Food Standards AUSTRALIA NEW ZEALAND review of genetically modified food safety assessments
Posted: July 28th, 2009 - 9:20am
In May 2008, an international expert was invited to undertake a review of FSANZ’s safety assessment procedures for genetically modified (GM) foods. The aim of this review was to assess FSANZ’s performance in the assessment of GM food safety against international best practice and to identify areas for enhancement. The reviewer prepared a report for FSANZ in which several recommendations were made.
The review report provided a comprehensive analysis of the current FSANZ approach to GM food safety assessments, benchmarked against international best practice in the area. As highlighted in the Review, the current approach used by FSANZ to assess GM foods is consistent with the Codex Principles for the Risk Analysis of Foods Derived from Biotechnology (1), developed by the Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology. Additionally, the report also notes that the comparative approach (or substantial equivalence) to identify potential new or altered hazards associated with GM food used by FSANZ is in line with other regulatory agencies.
The report identifies a number of strengths in the FSANZ approach to GM food safety assessments including:
* highly knowledgeable and multidisciplinary scientific staff involved in the assessment of GM food.
* use of relevant external experts engaged in the FSANZ Fellows program to provide additional scientific input.
* transparency of the communication on GM food safety assessments, including inviting comment from all interested stakeholders and providing documents on the website.
* holding workshops to further educate interested stakeholders in the assessment of GM foods.
* strong international engagement and input into GM areas.
The report also identifies areas where FSANZ could further strengthen its approach to GM food assessments, including:
* ensuring staff have the appropriate expertise to meet any new challenges in GM food assessments arising for the next generation of GM foods currently in the pipeline (e.g. GM animals).
* ensuring capacity within the GM team to continue with international work.
The report identified six key recommendations for FSANZ to consider in relation to the assessment of GM food. The key recommendations from the report are outlined below.
1. Maintain strong scientific GM team and further strengthen expertise to address future challenges associated with the safety assessment of the next generation of complex GM food.
2. Enhance the engagement of external scientific expertise as appropriate to address future knowledge gaps in assessing the safety of GM food.
3. Investigate the feasibility of managing workload associated with the safety assessment of a GM food application.
4. Continue to engage and establish closer working relationships with other Australian and New Zealand regulatory agencies.
5. Continue to build on FSANZ’s strong international reputation as a leader in GM food safety assessment and explore mechanism(s) to enhance collaboration with international regulatory partners.
6. Continue to provide an open and transparent GM food safety assessment process and enhance the risk communication efforts with key stakeholders.
Proposed FSANZ Actions
Following consideration of the key recommendations in this Review, a number of responses have been developed that address where FSANZ can directly or indirectly implement actions to enhance the standard of GM food assessments. These are:
1. In the future, it is likely that FSANZ will receive applications for GM foods derived from species other than plants, e.g. GM animals. FSANZ will exploit recruitment opportunities to ensure that the scientific capability and technical expertise of staff in the GM team are appropriate to the changing needs of the organisation. FSANZ will also continue to participate in forums to keep abreast of future developments and ensure adequate skills within the organisation.(Recommendations 1 and 3)
2. The development and widespread commercialisation of GM crops results in the need for regulatory approvals to be obtained in many different countries. FSANZ will actively collaborate and share information on GM foods and assessment methodologies with regulatory partners overseas to promote consistency with internationally accepted processes. This could be achieved by using existing Memorandums of Understanding (MoUs) with other food agencies, exploring the possibility of new MoUs and utilising contacts established through existing networks including the International Chemical Food Safety Liaison Group.(Recommendation 4)
3. Working at the international level to share knowledge and expertise and to develop harmonised approaches to assessing GM food is integral to maintaining the rigor of the safety assessment process and, therefore, is an important component of FSANZ work. FSANZ (representing Australia) will continue to Chair and actively participate in the OECD Taskforce for the Safety of Novel Foods and Feeds and will maintain its role as delegation leader to the Codexad-hocIntergovernmental Task Force on Foods Derived from Biotechnology, should it be re-convened in the future. FSANZ will also consider participation at other forums, e.g. Expert Consultations, to continue to build capacity in assessing GM food.(Recommendation 5)
4. Strengthening capability, including ensuring adequate resources and expertise, will assist in meeting future challenges in relation to GM food safety assessment and enhancing the FSANZ knowledge base. FSANZ will investigate opportunities for FSANZ staff, external to the GM team, to undertake training to increase the pool of internal expertise available to undertake GM food safety assessments. FSANZ will also consider expanding linkages with external experts, including through the FSANZ Fellows Program, to ensure an adequate breadth of scientific knowledge relating to GM food is covered. FSANZ will continue the practice of using external expertise to undertake ad-hoc peer reviews of FSANZ GM food safety assessments. (Recommendation 1,2 and 3)
5. Communicating GM food safety assessment outcomes to a wide range of stakeholders continues to be a challenging process. FSANZ will actively consider ways to engage different stakeholders in the GM food safety assessment process. FSANZ will also continue to use existing forums such as the Consumer Liaison Committee (CLC), Retailers and Manufacturers Liaison Committee (RML) and the Jurisdictional Forum for sharing information related to GM food safety assessments. Additionally, due to the wide and varied nature of stakeholders interested in GM food, FSANZ will consider alternative communication mechanisms including webinars, to communicate GM food issues.(Recommendation 6)
An external review of FSANZ GM food safety assessment procedures was undertaken by FSANZ in May 2008. The review was undertaken as part of the Science Strategy 2006-09, which aimed to achieve continuous improvement of our scientific capability, by evaluating and monitoring the quality of our science. The purpose of this external review was to benchmark FSANZ performance in GM food safety assessment against international best practice and to identify areas for enhancement of FSANZ’s scientific capability.
To do this, FSANZ appointed Dr William Yan to undertake the review. Dr Yan is the Director of the Health Effects Division 1 in the Pest Management Regulatory Agency in Health Canada. Dr Yan has significant experience in the area of GM foods and has participated in and led various research, regulatory and policy development programs in Health Canada in the GM area. Dr Yan was the head of the Food Directorate team responsible for the regulation and safety assessment of novel foods (including genetically modified foods) from 2001 to 2008, leader of the Canadian delegation for the OECD Task Force for the Safety of Novel Foods and Feeds since 2002 and was Canada’s Head Delegate to the CodexAd HocIntergovernmental Task Force for Foods Derived from Biotechnology. Dr. Yan is also an Adjunct Professor in the Department of Biochemistry, Microbiology and Immunology at the University of Ottawa.
The review of FSANZ GM food safety assessments focussed on the following areas:
* Technical and scientific aspects, such as the data requirements for safety assessments, concordance of the FSANZ assessment procedures with international best practice for GM foods;
* Procedural and regulatory aspects (to extent that can be accommodated within existing FSANZ legislation), such as the interaction of scientific disciplines within FSANZ to undertake the evaluations, the use of the safety assessment to inform the regulatory decision; and
* Communication aspects, such as documentation of FSANZ GM food safety assessment principles and procedures, presentation of safety assessment reports, interactions with stakeholders.
The review was finalised in December 2008.