Having prepared a RARMP, the Regulator must, under Section 52 of the Act, seek comment from stakeholders, including those outlined in Section 3 and the public.
All issues relating to the protection of human health and safety and the environment raised in written submissions on an application or RARMP are considered carefully, and weighed against the body of current scientific information, in reaching the conclusions set out in a final RARMP. Section 56 of the Act requires that these be taken into account in making a decision on whether or not to issue a licence for the proposed release.
Comments received in written submissions on this risk assessment and risk management plan are very important in shaping the final risk assessment and risk management plan and in informing the Regulator’s final decision on an application. A summary of public submissions and an indication of where such issues have been taken into account are provided in an Appendix to the RARMP.
It is important to note that the legislation requires the Regulator to base the licence decision on whether risks posed by the dealings are able to be managed so as to protect human health and safety and the environment. Matters in submissions that do not address these issues and/or concern broader issues outside the objective of the legislation will not be considered in the assessment process. In most instances, as determined in the extensive consultation process that led to the development of the legislation, they fall within the responsibilities of other authorities.
Section 6 Decision on licence
Having taken the required steps for assessment of a licence application, the Regulator must decide whether to issue or refuse a licence (Section 55 of the Act). The Regulator must not issue the licence unless satisfied that any risks posed by the dealings proposed to be authorised by the licence are able to be managed in such a way as to protect the health and safety of people and the environment.
The Regulator must also be satisfied, under section 57 of the Act, that the applicant is a suitable person to hold the licence. Section 58 outlines matters the Regulator must consider in deciding whether a person or company is suitable to hold a licence eg.:
any relevant convictions;
any relevant revocations or suspensions of a licences or permits; and
the capacity of the person or company to meet the conditions of the licence.
The Regulator carefully considers all of this information which is supplied in a declaration signed by licence applicants.
The Monitoring and Compliance Section of the OGTR compiles compliance histories of applicants, considering all previous approvals to deal with GMOs under the Act and the previous voluntary system. These histories as well as other information such as follow-up actions from audits may be taken into account. The ability of an organisation to provide resources to adequately meet monitoring and compliance requirements may also be taken into account.
If a licence is issued, the Regulator may impose licence conditions (Section 62 of the Act). Conditions may be imposed to:
limiting the dissemination or persistence of the GMO or its genetic material in the environment.
It is also required as a condition of a licence that the licence holder inform any person covered by the licence of any condition of the licence which applies to them (Section 63). Access to the site of a dealing must also be provided to persons authorised by the regulator for the purpose of auditing and monitoring the dealing and compliance with other licence conditions (Section 64). It is a condition of any licence that the licence holder inform the Regulator of:
any new information as to any risks to the health and safety of people, or to the environment, associated with the dealings authorised by the licence;
any contraventions of the licence by a person covered by the licence; and
any unintended effects of the dealings authorised by the licence.
appendix 7 SUMMARY of PUBLIC SUBMISSIONs ON the Risk assessment and risk management plan
Abbreviations: Approval (general tone): n = neutral; x = do not support; y = support
Issues raised: A: allergenicity; APVMA: issues dealt with by APVMA; D: insufficient data/evidence; EN: environmental risks; ET: ethical concerns; FC: food chain; FSANZ: food safety and labelling; G: gene transfer; GTR: the Gene Technology Regulator; H: human health and safety; HB: herbicide resistance; IR: insecticide resistance; LC: licence conditions; MA: markets; PU: pesticide use; RA: risk assessment; RARMP: risk assessment and risk management plan; RM: risk management; SE: socioeconomic impacts; SEG: segregation; T: toxicity; U: unknown risks; W: weediness.
OSA: outside scope of the assessment; NR: No specific response
a Submission from: A: agricultural organisation; I: individual; E: environmental organisation; F: food interest organisation; C: consumer/public interest organisation.
Summary of issues raised
Consideration of issue
The following are concerns about the above Risk Framework:
The term Risk Management is … used out of context … This definition is in clear conflict with AS/NZS 4360 [risk assessment standard] and refers more to the process of Risk Control than Risk Management…
There is no definition of each risk level…. [and]… no explanation on how to allocate a particular risk level!
There is no reference to risk assessment matrices or calculators.
There are no examples of quantitative and qualitative risk assessment methods!
I object to the proposed release [DIR 026/2002]
All these genetically engineered organisms pose unknown …risks.... However slight you think these risks are you have no right to take them. I am outraged at this abuse of power.