Chapter 3 Risk management plan

Section 1 Background

343. Risk management is used to protect the health and safety of people and to protect the environment by controlling or mitigating risk. The risk management plan evaluates and treats identified risks, evaluates controls and limits proposed by the applicant, and considers general risk management measures. The risk management plan informs the Regulator’s decision-making process and is given effect through proposed licence conditions.

344. Under section 56 of the Act, the Regulator must not issue a licence unless satisfied that any risks posed by the dealings proposed to be authorised by the licence are able to be managed in a way that protects the health and safety of people and the environment.

345.All licences are subject to three conditions prescribed in the Act. Section 63 of the Act requires that each licence holder inform relevant people of their obligations under the licence. The other statutory conditions allow the Regulator to maintain oversight of licensed dealings: section 64 requires the licence holder to provide access to premises to OGTR inspectors and section 65 requires the licence holder to report any information about risks or unintended effects of the dealing to the Regulator on becoming aware of them. Matters related to the ongoing suitability of the licence holder are also required to be reported to the Regulator.

346. The licence is also subject to any conditions imposed by the Regulator. Examples of the matters to which conditions may relate are listed in section 62 of the Act. Licence conditions can be imposed to limit and control the scope of the dealings. In addition, the Regulator has extensive powers to monitor compliance with licence conditions under section 152 of the Act.

Section 2 Risk treatment measures for identified risks

347. The risk assessment of risk scenarios listed in Chapter 2 concluded that there are negligible risks to people and the environment from the proposed release of GM canola. These risk scenarios were considered in the context of the large scale of the proposed release and the receiving environment and considering both the short and long term. The Risk Analysis Framework (OGTR 2009a), which guides the risk assessment and risk management process, defines negligible risks as insubstantial with no present need to invoke actions for their mitigation. Therefore, no conditions are imposed to treat these negligible risks.

Section 3 General risk management

348. All DIR licences issued by the Regulator contain a number of general conditions that relate to general risk management. These include conditions relating to:
  • applicant suitability
  • identification of the persons or classes of persons covered by the licence
  • reporting structures
  • a requirement that the applicant allows access to specified sites for purpose of monitoring or auditing.

3.1 Applicant suitability

349. In making a decision whether or not to issue a licence, the Regulator must have regard to the suitability of the applicant to hold a licence. Under section 58 of the Act, matters that the Regulator must take into account include:
  • any relevant convictions of the applicant (both individuals and the body corporate)
  • any revocation or suspension of a relevant licence or permit held by the applicant under a law of the Commonwealth, a State or a foreign country
  • the capacity of the applicant to meet the conditions of the licence.

350. On the basis of information submitted by the applicant and records held by the OGTR, the Regulator considers Bayer suitable to hold a licence.

351. The licence includes a requirement for the licence holder to inform the Regulator of any circumstances that would affect their suitability or their capacity to meet the conditions of the licence.

352. Bayer must continue to have access to a properly constituted Institutional Biosafety Committee and be an accredited organisation under the Act.

3.2 Testing methodology

353. Bayer is required to provide a method to the Regulator for the reliable detection of the presence of the GMOs and the introduced genetic materials in a recipient organism. This instrument is required within 30 days of the issue date of the licence.

3.3 Identification of the persons or classes of persons covered by the licence

354. Any person, including the licence holder, may conduct any permitted dealing with the GMOs.

3.4 Reporting requirements

355. The licence obliges the licence holder to immediately report any of the following to the Regulator:
  • any additional information regarding risks to the health and safety of people or the environment associated with the dealings
  • any contraventions of the licence by persons covered by the licence
  • any unintended effects of the release.

356. The licence holder is also obliged to submit an Annual Report containing any information required by the licence.

357. There are also provisions that enable the Regulator to obtain information from the licence holder relating to the progress of the commercial release (see Section 4, below).

3.5 Monitoring for Compliance

358. The Act stipulates, as a condition of every licence, that a person who is authorised by the licence to deal with a GMO, and who is required to comply with a condition of the licence, must allow inspectors and other persons authorised by the Regulator to enter premises where a dealing is being undertaken for the purpose of monitoring or auditing the dealing.

359. In cases of non-compliance with licence conditions, the Regulator may instigate an investigation to determine the nature and extent of non-compliance. The Act provides for criminal sanctions of large fines and/or imprisonment for failing to abide by the legislation, conditions of the licence or directions from the Regulator, especially where significant damage to health and safety of people or the environment could result.

Section 4 Post release review

360. Regulation 10 requires the Regulator to consider the short and the long term when assessing risks. The Regulator does not fix durations, but takes account of the likelihood and impact of an adverse outcome over the foreseeable future, and does not disregard a risk on the basis that an adverse outcome might only occur in the longer term. However, as with any predictive process, accuracy is often greater in the shorter rather than longer term.

361. For the current application for a DIR licence, the Regulator has incorporated a requirement in the licence for ongoing oversight to provide feedback on the findings of the RARMP and ensure the outcomes remain valid for future findings or changes in circumstances. This ongoing oversight will be achieved through post release review (PRR) activities. The three components of PRR are:
  • adverse effects reporting system (Section 4.1)
  • requirement to monitor specific indicators of harm (Section 4.2)
  • review of the RARMP (Section 4.3).

362. The outcomes of these PRR activities may result in no change to the licence or could result in the variation, cancellation or suspension of the licence.

4.1 Adverse effects reporting system

363. Any member of the public can report adverse experiences/effects resulting from an intentional release to the OGTR through the Free-call number (1800 181 030), fax (02 6271 4202), mail (MDP 54 – GPO Box 9848, Canberra ACT 2601) or via email to the OGTR inbox. Reports can be made at any time on any DIR licence. Credible information would form the basis of further investigation and may be used to inform a review of a RARMP (see 4.3 below) as well as the risk assessment of future applications involving similar GMO(s).

4.2 Requirement to monitor specific indicators of harm

364. Additional specific information on the release provides a mechanism for ‘closing the loop’ in the risk analysis process and for verifying findings of the RARMP, by monitoring the specific indicators of harm that have been identified in the risk assessment. Specific indicators of harm may also be identified at a later stage, eg through either of the other components of PRR.

365. The term ‘specific indicators of harm’ does not mean that it is expected that harm would necessarily occur if a licence was issued. Instead, it refers to measurement endpoints which are expected to change should the authorised dealings result in harm. If specific indicators or harm were identified, licence holders would be required to monitor them as mandated by the licence.

366. The triggers for this component of PRR may include risk estimates greater than negligible or uncertainty in the risk assessment.

367. The characterisation of the risk scenarios discussed in Chapter 2 did not identify any risks that could be greater than negligible and the level of uncertainty is considered to be low. Therefore, no specific indicators of harm have been identified in this RARMP for application DIR 108.

4.3 Review of the RARMP

368. The third component of PRR is the review of RARMPs after a commercial/general release licence is issued. Such a review would be desktop-based and take into account any relevant new information, including any changes in the context of the release, to determine if the findings of the RARMP remained current. The timing of the review would be determined on a case-by-case basis and may be triggered by findings from either of the other components of PRR or be undertaken after the authorised dealings have been conducted for some time. If the review findings justified either an increase or decrease in the initial risk estimate(s), or identified new risks to people or to the environment that needed managing, this could lead to changes to the licence conditions.

Section 5 Conclusions of the RARMP

369. The risk assessment concluded that this commercial release of GM canola poses negligible risks to the health and safety of people or the environment as a result of gene technology.

370. The risk management plan concluded that these negligible risks do not require specific risk treatment measures. However, general conditions have been imposed to ensure that there is ongoing oversight of the release.