Activities of the Open-Ended Online Forum (2014-2016)

Dear members of the Online Forum,

Following a request by Francisca, moderator of this discussion, dedicated threads are being created for each of the four topics under discussion.

Please use this thread to share views, relevant guidance and sources information on on “LMOs introduced in centres of origin and genetic diversity” and “LMOs intended for introduction into unmanaged ecosystems”.

To post your contribution, click on the "Reply" link **below** this message when viewing it through an email or through the discussion page at https://bch.cbd.int/onlineconferences/onlineconferences/forum_ra/discussion.shtml .

Thank you and regards,
Manoela

Dear Forum participants, Francisca and members of the Secretariat,

By this mean I would like to like to share some comments on the subject regarding “LMOs introduced in centres of origin and genetic diversity” and “LMOs intended for introduction into unmanaged ecosystems”; trying to give some elements for the different questions that have been established.


(a) Where would each topic best be inserted in the Roadmap (Part I)?, Would it need to be mentioned somewhere else as well? Where?
R:  The topics relating to Centres of origin and genetic diversity as well as those of unmanaged ecosystems could be inserted in a specific “text box” containing a synthesis of the most  relevant elements to be considered. The box should have a link to a reference list on the topics to be inserted at the end of the document. A possibility is to place this box just after the box on “attributes of the receiving environment”.

Reference to this box could be made along the different parts of the text where these issues need to be taken into account during the analysis (see also question c)

(b) According to your own knowledge on the matter, what would the most relevant elements be that should be considered related to each topic (try adding them in a logical stepwise manner and not repeating what is already mentioned in the Roadmap)?

R:Here is a proposal of an outline with some of the key elements that the box should at least include for the centres  of origin and genetic diversity (without considering in this moment more specific wording or content; other aspects might be added,  particularly also for the case of unmanaged ecosystems for this kind of box):

• Define what is a centre of origin, and centre of genetic diversity. Definitions available in different publications can be useful to elaborate this point, (for example  Acevedo et al., in press, and see also question e) 
• Why are these regions so relevant for mankind and food security
• What are  the eventual/possible adverse effects/risks of  releasing GMOs in CDODG. Emphasis can be done in relation to gene flow and it’s eventual/potential effects in biological, legal and socioeconomic issues.
• What biological, ecological baseline information needs to be available/generated as an input to the risk analysis (natural distribution of wild relatives, inter and intraspecific hybridization possibilities, potential invasiveness of LMO and its novel trait(s); ecological and habitat interactions).
• The  Importance to identify gaps of knowledge and its relation to uncertainty
• Other aspects that might need to be considered in the analysis, such as additional productive activities and management practices that might be held in the same receiving environment (or the region of influence of the receiving environment) such as the use of local landraces, management practices that encourage of the interactions between wild relatives and crops, etc, that  in many cases are involved in generating genetic diversity.

• Indicate that some countries have initiated regulatory attempts to define centres of origin  inside their territories.
• A link to  a reference list


(c) How would these elements be taken into consideration in the context of the framework of the Roadmap (part I)?
R: During the planning phase of the risk assessment, particularly in “Establishing the context and scope”, as well as  in “conducting the risk assessment”, where considering this issues  of “relevant characteristics of the non modified recipient or parental organisms”, and “elements for consideration regarding the intended use and the likely potential receiving environment”.

Some of the identified sections/lines of the text where reference to this box could be inserted are the following:

Pg 27. L 387. (vi) “availability of base line information for the likely potential receiving environment”.

Pg 27. L404. (xii) “proposed limits and controls to restrict the spread and persistence of the LMO”… this point might not only be relevant  only for field trials).

Pg 32. L545. (iii) its provenance, centre(s) of origin and centre(s) of genetic diversity

Pg 33. L 573-585.  Section on “Elements for consideration regarding the intended use and the likely potential receiving environment.2

Pg 35, L-603-630. Section on  “Elements for consideration regarding the potential adverse effects resulting from the interaction between the LMO and the likely potential receiving environment.”, particularly in (m), (n), (o), (p), (r),

Pg 37. Section from step 2, starting L 662 “Elements for consideration”, the box is useful for many of the points expressed there,for example point (a), (c), (e), (f), (g), (h)

...etc.

(d) Are there examples that could be illustrative of the elements provided?

R. Here are some examples of the efforts that have been done in this subject in Mexico, in order to generate baseline information for important native crops:

• Global maize project:
http://www.biodiversidad.gob.mx/genes/proyectoMaices.html
The project database is publicly available in the left section of the web page (“base maices nativos(xlsx or mdb)” link)

• Documento: Elementos para la determinación de centros de origen y centros de diversidad genética para el caso de los maíces de México a partir de los resultados del proyecto “Recopilación, generación, actualización y análisis de información acerca de la diversidad genética de maíces nativos y sus parientes silvestres en México” (2006-2011):
http://www.biodiversidad.gob.mx/genes/pdf/proyecto/Elementos_2011_2.pdf

• Documento:  Elementos para la determinación de centros de origen y centros de diversidad  genética en general y el caso específico de la liberación experimental de maíz  transgénico al medio ambiente en México (2006):

http://www.biodiversidad.gob.mx/genes/pdf/proyecto/Elementos%202006.pdf


• Species domesticated in Mexico
http://www.biodiversidad.gob.mx/genes/otrosCentros.html

• Proyects on centres of origin and genetic diversification
http://www.biodiversidad.gob.mx/genes/centrosOrigen/proyectosCdeO.html



(d) Is there relevant guidance and/or relevant sources of information related to this topic? Please provide them;

R: you will find here an initial list of relevant public information concerning Mexico and Mesoamerica (Many of them chapters of the Capital Natural de México publication, available  in http://www.biodiversidad.gob.mx/pais/capitalNatMex.html).

Acevedo Gasman, F., et al. 2009. La bioseguridad en México y los organismos genéticamente modificados: cómo enfrentar un nuevo desafío, en Capital natural de México, vol. II : Estado de conservación y tendencias de cambio. Conabio, México, pp. 319-353. http://www.biodiversidad.gob.mx/pais/pdf/CapNatMex/Vol%20II/II07_La%20bioseguridad%20en%20Mexico%20y%20los%20organismos%20geneticame.pdf

Acevedo et al, in press. Biosafety and Environmental Releases of GM Crops in Mesoamerica: Context Does Matter. Chapter 21 in Ethnobotany of Mexico, Interactions of People and Plants in Mesoamerica.Springer

Bellon, M.R., et al. 2009. Diversidad y conservación de recursos genéticos en plantas cultivadas, en Capital natural de México, vol. II: Estado de conservación y tendencias de cambio. Conabio, México, pp. 355-382. http://www.biodiversidad.gob.mx/pais/pdf/CapNatMex/Vol%20II/II08_Diversidad%20y%20conservacion%20de%20recursos%20geneticos%20en%20pl.pdf

Perales, H.R., y J.R. Aguirre. 2008. Biodiversidad humanizada, en Capital natural de México, vol. I: Conocimiento actual de la biodiversidad. Conabio, México, pp. 565-603. http://www.biodiversidad.gob.mx/pais/pdf/CapNatMex/Vol%20I/I18_Biodivhum.pdf


Piñero, D., et al. (2008). La diversidad genética como instrumento para la conservación y el aprovechamiento de la biodiversidad: estudios en especies mexicanas, en Capital natural de México, vol. I : Conocimiento actual de la biodiversidad. Conabio, México, pp. 437-494. http://www.biodiversidad.gob.mx/pais/pdf/CapNatMex/Vol%20I/I15_Ladiversidadgen.pdf


(f) What are the existing gaps of knowledge? How would you suggest them to be tackled?

Very shortly, in terms of gaps of knowledge, information should be generated about the potential distribution of wild relatives, and intra and interspecific hybridization possibilities. The degree of information available for this issues might be very variable depending on the organisms considered (just as an example, this kind of information is lacking in many cases for GM fish)



Looking forward to read and share more comments on these subjects!
All the best
Caroline Burgeff

Dear participants of the Online Forum,
Regarding the point “LMOs introduced in centers of origin and genetic diversity “ the following comment coming from our experience in the biosafety assessment of LMOs in Italy could be useful .
The study is the following :
Ilardi V & Barba M (2002) Assessment of functional transgene flow in tomato fields. Molecular Breeding 0:  1-5.

The results show that under experimental conditions, no transgene flow was detected in cv. UC82B tomatoes in the two Italian fields tested.
Instead, another kind of risk has emerged from our work, which is seed contamination. It involves every plant regardless of the species. 
This way of transgene dissemination is important especially for LMOs introduced in centers of origin and genetic diversity.
Constant attention must be paid to avoid seed contamination during and after commercial seed production.


Best regards
Biancamaria Pietrangeli  and Vincenza Ilardi
ITALY

POSTED ON BEHALF OF PHILIP BEREANO

-----

Colleagues--I am pleased to contribute to these discussions by offering a report prepared by colleagues at Testbiotech, the Institute for Independent Impact Assessment in Biotechnology in Munich. Here are their conclusions, and a link to the whole document:

6. Conclusion and demands

There is no doubt that in the age of the “Anthropocene”, biodiversity has already been severely impacted by human activities such as those in agriculture and land use. Gene flow from transgenic organisms and/or from organisms derived from synthetic gene technologies, is adding an extra level of risk to biodiversity.

The only choice we have in dealing with these problems is to strengthen the precautionary principle. In the same way that we seek to protect ecosystems from long-lasting chemical substances that can accumulate in the environment, we should seek to protect the ecological and evolutionary integrity (Pimentel et al., 2000) of natural biodiversity by preventing the uncontrolled spread of synthetic and genetically engineered organisms in the environment.

However, current international regulatory frameworks and instruments are not sufficiently robust to effectively prevent gene flow from genetically engineered organisms to native populations. Consequently, we need much stronger regulatory tools to allow a global ban on the release of any synthetic organisms (or transgenic organisms) that cannot be controlled in their spatio-temporal dimension, especially if they have a long-term potential for spontaneous unintentional transboundary movements.

So we see an obvious pressing need for international and national political action. Starting with the recommendations made by Bauer-Panskus et al. (2013a,b), we propose establishing international regulations that will make it possible to ban any release of genetically engineered or synthetic organisms if ›› they can persist and invade the environment if they unintentionally escape their containment; ›› there are major doubts about whether they can be withdrawn from the environment within a reasonable period of time if this is so required in cases of urgency; ›› it is already known that they will persist or show invasive behaviour after release into the environment.

Further, all possible measures should be taken to prevent the transgenes which have already escaped from spreading even further. In addition, the cultivation of genetically engineered plants in regions where they can contaminate farmers’ seed saving systems should be stopped as quickly as possible to prevent farmers from unintentionally promoting the spread of the transgenes within the agroecological systems.


The full report may be accessed at https://www.testbiotech.org/sites/default/files/Testbiotech_Transgene_escape_II_en.pdf


My best regards to all of you,

Phil Bereano

***************************
Philip L. Bereano
Professor Emeritus
Technology and Public Policy
University of Washington
Seattle, Wash. 98195
***************************

Dear all,

Thank you for the opportunity to comment on the issue of LMO’s introduced into centres of origin and genetic diversity.  I would like to share a few thoughts on this topic. 

In any risk assessment, a primary question that must be addressed is, how protective must we be of a given geographical area?  Whether or not a “center” has been defined within jurisdictional boundaries does not change the need and extent to which this question must be considered.   However, the answer to this question is found in public policy i.e., protection goals. 

As a related but purely technical matter, the term “center of origin” is an empirically based theory and highly uncertain.  I strongly recommend reading pages 48 to 53 in Jack Harlan’s “Crops & Man”, second edition (American Society of Agronomy, Crop Science Society of America, Madison, WI).  Harlan points out that the center of origin and domestication may be a confusing and misleading concept.  He notes that “[t]he geography of crop variation depends a lot on the geography of human history.”  Further, more recent studies designed to test the Vavilov hypothesis (to “reliably determine the center of origin of a crop by an analysis of patterns of variation”) have failed to confirm it for a significant number of crops.  For many crops, the term “center of origin” simply does not apply as it was originally proposed.  I think the additional understanding Harlan has brought to this concept should be kept in mind as we consider the degree to which we incorporate ideas into the guidance.

I applaud the quality and extent of the scientific work that has been done in Mexico with regard to maize as pointed out in Caroline Burgeff’s comment [#7592].  These references should be readily available in the Biosafety Clearing House and through other mechanisms of information exchange.  They clearly point to the extent of care and concern Mexican authorities have shown for maize – a national treasure.  My question is whether it is prudent to expand the guidance with many details at the risk of creating confusion and reducing the usefulness of the document.  Rather, we should take care to ensure that the guidance clearly points risk assessors to ask relevant questions about the receiving environment like:  1) are there wild relatives in proximity to the release where gene flow could reasonably occur; 2) what are the likely consequence of gene flow; and 3) is there genetic diversity in the environment that must be protected.   Again, all national risk assessors must answer the question of appropriate level of environmental protection, and in so doing they account for the values of a country (protection goals).  If they approach the risk assessment in this manner, they will necessarily address the national concerns. 

Because (1) risk assessments should always ensure that a country’s environment is adequately protected, (2) the concept of center of origin is technically uncertain, and (3) it will introduce unnecessary complexity to the guidance, I do not support adding additional references on this topic in the guidance.

Dear Forum participants, Francisca and members of the Secretariat,

I agree with Caroline Burgeff on her comment [#7592] to include such a text box on subject “LMOs introduced in centers of origin and genetic diversity” and “LMOs intended for introduction into unmanaged ecosystems”. In addition, it would be relevant to include in this text box a paragraph that describes the importance of evaluating the potential impact of LMOs on the domestication processes. These processes are still present for many genetic resources within countries that are centers of origin and genetic diversity. This evaluation should be analyzed from different scale analyses. For example, from the impact on landraces and their wild relatives that the genetic construction can have per se, to the intellectual property issues that could limit seed exchange among traditional farmers.

The aforementioned should take into account that, when we are talking about any managed species, it is not possible to disregard the social, economic and cultural effects that the release of LMOs has on farmers. In the National Commission for Knowledge and Use of Biodiversity (CONABIO), cultural biodiversity is a part of the organizational levels of biodiversity, and for that reason the impact on biodiversity should include both the socioeconomic and cultural contexts.

Also, with respect to subparagraph d), I include the link of a regulatory example in Mexico, which is an agreement where the centers of origin and centers of genetic diversity of maize are determined, according to the Biosafety Law in Mexico.

Acuerdo por el que se determinan Centros de Origen y Centros de Diversidad Genética del Maíz
http://dof.gob.mx/nota_detalle_popup.php?codigo=5276453

Finally, with respect to paragraph e), I will include the following references relevant to this topic: https://www.dropbox.com/s/j39c8wnhvlwjxx2/Literature%20of%20interest%20about%20centers%20of%20origin%20and%20genetic%20diversity.pdf?dl=0

Thank you all for your attention.

Best regards,

Oswaldo Oliveros.

POSTED ON BEHALF OF SWEE LIAN TAN
-----------------------------------------------

I agree with the comments of Ms Caroline Burgeff, and would like to add to the discussion.

How is the introduction of LMOs in centres of origin and genetic diversity different from introducing "improved" non-LMOs?  For example, there is a non-LMO herbicide-resistant rice - the imidazolinone-resistant Clearfield rice.  Won't this also affect genetic diversity in the centre of origin for rice?  It is bothersome that "red" or "weedy" rice which was targeted by planting this HR rice has shown evidence of the HR gene. (Ref: Burgos, N.R., Norsworthy, J.K., Scott, R.C. and Smith, K.L. (2008).  Red rice (Oryza sativa) status after 5 years of imidazolinone-resistant rice technology in Arkansas.  Weed Technology 22: 200-208).  Yet, there is little or no risk assessment of the stringent kind used for LMOs.
Swee Lian Tan

Dears,

Thank you for the opportunity to contribute to the discussion.

Being involved in the ERA of LMPs for cultivation, I struggle to understand why a specific box should be dedicated to the issue of “centres of origin/genetic diversity”. As indicated by others, these aspects are typically considered throughout the ERA process of LMPs for cultivation via protection goals, problem formulation and the receiving environments. I therefore add my support to those who consider that such a box is redundant.

With thanks,
Yann

I'd like to once again thank the Secretariat for the opportunity to participate, and Francisca for moderating the session.

I am also very appreciative of the amount and quality of information that has been shared by Caroline Burgeff (# 7592) and by Tom Nickson (#7609).  These kind of substantive contributions really highlight the potential of an online forum.

In considering the utility of a section on LMOs introduced in centers of origin and genetic diversity, and introduction in to unmanaged ecosystems, I'm in full agreement with Tom and with Yann Devos (#7618).  These are issues primarily concerning the identification and refinement of protection goals.  The Roadmap already contains sections addressing scoping and context, problem formulation, and identifying assessment endpoints (although these sections still require a lot of work).  I don't see what could usefully be included in an additional "box" on this topic that wouldn't also be included in these sections and applicable to other environments as well. Especially being mindful of the fact that it is not the role of the AHTEG to infringe on the rights and obligations of Parties to identify their own protection goals for the conservation and sustainable use of biodiversity.

I'd also like to add recognition of the very important point brought up by Swee Lian Tan (#7612).  It has been well recognized since before the first releases of LMO plants that any risk to the environment does not come from the process of genetic engineering, but rather the product and that similar plants produced through other methods would present similar risks to the environment.  This highlights the fact that protection goals for centers of origin and genetic diversity or unmanaged ecosystems cannot be identified in a vacuum where only LMOs are considered.

Dear All,
first of all I wish to thanks Francisca for her work in moderating this forum.
I agree on how the Road Map is settled and on the described process that recall the precautionary and the case by case approach.
Here I’m trying to answer to some of the point that Francisca have kindly proposed to help the discussion on this topic, in particular related to “LMOs introduced in centres of origin and genetic diversity”:
(a) Where would each topic best be inserted in the Roadmap (Part I)?, Would it need to be mentioned somewhere else as well? Where?
R: I agree with Caroline Burgeff to insert a specific “text box” containing a synthesis of the most  relevant elements to be considered and to place this box just after the box on “attributes of the receiving environment”. Nevertheless, I think that the concepts should be recalled in different parts of the road map.

c) How would these elements be taken into consideration in the context of the framework of the Roadmap (part I)?
R: As far as My suggestion is that a reminder on this topic could be inserted in:
- page 35 line 615: when considering the potential of outcrossing and transfer of transgene to sexually compatible plants.  If the release of the LMO is in a centre of origin and  genetic diversity particular attention should be made.
- page 37. Elements for consideration, point D (“factors that may affect spread…”) and/or pag 38 (f) (“when assessing the likelihood of outcrossing…..”). Indeed the potential of a high presence of diverse sexually compatible wild and cultivated species should be taken highly into account  in case the release of the LMOs is in the centre of origin and genetic biodiversity of the recipient organism.
Furthermore, even if the importance of  centre of origin and  genetic diversity is highlighted in the rationale of step 3 of the  RA process:“An evaluation of the consequences should these adverse effects be  realized”; in my opinion the issue should be also inserted in the list of elements for consideration (page 40, point f). In case the receiving environment is centre of origin and  genetic diversity, the introgression of the transgene, following a vertical gene flow, would lead to more and  important consequences having effects on the wild genetic resource and/or germ plasm in situ collections.
A last consideration is that the topic should be considered when planning monitoring activities, i.e. on page 99, point f: “Appraisal of protected areas and centres of origin and genetic diversity or ecologically ........, particularly in the context of monitoring the presence of LMOs;” the sentence: “ and the potential introgression of trangene in germ plasm” should be added.
It is possible that the effects related to the introgression into germ plasm  can be identified only after some years (delayed and indirect effects), asking for long term and focused monitoring activities.
(d) Is there relevant guidance and/or relevant sources of information related to this topic? Please provide them;
R: An useful reference can be Engels J.M.M., Ebert  A.W., Thormann  I. and de Vicente M.C., (2006). Centres of crop diversity and/or origin, genetically modified crops and implications for plant genetic resources conservation.Genetic Resources and Crop Evolution (2006) 53:1675–1688

Thanks to every participant to the on line forum for this interesting “brain storming.

Valeria Giovannelli, PhD
ISPRA - Istituto Superiore per la Protezione e la Ricerca Ambientale
Dipartimento Difesa della Natura -  settore OGM (http://www.isprambiente.gov.it/it)

Dear all
thank you all for the very interesting discussion and the opportunity to participate in this forum.
I support Valeria Giovannelli.
(b) According to your own knowledge on the matter, what would the most relevant elements be that should be considered related to each topic (try adding them in a logical stepwise manner and not repeating what is already mentioned in the Roadmap)?
Many countries  established gene-banks and germ plasm collection to conserve the threatened genetic resources of the major cultivated crops. Adaptation and selection processes in the crop gene pools are ongoing in the centers of origin and biodiversity, especially in traditional agricultural production systems, where farmers continue to play an important role in the management and maintenance of this genetic diversity. Furthermore, it is well known that conservation in situ of the genetic diversity of wild species and wild relatives of cultivated crops is the only efficient strategy to ensure their survival for the future. As a  consequence, the conservation status of crop genetic resources cultivated or wild, either ex situ or in situ, need to be strongly took into account during RA for deliberate release of genetically modified crops into centers of origin and biodiversity.

(d) Is there relevant guidance and/or relevant sources of information related to this topic? Please provide them;
The Italian Istituto Superiore per la Protezione e la Ricerca Ambientale (ISPRA), in collaboration with Perugia University, has edited a database on wild plant species, parental of crop species (Crop Wild Relatives - CWR), listed in the FAO International Treaty on Plant Genetic Resource for Food and Agriculture (ITPGRFA). The database provide, inter alia, information on CWR present in Italy in in situ and ex situ collection , taxonomy, presence/absence in protected area, risk category (belonging to the European/Italian Red List), etc.. (project funded by the Italian Ministry of the Environment, Land and Sea Protection) http://193.206.192.106/portalino/home_it/dati.php.

Kind regards
Laura Mancini
Istituto Superiore di Sanità- Italy

Dear all, dear Francisca,

I like echo the points made by Tom Nickson(#7609), Yann Devos (#7618) and Andrew  Roberts (#37620) with respect to the requested information on “LMOs introduced in centres of origin and genetic diversity” and “LMOs intended for introduction into unmanaged ecosystems”. These aspects are typically taken into account in the protection goals and are part of the environmental risk assessment of any LMO. Instead including ‘boxes’ with extra information in the current part I of the guidance, it would be better to improve the text of part I of the guidance in general, thereby  keeping in mind that the receiving environment of the LMOs could take place in a centre of origin of in a unmanaged ecosystem.

Dear all,

I just want to agree with Dr. Yann Devos [#7618] and Boet Glandorf [#7631], an specific box is not necessary for centers of origin and genetic diversity because the particularities of a receiving environment are a intrinsically part of the risk assessment and are already captured by many Elements for Consideration presented in the Road Map.

Thank you.

Best regards,
Luciana

Dear Forum participants,

Annex III of the Cartagena Protocol includes relevant information on biological diversity and centres of origin of the likely potential receiving environment as one of the considerations for risk assessment. 

While this indeed should be an important consideration for risk assessment, the issues are not qualitatively different from those that would arise when considering any introduction of an LMO into any area that has sexually compatible wild relatives.

For the purposes of risk assessment, in areas where sexually compatible relatives exist, it is a reasonable assumption that gene flow will occur, and the assessment can turn to whether any harms will result.  Thus, gene flow inherently is not a harm. The cases cited in the document shared by Philip Bereano (#7607) therefore do not help with a useful risk assessment, since it does not consider any evidence of adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.  The management proposed is therefore not supported by a risk assessment of the type that we are supposed to be helping less experienced regulators to conduct.  To assume that gene flow, or even persistence of LMOs in the environment (centre of origin/diversity or not), is universally a harm does not allow for a case-by-case risk assessment as laid out in Annex III.

Certainly, countries that are the recognized centers of origin of a species may decide that those species require preservation or protection, as in the case of Mexico and maize.  In those cases, risk management measures could be imposed that include the prevention of gene flow into natural populations, if that is consistent with the protection goals of the country, and the risk assessment reveals that there is sufficient risk to warrant regulatory action.  This echoes a point made by Tom Nickson in his contribution (#7609).

Whether or not an LMO is introduced into a centre of origin or biological diversity (not necessarily the same thing), there are questions that should be addressed.  Good illustrations of such risk assessments can be found in the examples I have uploaded.  The issue of release into centres of biological diversity or origin would be a subset of considerations under such risk assessments, and as pointed out by Yann DeVos (#7618) and Andrew Roberts (#7620), are covered during appropriate identification of protection goals and problem formulation .  If any further guidance is required, I would suggest providing examples in addition to those I have just shared, rather than a separate box.

Finally, the considerations exemplified by the risk assessments I have shared can be extended to LMOs intended for introduction into unmanaged ecosystems, in particular those that are intended to cross with compatible relatives.  In the future, deployment of such LMOs will have far-reaching public benefits, and gene flow from LMOs into those systems will be necessary and desirable.  In those cases, the risk assessments that will be done can draw on the experience already gained from risk assessments conducted on gene flow in areas where there are sexually compatible relatives, either within centres of biological diversity or origin, or outside of those areas.

POSTED ON BEHALF OF ALEJANDRA BARRIOS PÉREZ
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Dear colleagues from the online forum, dear Francisca:

I appreciate the effort made by the Secretariat, the AHTEG and the moderator of the online forum. I agree with the comments made by Biancamaria Pietrangeli [[#7599], Caroline Burgeff  [#7592], Oswaldo Oliveros [#7611], Laura Mancini [#7629], and Valeria Giovannelli [#7626]. As part of a regulatory office responsible of the emission of biosafety, biodiversity as well as genetic resources regulatory instruments, I consider it very important for risk assessors of countries which are center of origin and center of genetic diversity to count with the necessary support elements.

I consider that counting with clear text boxes that support the evaluator around the issue of how to consider the centers of origin/diversification/domestication (or even secondary diversification areas which are not strictly considered Vavilov centers), will permit that the risks are evaluated in a holistic way. I agree with the questions posed by Caroline, these allow putting into context the importance of conservation in such areas, and including the associated diversity.

My opinion is that counting with these elements in a box in the roadmap is an additional mechanism to assist Parties in implementing the Aichi Biodiversity Targets, in particular 13 and 7 for the case of centers of origin/diversification/domestication; while for the unmanaged ecosystems, it could add to Targets 5 and 14.

Finally, I thank Oswaldo Oliveros for mentioning the Mexican experience of the legal determination of the centers of origin and of genetic diversity, which is a regulatory mechanism leading to the protection of domesticated native species and their wild relatives.

Kind regards,
Alejandra Barrios Pérez

I agree completely with the views of  Mr. Hector Quemada in this post!  Gene flow happens and it is not necessarily an 'adverse' effect. 

If there was a way to 'like' certain posts, this would be most helpful in this on-line discussion as not all submissions are within scope or are of the same scientific 'value'.

Thanks, Jim, for your suggestion (#7641).

At the moment, it is not possible to "like" or "dislike" a post, I will talk to our IT colleagues and try to implement the feature for future discussions.

Best regards,
Manoela

Dear Manoela and Jim

I understood that this discussion is for brainstorming and other discussion are for allowing views to be expressed by those who have been deemed qualified by the vetting process to be part of this forum. It is useful to read those views and allow ideas to influence thinking. I am not sure a Facebook style popularity ranking is either needed or desirable. Saying that you agree or disagree with someone has limited value without a rationale. If that rationale is an assessment of 'scientific value', for example, then that is not made explicit by clicking the 'like' or 'dislike' button, but is by presenting the argument.
While having such a provision might create greater numerical participation, I don't agree that it would necessarily result in better engagement with ideas in the forum.

Best regards,
Jack

Dear all

Many thanks for the interesting discussions on this topic.

The Cartagena Protocol on Biosafety specifically recognizes the importance of centres of origin and centres of genetic diversity, and the special needs of countries that are also such centres of origin and centres of genetic diversity. Likewise, the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), which in addition also provides legal definitions of the terms.

As such, text boxes on the issue in the Guidance would be beneficial, and several colleagues have already described in detail the elements and placing of such information, drawing from their national experiences. We would just like to further highlight one element, and that is with regard to the close inter-linkage with socio-economic considerations, particularly the contribution of farmers and indigenous peoples in such centres of origin and centres of genetic diversity, which are the basis of the recognition of farmers' rights as elaborated in the ITPGRFA.

Kind regards
Lim Li Ching
Third World Network

Dear colleagues:
I would like to start my comments by thanking all contributions to this thread.

I agree with the ideas and arguments presented by Yann Devos [#7618], Boet Glandorf  [#7631], Thomas Nickson [#7609],  Luciana Ambrozevicius [#7635] and Andrew  Roberts [#7620].  I do not see the need to add a different box to the Roadmap on centers of origin/genetic diversity. As indicated by others, these aspects are considered throughout the ERA process of LMPs for cultivation via protection goals, problem formulation, the receiving environments, the presence of sexually compatible species, etc. and all are mentioned already in the different steps of the Roadmap. Caroline [#7592], pointed out all the sections/lines of the text where the Roadmap makes references to elements that will be considered when assessing a LMP in its center of origin/diversity, and those are not the only ones. An additional box will be repeating what is already mentioned in the Roadmap and extra redundancy will be confusing.

In my opinion what the available text needs is work to present these considerations in a more logical way. For example getting rid of text that is confusing: in line 391when presenting an example of environmental exposure using “whether it is for import only” leads to the question on why to trigger an environmental risk assessment for the intentional release of an LMO if it is only for importation?.  The example there could be “whether the potential receiving environment has sexually compatible species”.

I also want to say that I really appreciate Hector Quemada’s comments, and encourage the Secretariat to explore the possibility to have the proposed “like” feature. I know for certain that many participants (including myself)  for whom English is not our mother language will feel a bit more encouraged to get involved in the discussions by showing agreement with arguments in an easy way.

My last comment  for now deals with the use of the term “contamination” when referring to gene flow. We all know that gene flow happens, it is a natural process and it is not an 'adverse' effect per se. In the context of an ERA it is part of the exposure step, once it happens to a certain level there is step 3 to evaluate and look into its consequences, and those would depend on the case. "The careless use of the term 'contamination', particularly if there is no evidence of harmful consequences associated [with the occurrence of gene flow or] with the presence of transgenes, can actually contribute to genetic erosion". I will not elaborate more on this point but just invite those interested, to look into a paper by Mauricio Bellon and Julian Berthaud 2006 attached to this post ,where they mentioned those unwanted consequences ten years ago.

Dear colleagues, dear Francisca:
We thank the Secretariat for the opportunity to contribute to this forum and Francisca for taking the task of moderating it and encouraging participation.
We agree with previous comments from Martin Lema (#7582) Boet Glandorf (#7585), Maria (#7593), Dr. Werner Schenkel (7600), and Dr. Andrew Roberts (#7622). In Mexico, as in several regulatory systems worldwide, the impact of herbicides is assessed separately from LMOs. Hence, we agree that there is no need, neither practical nor as regards to content issues, to include a separated box for the assessment of herbicide safety in the existing guidance. Since resources are limited this would represent unwanted repetition.
Some issues mentioned are already considered in the text of the Roadmap (lines 601, 627 and 845) and there is no need for an extra box of text. Thanks

Dear all,

Following my earlier comment, we all agree it is in the best interest of inexperienced regulators to keep the guide as simple as possible, so it is useful and practical. Thus, I  support the statements by Yann Devos (#7618) and others (#7631, #7609, #37620, #7637) that  extra boxes are not required for this topic, since relevant questions regarding the  introduction of an LMO in a center of origin,  is adequately dealt with in the protection goals and problem formulation stage.

I also strongly agree with Sol (#7655 ) and Hector (#7637) that the term  “contamination” when referring to gene flow, is not biologically appropriate  and should be avoided, as it is laden with negative connotations that will cause  bias  in an inexperienced  risk assessor, not necessarily familiar with  evolutionary dynamics of genetic drift and selection, or with pathogenic processes caused by toxicity. Gene flow is a natural process and an engine of evolution and it is inherently not a harm, as Hector already pointed out.

In my experience in Mesoamerica, many take for granted that the introduction of GM maize in this region - center of origin and diversification of maize -  will result in a diminished genetic diversity of the landraces, or even  in the disappearance of some landraces. When questioned “why”, they wrongly assume that the genes from the GM pollen or seed (eg. insect or herbicide resistant), will be somehow toxic or pathogenic to the native varities. 

In the bibliography section of this message, I have  posted a paragraph of a useful paper that explains this natural phenomenon rather well:

Mercer, K.L., Wainwright, J.D., Gene flow from transgenic maize to landraces in Mexico: An analysis, Agric. Ecosyst. Environ. (2007), doi:10.1016/j.agee.2007.05.007
http://www.biosci.ohio-state.edu/~asnowlab/Mercer_Wainwright07.pdf

One commentator (#7611) rightly pointed out that it is not possible or prudent  to disregard  the social, economic or cultural effects that the release of GM maize may have in Mesoamerica (Mexico and Central America). Many have attempted to answer  these very important questions with speculative scenarios and using "expected data" instead of "observed data". No observed data can be generated until commercial GM maize can been released in Mexico to allow this data generation.

The Government of  Honduras, in Mesoamerica and also a center of diversification and with strong cultural and religious links to maize, introduced GM maize for commercial cultivation in 2003 after carefully considering the benefits and possible adverse effects. I share a recent  publication  that explores socio-economic issues of small farmer´s adoption of GM crops around the world that includes a chapter of the Honduran experience, where observed data was collected from 12 years after commercial release.

Interestingly, a strong cause of biodiversity loss in  maize landraces in Mesoamerica is not gene flow from GM varieties, but rather farmer´s practices  (Bellon & Berthaud, 2004). In many circumstances, farmers abandon their low-yielding  traditional varieties, in favor of an improved conventional  hybrid or GM variety, or more commonly, they abandon agriculture altogether to move to urban  areas and/or migrate to North America.  Local varieties disappear when farmers stop cultivating them for whatever reason. Maize was domesticated more than 10,000 years ago and cannot become feral or an invasive species if abandoned by man.  Unlike many plant species, maize is totally dependent on human intervention and without careful care by a farmer, maize is unable to propagate and survive in an ecosystem.

In the section below, I contribute bibliography that may be useful as further sources of references.

Best regards,

Maria

Bibliography related to introduction of  maize in a center of origin or genetic diversification  (Mexico and Honduras)


Falck-Zepeda, J; Zambrano, P; McLean, D; Sanders, A; Roca, C; Chi-Ham, C; Bennett, A. (2015). Honduras and Bt/HT maize – a small country model for GM crop 106 adoption?. In Mitton, P. and Bennett, D. (eds.) 2015. Analyses: Africa’s Future ...
Can Biosciences Contribute? Banson/B4FA.

Raven, Peter H. Transgenes  in Mexican maize: Desirability or inevitability? Proc. National Acad. Sci. 102 ( 37): 13003-13004
http://www.pnas.org/content/102/37/13003.full?ck=nck

Bellon, M. R & Berthaud: Transgenic maize and the evolution of landraces diversity in Mexico. The importance of farmer´s behavior. Plant Physiology, March 2004, Vl.134, pp.883-888

Ortiz-Garcı´a, S., Ezcurra, E., Schoel, B., Acevedo, F., Sobero´n, J., Snow, A.A., 2005a. Absence of detectable transgenes in local landraces of maize in Oaxaca, Mexico (2003–2004). Proc. Natl. Acad. Sci. U.S.A. 102, 12338–12343.

Ortiz-Garcı´a, S., Ezcurra, E., Schoel, B., Acevedo, F., Sobero´n, J., Snow, A.A., 2005b. Correction. Proc. Natl. Acad. Sci. U.S.A. 102, 18242. Ortiz-Garcı´a, S., Ezcurra, E., Schoel, B., Acevedo, F., Sobero´n, J., Snow, A.A., 2005c. Reply to Cleveland et al.’s critique of ‘Absence of detectable transgenes in local landraces of maize in Oaxaca, Mexico (2003–2004)’ Environ. Biosaf. Res. 4, 209–215.

Ortiz-Garcı´a, S., Ezcurra, E., Schoel, B., Acevedo, F., Sobero´n, J., Snow, A.A., 2006. Transgenic maize in Mexico. Bioscience 56, 709.

Mercer, K.L., Wainwright, J.D., Gene flow from transgenic maize to landraces in Mexico: An analysis, Agric. Ecosyst. Environ. (2007), doi:10.1016/j.agee.2007.05.007
http://www.biosci.ohio-state.edu/~asnowlab/Mercer_Wainwright07.pdf

"If transgenes are introduced into a population via hybridization or seed-mediated gene flow, transgenes introgression into the landrace population depends primarily on two evolutionary forces: genetic drift and selection. The random process of drift can result in the loss or fixation of transgenes due to sampling effects, especially in smaller populations (Ellstrand and Elam, 1993). On the other hand, the impact of selection on introgression will depend on how the transgene and other genes linked to it (physically or pleiotropically) influence plant survival, plant health, and pollen and seed production (i.e., lifetime fitness). If the survival, health, or yield of individual transgenic plants is compromised, seeds containing transgenes will be less likely to be selected by the farmer to plant the subsequent year’s crop. If the transgene, and genes linked to it, reduce fitness, then transgenes should decline in frequency or be lost. By contrast, if these genes increase fitness, then the frequency of transgenes will increase over time, ultimately leading to adaptive introgression (Whitney et al., 2006). Transgenes encoding herbicide or insect resistance are not expected to increase fitness in the absence of the herbicide or insect pest, but may or may not confer a cost (Bergelson and Purrington, 1996; Snow et al., 1999, 2003). Also, the non-transgenic segments of the genetic background of a transgenic plant may have significant negative effects on fitness since transgenic maize is bred for the agroecological conditions of the US maize belt, which differ from southern Mexico" (Mercer & Wainwright, 2007).

Thanks to all for the excellent discussion. I would like to strongly support Yann that the addition of an extra box would be redundant but I would add also confusing as the considerations of release into a centre of origin are captured explicitly throughout the ERA.

As Swee Lian Tan has accurately pointed out the Clearfield and similar herbicide tolerant crops have been released into centres of diversity without concerns being raised. Canada has conducted ERAs on some of the Clearfiled products as in some cases these crops will trigger the need for a pre-market risk assessment. North America is a centre of diversity for sunflower (Helianthus) yet  Canada  found no need for additional steps and approached the ERA on the Cleafield herbicide tolerant sunflower with the same structure and  using the same considerations. Potential pathways such as gene flow to related species and the consequences, the effects on weed population, effects on biodiversity etc. are considered just as they are in any ERA.

Thanks to all of you for the good discussion and the opporunity to reply here.
I totaly agree with Caroline Burgeff and Valeria Giovanelli concerning the text  box that should consider the centres of origin and the list of elements that Caroline provided. I also agree with Lim Li that it is necessary to consider the effects on farmers and indigenous people.
In my opinion there are two more points to consider:
- What is the effect of an outcrossing on protected plants animals and habitats.
- Why are the regions important for biodiversity.
Concerning the question on ecological damage or environmental damage. The following publication helps defining damage and the use of indicators to assess potential damage.  They are especially helpful  for the definition of environmental damage in centres of origin or in unmanaged ecosystems. 
Heink, U., Bartz,R., Kowarik, I., 2010:  How Useful are the Concepts of Familiarity, Biological Integrity, and Ecosystem Health for Evaluating Damages by GM Crops? Journal of Agricultural and Environmental Ethics, Volume 25, Issue 1, pp 3-17
Abstract
In the discussion about consequences of the release of genetically modified (GM) crops, the meaning of the term “environmental damage” is difficult to pin down. We discuss some established concepts and criteria for understanding and evaluating such damages. Focusing on the concepts of familiarity, biological integrity, and ecosystem health, we argue that, for the most part, these concepts are highly ambiguous. While environmental damage is mostly understood as significant adverse effects on conservation resources, these concepts may not relate directly to effects on tangible natural resources but rather to parameters of land use or ecological processes (e.g., the concept of biological integrity). We stress the importance of disclosing the normative assumptions underlying damage concepts and procedures for the evaluation of damages by GM crops. A conceptualization of environmental damage should precede its operationalization. We recommend an unambiguous definition for damage developed earlier and recommend that evaluation criteria be based on this. However, a general damage definition cannot replace case-specific operationalization of damage, which remains an important future challenge.
Bartz, R., Heink, U., Kowarik, I., 2009:  Proposed Definition of Environmental Damage Illustrated by the Cases of Genetically Modified Crops and Invasive Species,  Conservation Biology, Volume 24, No. 3, pp 675-681
Abstract:
The introduction of non-native plant species and the release of genetically modified (GM) crops can induce environmental changes at gene to ecosystem levels. Regulatory frameworks such as the Convention on Biological Diversity or the EU Deliberate Release Directive aim to prevent environmental damage but do not define the term. Although ecologists and conservationists often refer to environmental effects of GM crops or invasive species as damage, most authors do not disclose their normative assumptions or explain why some environmental impacts are regarded as detrimental and others are not. Thus far, a concise definition of environmental damage is missing and is necessary for a transparent assessment of environmental effects or risks. Therefore, we suggest defining environmental damage as a significant adverse effect on a biotic or abiotic conservation resource (i.e., a biotic or abiotic natural resource that is protected by conservational or environmental legislation) that has an impact on the value of the conservation resource, the conservation
resource as an ecosystem component, or the sustainable use of the conservation resource. This definition relies on three normative assumptions: only concrete effects on a conservation resource can be damages; only adverse effects that lead to a decrease in the value of the conservation resource can be damages; and only significant adverse effects constitute damage to a conservation resource. Applying this definition within the framework of environmental risk assessment requires further normative determinations, for example, selection of a threshold to distinguish between adverse and significant adverse effects and approaches for assessing the environmental value of conservation resources. Such determinations, however, are not part of the definition of environmental damage. Rather they are part of the definition’s operationalization through assessment procedures, which must be grounded in a comprehensible definition of environmental damage.
Kowarik, I., Bartz, R. und Heink, U. (2008) Bewertung "ökologischer Schäden" infolge des Anbaus gentechnisch veränderter Organismen in der Landwirtschaft, Naturschutz und Biologische Vielfalt 56, Bonn-Bad Godesberg.
regards Birgit