Foundational activities at the international level underlie current risk and safety assessment approaches for genetically engineered/modified organisms (GEOs/GMOs). Early risk assessment considerations beginning with the OECD ‘Blue Book’ established risk/safety assessment as the characterization of the organism and its environmental release; establishment and persistence in the environment; and human and ecological effects, analyzed in principle through existing methods. Important in this context was recognition that GEOs/GMOs as a class did not represent new risks relative to products of traditional plant breeding and that any incremental risk would need to be established on a stepwise case-by-case comparative basis with existing crops and derived-foods as the baseline. Accordingly, concepts of familiarity and substantial equivalence were advanced by OECD and WHO as ways to establish a risk analysis baseline for determining whether and to what extent risk/safety assessment was needed. Regulatory implementations of this paradigm have skewed to increasingly complex portfolios of studies rather than adhering to analysis which is formulated to fit the risk/safety questions relevant to a given case. Plants produced through genome editing technology will benefit from risk analysis that implements sound problem formulation to guide the need for and nature of risk/safety assessments.
This is a preview of subscription content, access via your institution.
Buy single article
Instant access to the full article PDF.
Tax calculation will be finalised during checkout.
Subscribe to journal
Immediate online access to all issues from 2019. Subscription will auto renew annually.
Tax calculation will be finalised during checkout.
CAC (Codex Alimentarius Commission) (2003a) Codex principles and guidelines on food derived from biotechnology. Codex Alimentarius Commission, Rome
CAC (Codex Alimentarius Commission) (2003b) Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants. CAC/GL 45:1–18
Constable A, Jonas D, Cockburn A, Davi A, Edwards G, Hepburn P, Herouet-Guicheney C, Knowles M, Moseley B, Oberdorfer R, Samuels F (2007) History of safe use as applied to the safety assessment of novel foods and foods derived from genetically modified organisms. Food Chem Toxicol 45:2513–2525
EC (European Commission) (2010) EA decade of EU-funded GMO research (2001–2010). In: D.-G.f.R.a. (ed) Innovation. European Commission, Luxembourg
Kalaitzandonakes N, Alston JM, Bradford KJ (2007) Compliance costs for regulatory approval of new biotech crops. Nat Biotechnol 25:509–511
Klümper W, Qaim M (2014) A meta-analysis of the impacts of genetically modified crops. PLoS ONE 9:e111629
Kuiper HA, Kleter GA, Noteborn HP, Kok EJ (2002) Substantial equivalence—an appropriate paradigm for the safety assessment of genetically modified foods? Toxicology 181:427–431
Lowrance WW (1976) Of acceptable risk: science and the determination of safety. William Kaufman, Los Altos
NASEM (National Academies of Sciences, Engineering and Medicine). (2017). Preparing for future products of biotechnology. National Academies Press
Nicolia A, Manzo A, Veronesi F, Rosellini D (2014) An overview of the last 10 years of genetically engineered crop safety research. Crit Rev Biotechnol 34:77–88
NRC (National Research Council) (1983) Risk assessment in the federal government: managing the process. National Academies Press, Washington
NRC (National Research Council) (2009) Science and decisions: advancing risk assessment. National Academies Press, Washington
OECD (Organization for Economic Cooperation and Development) (1986) Recombinant DNA safety considerations. Organization for Economic Cooperation and Development, Paris
OECD (Organization for Economic Cooperation and Development) (1992) Safety considerations for biotechnology, Part 2 Good Developmental Principles (GDP): guidance for the design of small-scale field research with genetically modified plants and micro-organisms. Organization for Economic Cooperation and Development, Paris
OECD (Organization for Economic Cooperation and Development) (1993a) Safety evaluation of foods derived by modern biotechnology: concepts and principles. Organization for Economic Cooperation and Development, Paris
OECD (Organization for Economic Cooperation and Development) (1993b) Safety considerations for biotechnology: scale-up of crop plants. Organization for Economic Cooperation and Development, Paris
OECD (Organization for Economic Cooperation and Development) (1993c) Traditional crop breeding practices: an historical review to serve as a baseline for assessing the role of modern biotechnology. Organization for Economic Cooperation and Development, Paris
OECD (Organization for Economic Cooperation and Development) (2016) Report of the OECD Workshop on Environmental Risk Assessment of Products Derived from New Plant Breeding Techniques. In: Directorate E (ed) Organization for Economic Cooperation and Development, Paris
Pellegrino E, Bedini S, Nuti M, Ercoli L (2018) Impact of genetically engineered maize on agronomic, environmental and toxicological traits: a meta-analysis of 21 years of field data. Sci Rep 8:3113
Raybould A (2006) Problem formulation and hypothesis testing for environmental risk assessments of genetically modified crops. Environ Biosaf Res 5:119–125
Shah T, Andleeb T, Lateef S, Noor MA (2018) Genome editing in plants: advancing crop transformation and overview of tools. Plant Physiol Biochem 131:12–21
Smyth SJ, McDonald J, Falck-Zepeda J (2014) Investment, regulation, and uncertainty: managing new plant breeding techniques. GM Crops Food 5:44–57
USEPA (United States environmental Protection Agency) (1998) Guidelines for ecological risk assessment. US Environmental Protection Agency, Washington
WHO (World Health Organization) (1991) Strategies for assessing the safety of foods produced by biotechnology: report of a joint FAO/WHO consultation. World Health Organization, Geneva
WHO (World Health Organization) (1995) Application of the principles of substantial equivalence to the safety evaluation of foods or food components from plants derived by modern biotechnology: report of a WHO workshop
WHO (World Health Organization) (2000) Safety aspects of genetically modified foods of plant origin: report of a joint FAO/WHO Expert Consultation. World Health Organization, Geneva
Wolt JD, Kees P, Raybould A, Fitzpatrick JW, Burachik M, Gray A, Olin SS, Schiemann J, Sears M, Wu F (2010) Problem formulation in the environmental risk assessment for genetically modified plants. Trans Res 19:425–436
Wolt JD, Wang K, Sashital D, Lawrence-Dill CJ (2016) Achieving plant CRISPR targeting that limits off-target effects. Plant Genome. https://doi.org/10.3835/plantgenome2016.05.0047
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Disclaimer: The opinions expressed and arguments employed in this paper are the sole responsibility of the author and do not necessarily reflect those of the OECD or of the governments of its Member countries.
About this article
Cite this article
Wolt, J.D. Current risk assessment approaches for environmental and food and feed safety assessment. Transgenic Res 28, 111–117 (2019). https://doi.org/10.1007/s11248-019-00140-7
- Genetically engineered
- Genome edited
- Novel food