New Zealand
July 27, 2009
FSANZ Response to the Review
Recommendations
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.
Overview
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.
KEY RECOMMENDATIONS
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-hoc
Intergovernmental 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)
Background
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 Hoc Intergovernmental 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.
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