The concept of a ‘roadmap’ for risk assessment and risk management is explained in the posted contribution ‘‘Roadmap’ for risk assessment and risk management under the Cartagena Protocol on Biosafety’.
One of the advantages of the roadmap is that it can be used as a framework for making clear what information is necessary for performing the different steps of a risk assessment.
This contribution discusses the type of information that is necessary and useful for the different points to consider in the steps of the risk assessment process, and provides some examples.
In order for the roadmap to function properly as a framework for information, the referenced information should be comprehensive. As a matter of fact, it should be possible in principle to indicate for all literature references in a database like the Biosafety Information Resource Centre (BIRC) of the BCH where the information comes in usefulness within the framework of the roadmap.
I would ask you and encourage you to provide further discussion on and examples of information that could be added at the different points to consider of each step. This subject is also on the agenda to be taken on board by the forthcoming AHTEGs, for further development.
The roadmap itself is presented here in ‘shorthand’, with shortened headings for the steps and point to consider. Please refer to the first posted document on the road map for full explanation.
Roadmap for risk assessment and risk management: useful information
Step 1: Identification of novel genotypic and phenotypic characteristics associated with the LMO.
Points to consider:
(a) The biological characteristics of the recipient organism.
The (potential adverse) effects that an LMO can have on the environment are to a large extent determined by the biological properties of the non-modified recipient organism. This type of information has been published for number of organisms in ‘biology documents’, e.g. the OECD consensus documents <
http://www.oecd.org/document/51/0,3343,en_2649_34387_1889395_1_1_1_1,00.html>), for instance the document for Zea mays <
http://www.olis.oecd.org/olis/2003doc.nsf/LinkTo/env-jm-mono(2003)11>.
Not all information that is available on the biology of plants will be relevant for the specific purpose of step 1. What type of information is particularly useful in biology documents may be further discussed, as is done in the OECD ‘points to consider’ document <
http://www.olis.oecd.org/olis/2006doc.nsf/LinkTo/NT00000B8E/$FILE/JT03206674.PDF> .
(b) Characteristics of the vector.
Usually this is very case specific information, and information can be found in the information submitted by applicants. The choice of vector will also depend on the typef of transformation procedure that is used (A. tumefaciens mediated transformation, biolistics), and general information on these techniques may come in useful here.
(c) Characterization of the insert(s): gene products, level of expression, function, physiological effect on the recipient organism.
What would be needed for characterization of the gene product and its physiological effect on the recipient organism are overview papers on the information that is relevant to the risk assessment of the gene products. This type of compilation is available for some traits that have been used, or are going to be used, in LMOs. We find that this kind of overview is less easily available than the ‘biology documents’ mentioned in paragraph (a) of this section.
Examples are: the OECD report on the biosafety of Bt protein expressed in plants <
http://www.olis.oecd.org/olis/2007doc.nsf/LinkTo/NT00002DF6/>, and a report on drought tolerance and on expression of omega-3 fatty acids, made available on the BIRC <
http://bch.cbd.int/database/attachedfile.aspx?id=1904>.
Requirements for detailed characterization, e.g. molecular characterization and characterization of levels of expression, are set by competent authorities, e.g. a document on molecular characterization <
http://www.aphis.usda.gov/brs/canadian/usda03e.pdf> that has been agreed upon by the US and Canada.
(d) Relevant biological characteristics of the donor organism(s).
This information differs from the information on the trait of the donor organism that has been introduced into the receiving organism (i.e. the information mentioned in paragraph (c) of this section), in that the activity of the trait in the donor organism may provide insight into what could be happening in the LMO.
Differences between the situation in the donor organism and in the LMO may also be important. An example would be the case of Bt toxin: the toxin is expressed in the donor organism as an inactive protein, that has to be activated by proteolytic cleavage. In the LMO it is expressed as a truncated protein that is immediately active as toxin. This has to be kept in mind when the potential effects of the LMO (with truncated toxin) are compared to the effects of the donor (with its full length protein, that has to be activated for toxicity).
(e) Characterization of the resulting LMO
The actual characterization of the phenotype of the LMO, is based on the characterization of the insert in paragraph (c) in this section.
The characterization is done on a case by case basis. General guidelines are available from bodies performing risk assessment, e.g. the EFSA guidance document <
http://www.efsa.europa.eu/cs/BlobServer/Scientific_Document/gmo_guidance_gm_plants_en,0.pdf?ssbinary=true>
Practical examples may be found in the summaries of risk assessments for specific LMOs, publishes on the BCH, depending on the level of detail of the summaries.
(f) Conclusions regarding significant intended and unintended changes in the LMO.
This conclusion is a summary of the considerations in (a) – (e) in this section, and is the basis for the considerations in the next steps. Clearly, the conclusions have to be drawn on a case by case basis. The changes are characterized by a comparative approach, comparing the LMO and its use to the relevant counterpart. This is generally explained in the guidance document mentioned in paragraph (e) of this section.
Step 2: Evaluation of the likelihood of these adverse effects being realized.
Points consider
(a) Information relating to the intended use of the LMO.
This information is provided on a case by case basis by the applicant.
(b) Likely receiving environment.
Characterization of the likely receiving environment will be the local environment of the risk assessor. The risk assessor, or by experts directly available to the risk assessor, e.g. local environmental or agricultural extension services, are therefore in the best position to do this characterization. It would be useful to make available lists of extension services, or actual examples of characterization of the receiving environment for purposes of LMO risk assessment, as examples.
Step 3: An evaluation of the consequences should these adverse effects be realized;
Points to consider
(a) Characteristics of the likely potential receiving environment, and of experience with similar consequences of traditional practices, as a baseline.
The use of baseline information is very important, for the comparative approach that is a principle of LMO risk assessment. The comparative approach has been described, e.g. in the EFSA guidance document referred to in Step 1, e.
Step 4: An estimation of the overall risk posed by the LMO.
The result of this step follows from the steps 1 – 3, on a case by case basis.
General guidance on this topic will be available for different legislative frameworks (e.g. the EFSA guidance referred to in Step 1, e).
Practical examples may be found in the summaries of risk assessments for specific LMOs, publishes on the BCH, depending on the level of detail of the summaries.
Step 5: A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks;
Points consider
With regard to acceptability of identified risks:
(a) Likely receiving environment and experience with similar consequences of traditional practices, as a baseline.
(b) Evaluation of the risk associated with the LMO in the context of the risks posed by the non-modified recipients in the likely potential receiving environment.
For both (a) and (b) baseline data are needed. Examples of the need for baseline data for a specific case, and of the discussion on the interpretation of baseline data, can be found in the previous discussion forum, on the topic of transgenic trees,
With regard to manageability of identified risks:
(c) Relevant management practices that are in use for the non-modified recipients, or for other organisms that require comparable risk management.
Examples of risk management practices are provided in Annex 5 of the 1995 UNEP International Guidelines for Safety in Modern Biotechnology <link
http://www.unep.org/biosafety/Documents/Techguidelines.pdf>. Identification of similar guidance material would be useful.
(d) Relevant methods for detection and identification of the LMO and their specificity, sensitivity and reliability.
One example of a document that is relevant, in this case for micro-organisms introduced into the environment, can be found at <
http://www.olis.oecd.org/olis/2004doc.nsf/LinkTo/NT0000A48A/$FILE/JT00166030.PDF >
Identification of similar guidance for higher organisms would be useful.
Step 6: Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment.
The Precautionary Principle of the Rio Declaration (principle 15 in <
http://www.unep.org/Documents.multilingual/Default.asp?DocumentID=78&ArticleID=1163> is an important instrument for decision making in case of scientific uncertainty.
See also a Communication by the Commission of the EU COM(2000) 1 <
http://ec.europa.eu/dgs/health_consumer/library/pub/pub07_en.pdf > for a general discussion on how to use the precautionary principle in environmental safety.
