clearly labelled with signs indicating the type of
facility and the containment level. These signs are available from the OGTR
only after the OGTR has approved certification of the facility.




                                                                                      64
     SECTION L:               Requirements for Physical
                               Containment of Fish and
                              other Aquatic Organisms
General

The primary objective in designing containment facilities and procedures for
gene technology work involving aquatic organisms is to prevent escape of
transgenic aquatic organisms or recombinant infectious agents into natural
waterways.

OGTR has not set out detailed specifications for facilities for containing
transgenic aquatic organisms or recombinant microorganisms used in aquatic
organisms. Applications for such work will be examined by the Regulator on a
case-by-case basis. Investigators submitting applications for contained gene
technology work involving aquatic organisms shall describe in the application
the containment facilities to be used and procedures proposed f or treatment of
waste water from the facility.

The following general guidelines are provided regarding the basic requirements
for genetic manipulation work involving aquatic organisms.

Work with transgenic aquatic organisms

1.     To prevent escape of adult aquatic organisms into the sewerage system,
       a grill or mesh, with an appropriate grid size to prevent passage of
       adults of the species being used, shall be fitted to outlets used for
       disposal of tank water.

2.     Water from tanks containing only adult transgenic aquatic organisms,
       and not involving use of recombinant infectious agents, may be
       discarded untreated down the sink, provided that a filtering mechanism
       to retain adult aquatic organisms is in place.

3.     Tank water that has any potential to contain embryos, sperm, eggs or
       larvae of transgenic aquatic organisms shall be treated to ensure
       inactivation of viable transgenic material before disposal. The proposed
       treatment procedures and evidence for their efficacy shall be provided to
       OGTR for case-by-case assessment.

4.     Since many fish species have sticky eggs which attach firmly to
       substrates, nets and other equipment used in the tank during spawning
       shall be sterilised after use. If fish are induced to spawn on the sides of


                                                                                     65
        tanks, the tanks shall be decontaminated after use by a procedure of
        demonstrable efficacy in sterilising eggs and sperm for the species
        used.

Work with infectious recombinant microorganisms in aquatic organisms

5.      To prevent escape of adult aquatic organisms into the sewerage system,
        a grill or mesh, with an appropriate grid size to prevent passage of
        adults of the species being used, shall be fitted to outlets used for
        disposal of tank water.

6.      Tank water used for work with infectious recombinant microorganisms,
        or tank water that has any potential to contain embryos, sperm, eggs or
        larvae of infected aquatic organisms, shall be treated to ensure
        inactivation of viable material before disposal. The proposed treatment
        procedures shall be provided to the Regulator for case-by-case
        assessment.

Signs

The entrance doors shall be clearly labelled with signs indicating the type of
facility and the containment level. These signs are available from the
OGTR only after the OGTR has approved certification of the facility.




                                                                                  66
SECTION M:                   Requirements for Physical
                               Containment PC2-LS

General

In addition to the minimum procedures outlined for Good Industrial Large
Scale Practice (GILSP), the following conditions shall be achieved in PC2-
LS facilities.

Primary containment system

1.    Cultures of viable organisms or cells containing GM material shall be
      handled in a closed system (e.g. closed vessel used for propagation,
      growth and storage, and closed lines used for transfer). Other
      primary containment equipment (e.g. biological safety cabinet or
      centrifuge used to process culture fluids) shall be designed to reduce
      the potential for escape of viable organisms.

2.    The equipment used for the propagation and harvesting of
      genetically manipulated organisms shall be checked regularly for the
      integrity of containment.

Handling of culture fluids

3.    Culture fluids (except as allowed in the paragraph below) shall not be
      removed from a closed system or other primary containment
      equipment unless the viable GM organisms have been rendered
      non-viable by a procedure which has been demonstrated to be
      effective using the proposed host organism.

4.    Where the process demands the collection of viable organisms from
      a closed system, the addition of materials to a closed system or the
      transfer of culture fluids from one closed system to another, such
      procedures shall be done in a manner which prevents the release of
      aerosols from the system or contamination of exposed surfaces.

Filtration of exhaust gases

5.    Exhaust gases removed from a closed system or other primary
      containment equipment shall be treated by filters which have
      efficiencies equivalent to HEPA* filters or by other equivalent

                               *   See Australian Standard AS2252, Part 2 - 1985,
                                   Amdt 1, 1990


                                                                                    67
        procedures (e.g. incineration) to minimise the release of viable
        genetically manipulated organisms from the facility.

Effluent Disposal

6.      The method of inactivation of all wastes of the process shall be fully
        validated.

Decontamination procedures

7.      A closed system, or other primary containment equipment that has
        held viable genetically manipulated organisms, shall not be opened
        (e.g. for maintenance) unless it has been decontaminated by a
        validated procedure.

Emergency provisions

8.      Emergency procedures and the design of closed systems shall be
        adequate to handle safely any losses of culture material in the event
        of partial or total rupture of the primary physical containment.

Signs

The entrance doors shall be clearly labelled with signs indicating the type of
facility and the containment level. These signs are available from the OGTR
only after the OGTR has approved certification of the facility.




                                                                                 68
SECTION N:                  Requirements for Physical
                              Containment PC4-LS
General

In addition to the containment requirements for GILSP and PC2-LS, the
following conditions shall be achieved in PC4-LS facilities.

Primary containment system

1.    Where a biological safety cabinet is used as the primary containment
      equipment, it shall be of Class II standard. Note: this condition is
      more stringent than PC2-LS.

Requirements for a controlled area

2.    Closed systems and other primary containment equipment used in
      handling cultures of viable genetically manipulated organisms shall
      be located within a controlled area which meets the following
      requirements:

      (a) There shall be an airlock for personnel entry and exit. Any
          service doors shall be designed to be airtight when closed. All
          doors shall open outward, using the negative pressure of the
          room (see (h) below) to assist in holding them in the closed
          position;

      (b) The surfaces of walls, ceilings and floors in the controlled area
          shall be such as to readily permit cleaning and decontamination;

      (c) The controlled area shall be capable of being sealed to permit
          decontamination by liquid, vapour or gas;

      (d) All utilities and service or process piping and wiring entering the
          controlled area shall be sealed to the room structure so as to
          prevent the passage of air, gas or liquids;

      (e) Hand-washing facilities equipped with foot, elbow or electronic
          hand-proximity operated valves shall be located at each major
          work area and near each primary exit;




                                                                                69
      (f) A change room and a shower facility shall be located near the
          personnel exit. Additional clean work garments shall be provided
          in these facilities in case of accidental contamination;

      (g) The controlled area shall be designed to preclude escape of
          culture fluids outside the controlled area in the event of an
          accidental spill or release from a closed system or other primary
          containment equipment; and

      (h) The controlled area (including the airlock) shall be ventilated
          independently of the rest of the complex by an air-supply and
          exhaust system giving a continuous minimum negative pressure
          in relation to adjacent rooms of 50 Pa in the facility and 25 Pa in
          the airlock. The movement of air shall be from areas of lower
          contamination potential. The system shall operate in a manner
          that prevents the reversal of the direction of air movement or shall
          be equipped with an alarm and cut off that would be activated if
          reversal in the direction of air movement were to occur. The
          supply and exhaust air shall be filtered through HEPA filters or
          otherwise treated so as to minimise the discharge of an
          accidental aerosol burden.

Personnel and operational practices

3.    The following personnel and operational practices shall be required:

      (a) Unauthorised persons shall not be permitted to enter the
          controlled area;

      (b) Entry into the controlled area when work is in progress shall be
          restricted to those persons required to meet program or support
          needs. Before entry, all persons shall become conversant with
          relevant Standard Operating Procedures, including emergency
          procedures, the nature of the work conducted and possible
          biohazards;

      (c) Access doors to the controlled area shall be kept closed, except
          as necessary for access, while work is in progress. Service doors
          leading directly outdoors shall remain closed and barred from
          external access while work is in progress;

      (d) Equipment and materials required for the management of
          accidents involving viable genetically manipulated organisms
          shall be available in the controlled area;




                                                                                 70
        (e) The controlled area shall be decontaminated in accordance with
            established procedures following spills or other accidental release
            of viable organisms;

        (f) Personnel shall enter the controlled area through the personnel
            airlock and shall exchange or cover their personal clothing with
            distinctive work garments such as jump-suits, laboratory coats,
            pants and shirts, head cover, and shoes or shoe covers. Before
            exit from the controlled area the work clothing shall be stored in a
            locker separate from that used for personal clothing or removed
            for laundering. Clothing shall be decontaminated before leaving
            the controlled area and then laundered;

        (g) The OGTR PC4-LS sign shall be posted not only on the entry
            doors to the controlled area, but also on all internal doors when
            any work involving the organism is in progress. This includes
            periods when decontamination procedures are in progress. As
            well, a statement of agents in use and personnel authorised to
            enter the controlled area shall be posted on the entry doors to the
            controlled area; and

        (h) Live animals and plants shall be prohibited from the containment
            facility unless they are part of the experiments or process. No
            live animal or plant shall be released from the facility except with
            the explicit agreement of the Regulator. Animal or plant products,
            wastes, feed, cages etc. shall be decontaminated before removal
            from the facility by autoclaving or incineration.

Signs

The entrance doors shall be clearly labelled with signs indicating the type of
facility and the containment level. These signs are available from the
OGTR only after the OGTR has approved certification of the facility.




                                                                                   71
SECTION O:                    Requirements for Physical
                               Containment for Large
                                Scale Animal Houses

Note:          The Australian Code of Practice for the Care and Use of
               Animals for Scientific Purposes (1991) is regarded as a
               suitable minimum standard for housing transgenic animals
               and poultry.

General

Facilities for animals used for GM work of either an infectious or non-
infectious nature shall be physically separated from other activities such as
animal production and animal quarantine areas.

Construction of livestock facilities

1.      The large scale animal facility may have two levels of containment to
        ensure that there is no inadvertent escape of the animals or the
        vector. If an infectious agent is present in the GM animal, then both
        primary and secondary containment facilities are required. Non-
        infectious GM animals may be housed in a physically secure area
        within the secondary containment facility only.

Primary containment

2.      The primary containment facility is designed to house transgenic
        animals where infectious agents have been used to insert foreign
        DNA. After full characterisation, which includes demonstration that
        the animal is free of the infectious agent, the animal may be
        contained in the secondary containment level.

3.      The facility shall be provided with a suitable impervious floor and,
        together with all drains, shall be designed to prevent entry of rodents.

4.      Air supply and exhaust ducts shall be fitted with fine screens (thirty-
        gauge 30/32 mesh wire gauze).

5.      If the animal house is free-standing, it shall have an anteroom for
        entry and exit. The innermost door shall have a door-closing device
        fitted. The anteroom shall be fitted with a sticky pest strip or


                                                                                   72
      automatic insecticide aerosol device designed to kill arthropods
      which gain entry. An anteroom is not necessary if the animal house
      connects directly with a certified small or large scale containment
      facility.

6.    Entrances to the transgenic animal house shall be posted with a sign
      listing the procedures applicable and emergency contact names and
      numbers.

7.    A wash basin shall be located either within the anteroom or in the
      animal house close to the entry. Where a laboratory is directly
      connected to the animal house, the basin may be in the laboratory.

Secondary containment

8.    A 2 m high chain mesh security fence built to Australian Standard
      AS 1725 shall surround the primary containment facility. Suitable
      barriers shall be provided beneath and above the fence to prevent
      animals and poultry from burrowing under or flying over the security
      fence.

9.    The gate to the area shall open over a road or footpath of solid
      construction with appropriate clearance to prevent escape of
      animals. This gate shall be kept closed when not in use and shall be
      locked when the facility is unattended.

Operating procedures

10.   The transgenic animal facility shall be inspected regularly to ensure
      that its security features are intact.

11.   Each transgenic animal shall be branded or tattooed to ensure easy
      permanent identification (tagging the animal is not sufficient).

12.   Records of the history of the transgenic animals in the facility shall be
      kept for quick reference.

13.   Only persons authorised by the IBC are to enter the transgenic
      animal facility.

14.   All such persons shall be trained to follow normal animal house
      routines as well as these operating procedures.

15.   All animals in the transgenic animal facility shall be treated as
      containing genetically manipulated DNA.




                                                                                  73
16.     Work in the animal facility, other than that involving genetic
        manipulation, shall be discouraged.

17.     At the end of the evaluation/experimental stage, the animal shall be
        slaughtered and the carcass incinerated. Alternative disposal
        procedures shall have the specific (written) approval of the Regulator
        and, if the carcass is to be sold, shall also be authorised by
        appropriate State and Commonwealth agencies.

Signs

The entrance doors shall be clearly labelled with signs indicating the type of
facility and the containment level. These signs are available from the OGTR
only after the OGTR has approved certification of the facility.




                                                                                 74
      SECTION P:             Requirements for PC2
                            Large Scale Plant Houses

Construction

1.    General: The facility shall be of sound construction, functional, easy
      to clean and able to be secured.

2.    Site: The facility shall not be accessible to the general public and
      shall be positioned so that it can be supervised by the responsible
      personnel.

3.    Signs: The facility shall be clearly identified as a PC2-LS Plant House
      facility. Emergency and maintenance procedures are to be
      prominently displayed.

4.    Structure: The structure shall be substantial, properly constructed
      and designed to withstand local climatic conditions.

5.    Anteroom: If the plant house is free-standing, an anteroom is
      required. Self closing doors are to be installed. Arthropod control,
      for example sticky tape or automatic aerosol dispenser, is to be
      employed in the anteroom.

6.    Glazing: All translucent glazings are to be substantial and able to
      withstand local climatic conditions. Claddings prone to rapid
      deterioration and failure, e.g. plastic films, shall not be used.

7.    Openings: All openings are to be effectively screened using a screen
      with openings no larger than 30/32 mesh.

8.    Floor: The floor is to be of concrete construction and the surface
      prepared and maintained so that it is impervious and can be readily
      cleaned.

9.    Drainage: Exits are to be designed to prevent the entry of rodents
      and insects.

10.   Security: Doors and other access points shall be able to be locked to
      prevent unauthorised entry.

11.   Decontamination: The facility shall be able to be decontaminated
      using the appropriate liquids and gases.



                                                                                75
Operating Procedures

12.   The plant house shall be inspected regularly to ensure that its
      containment features are intact. Screens, filters and the like shall be
      cleaned regularly (in accord with manufacturer's specifications when
      provided).

13.   All doors to the plant house shall be locked for the duration of the
      work except for those periods when personnel are actually working
      inside the plant house.

14.   Hands shall be washed with soap and water before leaving the plant
      house.

15.   Only persons authorised by the IBC are to enter the plant house. All
      such persons shall be trained to follow normal plant house routines
      as well as these operating procedures.

16.   All plants in the plant house shall be treated as containing genetically
      manipulated DNA. Work in the plant house other than that involving
      genetic manipulation shall be discouraged.

17.   Operations which may generate aerosols shall be done in a
      biological safety cabinet as specified for PC2 containment.

18.   Plants and tissues taken into or out of the plant house shall be
      carried in closed containers. Waste plants, tissues, soil, soil
      substitutes and the containers shall be sterilised.

19.   Living plants or tissues shall not be taken from the plant house
      except to a containment laboratory or, with the approval of the IBC,
      when they are being transferred to another organisation.

20.   If the work permits, plants shall be sprayed regularly with a systemic
      insecticide. The plant house shall be sprayed or fumigated to kill
      other arthropods (especially mites) at regular intervals and at the end
      of each series of experiments. The organisation shall have an
      effective insect and rodent control program.

21.   The experimental materials shall be inspected regularly for signs of
      arthropod infestation. The inspection regime shall pay particular
      attention to mites as they would not normally be excluded by the
      window and vent screens.




                                                                                 76
     SECTION Q:              Requirements for PC3
                            Large Scale Plant Houses
General

The PC3-LS Plant House and operating procedures shall meet all
requirements of the PC2-LS Plant House standard, as well as the following.

Construction

1.    Site: The facility shall be isolated from the general public and
      surrounded by a security fence or equivalent means of security. It
      shall be positioned so that it can be supervised by the responsible
      personnel.

2.    Signs: The facility classification of PC3-LS Plant House shall be
      clearly identified. Emergency and maintenance procedures are to be
      displayed.

3.    Structure: The structure shall be designed and constructed to
      withstand local climatic conditions. It shall also not be vulnerable to
      damage from vehicles, materials handling equipment or similar
      machinery.

4.    Anteroom: The anteroom is to have lockable self-closing doors. A
      wash basin is to be located within the anteroom, or nearby in the
      plant house growing area.

5.    Glazing: The glazing materials are required to withstand breakage
      from hail, stones or other potentially damaging projectiles. The
      glazing materials are to be effectively sealed when fixed on to the
      supporting structure. A hail guard is to be installed over all glazing
      materials, e.g. reinforced glass, that are prone to failure from impact
      loads.

6.    Operating Pressure: The plant house growing space is to be
      maintained at a negative pressure of 50 Pa.

7.    Air Handling: Air supply and exhaust ducts are to be fitted with fine
      screens with openings no larger than 30/32 mesh.

8.    Drainage: All drainage and waste materials are to be able to be
      collected and decontaminated. Inlets to drainage collection points




                                                                                77
        are to be screened using screens with openings no larger than 30/32
        mesh.

9.      Services: Penetrations through the structure from water, electricity
        and other services are be to sealed to prevent the passage of
        arthropods.

10.     Benches: Benches shall be designed and constructed so that they
        can be readily cleaned and decontaminated.

11.     Decontamination: The facility shall be able to be decontaminated
        using appropriate liquids and gases.

Operating Procedures

12.     Personnel shall wash their hands with soap and warm water in the
        wash basin provided on entering and leaving the plant house. When
        entering, personnel shall put on overshoes, covering clothes (e.g.
        gown/boiler suit) and a hat in the anteroom. These garments shall
        be removed on leaving the plant house and kept in the anteroom (or
        laboratory) between uses. They shall be laundered regularly.

13.     Materials and equipment taken into or out of the plant house shall be
        treated by a technique demonstrated to be effective in destroying or
        removing all stages of the life-cycle of arthropods. This requirement
        applies to soil substitutes and where feasible to soil. Soil substitutes
        which can be readily decontaminated shall be used whenever
        possible. Use of soil is discouraged.

Signs

The entrance doors shall be clearly labelled with signs indicating the type of
facility and the containment level. These signs are available from the OGTR
only after the OGTR has approved certification of the facility.




                                                                                   78
     SECTION R:                  Requirements for Large
                                     Scale Aquaria

Note:          The primary objective in the provision of aquaria for work
               with transgenic fish is the retention of the smallest water-
               borne viable particles, such as sperm at approximately 5
               micrometres, and the prevention of the escape of any
               transgenic fish.


Aquarium design

1.      Aquaria used for hatching and raising fingerlings to grow-out stage
        shall be located in totally enclosed buildings of vermin and
        amphibia-proof design. Entry and exit to the facility shall be through
        an air-locked entrance with provision for clothing changes and
        showers.

2.      The building shall not form an access way to other buildings or parts
        of a building. Full provision shall be made to prevent unauthorised
        entry to the building.

3.      The building shall not be located in any area classified by the
        appropriate state authority as flood-prone, nor shall it drain naturally
        into rivers, streams or beaches.

4.      Aquaria shall use recirculating water where transgenic work is being
        carried out. Flow-through systems shall not be used.

5.      Water input and output pipes shall be double-screened. Discharged
        water shall be passed through an appropriate trap prior to discharge.

Effluent water

6.      It is necessary to change water used in a recirculating system. For
        some species of fish, it may be necessary to remove and replace 5-
        10% of the water daily. Larval fish and eggs of many Australian
        freshwater and marine species are extremely small and transparent
        and it is essential to ensure that escapees are trapped and/or killed by
        filtration, heat or chemical treatment before aquarium water flows out
        of the facility.




                                                                                   79
Spawning

7.    Nests, spawning mats or other spawning substrates shall be
      sterilised or incinerated once the hatch is completed.

8.    If fish are induced to spawn on the side of tanks, it will be necessary
      to decontaminate the tanks. Decontamination shall be by a
      procedure of demonstrable efficacy in sterilising eggs and sperm for
      species used in the work.

9.    All nets and utensils used during spawning shall be sterilised.

Predators and Theft

10.    Transgenic aquatic organisms shall be housed in aquaria enclosed
      by a building to prevent predator attacks.

11.    To protect aquaria, outside ponds and raceways from theft and
      vandalism, movement sensors, light beams and alarms are required,
      as perimeter fencing alone is not an effective deterrent.

Personnel

12.   Personnel working at the facility shall be limited to those involved in
      the project.

13.   Protective clothing shall be encouraged in any aquaculture facility to
      reduce disease risks.

Grow-out facilities

14.   Commercial trials with transgenic fish or other transgenic aquatic
      organisms may necessitate use of outdoor tanks and raceways. On
      no account shall such trials be permitted in net cages either in fresh
      water or in the sea.

15.   Grow-out facilities such as tanks and raceways, which usually rely on
      flow-through systems, shall not be used for transgenic aquatic
      organisms: flow-through systems rely on a substantial water source
      which is always difficult to control during flood. Recirculating
      systems such as those using biodrums should be considered.

16.   Facilities shall be isolated from natural watercourses and/or coastal
      or estuarine areas, and sited in areas not prone to flooding.




                                                                                80
Signs

The entrance doors shall be clearly labelled with signs indicating the type of
facility and the containment level. These signs are available from the
OGTR only after the OGTR has approved certification of the facility.




                                                                                 81
SECTION S: Requirements for PC2
Large Scale Insect Houses

Construction

1.   General: The facility shall be of a sound construction, functional,
     easy to clean and decontaminate on a regular basis, and able to be
     secured.

2.   Site: The facility shall be situated well away from public access areas
     and shall be positioned so that it can be adequately supervised and
     security maintained by the appropriate personnel.

3.   Signs: The facility shall be clearly identified as containing genetically
     engineered insects and/or their pathogens. Emergency and
     maintenance procedures are to be prominently displayed.

4.   Structure: The structure shall be substantial, properly constructed
     and designed to withstand local climatic conditions.

5.   Anteroom: Entrance to the facility shall only be by access through an
     anteroom. The anteroom shall be accessible only to authorised
     personnel and have lockable self-closing doors that are readily
     openable from inside the facility. It shall contain ample room for
     storage of workers' clothing, arthropod control measures and
     facilities for the decontamination of personnel.

6.   Glazing: All translucent glazing shall be of materials capable of
     withstanding local climatic conditions. All glazing portals shall be
     adequately sealed and covered on the inside of the facility with a
     material, e.g. plastic gauze, capable of stopping the passage of
     arthropods.

7.   Openings: All openings into and out of the facility shall be sealed in
     such a way as to prevent the passage of any arthropod. All these
     openings shall also be resistant to the entry of rodents and other
     large animals.

8.   Floor: The floor shall be of solid concrete construction and sealed to
     prevent seepage of fluids and allow easy regular cleaning.

9.   Drainage: All drainage and waste materials are to be collected and
     decontaminated.




                                                                                 82
10.   Decontamination: The facility shall be constructed to allow
      decontamination using the appropriate liquids and gases. Adequate
      facilities shall be provided to allow for the decontamination of all solid
      material that is to be removed from the facility, prior to disposal.

11.   Air-conditioning: All air-conditioning shall be performed by air-
      conditioners capable of recirculating air. No air shall be voided
      directly into the environment from inside the facility.

Operating Procedures

12.   The facility shall be regularly inspected (at three monthly intervals) to
      ensure that its containment features are intact. Reports of all
      inspections are to be lodged with the responsible IBC.

13.   All doors to the facility are to be kept locked at all times. Doors shall
      be of the type that allow personnel inside the facility to exit easily in
      the case of an emergency.

14.   Only persons authorised by the IBC are to enter the facility. All such
      persons shall have adequate training in normal operating
      procedures.

15.   All materials taken into and out of the facility shall be treated by a
      technique proven to destroy all life stages of arthropods and their
      pathogens.

16.   All personnel entering the facility shall put on overshoes, covering
      clothing and a hat in the anteroom. Upon leaving the facility these
      garments are to be removed in the anteroom, suitably
      decontaminated, e.g. by use of an industrial vacuum cleaner, and
      stored in a suitable place. Personnel are to wash their hands with
      soap and warm water before leaving the anteroom.

17.   All protective clothing worn in the facility shall be routinely
      decontaminated and laundered on a regular basis.

18.   Any procedures that generate aerosols are to be carried out in a
      biological safety cabinet specified for PC2 containment. Should
      practices require that aerosols be generated, for example the
      spraying of plants/insects/insect food, personnel shall be provided
      with the necessary protective clothing as outlined in Australian
      Standard 2013 Cleanroom Garments. These materials shall be
      decontaminated after use by a method demonstrated to destroy the
      agent contained in the aerosol.




                                                                                   83
Signs

The entrance doors shall be clearly labelled with signs indicating the type of
facility and the containment level. These signs are available from the
OGTR only after the OGTR has approved certification of the facility.

Note:         Those facilities that meet PC3-LS Plant House requirements
              could be used for the housing and containment of genetically
              engineered insects and their pathogens, if permitted by the
              Regulator. Operational procedures are as outlined for PC3-
              LS Plant Houses.




                                                                                 84
                   SECTION O:                   Other
The Regulator may also certify other unique facilities if the Regulator is
satisfied that the facility is adequately deigned to contain the particular
GMO proposed to be used in the facility.




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