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Science & SocietyVolume 39, Issue 10p965-969October 2021Open access
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BIOTECHNOLOGY AND BIOSAFETY POLICY AT OECD: FUTURE TRENDS
Peter W.E. Kearns
Peter W.E. Kearns
Affiliations
Former Principal Administrator (Biosafety), Organisation for Economic
Co-operation and Development (OECD), Paris, France
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1 ∙ Gijs A. Kleter
Gijs A. Kleter 0000-0001-7030-1149
Correspondence
Correspondence:
gijs.kleter@wur.nl
Affiliations
Wageningen Food Safety Research (part of Wageningen University and Research),
Wageningen, The Netherlands
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2 gijs.kleter@wur.nl ∙ Hans E.N. Bergmans
Hans E.N. Bergmans
Affiliations
Retired Official, Genetically Modified Organism (GMO) Office, National Institute
for Public Health and the Environment (RIVM), Bilthoven, The Netherlands
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3 ∙ Harry A. Kuiper
Harry A. Kuiper
Affiliations
Former GMO Panel Chair, European Food Safety Authority (EFSA), Parma, Italy
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4
Affiliations & NotesArticle Info
1Former Principal Administrator (Biosafety), Organisation for Economic
Co-operation and Development (OECD), Paris, France
2Wageningen Food Safety Research (part of Wageningen University and Research),
Wageningen, The Netherlands
3Retired Official, Genetically Modified Organism (GMO) Office, National
Institute for Public Health and the Environment (RIVM), Bilthoven, The
Netherlands
4Former GMO Panel Chair, European Food Safety Authority (EFSA), Parma, Italy
Publication History:
Published online March 19, 2021
DOI: 10.1016/j.tibtech.2021.03.001Also available on ScienceDirect
Copyright: © 2021 The Authors. Published by Elsevier Ltd.
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ABSTRACT
The OECD Council Recommendation on Recombinant DNA Safety Considerations is a
legal instrument which has been in force since 1986. It outlines the safety
assessment practices that countries should have in place for agricultural and
environmental biotechnology. This article suggests possible updates to make it
suitable for the modern era.
KEYWORDS
1. recombinant DNA
2. food and feed safety
3. environmental safety
4. risk assessment
5. international harmonisation
6. OECD
OECD AND ITS LEGAL INSTRUMENTS
The Organisation for Economic Co-operation and Development (OECD) is an
intergovernmental organisation with 37 member countries. In 1986, the OECD
Council adopted a Recommendation entitled Recombinant DNA Safety Considerations:
Safety Considerations for Industrial, Agricultural and Environmental
Applications of Organisms Derived by Recombinant DNA Techniques [1
1.
OECD
Recommendation of the Council Concerning Safety Considerations for Applications
of Recombinant DNA Organisms in Industry, Agriculture and the Environment
(OECD/LEGAL/0225)
Organisation for Economic Co-operation and Development, 1986
Google Scholar
]. This OECD legal instrument was intended to promote international
understanding of safety issues raised by recombinant DNA (rDNA) techniques so as
to take steps towards an international consensus on the protection of health and
the environment as well as a reduction of non-tariff barriers to trade. It also
marked the start of OECD's engagement with modern biotechnology, which continues
today with a track record of seminal events and publications that have
facilitated the international harmonisation of risk assessment principles (Box
1). More information on the OECD Convention and OECD legal instruments is
available on the OECD website (www.oecd.org/legal/oecd-convention.htm).
Box 1
OECD and Modern Biotechnology Since 1986
The OECD has published many documents since 1986 that include principles and/or
guidance related to the risk/safety assessment of genetically modified organisms
(GMOs) as well as of foods and animal feed derived from them (Figure I). Today,
these principles and guidance documents could be important additions to the
Recommendation (a summary of relevant OECD principles and guidance is given in
Table I).
The Recommendation was a good example of foresight when it was adopted in 1986,
when most applications were restricted to containment facilities, although some
of the first open-air field trials of GMOs were underway. It addresses issues
relevant to human health, the environment, and agriculture that might be
considered in a risk/safety assessment.
Figure I Chronology of Seminal OECD Events and Publications on the Safety of
Modern Biotechnology (1986–Present).
Show full captionFigure viewer
Abbreviations: WG-HROB, OECD Working Group on Harmonisation of Regulatory
Oversight in Biotechnology; WG-SNFF, OECD Working Group on the Safety of Novel
Foods and Feeds.
Principle or guidanceSourceGMO development follows the principle of a stepwise
approach, with risk/safety assessment being performed at each stage, from the
laboratory to the growth chamber and greenhouse, to limited field testing, and
finally to large-scale field testing.OECD, 1986 (Blue Book) [2
2.
OECD
Recombinant DNA Safety Considerations
Organisation for Economic Co-operation and Development, 1986
Google Scholar
]
OECD, 1986 (Council Recommendation) [1
1.
OECD
Recommendation of the Council Concerning Safety Considerations for Applications
of Recombinant DNA Organisms in Industry, Agriculture and the Environment
(OECD/LEGAL/0225)
Organisation for Economic Co-operation and Development, 1986
Google Scholar
]Principle of case-by-case assessment. This principle implies that the
risk/safety assessment of each case is performed individually using assessment
criteria relevant to the particular case.OECD, 1986 (Blue Book) [2
2.
OECD
Recombinant DNA Safety Considerations
Organisation for Economic Co-operation and Development, 1986
Google Scholar
].
OECD, 1986 (Council Recommendation) [1
1.
OECD
Recommendation of the Council Concerning Safety Considerations for Applications
of Recombinant DNA Organisms in Industry, Agriculture and the Environment
(OECD/LEGAL/0225)
Organisation for Economic Co-operation and Development, 1986
Google Scholar
]Principle of risk/safety assessment and risk management. This process includes
hazard identification and, if a hazard is identified, risk assessment. The
process is based on the characteristics of the organism, the trait introduced,
and the environment into which the organism is introduced, as well as the
intended application.OECD, 1993 [6
6.
OECD
Safety Considerations for Biotechnology: Scale-up of Crop Plants
Organisation for Economic Co-operation and Development, 1993
Google Scholar
,7
7.
OECD
Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts &
Principles
Organisation for Economic Co-operation and Development, 1993
Google Scholar
].
Published under the auspices of the former OECD Group of National Experts on
Safety in BiotechnologyThe principle of familiarity is used to address the
environmental safety of GMOs. It is based on the understanding that most GMOs
are developed from organisms such as crop plants whose biological
characteristics are well understood. It allows risk assessors to use previous
knowledge and experience with the introduction of GMOs into the environment, and
this can indicate management measures.OECD, 1993 [6
6.
OECD
Safety Considerations for Biotechnology: Scale-up of Crop Plants
Organisation for Economic Co-operation and Development, 1993
Google Scholar
,7
7.
OECD
Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts &
Principles
Organisation for Economic Co-operation and Development, 1993
Google Scholar
].
Published under the auspices of the former OECD Group of National Experts on
Safety in BiotechnologyThe OECD regularly publishes environmental safety
Consensus Documents. These are in line with the principle of familiarity in that
they contain information that member countries have agreed is relevant to the
risk/safety assessment of GM plants and other GMOs. The subject of each document
is a crop plant or another organism where GM varieties have been commercialised
or are expected in the future.OECD, 2017 [8
8.
OECD
Introduction to the biosafety consensus documents
Safety Assessment of Transgenic Organisms in the Environment (Vol. 7, OECD
Consensus Documents)
Organisation for Economic Co-operation and Development, 2017; 15-26
Crossref
Google Scholar
].The principle of 'substantial equivalence', otherwise known as the comparative
approach, is used in the food and feed safety assessment of products derived
from GMOs. It involves the comparison of a new food or feed derived from a GMO
with a similar product having a history of safe use, such that the safety
evaluation can subsequently focus on any differences identified.OECD, 1993 [7
7.
OECD
Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts &
Principles
Organisation for Economic Co-operation and Development, 1993
Google Scholar
].
Codex Alimentarius, 2009 [9
9.
Codex Alimentarius
Foods Derived from Modern Biotechnology
Codex Alimentarius Commission, Joint FAO/WHO Food Standards Program, 2009
Google Scholar
].The OECD regularly publishes food/feed safety Consensus Documents which
support the comparative approach. Each document has a crop plant as its subject,
and includes data on key compositional parameters (nutrients, anti-nutrients,
toxins, allergens) for the analysis of new variants of food- or feed-producing
organisms including GM crops and several fungal species.OECD, 2019 [10
10.
OECD
Introduction to OECD work on novel food and feed safety
Safety Assessment of Foods and Feeds Derived from Transgenic Crops (Vol. 3):
Common Bean, Rice, Cowpea and Apple Compositional Considerations
Organisation for Economic Co-operation and Development, 2019; 19-26
Crossref
Google Scholar
].
Table I
Summary of Relevant OECD Principles and Guidance (Consensus Documents)
* Open table in a new tab
This article argues that the Recommendation remains important and should be more
widely known. First, it remains in force today and, although it is a
recommendation, OECD practice accords recommendations 'great moral force as
representing the political will of Adherents. There is an expectation that
Adherents will do their utmost to fully implement a Recommendation'. It is
unclear whether OECD members or the wider biotechnology community are aware of
the Recommendation and its content.
Second, candidate countries aspiring to OECD membership need to show that they
are compliant with OECD legal instruments. Thirteen new members have joined the
Organisation since the Recommendation was adopted. The OECD continues to expand
its relationship with other non-members, many of which participate in its
activities. In line with current OECD practice, the Recommendation is open to
non-members. On December 2nd, 2020, Brazil became the first non-OECD country to
adhere to the Recommendation.
Many elements of the Recommendation are relevant today despite subsequent
developments in genomic technologies as well as risk/safety assessment
initiatives. An accompanying text that underpins the Recommendation, entitled
Recombinant DNA Safety Considerations, coined the 'Blue Book' [2
2.
OECD
Recombinant DNA Safety Considerations
Organisation for Economic Co-operation and Development, 1986
Google Scholar
], is an important reference to the thinking behind the Recommendation.
SUGGESTIONS FOR AN UPDATE TO THE RECOMMENDATION
This article has several suggestions for an update to the Recommendation,
bearing in mind that a revision can only be undertaken by OECD through its
committee structure. However, these suggestions are made in the belief that this
Recommendation is an important instrument that should be more widely known and
should be updated to accommodate developments since 1986.
The Recommendation refers to 'recombinant DNA techniques' and rDNA organisms.
Since 1986, however, a range of genomic techniques have been developed for
modifying genomes that do not necessarily depend on rDNA. 'Genome editing', for
instance, leads to some products that could also be produced using traditional
techniques. In 2018, OECD held an international Conference on Genome Editing
focusing on agricultural applications. It considered applications of genome
editing in agriculture, including plant and animal breeding, and their
implications for risk and safety considerations as well as regulatory aspects [3
3.
Friedrichs, S. ...
Meeting report of the OECD conference on 'Genome Editing: Applications in
Agriculture – Implications for Health, Environment and Regulation'
Transgenic Res. 2019; 28:419-463
Crossref
Scopus (43)
PubMed
Google Scholar
]. From the panel discussions during this event, one of the findings that
emerged was that there is a need for mutual understanding among nations about
their respective regulatory approaches towards genome editing, possibly being
even conducive to policy agreement. The need for such exchange among governments
may be further compounded by the fact that genome editing is not solely the
domain of major, globally operating biotechnology companies, and also engages
small entrepreneurs and academics, as evident from the Argentinean experience [3
3.
Friedrichs, S. ...
Meeting report of the OECD conference on 'Genome Editing: Applications in
Agriculture – Implications for Health, Environment and Regulation'
Transgenic Res. 2019; 28:419-463
Crossref
Scopus (43)
PubMed
Google Scholar
]. The scope of the Recommendation could be revised to encompass these new
techniques should OECD Member States indeed have a shared need for harmonisation
and extension of the current focus on rDNA. This article suggests that the
Recommendation should be renamed 'Safety Considerations for Products of Modern
Biotechnology: Applications in the Environment, Agriculture, and Food/Feed
Production'.
Section I of the Recommendation focuses on sharing experiences with rDNA
organisms so as to harmonise approaches to rDNA techniques, emphasising that
regulatory oversight should not unduly hamper technological developments.
Exchange of information has always been a recurrent theme of OECD activities. It
would be good to review the texts about not hampering technological developments
in the light of the regulatory practice of today. It would also be advisable to
attach an Annex to the Recommendation that provides a continuously updated list
of existing Consensus Documents and other OECD documents that support
risk/safety assessment.
Section II could point out that the principle of good industrial large-scale
practice, a topic which was last addressed at OECD in 1992 [4
4.
OECD
Safety Considerations for Biotechnology 1992
Organisation for Economic Co-operation and Development, 1992 7-16
Google Scholar
], remains valid for the handling of industrial microbial strains derived by
modern biotechnology from safe parental strains.
Section III, on agricultural and environmental applications, recommends that
risk/safety assessment should take into account the familiarity that has been
gained with 'the environmental and human health effects of living organisms'.
The recommendations describe approaches to risk assessment that have become
commonplace since the publication of the Recommendation, such as prior risk
assessment, stepwise development, and the encouragement of 'research to improve
the prediction, evaluation, and monitoring of the outcome of applications of
rDNA organisms'. The footnote: '... this is not intended to imply that every
case will require review by a national or other authority since various classes
of proposals may be excluded' should be retained because probably not all member
countries will wish to include all applications in their regulatory systems.
The recitals, the introduction to the Recommendation, consider the future use of
rDNA organisms. Many of the expectations in the recitals have come about.
However, the landscape of 'rDNA' has changed, with many new possibilities. There
is ongoing discussion about whether new products have the same novelty that led
to the regulatory oversight that was deemed necessary for rDNA organisms. The
recitals would also lend themselves to providing context and a future outlook.
The approaches outlined by the Recommendation may be extended to other genomic
techniques that do not entail the use of rDNA. A regular review and updating of
the Recommendation would help to engender innovative safety assessment
methodologies (e.g., analytical 'omic' approaches) that may be necessary to
address the challenges that future synthetic biology products (e.g.,
xenobiotics, extensive engineering) may pose to the application of familiarity
and the comparative safety assessment approach (Figure 1) [5
5.
EFSA Scientific Committee ...
Evaluation of existing guidelines for their adequacy for the microbial
characterisation and environmental risk assessment of microorganisms obtained
through synthetic biology
EFSA J. 2020; 18:6263
Crossref
Scopus (21)
Google Scholar
].
Figure viewer
Figure 1 The Comparative Approach as Applied to Food/Feed and Environmental
Safety Assessments of Genetically Modified (GM) Crops.
CONCLUDING REMARKS
The Recommendation should take into account the accomplishments since 1986, and
how the intentions of the Recommendation have largely come true, stating the
importance of the principles of familiarity and the comparative approach as well
as the case-by-case nature of the pre-market safety assessment of products of
modern biotechnology. The revised Recommendation (an overview of detailed
suggestions for amendments is given in Table 1) could look forward to the likely
and preferred future developments within the purview of modern biotechnology,
reflecting present-day discussions similarly to the original Recommendation.
Section1986 RecommendationSuggested amendmentsI-aShare, as freely as possible,
information on principles or guidelines for national regulations, on
developments in risk analysis and on practical experience in risk management
with a view to facilitating harmonization of approaches to recombinant DNA
techniques.Expand scope by including non-recombinant DNA techniques.
Also include non-agricultural applications.
Mention OECD BioTrackb as a platform to exchange information.
Expand the use of unique identifiers to microorganisms and animals.I-bExamine
their existing oversight and review mechanisms to ensure that adequate review
and control of the implementation of recombinant DNA techniques and applications
can be achieved while avoiding any undue burdens that may hamper technological
developments in this field.(same as for I-a above)I-cRecognise, when aiming at
international harmonization, that any approach to implementing guidelines should
not impede future developments in recombinant DNA techniques.Refer to
internationally harmonised guidelines for food safety assessment (Codex
Alimentarius Commission).I-dExamine at both national and international levels
further developments such as testing methods, equipment design, and knowledge of
microbial taxonomy to facilitate data exchange and minimise trade barriers
between countries. Due account should be taken of ongoing work on standards
within international organisations.Expand the scope (beyond microorganisms) to
plants and animals.I-eMake special efforts to improve public understanding of
the various aspects of recombinant DNA techniques.Include recent developments
such as new breeding techniques.I-fWatch the development of recombinant DNA
techniques for applications in industry, agriculture and the environment, while
recognising that for certain industrial applications, and for environmental and
agricultural applications of recombinant DNA organisms, some countries may wish
to have a notification scheme.Replace 'recombinant DNA' by 'recently emerging
genome-editing methods'.I-gEnsure that assessment and review procedures protect
intellectual property and confidentiality interests in applications of
recombinant DNA, recognising the need for innovation while still ensuring that
all necessary information is made available to assess safety.Add that maximum
transparency should be pursued, for example by making data accessible to public
scrutiny. RECOMMENDS, with specific reference to agricultural and environmental
applications, that Member countries: III-aUse the existing considerable data on
the environmental and human health effects of living organisms to guide risk
assessments.Refer to familiarity with particular modifications and/or traits.
Acknowledge lack of familiarity with, for example, gene drives and synthetic
organisms.III-bEnsure that recombinant DNA organisms are evaluated for potential
risk, prior to applications in agriculture and the environment by means of an
independent review of potential risks on a case-by-case basis.Require that
safety assessments follow the principle of the comparative approach/substantial
equivalence.
Allow the assessment to be expedited based on familiarity.III-cConduct the
development of recombinant DNA organisms for agricultural or environmental
applications in a stepwise fashion, moving, where appropriate, from the
laboratory to the growth chamber and greenhouse, to limited field testing and
finally, to large-scale field testing.Maintain this recommendation for a
stepwise approach.III-dEncourage further research to improve the prediction,
evaluation, and monitoring of the outcome of applications of recombinant DNA
organisms.Refer to the various Consensus Documents that will inform the risk
assessment (to be appended).
Table 1
OECD Council Recommendations Parts I and IIIa, and Suggested Amendments
a
Sections I and III contain recommendations to member countries on risk
management in general (I) and specifically for environmental and agricultural
purposes (III) [1
1.
OECD
Recommendation of the Council Concerning Safety Considerations for Applications
of Recombinant DNA Organisms in Industry, Agriculture and the Environment
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b
www.oecd.org/science/biotrack/
* Open table in a new tab
ACKNOWLEDGMENTS
ACKNOWLEDGEMENTS
Financial support from the Dutch Ministry of Agriculture, Nature, and Food
Quality (project WOT-02-004-052) for G.K.'s contribution is gratefully
acknowledged.
DECLARATION OF INTERESTS
The authors declare no conflicts of interest. The views presented here are
solely those of the authors and do not necessarily represent those of the OECD,
the EFSA, or any other institution with which the authors are or have been
associated.
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